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Higher resting heart rate tied to increased dementia risk
independent of the presence of cardiovascular disease (CVD) risk factors, new research shows.
“RHR is easy to measure and might be used to identify older people potentially at high risk of dementia and cognitive decline for early interventions,” Yume Imahori, MD, PhD, with the Aging Research Center, Karolinska Institutet, Stockholm, said in an interview.
“Health care professionals should be aware of potential cognitive consequences associated with elevated RHR in older people and may advise older people with high RHR to have a follow-up assessment of cognitive function,” Dr. Imahori said.
The study was published online Dec. 3, 2021, in Alzheimer’s & Dementia.
Heart-brain connection
The findings are based on 2,147 adults (62% women) aged 60 years and older (mean age, 70.6 years) from the population-based Swedish National Aging and Care in Kungsholmen (SNAC-K) study. All were free of dementia at baseline and were followed regularly from 2001-2004 to 2013-2016.
The average RHR at baseline was 65.7 bpm. Individuals in higher RHR groups were older, less educated, and were more likely to be smokers and sedentary and to have hypertension. There were no differences among RHR groups in the prevalence of CVD at baseline.
During a median follow-up of 11.4 years, 289 participants were diagnosed with dementia.
In the fully adjusted model, participants with RHR of 80 bpm or higher had a 55% increased risk of developing dementia, compared with peers with lower RHR of 60 to 69 bpm (hazard ratio, 1.55; 95% CI, 1.06-2.27).
“This association was not due to underlying cardiovascular diseases such as atrial fibrillation and heart failure, which is important because elevated RHR is often related to heart disease,” Dr. Imahori said in an interview.
Regarding cognitive function, Mini-Mental State Examination scores declined over time during the follow-up period in all RHR groups, but participants with RHR 70-79 and 80+ bpm had a greater decline, compared with those with lower RHR of 60-69 bpm.
Dr. Imahori said these findings are in line with data from the U.S. Atherosclerosis Risk in Communities study linking elevated RHR of 80+ bpm in midlife to dementia and cognitive decline in late life.
Public health implications
Reached for comment, Claire Sexton, DPhil, Alzheimer’s Association director of scientific programs and outreach, said this study adds to the “growing body of research showing the health of the heart and brain are closely connected. However, this study only shows a correlation between resting heart rate and cognition, not causation. More research is needed.
“Evidence shows that other risk factors for cardiovascular disease and stroke – obesity, high blood pressure, and diabetes – negatively impact your cognitive health,” Dr. Sexton said in an interview.
“The Alzheimer’s Association believes the conversation about heart health management is something everyone should be having with their doctor,” she said.
“There are things you can do today to lower your risk for cardiovascular disease, including regular exercise and maintaining a healthy diet. Improving your heart health is an important step to maintaining your brain health as you age,” Dr. Sexton added.
SNAC-K is supported by the Swedish Ministry of Health and Social Affairs and the participating county councils and municipalities and in part by additional grants from the Swedish Research Council and the Swedish Research Council for Health, Working Life and Welfare. Dr. Imahori and Dr. Sexton disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
independent of the presence of cardiovascular disease (CVD) risk factors, new research shows.
“RHR is easy to measure and might be used to identify older people potentially at high risk of dementia and cognitive decline for early interventions,” Yume Imahori, MD, PhD, with the Aging Research Center, Karolinska Institutet, Stockholm, said in an interview.
“Health care professionals should be aware of potential cognitive consequences associated with elevated RHR in older people and may advise older people with high RHR to have a follow-up assessment of cognitive function,” Dr. Imahori said.
The study was published online Dec. 3, 2021, in Alzheimer’s & Dementia.
Heart-brain connection
The findings are based on 2,147 adults (62% women) aged 60 years and older (mean age, 70.6 years) from the population-based Swedish National Aging and Care in Kungsholmen (SNAC-K) study. All were free of dementia at baseline and were followed regularly from 2001-2004 to 2013-2016.
The average RHR at baseline was 65.7 bpm. Individuals in higher RHR groups were older, less educated, and were more likely to be smokers and sedentary and to have hypertension. There were no differences among RHR groups in the prevalence of CVD at baseline.
During a median follow-up of 11.4 years, 289 participants were diagnosed with dementia.
In the fully adjusted model, participants with RHR of 80 bpm or higher had a 55% increased risk of developing dementia, compared with peers with lower RHR of 60 to 69 bpm (hazard ratio, 1.55; 95% CI, 1.06-2.27).
“This association was not due to underlying cardiovascular diseases such as atrial fibrillation and heart failure, which is important because elevated RHR is often related to heart disease,” Dr. Imahori said in an interview.
Regarding cognitive function, Mini-Mental State Examination scores declined over time during the follow-up period in all RHR groups, but participants with RHR 70-79 and 80+ bpm had a greater decline, compared with those with lower RHR of 60-69 bpm.
Dr. Imahori said these findings are in line with data from the U.S. Atherosclerosis Risk in Communities study linking elevated RHR of 80+ bpm in midlife to dementia and cognitive decline in late life.
Public health implications
Reached for comment, Claire Sexton, DPhil, Alzheimer’s Association director of scientific programs and outreach, said this study adds to the “growing body of research showing the health of the heart and brain are closely connected. However, this study only shows a correlation between resting heart rate and cognition, not causation. More research is needed.
“Evidence shows that other risk factors for cardiovascular disease and stroke – obesity, high blood pressure, and diabetes – negatively impact your cognitive health,” Dr. Sexton said in an interview.
“The Alzheimer’s Association believes the conversation about heart health management is something everyone should be having with their doctor,” she said.
“There are things you can do today to lower your risk for cardiovascular disease, including regular exercise and maintaining a healthy diet. Improving your heart health is an important step to maintaining your brain health as you age,” Dr. Sexton added.
SNAC-K is supported by the Swedish Ministry of Health and Social Affairs and the participating county councils and municipalities and in part by additional grants from the Swedish Research Council and the Swedish Research Council for Health, Working Life and Welfare. Dr. Imahori and Dr. Sexton disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
independent of the presence of cardiovascular disease (CVD) risk factors, new research shows.
“RHR is easy to measure and might be used to identify older people potentially at high risk of dementia and cognitive decline for early interventions,” Yume Imahori, MD, PhD, with the Aging Research Center, Karolinska Institutet, Stockholm, said in an interview.
“Health care professionals should be aware of potential cognitive consequences associated with elevated RHR in older people and may advise older people with high RHR to have a follow-up assessment of cognitive function,” Dr. Imahori said.
The study was published online Dec. 3, 2021, in Alzheimer’s & Dementia.
Heart-brain connection
The findings are based on 2,147 adults (62% women) aged 60 years and older (mean age, 70.6 years) from the population-based Swedish National Aging and Care in Kungsholmen (SNAC-K) study. All were free of dementia at baseline and were followed regularly from 2001-2004 to 2013-2016.
The average RHR at baseline was 65.7 bpm. Individuals in higher RHR groups were older, less educated, and were more likely to be smokers and sedentary and to have hypertension. There were no differences among RHR groups in the prevalence of CVD at baseline.
During a median follow-up of 11.4 years, 289 participants were diagnosed with dementia.
In the fully adjusted model, participants with RHR of 80 bpm or higher had a 55% increased risk of developing dementia, compared with peers with lower RHR of 60 to 69 bpm (hazard ratio, 1.55; 95% CI, 1.06-2.27).
“This association was not due to underlying cardiovascular diseases such as atrial fibrillation and heart failure, which is important because elevated RHR is often related to heart disease,” Dr. Imahori said in an interview.
Regarding cognitive function, Mini-Mental State Examination scores declined over time during the follow-up period in all RHR groups, but participants with RHR 70-79 and 80+ bpm had a greater decline, compared with those with lower RHR of 60-69 bpm.
Dr. Imahori said these findings are in line with data from the U.S. Atherosclerosis Risk in Communities study linking elevated RHR of 80+ bpm in midlife to dementia and cognitive decline in late life.
Public health implications
Reached for comment, Claire Sexton, DPhil, Alzheimer’s Association director of scientific programs and outreach, said this study adds to the “growing body of research showing the health of the heart and brain are closely connected. However, this study only shows a correlation between resting heart rate and cognition, not causation. More research is needed.
“Evidence shows that other risk factors for cardiovascular disease and stroke – obesity, high blood pressure, and diabetes – negatively impact your cognitive health,” Dr. Sexton said in an interview.
“The Alzheimer’s Association believes the conversation about heart health management is something everyone should be having with their doctor,” she said.
“There are things you can do today to lower your risk for cardiovascular disease, including regular exercise and maintaining a healthy diet. Improving your heart health is an important step to maintaining your brain health as you age,” Dr. Sexton added.
SNAC-K is supported by the Swedish Ministry of Health and Social Affairs and the participating county councils and municipalities and in part by additional grants from the Swedish Research Council and the Swedish Research Council for Health, Working Life and Welfare. Dr. Imahori and Dr. Sexton disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ALZHEIMER’S & DEMENTIA
Blood pressure control worsened during COVID pandemic
Blood pressure control declined in both men and women with the onset of the COVID-19 pandemic in the United States in 2020, especially among women and older adults, according to a new analysis.
“We know that even small rises in blood pressure increase one’s risk of stroke and other adverse cardiovascular disease events,” lead author Luke J. Laffin, MD, codirector, Center for Blood Pressure Disorders, Cleveland Clinic, Ohio, said in a news release.
The researchers say increases in systolic BP among U.S. adults during the COVID-19 pandemic “could signal a forthcoming increase in incident cardiovascular disease mortality.”
Their study was published online Dec. 6 in Circulation.
Dr. Laffin and colleagues analyzed BP data from 464,585 U.S. adults (mean age, 46, 54% women) who had their BP measured as part of employee health screening annually from 2018 through 2020.
They found that BP levels went up between April and Dec. of 2020 – around the same time stay-at-home orders and other restrictions were put in place.
During this pandemic period, average monthly increases in BP ranged from 1.10 to 2.50 mm Hg higher for systolic BP and 0.14 to 0.53 mm Hg higher for diastolic BP, compared with the prepandemic period of April to Dec. 2019.
Increases in systolic and diastolic BP were seen among men and women and across age groups. Larger increases were evident in women for both systolic and diastolic BP: in older individuals for systolic BP and in younger individuals for diastolic BP (all P < .0001).
Dr. Laffin and colleagues also assessed changes in BP category based on current American Heart Association blood pressure guidelines (normal, elevated, stage 1, or stage 2 hypertension).
During the pandemic, more adults (26.8%) were recategorized to a higher BP category, whereas only 22% moved to a lower BP category, compared with before the pandemic.
“At the start of the pandemic, most people were not taking good care of themselves. Increases in blood pressure were likely related to changes in eating habits, increased alcohol consumption, less physical activity, decreased medication adherence, more emotional stress, and poor sleep,” Dr. Laffin said.
However, the increases in BP during the pandemic could not be explained by weight gain, the researchers note, because the observed changes in weight during the pandemic were similar to the prepandemic period among 86% of adults completing weight data.
The study authors are following up on these results to determine if this trend continued in 2021.
“Unfortunately, this research confirms what is being seen across the country – the COVID-19 pandemic has had and will continue to have long-reaching health impacts across the country and particularly related to uncontrolled hypertension,” Eduardo Sanchez, MD, MPH, the AHA’s chief medical officer for prevention, said in the news release.
“These results validate why the American Heart Association’s National Hypertension Control Initiative (NHCI) is critically important,” he said.
“With a particular emphasis on historically under-resourced communities in the United States, the comprehensive program supports health care teams at community health centers through regular blood pressure management training; technical assistance and resources that include the proper blood pressure measurement technique; self-measured blood pressure monitoring and management; medication adherence; and healthy lifestyle services,” Dr. Sanchez noted.
The study had no specific funding. Dr. Laffin is a paid consultant for Medtronic and medical advisor for LucidAct Health.
A version of this article first appeared on Medscape.com.
Blood pressure control declined in both men and women with the onset of the COVID-19 pandemic in the United States in 2020, especially among women and older adults, according to a new analysis.
“We know that even small rises in blood pressure increase one’s risk of stroke and other adverse cardiovascular disease events,” lead author Luke J. Laffin, MD, codirector, Center for Blood Pressure Disorders, Cleveland Clinic, Ohio, said in a news release.
The researchers say increases in systolic BP among U.S. adults during the COVID-19 pandemic “could signal a forthcoming increase in incident cardiovascular disease mortality.”
Their study was published online Dec. 6 in Circulation.
Dr. Laffin and colleagues analyzed BP data from 464,585 U.S. adults (mean age, 46, 54% women) who had their BP measured as part of employee health screening annually from 2018 through 2020.
They found that BP levels went up between April and Dec. of 2020 – around the same time stay-at-home orders and other restrictions were put in place.
During this pandemic period, average monthly increases in BP ranged from 1.10 to 2.50 mm Hg higher for systolic BP and 0.14 to 0.53 mm Hg higher for diastolic BP, compared with the prepandemic period of April to Dec. 2019.
Increases in systolic and diastolic BP were seen among men and women and across age groups. Larger increases were evident in women for both systolic and diastolic BP: in older individuals for systolic BP and in younger individuals for diastolic BP (all P < .0001).
Dr. Laffin and colleagues also assessed changes in BP category based on current American Heart Association blood pressure guidelines (normal, elevated, stage 1, or stage 2 hypertension).
During the pandemic, more adults (26.8%) were recategorized to a higher BP category, whereas only 22% moved to a lower BP category, compared with before the pandemic.
“At the start of the pandemic, most people were not taking good care of themselves. Increases in blood pressure were likely related to changes in eating habits, increased alcohol consumption, less physical activity, decreased medication adherence, more emotional stress, and poor sleep,” Dr. Laffin said.
However, the increases in BP during the pandemic could not be explained by weight gain, the researchers note, because the observed changes in weight during the pandemic were similar to the prepandemic period among 86% of adults completing weight data.
The study authors are following up on these results to determine if this trend continued in 2021.
“Unfortunately, this research confirms what is being seen across the country – the COVID-19 pandemic has had and will continue to have long-reaching health impacts across the country and particularly related to uncontrolled hypertension,” Eduardo Sanchez, MD, MPH, the AHA’s chief medical officer for prevention, said in the news release.
“These results validate why the American Heart Association’s National Hypertension Control Initiative (NHCI) is critically important,” he said.
“With a particular emphasis on historically under-resourced communities in the United States, the comprehensive program supports health care teams at community health centers through regular blood pressure management training; technical assistance and resources that include the proper blood pressure measurement technique; self-measured blood pressure monitoring and management; medication adherence; and healthy lifestyle services,” Dr. Sanchez noted.
The study had no specific funding. Dr. Laffin is a paid consultant for Medtronic and medical advisor for LucidAct Health.
A version of this article first appeared on Medscape.com.
Blood pressure control declined in both men and women with the onset of the COVID-19 pandemic in the United States in 2020, especially among women and older adults, according to a new analysis.
“We know that even small rises in blood pressure increase one’s risk of stroke and other adverse cardiovascular disease events,” lead author Luke J. Laffin, MD, codirector, Center for Blood Pressure Disorders, Cleveland Clinic, Ohio, said in a news release.
The researchers say increases in systolic BP among U.S. adults during the COVID-19 pandemic “could signal a forthcoming increase in incident cardiovascular disease mortality.”
Their study was published online Dec. 6 in Circulation.
Dr. Laffin and colleagues analyzed BP data from 464,585 U.S. adults (mean age, 46, 54% women) who had their BP measured as part of employee health screening annually from 2018 through 2020.
They found that BP levels went up between April and Dec. of 2020 – around the same time stay-at-home orders and other restrictions were put in place.
During this pandemic period, average monthly increases in BP ranged from 1.10 to 2.50 mm Hg higher for systolic BP and 0.14 to 0.53 mm Hg higher for diastolic BP, compared with the prepandemic period of April to Dec. 2019.
Increases in systolic and diastolic BP were seen among men and women and across age groups. Larger increases were evident in women for both systolic and diastolic BP: in older individuals for systolic BP and in younger individuals for diastolic BP (all P < .0001).
Dr. Laffin and colleagues also assessed changes in BP category based on current American Heart Association blood pressure guidelines (normal, elevated, stage 1, or stage 2 hypertension).
During the pandemic, more adults (26.8%) were recategorized to a higher BP category, whereas only 22% moved to a lower BP category, compared with before the pandemic.
“At the start of the pandemic, most people were not taking good care of themselves. Increases in blood pressure were likely related to changes in eating habits, increased alcohol consumption, less physical activity, decreased medication adherence, more emotional stress, and poor sleep,” Dr. Laffin said.
However, the increases in BP during the pandemic could not be explained by weight gain, the researchers note, because the observed changes in weight during the pandemic were similar to the prepandemic period among 86% of adults completing weight data.
The study authors are following up on these results to determine if this trend continued in 2021.
“Unfortunately, this research confirms what is being seen across the country – the COVID-19 pandemic has had and will continue to have long-reaching health impacts across the country and particularly related to uncontrolled hypertension,” Eduardo Sanchez, MD, MPH, the AHA’s chief medical officer for prevention, said in the news release.
“These results validate why the American Heart Association’s National Hypertension Control Initiative (NHCI) is critically important,” he said.
“With a particular emphasis on historically under-resourced communities in the United States, the comprehensive program supports health care teams at community health centers through regular blood pressure management training; technical assistance and resources that include the proper blood pressure measurement technique; self-measured blood pressure monitoring and management; medication adherence; and healthy lifestyle services,” Dr. Sanchez noted.
The study had no specific funding. Dr. Laffin is a paid consultant for Medtronic and medical advisor for LucidAct Health.
A version of this article first appeared on Medscape.com.
No serious CV risks for elderly after Pfizer COVID-19 vaccine
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.
The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.
“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.
The study was published as a research letter online Nov. 22 in JAMA.
The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.
As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.
Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.
During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.
In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.
The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.
For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.
For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.
There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.
“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.
“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.
The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.
As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.
The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Celiac disease and COVID-19: Reassuring data on outcomes
according to a new study.
Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.
There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.
The study was published online Nov. 11, 2021, in Gut.
To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.
After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.
Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).
After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).
Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).
The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.
Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.
“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.
They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.
“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.
The study had no specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.
There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.
The study was published online Nov. 11, 2021, in Gut.
To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.
After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.
Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).
After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).
Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).
The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.
Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.
“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.
They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.
“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.
The study had no specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
Patients with CD are a “population of interest” in terms of the clinical outcomes of COVID-19, Emad Mansoor, MD, Digestive Health Institute, University Hospitals of Cleveland, and colleagues said.
There is emerging evidence that chronic disorders may have an impact on COVID-19 outcomes. But until now, the consequences of COVID-19 in patients with CD have been unclear.
The study was published online Nov. 11, 2021, in Gut.
To investigate, Dr. Mansoor and colleagues used the TriNetX EHR database to identify 599 patients with CD and confirmed COVID-19 and 810,972 patients without CD but with confirmed COVID-19 from 51 health care organizations in the United States.
After propensity-score matching, the CD and non-CD cohorts were “relatively balanced”; there were 598 patients in each group.
Before propensity-score matching, COVID-19 patients with CD were significantly more likely to be hospitalized than peers without CD (18.2% vs. 11.3%; odds ratio, 1.74; 95% confidence interval, 1.41-2.14; P < .0001).
After matching, however, this association became insignificant (OR, 0.96; 95% CI, 0.71-1.11; P = .0906).
Before matching, patients with CD were also more apt to develop blood clots (5.3% vs. 2.1%; OR, 2.69; 95% CI, 1.88-3.83; P < .0001) but not after matching (OR, 0.938; 95% CI, 0.57-1.54; P = .800).
The same pattern was observed for the two other outcomes of interest: mortality and need for care in the ICU.
Overall, there were no significant differences among any of the measured outcomes between CD and non-CD patients with COVID-19 after propensity-score matching, Dr. Mansoor and colleagues reported.
“This is the largest study characterizing CD patients with COVID-19 to date to systematically investigate outcomes of CD patients with COVID-19,” Dr. Mansoor and colleagues wrote.
They also say that their findings are in line with a recent population-based study from Sweden, which found no significant increase in risk for hospitalization, severe COVID-19, or increase in death between CD and non-CD patients with COVID-19.
“Although reassuring, this study is all about outcomes in individuals with diagnosed CD and the potential impact of COVID-19 in patients with undiagnosed CD remains unknown,” the researchers wrote.
The study had no specific funding. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM GUT
AHA statement on impact of major life events on physical activity
Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.
With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.
The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.
The statement was published online Dec. 1 in the journal Circulation.
The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.
“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.
The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
Some more vulnerable than others
The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.
The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.
They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.
“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.
“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.
The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”
The statement provides a list of resources for individuals and health care professionals, many of which are free and online.
This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.
With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.
The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.
The statement was published online Dec. 1 in the journal Circulation.
The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.
“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.
The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
Some more vulnerable than others
The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.
The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.
They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.
“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.
“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.
The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”
The statement provides a list of resources for individuals and health care professionals, many of which are free and online.
This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.
With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.
The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.
The statement was published online Dec. 1 in the journal Circulation.
The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.
“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.
The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
Some more vulnerable than others
The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.
The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.
They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.
“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.
“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.
The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”
The statement provides a list of resources for individuals and health care professionals, many of which are free and online.
This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Colorectal cancer rates rising in people aged 50-54 years
mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.
“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.
“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.
The study was published online October 28 in Gastroenterology .
Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.
During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.
Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.
Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.
“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.
They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.
These data send a clear message, Dr. Murphy told this news organization.
“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
Concerning but not surprising
Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.
What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.
“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.
“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.
The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.
“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.
“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.
The study was published online October 28 in Gastroenterology .
Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.
During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.
Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.
Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.
“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.
They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.
These data send a clear message, Dr. Murphy told this news organization.
“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
Concerning but not surprising
Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.
What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.
“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.
“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.
The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.
“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.
“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.
The study was published online October 28 in Gastroenterology .
Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.
During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.
Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.
Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.
“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.
They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.
These data send a clear message, Dr. Murphy told this news organization.
“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
Concerning but not surprising
Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.
What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”
David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.
“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.
“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.
The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM GASTROENTEROLOGY
AAN issues ethical guidance on controversial Alzheimer’s drug
The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.
“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.
The statement was published online Nov. 17 in Neurology.
Open, honest communication
The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.
The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.
All of this should be communicated to patients, the AAN advises.
Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.
The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.
It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous.
“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
‘New territory’ for neurologists
“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.
Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.
The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.
“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.
“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.
This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.
This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.
“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.
The statement was published online Nov. 17 in Neurology.
Open, honest communication
The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.
The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.
All of this should be communicated to patients, the AAN advises.
Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.
The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.
It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous.
“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
‘New territory’ for neurologists
“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.
Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.
The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.
“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.
“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.
This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.
This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.
“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.
The statement was published online Nov. 17 in Neurology.
Open, honest communication
The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.
The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.
All of this should be communicated to patients, the AAN advises.
Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.
The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.
It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous.
“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
‘New territory’ for neurologists
“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.
Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.
The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.
“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.
“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.
This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.
This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
Lithium’s antisuicidal effects questioned
Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.
The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.
“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.
The study was published online JAMA Psychiatry.
Surprising findings
The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.
However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.
This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.
Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.
The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.
The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.
There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).
One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
Caveats, cautionary notes
The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.
They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.
As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.
The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.
In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.
Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.
“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.
Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.
Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.
Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.
The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.
Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.
A version of this article first appeared on Medscape.com.
Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.
The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.
“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.
The study was published online JAMA Psychiatry.
Surprising findings
The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.
However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.
This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.
Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.
The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.
The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.
There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).
One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
Caveats, cautionary notes
The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.
They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.
As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.
The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.
In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.
Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.
“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.
Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.
Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.
Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.
The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.
Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.
A version of this article first appeared on Medscape.com.
Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.
The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.
“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.
The study was published online JAMA Psychiatry.
Surprising findings
The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.
However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.
This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.
Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.
The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.
The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.
There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).
One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
Caveats, cautionary notes
The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.
They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.
As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.
The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.
In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.
Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.
“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.
Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.
Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.
Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.
The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.
Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
CDC unveils mental health protection plan for health care workers
Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.
“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
Burnout is not selective
There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.
He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.
Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.
Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. , Dr. Howard said.
Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data.
“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.
Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.
“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
Primary prevention approach
To tackle the burnout crisis, NIOSH plans to:
- Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
- Assimilate the evidence and create a repository of best practices, resources, and interventions.
- Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
- Identify and adapt tools for the health care workplace that emphasize stress reduction.
NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.
This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.
Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.
A version of this article first appeared on Medscape.com.
Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.
“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
Burnout is not selective
There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.
He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.
Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.
Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. , Dr. Howard said.
Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data.
“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.
Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.
“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
Primary prevention approach
To tackle the burnout crisis, NIOSH plans to:
- Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
- Assimilate the evidence and create a repository of best practices, resources, and interventions.
- Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
- Identify and adapt tools for the health care workplace that emphasize stress reduction.
NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.
This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.
Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.
A version of this article first appeared on Medscape.com.
Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.
“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.
“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
Burnout is not selective
There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.
He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.
Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.
Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. , Dr. Howard said.
Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data.
“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.
Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.
“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
Primary prevention approach
To tackle the burnout crisis, NIOSH plans to:
- Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
- Assimilate the evidence and create a repository of best practices, resources, and interventions.
- Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
- Identify and adapt tools for the health care workplace that emphasize stress reduction.
NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.
This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.
Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.
A version of this article first appeared on Medscape.com.
Growing evidence supports repurposing antidepressants to treat COVID-19
Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.
A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.
“We can’t tell if the drugs are causing these effects, but the statistical analysis is showing significant association. There’s power in the numbers,” Marina Sirota, PhD, University of California, San Francisco (UCSF), said in a statement.
The study was published online Nov. 15 in JAMA Network Open.
Data-driven approach
, including 3,401 patients who were prescribed SSRIs.
When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.
Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).
“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.
“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.
“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.
Urgent need
The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.
Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.
“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.
“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.
The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.
A version of this article first appeared on Medscape.com.
Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.
A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.
“We can’t tell if the drugs are causing these effects, but the statistical analysis is showing significant association. There’s power in the numbers,” Marina Sirota, PhD, University of California, San Francisco (UCSF), said in a statement.
The study was published online Nov. 15 in JAMA Network Open.
Data-driven approach
, including 3,401 patients who were prescribed SSRIs.
When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.
Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).
“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.
“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.
“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.
Urgent need
The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.
Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.
“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.
“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.
The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.
A version of this article first appeared on Medscape.com.
Mounting evidence suggests selective serotonin reuptake inhibitors (SSRI) are associated with lower COVID-19 severity.
A large analysis of health records shows patients with COVID-19 taking an SSRI were significantly less likely to die of COVID-19 than a matched control group.
“We can’t tell if the drugs are causing these effects, but the statistical analysis is showing significant association. There’s power in the numbers,” Marina Sirota, PhD, University of California, San Francisco (UCSF), said in a statement.
The study was published online Nov. 15 in JAMA Network Open.
Data-driven approach
, including 3,401 patients who were prescribed SSRIs.
When compared with matched patients with COVID-19 taking SSRIs, patients taking fluoxetine were 28% less likely to die (relative risk, 0.72; 95% CI, 0.54-0.97; adjusted P = .03) and those taking either fluoxetine or fluvoxamine were 26% less likely to die (RR, 0.74; 95% CI, 0.55-0.99; adjusted P = .04) versus those not on these medications.
Patients with COVID-19 taking any kind of SSRI were 8% less likely to die than the matched controls (RR, 0.92; 95% CI, 0.85-0.99; adjusted P = .03).
“We observed a statistically significant reduction in mortality of COVID-19 patients who were already taking SSRIs. This is a demonstration of a data-driven approach for identifying new uses for existing drugs,” Dr. Sirota said in an interview.
“Our study simply shows an association between SSRIs and COVID-19 outcomes and doesn’t investigate the mechanism of action of why the drugs might work. Additional clinical trials need to be carried out before these drugs can be used in patients going forward,” she cautioned.
“There is currently an open-label trial investigating fluoxetine to reduce intubation and death after COVID-19. To our knowledge, there are no phase 3 randomized controlled trials taking place or planned,” study investigator Tomiko Oskotsky, MD, with UCSF, told this news organization.
Urgent need
The current results “confirm and expand on prior findings from observational, preclinical, and clinical studies suggesting that certain SSRI antidepressants, including fluoxetine or fluvoxamine, could be beneficial against COVID-19,” Nicolas Hoertel, MD, PhD, MPH, with Paris University and Corentin-Celton Hospital, France, writes in a linked editorial.
Dr. Hoertel notes that the anti-inflammatory properties of SSRIs may underlie their potential action against COVID-19, and other potential mechanisms may include reduction in platelet aggregation, decreased mast cell degranulation, increased melatonin levels, interference with endolysosomal viral trafficking, and antioxidant activities.
“Because most of the world’s population is currently unvaccinated and the COVID-19 pandemic is still active, effective treatments of COVID-19 – especially those that are easy to use, show good tolerability, can be administered orally, and have widespread availability at low cost to allow their use in resource-poor countries – are urgently needed to reduce COVID-19-related mortality and morbidity,” Dr. Hoertel points out.
“In this context, short-term use of fluoxetine or fluvoxamine, if proven effective, should be considered as a potential means of reaching this goal,” he adds.
The study was supported by the Christopher Hess Research Fund and, in part, by UCSF and the National Institutes of Health. Dr. Sirota has reported serving as a scientific advisor at Aria Pharmaceuticals. Dr. Hoertel has reported being listed as an inventor on a patent application related to methods of treating COVID-19, filed by Assistance Publique-Hopitaux de Paris, and receiving consulting fees and nonfinancial support from Lundbeck.
A version of this article first appeared on Medscape.com.