Megan Brooks

The composition of gut bacteria in people with preclinical Alzheimer’s disease (AD) differs from that of healthy people, a new study shows.

The findings open up the possibility of analyzing the gut microbiome to identify individuals at a higher risk for dementia and perhaps designing microbiome-altering preventive treatments to help stave off cognitive decline, researchers noted.

Study investigator Gautam Dantas, PhD, cautioned that it’s not known whether the gut is influencing the brain, or the brain is influencing the gut, “but this association is valuable to know in either case.

“It could be that the changes in the gut microbiome are just a readout of pathological changes in the brain. The other alternative is that the gut microbiome is contributing to AD, in which case, altering the gut microbiome with probiotics or fecal transfers might help change the course of the disease,” Dr. Dantas, Washington University, St. Louis, said in a news release.

The study was published online in Science Translational Medicine.
 

Stool test?

Multiple lines of evidence suggest a role for gut microbes in the evolution of AD pathogenesis. However, less is known about gut microbiome changes in the preclinical (presymptomatic) phase of AD.

To investigate, Dr. Dantas and colleagues studied 164 cognitively normal adults, 49 of whom had biomarker evidence of preclinical AD.

After the researchers accounted for clinical covariates and diet, those with preclinical AD had distinct gut microbial taxonomic profiles compared with their healthy controls.

The observed microbiome features correlated with amyloid and tau but not neurodegeneration biomarkers, “suggesting that the gut microbial community changes early in the disease process,” the researchers suggested.

They identified specific taxa that were associated with preclinical AD and including these microbiome features improved the accuracy, sensitivity, and specificity of machine learning classifiers for predicting preclinical AD status.

The findings suggest “markers in the stool might complement early screening measures for preclinical AD,” the researchers noted.

“The nice thing about using the gut microbiome as a screening tool is its simplicity and ease,” Beau Ances, MD, PhD, professor of neurology, at Washington University, St. Louis, said in the release.

“One day, individuals may be able to provide a stool sample and find out if they are at increased risk for developing AD. It would be much easier and less invasive and more accessible for a large proportion of the population, especially underrepresented groups, compared to brain scans or spinal taps,” Dr. Ances added.

The researchers have launched a 5-year follow-up study designed to help determine whether the differences in the gut microbiome are a cause or a result of the brain changes seen in early AD.
 

Caveats, cautionary notes

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, cautioned that the study design means that it’s “not possible to prove one thing causes another. What it can show is that two or more aspects are in some way related, thus setting the stage for further research.”

Dr. Sexton noted that though the authors accounted for a number of variables in their models, including age, sex, race, education, body mass index, hypertension, and diabetes, and observed no differences in intake of any major nutrient group, “it’s still not possible to rule out that additional factors beyond the variations in gut microbiome contributed to the changes in brain markers of Alzheimer’s.”

Dr. Sexton also noted that the study population is not representative of all people living with AD, with the vast majority of those with preclinical AD in the study being White.

“If these findings are replicated and confirmed in study groups that are representative of our communities, it is possible that gut microbiome signatures could be a further addition to the suite of diagnostic tools employed in certain settings,” Dr. Sexton said.

This research was supported by the Infection Disease Society of America Foundation, the National Institute on Aging, the Brennan Fund and the Paula and Rodger Riney Foundation. Dr. Dantas, Dr. Ances and Dr. Sexton have no relevant disclosures.

A version of this article first appeared on Medscape.com.

The composition of gut bacteria in people with preclinical Alzheimer’s disease (AD) differs from that of healthy people, a new study shows.

The findings open up the possibility of analyzing the gut microbiome to identify individuals at a higher risk for dementia and perhaps designing microbiome-altering preventive treatments to help stave off cognitive decline, researchers noted.

Study investigator Gautam Dantas, PhD, cautioned that it’s not known whether the gut is influencing the brain, or the brain is influencing the gut, “but this association is valuable to know in either case.

“It could be that the changes in the gut microbiome are just a readout of pathological changes in the brain. The other alternative is that the gut microbiome is contributing to AD, in which case, altering the gut microbiome with probiotics or fecal transfers might help change the course of the disease,” Dr. Dantas, Washington University, St. Louis, said in a news release.

The study was published online in Science Translational Medicine.
 

Stool test?

Multiple lines of evidence suggest a role for gut microbes in the evolution of AD pathogenesis. However, less is known about gut microbiome changes in the preclinical (presymptomatic) phase of AD.

To investigate, Dr. Dantas and colleagues studied 164 cognitively normal adults, 49 of whom had biomarker evidence of preclinical AD.

After the researchers accounted for clinical covariates and diet, those with preclinical AD had distinct gut microbial taxonomic profiles compared with their healthy controls.

The observed microbiome features correlated with amyloid and tau but not neurodegeneration biomarkers, “suggesting that the gut microbial community changes early in the disease process,” the researchers suggested.

They identified specific taxa that were associated with preclinical AD and including these microbiome features improved the accuracy, sensitivity, and specificity of machine learning classifiers for predicting preclinical AD status.

The findings suggest “markers in the stool might complement early screening measures for preclinical AD,” the researchers noted.

“The nice thing about using the gut microbiome as a screening tool is its simplicity and ease,” Beau Ances, MD, PhD, professor of neurology, at Washington University, St. Louis, said in the release.

“One day, individuals may be able to provide a stool sample and find out if they are at increased risk for developing AD. It would be much easier and less invasive and more accessible for a large proportion of the population, especially underrepresented groups, compared to brain scans or spinal taps,” Dr. Ances added.

The researchers have launched a 5-year follow-up study designed to help determine whether the differences in the gut microbiome are a cause or a result of the brain changes seen in early AD.
 

Caveats, cautionary notes

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, cautioned that the study design means that it’s “not possible to prove one thing causes another. What it can show is that two or more aspects are in some way related, thus setting the stage for further research.”

Dr. Sexton noted that though the authors accounted for a number of variables in their models, including age, sex, race, education, body mass index, hypertension, and diabetes, and observed no differences in intake of any major nutrient group, “it’s still not possible to rule out that additional factors beyond the variations in gut microbiome contributed to the changes in brain markers of Alzheimer’s.”

Dr. Sexton also noted that the study population is not representative of all people living with AD, with the vast majority of those with preclinical AD in the study being White.

“If these findings are replicated and confirmed in study groups that are representative of our communities, it is possible that gut microbiome signatures could be a further addition to the suite of diagnostic tools employed in certain settings,” Dr. Sexton said.

This research was supported by the Infection Disease Society of America Foundation, the National Institute on Aging, the Brennan Fund and the Paula and Rodger Riney Foundation. Dr. Dantas, Dr. Ances and Dr. Sexton have no relevant disclosures.

A version of this article first appeared on Medscape.com.

The composition of gut bacteria in people with preclinical Alzheimer’s disease (AD) differs from that of healthy people, a new study shows.

The findings open up the possibility of analyzing the gut microbiome to identify individuals at a higher risk for dementia and perhaps designing microbiome-altering preventive treatments to help stave off cognitive decline, researchers noted.

Study investigator Gautam Dantas, PhD, cautioned that it’s not known whether the gut is influencing the brain, or the brain is influencing the gut, “but this association is valuable to know in either case.

“It could be that the changes in the gut microbiome are just a readout of pathological changes in the brain. The other alternative is that the gut microbiome is contributing to AD, in which case, altering the gut microbiome with probiotics or fecal transfers might help change the course of the disease,” Dr. Dantas, Washington University, St. Louis, said in a news release.

The study was published online in Science Translational Medicine.
 

Stool test?

Multiple lines of evidence suggest a role for gut microbes in the evolution of AD pathogenesis. However, less is known about gut microbiome changes in the preclinical (presymptomatic) phase of AD.

To investigate, Dr. Dantas and colleagues studied 164 cognitively normal adults, 49 of whom had biomarker evidence of preclinical AD.

After the researchers accounted for clinical covariates and diet, those with preclinical AD had distinct gut microbial taxonomic profiles compared with their healthy controls.

The observed microbiome features correlated with amyloid and tau but not neurodegeneration biomarkers, “suggesting that the gut microbial community changes early in the disease process,” the researchers suggested.

They identified specific taxa that were associated with preclinical AD and including these microbiome features improved the accuracy, sensitivity, and specificity of machine learning classifiers for predicting preclinical AD status.

The findings suggest “markers in the stool might complement early screening measures for preclinical AD,” the researchers noted.

“The nice thing about using the gut microbiome as a screening tool is its simplicity and ease,” Beau Ances, MD, PhD, professor of neurology, at Washington University, St. Louis, said in the release.

“One day, individuals may be able to provide a stool sample and find out if they are at increased risk for developing AD. It would be much easier and less invasive and more accessible for a large proportion of the population, especially underrepresented groups, compared to brain scans or spinal taps,” Dr. Ances added.

The researchers have launched a 5-year follow-up study designed to help determine whether the differences in the gut microbiome are a cause or a result of the brain changes seen in early AD.
 

Caveats, cautionary notes

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, cautioned that the study design means that it’s “not possible to prove one thing causes another. What it can show is that two or more aspects are in some way related, thus setting the stage for further research.”

Dr. Sexton noted that though the authors accounted for a number of variables in their models, including age, sex, race, education, body mass index, hypertension, and diabetes, and observed no differences in intake of any major nutrient group, “it’s still not possible to rule out that additional factors beyond the variations in gut microbiome contributed to the changes in brain markers of Alzheimer’s.”

Dr. Sexton also noted that the study population is not representative of all people living with AD, with the vast majority of those with preclinical AD in the study being White.

“If these findings are replicated and confirmed in study groups that are representative of our communities, it is possible that gut microbiome signatures could be a further addition to the suite of diagnostic tools employed in certain settings,” Dr. Sexton said.

This research was supported by the Infection Disease Society of America Foundation, the National Institute on Aging, the Brennan Fund and the Paula and Rodger Riney Foundation. Dr. Dantas, Dr. Ances and Dr. Sexton have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Confirming the importance of sleep health, new research shows that short and disrupted sleep increases the risk of fall-related and motor vehicle–related injury among U.S. adults.

Among the study’s key findings – adults who get 4 hours or less nightly and those who have trouble staying asleep are significantly more likely to be injured than peers who sleep the recommended 7-8 hours and those who never have trouble staying asleep.

The findings were presented at SLEEP 2023: 37th Annual Meeting of the Associated Professional Sleep Societies.
 

‘Stark differences’

In 2020, 55.4 million (roughly 1 in 6) Americans sought medical attention for nonfatal, preventable injuries.

“Poor sleep has been identified as a risk factor for preventable injuries,” study investigator Clarence Locklear, MA, who is a PhD student with the Center for Translational Sleep and Circadian Sciences, University of Miami Miller School of Medicine, told this news organization.

For the study, the researchers examined associations between different types of sleep problems and different types of injuries utilizing data on 31,568 adults who participated in the 2020 National Health Interview Survey.

They investigated three types of injuries (fall-related, sports-related, and motor vehicle–related) and four domains of past-month sleep health: (1) sleep quantity: very short (≤ 4 hours), short (5-6 hours), healthy (7-8 hours), or long (≥ 9 hours); (2) sleep quality: trouble falling asleep and trouble staying asleep; (3) feeling well rested upon waking up; and (4) sleep medications.

Overall, 9% of adults suffered an injury in the prior 3 months. Among injured adults, 47% had a fall-related injury, 29% had a sports-related injury, and 6% had a motor vehicle–related injury.

Adults with very short sleep, those with short sleep, and those with long sleep were 37%, 15%, and 22% more likely to be injured, respectively, than adults with healthy sleep (P < .05), the researchers found.

Those who had trouble staying asleep were 36% more likely to be injured than peers who never had trouble staying asleep (P < .01).

Adults who never woke up feeling rested and those who woke up feeling rested only on some days were 49% and 36% more likely to be injured (P < .01), respectively, than peers who always felt rested on waking.

Individuals who on some days took medication for sleep were 24% (P < .05) more likely to suffer an injury and those who took sleep medication every day were 36% (P < .001) more likely to get injured than those who never took sleep medication.

“These are pretty stark differences,” said Mr. Locklear.

Regarding injury type, those who had trouble staying asleep some days were 22% (P < .05) more likely to have a fall-related injury and were 3.5 times (P < .01) more likely to experience a motor vehicle–related injury than peers who didn’t have trouble staying asleep.

People who took sleep medication most days were 2.4 times more likely to suffer a fall than those who never took sleep medication. In addition, adults who reported long sleep (9+ hours nightly) were 43% less likely to have sports-related injuries (P < .05) than healthy sleepers (7-8 hours).
 

Quantity and quality matter

Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, said the results are “not particularly surprising but are consistent with other data.”

Dr. Breus said, “Many people don’t realize it’s not just sleep deprivation, in terms of minutes, that’s a problem. Our quality of sleep also matters. You can get 8 hours of crappy sleep and still injure yourself playing sports or get into a car accident due to poor reaction time.”

As previously reported by this news organization, the American Heart Association recently added healthy sleep as an essential component of heart health. “It’s nice to see them recognize that sleep is a big deal, and we’ve got the data to back it up,” said Dr. Breus.

He noted that people often ask him what’s the one thing they can do to improve sleep.

“The answer is always, wake up at the same time every single day, including the weekend, because your circadian system realigns every single morning.

“I solve maybe 50%-60% of people’s problems by just telling them to just wake up at the same time 7 days a week. I personally have been doing it for a very long time,” said Dr. Breus.

The study was supported by the National Heart Lung and Blood Institute. Mr. Locklear and Dr. Breus have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Confirming the importance of sleep health, new research shows that short and disrupted sleep increases the risk of fall-related and motor vehicle–related injury among U.S. adults.

Among the study’s key findings – adults who get 4 hours or less nightly and those who have trouble staying asleep are significantly more likely to be injured than peers who sleep the recommended 7-8 hours and those who never have trouble staying asleep.

The findings were presented at SLEEP 2023: 37th Annual Meeting of the Associated Professional Sleep Societies.
 

‘Stark differences’

In 2020, 55.4 million (roughly 1 in 6) Americans sought medical attention for nonfatal, preventable injuries.

“Poor sleep has been identified as a risk factor for preventable injuries,” study investigator Clarence Locklear, MA, who is a PhD student with the Center for Translational Sleep and Circadian Sciences, University of Miami Miller School of Medicine, told this news organization.

For the study, the researchers examined associations between different types of sleep problems and different types of injuries utilizing data on 31,568 adults who participated in the 2020 National Health Interview Survey.

They investigated three types of injuries (fall-related, sports-related, and motor vehicle–related) and four domains of past-month sleep health: (1) sleep quantity: very short (≤ 4 hours), short (5-6 hours), healthy (7-8 hours), or long (≥ 9 hours); (2) sleep quality: trouble falling asleep and trouble staying asleep; (3) feeling well rested upon waking up; and (4) sleep medications.

Overall, 9% of adults suffered an injury in the prior 3 months. Among injured adults, 47% had a fall-related injury, 29% had a sports-related injury, and 6% had a motor vehicle–related injury.

Adults with very short sleep, those with short sleep, and those with long sleep were 37%, 15%, and 22% more likely to be injured, respectively, than adults with healthy sleep (P < .05), the researchers found.

Those who had trouble staying asleep were 36% more likely to be injured than peers who never had trouble staying asleep (P < .01).

Adults who never woke up feeling rested and those who woke up feeling rested only on some days were 49% and 36% more likely to be injured (P < .01), respectively, than peers who always felt rested on waking.

Individuals who on some days took medication for sleep were 24% (P < .05) more likely to suffer an injury and those who took sleep medication every day were 36% (P < .001) more likely to get injured than those who never took sleep medication.

“These are pretty stark differences,” said Mr. Locklear.

Regarding injury type, those who had trouble staying asleep some days were 22% (P < .05) more likely to have a fall-related injury and were 3.5 times (P < .01) more likely to experience a motor vehicle–related injury than peers who didn’t have trouble staying asleep.

People who took sleep medication most days were 2.4 times more likely to suffer a fall than those who never took sleep medication. In addition, adults who reported long sleep (9+ hours nightly) were 43% less likely to have sports-related injuries (P < .05) than healthy sleepers (7-8 hours).
 

Quantity and quality matter

Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, said the results are “not particularly surprising but are consistent with other data.”

Dr. Breus said, “Many people don’t realize it’s not just sleep deprivation, in terms of minutes, that’s a problem. Our quality of sleep also matters. You can get 8 hours of crappy sleep and still injure yourself playing sports or get into a car accident due to poor reaction time.”

As previously reported by this news organization, the American Heart Association recently added healthy sleep as an essential component of heart health. “It’s nice to see them recognize that sleep is a big deal, and we’ve got the data to back it up,” said Dr. Breus.

He noted that people often ask him what’s the one thing they can do to improve sleep.

“The answer is always, wake up at the same time every single day, including the weekend, because your circadian system realigns every single morning.

“I solve maybe 50%-60% of people’s problems by just telling them to just wake up at the same time 7 days a week. I personally have been doing it for a very long time,” said Dr. Breus.

The study was supported by the National Heart Lung and Blood Institute. Mr. Locklear and Dr. Breus have no relevant disclosures.

A version of this article first appeared on Medscape.com.

Confirming the importance of sleep health, new research shows that short and disrupted sleep increases the risk of fall-related and motor vehicle–related injury among U.S. adults.

Among the study’s key findings – adults who get 4 hours or less nightly and those who have trouble staying asleep are significantly more likely to be injured than peers who sleep the recommended 7-8 hours and those who never have trouble staying asleep.

The findings were presented at SLEEP 2023: 37th Annual Meeting of the Associated Professional Sleep Societies.
 

‘Stark differences’

In 2020, 55.4 million (roughly 1 in 6) Americans sought medical attention for nonfatal, preventable injuries.

“Poor sleep has been identified as a risk factor for preventable injuries,” study investigator Clarence Locklear, MA, who is a PhD student with the Center for Translational Sleep and Circadian Sciences, University of Miami Miller School of Medicine, told this news organization.

For the study, the researchers examined associations between different types of sleep problems and different types of injuries utilizing data on 31,568 adults who participated in the 2020 National Health Interview Survey.

They investigated three types of injuries (fall-related, sports-related, and motor vehicle–related) and four domains of past-month sleep health: (1) sleep quantity: very short (≤ 4 hours), short (5-6 hours), healthy (7-8 hours), or long (≥ 9 hours); (2) sleep quality: trouble falling asleep and trouble staying asleep; (3) feeling well rested upon waking up; and (4) sleep medications.

Overall, 9% of adults suffered an injury in the prior 3 months. Among injured adults, 47% had a fall-related injury, 29% had a sports-related injury, and 6% had a motor vehicle–related injury.

Adults with very short sleep, those with short sleep, and those with long sleep were 37%, 15%, and 22% more likely to be injured, respectively, than adults with healthy sleep (P < .05), the researchers found.

Those who had trouble staying asleep were 36% more likely to be injured than peers who never had trouble staying asleep (P < .01).

Adults who never woke up feeling rested and those who woke up feeling rested only on some days were 49% and 36% more likely to be injured (P < .01), respectively, than peers who always felt rested on waking.

Individuals who on some days took medication for sleep were 24% (P < .05) more likely to suffer an injury and those who took sleep medication every day were 36% (P < .001) more likely to get injured than those who never took sleep medication.

“These are pretty stark differences,” said Mr. Locklear.

Regarding injury type, those who had trouble staying asleep some days were 22% (P < .05) more likely to have a fall-related injury and were 3.5 times (P < .01) more likely to experience a motor vehicle–related injury than peers who didn’t have trouble staying asleep.

People who took sleep medication most days were 2.4 times more likely to suffer a fall than those who never took sleep medication. In addition, adults who reported long sleep (9+ hours nightly) were 43% less likely to have sports-related injuries (P < .05) than healthy sleepers (7-8 hours).
 

Quantity and quality matter

Michael Breus, PhD, clinical psychologist and founder of TheSleepDoctor.com, said the results are “not particularly surprising but are consistent with other data.”

Dr. Breus said, “Many people don’t realize it’s not just sleep deprivation, in terms of minutes, that’s a problem. Our quality of sleep also matters. You can get 8 hours of crappy sleep and still injure yourself playing sports or get into a car accident due to poor reaction time.”

As previously reported by this news organization, the American Heart Association recently added healthy sleep as an essential component of heart health. “It’s nice to see them recognize that sleep is a big deal, and we’ve got the data to back it up,” said Dr. Breus.

He noted that people often ask him what’s the one thing they can do to improve sleep.

“The answer is always, wake up at the same time every single day, including the weekend, because your circadian system realigns every single morning.

“I solve maybe 50%-60% of people’s problems by just telling them to just wake up at the same time 7 days a week. I personally have been doing it for a very long time,” said Dr. Breus.

The study was supported by the National Heart Lung and Blood Institute. Mr. Locklear and Dr. Breus have no relevant disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

A new analysis shows a significant association between plant-rich, low-carbohydrate diets and overall survival, but not breast cancer–specific survival, among women with stage I-III breast cancer.

METHODOLOGY:

• The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
• Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
• Cox proportional hazards regression models adjusted for multiple potential confounding factors.
• Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.

TAKEAWAY:

• Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
• Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
• Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
• But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.

IN PRACTICE:

“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.

STUDY DETAILS:

The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.

LIMITATIONS:

Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.

DISCLOSURES:

Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.

A version of this article first appeared on Medscape.com.

TOPLINE:

A new analysis shows a significant association between plant-rich, low-carbohydrate diets and overall survival, but not breast cancer–specific survival, among women with stage I-III breast cancer.

METHODOLOGY:

• The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
• Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
• Cox proportional hazards regression models adjusted for multiple potential confounding factors.
• Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.

TAKEAWAY:

• Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
• Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
• Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
• But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.

IN PRACTICE:

“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.

STUDY DETAILS:

The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.

LIMITATIONS:

Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.

DISCLOSURES:

Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.

A version of this article first appeared on Medscape.com.

TOPLINE:

A new analysis shows a significant association between plant-rich, low-carbohydrate diets and overall survival, but not breast cancer–specific survival, among women with stage I-III breast cancer.

METHODOLOGY:

• The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
• Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
• Cox proportional hazards regression models adjusted for multiple potential confounding factors.
• Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.

TAKEAWAY:

• Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
• Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
• Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
• But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.

IN PRACTICE:

“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.

STUDY DETAILS:

The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.

LIMITATIONS:

Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.

DISCLOSURES:

Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.

A version of this article first appeared on Medscape.com.

An oral oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD) led to a significant and meaningful reduction in motor and vocal tics in patients with severe Tourette syndrome (TS), results of a double-blind, placebo-controlled, crossover study show.

“In a methodologically robust manner (and independent of any drug company sponsorship), we provide evidence for the effectiveness of repeated dosing with THC:CBD vs. placebo in tic suppression, as well as reduction of comorbid anxiety and obsessive-compulsive disorder in severe TS,” neuropsychiatrist and lead investigator Philip Mosley, PhD, said in an interview.

The results offer support to people with TS who “want to approach their doctor to try medicinal cannabis when other drugs have not worked or are intolerable,” said Dr. Mosley, of the Wesley Research Institute and QIMR Berghofer Medical Research Institute, Herston, Australia.

The study was published online in NEJM Evidence.
 

A viable treatment option

Twenty-two adults (mean age, 31 years) with severe TS received THC:CBD oil titrated upward over 6 weeks to a daily dose of 20 mg of THC and 20 mg of CBD, followed by a 6-week course of placebo (or vice versa). Six participants had not previously used cannabis.

The primary outcome was the total tic score on the Yale Global Tic Severity Scale (YGTSS; range 0 to 50 with higher scores = greater tic severity).

The mean baseline YGTSS total tic score was 35.7. At 6 weeks, the reduction in total tic score was 8.9 with THC:CBD vs. 2.5 with placebo.

A linear mixed-effects model (intention-to-treat) showed a significant interaction of treatment and visit number (P = .008), indicating a greater decrease (improvement) in tic score over time with THC:CBD, the study team reported.

On average, the magnitude of the tic reduction was “moderate” and comparable to the effect observed with existing treatments such as antipsychotic agents, the investigators noted.

THC:CBD also led to a reduction in other symptoms associated with TS, particularly symptoms of OCD and anxiety.

The symptomatic response to THC:CBD correlated with serum metabolites of the cannabinoids, further supporting a biological relationship, the researchers noted.

There were no serious adverse events. Adverse effects with THC:CBD were generally mild. The most common adverse effect was cognitive difficulties, including slowed mentation, memory lapses, and poor concentration.

“Like many studies of psychoactive compounds, blinding among participants was a problem,” the researchers noted. Despite best efforts to conceal treatment allocation and match placebo to the active agent in terms of color and smell, most participants were able to correctly guess their treatment order.

Based on the findings in this small trial, larger and longer trials of THC:CBD in TS are warranted, they concluded.

“We need a plurality of treatment options in Tourette syndrome. For some, antipsychotics are effective tic-suppressing agents but for many these benefits are complicated by side effects such as weight gain & sedation,” Dr. Mosley tweeted. “Cannabinoids are a biologically plausible therapeutic agent. The body’s own ‘endocannabinoid’ receptors are concentrated in the basal ganglia – the neuroanatomical nexus of TS.”

The study was funded by the Wesley Medical Research Institute, Brisbane, and the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research organization at the University of Sydney, Australia. Dr. Mosley reports no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

An oral oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD) led to a significant and meaningful reduction in motor and vocal tics in patients with severe Tourette syndrome (TS), results of a double-blind, placebo-controlled, crossover study show.

“In a methodologically robust manner (and independent of any drug company sponsorship), we provide evidence for the effectiveness of repeated dosing with THC:CBD vs. placebo in tic suppression, as well as reduction of comorbid anxiety and obsessive-compulsive disorder in severe TS,” neuropsychiatrist and lead investigator Philip Mosley, PhD, said in an interview.

The results offer support to people with TS who “want to approach their doctor to try medicinal cannabis when other drugs have not worked or are intolerable,” said Dr. Mosley, of the Wesley Research Institute and QIMR Berghofer Medical Research Institute, Herston, Australia.

The study was published online in NEJM Evidence.
 

A viable treatment option

Twenty-two adults (mean age, 31 years) with severe TS received THC:CBD oil titrated upward over 6 weeks to a daily dose of 20 mg of THC and 20 mg of CBD, followed by a 6-week course of placebo (or vice versa). Six participants had not previously used cannabis.

The primary outcome was the total tic score on the Yale Global Tic Severity Scale (YGTSS; range 0 to 50 with higher scores = greater tic severity).

The mean baseline YGTSS total tic score was 35.7. At 6 weeks, the reduction in total tic score was 8.9 with THC:CBD vs. 2.5 with placebo.

A linear mixed-effects model (intention-to-treat) showed a significant interaction of treatment and visit number (P = .008), indicating a greater decrease (improvement) in tic score over time with THC:CBD, the study team reported.

On average, the magnitude of the tic reduction was “moderate” and comparable to the effect observed with existing treatments such as antipsychotic agents, the investigators noted.

THC:CBD also led to a reduction in other symptoms associated with TS, particularly symptoms of OCD and anxiety.

The symptomatic response to THC:CBD correlated with serum metabolites of the cannabinoids, further supporting a biological relationship, the researchers noted.

There were no serious adverse events. Adverse effects with THC:CBD were generally mild. The most common adverse effect was cognitive difficulties, including slowed mentation, memory lapses, and poor concentration.

“Like many studies of psychoactive compounds, blinding among participants was a problem,” the researchers noted. Despite best efforts to conceal treatment allocation and match placebo to the active agent in terms of color and smell, most participants were able to correctly guess their treatment order.

Based on the findings in this small trial, larger and longer trials of THC:CBD in TS are warranted, they concluded.

“We need a plurality of treatment options in Tourette syndrome. For some, antipsychotics are effective tic-suppressing agents but for many these benefits are complicated by side effects such as weight gain & sedation,” Dr. Mosley tweeted. “Cannabinoids are a biologically plausible therapeutic agent. The body’s own ‘endocannabinoid’ receptors are concentrated in the basal ganglia – the neuroanatomical nexus of TS.”

The study was funded by the Wesley Medical Research Institute, Brisbane, and the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research organization at the University of Sydney, Australia. Dr. Mosley reports no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

An oral oil containing tetrahydrocannabinol (THC) and cannabidiol (CBD) led to a significant and meaningful reduction in motor and vocal tics in patients with severe Tourette syndrome (TS), results of a double-blind, placebo-controlled, crossover study show.

“In a methodologically robust manner (and independent of any drug company sponsorship), we provide evidence for the effectiveness of repeated dosing with THC:CBD vs. placebo in tic suppression, as well as reduction of comorbid anxiety and obsessive-compulsive disorder in severe TS,” neuropsychiatrist and lead investigator Philip Mosley, PhD, said in an interview.

The results offer support to people with TS who “want to approach their doctor to try medicinal cannabis when other drugs have not worked or are intolerable,” said Dr. Mosley, of the Wesley Research Institute and QIMR Berghofer Medical Research Institute, Herston, Australia.

The study was published online in NEJM Evidence.
 

A viable treatment option

Twenty-two adults (mean age, 31 years) with severe TS received THC:CBD oil titrated upward over 6 weeks to a daily dose of 20 mg of THC and 20 mg of CBD, followed by a 6-week course of placebo (or vice versa). Six participants had not previously used cannabis.

The primary outcome was the total tic score on the Yale Global Tic Severity Scale (YGTSS; range 0 to 50 with higher scores = greater tic severity).

The mean baseline YGTSS total tic score was 35.7. At 6 weeks, the reduction in total tic score was 8.9 with THC:CBD vs. 2.5 with placebo.

A linear mixed-effects model (intention-to-treat) showed a significant interaction of treatment and visit number (P = .008), indicating a greater decrease (improvement) in tic score over time with THC:CBD, the study team reported.

On average, the magnitude of the tic reduction was “moderate” and comparable to the effect observed with existing treatments such as antipsychotic agents, the investigators noted.

THC:CBD also led to a reduction in other symptoms associated with TS, particularly symptoms of OCD and anxiety.

The symptomatic response to THC:CBD correlated with serum metabolites of the cannabinoids, further supporting a biological relationship, the researchers noted.

There were no serious adverse events. Adverse effects with THC:CBD were generally mild. The most common adverse effect was cognitive difficulties, including slowed mentation, memory lapses, and poor concentration.

“Like many studies of psychoactive compounds, blinding among participants was a problem,” the researchers noted. Despite best efforts to conceal treatment allocation and match placebo to the active agent in terms of color and smell, most participants were able to correctly guess their treatment order.

Based on the findings in this small trial, larger and longer trials of THC:CBD in TS are warranted, they concluded.

“We need a plurality of treatment options in Tourette syndrome. For some, antipsychotics are effective tic-suppressing agents but for many these benefits are complicated by side effects such as weight gain & sedation,” Dr. Mosley tweeted. “Cannabinoids are a biologically plausible therapeutic agent. The body’s own ‘endocannabinoid’ receptors are concentrated in the basal ganglia – the neuroanatomical nexus of TS.”

The study was funded by the Wesley Medical Research Institute, Brisbane, and the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research organization at the University of Sydney, Australia. Dr. Mosley reports no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

With the exception of lysergic acid diethylamide, use of hallucinogens surged between 2018 and 2021 among adults younger than 30 years in the United States, new research shows.

In 2018, the prevalence of young adults’ past-year use of non-LSD hallucinogens was 3.4%. By 2021, it had jumped to 6.6%.

The increase in non-LSD hallucinogen use occurred while LSD use remained stable at around 4% in 2018 and 2021.

“While non-LSD hallucinogen use remains substantially less prevalent than use of substances such as alcohol and cannabis, a doubling of prevalence in just three years is a dramatic increase and raises possible public health concerns,” co-author Megan Patrick, PhD, with the University of Michigan Institute for Social Research, Ann Arbor, said in a news release.

The results were published online in the journal Addiction.
 

Health concerns

The estimates are derived from the Monitoring the Future study, which includes annual assessments of adolescent and adult health in the United States.

The analysis focused on 11,304 persons (52% female) aged 9-30 years from the U.S. general population who were interviewed between 2018 and 2021.

Participants were asked about past 12-month use of LSD, as well as use of non-LSD hallucinogens, such as psilocybin.

From 2018 to 2021, past 12-month use of LSD remained relatively stable; it was 3.7% in 2018 and 4.2% in 2021.

However, non-LSD hallucinogen use increased in prevalence from 3.4% to 6.6% from 2018 to 2021.

Across years, the odds of non-LSD use were higher among males, White people, and individuals from households with higher parental education – a proxy for higher socioeconomic status.

The most commonly used non-LSD hallucinogen was psilocybin.

The survey did not ask whether young adults used non-LSD hallucinogens for therapeutic or medical reasons.

“The use of psychedelic and hallucinogenic drugs for a range of therapeutic uses is increasing, given accumulating yet still preliminary data from randomized trials on clinical effectiveness,” lead author Katherine Keyes, PhD, with Columbia University Mailman School of Public Health, New York, said in the release.

“With increased visibility for medical and therapeutic use, however, potentially comes diversion and unregulated product availability, as well as a lack of understanding among the public of potential risks,” Dr. Keyes added.

“However, approved therapeutic use of psychedelics under a trained health professional’s care remains uncommon in the United States, thus the trends we observe here are undoubtedly in nonmedical and nontherapeutic use,” Dr. Keyes noted.

Dr. Patrick said the increased use of hallucinogens raises “concern for young adult health” and is not without risk. While hallucinogen dependence has historically been rare in the U.S. population, it could become more common as use increases, she noted.

The researchers will continue to track these trends to see whether the increases continue.

“We need additional research, including about the motives for hallucinogen use and how young adults are using these substances, in order to be able to mitigate the associated negative consequences,” Dr. Patrick said.

The study was funded by the National Institute on Drug Abuse, part of the National Institutes of Health. Dr. Keyes and Dr. Patrick have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

With the exception of lysergic acid diethylamide, use of hallucinogens surged between 2018 and 2021 among adults younger than 30 years in the United States, new research shows.

In 2018, the prevalence of young adults’ past-year use of non-LSD hallucinogens was 3.4%. By 2021, it had jumped to 6.6%.

The increase in non-LSD hallucinogen use occurred while LSD use remained stable at around 4% in 2018 and 2021.

“While non-LSD hallucinogen use remains substantially less prevalent than use of substances such as alcohol and cannabis, a doubling of prevalence in just three years is a dramatic increase and raises possible public health concerns,” co-author Megan Patrick, PhD, with the University of Michigan Institute for Social Research, Ann Arbor, said in a news release.

The results were published online in the journal Addiction.
 

Health concerns

The estimates are derived from the Monitoring the Future study, which includes annual assessments of adolescent and adult health in the United States.

The analysis focused on 11,304 persons (52% female) aged 9-30 years from the U.S. general population who were interviewed between 2018 and 2021.

Participants were asked about past 12-month use of LSD, as well as use of non-LSD hallucinogens, such as psilocybin.

From 2018 to 2021, past 12-month use of LSD remained relatively stable; it was 3.7% in 2018 and 4.2% in 2021.

However, non-LSD hallucinogen use increased in prevalence from 3.4% to 6.6% from 2018 to 2021.

Across years, the odds of non-LSD use were higher among males, White people, and individuals from households with higher parental education – a proxy for higher socioeconomic status.

The most commonly used non-LSD hallucinogen was psilocybin.

The survey did not ask whether young adults used non-LSD hallucinogens for therapeutic or medical reasons.

“The use of psychedelic and hallucinogenic drugs for a range of therapeutic uses is increasing, given accumulating yet still preliminary data from randomized trials on clinical effectiveness,” lead author Katherine Keyes, PhD, with Columbia University Mailman School of Public Health, New York, said in the release.

“With increased visibility for medical and therapeutic use, however, potentially comes diversion and unregulated product availability, as well as a lack of understanding among the public of potential risks,” Dr. Keyes added.

“However, approved therapeutic use of psychedelics under a trained health professional’s care remains uncommon in the United States, thus the trends we observe here are undoubtedly in nonmedical and nontherapeutic use,” Dr. Keyes noted.

Dr. Patrick said the increased use of hallucinogens raises “concern for young adult health” and is not without risk. While hallucinogen dependence has historically been rare in the U.S. population, it could become more common as use increases, she noted.

The researchers will continue to track these trends to see whether the increases continue.

“We need additional research, including about the motives for hallucinogen use and how young adults are using these substances, in order to be able to mitigate the associated negative consequences,” Dr. Patrick said.

The study was funded by the National Institute on Drug Abuse, part of the National Institutes of Health. Dr. Keyes and Dr. Patrick have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

With the exception of lysergic acid diethylamide, use of hallucinogens surged between 2018 and 2021 among adults younger than 30 years in the United States, new research shows.

In 2018, the prevalence of young adults’ past-year use of non-LSD hallucinogens was 3.4%. By 2021, it had jumped to 6.6%.

The increase in non-LSD hallucinogen use occurred while LSD use remained stable at around 4% in 2018 and 2021.

“While non-LSD hallucinogen use remains substantially less prevalent than use of substances such as alcohol and cannabis, a doubling of prevalence in just three years is a dramatic increase and raises possible public health concerns,” co-author Megan Patrick, PhD, with the University of Michigan Institute for Social Research, Ann Arbor, said in a news release.

The results were published online in the journal Addiction.
 

Health concerns

The estimates are derived from the Monitoring the Future study, which includes annual assessments of adolescent and adult health in the United States.

The analysis focused on 11,304 persons (52% female) aged 9-30 years from the U.S. general population who were interviewed between 2018 and 2021.

Participants were asked about past 12-month use of LSD, as well as use of non-LSD hallucinogens, such as psilocybin.

From 2018 to 2021, past 12-month use of LSD remained relatively stable; it was 3.7% in 2018 and 4.2% in 2021.

However, non-LSD hallucinogen use increased in prevalence from 3.4% to 6.6% from 2018 to 2021.

Across years, the odds of non-LSD use were higher among males, White people, and individuals from households with higher parental education – a proxy for higher socioeconomic status.

The most commonly used non-LSD hallucinogen was psilocybin.

The survey did not ask whether young adults used non-LSD hallucinogens for therapeutic or medical reasons.

“The use of psychedelic and hallucinogenic drugs for a range of therapeutic uses is increasing, given accumulating yet still preliminary data from randomized trials on clinical effectiveness,” lead author Katherine Keyes, PhD, with Columbia University Mailman School of Public Health, New York, said in the release.

“With increased visibility for medical and therapeutic use, however, potentially comes diversion and unregulated product availability, as well as a lack of understanding among the public of potential risks,” Dr. Keyes added.

“However, approved therapeutic use of psychedelics under a trained health professional’s care remains uncommon in the United States, thus the trends we observe here are undoubtedly in nonmedical and nontherapeutic use,” Dr. Keyes noted.

Dr. Patrick said the increased use of hallucinogens raises “concern for young adult health” and is not without risk. While hallucinogen dependence has historically been rare in the U.S. population, it could become more common as use increases, she noted.

The researchers will continue to track these trends to see whether the increases continue.

“We need additional research, including about the motives for hallucinogen use and how young adults are using these substances, in order to be able to mitigate the associated negative consequences,” Dr. Patrick said.

The study was funded by the National Institute on Drug Abuse, part of the National Institutes of Health. Dr. Keyes and Dr. Patrick have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Insomnia may increase vulnerability to influenza-like illness, a novel finding that was revealed by the passive collection of biometric data from a smart bed.

The study of smart-bed sleepers found that there was a statistically significant correlation between a higher number of episodes of influenza-like illnesses (ILI) per year with longer duration compared to people without insomnia.

However, more research is needed to determine causality and whether insomnia may predispose to ILI or whether ILI affects long-term sleep behavior, the researchers noted. 

“Several lines of evidence make me think that it’s more likely that insomnia makes one more vulnerable to influenza through pathways that involve decreased immune function,” study investigator Gary Garcia-Molina, PhD, with Sleep Number Labs, San Jose, Calif., said in an interview.

Sleep disorders, including insomnia, can dampen immune function and an individual’s ability to fight off illness, he noted.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Smart, connected devices

Pathophysiological responses to respiratory viral infection affect sleep duration and quality in addition to breathing function. “Smart” and “connected” devices that monitor biosignals over time have shown promise for monitoring infectious disease.

In an earlier study presented at SLEEP 2021, Dr. Garcia-Molina and colleagues found that real-world biometric data obtained from a smart bed can help predict and track symptoms of COVID-19 and other respiratory infections. They showed that worsening of COVID-19 symptoms correlated with an increase in sleep duration, breathing rate, and heart rate and a decrease in sleep quality.

In the new study, the researchers evaluated vulnerability to ILI in people with insomnia.

They quantified insomnia over time using the insomnia severity index (ISI). They quantified ILI vulnerability using an established artificial intelligence model they developed that estimates the daily probability of ILI symptoms from a Sleep Number smart bed using ballistocardiograph sensors.

Smart bed data – including daily and restful sleep duration, sleep latency, sleep quality, heart rate, breathing rate and motion level – were queried from 2019 (pre-COVID) and 2021.

A total of 1,680 smart sleepers had nearly constant ISI scores over the study period, with 249 having insomnia and 1,431 not having insomnia.

Data from both 2019 and 2021 show that smart sleepers with insomnia had significantly more and longer ILI episodes per year, compared with peers without insomnia.

For 2019, individuals without insomnia had 1.2 ILI episodes on average, which was significantly less (P < .01) than individuals with insomnia, at 1.5 episodes. The average ILI episode duration for those without insomnia was 4.3 days, which was significantly lower (P < .01) in those with insomnia group, at 6.1 days.

The data for 2021 show similar results, with the no-insomnia group having significantly fewer (P < .01) ILI episodes (about 1.2), compared with the insomnia group (about 1.5).

The average ILI episode duration for the no-insomnia group was 5 days, which was significantly less (P < .01) than the insomnia group, at 6.1 days.

The researchers said their study adds to other data on the relationship between sleep and overall health and well-being. It also highlights the potential health risk of insomnia and the importance of identifying and treating sleep disorders.

“Sleep has such a profound influence on health and wellness and the ability to capture these data unobtrusively in such an easy way and with such a large number of participants paves the way to investigate different aspects of health and disease,” Dr. Garcia-Molina said.
 

Rich data source

In a comment, Adam C. Powell, PhD, president of Payer+Provider Syndicate, a management advisory and operational consulting firm, said “smart beds provide a new data source for passively monitoring the health of individuals.”

“Unlike active monitoring methods requiring self-report, passive monitoring enables data to be captured without an individual taking any action. This data can be potentially integrated with data from other sources, such as pedometers, smart scales, and smart blood pressure cuffs, to gain a more holistic understanding of how an individual’s activities and behaviors impact their well-being,” said Dr. Powell, who wasn’t involved in the study.

There are some methodological limitations to the study, he noted.

“While the dependent variables examined were the duration and presence of episodes of influenza-like illness, they did not directly measure these episodes. Instead, they calculated the daily probability of influenza-like illness symptoms using a model that received input from the ballistocardiograph sensors in the smart beds,” Dr. Powell noted.

“The model used to calculate daily probability of influenza-like illness was created by examining associations between individuals’ smart-bed sensor data and population-level trends in influenza-like illness reported by the Centers for Disease Control and Prevention,” he explained.

Nonetheless, the findings are “consistent with the literature. It has been established by other researchers that impaired sleep is associated with greater risk of influenza, as well as other illnesses,” Dr. Powell said.

Funding for the study was provided by Sleep Number. Dr. Garcia-Molina and five coauthors are employed by Sleep Number. Dr. Powell reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Insomnia may increase vulnerability to influenza-like illness, a novel finding that was revealed by the passive collection of biometric data from a smart bed.

The study of smart-bed sleepers found that there was a statistically significant correlation between a higher number of episodes of influenza-like illnesses (ILI) per year with longer duration compared to people without insomnia.

However, more research is needed to determine causality and whether insomnia may predispose to ILI or whether ILI affects long-term sleep behavior, the researchers noted. 

“Several lines of evidence make me think that it’s more likely that insomnia makes one more vulnerable to influenza through pathways that involve decreased immune function,” study investigator Gary Garcia-Molina, PhD, with Sleep Number Labs, San Jose, Calif., said in an interview.

Sleep disorders, including insomnia, can dampen immune function and an individual’s ability to fight off illness, he noted.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Smart, connected devices

Pathophysiological responses to respiratory viral infection affect sleep duration and quality in addition to breathing function. “Smart” and “connected” devices that monitor biosignals over time have shown promise for monitoring infectious disease.

In an earlier study presented at SLEEP 2021, Dr. Garcia-Molina and colleagues found that real-world biometric data obtained from a smart bed can help predict and track symptoms of COVID-19 and other respiratory infections. They showed that worsening of COVID-19 symptoms correlated with an increase in sleep duration, breathing rate, and heart rate and a decrease in sleep quality.

In the new study, the researchers evaluated vulnerability to ILI in people with insomnia.

They quantified insomnia over time using the insomnia severity index (ISI). They quantified ILI vulnerability using an established artificial intelligence model they developed that estimates the daily probability of ILI symptoms from a Sleep Number smart bed using ballistocardiograph sensors.

Smart bed data – including daily and restful sleep duration, sleep latency, sleep quality, heart rate, breathing rate and motion level – were queried from 2019 (pre-COVID) and 2021.

A total of 1,680 smart sleepers had nearly constant ISI scores over the study period, with 249 having insomnia and 1,431 not having insomnia.

Data from both 2019 and 2021 show that smart sleepers with insomnia had significantly more and longer ILI episodes per year, compared with peers without insomnia.

For 2019, individuals without insomnia had 1.2 ILI episodes on average, which was significantly less (P < .01) than individuals with insomnia, at 1.5 episodes. The average ILI episode duration for those without insomnia was 4.3 days, which was significantly lower (P < .01) in those with insomnia group, at 6.1 days.

The data for 2021 show similar results, with the no-insomnia group having significantly fewer (P < .01) ILI episodes (about 1.2), compared with the insomnia group (about 1.5).

The average ILI episode duration for the no-insomnia group was 5 days, which was significantly less (P < .01) than the insomnia group, at 6.1 days.

The researchers said their study adds to other data on the relationship between sleep and overall health and well-being. It also highlights the potential health risk of insomnia and the importance of identifying and treating sleep disorders.

“Sleep has such a profound influence on health and wellness and the ability to capture these data unobtrusively in such an easy way and with such a large number of participants paves the way to investigate different aspects of health and disease,” Dr. Garcia-Molina said.
 

Rich data source

In a comment, Adam C. Powell, PhD, president of Payer+Provider Syndicate, a management advisory and operational consulting firm, said “smart beds provide a new data source for passively monitoring the health of individuals.”

“Unlike active monitoring methods requiring self-report, passive monitoring enables data to be captured without an individual taking any action. This data can be potentially integrated with data from other sources, such as pedometers, smart scales, and smart blood pressure cuffs, to gain a more holistic understanding of how an individual’s activities and behaviors impact their well-being,” said Dr. Powell, who wasn’t involved in the study.

There are some methodological limitations to the study, he noted.

“While the dependent variables examined were the duration and presence of episodes of influenza-like illness, they did not directly measure these episodes. Instead, they calculated the daily probability of influenza-like illness symptoms using a model that received input from the ballistocardiograph sensors in the smart beds,” Dr. Powell noted.

“The model used to calculate daily probability of influenza-like illness was created by examining associations between individuals’ smart-bed sensor data and population-level trends in influenza-like illness reported by the Centers for Disease Control and Prevention,” he explained.

Nonetheless, the findings are “consistent with the literature. It has been established by other researchers that impaired sleep is associated with greater risk of influenza, as well as other illnesses,” Dr. Powell said.

Funding for the study was provided by Sleep Number. Dr. Garcia-Molina and five coauthors are employed by Sleep Number. Dr. Powell reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Insomnia may increase vulnerability to influenza-like illness, a novel finding that was revealed by the passive collection of biometric data from a smart bed.

The study of smart-bed sleepers found that there was a statistically significant correlation between a higher number of episodes of influenza-like illnesses (ILI) per year with longer duration compared to people without insomnia.

However, more research is needed to determine causality and whether insomnia may predispose to ILI or whether ILI affects long-term sleep behavior, the researchers noted. 

“Several lines of evidence make me think that it’s more likely that insomnia makes one more vulnerable to influenza through pathways that involve decreased immune function,” study investigator Gary Garcia-Molina, PhD, with Sleep Number Labs, San Jose, Calif., said in an interview.

Sleep disorders, including insomnia, can dampen immune function and an individual’s ability to fight off illness, he noted.

The findings were presented at the annual meeting of the Associated Professional Sleep Societies.
 

Smart, connected devices

Pathophysiological responses to respiratory viral infection affect sleep duration and quality in addition to breathing function. “Smart” and “connected” devices that monitor biosignals over time have shown promise for monitoring infectious disease.

In an earlier study presented at SLEEP 2021, Dr. Garcia-Molina and colleagues found that real-world biometric data obtained from a smart bed can help predict and track symptoms of COVID-19 and other respiratory infections. They showed that worsening of COVID-19 symptoms correlated with an increase in sleep duration, breathing rate, and heart rate and a decrease in sleep quality.

In the new study, the researchers evaluated vulnerability to ILI in people with insomnia.

They quantified insomnia over time using the insomnia severity index (ISI). They quantified ILI vulnerability using an established artificial intelligence model they developed that estimates the daily probability of ILI symptoms from a Sleep Number smart bed using ballistocardiograph sensors.

Smart bed data – including daily and restful sleep duration, sleep latency, sleep quality, heart rate, breathing rate and motion level – were queried from 2019 (pre-COVID) and 2021.

A total of 1,680 smart sleepers had nearly constant ISI scores over the study period, with 249 having insomnia and 1,431 not having insomnia.

Data from both 2019 and 2021 show that smart sleepers with insomnia had significantly more and longer ILI episodes per year, compared with peers without insomnia.

For 2019, individuals without insomnia had 1.2 ILI episodes on average, which was significantly less (P < .01) than individuals with insomnia, at 1.5 episodes. The average ILI episode duration for those without insomnia was 4.3 days, which was significantly lower (P < .01) in those with insomnia group, at 6.1 days.

The data for 2021 show similar results, with the no-insomnia group having significantly fewer (P < .01) ILI episodes (about 1.2), compared with the insomnia group (about 1.5).

The average ILI episode duration for the no-insomnia group was 5 days, which was significantly less (P < .01) than the insomnia group, at 6.1 days.

The researchers said their study adds to other data on the relationship between sleep and overall health and well-being. It also highlights the potential health risk of insomnia and the importance of identifying and treating sleep disorders.

“Sleep has such a profound influence on health and wellness and the ability to capture these data unobtrusively in such an easy way and with such a large number of participants paves the way to investigate different aspects of health and disease,” Dr. Garcia-Molina said.
 

Rich data source

In a comment, Adam C. Powell, PhD, president of Payer+Provider Syndicate, a management advisory and operational consulting firm, said “smart beds provide a new data source for passively monitoring the health of individuals.”

“Unlike active monitoring methods requiring self-report, passive monitoring enables data to be captured without an individual taking any action. This data can be potentially integrated with data from other sources, such as pedometers, smart scales, and smart blood pressure cuffs, to gain a more holistic understanding of how an individual’s activities and behaviors impact their well-being,” said Dr. Powell, who wasn’t involved in the study.

There are some methodological limitations to the study, he noted.

“While the dependent variables examined were the duration and presence of episodes of influenza-like illness, they did not directly measure these episodes. Instead, they calculated the daily probability of influenza-like illness symptoms using a model that received input from the ballistocardiograph sensors in the smart beds,” Dr. Powell noted.

“The model used to calculate daily probability of influenza-like illness was created by examining associations between individuals’ smart-bed sensor data and population-level trends in influenza-like illness reported by the Centers for Disease Control and Prevention,” he explained.

Nonetheless, the findings are “consistent with the literature. It has been established by other researchers that impaired sleep is associated with greater risk of influenza, as well as other illnesses,” Dr. Powell said.

Funding for the study was provided by Sleep Number. Dr. Garcia-Molina and five coauthors are employed by Sleep Number. Dr. Powell reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Mounting evidence supports that chronic environmental exposure to low levels of lead, cadmium, and arsenic contribute significantly to cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.

“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.

“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.

The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
 

Involuntary exposure harms the heart

Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.

These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.

Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.

Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.

“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.

“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.

Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.

“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.

“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”

Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
 

A version of this article originally appeared on Medscape.com.

Mounting evidence supports that chronic environmental exposure to low levels of lead, cadmium, and arsenic contribute significantly to cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.

“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.

“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.

The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
 

Involuntary exposure harms the heart

Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.

These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.

Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.

Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.

“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.

“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.

Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.

“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.

“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”

Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
 

A version of this article originally appeared on Medscape.com.

Mounting evidence supports that chronic environmental exposure to low levels of lead, cadmium, and arsenic contribute significantly to cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.

“In reality, identifying a new type of cardiovascular risk factor leads to more questions than answers,” Gervasio A. Lamas, MD, chair of the statement writing group, said in an interview.

“For the most part, as cardiologists, we are used to risk factors we can manage with antihypertensives, statins, weight loss, exercise, and avoidance of smoking. Unfortunately, the ubiquity of toxic metals and their multiple sources increases the complexity of potential treatment,” said Dr. Lamas, chairman of medicine and chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla.

The statement addressing contaminant metals as CV risk factors was published online in the Journal of the American Heart Association.
 

Involuntary exposure harms the heart

Exposure to contaminant metals most often happens involuntarily through air, water, soil, and food, and extensive industrial and public use, the writing group notes.

These contaminant metals interfere with critical intracellular reactions and functions, leading to oxidative stress and chronic inflammation; this in turn leads to endothelial dysfunction, hypertension, epigenetic dysregulation, dyslipidemia, and changes in myocardial excitation and contractile function, the authors point out.

Lead, cadmium, and arsenic have been linked to subclinical atherosclerosis, coronary artery stenosis and calcification, as well as to an increased risk for ischemic heart disease and stroke, left ventricular hypertrophy, and heart failure and peripheral artery disease.

Epidemiologic studies show that exposure to lead, cadmium, or arsenic is associated with cardiovascular death mostly attributable to ischemic heart disease. In the United States alone, one study suggested that more than 450,000 deaths annually could be attributed to lead exposure.

“This is a global issue in which lower-income communities are disproportionately exposed to toxic metals through contaminated air, water, and soil,” Ana Navas-Acien, MD, PhD, vice chair of the statement writing group, said in a news release.

“Addressing metal exposure in these populations may provide a strategy to reduce cardiovascular disease disparities and advance environmental justice,” adds Dr. Navas-Acien, professor of environmental health sciences at Columbia University, New York.

Dr. Lamas said in an interview that the writing group is “hopeful that there will be a multilevel response” to publication of the scientific statement.

“On the societal level, we believe more effort can be made to measure these pollutants and protect the public. On the physician level, knowledge of metal levels could become part of the routine risk evaluation of the cardiac patient. On the individual level, patients can try to avoid these pollutants, by knowing arsenic levels of well-water, lead and cadmium levels of drinking water, avoiding tobacco and vaping, and using filters when available or necessary,” Dr. Lamas said.

“On the scientific level, identifying ubiquitous pollutants should spur scientists and pharmaceutical companies to develop preventive and therapeutic approaches.”

Finally, clinical trials should be encouraged to assess existing drugs that can remove these atherogenic toxins from the body or treat their ill effects. One such trial is expected to be completed within a year, Dr. Lamas added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Cardiovascular and Stroke Nursing; the Council on Lifestyle and Cardiometabolic Health; the Council on Peripheral Vascular Disease; and the Council on the Kidney in Cardiovascular Disease.
 

A version of this article originally appeared on Medscape.com.

A new study provides novel insights into why light to moderate alcohol consumption may be associated with reduced cardiovascular disease (CVD) risk.

The study shows that light to moderate drinking was associated with lower major adverse cardiovascular events (MACE), and this was partly mediated by decreased stress signaling in the brain.

In addition, the benefit of light to moderate drinking with respect to MACE was most pronounced among people with a history of anxiety, a condition known to be associated with higher stress signaling in the brain.

However, the apparent CVD benefits of light to moderate drinking were counterbalanced by an increased risk of cancer.

“There is no safe level of alcohol consumption,” senior author and cardiologist Ahmed Tawakol, MD, codirector of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, Boston, said in an interview.

“We see cancer risk even at the level that we see some protection from heart disease. And higher amounts of alcohol clearly increase heart disease risk,” Dr. Tawakol said.

The study was published online in the Journal of the American College of Cardiology.
 

Clear mechanistic link

Chronic stress is associated with MACE via stress-related neural network activity (SNA). Light to moderate alcohol consumption has been linked to lower MACE risk, but the mechanisms behind this connection remain unclear.

“We know that when the neural centers of stress are activated, they trigger downstream changes that result in heart disease. And we’ve long appreciated that alcohol in the short term reduces stress, so we hypothesized that maybe alcohol impacts those stress systems chronically and that might explain its cardiovascular effects,” Dr. Tawakol explained.

The study included roughly 53,000 adults (mean age, 60 years; 60% women) from the Mass General Brigham Biobank. The researchers first evaluated the relationship between light to moderate alcohol consumption and MACE after adjusting for a range of genetic, clinical, lifestyle, and socioeconomic factors.

During mean follow-up of 3.4 years, 1,914 individuals experienced MACE. Light to moderate alcohol consumption (compared to none/minimal) was associated with lower MACE risk (hazard ratio [HR], 0.786; 95% confidence interval [CI], 0.717-0.862; P < .0001) after adjustment for cardiovascular risk factors.

The researchers then studied a subset of 713 individuals who had undergone previous PET/CT brain imaging (primarily for cancer surveillance) to determine the effect of light to moderate alcohol consumption on resting SNA.

They found that light to moderate alcohol consumption correlated with decreased SNA (standardized beta, –0.192; 95% CI, –0.338 to 0.046; P = .01). Lower SNA partially mediated the beneficial effect of light to moderate alcohol intake on MACE risk (odds ratio [OR], –0.040; 95% CI, –0.097 to –0.003; P < .05).

Light to moderate alcohol consumption was associated with larger decreases in MACE risk among individuals with a history of anxiety (HR, 0.60; 95% CI, 0.50-0.72, vs. HR, 1.78; 95% CI, 0.73-0.80; P = .003).

The coauthors of an editorial say the discovery of a “new possible mechanism of action” for why light to moderate alcohol consumption might protect the heart “deserves closer attention in future investigations.”

However, Giovanni de Gaetano, MD, PhD, department of epidemiology and prevention, IRCCS NEUROMED, Pozzilli, Italy, one of the authors, emphasized that individuals who consume alcohol should not “exceed the recommended daily dose limits suggested in many countries and that no abstainer should start to drink, even in moderation, solely for the purpose of improving his/her health outcomes.”

Dr. Tawakol and colleagues said that, given alcohol’s adverse health effects, such as heightened cancer risk, new interventions that have positive effects on the neurobiology of stress but without the harmful effects of alcohol are needed.

To that end, they are studying the effect of exercise, stress-reduction interventions such as meditation, and pharmacologic therapies on stress-associated neural networks, and how they might induce CV benefits.

Dr. Tawakol said in an interview that one “additional important message is that anxiety and other related conditions like depression have really substantial health consequences, including increased MACE. Safer interventions that reduce anxiety may yet prove to reduce the risk of heart disease very nicely.”

The study was supported by the National Institutes of Health. Dr. Tawakol and Dr. de Gaetano have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

A new study provides novel insights into why light to moderate alcohol consumption may be associated with reduced cardiovascular disease (CVD) risk.

The study shows that light to moderate drinking was associated with lower major adverse cardiovascular events (MACE), and this was partly mediated by decreased stress signaling in the brain.

In addition, the benefit of light to moderate drinking with respect to MACE was most pronounced among people with a history of anxiety, a condition known to be associated with higher stress signaling in the brain.

However, the apparent CVD benefits of light to moderate drinking were counterbalanced by an increased risk of cancer.

“There is no safe level of alcohol consumption,” senior author and cardiologist Ahmed Tawakol, MD, codirector of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, Boston, said in an interview.

“We see cancer risk even at the level that we see some protection from heart disease. And higher amounts of alcohol clearly increase heart disease risk,” Dr. Tawakol said.

The study was published online in the Journal of the American College of Cardiology.
 

Clear mechanistic link

Chronic stress is associated with MACE via stress-related neural network activity (SNA). Light to moderate alcohol consumption has been linked to lower MACE risk, but the mechanisms behind this connection remain unclear.

“We know that when the neural centers of stress are activated, they trigger downstream changes that result in heart disease. And we’ve long appreciated that alcohol in the short term reduces stress, so we hypothesized that maybe alcohol impacts those stress systems chronically and that might explain its cardiovascular effects,” Dr. Tawakol explained.

The study included roughly 53,000 adults (mean age, 60 years; 60% women) from the Mass General Brigham Biobank. The researchers first evaluated the relationship between light to moderate alcohol consumption and MACE after adjusting for a range of genetic, clinical, lifestyle, and socioeconomic factors.

During mean follow-up of 3.4 years, 1,914 individuals experienced MACE. Light to moderate alcohol consumption (compared to none/minimal) was associated with lower MACE risk (hazard ratio [HR], 0.786; 95% confidence interval [CI], 0.717-0.862; P < .0001) after adjustment for cardiovascular risk factors.

The researchers then studied a subset of 713 individuals who had undergone previous PET/CT brain imaging (primarily for cancer surveillance) to determine the effect of light to moderate alcohol consumption on resting SNA.

They found that light to moderate alcohol consumption correlated with decreased SNA (standardized beta, –0.192; 95% CI, –0.338 to 0.046; P = .01). Lower SNA partially mediated the beneficial effect of light to moderate alcohol intake on MACE risk (odds ratio [OR], –0.040; 95% CI, –0.097 to –0.003; P < .05).

Light to moderate alcohol consumption was associated with larger decreases in MACE risk among individuals with a history of anxiety (HR, 0.60; 95% CI, 0.50-0.72, vs. HR, 1.78; 95% CI, 0.73-0.80; P = .003).

The coauthors of an editorial say the discovery of a “new possible mechanism of action” for why light to moderate alcohol consumption might protect the heart “deserves closer attention in future investigations.”

However, Giovanni de Gaetano, MD, PhD, department of epidemiology and prevention, IRCCS NEUROMED, Pozzilli, Italy, one of the authors, emphasized that individuals who consume alcohol should not “exceed the recommended daily dose limits suggested in many countries and that no abstainer should start to drink, even in moderation, solely for the purpose of improving his/her health outcomes.”

Dr. Tawakol and colleagues said that, given alcohol’s adverse health effects, such as heightened cancer risk, new interventions that have positive effects on the neurobiology of stress but without the harmful effects of alcohol are needed.

To that end, they are studying the effect of exercise, stress-reduction interventions such as meditation, and pharmacologic therapies on stress-associated neural networks, and how they might induce CV benefits.

Dr. Tawakol said in an interview that one “additional important message is that anxiety and other related conditions like depression have really substantial health consequences, including increased MACE. Safer interventions that reduce anxiety may yet prove to reduce the risk of heart disease very nicely.”

The study was supported by the National Institutes of Health. Dr. Tawakol and Dr. de Gaetano have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

A new study provides novel insights into why light to moderate alcohol consumption may be associated with reduced cardiovascular disease (CVD) risk.

The study shows that light to moderate drinking was associated with lower major adverse cardiovascular events (MACE), and this was partly mediated by decreased stress signaling in the brain.

In addition, the benefit of light to moderate drinking with respect to MACE was most pronounced among people with a history of anxiety, a condition known to be associated with higher stress signaling in the brain.

However, the apparent CVD benefits of light to moderate drinking were counterbalanced by an increased risk of cancer.

“There is no safe level of alcohol consumption,” senior author and cardiologist Ahmed Tawakol, MD, codirector of the Cardiovascular Imaging Research Center at Massachusetts General Hospital, Boston, said in an interview.

“We see cancer risk even at the level that we see some protection from heart disease. And higher amounts of alcohol clearly increase heart disease risk,” Dr. Tawakol said.

The study was published online in the Journal of the American College of Cardiology.
 

Clear mechanistic link

Chronic stress is associated with MACE via stress-related neural network activity (SNA). Light to moderate alcohol consumption has been linked to lower MACE risk, but the mechanisms behind this connection remain unclear.

“We know that when the neural centers of stress are activated, they trigger downstream changes that result in heart disease. And we’ve long appreciated that alcohol in the short term reduces stress, so we hypothesized that maybe alcohol impacts those stress systems chronically and that might explain its cardiovascular effects,” Dr. Tawakol explained.

The study included roughly 53,000 adults (mean age, 60 years; 60% women) from the Mass General Brigham Biobank. The researchers first evaluated the relationship between light to moderate alcohol consumption and MACE after adjusting for a range of genetic, clinical, lifestyle, and socioeconomic factors.

During mean follow-up of 3.4 years, 1,914 individuals experienced MACE. Light to moderate alcohol consumption (compared to none/minimal) was associated with lower MACE risk (hazard ratio [HR], 0.786; 95% confidence interval [CI], 0.717-0.862; P < .0001) after adjustment for cardiovascular risk factors.

The researchers then studied a subset of 713 individuals who had undergone previous PET/CT brain imaging (primarily for cancer surveillance) to determine the effect of light to moderate alcohol consumption on resting SNA.

They found that light to moderate alcohol consumption correlated with decreased SNA (standardized beta, –0.192; 95% CI, –0.338 to 0.046; P = .01). Lower SNA partially mediated the beneficial effect of light to moderate alcohol intake on MACE risk (odds ratio [OR], –0.040; 95% CI, –0.097 to –0.003; P < .05).

Light to moderate alcohol consumption was associated with larger decreases in MACE risk among individuals with a history of anxiety (HR, 0.60; 95% CI, 0.50-0.72, vs. HR, 1.78; 95% CI, 0.73-0.80; P = .003).

The coauthors of an editorial say the discovery of a “new possible mechanism of action” for why light to moderate alcohol consumption might protect the heart “deserves closer attention in future investigations.”

However, Giovanni de Gaetano, MD, PhD, department of epidemiology and prevention, IRCCS NEUROMED, Pozzilli, Italy, one of the authors, emphasized that individuals who consume alcohol should not “exceed the recommended daily dose limits suggested in many countries and that no abstainer should start to drink, even in moderation, solely for the purpose of improving his/her health outcomes.”

Dr. Tawakol and colleagues said that, given alcohol’s adverse health effects, such as heightened cancer risk, new interventions that have positive effects on the neurobiology of stress but without the harmful effects of alcohol are needed.

To that end, they are studying the effect of exercise, stress-reduction interventions such as meditation, and pharmacologic therapies on stress-associated neural networks, and how they might induce CV benefits.

Dr. Tawakol said in an interview that one “additional important message is that anxiety and other related conditions like depression have really substantial health consequences, including increased MACE. Safer interventions that reduce anxiety may yet prove to reduce the risk of heart disease very nicely.”

The study was supported by the National Institutes of Health. Dr. Tawakol and Dr. de Gaetano have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira), but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina.

All patients with pediatric Crohn’s disease starting on adalimumab, and their parents, should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online in Gastroenterology and was presented in May in Chicago at the annual Digestive Disease Week® (DDW).

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study, said.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab vs. TNFi therapy alone in 297 children with Crohn’s disease. The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 kg to less than 40 kg, and 10 mg for children 20 kg to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following:

• Short Pediatric Crohn’s Disease Activity Index (SPCDAI) score of less than 15 by week 26.
• Failure to complete a steroid taper by week 16.
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26.
• Hospitalization or surgery for Crohn’s disease beyond week 26.
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16.
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity.

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of antidrug antibodies with combination therapy (risk ratio 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers note.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone.

“This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

The trial was not designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab, but not infliximab,” Dr. Kappelman and colleagues say.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of deimplementation of combination therapy in infliximab-treated patients,” they add.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization,” he said. “The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira), but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina.

All patients with pediatric Crohn’s disease starting on adalimumab, and their parents, should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online in Gastroenterology and was presented in May in Chicago at the annual Digestive Disease Week® (DDW).

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study, said.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab vs. TNFi therapy alone in 297 children with Crohn’s disease. The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 kg to less than 40 kg, and 10 mg for children 20 kg to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following:

• Short Pediatric Crohn’s Disease Activity Index (SPCDAI) score of less than 15 by week 26.
• Failure to complete a steroid taper by week 16.
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26.
• Hospitalization or surgery for Crohn’s disease beyond week 26.
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16.
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity.

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of antidrug antibodies with combination therapy (risk ratio 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers note.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone.

“This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

The trial was not designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab, but not infliximab,” Dr. Kappelman and colleagues say.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of deimplementation of combination therapy in infliximab-treated patients,” they add.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization,” he said. “The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira), but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina.

All patients with pediatric Crohn’s disease starting on adalimumab, and their parents, should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online in Gastroenterology and was presented in May in Chicago at the annual Digestive Disease Week® (DDW).

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study, said.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab vs. TNFi therapy alone in 297 children with Crohn’s disease. The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 kg to less than 40 kg, and 10 mg for children 20 kg to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following:

• Short Pediatric Crohn’s Disease Activity Index (SPCDAI) score of less than 15 by week 26.
• Failure to complete a steroid taper by week 16.
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26.
• Hospitalization or surgery for Crohn’s disease beyond week 26.
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16.
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity.

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of antidrug antibodies with combination therapy (risk ratio 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers note.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone.

“This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

The trial was not designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab, but not infliximab,” Dr. Kappelman and colleagues say.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of deimplementation of combination therapy in infliximab-treated patients,” they add.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization,” he said. “The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

The Food and Drug Administration has expanded the indication for linaclotide (Linzess) to children as young as age 6 years with functional constipation, making it the first approved treatment for pediatric functional constipation.

The recommended dosage in pediatric patients is 72 mcg orally once daily.

Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.

Olivier Le Moal/Getty Images

There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.

The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.

The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
 

Study details

To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.

They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:

• History of stool withholding or excessive voluntary stool retention.
• History of painful or hard bowel movements.
• History of large diameter stools that may obstruct the toilet.
• Presence of a large fecal mass in the rectum.
• At least one episode of fecal incontinence per week.

The primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.

SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.

The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.

The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.

Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.

Full prescribing information is available online.

The application for linaclotide in children received priority review.

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for linaclotide (Linzess) to children as young as age 6 years with functional constipation, making it the first approved treatment for pediatric functional constipation.

The recommended dosage in pediatric patients is 72 mcg orally once daily.

Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.

Olivier Le Moal/Getty Images

There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.

The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.

The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
 

Study details

To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.

They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:

• History of stool withholding or excessive voluntary stool retention.
• History of painful or hard bowel movements.
• History of large diameter stools that may obstruct the toilet.
• Presence of a large fecal mass in the rectum.
• At least one episode of fecal incontinence per week.

The primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.

SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.

The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.

The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.

Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.

Full prescribing information is available online.

The application for linaclotide in children received priority review.

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for linaclotide (Linzess) to children as young as age 6 years with functional constipation, making it the first approved treatment for pediatric functional constipation.

The recommended dosage in pediatric patients is 72 mcg orally once daily.

Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.

Olivier Le Moal/Getty Images

There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.

The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.

The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
 

Study details

To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.

They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:

• History of stool withholding or excessive voluntary stool retention.
• History of painful or hard bowel movements.
• History of large diameter stools that may obstruct the toilet.
• Presence of a large fecal mass in the rectum.
• At least one episode of fecal incontinence per week.

The primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.

SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.

The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.

The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.

Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.

Full prescribing information is available online.

The application for linaclotide in children received priority review.

A version of this article originally appeared on Medscape.com.