Nocturnal Hot Flashes and Alzheimer’s Risk

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Changed
Wed, 05/15/2024 - 11:10

In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).

Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.

A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.

Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.

The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
 

Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.

A version of this article appeared on Medscape.com.

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In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).

Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.

A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.

Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.

The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
 

Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.

A version of this article appeared on Medscape.com.

In a recent article in the American Journal of Obstetrics & Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menopause’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).

Hot flashes are known to be associated with changes in brain white matter, carotid atherosclerosis, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of Alzheimer’s disease biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.

A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.

Previous research has found that menopausal hormone therapy is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who initiate hormone therapy in their late perimenopausal or early postmenopausal years and continue such therapy long term.

The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.
 

Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.

A version of this article appeared on Medscape.com.

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KAUNITZ, MD</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>In a recent article in the American Journal of Obstetrics &amp; Gynecology, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of menop</metaDescription> <articlePDF/> <teaserImage/> <teaser>Study results provide further evidence to support the possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.</teaser> <title>Nocturnal Hot Flashes and Alzheimer’s Risk</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>nr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Neurology Reviews</journalTitle> <journalFullTitle>Neurology Reviews</journalFullTitle> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> </publications_g> <publications> <term>15</term> <term>21</term> <term canonical="true">23</term> <term>22</term> </publications> <sections> <term canonical="true">52</term> </sections> <topics> <term>206</term> <term>215</term> <term>322</term> <term>180</term> <term>296</term> <term canonical="true">247</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Nocturnal Hot Flashes and Alzheimer’s Risk</title> <deck/> </itemMeta> <itemContent> <p>In a <span class="Hyperlink"><a href="https://www.ajog.org/article/S0002-9378(23)00804-9/abstract">recent article</a></span> in the <span class="Emphasis">American Journal of Obstetrics &amp; Gynecology</span>, Rebecca C. Thurston, PhD, and Pauline Maki, PhD, leading scientists in the area of <span class="Hyperlink">menopause</span>’s impact on brain function, presented data from their assessment of 248 late perimenopausal and postmenopausal women who reported hot flashes, also known as vasomotor symptoms (VMS).</p> <p>Hot flashes are known to be associated with changes in brain white matter, carotid <span class="Hyperlink">atherosclerosis</span>, brain function, and memory. Dr. Thurston and colleagues objectively measured VMS over 24 hours, using skin conductance monitoring. Plasma concentrations of <span class="Hyperlink">Alzheimer’s disease</span> biomarkers, including the amyloid beta 42–to–amyloid beta 40 ratio, were assessed. The mean age of study participants was 59 years, and they experienced a mean of five objective VMS daily.<br/><br/>A key finding was that VMS, particularly those occurring during sleep, were associated with a significantly lower amyloid beta 42–to–beta 40 ratio. This finding suggests that nighttime VMS may be a marker of risk for Alzheimer’s disease.<br/><br/><span class="Hyperlink"><a href="https://mayoclinic.elsevierpure.com/en/publications/early-postmenopausal-transdermal-17%CE%B2-estradiol-therapy-and-amyloi">Previous research</a></span> has found that <span class="Hyperlink">menopausal hormone therapy</span> is associated with favorable changes in Alzheimer’s disease biomarkers. Likewise, large observational studies have shown a lower incidence of Alzheimer’s disease among women who <span class="Hyperlink"><a href="https://www.neurology.org/doi/10.1212/WNL.0b013e318271f823?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub%20%200pubmed">initiate hormone therapy in their late perimenopausal or early postmenopausal years</a></span> and <span class="Hyperlink"><a href="https://www.neurology.org/doi/10.1212/WNL.0000000000003696?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub%20%200pubmed">continue such therapy long term</a></span>.<br/><br/>The findings of this important study by Thurston and colleagues provide further evidence to support the tantalizing possibility that agents that reduce nighttime hot flashes (including hormone therapy) may lower the subsequent incidence of Alzheimer’s disease in high-risk women.<br/><br/></p> <p> <em>Dr. Kaunitz is a tenured professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine–Jacksonville, and medical director and director of menopause and gynecologic ultrasound services at the University of Florida Southside Women’s Health, Jacksonville. He disclosed ties to Sumitomo Pharma America, Mithra, Viatris, Bayer, Merck, Mylan (Viatris), and UpToDate.</em> </p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/nocturnal-hot-flashes-and-alzheimers-risk-2024a100083x">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Traffic Noise Negatively Impacts Health

Article Type
Changed
Mon, 05/13/2024 - 14:49

 

New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results were published in Circulation Research.

Morbidity and Mortality

Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain. These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.

Consequences and Pathomechanisms

In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.

The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.

Confirmed Cardiovascular Risk Factor

“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”

Heart Attack Outcomes

Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results were published last year in Cardiovascular Research. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.

The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.

The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.

 

 

Clinical Confirmation

These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”

Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; P = .0053).

The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.

Mental Health Effects

Traffic noise also may be associated with an increased risk for depression and anxiety disorders, as reported 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.

Depression Risk Doubled

Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.

Fine Particulate Matter

According to an evaluation of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results were published in Circulation Research.

Morbidity and Mortality

Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain. These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.

Consequences and Pathomechanisms

In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.

The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.

Confirmed Cardiovascular Risk Factor

“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”

Heart Attack Outcomes

Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results were published last year in Cardiovascular Research. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.

The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.

The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.

 

 

Clinical Confirmation

These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”

Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; P = .0053).

The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.

Mental Health Effects

Traffic noise also may be associated with an increased risk for depression and anxiety disorders, as reported 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.

Depression Risk Doubled

Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.

Fine Particulate Matter

According to an evaluation of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results were published in Circulation Research.

Morbidity and Mortality

Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain. These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.

Consequences and Pathomechanisms

In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.

The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.

Confirmed Cardiovascular Risk Factor

“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”

Heart Attack Outcomes

Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results were published last year in Cardiovascular Research. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.

The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.

The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.

 

 

Clinical Confirmation

These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”

Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; P = .0053).

The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.

Mental Health Effects

Traffic noise also may be associated with an increased risk for depression and anxiety disorders, as reported 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.

Depression Risk Doubled

Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.

Fine Particulate Matter

According to an evaluation of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”

This story was translated from Univadis Germany, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168051</fileName> <TBEID>0C0500FF.SIG</TBEID> <TBUniqueIdentifier>MD_0C0500FF</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240513T144508</QCDate> <firstPublished>20240513T144533</firstPublished> <LastPublished>20240513T144533</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240513T144532</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Thomas Kron, MD</byline> <bylineText>THOMAS KRON, MD</bylineText> <bylineFull>THOMAS KRON, MD</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nightt</metaDescription> <articlePDF/> <teaserImage/> <teaser>Traffic-related noise can lead to sleep fragmentation, increased stress hormone levels, and oxidative stress.</teaser> <title>Traffic Noise Negatively Impacts Health</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>nr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Neurology Reviews</journalTitle> <journalFullTitle>Neurology Reviews</journalFullTitle> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">5</term> <term>6</term> <term>21</term> <term>15</term> <term>9</term> <term>22</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>301</term> <term canonical="true">224</term> <term>194</term> <term>296</term> <term>202</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Traffic Noise Negatively Impacts Health</title> <deck/> </itemMeta> <itemContent> <p>New research by Thomas Münzel, MD, senior professor of cardiology at Johannes Gutenberg University Mainz in Mainz, Germany, and colleagues again emphasized the harmful effects of noise on the heart and blood vessels. An analysis of current epidemiologic data provided strong indications that transportation noise is closely related to cardiovascular and cerebrovascular diseases, according to a statement on the data analysis. The results <a href="https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.123.323584">were published</a> in <em>Circulation Research</em>.</p> <h2>Morbidity and Mortality</h2> <p>Epidemiologic studies have shown that road, rail, or air traffic noise increases the risk for cardiovascular morbidity and mortality, with strong evidence for ischemic heart disease, heart failure, and stroke, according to the scientists. <span class="tag metaDescription">The World Health Organization reported that at least 1.6 million healthy life years are lost annually in Western Europe because of traffic-related noise. Nighttime traffic noise leads to sleep fragmentation and shortening, an increase in stress hormone levels, and increased oxidative stress in the vessels and brain.</span> These factors could favor vascular (endothelial) dysfunction, inflammation, and hypertension, thereby increasing cardiovascular risk.</p> <h2>Consequences and Pathomechanisms</h2> <p>In the current publication, the authors provided an overview of epidemiologic research on the effects of transportation noise on cardiovascular risk factors and diseases, discussed mechanistic insights from the latest clinical and experimental studies, and proposed new risk markers to address noise-induced cardiovascular effects in the general population. An integrated analysis in the article demonstrated that for every 10 dB(A) increase, the risk for cardiovascular diseases such as heart attack, stroke, and heart failure significantly increases by 3.2%.</p> <p>The authors also explained the possible effects of noise on changes in gene networks, epigenetic pathways, circadian rhythms, signal transmission along the neuronal-cardiovascular axis, oxidative stress, inflammation, and metabolism. Finally, current and future noise protection strategies are described, and the existing evidence on noise as a cardiovascular risk factor is discussed.</p> <h2>Confirmed Cardiovascular Risk Factor</h2> <p>“As an increasing proportion of the population is exposed to harmful traffic noise, efforts to reduce noise and laws for noise reduction are of great importance for future public health,” said Dr. Münzel. “It is also important for us that due to the strong evidence, traffic noise is finally recognized as a risk factor for cardiovascular diseases.”</p> <h2>Heart Attack Outcomes</h2> <p>Dr. Münzel and other researchers from Mainz have been studying the cardiovascular consequences of air pollution and traffic noise for several years. For example, they found that heart attacks in people and animals exposed to high noise levels earlier in life healed poorly. These results <a href="https://academic.oup.com/cardiovascres/article/119/6/1416/7005408?login=false">were published</a> last year in <em>Cardiovascular Research</em>. According to the authors, the findings suggest that traffic noise may play a significant role in the development and course of coronary heart disease, such as after a heart attack.</p> <p>The scientists initially found in animal experiments that exposure to aircraft noise for 4 days led to increased inflammation in the vessels. Compared with mice not exposed to aircraft noise, the noise-exposed animals showed an increase in free radicals; these animals exhibited a significant inflammatory response and had impaired vessel function.<br/><br/>The researchers explained that the experimental data showed aircraft noise alone triggers a proinflammatory transcription program that promotes the infiltration of immune cells into cardiovascular tissue in animals with acute myocardial infarction. They noted an increased infiltration of CD45+ cells into the vessels and heart, dominated by neutrophils in vessel tissue and Ly6Chigh monocytes in heart tissue. This infiltration creates a proinflammatory milieu that adversely affects the outcome after myocardial infarction by predisposing the heart tissue to greater ischemic damage and functional impairment. Exposure of animals to aircraft noise before induction of myocardial infarction by left anterior descending (LAD) coronary artery ligation impaired left ventricular function and increased infarct size after cardiac ischemia. In addition, noise exposure exacerbated infarct-induced endothelial dysfunction of peripheral vessels as early as 24 hours after LAD ligation.</p> <h2>Clinical Confirmation</h2> <p>These experimental results were confirmed by observations in the population-based Gutenberg Health Study. The researchers analyzed data from 100 patients with heart attack. The lead and senior authors of the study Michael Molitor, MD, and Philip Wenzel, MD, of the University of Mainz, explained, “From our studies, we have learned that exposure to aircraft noise before a heart attack significantly amplifies subsequent cardiovascular inflammation and exacerbates ischemic heart failure, which is favored by inflammation-promoting vascular conditioning. Our translational results show that people who have been exposed to noise in the past have a worse course if they experience a heart attack later in life.”</p> <p>Study participants who had experienced a heart attack in their medical history had elevated levels of C-reactive protein if they had been exposed to aircraft noise in the past and subsequently developed noise annoyance reactions (0.305 vs 1.5; P = .0094). In addition, left ventricular ejection fraction in these patients after a heart attack was worse than that in patients with infarction without noise exposure in their medical history (62.5 vs 65.6; <em>P</em> = .0053).<br/><br/>The results suggest that measures to reduce environmental noise could help improve the clinical outcomes of heart attack patients, according to the authors.</p> <h2>Mental Health Effects</h2> <p>Traffic noise also may be associated with an increased risk for depression and anxiety disorders, <a href="https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-1546-7419">as reported</a> 2 years ago by the German Society for Psychosomatic Medicine and Medical Psychotherapy. Evolution has programmed the human organism to perceive noises as indicators of potential sources of danger — even during sleep. “Noise puts the body on alert,” explained Manfred E. Beutel, MD, director of the Clinic for Psychosomatic Medicine and Psychotherapy at the University of Mainz. As a result, the autonomic nervous system activates stress hormones such as adrenaline and cortisol, leading to an increase in heart rate and blood pressure. If noise becomes chronic, chronic diseases can develop. “Indeed, observational and experimental studies have shown that persistent noise annoyance promotes incident hypertension, cardiovascular diseases, and type 2 diabetes,” said Dr. Beutel.</p> <h2>Depression Risk Doubled</h2> <p>Among the negative effects of noise annoyance are also mental illnesses, as has become increasingly clear. “Noise annoyance disrupts daily activities and interferes with feelings and thoughts, sleep, and recovery,” said Dr. Beutel. The interruptions trigger negative emotional reactions such as anger, distress, exhaustion, flight impulses, and stress symptoms. “Such conditions promote the development of depression over time,” said Dr. Beutel. This observation was confirmed by the large-scale Gutenberg Health Study using the example of the Mainz population, which suffers to a large extent from noise annoyance because of the nearby Frankfurt Airport. “With increasing noise annoyance, the rates of depression and anxiety disorders steadily increased, until the risks eventually doubled with extreme annoyance,” said Dr. Beutel. Other studies point in the same direction. For example, a meta-analysis found a 12% increase in the risk for depression per 10-dB increase in noise. Another study found an association between nocturnal noise annoyance and the use of antidepressants.</p> <h2>Fine Particulate Matter</h2> <p>According to <a href="https://academic.oup.com/eurpub/article/30/3/487/5731324?login=false">an evaluation</a> of the Gutenberg Study, people perceive noise annoyance from aircraft noise as the most pronounced, followed by road, neighborhood, industrial, and railway noise. Noise occurs most frequently in urban areas that also produce air pollution such as fine particulate matter. “Fine particulate matter is also suspected of promoting anxiety and depression,” said Dr. Beutel, “because the small particles of fine particulate matter can enter the bloodstream and trigger inflammatory processes there, which in turn are closely related to depression.”</p> <p> <em>This story was translated from <a href="https://www.univadis.de/viewarticle/erneutes-pl%25C3%25A4doyer-f%25C3%25BCr-mehr-schutz-vor-2024a100086m">Univadis Germany</a>, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/data-underscore-negative-health-effects-traffic-noise-2024a1000915">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

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Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167957</fileName> <TBEID>0C04FF2C.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FF2C</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240507T155610</QCDate> <firstPublished>20240507T163825</firstPublished> <LastPublished>20240507T163825</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240507T163825</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Yash B. Shah</byline> <bylineText>YASH B. SHAH; ROBERT D. GLATTER, MD; AND PETER J. PAPADAKOS, MD</bylineText> <bylineFull>YASH B. SHAH; ROBERT D. GLATTER, MD; AND PETER J. PAPADAKOS, MD</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have conce</metaDescription> <articlePDF/> <teaserImage/> <teaser>Eli Lilly to prescribe GLP-1 RAs through its own telehealth platform, and Rx shipped directly to patients.</teaser> <title>From Pharma’s Factories Direct to You</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">34</term> <term>15</term> <term>21</term> <term>6</term> <term>5</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">205</term> <term>261</term> <term>296</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>From Pharma’s Factories Direct to You</title> <deck/> </itemMeta> <itemContent> <p>Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a <span class="Hyperlink">glucagon</span>-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers <span class="Hyperlink"><a href="https://www.medscape.com/s/viewarticle/eli-lilly-offers-obesity-drug-directly-consumers-2024a10000fl">on a platform</a></span> managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. </p> <p>This arrangement raises serious concerns about an inherent conflict of interest, as we <span class="Hyperlink"><a href="https://time.com/6266695/direct-to-consumer-advertising-harm-patients/">previously discussed.</a></span> What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? <span class="tag metaDescription">Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?</span><br/><br/>Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow <span class="Hyperlink"><a href="https://time.com/6266695/direct-to-consumer-advertising-harm-patients/">DTC advertising of prescription drugs,</a></span> and the explosion in demand for GLP-1 RAs is partly attributable to this model (<span class="Hyperlink"><a href="https://www.ozempic.com/lifestyle-tips/story-behind-ozempic-song.html">Oh, oh, Ozempic, anyone?).</a></span> Americans spent <span class="Hyperlink"><a href="https://blog.marketresearch.com/71-billion-u.s.-weight-loss-market-pivots-to-survive-pandemic">over $78 billion</a></span> on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.<br/><br/>LillyDirect, which in addition to Zepbound offers <span class="Hyperlink">migraine</span> medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.<br/><br/>On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? <br/><br/>Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.<br/><br/>Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.<br/><br/>Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by <span class="Hyperlink"><a href="https://www.reuters.com/business/healthcare-pharmaceuticals/some-doses-lillys-zepbound-short-supply-through-april-end-us-fda-says-2024-04-03/">supply chain and manufacturing issues</a></span>, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. <br/><br/>Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a <span class="Hyperlink"><a href="https://www.pharmexec.com/view/2022-prescription-trends">352% increase</a></span> in 2023.<br/><br/>These drugs have shown great promise and are generally safe when used in the right patient, but important <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2790398">contraindications</a></span> exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.<br/><br/>The American College of Physicians cautioned against such prescribing practices in a recent position <span class="Hyperlink"><a href="https://www.acponline.org/acp-newsroom/internal-medicine-physicians-concerned-by-direct-to-consumer-pharmaceutical-sales-of-prescription">statement</a></span>, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where <span class="Hyperlink">obesity</span>, lack of insurance, and low health literacy are more common. <br/><br/>But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. <br/><br/>Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. <br/><br/>Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.</p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/pharmas-factories-direct-you-2024a10008be">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Home ventilation consult

Article Type
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Wed, 05/08/2024 - 10:58

Specialist input on a sudden shift in device availability

Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators.

For years, Respironics devices have been broadly used in the world of sleep medicine and chronic respiratory failure; thus, this announcement has significantly impacted clinical management options for clinicians engaged in the care of individuals on home ventilation. There are many unknowns and uncertainties about how to proceed with care for patients requiring these devices. So we gathered an expert panel of clinicians from CHEST’s Home-Based Mechanical Ventilation and Neuromuscular Section within the Sleep Medicine Network to explain the current situation and offer suggestions on moving forward in caring for these patients.
 

Why is this happening?

vethidreprewrojubrisluspaceslawiwidujelafrelopabrepripathosaspelujenisheuashev
Dr. John M. Coleman III


John M. Coleman III, MD, FCCP: To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm.

Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO.

Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories.
 

What devices does this apply to?

baguphujuslijumobuspostokodraspuloprujutrivuwumugiclimotuhestamicrastechidritrohuwrugakachiricuredroslusworikonifruchiwocladredibamemosweswisheslechoclulochiwehubrukicrowrudro
Dr. Jason Ackrivo


Jason Ackrivo, MD: This notice affects the devices shown in Table 1. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks.

shujaweclokepidrostifrumaclispojusacrebracubuwrihamutritapimadrubrewroframelophaspuphestogishuwoslekuthibahiduchemawradritracluclesluvilakuslajusauushekacreraswuphoclobrevicafrivuhobraslogacriuewrunuspedipudrauivavoviruhegopresos

 

What are my options for home mechanical ventilators?

Lussier_Bethany_L_web.jpg
Dr. Bethany L. Lussier


Bethany L. Lussier, MD, FCCP: In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode.

How are these alternative devices similar to and different from the Trilogy EVO?

Dr. Ackrivo:All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO2 monitoring (both TcCO2 and EtCO2).

All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (Table 2). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode.

travasputhuwraphestamastephuveclacledrubrabrumajikeph


Unique ventilator characteristics are shown in Table 2. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy.
 

I just provided my patient with a Trilogy EVO. Do I need to change this immediately?

Dr. Coleman: No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.

For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (Table 1). Refer to the Philips Respironics Sleep & Respiratory Product Portfolio Changes website for the most up-to-date information.
 

I have a patient on AVAPS, and I must change to iVAPS. What now?

Dr. Lussier: As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved.

What will happen to Philips Respironics’ cloud patient data?

Dr. Lussier: Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads.

----------

The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation.
 

John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.

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Specialist input on a sudden shift in device availability

Specialist input on a sudden shift in device availability

Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators.

For years, Respironics devices have been broadly used in the world of sleep medicine and chronic respiratory failure; thus, this announcement has significantly impacted clinical management options for clinicians engaged in the care of individuals on home ventilation. There are many unknowns and uncertainties about how to proceed with care for patients requiring these devices. So we gathered an expert panel of clinicians from CHEST’s Home-Based Mechanical Ventilation and Neuromuscular Section within the Sleep Medicine Network to explain the current situation and offer suggestions on moving forward in caring for these patients.
 

Why is this happening?

vethidreprewrojubrisluspaceslawiwidujelafrelopabrepripathosaspelujenisheuashev
Dr. John M. Coleman III


John M. Coleman III, MD, FCCP: To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm.

Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO.

Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories.
 

What devices does this apply to?

baguphujuslijumobuspostokodraspuloprujutrivuwumugiclimotuhestamicrastechidritrohuwrugakachiricuredroslusworikonifruchiwocladredibamemosweswisheslechoclulochiwehubrukicrowrudro
Dr. Jason Ackrivo


Jason Ackrivo, MD: This notice affects the devices shown in Table 1. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks.

shujaweclokepidrostifrumaclispojusacrebracubuwrihamutritapimadrubrewroframelophaspuphestogishuwoslekuthibahiduchemawradritracluclesluvilakuslajusauushekacreraswuphoclobrevicafrivuhobraslogacriuewrunuspedipudrauivavoviruhegopresos

 

What are my options for home mechanical ventilators?

Lussier_Bethany_L_web.jpg
Dr. Bethany L. Lussier


Bethany L. Lussier, MD, FCCP: In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode.

How are these alternative devices similar to and different from the Trilogy EVO?

Dr. Ackrivo:All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO2 monitoring (both TcCO2 and EtCO2).

All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (Table 2). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode.

travasputhuwraphestamastephuveclacledrubrabrumajikeph


Unique ventilator characteristics are shown in Table 2. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy.
 

I just provided my patient with a Trilogy EVO. Do I need to change this immediately?

Dr. Coleman: No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.

For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (Table 1). Refer to the Philips Respironics Sleep & Respiratory Product Portfolio Changes website for the most up-to-date information.
 

I have a patient on AVAPS, and I must change to iVAPS. What now?

Dr. Lussier: As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved.

What will happen to Philips Respironics’ cloud patient data?

Dr. Lussier: Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads.

----------

The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation.
 

John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.

Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators.

For years, Respironics devices have been broadly used in the world of sleep medicine and chronic respiratory failure; thus, this announcement has significantly impacted clinical management options for clinicians engaged in the care of individuals on home ventilation. There are many unknowns and uncertainties about how to proceed with care for patients requiring these devices. So we gathered an expert panel of clinicians from CHEST’s Home-Based Mechanical Ventilation and Neuromuscular Section within the Sleep Medicine Network to explain the current situation and offer suggestions on moving forward in caring for these patients.
 

Why is this happening?

vethidreprewrojubrisluspaceslawiwidujelafrelopabrepripathosaspelujenisheuashev
Dr. John M. Coleman III


John M. Coleman III, MD, FCCP: To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm.

Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO.

Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories.
 

What devices does this apply to?

baguphujuslijumobuspostokodraspuloprujutrivuwumugiclimotuhestamicrastechidritrohuwrugakachiricuredroslusworikonifruchiwocladredibamemosweswisheslechoclulochiwehubrukicrowrudro
Dr. Jason Ackrivo


Jason Ackrivo, MD: This notice affects the devices shown in Table 1. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks.

shujaweclokepidrostifrumaclispojusacrebracubuwrihamutritapimadrubrewroframelophaspuphestogishuwoslekuthibahiduchemawradritracluclesluvilakuslajusauushekacreraswuphoclobrevicafrivuhobraslogacriuewrunuspedipudrauivavoviruhegopresos

 

What are my options for home mechanical ventilators?

Lussier_Bethany_L_web.jpg
Dr. Bethany L. Lussier


Bethany L. Lussier, MD, FCCP: In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode.

How are these alternative devices similar to and different from the Trilogy EVO?

Dr. Ackrivo:All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO2 monitoring (both TcCO2 and EtCO2).

All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (Table 2). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode.

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Unique ventilator characteristics are shown in Table 2. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy.
 

I just provided my patient with a Trilogy EVO. Do I need to change this immediately?

Dr. Coleman: No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.

For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (Table 1). Refer to the Philips Respironics Sleep & Respiratory Product Portfolio Changes website for the most up-to-date information.
 

I have a patient on AVAPS, and I must change to iVAPS. What now?

Dr. Lussier: As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved.

What will happen to Philips Respironics’ cloud patient data?

Dr. Lussier: Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads.

----------

The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation.
 

John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary & Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.

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This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>For years, Respironics devices have been broadly used in the world of sleep medicine and chronic respiratory failure; thus, this announcement has significantly </metaDescription> <articlePDF/> <teaserImage>301354</teaserImage> <teaser>CHEST’s Sleep Medicine Network discusses the impact of Philips’ decision to stop producing its mechanical ventilation products.</teaser> <title>Home ventilation consult</title> <deck>Specialist input on a sudden shift in device availability</deck> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">6</term> </publications> <sections> <term canonical="true">29297</term> <term>52072</term> </sections> <topics> <term canonical="true">296</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240128e6.jpg</altRep> <description role="drol:caption">Dr. John M. Coleman III</description> <description role="drol:credit">CHEST</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240128e3.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">CHEST</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/2400d744.jpg</altRep> <description role="drol:caption">Dr. Bethany L. Lussier</description> <description role="drol:credit">CHEST</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240128e2.jpg</altRep> <description role="drol:caption">Dr. Jason Ackrivo</description> <description role="drol:credit">CHEST</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240128e4.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">CHEST</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Home ventilation consult</title> <deck>Specialist input on a sudden shift in device availability</deck> </itemMeta> <itemContent> <p>Philips Respironics released a public statement on January 25, 2024, that would dramatically change the landscape of home mechanical ventilation and sleep-disordered breathing management in the United States. The company announced that, effective immediately in the US and US territories, Philips Respironics would stop production and sale of all hospital and home mechanical ventilation products, home and hospital ventilation devices, and oxygen concentrators. </p> <p><span class="tag metaDescription">For years, Respironics devices have been broadly used in the world of sleep medicine and chronic respiratory failure; thus, this announcement has significantly impacted clinical management options for clinicians engaged in the care of individuals on home ventilation.</span> There are many unknowns and uncertainties about how to proceed with care for patients requiring these devices. So we gathered an expert panel of clinicians from CHEST’s Home-Based Mechanical Ventilation and Neuromuscular Section within the Sleep Medicine Network to explain the current situation and offer suggestions on moving forward in caring for these patients. <br/><br/></p> <p><strong>Why is this happening?<br/><br/>John M. Coleman III, MD, FCCP:</strong> To understand the current Philips Respironics announcement, we must go back to June 2021. At that time, Philips recalled certain home mechanical ventilators, CPAP machines, and BiPAP machines due to potential health risks related to breakdown of the polyester-based polyurethane (PE-PUR) foam placed in these devices for noise reduction. Small and microscopic particles of this foam were at risk for being inhaled or ingested by patients using these devices. It was suspected that inhalation of these particles could potentially result in temporary or permanent injury. Machines in hot temperatures or using ozone cleaning were at increased risk. The US Food and Drug Administration (FDA) issued a class 1 recall, defined as “a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”[[{"fid":"301354","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"","field_file_image_credit[und][0][value]":"CHEST","field_file_image_caption[und][0][value]":"Dr. John M. Coleman III"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]</p> <p>In the months following the initial recall, there were additional recalls of both in-hospital and home ventilators related to the potential of these foam particles to move and block the air path, reducing airflow and causing the device to alarm. <br/><br/>Over the next few years, tens of thousands of medical device reports were filed about PE-PUR foam-related injuries, with some cases resulting in death. At this time, the Department of Justice began collaborating with the FDA on a consent decree. There were ongoing recalls of the CoughAssist T70 device, as well as the newest generation of Philips Respironics home ventilators, the Trilogy EVO. <br/><br/>Ultimately, after years of ongoing recalls and reports of numerous deaths and injuries, with multiple class action lawsuits, the consent decree was finalized. Philips Respironics agreed to stop production of all respiratory-related products in the US and US territories. <br/><br/></p> <p><strong>What devices does this apply to?</strong> <br/><br/><strong>Jason Ackrivo, MD:</strong> This notice affects the devices shown in <strong>Table 1</strong>. All sales and device shipments have been discontinued as of January 25, 2024. Philips Respironics will continue to service the devices, subject to part availability, up to 5 years after sales discontinuation. However, Philips Respironics will continue to sell consumables and accessories, including masks. </p> <p>[[{"fid":"301355","view_mode":"medstat_image_full_text","fields":{"format":"medstat_image_full_text","field_file_image_alt_text[und][0][value]":"Discontinued Philips Respironics products, by product type","field_file_image_credit[und][0][value]":"CHEST","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_full_text"}}]]<br/><br/> </p> <p><strong>What are my options for home mechanical ventilators?<br/><br/>Bethany L. Lussier, MD, FCCP:</strong> In the US, alternative approved home mechanical ventilator (HMV) devices include Astral by ResMed, Vivo 45 and Vivo 65 by Breas, and VOCSN by Ventec. Additional options made available through emergency use authorization by the FDA between 2020 and 2022 included Luisa by Löwenstein Medical, the V+ by Ventec, and Life2000 by Baxter. Many of us expedite disposition from the hospital by prescribing HMVs rather than respiratory assist devices (RADs) because it is easier to meet qualifying criteria for insurance. In efforts to promote just allocation of resources, now might be the ideal time to reconsider higher utilization of RADs over HMVs. Reasonable RAD candidates are those who do not need autotitration of EPAP, dual mode therapy, or invasive ventilation. In these cases, the qualifying criteria and patient needs may be met with a RAD capable of VAPS or BPAP-ST mode. [[{"fid":"257536","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Bethany L. Lussier, UT Southwestern Medical Center, Dallas","field_file_image_credit[und][0][value]":"CHEST","field_file_image_caption[und][0][value]":"Dr. Bethany L. Lussier"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]</p> <p><b>How are these alternative devices similar to and different from the Trilogy EVO?<br/><br/>Dr. Ackrivo</b>: All these devices are portable ventilators that can deliver noninvasive or invasive ventilation. They have internal batteries for enabling portability. They offer multiple programmable presets and mouthpiece ventilation, and some offer both oxygenation and CO<sub>2</sub> monitoring (both TcCO<sub>2</sub> and EtCO<sub>2</sub>). [[{"fid":"301353","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Jason Ackrivo, Perelman School of Medicine, University of Pennsylvania","field_file_image_credit[und][0][value]":"CHEST","field_file_image_caption[und][0][value]":"Dr. Jason Ackrivo"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]</p> <p>All alternative portable ventilators include a proprietary ventilation mode analogous to the Trilogy AVAPS algorithm (<strong>Table 2</strong>). The ResMed Astral has a safety tidal volume feature that targets a minimum tidal volume in PS, S/T, or P(A)C modes. The ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. The Breas Vivo can target a tidal volume (TgV) in either PSV or PCV mode. <br/><br/>[[{"fid":"301356","view_mode":"medstat_image_full_text","fields":{"format":"medstat_image_full_text","field_file_image_alt_text[und][0][value]":"Table 2. VAPS modes and key unique characteristics by ventilator","field_file_image_credit[und][0][value]":"CHEST","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_full_text"}}]] <br/><br/>Unique ventilator characteristics are shown in <strong>Table 2</strong>. ResMed Astral mode options will differ between leak (passive) or valve (active) circuits. Both the Breas Vivo and Löwenstein Luisa enable high-flow oxygen delivery. Only the Breas Vivo enables connecting to a transcutaneous carbon dioxide monitor. The VOCSN name is an acronym for its multifunctional capabilities: ventilation, oxygenation, cough assist, suction, and nebulizer treatments. Lastly, the VOCSN can disable leak compensation, which may be advantageous for enabling leak speech with a tracheostomy. <br/><br/></p> <p> <strong>I just provided my patient with a Trilogy EVO. Do I need to change this immediately?</strong> </p> <p><strong>Dr. Coleman:</strong> No, but you should start conversations with your patient/caregiving support and with your durable medical equipment (DME) provider about alternative options. The ripple effects of the Philips Respironics recall will be ongoing for years. The silver lining of this situation is that there are numerous HMV options on the market currently. It is important to review the differences between these new devices and consider what will work best for your patient and your practice. In addition, it is critical that your DME provider is familiar with these new devices, both for support and education, and is taking steps to make alternate devices available. We anticipate a push in coming months to switch patients off Trilogy EVO, so it important to get this process started.</p> <p>For patients not interested in switching just yet, Philips Respironics will continue to service and offer supplies for these devices for up to 5 years, depending on part availability (<strong>Table 1</strong>). Refer to the Philips Respironics Sleep &amp; Respiratory Product Portfolio Changes <span class="Hyperlink"><a href="https://www.usa.philips.com/healthcare/e/sleep-and-respiratory-care/src-portfolio-update">website</a></span> for the most up-to-date information.<br/><br/></p> <p><strong>I have a patient on AVAPS, and I must change to iVAPS. What now?<br/><br/>Dr. Lussier:</strong> As mentioned previously by Dr. Ackrivo, the ResMed iVAPS algorithm adjusts inspiratory pressure and respiratory rate to target an alveolar ventilation based on patient-entered height. A download from a current VAPS setting can be helpful in defining target ventilation and pressure ranges for a tailored prescription. ResMed has an online iVAPS calculator (resmed.com) to assist in making this switch. Close clinical monitoring with data downloads is recommended to assure desired targets are still achieved. </p> <p><strong>What will happen to Philips Respironics’ cloud patient data?<br/><br/>Dr. Lussier:</strong> Representatives have reported that both providers and DME companies will have continued access to Care Orchestrator going forward. Currently, the logistics of data maintenance and ownership remain unclear, which poses additional questions about global access to patients’ data downloads. </p> <p>----------<br/><br/>The recent discontinuation of Philips Respironics ventilation devices will induce a dramatic shift in home ventilation options in the US. Clinicians and DME companies should begin familiarizing themselves with alternative ventilators and their unique features. While significant uncertainty exists, we encourage a proactive approach to education and communication to ensure a smooth transition for patients on home ventilation. <br/><br/></p> <p> <em>John M. Coleman III, MD, FCCP, is Associate Professor, Division of Pulmonary &amp; Critical Care Medicine, Department of Neurology, Northwestern University Feinberg School of Medicine. Bethany L. Lussier, MD, FCCP, is in the Department of Internal Medicine, Division of Pulmonary &amp; Critical Care Medicine, Department of Neurology, Division of Neurocritical Care, UT Southwestern Medical Center. Jason Ackrivo, MD, is Assistant Professor of Medicine and Neurology, and Associate Director, Jay and Randy Fishman Program for Home Assisted Ventilation, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Robotic Pet Therapy in the Intensive Care Unit

Article Type
Changed
Mon, 05/13/2024 - 14:38

Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.1 Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.2

Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.3,4 Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.5,6 Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated.

Pet therapy has been implemented in some ICU settings, but is not widely adopted.7 Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.8 Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.9 As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.10,11 Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.12 Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits.

 

OBSERVATIONS

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The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for AllCompanion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.

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It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members.

 

 

Program Impact

A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged < 18 years or > 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay.

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Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients.

Limitations

The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction.

 

CONCLUSIONS

Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS.

Acknowledgments

The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.

References

1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299

2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14. doi:10.1097/CCM.0000000000003482

3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868

4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. N Engl J Med. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217

5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489-499. doi:10.1001/jama.2009.56

6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104:21-26. doi:10.1097/00000542-200601000-00005

7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles

8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. Intensive Crit Care Nurs. 2022;73:103304. doi:10.1016/j.iccn.2022.103304

9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. Crit Care. 2018;22:22. doi:10.1186/s13054-018-1946-8

10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. J Am Med Dir Assoc. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002

11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007

12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. Am J Med. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039

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Andrew J. Franck, PharmDa

Correspondence:  Andrew Franck  (andrew.franck@va.gov)

aNorth Florida/South Georgia Veterans Health System, Gainesville

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The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Correspondence:  Andrew Franck  (andrew.franck@va.gov)

aNorth Florida/South Georgia Veterans Health System, Gainesville

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Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

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Correspondence:  Andrew Franck  (andrew.franck@va.gov)

aNorth Florida/South Georgia Veterans Health System, Gainesville

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Related Articles

Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.1 Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.2

Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.3,4 Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.5,6 Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated.

Pet therapy has been implemented in some ICU settings, but is not widely adopted.7 Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.8 Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.9 As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.10,11 Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.12 Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits.

 

OBSERVATIONS

chuspeprethedatrachuslodraswiuejiwethuthepovoroswapebruvudophefrokeswogeriuadonikucoslafropekeroueticutathigatracrahubradahuprab

The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for AllCompanion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.

dredrishipruchefrojestetustuprichochevupipivelobrachephulaswudrocrawriswophedrudohopristomusluvuhuclaspetrifrutrimiludrucrapraswigicucrajajodephospitrijaclorichatrichejuwufrethostuwrifrocouaswashebruhaduswerispunadututheti

It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members.

 

 

Program Impact

A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged < 18 years or > 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay.

voclataswaleswebrespespuwuwrabrostutrucliswicogalacacrethecalucevitobithunihulehospacruwefrafracufrepribrothacrapriwatrilegunoshugasauehedesuhatajoloclawraprejukachucrogidrawribrobeuuspiuilunaclurispuphijudraswuthavojicravutoswostacusepilasijos

Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients.

Limitations

The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction.

 

CONCLUSIONS

Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS.

Acknowledgments

The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.

Critical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.1 Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.2

Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.3,4 Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.5,6 Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated.

Pet therapy has been implemented in some ICU settings, but is not widely adopted.7 Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.8 Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.9 As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.10,11 Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.12 Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits.

 

OBSERVATIONS

chuspeprethedatrachuslodraswiuejiwethuthepovoroswapebruvudophefrokeswogeriuadonikucoslafropekeroueticutathigatracrahubradahuprab

The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for AllCompanion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.

dredrishipruchefrojestetustuprichochevupipivelobrachephulaswudrocrawriswophedrudohopristomusluvuhuclaspetrifrutrimiludrucrapraswigicucrajajodephospitrijaclorichatrichejuwufrethostuwrifrocouaswashebruhaduswerispunadututheti

It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members.

 

 

Program Impact

A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged < 18 years or > 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay.

voclataswaleswebrespespuwuwrabrostutrucliswicogalacacrethecalucevitobithunihulehospacruwefrafracufrepribrothacrapriwatrilegunoshugasauehedesuhatajoloclawraprejukachucrogidrawribrobeuuspiuilunaclurispuphijudraswuthavojicravutoswostacusepilasijos

Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients.

Limitations

The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction.

 

CONCLUSIONS

Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS.

Acknowledgments

The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.

References

1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299

2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14. doi:10.1097/CCM.0000000000003482

3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868

4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. N Engl J Med. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217

5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489-499. doi:10.1001/jama.2009.56

6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104:21-26. doi:10.1097/00000542-200601000-00005

7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles

8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. Intensive Crit Care Nurs. 2022;73:103304. doi:10.1016/j.iccn.2022.103304

9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. Crit Care. 2018;22:22. doi:10.1186/s13054-018-1946-8

10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. J Am Med Dir Assoc. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002

11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007

12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. Am J Med. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039

References

1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299

2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. Crit Care Med. 2019;47:3-14. doi:10.1097/CCM.0000000000003482

3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. N Engl J Med. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868

4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. N Engl J Med. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217

5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009;301:489-499. doi:10.1001/jama.2009.56

6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006;104:21-26. doi:10.1097/00000542-200601000-00005

7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles

8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. Intensive Crit Care Nurs. 2022;73:103304. doi:10.1016/j.iccn.2022.103304

9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. Crit Care. 2018;22:22. doi:10.1186/s13054-018-1946-8

10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. J Am Med Dir Assoc. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002

11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. J Am Med Dir Assoc. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007

12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. Am J Med. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039

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All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">16</term> </publications> <sections> <term canonical="true">61535</term> </sections> <topics> <term>27442</term> <term>248</term> <term canonical="true">258</term> <term>268</term> <term>296</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Robotic Pet Therapy in the Intensive Care Unit</title> <deck/> </itemMeta> <itemContent> <p class="abstract"><b>Background:</b> Robotic pet therapy could aid in the nonpharmacologic treatment of pain, agitation, delirium, immobility, and sleep disruption (PADIS) in the intensive care unit (ICU), similar to traditional pet therapy.<br/><br/><b>Observations:</b> The North Florida/South Georgia Veterans Health System implemented a robotic pet therapy program for patients requiring ICU care. Details of this program are described in this article, including evaluating its impact on PADIS management.<br/><br/><b>Conclusions:</b> Robotic pet therapy can be successfully implemented in the ICU and could be a simple, safe, and beneficial nonpharmacologic intervention for PADIS.</p> <p><span class="Drop">C</span>ritical illness is commonly associated with interrelated conditions including pain, agitation, delirium, immobility, and sleep disruption (PADIS). Managing PADIS is often complex and includes pharmacologic and nonpharmacologic interventions.<sup>1</sup> Incorporating multifaceted practices to enhance PADIS management has been shown to improve several intensive care unit (ICU)-related outcomes.<sup>2</sup> </p> <p>Many pharmacologic PADIS treatments are ineffective or associated with adverse effects. For example, antipsychotics used for treating ICU-related delirium have not shown improved outcomes.<sup>3,4 </sup>Commonly used medications for agitation, such as benzodiazepines, increase delirium risk.<sup>5,6</sup> Because of these limitations, several nonpharmacologic interventions for PADIS have been evaluated. <br/><br/>Pet therapy has been implemented in some ICU settings, but is not widely adopted.<sup>7</sup> Also referred to as animal-assisted activities, animal-assisted therapy, or animal-assisted interventions, pet therapy typically involves interaction between a patient and a live animal (most commonly a dog) under the direction of an animal handler, with the intention of providing therapeutic benefit. Interactions frequently include meet and greet activities such as petting, but also could include walking or other activities. Pet therapy has been reported to reduce pain, agitation, and stress among ICU patients.<sup>8</sup> Introducing a pet therapy program with live animals in the ICU could be challenging because of factors such as identifying trained, accredited animals and handlers, and managing infection control and other risks.<sup>9</sup> As an alternative to live pets, robotic pet therapy has been shown to be beneficial—mostly outside the ICU—in settings such as long-term care.<sup>10,11</sup> Although uncommon, robotic pets have been used in the ICU and hospital settings for therapeutic purposes.<sup>12</sup> Robotic pets reduce many concerns associated with live animals while mimicking the behaviors of live animals and potentially offering many of the same benefits. </p> <h2>OBSERVATIONS</h2> <p>The North Florida/South Georgia Veterans Health System (NF/SGVHS) implemented a novel robotic pet therapy program for patients requiring ICU care to improve the treatment of PADIS. Funding was provided through a Veterans Health Administration Innovation Grant procured by a clinical pharmacy specialist as the program’s champion. Goals of the robotic pet therapy program include reductions in: distressing symptoms associated with PADIS, use of psychoactive drugs and physical restraints, and ICU length of stay. The ICU team developed standard operating procedures and an order menu, which were integrated into the ICU prescriber ordering menu. Patients were selected for pet therapy based on PADIS scores and potential for positive response to pet therapy as assessed by the ICU team.Patients in medical and surgical ICU settings were eligible for the program. The robotic pets used in the program were Joy for All<sup> </sup>Companion Pets (Ageless Innovation LLC). Robotic cats and dogs were available and pets were “adopted’ by each patient (Figure). As an infection control measure, pets were not reissued or shared amongpatients and pets could be cleaned with a disinfectant solution. Nurses were primarily responsible for monitoring and documenting responses to robotic pet therapy.</p> <p>It was necessary to secure buy-in from several services to successfully implement the program. The critical care clinical pharmacy specialists were responsible for ordering, storing, and dispensing the robotic pets. The NF/SGVHS innovation specialist helped secure funding, procure the robotic pet, and promote the program. The standard operating procedures for the program were developed by a multidisciplinary team with input from critical care nurses, intensivists, pharmacists, patient safety, and infection control (Table 1). Success of the program also required buy-in from ICU team members. </p> <h2>program Impact</h2> <p>A retrospective cohort study was conducted to assess for improvements in PADIS symptoms and medication use post-intervention. Patients were included if they received robotic pet therapy in the ICU from July 10, 2019, to February 1, 2021. Individuals aged &lt; 18 years or &gt; 89 years, were pregnant, or were not receiving ICU-level care were excluded. Outcomes assessed included improvement in pain scores, agitation scores, sleep quality, resolution of delirium, and use of pain or psychoactive medications during patients’ ICU stay. </p> <p>Thirty patients were included in the study (Table 2). After receiving a robotic pet, 9 (30%) patients recorded decreased pain scores, 15 (50%) recorded decreased agitation scores, 8 (27%) had resolution of delirium, and 2 (7%) described improvement in sleep. Pain medication use decreased in 12 (40%) patients and psychoactive medication use was reduced in 7 (23%) patients. </p> <h3>Limitations</h3> <p>The robotic pet therapy program has shown promising results; however, some aspects merit discussion. Evaluation of this program is limited by factors such as the observational study design, single-center patient sample, and lack of comparator group. Although no known adverse effects of robotic pet therapy were seen, it is possible that some patients may not have a favorable response. Challenges of implementing a robotic pet therapy program include cost and additional operational activities (storage, ordering, dispensing) necessary to maintain the program. Additional research is needed to evaluate the impact of robotic pet therapy on other outcomes including cost, ICU length of stay, and patient satisfaction. </p> <h2>CONCLUSIONS</h2> <p>Robotic pet therapy can be successfully implemented in the ICU and appears to provide a simple, safe, beneficial, nonpharmacologic intervention for PADIS. This study showed that many patients had favorable response to robotic pet therapy, indicating that it may be a viable alternative to traditional pet therapy. Other health systems could benefit from implementing programs similar to the robotic pet therapy program at NF/SGVHS. </p> <h3> Acknowledgments </h3> <p> <em>The author would like to acknowledge Simran Panesar, PharmD, and Theresa Faison, PharmD, for their contributions to this project.</em> </p> <h3> Author affiliation </h3> <p> <em><sup>a</sup>North Florida/South Georgia Veterans Health System, Gainesville</em> </p> <h3> Author disclosures </h3> <p> <em>The author reports no actual or potential conflicts of interest or outside sources of funding with regard to this article.</em> </p> <h3> Disclaimer </h3> <p> <em>The opinions expressed herein are those of the author and do not necessarily reflect those of <i>Federal Practitioner,</i> Frontline Medical Communications Inc., the US Government, or any of its agencies. </em> </p> <h3> References </h3> <p class="reference"> 1. Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. <i>Crit Care Med</i>. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299 <br/><br/> 2. Pun BT, Balas MC, Barnes-Daly MA, et al. Caring for critically ill patients with the ABCDEF bundle: results of the ICU Liberation Collaborative in over 15,000 adults. <i>Crit Care Med</i>. 2019;47:3-14. doi:10.1097/CCM.0000000000003482 <br/><br/> 3. Andersen-Ranberg NC, Poulsen LM, Perner A, et al; AID-ICU Trial Group. Haloperidol for the treatment of delirium in ICU patients. <i>N Engl J Med</i>. 2022;387:2425-2435. doi:10.1056/NEJMoa2211868<br/><br/> 4. Girard TD, Exline MC, Carson SS, et al; MIND-USA Investigators. Haloperidol and ziprasidone for treatment of delirium in critical illness. <i>N Engl J Med</i>. 2018;379:2506-2516. doi:10.1056/NEJMoa1808217<br/><br/> 5. Riker RR, Shehabi Y, Bokesch PM, et al; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. <i>JAMA</i>. 2009;301:489-499. doi:10.1001/jama.2009.56<br/><br/> 6. Pandharipande P, Shintani A, Peterson J, et al. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. <i>Anesthesiology</i>. 2006;104:21-26. doi:10.1097/00000542-200601000-00005<br/><br/> 7. Society of Critical Care Medicine. ICU liberation bundle. Accessed February 27, 2024. https://www.sccm.org/ICULiberation/Home/ABCDEF-Bundles<br/><br/> 8. Lovell T, Ranse K. Animal-assisted activities in the intensive care unit: a scoping review. <i>Intensive Crit Care Nurs</i>. 2022;73:103304. doi:10.1016/j.iccn.2022.103304<br/><br/> 9. Hosey MM, Jaskulski J, Wegener ST, Chlan LL, Needham DM. Animal-assisted intervention in the ICU: a tool for humanization. <i>Crit Care</i>. 2018;22:22. doi:10.1186/s13054-018-1946-8<br/><br/>10. Jøranson N, Pedersen I, Rokstad AM, Ihlebæk C. Effects on symptoms of agitation and depression in persons with dementia participating in robot-assisted activity: a cluster-randomized controlled trial. <i>J Am Med Dir Assoc</i>. 2015;16:867-873. doi:10.1016/j.jamda.2015.05.002<br/><br/>11. Robinson H, Macdonald B, Kerse N, Broadbent E. The psychosocial effects of a companion robot: a randomized controlled trial. <i>J Am Med Dir Assoc</i>. 2013;14:661-667. doi:10.1016/j.jamda.2013.02.007 <br/><br/>12. Schulman-Marcus J, Mookherjee S, Rice L, Lyubarova R. New approaches for the treatment of delirium: a case for robotic pets. <i>Am J Med</i>. 2019;132:781-782. doi:10.1016/j.amjmed.2018.12.039.</p> </itemContent> </newsItem> </itemSet></root>
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Is it time to embrace a multinight sleep study?

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Changed
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kedribroswikubecoceslehacepihehupesha
Dr. Luis D. Quintero

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.1

Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.2 This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.3

The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.

Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.


References

1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. Sleep Med. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007

2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. Am J Respir Crit Care Med. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC

3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? Am J Respir Crit Care Med. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE

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kedribroswikubecoceslehacepihehupesha
Dr. Luis D. Quintero

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.1

Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.2 This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.3

The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.

Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.


References

1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. Sleep Med. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007

2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. Am J Respir Crit Care Med. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC

3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? Am J Respir Crit Care Med. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE

kedribroswikubecoceslehacepihehupesha
Dr. Luis D. Quintero

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.1

Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.2 This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.3

The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.

Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.


References

1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. Sleep Med. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007

2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. Am J Respir Crit Care Med. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC

3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? Am J Respir Crit Care Med. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE

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A meta-analysis by Ding and colleagues </metaDescription> <articlePDF/> <teaserImage>301347</teaserImage> <teaser>Advances in technology and monitoring may make sleep studies across mutiple nights possible.</teaser> <title>Is it time to embrace a multinight sleep study?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">6</term> </publications> <sections> <term canonical="true">39299</term> <term>52074</term> </sections> <topics> <term canonical="true">28399</term> <term>296</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240128db.jpg</altRep> <description role="drol:caption">Dr. Luis D. Quintero</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Is it time to embrace a multinight sleep study?</title> <deck/> </itemMeta> <itemContent> <h2>Sleep Medicine Network</h2> <h3>Respiratory-Related Sleep Disorders Section</h3> <p>Since the 1960s, sleep researchers have been intrigued by the first-night effect (FNE) in polysomnography (PSG) studies. A meta-analysis by Ding and colleagues revealed FNE’s impact on sleep metrics, like total sleep time and REM sleep, without affecting the apnea-hypopnea index, highlighting PSG’s limitations in simulating natural sleep patterns.<sup>1</sup></p> <p>Lechat and colleagues conducted a study using a home-based sleep analyzer on more than 67,000 individuals, averaging 170 nights each.<sup>2</sup> This study found that single-night studies could lead to a 20% misdiagnosis rate in OSA, attributed to overlooking real sleep factors such as body posture, environmental effects, alcohol, and medication. Despite this, the wider use of multinight studies for accurate diagnosis is limited by insurance coverage issues.<sup>3</sup><br/><br/>The last decade has seen substantial advances in health technology, particularly in consumer wearables capable of detecting various medical conditions. Devices employing techniques like actigraphy and accelerometry have reached a level of performance comparable with US Food and Drug Administration-approved clinical tools. However, these technologies are still in development for the diagnosis and classification of sleep-disordered breathing.[[{"fid":"301347","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Luis D. Quintero, Northwell Health, New York","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Luis D. Quintero"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>Tech companies are actively innovating sleep sensing technologies, smartwatches, bed sensors, wireless EEG, radiofrequency, and ultrasound sensors. With significant investments in this sector, these technologies could be ready for widespread use in the next 5 to 10 years. Health care professionals should consider data from sleep-tracking wearables when there are inconsistencies between a patient’s sleep study results and symptoms. The insights from these devices could provide crucial diagnostic information, enhancing the accuracy of sleep disorder diagnoses.<br/><br/><br/><br/><b>References<br/><br/></b>1. Ding L, Chen B, Dai Y, Li Y. A meta-analysis of the first-night effect in healthy individuals for the full age spectrum. <em>Sleep Med</em>. 2022;89:159-165. Preprint. Posted online December 17, 2021. PMID: 34998093. doi: 10.1016/j.sleep.2021.12.007<br/><br/>2. Lechat B, Naik G, Reynolds A, et al. Multinight prevalence, variability, and diagnostic misclassification of obstructive sleep apnea. <em>Am J Respir Crit Care Med</em>. 2022;205(5):563-569. PMID: 34904935; PMCID: PMC8906484. doi: 10.1164/rccm.202107-1761OC<br/><br/>3. Abreu A, Punjabi NM. How many nights are really needed to diagnose obstructive sleep apnea? <em>Am J Respir Crit Care Med</em>. 2022;206(1):125-126. PMID: 35476613; PMCID: PMC9954337. doi: 10.1164/rccm.202112-2837LE</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Device Uses Sleep Data to Pinpoint Stress Risk

Article Type
Changed
Fri, 04/26/2024 - 11:26

 

TOPLINE:

Decreased total sleep time (TST) and increased resting heart rate (RHR), heart rate variability (HRV), and average nightly respiratory rate (ARR) as measured by a multisensor device worn during sleep accurately correlated with self-reported stress levels in college students, a new study suggests. Investigators say the findings support the potential utility of wearable devices to collect data that identify young adults at greatest risk for stress. 

METHODOLOGY:

  • First-semester college students (n = 525; aged 18-24 years) enrolled in the Lived Experiences measured Using Rings Study (LEMURS) provided continuous biometric data via a wearable device (Oura Ring; Oura Health) and answered weekly surveys regarding stress levels.
  • The researchers used mixed-effects regression models to identify associations between perceived stress scores and average nightly TST, RHR, HRV, and ARR.

TAKEAWAY:

  • Consistent associations were found between perceived stress scores and TST, RHR, HRV, and ARR, which persisted even after controlling for gender and week of the semester.
  • Risk for moderate to high stress decreased by 38% with every additional hour of TST (P < .01) and by 1.2% with each millisecond increase in HRV (P < .05).
  • Moderate to high stress risk increased by 3.6% with each beat-per-minute-increase in RHR (P < .01) and by 23% with each additional breath-per-minute increase in ARR (P < .01).
  • Participants who identified as female, nonbinary, or transgender reported significantly higher stress throughout the study.

IN PRACTICE:

“The present work highlights the potential utility of monitoring sleep, suggesting that these measures may identify within individual changes that are concerning for stress. As the demand for mental health services grows, determining which wearable-derived sleep estimates provide information about well-being and can predict worsening mental health in young adults is an important area of study,” study authors wrote.

SOURCE:

The study, led by Laura S.P. Bloomfield, University of Vermont, Burlington, Vermont, was published online in PLOS Digital Health.

LIMITATIONS:

The study focused on raw sleep measures; the researchers suggest that future studies evaluate additional sleep variables (eg, daytime naps), which have been associated with mental health in college students. In addition, the researchers did not have stress or sleep data before participants started college, so they could not assess the impact of starting college on participants’ sleep.

DISCLOSURES:

Bloomfield was supported by the Gund Fellowship and received a partial salary from the Mass Mutual Insurance Wellness Initiative. Other authors’ funding is reported in the original article.

A version of this article appeared on Medscape.com.

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TOPLINE:

Decreased total sleep time (TST) and increased resting heart rate (RHR), heart rate variability (HRV), and average nightly respiratory rate (ARR) as measured by a multisensor device worn during sleep accurately correlated with self-reported stress levels in college students, a new study suggests. Investigators say the findings support the potential utility of wearable devices to collect data that identify young adults at greatest risk for stress. 

METHODOLOGY:

  • First-semester college students (n = 525; aged 18-24 years) enrolled in the Lived Experiences measured Using Rings Study (LEMURS) provided continuous biometric data via a wearable device (Oura Ring; Oura Health) and answered weekly surveys regarding stress levels.
  • The researchers used mixed-effects regression models to identify associations between perceived stress scores and average nightly TST, RHR, HRV, and ARR.

TAKEAWAY:

  • Consistent associations were found between perceived stress scores and TST, RHR, HRV, and ARR, which persisted even after controlling for gender and week of the semester.
  • Risk for moderate to high stress decreased by 38% with every additional hour of TST (P < .01) and by 1.2% with each millisecond increase in HRV (P < .05).
  • Moderate to high stress risk increased by 3.6% with each beat-per-minute-increase in RHR (P < .01) and by 23% with each additional breath-per-minute increase in ARR (P < .01).
  • Participants who identified as female, nonbinary, or transgender reported significantly higher stress throughout the study.

IN PRACTICE:

“The present work highlights the potential utility of monitoring sleep, suggesting that these measures may identify within individual changes that are concerning for stress. As the demand for mental health services grows, determining which wearable-derived sleep estimates provide information about well-being and can predict worsening mental health in young adults is an important area of study,” study authors wrote.

SOURCE:

The study, led by Laura S.P. Bloomfield, University of Vermont, Burlington, Vermont, was published online in PLOS Digital Health.

LIMITATIONS:

The study focused on raw sleep measures; the researchers suggest that future studies evaluate additional sleep variables (eg, daytime naps), which have been associated with mental health in college students. In addition, the researchers did not have stress or sleep data before participants started college, so they could not assess the impact of starting college on participants’ sleep.

DISCLOSURES:

Bloomfield was supported by the Gund Fellowship and received a partial salary from the Mass Mutual Insurance Wellness Initiative. Other authors’ funding is reported in the original article.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Decreased total sleep time (TST) and increased resting heart rate (RHR), heart rate variability (HRV), and average nightly respiratory rate (ARR) as measured by a multisensor device worn during sleep accurately correlated with self-reported stress levels in college students, a new study suggests. Investigators say the findings support the potential utility of wearable devices to collect data that identify young adults at greatest risk for stress. 

METHODOLOGY:

  • First-semester college students (n = 525; aged 18-24 years) enrolled in the Lived Experiences measured Using Rings Study (LEMURS) provided continuous biometric data via a wearable device (Oura Ring; Oura Health) and answered weekly surveys regarding stress levels.
  • The researchers used mixed-effects regression models to identify associations between perceived stress scores and average nightly TST, RHR, HRV, and ARR.

TAKEAWAY:

  • Consistent associations were found between perceived stress scores and TST, RHR, HRV, and ARR, which persisted even after controlling for gender and week of the semester.
  • Risk for moderate to high stress decreased by 38% with every additional hour of TST (P < .01) and by 1.2% with each millisecond increase in HRV (P < .05).
  • Moderate to high stress risk increased by 3.6% with each beat-per-minute-increase in RHR (P < .01) and by 23% with each additional breath-per-minute increase in ARR (P < .01).
  • Participants who identified as female, nonbinary, or transgender reported significantly higher stress throughout the study.

IN PRACTICE:

“The present work highlights the potential utility of monitoring sleep, suggesting that these measures may identify within individual changes that are concerning for stress. As the demand for mental health services grows, determining which wearable-derived sleep estimates provide information about well-being and can predict worsening mental health in young adults is an important area of study,” study authors wrote.

SOURCE:

The study, led by Laura S.P. Bloomfield, University of Vermont, Burlington, Vermont, was published online in PLOS Digital Health.

LIMITATIONS:

The study focused on raw sleep measures; the researchers suggest that future studies evaluate additional sleep variables (eg, daytime naps), which have been associated with mental health in college students. In addition, the researchers did not have stress or sleep data before participants started college, so they could not assess the impact of starting college on participants’ sleep.

DISCLOSURES:

Bloomfield was supported by the Gund Fellowship and received a partial salary from the Mass Mutual Insurance Wellness Initiative. Other authors’ funding is reported in the original article.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Investigators say the findings support the potential utility of wearable devices to collect data that identify young adults at greatest risk for stress.</metaDescription> <articlePDF/> <teaserImage/> <teaser>A device worn during sleep linked self-reported stress and sleep time, changes in heart rate, and respiration rate, study finds.</teaser> <title>Device Uses Sleep Data to Pinpoint Stress Risk</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>cpn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>6</term> <term>9</term> <term canonical="true">21</term> <term>15</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>296</term> <term canonical="true">248</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Device Uses Sleep Data to Pinpoint Stress Risk</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p>Decreased total sleep time (TST) and increased resting heart rate (RHR), heart rate variability (HRV), and average nightly respiratory rate (ARR) as measured by a multisensor device worn during sleep accurately correlated with self-reported stress levels in college students, a new study suggests. <span class="tag metaDescription">Investigators say the findings support the potential utility of wearable devices to collect data that identify young adults at greatest risk for stress.</span> </p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>First-semester college students (n = 525; aged 18-24 years) enrolled in the Lived Experiences measured Using Rings Study (LEMURS) provided continuous biometric data via a wearable device (Oura Ring; Oura Health) and answered weekly surveys regarding stress levels.</li> <li>The researchers used mixed-effects regression models to identify associations between perceived stress scores and average nightly TST, RHR, HRV, and ARR.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Consistent associations were found between perceived stress scores and TST, RHR, HRV, and ARR, which persisted even after controlling for gender and week of the semester.</li> <li>Risk for moderate to high stress decreased by 38% with every additional hour of TST (<em>P</em> &lt; .01) and by 1.2% with each millisecond increase in HRV (<em>P</em> &lt; .05).</li> <li>Moderate to high stress risk increased by 3.6% with each beat-per-minute-increase in RHR (<em>P</em> &lt; .01) and by 23% with each additional breath-per-minute increase in ARR (<em>P</em> &lt; .01).</li> <li>Participants who identified as female, nonbinary, or transgender reported significantly higher stress throughout the study.</li> </ul> <h2>IN PRACTICE:</h2> <p>“The present work highlights the potential utility of monitoring sleep, suggesting that these measures may identify within individual changes that are concerning for stress. As the demand for mental health services grows, determining which wearable-derived sleep estimates provide information about well-being and can predict worsening mental health in young adults is an important area of study,” study authors wrote.</p> <h2>SOURCE:</h2> <p>The study, led by Laura S.P. Bloomfield, University of Vermont, Burlington, Vermont, was <span class="Hyperlink"><a href="https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000473">published online</a></span> in <em>PLOS Digital Health</em>.</p> <h2>LIMITATIONS:</h2> <p>The study focused on raw sleep measures; the researchers suggest that future studies evaluate additional sleep variables (eg, daytime naps), which have been associated with mental health in college students. In addition, the researchers did not have stress or sleep data before participants started college, so they could not assess the impact of starting college on participants’ sleep.</p> <h2>DISCLOSURES:</h2> <p>Bloomfield was supported by the Gund Fellowship and received a partial salary from the Mass Mutual Insurance Wellness Initiative. Other authors’ funding is reported in the original article.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/wearable-device-uses-sleep-data-identify-stress-risk-2024a1000804">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Adding Life to Your Patients’ Years

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Tue, 04/23/2024 - 11:31

 

Caring for older adults was one of the most rewarding parts of my years practicing as a clinical cardiologist. I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of atrial fibrillation and recognize that it could have major health ramifications.

Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?

That is not just a question for geriatric care. With fewer than two practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.

Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and concluded that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.
 

Optimal Nutrition

For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat can lower the risk of developing frailty.

Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.
 

Physical Activity

Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research demonstrates that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.

The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.
 

Restorative Sleep

“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s report on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.
 

 

 

Stress Management

Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress has been shown to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.
 

Positive Social Connections

Loneliness puts individuals at higher risk for heart disease, stroke, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients rarely discuss social connections during medical appointments. Tools such as the UCLA Loneliness Scale exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to integrate social care into the delivery of healthcare.
 

Avoidance of Risky Substances

Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older engaged in binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. 

Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “Lifestyle Medicine and Food as Medicine Essentials,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.

By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Caring for older adults was one of the most rewarding parts of my years practicing as a clinical cardiologist. I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of atrial fibrillation and recognize that it could have major health ramifications.

Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?

That is not just a question for geriatric care. With fewer than two practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.

Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and concluded that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.
 

Optimal Nutrition

For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat can lower the risk of developing frailty.

Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.
 

Physical Activity

Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research demonstrates that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.

The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.
 

Restorative Sleep

“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s report on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.
 

 

 

Stress Management

Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress has been shown to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.
 

Positive Social Connections

Loneliness puts individuals at higher risk for heart disease, stroke, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients rarely discuss social connections during medical appointments. Tools such as the UCLA Loneliness Scale exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to integrate social care into the delivery of healthcare.
 

Avoidance of Risky Substances

Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older engaged in binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. 

Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “Lifestyle Medicine and Food as Medicine Essentials,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.

By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

Caring for older adults was one of the most rewarding parts of my years practicing as a clinical cardiologist. I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of atrial fibrillation and recognize that it could have major health ramifications.

Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?

That is not just a question for geriatric care. With fewer than two practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.

Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and concluded that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.
 

Optimal Nutrition

For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat can lower the risk of developing frailty.

Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.
 

Physical Activity

Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research demonstrates that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.

The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.
 

Restorative Sleep

“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s report on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.
 

 

 

Stress Management

Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress has been shown to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.
 

Positive Social Connections

Loneliness puts individuals at higher risk for heart disease, stroke, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients rarely discuss social connections during medical appointments. Tools such as the UCLA Loneliness Scale exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to integrate social care into the delivery of healthcare.
 

Avoidance of Risky Substances

Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older engaged in binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. 

Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “Lifestyle Medicine and Food as Medicine Essentials,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.

By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.

Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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I appreciated their wisdom, humor, and, very often, their respect and appreciation for physicians. It was always upsetting to see them suffer a mild fall or episode of <span class="Hyperlink">atrial fibrillation</span> and recognize that it could have major health ramifications.</p> <p><span class="tag metaDescription">Life expectancy has improved dramatically, but longer lifespans also mean more opportunity for illness, pain, chronic disease, and dependence on others. Having successfully helped older adults live longer, the question now becomes, how can we, as physicians, add more life to those years? How can we increase their “healthspans”?</span><br/><br/>That is not just a question for geriatric care. With <span class="Hyperlink"><a href="https://www.americangeriatrics.org/geriatrics-profession/about-geriatrics/geriatrics-workforce-numbers">fewer than two</a></span> practicing geriatricians for every 10,000 older individuals, it is obvious that geriatricians cannot shoulder this responsibility alone. Almost all primary care physicians and subspecialists should prepare to care for older individuals and help them age healthfully.<br/><br/>Susan Friedman, MD, a board-certified geriatrics and lifestyle medicine clinician at the University of Rochester School of Medicine and Dentistry, Rochester, New York, reviewed the literature on the connection between lifestyle and healthy aging and <span class="Hyperlink"><a href="https://www.geriatric.theclinics.com/article/S0749-0690(20)30049-5/abstract">concluded</a></span> that the integration of lifestyle medicine into medical care for older adults is key to compressing morbidity. The pillars of lifestyle medicine — optimal nutrition, physical activity, stress management, restorative sleep, positive social connections, and avoidance of risky substances — both individually or as a sum are associated with less chronic disease, improved engagement in life, better physical and cognitive function, less frailty, and less sarcopenia. Framing discussions with patients around the six pillars of lifestyle medicine can be an effective strategy.<br/><br/></p> <h2>Optimal Nutrition</h2> <p>For a variety of reasons, older adults, especially those living alone, often lose the desire to prepare a nourishing meal. Older adults require different protein intake than younger patients to offset age-related sarcopenia, but helping them select healthy sources of protein is imperative. Both adequate protein consumption and eating patterns high in vegetables, legumes, fruit, and nuts and low in saturated fat, red meat, and processed meat <span class="Hyperlink"><a href="https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.15251">can</a></span> lower the risk of developing frailty.<br/><br/>Asking a patient to share a 24-hour food recall, and based upon that, resourcing nutritional guidance, a lifestyle medicine program or specialist, and insurance or community resources for food-as-medicine services, is a good first step.<br/><br/></p> <h2>Physical Activity</h2> <p>Increasing general physical activity can be a tough ask for many older adults, and joint pain is a common reason they demur. Messaging around targeted exercises to mitigate falls, improve muscle strength, and reduce joint pain may be more appealing. Contemporary research <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10046723/">demonstrates</a></span> that exercise, particularly open-skill exercise that requires quick decisions (such as table tennis) can be powerful. Maintaining cognition, mood enhancement, and independence may also be motivating messages.<br/><br/>The first step is curiosity: What does your patient like to do? Referral to a physical therapist or an exercise specialist to provide stepwise guidance along with resourcing community opportunities can then follow.<br/><br/></p> <h2>Restorative Sleep</h2> <p>“I’m old. I don’t need as much sleep.” We’ve probably all heard older patients say this. But the National Sleep Foundation’s <span class="Hyperlink"><a href="https://www.sleephealthjournal.org/action/showPdf?pii=S2352-7218%2823%2900196-1">report</a></span> on sleep health and aging indicates that the need to sleep does not decrease with age. The ability to sleep, however, may decline. Assessing and treating disordered sleep is another example of how each lifestyle medicine pillar, such as nutrition and physical activity, is multidimensional and interacts to support the functional integrity of older patients. It’s hard to feel motivated to go for a walk if you lack adequate sleep.<br/><br/></p> <h2>Stress Management</h2> <p>Exploring stress with patients can be very revealing. Do they experience stress that energizes and has a positive effect? How much of their day is spent in negatively impactful distress? Chronic stress <span class="Hyperlink"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676338">has been shown</a></span> to affect immune function in older individuals. Start conversations with your older patients to normalize the importance of stress as a health measure.<br/><br/></p> <h2>Positive Social Connections</h2> <p>Loneliness <span class="Hyperlink"><a href="https://www.hhs.gov/sites/default/files/surgeon-general-social-connection-advisory.pdf">puts</a></span> individuals at higher risk for heart disease, <span class="Hyperlink">stroke</span>, and dementia and even increases the risk for premature death by up to 60%. Yet, clinicians and patients <span class="Hyperlink"><a href="https://connect2affect.org/wp-content/uploads/2020/10/The-Pandemic-Effect-A-Social-Isolation-Report-AARP-Foundation.pdf">rarely</a></span> discuss social connections during medical appointments. Tools such as the <span class="Hyperlink"><a href="https://fetzer.org/sites/default/files/images/stories/pdf/selfmeasures/Self_Measures_for_Loneliness_and_Interpersonal_Problems_UCLA_LONELINESS.pdf">UCLA Loneliness Scale</a></span> exist for health practitioners to assess and identify patients at risk for loneliness, as do resources to <span class="Hyperlink"><a href="https://nap.nationalacademies.org/catalog/25467/integrating-social-care-into-the-delivery-of-health-care-moving">integrate</a></span> social care into the delivery of healthcare.<br/><br/></p> <h2>Avoidance of Risky Substances</h2> <p>Alcohol assessments are not just for younger patients. One study found that 5.6 million adults ages 65 or older <span class="Hyperlink"><a href="https://link.springer.com/article/10.1007/s13670-021-00359-5">engaged in</a></span> binge drinking in the past month. Because of body changes, the negative effects of alcohol may be greater on older adults, including interactions between alcohol and commonly prescribed medications. <br/><br/>Conducting a lifestyle assessment is an important way to engage with older patients and allows clinicians to identify opportunities to improve health behaviors, understand obstacles, and support patients to make lifestyle changes. It may uncover ways to remove some of the pill and treatment burdens that older adults often experience. The American College of Lifestyle Medicine (ACLM) offers clinical practice resources to support clinicians as well as “<span class="Hyperlink"><a href="https://portal.lifestylemedicine.org/Portal/ACLM/Education/Campaigns/White-House/WHconference-SignIn.aspx">Lifestyle Medicine and Food as Medicine Essentials</a></span>,” a 5.5-hour complimentary CE/CME course on food and lifestyle medicine that introduces clinicians to the therapeutic use of lifestyle medicine. ACLM also offers members interest groups focused on geriatrics, fitness, and mental health, which may be beneficial to clinicians treating older adults.<br/><br/>By engaging with older patients on their lifestyle behaviors, we can ensure that we are doing all we can to help them live longer — and live better.<span class="end"/></p> <p> <em>Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development, and past president, American College of Lifestyle Medicine, Mountain View, California. She has disclosed no relevant financial relationships. </em> </p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/adding-life-your-patients-years-2024a10007gd">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Both Promise and Concern for OSA and CPAP with GLP-1s

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Fri, 04/19/2024 - 13:47

 

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

good_health_prescription_web.jpg


Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (doi: 10.1093/sleep/zsad224) published in Sleep citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies.

Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.”

Dr. Kuna agreed with the Sleep article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.
 

 

 

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Faiz_Saadia_web.jpg
Dr. Saadia A. Faiz

 

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

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Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

good_health_prescription_web.jpg


Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (doi: 10.1093/sleep/zsad224) published in Sleep citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies.

Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.”

Dr. Kuna agreed with the Sleep article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.
 

 

 

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Faiz_Saadia_web.jpg
Dr. Saadia A. Faiz

 

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

 

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

good_health_prescription_web.jpg


Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (doi: 10.1093/sleep/zsad224) published in Sleep citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies.

Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.”

Dr. Kuna agreed with the Sleep article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.
 

 

 

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Faiz_Saadia_web.jpg
Dr. Saadia A. Faiz

 

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.</metaDescription> <articlePDF/> <teaserImage>301145</teaserImage> <teaser>Weight loss drugs, GLP-1s, could aid in obesity-related conditions such as OSA, but do not eliminate the need for lifestyle changes.</teaser> <title>Both Promise and Concern for OSA and CPAP with GLP-1s</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>2</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">6</term> </publications> <sections> <term canonical="true">27980</term> </sections> <topics> <term canonical="true">296</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012858.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">Milleflore Images/Shutterstock</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/2400d5a9.jpg</altRep> <description role="drol:caption">Dr. Saadia A. Faiz</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Both Promise and Concern for OSA and CPAP with GLP-1s</title> <deck/> </itemMeta> <itemContent> <p>Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? <span class="tag metaDescription">Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.</span> </p> <p>“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with <em>CHEST Physician</em>. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (<span class="Hyperlink"><a href="https://doi.org/10.1164/rccm.201912-2511OC">doi: 10.1164/rccm.201912-2511OC</a></span>) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.</p> <h2>Potential for OSA impact</h2> <p>In a <em>JAMA Network Open</em>/Pulmonary Medicine article on a 2022 study (<span class="id-label">doi: </span><span class="Hyperlink"><a href="https://doi.org/10.1001/jamanetworkopen.2022.8212">10.1001/jamanetworkopen.2022.8212</a></span><span class="identifier">)</span> conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”<br/><br/>Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added. [[{"fid":"301145","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Prescription for good health overhead","field_file_image_credit[und][0][value]":"Milleflore Images/Shutterstock","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (<span class="Hyperlink"><a href="https://doi.org/10.1093/sleep/zsad224">doi: 10.1093/sleep/zsad224</a></span>) published in <em>Sleep</em> citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies. <br/><br/>Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.” <br/><br/>Dr. Kuna agreed with the <em>Sleep</em> article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.<br/><br/></p> <h2>Significant impact on OSA and CPAP</h2> <p>“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a <em>CHEST Physician</em> interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”[[{"fid":"256581","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Saadia A. Faiz, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Saadia A. Faiz"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]<br/><br/></p> <h2>Cost an obstacle for some</h2> <p>“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a <em>Respirology</em> (<span class="Hyperlink"><a href="https://doi.org/10.1111/resp.14545">doi: 10.1111/resp.14545</a></span>) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”<br/><br/></p> <h2>Beyond health equity concerns</h2> <p>The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing. <br/><br/>Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (<span class="Hyperlink"><a href="https://doi.org/10.1016/j.cmet.2019.05.008">doi: 10.1016/j.cmet.2019.05.008</a></span>), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [<em>P</em> = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [<em>P</em> = .007]) and body fat. <br/><br/>“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.<br/><br/>Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Eli Lilly to Ask FDA to Approve Weight Loss Drug for Sleep Apnea

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Mon, 04/22/2024 - 11:34

 

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

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Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

 

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

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People in both studies taking tirzepat</metaDescription> <articlePDF/> <teaserImage/> <teaser>Non–peer-reviewed early results of two studies indicate significant improvement in OSA symptoms, according to drug maker Eli Lilly.</teaser> <title>Eli Lilly to Ask FDA to Approve Weight Loss Drug for Sleep Apnea</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">6</term> <term>34</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">296</term> <term>261</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Eli Lilly to Ask FDA to Approve Weight Loss Drug for Sleep Apnea</title> <deck/> </itemMeta> <itemContent> <p>Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.</p> <p>Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.<br/><br/>The newly announced <span class="Hyperlink"><a href="https://investor.lilly.com/news-releases/news-release-details/tirzepatide-reduced-sleep-apnea-severity-nearly-two-thirds">results</a></span> came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. <span class="tag metaDescription">One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight.</span> About 70% of people in the studies were men.<br/><br/>The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.<br/><br/>People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.<br/><br/>A sleep expert from Washington University in St. Louis told <em><a href="https://www.nytimes.com/2024/04/17/health/sleep-apnea-obesity-zepbound.html">The New York Times</a> </em>the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.<br/><br/>Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told <em>The New York Times.</em> <br/><br/>Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.<br/><br/>An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to <span class="Hyperlink">The National Council on Aging</span>. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.webmd.com/sleep-disorders/sleep-apnea/news/20240417/eli-lilly-to-ask-fda-to-approve-weight-loss-drug-sleep-apnea">WebMD.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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