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In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
 

CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.

They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.

The scientific statement was published online in Circulation.
 

Look beyond traditional risk factors

“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release. 

“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.

Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.

Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.

The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.

“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.

“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
 

No one-size-fits-all approach

The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.

It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.

“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.

“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.

Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.

They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
 

CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.

They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.

The scientific statement was published online in Circulation.
 

Look beyond traditional risk factors

“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release. 

“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.

Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.

Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.

The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.

“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.

“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
 

No one-size-fits-all approach

The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.

It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.

“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.

“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.

Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.

They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

In a new scientific statement, the American Heart Association highlighted the importance of incorporating nonbiological risk factors and social determinants of health in cardiovascular disease (CVD) risk assessment for women, particularly women from different racial and ethnic backgrounds.
 

CVD risk assessment in women is multifaceted and goes well beyond traditional risk factors to include sex-specific biological risk factors, as well as social, behavioral, and environmental factors, the writing group noted.

They said a greater focus on addressing all CVD risk factors among women from underrepresented races and ethnicities is warranted to avert future CVD.

The scientific statement was published online in Circulation.
 

Look beyond traditional risk factors

“Risk assessment is the first step in preventing heart disease, yet there are many limitations to traditional risk factors and their ability to comprehensively estimate a woman’s risk for cardiovascular disease,” Jennifer H. Mieres, MD, vice chair of the writing group and professor of cardiology at Hofstra University, Hempstead, N.Y., said in a news release. 

“The delivery of equitable cardiovascular health care for women depends on improving the knowledge and awareness of all members of the healthcare team about the full spectrum of cardiovascular risk factors for women, including female-specific and female-predominant risk factors,” Dr. Mieres added.

Female-specific factors that should be included in CVD risk assessment include pregnancy-related conditions such as preeclampsia, preterm delivery, and gestational diabetes, the writing group said.

Other factors include menstrual cycle history; types of birth control and/or hormone replacement therapy used; polycystic ovarian syndrome (PCOS), which affects 10% of women of reproductive age and is associated with increased CVD risk; and autoimmune disorders, depression, and PTSD, all of which are more common in women and are also associated with higher risk for CVD.

The statement also highlights the key role that social determinants of health (SDOH) play in the development of CVD in women, particularly women from diverse racial and ethnic backgrounds. SDOH include education level, economic stability, neighborhood safety, working conditions, environmental hazards, and access to quality health care.

“It is critical that risk assessment be expanded to include [SDOH] as risk factors if we are to improve health outcomes in all women,” Laxmi Mehta, MD, chair of the writing group and director of preventative cardiology and women’s cardiovascular health at Ohio State University Wexner Medical Center, Columbus, said in the news release.

“It is also important for the health care team to consider [SDOH] when working with women on shared decisions about cardiovascular disease prevention and treatment,” Dr. Mehta noted.
 

No one-size-fits-all approach

The statement highlighted significant differences in CVD risk among women of different racial and ethnic backgrounds and provides detailed CV risk factor profiles for non-Hispanic Black, Hispanic/Latinx, Asian and American Indian/Alaska Native women.

It noted that language barriers, discrimination, acculturation, and health care access disproportionately affect women of underrepresented racial and ethnic groups. These factors result in a higher prevalence of CVD and significant challenges in CVD diagnosis and treatment.

“When customizing CVD prevention and treatment strategies to improve cardiovascular health for women, a one-size-fits-all approach is unlikely to be successful,” Dr. Mieres said.

“We must be cognizant of the complex interplay of sex, race and ethnicity, as well as social determinants of health, and how they impact the risk of cardiovascular disease and adverse outcomes in order to avert future CVD morbidity and mortality,” Dr. Mieres added.

Looking ahead, the writing group said future CVD prevention guidelines could be strengthened by including culturally-specific lifestyle recommendations.

They also said community-based approaches, faith-based community partnerships, and peer support to encourage a healthy lifestyle could play a key role in preventing CVD among all women.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Cardiovascular Disease and Stroke in Women and Underrepresented Populations Committee of the Council on Clinical Cardiology, the Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifelong Congenital Heart Disease and Heart Health in the Young, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

The American Society of Echocardiography (ASE) has issued guidance on all critical aspects of training for cardiology and anesthesiology trainees and postgraduate echocardiographers who plan to specialize in interventional echocardiography (IE).

The guideline outlines requirements of the training institution, the duration and core competencies of training, minimal procedural volume for competency in IE, and knowledge of specific structural health disease (SHD) procedures.

The 16-page guideline was published online  in the Journal of the American Society of Echocardiography.
 

Specific skill set

IE is the primary imaging modality used to support and guide SHD interventions, such as heart valve replacements and other cardiac catheterization procedures, the writing group notes.

They say the “emerging specialty” of IE requires a specific set of skills to support an array of transcatheter therapies, with successful outcomes highly dependent on the skill of the echocardiography team.

“IE techniques are unique since imaging is performed in real-time, it is highly dependent on 3D and non-standard views, and it has immediate and profound implications for patient management,” Stephen H. Little, MD, ASE president and co-chair of the guideline writing group, says in a news release.

“Additionally, IE requires candid, accurate, and timely communication with other members of the multidisciplinary SHD team,” Dr. Little adds.

The new ASE guideline expands on the 2019 statement on echocardiography training put forward by the American College of Cardiology, American Heart Association, and ASE, by focusing specifically on interventional echocardiographers.

It outlines core competencies common to all transcatheter therapies, as well as specific transcatheter procedures. It provides consensus recommendations for specific knowledge, experience, and skills to be learned and demonstrated within an IE training program or during postgraduate training.

A “core principle” in the guideline states that the length of IE training or achieved number of procedures performed are less important than the demonstration of procedure-specific competencies within the milestone domains of knowledge, skill, and communication.

“Transcatheter therapies for SHD continue to grow at a rapid pace, which means that the demand for skilled interventional echocardiographers has steadily increased,” Vera H. Rigolin, MD, co-chair of the guideline writing, says in the release.

“Training standards are needed to ensure that interventional echocardiographers have the necessary expertise to provide fast, accurate, and high-quality image acquisition and interpretation in real-time,” Dr. Rigolin adds.

In addition, the guidelines states that use of simulation training has a role in IE training.

Virtual and simulation training could shorten the learning curve for trainees and, when combined with remote learning, could permit societies to standardize a teaching curriculum and allow the trainee to complete training in a reasonable timeframe. Simulator training may also improve access to training and thus promote diversity and inclusivity, the writing group says.

The guideline has been endorsed by 21 ASE international partners.

Writing group co-chairs Little and Rigolin have declared no conflicts of interest. A complete list of disclosures for the writing group is available with the original article.

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

The American Society of Echocardiography (ASE) has issued guidance on all critical aspects of training for cardiology and anesthesiology trainees and postgraduate echocardiographers who plan to specialize in interventional echocardiography (IE).

The guideline outlines requirements of the training institution, the duration and core competencies of training, minimal procedural volume for competency in IE, and knowledge of specific structural health disease (SHD) procedures.

The 16-page guideline was published online  in the Journal of the American Society of Echocardiography.
 

Specific skill set

IE is the primary imaging modality used to support and guide SHD interventions, such as heart valve replacements and other cardiac catheterization procedures, the writing group notes.

They say the “emerging specialty” of IE requires a specific set of skills to support an array of transcatheter therapies, with successful outcomes highly dependent on the skill of the echocardiography team.

“IE techniques are unique since imaging is performed in real-time, it is highly dependent on 3D and non-standard views, and it has immediate and profound implications for patient management,” Stephen H. Little, MD, ASE president and co-chair of the guideline writing group, says in a news release.

“Additionally, IE requires candid, accurate, and timely communication with other members of the multidisciplinary SHD team,” Dr. Little adds.

The new ASE guideline expands on the 2019 statement on echocardiography training put forward by the American College of Cardiology, American Heart Association, and ASE, by focusing specifically on interventional echocardiographers.

It outlines core competencies common to all transcatheter therapies, as well as specific transcatheter procedures. It provides consensus recommendations for specific knowledge, experience, and skills to be learned and demonstrated within an IE training program or during postgraduate training.

A “core principle” in the guideline states that the length of IE training or achieved number of procedures performed are less important than the demonstration of procedure-specific competencies within the milestone domains of knowledge, skill, and communication.

“Transcatheter therapies for SHD continue to grow at a rapid pace, which means that the demand for skilled interventional echocardiographers has steadily increased,” Vera H. Rigolin, MD, co-chair of the guideline writing, says in the release.

“Training standards are needed to ensure that interventional echocardiographers have the necessary expertise to provide fast, accurate, and high-quality image acquisition and interpretation in real-time,” Dr. Rigolin adds.

In addition, the guidelines states that use of simulation training has a role in IE training.

Virtual and simulation training could shorten the learning curve for trainees and, when combined with remote learning, could permit societies to standardize a teaching curriculum and allow the trainee to complete training in a reasonable timeframe. Simulator training may also improve access to training and thus promote diversity and inclusivity, the writing group says.

The guideline has been endorsed by 21 ASE international partners.

Writing group co-chairs Little and Rigolin have declared no conflicts of interest. A complete list of disclosures for the writing group is available with the original article.

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

The American Society of Echocardiography (ASE) has issued guidance on all critical aspects of training for cardiology and anesthesiology trainees and postgraduate echocardiographers who plan to specialize in interventional echocardiography (IE).

The guideline outlines requirements of the training institution, the duration and core competencies of training, minimal procedural volume for competency in IE, and knowledge of specific structural health disease (SHD) procedures.

The 16-page guideline was published online  in the Journal of the American Society of Echocardiography.
 

Specific skill set

IE is the primary imaging modality used to support and guide SHD interventions, such as heart valve replacements and other cardiac catheterization procedures, the writing group notes.

They say the “emerging specialty” of IE requires a specific set of skills to support an array of transcatheter therapies, with successful outcomes highly dependent on the skill of the echocardiography team.

“IE techniques are unique since imaging is performed in real-time, it is highly dependent on 3D and non-standard views, and it has immediate and profound implications for patient management,” Stephen H. Little, MD, ASE president and co-chair of the guideline writing group, says in a news release.

“Additionally, IE requires candid, accurate, and timely communication with other members of the multidisciplinary SHD team,” Dr. Little adds.

The new ASE guideline expands on the 2019 statement on echocardiography training put forward by the American College of Cardiology, American Heart Association, and ASE, by focusing specifically on interventional echocardiographers.

It outlines core competencies common to all transcatheter therapies, as well as specific transcatheter procedures. It provides consensus recommendations for specific knowledge, experience, and skills to be learned and demonstrated within an IE training program or during postgraduate training.

A “core principle” in the guideline states that the length of IE training or achieved number of procedures performed are less important than the demonstration of procedure-specific competencies within the milestone domains of knowledge, skill, and communication.

“Transcatheter therapies for SHD continue to grow at a rapid pace, which means that the demand for skilled interventional echocardiographers has steadily increased,” Vera H. Rigolin, MD, co-chair of the guideline writing, says in the release.

“Training standards are needed to ensure that interventional echocardiographers have the necessary expertise to provide fast, accurate, and high-quality image acquisition and interpretation in real-time,” Dr. Rigolin adds.

In addition, the guidelines states that use of simulation training has a role in IE training.

Virtual and simulation training could shorten the learning curve for trainees and, when combined with remote learning, could permit societies to standardize a teaching curriculum and allow the trainee to complete training in a reasonable timeframe. Simulator training may also improve access to training and thus promote diversity and inclusivity, the writing group says.

The guideline has been endorsed by 21 ASE international partners.

Writing group co-chairs Little and Rigolin have declared no conflicts of interest. A complete list of disclosures for the writing group is available with the original article.

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

Older adults in cities are at lower risk of serious psychological distress – and potentially of later cognitive impairment and dementia – when they live close to so-called green and blue spaces, which can include public parks, community gardens, cemeteries, and bodies of water.

The findings of the study, which was released ahead of its scheduled presentation at the annual meeting of the American Academy of Neurology, build on a growing understanding of the relationship between types and qualities of urban environments and dementia risk.

Adithya Vegaraju, a student at Washington State University, Spokane, led the study, which looked at data from the Washington State Behavioral Risk Factor Surveillance System to assess prevalence of serious psychological distress among 42,980 Washington state residents aged 65 and over.

The data, collected between 2011 and 2019, used a self-reported questionnaire to determine serious psychological distress, which is defined as a level of mental distress considered debilitating enough to warrant treatment.

Mr. Vegaraju and his coauthor Solmaz Amiri, DDes, also of Washington State University, used ZIP codes, along with U.S. census data, to approximate the urban adults’ proximity to green and blue spaces.

After controlling for potential confounders of age, sex, ethnicity, education, and marital status, the investigators found that people living within half a mile of green or blue spaces had a 17% lower risk of experiencing serious psychological distress, compared with people living farther from these spaces, the investigators said in a news release.
 

Implications for cognitive decline and dementia?

Psychological distress in adults has been linked in population-based longitudinal studies to later cognitive decline and dementia. One study in older adults found the risk of dementia to be more than 50% higher among adults aged 50-70 with persistent depression. Blue and green spaces have also been investigated in relation to neurodegenerative disease among older adults; a 2022 study looking at data from some 62 million Medicare beneficiaries found those living in areas with more vegetation saw lower risk of hospitalizations for Alzheimer’s disease and related dementias.

“Since we lack effective prevention methods or treatments for mild cognitive impairment and dementia, we need to get creative in how we look at these issues,” Dr. Amiri commented in a press statement about her and Mr. Vegaraju’s findings. “Our hope is that this study showing better mental health among people living close to parks and water will trigger other studies about how these benefits work and whether this proximity can help prevent or delay mild cognitive impairment and dementia.”

The investigators acknowledged that their findings were limited by reliance on a self-reported measure of psychological distress.
 

A bidirectional connection with depression and dementia

In a comment, Anjum Hajat, PhD, an epidemiologist at University of Washington School of Public Health in Seattle who has also studied the relationship between green space and dementia risk in older adults, noted some further apparent limitations of the new study, for which only an abstract was available at publication.

“It has been shown that people with depression are at higher risk for dementia, but the opposite is also true,” Dr. Hajat commented. “Those with dementia are more likely to develop depression. This bidirectionality makes this study abstract difficult to interpret since the study is based on cross-sectional data: Individuals are not followed over time to see which develops first, dementia or depression.”

Additionally, Dr. Hajat noted, the data used to determine proximity to green and blue spaces did not allow for the calculation of precise distances between subjects’ homes and these spaces.

Mr. Vegaraju and Dr. Amiri’s study had no outside support, and the investigators declared no conflicts of interest. Dr. Hajat declared no conflicts of interest.

Older adults in cities are at lower risk of serious psychological distress – and potentially of later cognitive impairment and dementia – when they live close to so-called green and blue spaces, which can include public parks, community gardens, cemeteries, and bodies of water.

The findings of the study, which was released ahead of its scheduled presentation at the annual meeting of the American Academy of Neurology, build on a growing understanding of the relationship between types and qualities of urban environments and dementia risk.

Adithya Vegaraju, a student at Washington State University, Spokane, led the study, which looked at data from the Washington State Behavioral Risk Factor Surveillance System to assess prevalence of serious psychological distress among 42,980 Washington state residents aged 65 and over.

The data, collected between 2011 and 2019, used a self-reported questionnaire to determine serious psychological distress, which is defined as a level of mental distress considered debilitating enough to warrant treatment.

Mr. Vegaraju and his coauthor Solmaz Amiri, DDes, also of Washington State University, used ZIP codes, along with U.S. census data, to approximate the urban adults’ proximity to green and blue spaces.

After controlling for potential confounders of age, sex, ethnicity, education, and marital status, the investigators found that people living within half a mile of green or blue spaces had a 17% lower risk of experiencing serious psychological distress, compared with people living farther from these spaces, the investigators said in a news release.
 

Implications for cognitive decline and dementia?

Psychological distress in adults has been linked in population-based longitudinal studies to later cognitive decline and dementia. One study in older adults found the risk of dementia to be more than 50% higher among adults aged 50-70 with persistent depression. Blue and green spaces have also been investigated in relation to neurodegenerative disease among older adults; a 2022 study looking at data from some 62 million Medicare beneficiaries found those living in areas with more vegetation saw lower risk of hospitalizations for Alzheimer’s disease and related dementias.

“Since we lack effective prevention methods or treatments for mild cognitive impairment and dementia, we need to get creative in how we look at these issues,” Dr. Amiri commented in a press statement about her and Mr. Vegaraju’s findings. “Our hope is that this study showing better mental health among people living close to parks and water will trigger other studies about how these benefits work and whether this proximity can help prevent or delay mild cognitive impairment and dementia.”

The investigators acknowledged that their findings were limited by reliance on a self-reported measure of psychological distress.
 

A bidirectional connection with depression and dementia

In a comment, Anjum Hajat, PhD, an epidemiologist at University of Washington School of Public Health in Seattle who has also studied the relationship between green space and dementia risk in older adults, noted some further apparent limitations of the new study, for which only an abstract was available at publication.

“It has been shown that people with depression are at higher risk for dementia, but the opposite is also true,” Dr. Hajat commented. “Those with dementia are more likely to develop depression. This bidirectionality makes this study abstract difficult to interpret since the study is based on cross-sectional data: Individuals are not followed over time to see which develops first, dementia or depression.”

Additionally, Dr. Hajat noted, the data used to determine proximity to green and blue spaces did not allow for the calculation of precise distances between subjects’ homes and these spaces.

Mr. Vegaraju and Dr. Amiri’s study had no outside support, and the investigators declared no conflicts of interest. Dr. Hajat declared no conflicts of interest.

Older adults in cities are at lower risk of serious psychological distress – and potentially of later cognitive impairment and dementia – when they live close to so-called green and blue spaces, which can include public parks, community gardens, cemeteries, and bodies of water.

The findings of the study, which was released ahead of its scheduled presentation at the annual meeting of the American Academy of Neurology, build on a growing understanding of the relationship between types and qualities of urban environments and dementia risk.

Adithya Vegaraju, a student at Washington State University, Spokane, led the study, which looked at data from the Washington State Behavioral Risk Factor Surveillance System to assess prevalence of serious psychological distress among 42,980 Washington state residents aged 65 and over.

The data, collected between 2011 and 2019, used a self-reported questionnaire to determine serious psychological distress, which is defined as a level of mental distress considered debilitating enough to warrant treatment.

Mr. Vegaraju and his coauthor Solmaz Amiri, DDes, also of Washington State University, used ZIP codes, along with U.S. census data, to approximate the urban adults’ proximity to green and blue spaces.

After controlling for potential confounders of age, sex, ethnicity, education, and marital status, the investigators found that people living within half a mile of green or blue spaces had a 17% lower risk of experiencing serious psychological distress, compared with people living farther from these spaces, the investigators said in a news release.
 

Implications for cognitive decline and dementia?

Psychological distress in adults has been linked in population-based longitudinal studies to later cognitive decline and dementia. One study in older adults found the risk of dementia to be more than 50% higher among adults aged 50-70 with persistent depression. Blue and green spaces have also been investigated in relation to neurodegenerative disease among older adults; a 2022 study looking at data from some 62 million Medicare beneficiaries found those living in areas with more vegetation saw lower risk of hospitalizations for Alzheimer’s disease and related dementias.

“Since we lack effective prevention methods or treatments for mild cognitive impairment and dementia, we need to get creative in how we look at these issues,” Dr. Amiri commented in a press statement about her and Mr. Vegaraju’s findings. “Our hope is that this study showing better mental health among people living close to parks and water will trigger other studies about how these benefits work and whether this proximity can help prevent or delay mild cognitive impairment and dementia.”

The investigators acknowledged that their findings were limited by reliance on a self-reported measure of psychological distress.
 

A bidirectional connection with depression and dementia

In a comment, Anjum Hajat, PhD, an epidemiologist at University of Washington School of Public Health in Seattle who has also studied the relationship between green space and dementia risk in older adults, noted some further apparent limitations of the new study, for which only an abstract was available at publication.

“It has been shown that people with depression are at higher risk for dementia, but the opposite is also true,” Dr. Hajat commented. “Those with dementia are more likely to develop depression. This bidirectionality makes this study abstract difficult to interpret since the study is based on cross-sectional data: Individuals are not followed over time to see which develops first, dementia or depression.”

Additionally, Dr. Hajat noted, the data used to determine proximity to green and blue spaces did not allow for the calculation of precise distances between subjects’ homes and these spaces.

Mr. Vegaraju and Dr. Amiri’s study had no outside support, and the investigators declared no conflicts of interest. Dr. Hajat declared no conflicts of interest.

Experts recommend that most adults get 7-9 hours of sleep a night. If your patient is among the roughly one-third of people who sleep less (or more), regular exercise may help them dodge possible long-term health consequences such as heart disease and early death.

Plenty of research points to sleep and physical activity as crucial factors affecting life expectancy. Regular exercise can lengthen life, while too little or too much sleep may cut it short.

But evidence is growing that exercise may counteract the negative effects of poor sleep. A 2022 study found that being physically active for at least 25 minutes a day can erase the risk of early death associated with too much sleep or trouble falling asleep. And a 2021 study found that lower levels of physical activity may exacerbate the impact of poor sleep on early death, heart disease, and cancer.

The latest such study, published in the European Journal of Preventive Cardiology, suggests that higher volumes of exercise can virtually eliminate the risk of early death associated with sleeping too little or too long.

This study is unique, the researchers say, because it used accelerometers (motion-tracking sensors) to quantify sleep and physical activity. Other studies asked participants to report their own data, opening the door to false reports and mistakes.

Some 92,000 participants in the United Kingdom (mean age, 62 years; 56% women) wore the activity trackers for a week to measure how much they moved and slept. In the following 7 years, 3,080 participants died, mostly from cardiovascular disease or cancer.

As one might expect, the participants who were least likely to die also exercised the most and slept the “normal” amount (6-8 hours a night, as defined by the study).

Compared with that group, those who exercised the least and slept less than 6 hours were 2.5 times more likely to die during those 7 years (P < .001). Less active persons who got the recommended sleep were 79% more likely to die (P < .001). The risk was slightly higher than that for those who logged more than 8 hours a night.

But those risks disappeared for short- or long-sleeping participants who logged at least 150 minutes a week of moderate to vigorous activity.

“Exercise fights inflammatory and metabolic dysregulations and abnormal sympathetic nervous system activity,” said study author Jihui Zhang, PhD, of the Affiliated Brain Hospital of Guangzhou (China). Those problems are associated with cardiovascular diseases and other potentially fatal conditions.
 

More objective data – with tech

A study’s findings are only as good as the data it relies on. That’s why obtaining objective data not influenced by individual perception is key.

“Self-report questionnaires are prone to misperception, or recall or response bias,” Dr. Zhang explains.

Take sleep, for example. Research reveals that several factors can affect how we judge our sleep. When people have to sleep at irregular times, they often underestimate how many hours they sleep but overestimate how long they nap, found a study in the Journal of Clinical Sleep Medicine.

Another study showed that when people are under a lot of stress, they’ll report more sleep problems than they actually have, as revealed by an Actiheart monitor.

With exercise, participants often report doing more exercise, and doing it at a higher intensity, than objective measurements show they did. At the same time, self-reports typically don’t account for much of the unplanned, low-effort movement people do throughout the day.
 

Staying active when you’re tired

The study raises a practical question: If you don’t get the proper amount of sleep, how are you supposed to find the time, energy, and motivation to exercise?

The solution is to use one to fix the other.

Exercise and sleep have “a robust directional relationship,” Dr. Zhang said. Exercise improves sleep, while better sleep makes it easier to stick with an exercise program.

Ideally, that program will include a mix of cardio and resistance exercise, said Mitch Duncan, PhD, a professor of public health at the University of Newcastle, Australia.

As Dr. Duncan and his co-authors showed in a recent study, “the largest benefits to health occur when people do a combination of both aerobic and muscle-strengthening activity,” Dr. Duncan said.

“In terms of benefits to sleep, there doesn’t seem to be consistent evidence that favors either as being most effective.”

The timing or intensity of exercise doesn’t seem to matter much, either.

“But there is evidence that a greater duration contributes to larger improvements in sleep,” Dr. Duncan said.

In other words, longer workouts are generally better, but they don’t necessarily have to be super-intense.

The strongest evidence of all, however, shows that recent and regular exercise offer the biggest benefits at bedtime.

Today’s workout will improve tonight’s sleep. And the better you sleep tonight, the more likely you are to stick with the program.

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

Experts recommend that most adults get 7-9 hours of sleep a night. If your patient is among the roughly one-third of people who sleep less (or more), regular exercise may help them dodge possible long-term health consequences such as heart disease and early death.

Plenty of research points to sleep and physical activity as crucial factors affecting life expectancy. Regular exercise can lengthen life, while too little or too much sleep may cut it short.

But evidence is growing that exercise may counteract the negative effects of poor sleep. A 2022 study found that being physically active for at least 25 minutes a day can erase the risk of early death associated with too much sleep or trouble falling asleep. And a 2021 study found that lower levels of physical activity may exacerbate the impact of poor sleep on early death, heart disease, and cancer.

The latest such study, published in the European Journal of Preventive Cardiology, suggests that higher volumes of exercise can virtually eliminate the risk of early death associated with sleeping too little or too long.

This study is unique, the researchers say, because it used accelerometers (motion-tracking sensors) to quantify sleep and physical activity. Other studies asked participants to report their own data, opening the door to false reports and mistakes.

Some 92,000 participants in the United Kingdom (mean age, 62 years; 56% women) wore the activity trackers for a week to measure how much they moved and slept. In the following 7 years, 3,080 participants died, mostly from cardiovascular disease or cancer.

As one might expect, the participants who were least likely to die also exercised the most and slept the “normal” amount (6-8 hours a night, as defined by the study).

Compared with that group, those who exercised the least and slept less than 6 hours were 2.5 times more likely to die during those 7 years (P < .001). Less active persons who got the recommended sleep were 79% more likely to die (P < .001). The risk was slightly higher than that for those who logged more than 8 hours a night.

But those risks disappeared for short- or long-sleeping participants who logged at least 150 minutes a week of moderate to vigorous activity.

“Exercise fights inflammatory and metabolic dysregulations and abnormal sympathetic nervous system activity,” said study author Jihui Zhang, PhD, of the Affiliated Brain Hospital of Guangzhou (China). Those problems are associated with cardiovascular diseases and other potentially fatal conditions.
 

More objective data – with tech

A study’s findings are only as good as the data it relies on. That’s why obtaining objective data not influenced by individual perception is key.

“Self-report questionnaires are prone to misperception, or recall or response bias,” Dr. Zhang explains.

Take sleep, for example. Research reveals that several factors can affect how we judge our sleep. When people have to sleep at irregular times, they often underestimate how many hours they sleep but overestimate how long they nap, found a study in the Journal of Clinical Sleep Medicine.

Another study showed that when people are under a lot of stress, they’ll report more sleep problems than they actually have, as revealed by an Actiheart monitor.

With exercise, participants often report doing more exercise, and doing it at a higher intensity, than objective measurements show they did. At the same time, self-reports typically don’t account for much of the unplanned, low-effort movement people do throughout the day.
 

Staying active when you’re tired

The study raises a practical question: If you don’t get the proper amount of sleep, how are you supposed to find the time, energy, and motivation to exercise?

The solution is to use one to fix the other.

Exercise and sleep have “a robust directional relationship,” Dr. Zhang said. Exercise improves sleep, while better sleep makes it easier to stick with an exercise program.

Ideally, that program will include a mix of cardio and resistance exercise, said Mitch Duncan, PhD, a professor of public health at the University of Newcastle, Australia.

As Dr. Duncan and his co-authors showed in a recent study, “the largest benefits to health occur when people do a combination of both aerobic and muscle-strengthening activity,” Dr. Duncan said.

“In terms of benefits to sleep, there doesn’t seem to be consistent evidence that favors either as being most effective.”

The timing or intensity of exercise doesn’t seem to matter much, either.

“But there is evidence that a greater duration contributes to larger improvements in sleep,” Dr. Duncan said.

In other words, longer workouts are generally better, but they don’t necessarily have to be super-intense.

The strongest evidence of all, however, shows that recent and regular exercise offer the biggest benefits at bedtime.

Today’s workout will improve tonight’s sleep. And the better you sleep tonight, the more likely you are to stick with the program.

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

Experts recommend that most adults get 7-9 hours of sleep a night. If your patient is among the roughly one-third of people who sleep less (or more), regular exercise may help them dodge possible long-term health consequences such as heart disease and early death.

Plenty of research points to sleep and physical activity as crucial factors affecting life expectancy. Regular exercise can lengthen life, while too little or too much sleep may cut it short.

But evidence is growing that exercise may counteract the negative effects of poor sleep. A 2022 study found that being physically active for at least 25 minutes a day can erase the risk of early death associated with too much sleep or trouble falling asleep. And a 2021 study found that lower levels of physical activity may exacerbate the impact of poor sleep on early death, heart disease, and cancer.

The latest such study, published in the European Journal of Preventive Cardiology, suggests that higher volumes of exercise can virtually eliminate the risk of early death associated with sleeping too little or too long.

This study is unique, the researchers say, because it used accelerometers (motion-tracking sensors) to quantify sleep and physical activity. Other studies asked participants to report their own data, opening the door to false reports and mistakes.

Some 92,000 participants in the United Kingdom (mean age, 62 years; 56% women) wore the activity trackers for a week to measure how much they moved and slept. In the following 7 years, 3,080 participants died, mostly from cardiovascular disease or cancer.

As one might expect, the participants who were least likely to die also exercised the most and slept the “normal” amount (6-8 hours a night, as defined by the study).

Compared with that group, those who exercised the least and slept less than 6 hours were 2.5 times more likely to die during those 7 years (P < .001). Less active persons who got the recommended sleep were 79% more likely to die (P < .001). The risk was slightly higher than that for those who logged more than 8 hours a night.

But those risks disappeared for short- or long-sleeping participants who logged at least 150 minutes a week of moderate to vigorous activity.

“Exercise fights inflammatory and metabolic dysregulations and abnormal sympathetic nervous system activity,” said study author Jihui Zhang, PhD, of the Affiliated Brain Hospital of Guangzhou (China). Those problems are associated with cardiovascular diseases and other potentially fatal conditions.
 

More objective data – with tech

A study’s findings are only as good as the data it relies on. That’s why obtaining objective data not influenced by individual perception is key.

“Self-report questionnaires are prone to misperception, or recall or response bias,” Dr. Zhang explains.

Take sleep, for example. Research reveals that several factors can affect how we judge our sleep. When people have to sleep at irregular times, they often underestimate how many hours they sleep but overestimate how long they nap, found a study in the Journal of Clinical Sleep Medicine.

Another study showed that when people are under a lot of stress, they’ll report more sleep problems than they actually have, as revealed by an Actiheart monitor.

With exercise, participants often report doing more exercise, and doing it at a higher intensity, than objective measurements show they did. At the same time, self-reports typically don’t account for much of the unplanned, low-effort movement people do throughout the day.
 

Staying active when you’re tired

The study raises a practical question: If you don’t get the proper amount of sleep, how are you supposed to find the time, energy, and motivation to exercise?

The solution is to use one to fix the other.

Exercise and sleep have “a robust directional relationship,” Dr. Zhang said. Exercise improves sleep, while better sleep makes it easier to stick with an exercise program.

Ideally, that program will include a mix of cardio and resistance exercise, said Mitch Duncan, PhD, a professor of public health at the University of Newcastle, Australia.

As Dr. Duncan and his co-authors showed in a recent study, “the largest benefits to health occur when people do a combination of both aerobic and muscle-strengthening activity,” Dr. Duncan said.

“In terms of benefits to sleep, there doesn’t seem to be consistent evidence that favors either as being most effective.”

The timing or intensity of exercise doesn’t seem to matter much, either.

“But there is evidence that a greater duration contributes to larger improvements in sleep,” Dr. Duncan said.

In other words, longer workouts are generally better, but they don’t necessarily have to be super-intense.

The strongest evidence of all, however, shows that recent and regular exercise offer the biggest benefits at bedtime.

Today’s workout will improve tonight’s sleep. And the better you sleep tonight, the more likely you are to stick with the program.

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

Among adults with diabetes but no history of heart failure (HF), taking a NSAID – even for only a month – sharply raises the risk of an HF hospitalization, suggests a prospective, controlled study.
 

Certain subgroups may account for much of the excess risk, the results suggest, including the very elderly, patients with uncontrolled diabetes, those prescribed an NSAID for the first time, and patients already taking both a renin-angiotensin system inhibitor (RASi) and a diuretic.

Such patients with a firm indication for NSAIDs potentially could “be the ones benefiting most from closer follow-up, reduced dosage, or other mitigation strategies,” Anders Holt, MD, said in an interview.

Dr. Holt, of Copenhagen University Hospital and Herlev-Gentofte Hospital in Hellerup, Denmark, is lead author on the analysis of Danish registry data published in the Journal of the American College of Cardiology. He presented essentially the same results in preliminary form at the 2022 annual congress of the European Society of Cardiology.

HF hospitalizations linked to NSAIDs, the published report notes, are often attributed to symptoms from temporary fluid overload, often without worsening cardiac function, that stem from the drugs’ renal effects.

“One could speculate,” Dr. Holt said, that such HF events might be less severe and even associated with better outcomes, compared with other forms of heart failure.

But the current analysis provides a hint to the contrary, he observed. The 5-year mortality was similar for patients with HF linked to NSAIDs and those with other forms of HF, “which could suggest that NSAID-associated heart failure is more than transient fluid overload.”

The drugs may promote HF through direct effects on the heart by any of several proposed mechanisms, including “induction of arrhythmias and heart fibrosis, vasoconstriction, subclinical inflammation, and blood pressure elevation,” Dr. Holt said.

The current study doesn’t determine whether NSAID-associated HF stems from transient fluid overload or direct cardiac effects, but it’s “most likely both.”

In other limitations, the analysis is unable to “reliably explore” whether promotion of HF is an NSAID class effect, a “clinically relevant” point given the drugs’ varying effects on cardiovascular risk, states an accompanying editorial. Nor was it able to determine whether the drugs exert a dose-response effect on HF risk, noted Hassan Khan, MD, PhD, Norton Healthcare, Louisville, Ky., and Setor K. Kunutsor, MD, PhD, University of Leicester (England).

Still, “given the well-established relationship between the use of NSAIDs and increased HF, these findings are not unexpected because type 2 diabetes is also a major risk factor for HF.”

But it may be “premature to issue guideline recommendations based on a single observational study,” the editorialists wrote. “Further robust clinical trial evidence is needed to replicate these results and investigate the relationship of the type and dose of NSAIDs with HF risk. However, it should be realized that short-term or long-term use of NSAIDs may be detrimental to cardiovascular health.”

The analysis covered 23,308 patients from throughout Denmark with a type 2 diabetes diagnosis and no HF history who experienced a first HF hospitalization; their age averaged 76 years and 39% were women.

They served as their own controls; their NSAID exposures at two 28-day periods preceding the HF event, the one immediately before and the other preceding it by 56 days, were compared as the index and control periods, respectively.

Exposure to NSAIDs was defined as obtaining a prescription for celecoxib, diclofenac, ibuprofen, or naproxen, “as these are NSAIDs used primarily in Denmark,” the report states.

The odds ratios for HF hospitalization associated with NSAID exposure within 28 days preceding the event were 1.43 (95% confidence interval, 1.27-1.63) overall, 1.41 (95% CI, 1.16-1.71) for an NSAID given on top of both RASi and diuretics, 1.68 (95% CI, 1.00-2.88) for patients with elevated hemoglobin A1c, 1.78 (95% CI, 1.39-2.28) for those 80 or older, and 2.71 (95% CI, 1.78-4.23) for those with prior NSAID use.

That NSAID use and diabetes are each associated with increased risk for HF is well established, Dr. Holt observed. Yet the drugs had been prescribed to 16% of patients in the study.

“One of the more surprising findings, to me, was the quite substantial use of prescribed NSAIDs in a population of patients with diabetes, a patient group with a well-established cardiovascular risk,” he said.

“This patient group is only growing, so emphasis on the possible associations between even short-term NSAID use and incident heart failure is probably timely and perhaps needed.”

Dr. Holt and the study were supported by grants from Ib Mogens Kristiansens Almene Fond, Helsefonden, Snedkermester Sophus Jacobsen og hustru Astrid Jacobsen Fond, Marie og M.B. Richters Fond, and the Dagmar Marshalls Fond. Dr. Khan and Dr. Kunutsor reported no relevant relationships.

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

Among adults with diabetes but no history of heart failure (HF), taking a NSAID – even for only a month – sharply raises the risk of an HF hospitalization, suggests a prospective, controlled study.
 

Certain subgroups may account for much of the excess risk, the results suggest, including the very elderly, patients with uncontrolled diabetes, those prescribed an NSAID for the first time, and patients already taking both a renin-angiotensin system inhibitor (RASi) and a diuretic.

Such patients with a firm indication for NSAIDs potentially could “be the ones benefiting most from closer follow-up, reduced dosage, or other mitigation strategies,” Anders Holt, MD, said in an interview.

Dr. Holt, of Copenhagen University Hospital and Herlev-Gentofte Hospital in Hellerup, Denmark, is lead author on the analysis of Danish registry data published in the Journal of the American College of Cardiology. He presented essentially the same results in preliminary form at the 2022 annual congress of the European Society of Cardiology.

HF hospitalizations linked to NSAIDs, the published report notes, are often attributed to symptoms from temporary fluid overload, often without worsening cardiac function, that stem from the drugs’ renal effects.

“One could speculate,” Dr. Holt said, that such HF events might be less severe and even associated with better outcomes, compared with other forms of heart failure.

But the current analysis provides a hint to the contrary, he observed. The 5-year mortality was similar for patients with HF linked to NSAIDs and those with other forms of HF, “which could suggest that NSAID-associated heart failure is more than transient fluid overload.”

The drugs may promote HF through direct effects on the heart by any of several proposed mechanisms, including “induction of arrhythmias and heart fibrosis, vasoconstriction, subclinical inflammation, and blood pressure elevation,” Dr. Holt said.

The current study doesn’t determine whether NSAID-associated HF stems from transient fluid overload or direct cardiac effects, but it’s “most likely both.”

In other limitations, the analysis is unable to “reliably explore” whether promotion of HF is an NSAID class effect, a “clinically relevant” point given the drugs’ varying effects on cardiovascular risk, states an accompanying editorial. Nor was it able to determine whether the drugs exert a dose-response effect on HF risk, noted Hassan Khan, MD, PhD, Norton Healthcare, Louisville, Ky., and Setor K. Kunutsor, MD, PhD, University of Leicester (England).

Still, “given the well-established relationship between the use of NSAIDs and increased HF, these findings are not unexpected because type 2 diabetes is also a major risk factor for HF.”

But it may be “premature to issue guideline recommendations based on a single observational study,” the editorialists wrote. “Further robust clinical trial evidence is needed to replicate these results and investigate the relationship of the type and dose of NSAIDs with HF risk. However, it should be realized that short-term or long-term use of NSAIDs may be detrimental to cardiovascular health.”

The analysis covered 23,308 patients from throughout Denmark with a type 2 diabetes diagnosis and no HF history who experienced a first HF hospitalization; their age averaged 76 years and 39% were women.

They served as their own controls; their NSAID exposures at two 28-day periods preceding the HF event, the one immediately before and the other preceding it by 56 days, were compared as the index and control periods, respectively.

Exposure to NSAIDs was defined as obtaining a prescription for celecoxib, diclofenac, ibuprofen, or naproxen, “as these are NSAIDs used primarily in Denmark,” the report states.

The odds ratios for HF hospitalization associated with NSAID exposure within 28 days preceding the event were 1.43 (95% confidence interval, 1.27-1.63) overall, 1.41 (95% CI, 1.16-1.71) for an NSAID given on top of both RASi and diuretics, 1.68 (95% CI, 1.00-2.88) for patients with elevated hemoglobin A1c, 1.78 (95% CI, 1.39-2.28) for those 80 or older, and 2.71 (95% CI, 1.78-4.23) for those with prior NSAID use.

That NSAID use and diabetes are each associated with increased risk for HF is well established, Dr. Holt observed. Yet the drugs had been prescribed to 16% of patients in the study.

“One of the more surprising findings, to me, was the quite substantial use of prescribed NSAIDs in a population of patients with diabetes, a patient group with a well-established cardiovascular risk,” he said.

“This patient group is only growing, so emphasis on the possible associations between even short-term NSAID use and incident heart failure is probably timely and perhaps needed.”

Dr. Holt and the study were supported by grants from Ib Mogens Kristiansens Almene Fond, Helsefonden, Snedkermester Sophus Jacobsen og hustru Astrid Jacobsen Fond, Marie og M.B. Richters Fond, and the Dagmar Marshalls Fond. Dr. Khan and Dr. Kunutsor reported no relevant relationships.

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

Among adults with diabetes but no history of heart failure (HF), taking a NSAID – even for only a month – sharply raises the risk of an HF hospitalization, suggests a prospective, controlled study.
 

Certain subgroups may account for much of the excess risk, the results suggest, including the very elderly, patients with uncontrolled diabetes, those prescribed an NSAID for the first time, and patients already taking both a renin-angiotensin system inhibitor (RASi) and a diuretic.

Such patients with a firm indication for NSAIDs potentially could “be the ones benefiting most from closer follow-up, reduced dosage, or other mitigation strategies,” Anders Holt, MD, said in an interview.

Dr. Holt, of Copenhagen University Hospital and Herlev-Gentofte Hospital in Hellerup, Denmark, is lead author on the analysis of Danish registry data published in the Journal of the American College of Cardiology. He presented essentially the same results in preliminary form at the 2022 annual congress of the European Society of Cardiology.

HF hospitalizations linked to NSAIDs, the published report notes, are often attributed to symptoms from temporary fluid overload, often without worsening cardiac function, that stem from the drugs’ renal effects.

“One could speculate,” Dr. Holt said, that such HF events might be less severe and even associated with better outcomes, compared with other forms of heart failure.

But the current analysis provides a hint to the contrary, he observed. The 5-year mortality was similar for patients with HF linked to NSAIDs and those with other forms of HF, “which could suggest that NSAID-associated heart failure is more than transient fluid overload.”

The drugs may promote HF through direct effects on the heart by any of several proposed mechanisms, including “induction of arrhythmias and heart fibrosis, vasoconstriction, subclinical inflammation, and blood pressure elevation,” Dr. Holt said.

The current study doesn’t determine whether NSAID-associated HF stems from transient fluid overload or direct cardiac effects, but it’s “most likely both.”

In other limitations, the analysis is unable to “reliably explore” whether promotion of HF is an NSAID class effect, a “clinically relevant” point given the drugs’ varying effects on cardiovascular risk, states an accompanying editorial. Nor was it able to determine whether the drugs exert a dose-response effect on HF risk, noted Hassan Khan, MD, PhD, Norton Healthcare, Louisville, Ky., and Setor K. Kunutsor, MD, PhD, University of Leicester (England).

Still, “given the well-established relationship between the use of NSAIDs and increased HF, these findings are not unexpected because type 2 diabetes is also a major risk factor for HF.”

But it may be “premature to issue guideline recommendations based on a single observational study,” the editorialists wrote. “Further robust clinical trial evidence is needed to replicate these results and investigate the relationship of the type and dose of NSAIDs with HF risk. However, it should be realized that short-term or long-term use of NSAIDs may be detrimental to cardiovascular health.”

The analysis covered 23,308 patients from throughout Denmark with a type 2 diabetes diagnosis and no HF history who experienced a first HF hospitalization; their age averaged 76 years and 39% were women.

They served as their own controls; their NSAID exposures at two 28-day periods preceding the HF event, the one immediately before and the other preceding it by 56 days, were compared as the index and control periods, respectively.

Exposure to NSAIDs was defined as obtaining a prescription for celecoxib, diclofenac, ibuprofen, or naproxen, “as these are NSAIDs used primarily in Denmark,” the report states.

The odds ratios for HF hospitalization associated with NSAID exposure within 28 days preceding the event were 1.43 (95% confidence interval, 1.27-1.63) overall, 1.41 (95% CI, 1.16-1.71) for an NSAID given on top of both RASi and diuretics, 1.68 (95% CI, 1.00-2.88) for patients with elevated hemoglobin A1c, 1.78 (95% CI, 1.39-2.28) for those 80 or older, and 2.71 (95% CI, 1.78-4.23) for those with prior NSAID use.

That NSAID use and diabetes are each associated with increased risk for HF is well established, Dr. Holt observed. Yet the drugs had been prescribed to 16% of patients in the study.

“One of the more surprising findings, to me, was the quite substantial use of prescribed NSAIDs in a population of patients with diabetes, a patient group with a well-established cardiovascular risk,” he said.

“This patient group is only growing, so emphasis on the possible associations between even short-term NSAID use and incident heart failure is probably timely and perhaps needed.”

Dr. Holt and the study were supported by grants from Ib Mogens Kristiansens Almene Fond, Helsefonden, Snedkermester Sophus Jacobsen og hustru Astrid Jacobsen Fond, Marie og M.B. Richters Fond, and the Dagmar Marshalls Fond. Dr. Khan and Dr. Kunutsor reported no relevant relationships.

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

Atrial fibrillation (AFib) is a known and serious side effect of some cancer treatments, but it is underreported in cancer drug trials, French investigators said in a new report.

As a result, oncologists likely underestimate the risk of atrial fibrillation when new cancer drugs come to market, they said.

The team came to these conclusions after conducting a meta-analysis of 191 phase 2 or 3 clinical trials that included 26,604 patients. The trials investigated 15 anticancer drugs used as monotherapy.

The meta-analysis showed that the annualized incidence rate of AFib ranged from 0.26 cases per 100 person-years – about the same as placebo – to 4.92 cases, a nearly 20 times’ higher risk.

Rates were the highest for ibrutinib, clofarabine, and ponatinib.

The study was published in JACC: CardioOncology, a journal of the American College of Cardiology.

Actual rates of AFib are probably higher than what they found in this meta-analysis, the authors suspect, because most oncology trials only identify and report severe cases of AFib that require immediate medical attention. Less severe cases can also lead to serious complications, including strokes, but they go unreported, said the investigators, led by Joachim Alexandre, MD, PhD, a member of the cardio-oncology program at the University of Caen Normandie Hospital Center, France.

“These findings suggest a global and systemic underreporting and/or underidentification of cardiotoxicity among cancer clinical trial participants,” and AFib reporting is “particularly affected,” they said.
 

Call for routine monitoring

The root of the problem is the lack of routine rhythm monitoring in cancer trials. This in turn “leads to a significant underestimation of AFib incidence” and rates “markedly lower than those observed among real-life” patients, the authors pointed out.

To address the issue, Dr. Alexandre and his team called for routine cardiac monitoring in trials to capture the true incidence of AFib and to “clearly define which anticancer drugs are significantly associated” with the condition.

Approached for comment, Michael G. Fradley, MD, medical director of cardio-oncology at the University of Pennsylvania, Philadelphia, agreed.

“It’s incredibly important” to “identify the drugs most likely to cause arrhythmias and determine the best prevention and treatment strategies. Unfortunately, systematic evaluation of arrhythmias in cancer clinical trials has often been lacking,” Dr. Fradley told this news organization.

The investigators said the issue is particularly pressing for drugs known to be associated with AFib. For Bruton’s tyrosine kinase inhibitors such as ibrutinib, for instance, they call for standardize AFib detection in trials “not only on 12-lead ECGs” for symptomatic AFib but also with “longer-term ambulatory monitoring or insertable cardiac monitors to detect subclinical AFib.”

Dr. Fradley said there might also be a role for newer wearable technologies that can detect arrhythmias through a skin patch or by other means.
 

Details of the meta-analysis

The investigators pulled the 191 studies they used in their meta-analysis from the ClinicalTrials.gov database.

The trials covered anticancer drugs used as monotherapy up to Sept. 18, 2020. Almost half were randomized trials, but only seven had placebo arms. Trials involving hematologic cancers outnumbered those involving solid tumors.

The 15 drugs examined were dacarbazine, abiraterone, clofarabine, azacitidine, ibrutinib, nilotinib, ponatinib, midostaurin, ipilimumab, aldesleukin, lenalidomide, pomalidomide, rituximab, bortezomib, and docetaxel.

The annualized incidence AFib rates per 100 person-years were 4.92 cases for ibrutinib, 2.38 cases for clofarabine, and 2.35 cases for ponatinib.

The lowest AFib rates were for ipilimumab (0.26 cases), rituximab (0.27), and nilotinib (0.29).

For placebo, the annualized rate was 0.25 cases per 100 person-years.

The team said caution is warranted regarding their estimations for clofarabine and midostaurin (0.65 cases) because no trials were registered after September 2009, when adverse event reporting became mandatory. As a result, estimates may be artificially low.

One of the limits of the study is that it focused on monotherapy in an age when combination treatment is generally the rule for cancer, the authors noted.

No external funding was reported for the study. Dr. Alexandre has received honoraria for presentations and consulting fees from Bayer, BMS, Pfizer, Amgen, and Bioserenity.
 

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

Atrial fibrillation (AFib) is a known and serious side effect of some cancer treatments, but it is underreported in cancer drug trials, French investigators said in a new report.

As a result, oncologists likely underestimate the risk of atrial fibrillation when new cancer drugs come to market, they said.

The team came to these conclusions after conducting a meta-analysis of 191 phase 2 or 3 clinical trials that included 26,604 patients. The trials investigated 15 anticancer drugs used as monotherapy.

The meta-analysis showed that the annualized incidence rate of AFib ranged from 0.26 cases per 100 person-years – about the same as placebo – to 4.92 cases, a nearly 20 times’ higher risk.

Rates were the highest for ibrutinib, clofarabine, and ponatinib.

The study was published in JACC: CardioOncology, a journal of the American College of Cardiology.

Actual rates of AFib are probably higher than what they found in this meta-analysis, the authors suspect, because most oncology trials only identify and report severe cases of AFib that require immediate medical attention. Less severe cases can also lead to serious complications, including strokes, but they go unreported, said the investigators, led by Joachim Alexandre, MD, PhD, a member of the cardio-oncology program at the University of Caen Normandie Hospital Center, France.

“These findings suggest a global and systemic underreporting and/or underidentification of cardiotoxicity among cancer clinical trial participants,” and AFib reporting is “particularly affected,” they said.
 

Call for routine monitoring

The root of the problem is the lack of routine rhythm monitoring in cancer trials. This in turn “leads to a significant underestimation of AFib incidence” and rates “markedly lower than those observed among real-life” patients, the authors pointed out.

To address the issue, Dr. Alexandre and his team called for routine cardiac monitoring in trials to capture the true incidence of AFib and to “clearly define which anticancer drugs are significantly associated” with the condition.

Approached for comment, Michael G. Fradley, MD, medical director of cardio-oncology at the University of Pennsylvania, Philadelphia, agreed.

“It’s incredibly important” to “identify the drugs most likely to cause arrhythmias and determine the best prevention and treatment strategies. Unfortunately, systematic evaluation of arrhythmias in cancer clinical trials has often been lacking,” Dr. Fradley told this news organization.

The investigators said the issue is particularly pressing for drugs known to be associated with AFib. For Bruton’s tyrosine kinase inhibitors such as ibrutinib, for instance, they call for standardize AFib detection in trials “not only on 12-lead ECGs” for symptomatic AFib but also with “longer-term ambulatory monitoring or insertable cardiac monitors to detect subclinical AFib.”

Dr. Fradley said there might also be a role for newer wearable technologies that can detect arrhythmias through a skin patch or by other means.
 

Details of the meta-analysis

The investigators pulled the 191 studies they used in their meta-analysis from the ClinicalTrials.gov database.

The trials covered anticancer drugs used as monotherapy up to Sept. 18, 2020. Almost half were randomized trials, but only seven had placebo arms. Trials involving hematologic cancers outnumbered those involving solid tumors.

The 15 drugs examined were dacarbazine, abiraterone, clofarabine, azacitidine, ibrutinib, nilotinib, ponatinib, midostaurin, ipilimumab, aldesleukin, lenalidomide, pomalidomide, rituximab, bortezomib, and docetaxel.

The annualized incidence AFib rates per 100 person-years were 4.92 cases for ibrutinib, 2.38 cases for clofarabine, and 2.35 cases for ponatinib.

The lowest AFib rates were for ipilimumab (0.26 cases), rituximab (0.27), and nilotinib (0.29).

For placebo, the annualized rate was 0.25 cases per 100 person-years.

The team said caution is warranted regarding their estimations for clofarabine and midostaurin (0.65 cases) because no trials were registered after September 2009, when adverse event reporting became mandatory. As a result, estimates may be artificially low.

One of the limits of the study is that it focused on monotherapy in an age when combination treatment is generally the rule for cancer, the authors noted.

No external funding was reported for the study. Dr. Alexandre has received honoraria for presentations and consulting fees from Bayer, BMS, Pfizer, Amgen, and Bioserenity.
 

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

Atrial fibrillation (AFib) is a known and serious side effect of some cancer treatments, but it is underreported in cancer drug trials, French investigators said in a new report.

As a result, oncologists likely underestimate the risk of atrial fibrillation when new cancer drugs come to market, they said.

The team came to these conclusions after conducting a meta-analysis of 191 phase 2 or 3 clinical trials that included 26,604 patients. The trials investigated 15 anticancer drugs used as monotherapy.

The meta-analysis showed that the annualized incidence rate of AFib ranged from 0.26 cases per 100 person-years – about the same as placebo – to 4.92 cases, a nearly 20 times’ higher risk.

Rates were the highest for ibrutinib, clofarabine, and ponatinib.

The study was published in JACC: CardioOncology, a journal of the American College of Cardiology.

Actual rates of AFib are probably higher than what they found in this meta-analysis, the authors suspect, because most oncology trials only identify and report severe cases of AFib that require immediate medical attention. Less severe cases can also lead to serious complications, including strokes, but they go unreported, said the investigators, led by Joachim Alexandre, MD, PhD, a member of the cardio-oncology program at the University of Caen Normandie Hospital Center, France.

“These findings suggest a global and systemic underreporting and/or underidentification of cardiotoxicity among cancer clinical trial participants,” and AFib reporting is “particularly affected,” they said.
 

Call for routine monitoring

The root of the problem is the lack of routine rhythm monitoring in cancer trials. This in turn “leads to a significant underestimation of AFib incidence” and rates “markedly lower than those observed among real-life” patients, the authors pointed out.

To address the issue, Dr. Alexandre and his team called for routine cardiac monitoring in trials to capture the true incidence of AFib and to “clearly define which anticancer drugs are significantly associated” with the condition.

Approached for comment, Michael G. Fradley, MD, medical director of cardio-oncology at the University of Pennsylvania, Philadelphia, agreed.

“It’s incredibly important” to “identify the drugs most likely to cause arrhythmias and determine the best prevention and treatment strategies. Unfortunately, systematic evaluation of arrhythmias in cancer clinical trials has often been lacking,” Dr. Fradley told this news organization.

The investigators said the issue is particularly pressing for drugs known to be associated with AFib. For Bruton’s tyrosine kinase inhibitors such as ibrutinib, for instance, they call for standardize AFib detection in trials “not only on 12-lead ECGs” for symptomatic AFib but also with “longer-term ambulatory monitoring or insertable cardiac monitors to detect subclinical AFib.”

Dr. Fradley said there might also be a role for newer wearable technologies that can detect arrhythmias through a skin patch or by other means.
 

Details of the meta-analysis

The investigators pulled the 191 studies they used in their meta-analysis from the ClinicalTrials.gov database.

The trials covered anticancer drugs used as monotherapy up to Sept. 18, 2020. Almost half were randomized trials, but only seven had placebo arms. Trials involving hematologic cancers outnumbered those involving solid tumors.

The 15 drugs examined were dacarbazine, abiraterone, clofarabine, azacitidine, ibrutinib, nilotinib, ponatinib, midostaurin, ipilimumab, aldesleukin, lenalidomide, pomalidomide, rituximab, bortezomib, and docetaxel.

The annualized incidence AFib rates per 100 person-years were 4.92 cases for ibrutinib, 2.38 cases for clofarabine, and 2.35 cases for ponatinib.

The lowest AFib rates were for ipilimumab (0.26 cases), rituximab (0.27), and nilotinib (0.29).

For placebo, the annualized rate was 0.25 cases per 100 person-years.

The team said caution is warranted regarding their estimations for clofarabine and midostaurin (0.65 cases) because no trials were registered after September 2009, when adverse event reporting became mandatory. As a result, estimates may be artificially low.

One of the limits of the study is that it focused on monotherapy in an age when combination treatment is generally the rule for cancer, the authors noted.

No external funding was reported for the study. Dr. Alexandre has received honoraria for presentations and consulting fees from Bayer, BMS, Pfizer, Amgen, and Bioserenity.
 

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

PARIS – A single 25-mg dose of a synthetic formulation of psilocybin appears to improve the core symptoms of treatment-resistant depression (TRD), a new analysis of phase 2 trial data suggests.

Known as COMP360, the synthetic agent, a proprietary, purified form of psilocybin, improved symptoms related to mood and anhedonia while leaving aspects such as appetite and weight changes unaffected, reported investigators led by Guy M. Goodwin, PhD, emeritus professor of psychiatry, University of Oxford, England, and chief medical officer, COMPASS Pathways.

The study was presented at the European Psychiatric Association (EPA) 2023 Congress.
 

100 million affected

Affecting up to 100 million people globally, TRD is “not an official diagnosis,” although it is often defined as the failure to elicit a response with at least two antidepressant treatments, said Dr. Goodwin.

Compared to their counterparts with non-TRD, those with TRD experience higher relapse rates, higher rates of suicidal behavior, and more residual symptoms even when they do respond to treatment.

Previous results from the study known as P-TRD indicated that a single 25-mg dose of COMP360 significantly reduced depression scores for up to 12 weeks when given along with psychological support, although a later analysis suggested the effect subsequently dropped off.

The vast majority of the patients in the trial were naive to psychedelics, and so, Dr. Goodwin explained, they undergo a preparation phase during which they receive psychoeducation and have at least two visits with a therapist, who then stays with them during administration of the drug to offer support if they experience psychological distress.

Following the psilocybin session, participants go through a process known as integration, which involves two sessions with a therapist within 2 weeks.

“That, in our view, is essentially about safety, and about identifying problems that have arisen as a result of taking the drug,” said Dr. Goodwin.

The phase 2b trial examined changes in specific depression symptoms after psilocybin treatment in 233 patients with TRD. Participants were a mean age of 39.8 years and 59% were women. They were randomized to receive one of three doses of the drug: a 1-mg dose (n = 79), a 10-mg dose (n = 75), or a 25-mg dose (n = 79).

The primary outcome was changes in individual items on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 16-item Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR-16) scale.

While the effect on overall depression scores is important, said Dr. Goodwin, many of the items included in the depression assessment scales are “uninformative.”
 

Reduction in ‘core’ symptoms

Participants were assessed by a blinded rater at baseline, day 1, day 2, and at 1, 2, 3, 6, 9, and 12 weeks after administration of COMP360. The primary endpoint was a reduction in individual items on MADRS and scores from baseline to 3 weeks. Individual items on the QIDS-SR-16 were rated by participants at the same time points.

Investigators found the largest mean changes from baseline were on reported and apparent sadness, lassitude, inability to feel, and concentration difficulties, with “very nice and clear dose-related differences,” Dr. Goodwin said.

The results indicate that the significant benefit with the largest dose at 3 weeks versus baseline was confined to items such as inability to feel and reported and apparent sadness on the MADRS and feeling sad and general interest on the QIDS-SR-16 (Table 1).

The results suggest the effect of COMP360 is “on the core symptoms of depression,” said Dr. Goodwin.

Enthusiasm running ahead of the data

Commenting on the findings, Bertha K. Madras, PhD, professor of psychobiology, department of psychiatry, Harvard Medical School, Boston, who was not involved in the study, said “hallucinogens are an intriguing class of drugs and I support ongoing high-quality research in this area.”

However, she told this news organization that the “breathtaking endorsement of this drug is far ahead of scientific data.”

She cited concerns such as the “narrow demographics” of participants, their previous experience with and expectations of hallucinogens, the “potential for symptom fluidity of enrollees,” such as depression evolving into psychosis, and the “undefined role” of the therapist during a hallucinogenic session.

“Finally, I am concerned that enthusiasm for therapeutic potential has been, and will continue to be, preempted and directed towards legalization and widespread access for vulnerable populations,” Dr. Madras said.

This, she said, “is occurring at breakneck speed in the U.S., with scant resistance or skepticism from the investigators engaged in therapeutic assessment.”

The study was funded by COMPASS Pathways. Dr. Goodwin has reported relationships with COMPASS Pathways, Buckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVA Pharma, Lundbeck, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda, and WebMD.
 

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

PARIS – A single 25-mg dose of a synthetic formulation of psilocybin appears to improve the core symptoms of treatment-resistant depression (TRD), a new analysis of phase 2 trial data suggests.

Known as COMP360, the synthetic agent, a proprietary, purified form of psilocybin, improved symptoms related to mood and anhedonia while leaving aspects such as appetite and weight changes unaffected, reported investigators led by Guy M. Goodwin, PhD, emeritus professor of psychiatry, University of Oxford, England, and chief medical officer, COMPASS Pathways.

The study was presented at the European Psychiatric Association (EPA) 2023 Congress.
 

100 million affected

Affecting up to 100 million people globally, TRD is “not an official diagnosis,” although it is often defined as the failure to elicit a response with at least two antidepressant treatments, said Dr. Goodwin.

Compared to their counterparts with non-TRD, those with TRD experience higher relapse rates, higher rates of suicidal behavior, and more residual symptoms even when they do respond to treatment.

Previous results from the study known as P-TRD indicated that a single 25-mg dose of COMP360 significantly reduced depression scores for up to 12 weeks when given along with psychological support, although a later analysis suggested the effect subsequently dropped off.

The vast majority of the patients in the trial were naive to psychedelics, and so, Dr. Goodwin explained, they undergo a preparation phase during which they receive psychoeducation and have at least two visits with a therapist, who then stays with them during administration of the drug to offer support if they experience psychological distress.

Following the psilocybin session, participants go through a process known as integration, which involves two sessions with a therapist within 2 weeks.

“That, in our view, is essentially about safety, and about identifying problems that have arisen as a result of taking the drug,” said Dr. Goodwin.

The phase 2b trial examined changes in specific depression symptoms after psilocybin treatment in 233 patients with TRD. Participants were a mean age of 39.8 years and 59% were women. They were randomized to receive one of three doses of the drug: a 1-mg dose (n = 79), a 10-mg dose (n = 75), or a 25-mg dose (n = 79).

The primary outcome was changes in individual items on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 16-item Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR-16) scale.

While the effect on overall depression scores is important, said Dr. Goodwin, many of the items included in the depression assessment scales are “uninformative.”
 

Reduction in ‘core’ symptoms

Participants were assessed by a blinded rater at baseline, day 1, day 2, and at 1, 2, 3, 6, 9, and 12 weeks after administration of COMP360. The primary endpoint was a reduction in individual items on MADRS and scores from baseline to 3 weeks. Individual items on the QIDS-SR-16 were rated by participants at the same time points.

Investigators found the largest mean changes from baseline were on reported and apparent sadness, lassitude, inability to feel, and concentration difficulties, with “very nice and clear dose-related differences,” Dr. Goodwin said.

The results indicate that the significant benefit with the largest dose at 3 weeks versus baseline was confined to items such as inability to feel and reported and apparent sadness on the MADRS and feeling sad and general interest on the QIDS-SR-16 (Table 1).

The results suggest the effect of COMP360 is “on the core symptoms of depression,” said Dr. Goodwin.

Enthusiasm running ahead of the data

Commenting on the findings, Bertha K. Madras, PhD, professor of psychobiology, department of psychiatry, Harvard Medical School, Boston, who was not involved in the study, said “hallucinogens are an intriguing class of drugs and I support ongoing high-quality research in this area.”

However, she told this news organization that the “breathtaking endorsement of this drug is far ahead of scientific data.”

She cited concerns such as the “narrow demographics” of participants, their previous experience with and expectations of hallucinogens, the “potential for symptom fluidity of enrollees,” such as depression evolving into psychosis, and the “undefined role” of the therapist during a hallucinogenic session.

“Finally, I am concerned that enthusiasm for therapeutic potential has been, and will continue to be, preempted and directed towards legalization and widespread access for vulnerable populations,” Dr. Madras said.

This, she said, “is occurring at breakneck speed in the U.S., with scant resistance or skepticism from the investigators engaged in therapeutic assessment.”

The study was funded by COMPASS Pathways. Dr. Goodwin has reported relationships with COMPASS Pathways, Buckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVA Pharma, Lundbeck, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda, and WebMD.
 

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

PARIS – A single 25-mg dose of a synthetic formulation of psilocybin appears to improve the core symptoms of treatment-resistant depression (TRD), a new analysis of phase 2 trial data suggests.

Known as COMP360, the synthetic agent, a proprietary, purified form of psilocybin, improved symptoms related to mood and anhedonia while leaving aspects such as appetite and weight changes unaffected, reported investigators led by Guy M. Goodwin, PhD, emeritus professor of psychiatry, University of Oxford, England, and chief medical officer, COMPASS Pathways.

The study was presented at the European Psychiatric Association (EPA) 2023 Congress.
 

100 million affected

Affecting up to 100 million people globally, TRD is “not an official diagnosis,” although it is often defined as the failure to elicit a response with at least two antidepressant treatments, said Dr. Goodwin.

Compared to their counterparts with non-TRD, those with TRD experience higher relapse rates, higher rates of suicidal behavior, and more residual symptoms even when they do respond to treatment.

Previous results from the study known as P-TRD indicated that a single 25-mg dose of COMP360 significantly reduced depression scores for up to 12 weeks when given along with psychological support, although a later analysis suggested the effect subsequently dropped off.

The vast majority of the patients in the trial were naive to psychedelics, and so, Dr. Goodwin explained, they undergo a preparation phase during which they receive psychoeducation and have at least two visits with a therapist, who then stays with them during administration of the drug to offer support if they experience psychological distress.

Following the psilocybin session, participants go through a process known as integration, which involves two sessions with a therapist within 2 weeks.

“That, in our view, is essentially about safety, and about identifying problems that have arisen as a result of taking the drug,” said Dr. Goodwin.

The phase 2b trial examined changes in specific depression symptoms after psilocybin treatment in 233 patients with TRD. Participants were a mean age of 39.8 years and 59% were women. They were randomized to receive one of three doses of the drug: a 1-mg dose (n = 79), a 10-mg dose (n = 75), or a 25-mg dose (n = 79).

The primary outcome was changes in individual items on the Montgomery-Åsberg Depression Rating Scale (MADRS) and 16-item Quick Inventory of Depressive Symptomatology–Self Report (QIDS-SR-16) scale.

While the effect on overall depression scores is important, said Dr. Goodwin, many of the items included in the depression assessment scales are “uninformative.”
 

Reduction in ‘core’ symptoms

Participants were assessed by a blinded rater at baseline, day 1, day 2, and at 1, 2, 3, 6, 9, and 12 weeks after administration of COMP360. The primary endpoint was a reduction in individual items on MADRS and scores from baseline to 3 weeks. Individual items on the QIDS-SR-16 were rated by participants at the same time points.

Investigators found the largest mean changes from baseline were on reported and apparent sadness, lassitude, inability to feel, and concentration difficulties, with “very nice and clear dose-related differences,” Dr. Goodwin said.

The results indicate that the significant benefit with the largest dose at 3 weeks versus baseline was confined to items such as inability to feel and reported and apparent sadness on the MADRS and feeling sad and general interest on the QIDS-SR-16 (Table 1).

The results suggest the effect of COMP360 is “on the core symptoms of depression,” said Dr. Goodwin.

Enthusiasm running ahead of the data

Commenting on the findings, Bertha K. Madras, PhD, professor of psychobiology, department of psychiatry, Harvard Medical School, Boston, who was not involved in the study, said “hallucinogens are an intriguing class of drugs and I support ongoing high-quality research in this area.”

However, she told this news organization that the “breathtaking endorsement of this drug is far ahead of scientific data.”

She cited concerns such as the “narrow demographics” of participants, their previous experience with and expectations of hallucinogens, the “potential for symptom fluidity of enrollees,” such as depression evolving into psychosis, and the “undefined role” of the therapist during a hallucinogenic session.

“Finally, I am concerned that enthusiasm for therapeutic potential has been, and will continue to be, preempted and directed towards legalization and widespread access for vulnerable populations,” Dr. Madras said.

This, she said, “is occurring at breakneck speed in the U.S., with scant resistance or skepticism from the investigators engaged in therapeutic assessment.”

The study was funded by COMPASS Pathways. Dr. Goodwin has reported relationships with COMPASS Pathways, Buckley Psytech, Boehringer Ingelheim, Clerkenwell Health, EVA Pharma, Lundbeck, Janssen Global Services, Novartis, Ocean Neurosciences, P1vital, Sage Therapeutics, Servier, Takeda, and WebMD.
 

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

NEW ORLEANS – Parents’ concerns about vaccinating their children against COVID-19 remain a substantial barrier to immunizing children against the disease, whether those children have chronic rheumatologic conditions or a history of multisystem inflammatory syndrome in children (MIS-C), according to two studies presented at the Pediatric Rheumatology Symposium.

Parents of children who developed MIS-C after a SARS-CoV-2 infection were particularly hesitant to vaccinate, despite strong encouragement from health care professionals at Baylor College of Medicine, Houston, said the presenter of one of the studies.

“Unfortunately, it remains unclear who is susceptible and what the mechanisms are” when it comes to MIS-C, Mariana Sanchez Villa, MS, a research coordinator at Baylor, told attendees. “Because of this, there is much hesitancy to vaccinate children with a history of MIS-C against COVID-19 out of a fear that hyperinflammation may occur.”

Ms. Sanchez Villa reported findings on the vaccination rate among patients who had been hospitalized with MIS-C. The researchers included all 295 patients who presented at the hospital with MIS-C between May 2020 and October 2022. Overall, 5% of these patients had been vaccinated against COVID-19 before they were diagnosed with MIS-C. When all these patients and their families came to outpatient follow-up appointments after discharge, the subspecialist clinicians recommended the children receive the COVID-19 vaccine 3 months after discharge. The researchers then reviewed the patients’ charts to see who did and did not receive the vaccine, which they confirmed through the state’s immunization registry.

Among the 295 patients with MIS-C, 1 died, and 99 (34%) received at least one COVID-19 vaccine dose after their diagnosis, including 7 of the 15 who had also been vaccinated prior to their MIS-C diagnosis. Just over half of the vaccinated patients (58%) were male. They received their vaccine an average 8.8 months after their hospitalization, when they were an average 10 years old, and all but one of the vaccine doses they received were the Pfizer/BioNTech mRNA vaccine.

Only 9 of the 99 vaccinated patients are fully vaccinated, defined as receiving the primary series plus the recommended boosters. Of the other patients, 13 received only one dose of the vaccine, 60 received two doses, and 17 received at least three doses of the primary series doses but no bivalent boosters. Over a subsequent average 11 months of follow-up, none of the vaccinated patients returned to the hospital with a recurrence of MIS-C or any other hyperinflammatory condition. The seven patients who had been vaccinated both before and after their MIS-C diagnosis have also not had any recurrence of a hyperinflammatory condition.

“SARS-CoV-2 vaccination is well-tolerated by children with a history of MIS-C,” the researchers concluded. Ms. Sanchez Villa referenced two other studies, in The Pediatric Infectious Disease Journal and in JAMA Network Open, with similar findings on the safety of COVID-19 vaccination in patients who have had MIS-C. “This is reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is considered.”

Dilan Dissanayake, MD, PhD, a rheumatologist at The Hospital for Sick Children in Toronto, who attended the presentation, told this news organization that data increasingly show a “synergistic protective effect” from COVID-19 infection and vaccination. That is, “having COVID or having MIS-C once doesn’t necessarily preclude you from having it again,” thereby supporting the importance of vaccination after an MIS-C diagnosis. In talking to parents about vaccinating, he has found it most helpful for them to hear about rheumatologists’ experience regarding COVID-19 vaccination.

“Particularly as the pandemic went on, being able to comfortably say that we have this large patient group, as well as collaborators across the world who have been monitoring for any safety issues, and that all the data has been reassuring” has been most useful for parents to hear, Dr. Dissanayake said.

The other study, led by Beth Rutstein, MD, MSCE, an attending rheumatologist at Children’s Hospital of Philadelphia, focused on the population of pediatric rheumatology patients by surveying pediatric rheumatologists who were members of the Childhood Arthritis and Rheumatology Research Alliance. The survey, conducted from March to May 2022, included questions about the rheumatologists’ COVID-19 vaccination practices as well as perceptions of the vaccine by the parents of their patients.

The 219 respondents included 74% pediatric rheumatologists and 21% fellows. Nearly all the respondents (98%) believed that any disease flares after COVID-19 vaccination would be mild and/or rare, and nearly all (98%) recommend their patients be vaccinated against COVID-19.

The primary finding from the study was that “we [rheumatologists] have different concerns from the families,” coauthor and presenter Vidya Sivaraman, MD, a pediatric rheumatologist at Nationwide Children’s Hospital and the Ohio State University in Columbus, told this news organization. “We’re more worried about the efficacy of the vaccine on immunosuppressive medications,” such as rituximab, which depletes B cells, Dr. Sivaraman said, but concerns about the vaccine’s immunogenicity or efficacy were very low among parents.

Just over half the clinicians surveyed (59%) were concerned about how effective the vaccine would be for their patients, especially those receiving immunosuppressive therapy. Health care professionals were most concerned about patients on rituximab – all clinicians reported concerns about the vaccine’s effectiveness in these patients – followed by patients taking systemic corticosteroids (86%), mycophenolate mofetil (59%), and Janus kinase inhibitors (46%).

Most clinicians (88%) reported that they had temporarily modified a patient’s immunosuppressive therapy to allow for vaccination, following guidelines by the American College of Rheumatology. Aside from a small proportion of health care professionals who checked patients’ post-vaccination serology primarily for research purposes, most clinicians (82%) did not collect this serology.

In regard to adverse events, the concern cited most often by respondents was myocarditis (76%), followed by development of new autoimmune conditions (29%) and thrombosis (22%), but the clinicians ranked these adverse events as low risk.

Meanwhile, the top three concerns about vaccination among parents, as reported to physicians, were worries about side effects, lack of long-term safety data on the vaccine, and misinformation they had heard, such as anxiety about changes to their child’s genetics or vaccination causing a COVID-19 infection. “They’re seeing things on social media from other parents [saying that COVID-19 vaccines are] going to affect their fertility, so they don’t want their daughters to get it,” Dr. Sivaraman said as another example of commonly cited misinformation.

Nearly half of the respondents (47%) said more than half of their families had concerns about side effects and the lack of data on long-term outcomes after vaccination. Only 8.5% of physicians said that fewer than 10% of their families were anxious about side effects. In addition, 39% of physicians said more than half of their families had concerns about misinformation they had heard, and only 16% of physicians had heard about misinformation concerns from fewer than 10% of their patients.

Other concerns cited by parents included their child’s disease flaring; lack of data on how well the vaccine would stimulate their child’s immune system; their child having already had COVID-19; and not believing COVID-19 was a major health risk to their child. Nearly every respondent (98%) said they had parents who turned down COVID-19 vaccination, and a majority (75%) reported that more than 10% of their patients had parents who were hesitant about COVID-19 vaccination.

No external funding was noted for either study. Ms. Sanchez Villa had no relevant financial relationships, but two abstract coauthors reported financial relationships with Pfizer and Moderna, and one reported a financial relationship with Novartis. Dr. Rutstein, Dr. Sivaraman, and Dr. Dissanayake had no relevant financial relationships.

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

NEW ORLEANS – Parents’ concerns about vaccinating their children against COVID-19 remain a substantial barrier to immunizing children against the disease, whether those children have chronic rheumatologic conditions or a history of multisystem inflammatory syndrome in children (MIS-C), according to two studies presented at the Pediatric Rheumatology Symposium.

Parents of children who developed MIS-C after a SARS-CoV-2 infection were particularly hesitant to vaccinate, despite strong encouragement from health care professionals at Baylor College of Medicine, Houston, said the presenter of one of the studies.

“Unfortunately, it remains unclear who is susceptible and what the mechanisms are” when it comes to MIS-C, Mariana Sanchez Villa, MS, a research coordinator at Baylor, told attendees. “Because of this, there is much hesitancy to vaccinate children with a history of MIS-C against COVID-19 out of a fear that hyperinflammation may occur.”

Ms. Sanchez Villa reported findings on the vaccination rate among patients who had been hospitalized with MIS-C. The researchers included all 295 patients who presented at the hospital with MIS-C between May 2020 and October 2022. Overall, 5% of these patients had been vaccinated against COVID-19 before they were diagnosed with MIS-C. When all these patients and their families came to outpatient follow-up appointments after discharge, the subspecialist clinicians recommended the children receive the COVID-19 vaccine 3 months after discharge. The researchers then reviewed the patients’ charts to see who did and did not receive the vaccine, which they confirmed through the state’s immunization registry.

Among the 295 patients with MIS-C, 1 died, and 99 (34%) received at least one COVID-19 vaccine dose after their diagnosis, including 7 of the 15 who had also been vaccinated prior to their MIS-C diagnosis. Just over half of the vaccinated patients (58%) were male. They received their vaccine an average 8.8 months after their hospitalization, when they were an average 10 years old, and all but one of the vaccine doses they received were the Pfizer/BioNTech mRNA vaccine.

Only 9 of the 99 vaccinated patients are fully vaccinated, defined as receiving the primary series plus the recommended boosters. Of the other patients, 13 received only one dose of the vaccine, 60 received two doses, and 17 received at least three doses of the primary series doses but no bivalent boosters. Over a subsequent average 11 months of follow-up, none of the vaccinated patients returned to the hospital with a recurrence of MIS-C or any other hyperinflammatory condition. The seven patients who had been vaccinated both before and after their MIS-C diagnosis have also not had any recurrence of a hyperinflammatory condition.

“SARS-CoV-2 vaccination is well-tolerated by children with a history of MIS-C,” the researchers concluded. Ms. Sanchez Villa referenced two other studies, in The Pediatric Infectious Disease Journal and in JAMA Network Open, with similar findings on the safety of COVID-19 vaccination in patients who have had MIS-C. “This is reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is considered.”

Dilan Dissanayake, MD, PhD, a rheumatologist at The Hospital for Sick Children in Toronto, who attended the presentation, told this news organization that data increasingly show a “synergistic protective effect” from COVID-19 infection and vaccination. That is, “having COVID or having MIS-C once doesn’t necessarily preclude you from having it again,” thereby supporting the importance of vaccination after an MIS-C diagnosis. In talking to parents about vaccinating, he has found it most helpful for them to hear about rheumatologists’ experience regarding COVID-19 vaccination.

“Particularly as the pandemic went on, being able to comfortably say that we have this large patient group, as well as collaborators across the world who have been monitoring for any safety issues, and that all the data has been reassuring” has been most useful for parents to hear, Dr. Dissanayake said.

The other study, led by Beth Rutstein, MD, MSCE, an attending rheumatologist at Children’s Hospital of Philadelphia, focused on the population of pediatric rheumatology patients by surveying pediatric rheumatologists who were members of the Childhood Arthritis and Rheumatology Research Alliance. The survey, conducted from March to May 2022, included questions about the rheumatologists’ COVID-19 vaccination practices as well as perceptions of the vaccine by the parents of their patients.

The 219 respondents included 74% pediatric rheumatologists and 21% fellows. Nearly all the respondents (98%) believed that any disease flares after COVID-19 vaccination would be mild and/or rare, and nearly all (98%) recommend their patients be vaccinated against COVID-19.

The primary finding from the study was that “we [rheumatologists] have different concerns from the families,” coauthor and presenter Vidya Sivaraman, MD, a pediatric rheumatologist at Nationwide Children’s Hospital and the Ohio State University in Columbus, told this news organization. “We’re more worried about the efficacy of the vaccine on immunosuppressive medications,” such as rituximab, which depletes B cells, Dr. Sivaraman said, but concerns about the vaccine’s immunogenicity or efficacy were very low among parents.

Just over half the clinicians surveyed (59%) were concerned about how effective the vaccine would be for their patients, especially those receiving immunosuppressive therapy. Health care professionals were most concerned about patients on rituximab – all clinicians reported concerns about the vaccine’s effectiveness in these patients – followed by patients taking systemic corticosteroids (86%), mycophenolate mofetil (59%), and Janus kinase inhibitors (46%).

Most clinicians (88%) reported that they had temporarily modified a patient’s immunosuppressive therapy to allow for vaccination, following guidelines by the American College of Rheumatology. Aside from a small proportion of health care professionals who checked patients’ post-vaccination serology primarily for research purposes, most clinicians (82%) did not collect this serology.

In regard to adverse events, the concern cited most often by respondents was myocarditis (76%), followed by development of new autoimmune conditions (29%) and thrombosis (22%), but the clinicians ranked these adverse events as low risk.

Meanwhile, the top three concerns about vaccination among parents, as reported to physicians, were worries about side effects, lack of long-term safety data on the vaccine, and misinformation they had heard, such as anxiety about changes to their child’s genetics or vaccination causing a COVID-19 infection. “They’re seeing things on social media from other parents [saying that COVID-19 vaccines are] going to affect their fertility, so they don’t want their daughters to get it,” Dr. Sivaraman said as another example of commonly cited misinformation.

Nearly half of the respondents (47%) said more than half of their families had concerns about side effects and the lack of data on long-term outcomes after vaccination. Only 8.5% of physicians said that fewer than 10% of their families were anxious about side effects. In addition, 39% of physicians said more than half of their families had concerns about misinformation they had heard, and only 16% of physicians had heard about misinformation concerns from fewer than 10% of their patients.

Other concerns cited by parents included their child’s disease flaring; lack of data on how well the vaccine would stimulate their child’s immune system; their child having already had COVID-19; and not believing COVID-19 was a major health risk to their child. Nearly every respondent (98%) said they had parents who turned down COVID-19 vaccination, and a majority (75%) reported that more than 10% of their patients had parents who were hesitant about COVID-19 vaccination.

No external funding was noted for either study. Ms. Sanchez Villa had no relevant financial relationships, but two abstract coauthors reported financial relationships with Pfizer and Moderna, and one reported a financial relationship with Novartis. Dr. Rutstein, Dr. Sivaraman, and Dr. Dissanayake had no relevant financial relationships.

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

NEW ORLEANS – Parents’ concerns about vaccinating their children against COVID-19 remain a substantial barrier to immunizing children against the disease, whether those children have chronic rheumatologic conditions or a history of multisystem inflammatory syndrome in children (MIS-C), according to two studies presented at the Pediatric Rheumatology Symposium.

Parents of children who developed MIS-C after a SARS-CoV-2 infection were particularly hesitant to vaccinate, despite strong encouragement from health care professionals at Baylor College of Medicine, Houston, said the presenter of one of the studies.

“Unfortunately, it remains unclear who is susceptible and what the mechanisms are” when it comes to MIS-C, Mariana Sanchez Villa, MS, a research coordinator at Baylor, told attendees. “Because of this, there is much hesitancy to vaccinate children with a history of MIS-C against COVID-19 out of a fear that hyperinflammation may occur.”

Ms. Sanchez Villa reported findings on the vaccination rate among patients who had been hospitalized with MIS-C. The researchers included all 295 patients who presented at the hospital with MIS-C between May 2020 and October 2022. Overall, 5% of these patients had been vaccinated against COVID-19 before they were diagnosed with MIS-C. When all these patients and their families came to outpatient follow-up appointments after discharge, the subspecialist clinicians recommended the children receive the COVID-19 vaccine 3 months after discharge. The researchers then reviewed the patients’ charts to see who did and did not receive the vaccine, which they confirmed through the state’s immunization registry.

Among the 295 patients with MIS-C, 1 died, and 99 (34%) received at least one COVID-19 vaccine dose after their diagnosis, including 7 of the 15 who had also been vaccinated prior to their MIS-C diagnosis. Just over half of the vaccinated patients (58%) were male. They received their vaccine an average 8.8 months after their hospitalization, when they were an average 10 years old, and all but one of the vaccine doses they received were the Pfizer/BioNTech mRNA vaccine.

Only 9 of the 99 vaccinated patients are fully vaccinated, defined as receiving the primary series plus the recommended boosters. Of the other patients, 13 received only one dose of the vaccine, 60 received two doses, and 17 received at least three doses of the primary series doses but no bivalent boosters. Over a subsequent average 11 months of follow-up, none of the vaccinated patients returned to the hospital with a recurrence of MIS-C or any other hyperinflammatory condition. The seven patients who had been vaccinated both before and after their MIS-C diagnosis have also not had any recurrence of a hyperinflammatory condition.

“SARS-CoV-2 vaccination is well-tolerated by children with a history of MIS-C,” the researchers concluded. Ms. Sanchez Villa referenced two other studies, in The Pediatric Infectious Disease Journal and in JAMA Network Open, with similar findings on the safety of COVID-19 vaccination in patients who have had MIS-C. “This is reassuring as SARS-CoV-2 becomes endemic and annual vaccination against SARS-CoV-2 is considered.”

Dilan Dissanayake, MD, PhD, a rheumatologist at The Hospital for Sick Children in Toronto, who attended the presentation, told this news organization that data increasingly show a “synergistic protective effect” from COVID-19 infection and vaccination. That is, “having COVID or having MIS-C once doesn’t necessarily preclude you from having it again,” thereby supporting the importance of vaccination after an MIS-C diagnosis. In talking to parents about vaccinating, he has found it most helpful for them to hear about rheumatologists’ experience regarding COVID-19 vaccination.

“Particularly as the pandemic went on, being able to comfortably say that we have this large patient group, as well as collaborators across the world who have been monitoring for any safety issues, and that all the data has been reassuring” has been most useful for parents to hear, Dr. Dissanayake said.

The other study, led by Beth Rutstein, MD, MSCE, an attending rheumatologist at Children’s Hospital of Philadelphia, focused on the population of pediatric rheumatology patients by surveying pediatric rheumatologists who were members of the Childhood Arthritis and Rheumatology Research Alliance. The survey, conducted from March to May 2022, included questions about the rheumatologists’ COVID-19 vaccination practices as well as perceptions of the vaccine by the parents of their patients.

The 219 respondents included 74% pediatric rheumatologists and 21% fellows. Nearly all the respondents (98%) believed that any disease flares after COVID-19 vaccination would be mild and/or rare, and nearly all (98%) recommend their patients be vaccinated against COVID-19.

The primary finding from the study was that “we [rheumatologists] have different concerns from the families,” coauthor and presenter Vidya Sivaraman, MD, a pediatric rheumatologist at Nationwide Children’s Hospital and the Ohio State University in Columbus, told this news organization. “We’re more worried about the efficacy of the vaccine on immunosuppressive medications,” such as rituximab, which depletes B cells, Dr. Sivaraman said, but concerns about the vaccine’s immunogenicity or efficacy were very low among parents.

Just over half the clinicians surveyed (59%) were concerned about how effective the vaccine would be for their patients, especially those receiving immunosuppressive therapy. Health care professionals were most concerned about patients on rituximab – all clinicians reported concerns about the vaccine’s effectiveness in these patients – followed by patients taking systemic corticosteroids (86%), mycophenolate mofetil (59%), and Janus kinase inhibitors (46%).

Most clinicians (88%) reported that they had temporarily modified a patient’s immunosuppressive therapy to allow for vaccination, following guidelines by the American College of Rheumatology. Aside from a small proportion of health care professionals who checked patients’ post-vaccination serology primarily for research purposes, most clinicians (82%) did not collect this serology.

In regard to adverse events, the concern cited most often by respondents was myocarditis (76%), followed by development of new autoimmune conditions (29%) and thrombosis (22%), but the clinicians ranked these adverse events as low risk.

Meanwhile, the top three concerns about vaccination among parents, as reported to physicians, were worries about side effects, lack of long-term safety data on the vaccine, and misinformation they had heard, such as anxiety about changes to their child’s genetics or vaccination causing a COVID-19 infection. “They’re seeing things on social media from other parents [saying that COVID-19 vaccines are] going to affect their fertility, so they don’t want their daughters to get it,” Dr. Sivaraman said as another example of commonly cited misinformation.

Nearly half of the respondents (47%) said more than half of their families had concerns about side effects and the lack of data on long-term outcomes after vaccination. Only 8.5% of physicians said that fewer than 10% of their families were anxious about side effects. In addition, 39% of physicians said more than half of their families had concerns about misinformation they had heard, and only 16% of physicians had heard about misinformation concerns from fewer than 10% of their patients.

Other concerns cited by parents included their child’s disease flaring; lack of data on how well the vaccine would stimulate their child’s immune system; their child having already had COVID-19; and not believing COVID-19 was a major health risk to their child. Nearly every respondent (98%) said they had parents who turned down COVID-19 vaccination, and a majority (75%) reported that more than 10% of their patients had parents who were hesitant about COVID-19 vaccination.

No external funding was noted for either study. Ms. Sanchez Villa had no relevant financial relationships, but two abstract coauthors reported financial relationships with Pfizer and Moderna, and one reported a financial relationship with Novartis. Dr. Rutstein, Dr. Sivaraman, and Dr. Dissanayake had no relevant financial relationships.

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

NEW ORLEANS – In the nearly 1 year since the Janus kinase (JAK) inhibitor baricitinib was approved for adults with severe alopecia areata (AA), mounting long-term efficacy and safety data suggest that the earlier candidates take the drug in the course of their disease, the better.

“The journey to JAK inhibition in alopecia areata has been incredible,” Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, said at the annual meeting of the American Academy of Dermatology. “JAK inhibitors are here to stay, and I think baricitinib offers an amazing opportunity for the right patients.”

The efficacy and safety of baricitinib (Olumiant) for AA was studied in two randomized, double-blind, placebo-controlled trials (BRAVE-AA1 and BRAVE-AA2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. Patients in these trials received either a placebo, 2 mg of baricitinib, or 4 mg of baricitinib every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved a SALT score of 20 or less, or at least 80% scalp hair coverage at week 36. The researchers found that 36%-39% of individuals in the 4-mg arm achieved a SALT score of less than 20, compared with 19%-23% of individuals in the 2 mg arm. Similar outcomes were observed for eyebrow and eyelash hair loss.

Most adverse events observed in BRAVE-AA1 and BRAVE-AA2 were in the mild to moderate range, and the actual number of adverse events leading to permanent discontinuation was extremely low. The most common adverse events were upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infections, and an increase in blood creatine kinase.

Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other potent immunosuppressants, Dr. Chovatiya said. Required lab evaluations include baseline testing for tuberculosis and viral hepatitis; CBC, hepatic function, and renal function at baseline and then as clinically indicated; and lipids after 12 weeks of therapy, then as clinically indicated. The recommended starting dose of baricitinib is 2 mg per day, which can be increased to 4 mg per day if the response is not adequate. “However, for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, 4 mg once daily is recommended,” he said. “Once an adequate response is achieved, it’s recommended to reduce from 4 to 2 mg daily.”

52-week, 76-week data

According to pooled data from BRAVE-AA1 and BRAVE-AA2 published online March 1, 2023, efficacy continues to increase out to 52 weeks. Specifically, by week 52, 39% of individuals in the 4 mg arm achieved a SALT score of 20 or less, compared with 22.6% of individuals in the 2 mg arm. “You see similar linear growth in the eyebrow and eyelash response loss as well,” Dr. Chovatiya said.

In other findings, patients in the 4 mg treatment arm who achieved a SALT score of 20 or less at week 52 were eligible for randomized down titration, provided that they had stayed on the same dose of baricitinib from initial randomization. According to data from baricitinib manufacturer Eli Lilly, 77.5% of patients who stepped down to the 2 mg dose from the 4 mg dose at week 52 achieved a SALT score of 20 or less at week 76, Dr. Chovatiya said. “If I can keep someone on 4 mg that’s great, but it looks like you can go to a lower dose and do a pretty good job,” he said.

Patients in the baricitinib arms who achieved a SALT score of 20 or less at week 52 were eligible for randomized withdrawal, provided that they had stayed on the same dose of the drug from initial randomization. According to Dr. Chovatiya, 89.4% of individuals who remained on the 4 mg dose to week 76 maintained a SALT score of 20 or less, compared with 33.3% of those who switched from the 4 mg to placebo. “The takeaway here is that clinically, longitudinal treatment looks to be required in this time period” for continued efficacy, he said. “However, what this looks like in the real world remains to be seen.”

A recently published integrated analysis of safety data from BRAVE-AA1 and BRAVE-AA2 reported that no deaths occurred and of the few reported serious infections, nearly half were COVID-19. There was a single case of multidermatomal herpes zoster and no cases of tuberculosis. One patient with risk factors for MI had an MI during a placebo-controlled period, and one study participant with a history of COVID-19 infection developed a pulmonary embolism at day 638. There was one case each of chronic lymphocytic leukemia, B-cell lymphoma, breast cancer, and appendicitis.
 

Baseline severity and treatment response

“Does treatment response vary with baseline disease status?” Dr. Chovatiya asked. “Yes. People with very severe hair loss [defined as a SALT score of 95 or higher] tended to do worse, while the rest of the study population did even better – an almost twofold difference. This means that you want to treat as early as you possibly can. It’s interesting to note that you don’t see this difference as much in the case of eyebrows and eyelashes. This makes sense, though. Eyebrows and eyelashes probably behave differently in terms of growth than the scalp does.”

Certain baseline characteristics of patients in BRAVE-AA1 and BRAVE-AA2 portended better outcomes. Women tended to fare better than men, but individuals who had longer histories of AA did not respond well. “People who had a shorter duration of their current episode of AA also did better than people who had a longer current episode, so we want to think about treating as soon as we possibly can,” Dr. Chovatiya said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including Eli Lilly.

NEW ORLEANS – In the nearly 1 year since the Janus kinase (JAK) inhibitor baricitinib was approved for adults with severe alopecia areata (AA), mounting long-term efficacy and safety data suggest that the earlier candidates take the drug in the course of their disease, the better.

“The journey to JAK inhibition in alopecia areata has been incredible,” Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, said at the annual meeting of the American Academy of Dermatology. “JAK inhibitors are here to stay, and I think baricitinib offers an amazing opportunity for the right patients.”

The efficacy and safety of baricitinib (Olumiant) for AA was studied in two randomized, double-blind, placebo-controlled trials (BRAVE-AA1 and BRAVE-AA2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. Patients in these trials received either a placebo, 2 mg of baricitinib, or 4 mg of baricitinib every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved a SALT score of 20 or less, or at least 80% scalp hair coverage at week 36. The researchers found that 36%-39% of individuals in the 4-mg arm achieved a SALT score of less than 20, compared with 19%-23% of individuals in the 2 mg arm. Similar outcomes were observed for eyebrow and eyelash hair loss.

Most adverse events observed in BRAVE-AA1 and BRAVE-AA2 were in the mild to moderate range, and the actual number of adverse events leading to permanent discontinuation was extremely low. The most common adverse events were upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infections, and an increase in blood creatine kinase.

Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other potent immunosuppressants, Dr. Chovatiya said. Required lab evaluations include baseline testing for tuberculosis and viral hepatitis; CBC, hepatic function, and renal function at baseline and then as clinically indicated; and lipids after 12 weeks of therapy, then as clinically indicated. The recommended starting dose of baricitinib is 2 mg per day, which can be increased to 4 mg per day if the response is not adequate. “However, for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, 4 mg once daily is recommended,” he said. “Once an adequate response is achieved, it’s recommended to reduce from 4 to 2 mg daily.”

52-week, 76-week data

According to pooled data from BRAVE-AA1 and BRAVE-AA2 published online March 1, 2023, efficacy continues to increase out to 52 weeks. Specifically, by week 52, 39% of individuals in the 4 mg arm achieved a SALT score of 20 or less, compared with 22.6% of individuals in the 2 mg arm. “You see similar linear growth in the eyebrow and eyelash response loss as well,” Dr. Chovatiya said.

In other findings, patients in the 4 mg treatment arm who achieved a SALT score of 20 or less at week 52 were eligible for randomized down titration, provided that they had stayed on the same dose of baricitinib from initial randomization. According to data from baricitinib manufacturer Eli Lilly, 77.5% of patients who stepped down to the 2 mg dose from the 4 mg dose at week 52 achieved a SALT score of 20 or less at week 76, Dr. Chovatiya said. “If I can keep someone on 4 mg that’s great, but it looks like you can go to a lower dose and do a pretty good job,” he said.

Patients in the baricitinib arms who achieved a SALT score of 20 or less at week 52 were eligible for randomized withdrawal, provided that they had stayed on the same dose of the drug from initial randomization. According to Dr. Chovatiya, 89.4% of individuals who remained on the 4 mg dose to week 76 maintained a SALT score of 20 or less, compared with 33.3% of those who switched from the 4 mg to placebo. “The takeaway here is that clinically, longitudinal treatment looks to be required in this time period” for continued efficacy, he said. “However, what this looks like in the real world remains to be seen.”

A recently published integrated analysis of safety data from BRAVE-AA1 and BRAVE-AA2 reported that no deaths occurred and of the few reported serious infections, nearly half were COVID-19. There was a single case of multidermatomal herpes zoster and no cases of tuberculosis. One patient with risk factors for MI had an MI during a placebo-controlled period, and one study participant with a history of COVID-19 infection developed a pulmonary embolism at day 638. There was one case each of chronic lymphocytic leukemia, B-cell lymphoma, breast cancer, and appendicitis.
 

Baseline severity and treatment response

“Does treatment response vary with baseline disease status?” Dr. Chovatiya asked. “Yes. People with very severe hair loss [defined as a SALT score of 95 or higher] tended to do worse, while the rest of the study population did even better – an almost twofold difference. This means that you want to treat as early as you possibly can. It’s interesting to note that you don’t see this difference as much in the case of eyebrows and eyelashes. This makes sense, though. Eyebrows and eyelashes probably behave differently in terms of growth than the scalp does.”

Certain baseline characteristics of patients in BRAVE-AA1 and BRAVE-AA2 portended better outcomes. Women tended to fare better than men, but individuals who had longer histories of AA did not respond well. “People who had a shorter duration of their current episode of AA also did better than people who had a longer current episode, so we want to think about treating as soon as we possibly can,” Dr. Chovatiya said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including Eli Lilly.

NEW ORLEANS – In the nearly 1 year since the Janus kinase (JAK) inhibitor baricitinib was approved for adults with severe alopecia areata (AA), mounting long-term efficacy and safety data suggest that the earlier candidates take the drug in the course of their disease, the better.

“The journey to JAK inhibition in alopecia areata has been incredible,” Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the center for eczema and itch at Northwestern University, Chicago, said at the annual meeting of the American Academy of Dermatology. “JAK inhibitors are here to stay, and I think baricitinib offers an amazing opportunity for the right patients.”

The efficacy and safety of baricitinib (Olumiant) for AA was studied in two randomized, double-blind, placebo-controlled trials (BRAVE-AA1 and BRAVE-AA2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months. Patients in these trials received either a placebo, 2 mg of baricitinib, or 4 mg of baricitinib every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved a SALT score of 20 or less, or at least 80% scalp hair coverage at week 36. The researchers found that 36%-39% of individuals in the 4-mg arm achieved a SALT score of less than 20, compared with 19%-23% of individuals in the 2 mg arm. Similar outcomes were observed for eyebrow and eyelash hair loss.

Most adverse events observed in BRAVE-AA1 and BRAVE-AA2 were in the mild to moderate range, and the actual number of adverse events leading to permanent discontinuation was extremely low. The most common adverse events were upper respiratory tract infections, headache, nasopharyngitis, acne, urinary tract infections, and an increase in blood creatine kinase.

Baricitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other potent immunosuppressants, Dr. Chovatiya said. Required lab evaluations include baseline testing for tuberculosis and viral hepatitis; CBC, hepatic function, and renal function at baseline and then as clinically indicated; and lipids after 12 weeks of therapy, then as clinically indicated. The recommended starting dose of baricitinib is 2 mg per day, which can be increased to 4 mg per day if the response is not adequate. “However, for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, 4 mg once daily is recommended,” he said. “Once an adequate response is achieved, it’s recommended to reduce from 4 to 2 mg daily.”

52-week, 76-week data

According to pooled data from BRAVE-AA1 and BRAVE-AA2 published online March 1, 2023, efficacy continues to increase out to 52 weeks. Specifically, by week 52, 39% of individuals in the 4 mg arm achieved a SALT score of 20 or less, compared with 22.6% of individuals in the 2 mg arm. “You see similar linear growth in the eyebrow and eyelash response loss as well,” Dr. Chovatiya said.

In other findings, patients in the 4 mg treatment arm who achieved a SALT score of 20 or less at week 52 were eligible for randomized down titration, provided that they had stayed on the same dose of baricitinib from initial randomization. According to data from baricitinib manufacturer Eli Lilly, 77.5% of patients who stepped down to the 2 mg dose from the 4 mg dose at week 52 achieved a SALT score of 20 or less at week 76, Dr. Chovatiya said. “If I can keep someone on 4 mg that’s great, but it looks like you can go to a lower dose and do a pretty good job,” he said.

Patients in the baricitinib arms who achieved a SALT score of 20 or less at week 52 were eligible for randomized withdrawal, provided that they had stayed on the same dose of the drug from initial randomization. According to Dr. Chovatiya, 89.4% of individuals who remained on the 4 mg dose to week 76 maintained a SALT score of 20 or less, compared with 33.3% of those who switched from the 4 mg to placebo. “The takeaway here is that clinically, longitudinal treatment looks to be required in this time period” for continued efficacy, he said. “However, what this looks like in the real world remains to be seen.”

A recently published integrated analysis of safety data from BRAVE-AA1 and BRAVE-AA2 reported that no deaths occurred and of the few reported serious infections, nearly half were COVID-19. There was a single case of multidermatomal herpes zoster and no cases of tuberculosis. One patient with risk factors for MI had an MI during a placebo-controlled period, and one study participant with a history of COVID-19 infection developed a pulmonary embolism at day 638. There was one case each of chronic lymphocytic leukemia, B-cell lymphoma, breast cancer, and appendicitis.
 

Baseline severity and treatment response

“Does treatment response vary with baseline disease status?” Dr. Chovatiya asked. “Yes. People with very severe hair loss [defined as a SALT score of 95 or higher] tended to do worse, while the rest of the study population did even better – an almost twofold difference. This means that you want to treat as early as you possibly can. It’s interesting to note that you don’t see this difference as much in the case of eyebrows and eyelashes. This makes sense, though. Eyebrows and eyelashes probably behave differently in terms of growth than the scalp does.”

Certain baseline characteristics of patients in BRAVE-AA1 and BRAVE-AA2 portended better outcomes. Women tended to fare better than men, but individuals who had longer histories of AA did not respond well. “People who had a shorter duration of their current episode of AA also did better than people who had a longer current episode, so we want to think about treating as soon as we possibly can,” Dr. Chovatiya said.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, investigator, and/or a member of the advisory board for several pharmaceutical companies, including Eli Lilly.

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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

A new compilation of nearly all research to date on the health impacts of sugar offers dozens of reasons to cut back.

Researchers from China and the United States rounded up 8,601 scientific studies on sugar and combined them to evaluate its impact on 83 health outcomes. The studies accounted for decades of research on the topic, stretching back to the beginning of the largest electronic databases for scientific papers.

The result is a list that cites the world’s most common health problems like heart disease, diabetes, obesity, high blood pressure, heart attack, high cholesterol, cancer, and depression. The findings were published in the BMJ. Researchers looked at studies that evaluated the impacts of consuming free sugars, which means any food that contains processed or naturally occurring sugars like table sugar, honey, or maple syrup. Sugar found in whole fruits and vegetables and in milk is not free sugar.

U.S. dietary guidelines recommend getting no more than 10% of daily calories from added sugars. For a typical 2,000-calorie-per-day diet, that equals no more than 200 calories, or about 12 teaspoons. The CDC reports that the average person consumes 17 teaspoons per day, with the largest sources being sugar-sweetened beverages, desserts, and snacks. (For context: one 12-ounce can of soda contains the equivalent of 9 teaspoons of sugar, according to beverage maker Coca-Cola.)

The new analysis also found links between sugary beverage consumption and other diet and lifestyle characteristics that may contribute to health problems.

“People who consumed sugar-sweetened beverages more frequently were likely to ingest more total and saturated fat, carbohydrate, and sodium, and less fruit, fiber, dairy products, and whole grain foods,” the authors wrote. “This dietary pattern was also associated with more frequent smoking and drinking, lower physical activity levels, and more time spent watching television. Therefore, the role of these confounding factors should be taken into consideration when explaining the association between sugar consumption and burden of disease.”

Recommendations for limiting sugar consumption are in place worldwide, the authors noted. They concluded that more needs to be done given the known health dangers of sugar.

“To change sugar consumption patterns, especially for children and adolescents, a combination of widespread public health education and policies worldwide is urgently needed,” they said.

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