Megan Brooks

Psychedelics can produce positive changes in attitudes about death and dying – and may be a way to help ease anxiety and depression toward the end of life, new research suggests.

In a retrospective study of more than 3,000 participants, near-death experiences occurring naturally or via a psychedelic drug had a “remarkably” similar effect on attitudes about death and dying, with most participants reporting less fear and anxiety around death.

“Individuals with existential anxiety and depression at end of life account for substantial suffering and significantly increased health care expenses from desperate and often futile seeking of intensive and expensive medical treatments,” co-investigator Roland Griffiths, PhD, Center for Psychedelics and Consciousness Research at Johns Hopkins Medicine, Baltimore, told this news organization.

Direct comparisons

Both psychedelic drug experiences and near-death experiences can alter perspectives on death and dying, but there have been few direct comparisons of these phenomena, the investigators note.

In the current study, they directly compared psychedelic-occasioned and nondrug experiences, which altered individuals’ beliefs about death.

The researchers surveyed 3,192 mostly White adults from the United States, including 933 who had a natural, nondrug near-death experience and 2,259 who had psychedelic near-death experiences induced with lysergic acid diethylamide, psilocybin, ayahuasca, or N,N-dimethyltryptamine.

The psychedelic group had more men than women and tended to be younger at the time of the experience than was the nondrug group.

Nearly 90% of individuals in both groups said that they were less afraid of death than they were before their experiences.

About half of both groups said they’d encountered something they might call “God” during the experience.

Three-quarters of the psychedelic group and 85% of the nondrug group rated their experiences as among the top five most personally meaningful and spiritually significant events of their life.

Individuals in both groups also reported moderate- to strong-lasting positive changes in personal well-being and life purpose and meaning after their experiences. 

However, there were some differences between the groups.
 

More research needed

Compared with the psychedelic group, the nondrug group was more likely to report being unconscious, clinically dead, or that their life was in imminent danger.

The nonpsychedelic group was also more likely to report that their experience was very brief, lasting 5 minutes or less.

Both the psychedelic and nondrug participants showed robust increases on standardized measures of mystical and near-death experiences, but these measures were significantly greater in the psychedelic group.

The survey findings are in line with several recent clinical trials showing that a single treatment with the psychedelic psilocybin produced sustained decreases in anxiety and depression among patients with a life-threatening cancer diagnosis.

This includes a 2016 study by Dr. Griffiths and colleagues, which included 51 patients with late-stage cancer. As reported at the time, results showed a single, high dose of psilocybin had rapid, clinically significant, and lasting effects on mood and anxiety.

Limitations of the current survey cited by the researchers include the use of retrospective self-report to describe changes in death attitudes and the subjective features of the experiences. Also, respondents were a self-selected study population that may not be representative of all psychedelic or near-death experiences.

In addition, the study did not attempt to document worldview and other belief changes, such as increased belief in afterlife, that might help explain why death attitudes changed.

Looking ahead, the researchers note that future studies are needed to better understand the potential clinical use of psychedelics in ameliorating suffering related to fear of death.

Support through the Johns Hopkins Center for Psychedelic and Consciousness Research was provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. Funding was also provided by the Y.C. Ho/Helen and Michael Chiang Foundation. The investigators have reported no relevant financial relationships.

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

Psychedelics can produce positive changes in attitudes about death and dying – and may be a way to help ease anxiety and depression toward the end of life, new research suggests.

In a retrospective study of more than 3,000 participants, near-death experiences occurring naturally or via a psychedelic drug had a “remarkably” similar effect on attitudes about death and dying, with most participants reporting less fear and anxiety around death.

“Individuals with existential anxiety and depression at end of life account for substantial suffering and significantly increased health care expenses from desperate and often futile seeking of intensive and expensive medical treatments,” co-investigator Roland Griffiths, PhD, Center for Psychedelics and Consciousness Research at Johns Hopkins Medicine, Baltimore, told this news organization.

Direct comparisons

Both psychedelic drug experiences and near-death experiences can alter perspectives on death and dying, but there have been few direct comparisons of these phenomena, the investigators note.

In the current study, they directly compared psychedelic-occasioned and nondrug experiences, which altered individuals’ beliefs about death.

The researchers surveyed 3,192 mostly White adults from the United States, including 933 who had a natural, nondrug near-death experience and 2,259 who had psychedelic near-death experiences induced with lysergic acid diethylamide, psilocybin, ayahuasca, or N,N-dimethyltryptamine.

The psychedelic group had more men than women and tended to be younger at the time of the experience than was the nondrug group.

Nearly 90% of individuals in both groups said that they were less afraid of death than they were before their experiences.

About half of both groups said they’d encountered something they might call “God” during the experience.

Three-quarters of the psychedelic group and 85% of the nondrug group rated their experiences as among the top five most personally meaningful and spiritually significant events of their life.

Individuals in both groups also reported moderate- to strong-lasting positive changes in personal well-being and life purpose and meaning after their experiences. 

However, there were some differences between the groups.
 

More research needed

Compared with the psychedelic group, the nondrug group was more likely to report being unconscious, clinically dead, or that their life was in imminent danger.

The nonpsychedelic group was also more likely to report that their experience was very brief, lasting 5 minutes or less.

Both the psychedelic and nondrug participants showed robust increases on standardized measures of mystical and near-death experiences, but these measures were significantly greater in the psychedelic group.

The survey findings are in line with several recent clinical trials showing that a single treatment with the psychedelic psilocybin produced sustained decreases in anxiety and depression among patients with a life-threatening cancer diagnosis.

This includes a 2016 study by Dr. Griffiths and colleagues, which included 51 patients with late-stage cancer. As reported at the time, results showed a single, high dose of psilocybin had rapid, clinically significant, and lasting effects on mood and anxiety.

Limitations of the current survey cited by the researchers include the use of retrospective self-report to describe changes in death attitudes and the subjective features of the experiences. Also, respondents were a self-selected study population that may not be representative of all psychedelic or near-death experiences.

In addition, the study did not attempt to document worldview and other belief changes, such as increased belief in afterlife, that might help explain why death attitudes changed.

Looking ahead, the researchers note that future studies are needed to better understand the potential clinical use of psychedelics in ameliorating suffering related to fear of death.

Support through the Johns Hopkins Center for Psychedelic and Consciousness Research was provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. Funding was also provided by the Y.C. Ho/Helen and Michael Chiang Foundation. The investigators have reported no relevant financial relationships.

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

Psychedelics can produce positive changes in attitudes about death and dying – and may be a way to help ease anxiety and depression toward the end of life, new research suggests.

In a retrospective study of more than 3,000 participants, near-death experiences occurring naturally or via a psychedelic drug had a “remarkably” similar effect on attitudes about death and dying, with most participants reporting less fear and anxiety around death.

“Individuals with existential anxiety and depression at end of life account for substantial suffering and significantly increased health care expenses from desperate and often futile seeking of intensive and expensive medical treatments,” co-investigator Roland Griffiths, PhD, Center for Psychedelics and Consciousness Research at Johns Hopkins Medicine, Baltimore, told this news organization.

Direct comparisons

Both psychedelic drug experiences and near-death experiences can alter perspectives on death and dying, but there have been few direct comparisons of these phenomena, the investigators note.

In the current study, they directly compared psychedelic-occasioned and nondrug experiences, which altered individuals’ beliefs about death.

The researchers surveyed 3,192 mostly White adults from the United States, including 933 who had a natural, nondrug near-death experience and 2,259 who had psychedelic near-death experiences induced with lysergic acid diethylamide, psilocybin, ayahuasca, or N,N-dimethyltryptamine.

The psychedelic group had more men than women and tended to be younger at the time of the experience than was the nondrug group.

Nearly 90% of individuals in both groups said that they were less afraid of death than they were before their experiences.

About half of both groups said they’d encountered something they might call “God” during the experience.

Three-quarters of the psychedelic group and 85% of the nondrug group rated their experiences as among the top five most personally meaningful and spiritually significant events of their life.

Individuals in both groups also reported moderate- to strong-lasting positive changes in personal well-being and life purpose and meaning after their experiences. 

However, there were some differences between the groups.
 

More research needed

Compared with the psychedelic group, the nondrug group was more likely to report being unconscious, clinically dead, or that their life was in imminent danger.

The nonpsychedelic group was also more likely to report that their experience was very brief, lasting 5 minutes or less.

Both the psychedelic and nondrug participants showed robust increases on standardized measures of mystical and near-death experiences, but these measures were significantly greater in the psychedelic group.

The survey findings are in line with several recent clinical trials showing that a single treatment with the psychedelic psilocybin produced sustained decreases in anxiety and depression among patients with a life-threatening cancer diagnosis.

This includes a 2016 study by Dr. Griffiths and colleagues, which included 51 patients with late-stage cancer. As reported at the time, results showed a single, high dose of psilocybin had rapid, clinically significant, and lasting effects on mood and anxiety.

Limitations of the current survey cited by the researchers include the use of retrospective self-report to describe changes in death attitudes and the subjective features of the experiences. Also, respondents were a self-selected study population that may not be representative of all psychedelic or near-death experiences.

In addition, the study did not attempt to document worldview and other belief changes, such as increased belief in afterlife, that might help explain why death attitudes changed.

Looking ahead, the researchers note that future studies are needed to better understand the potential clinical use of psychedelics in ameliorating suffering related to fear of death.

Support through the Johns Hopkins Center for Psychedelic and Consciousness Research was provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. Funding was also provided by the Y.C. Ho/Helen and Michael Chiang Foundation. The investigators have reported no relevant financial relationships.

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

The American College of Cardiology/American Heart Association have issued a set of data standards for chest pain and acute myocardial infarction to accompany the 2021 guidelines for evaluation and diagnosis of chest pain.

In October 2021, the AHA/ACC issued a joint clinical practice guideline encouraging clinicians to use standardized risk assessments, clinical pathways, and tools to evaluate and communicate with patients who present with chest pain, as reported by this news organization.

The writing group underscored the need to reach a consensus for the definitions of chest pain. The new document standardizes related data elements for consistent reporting on chest pain syndromes.

“This is an appendix to the guidelines and a planned effort to try to harmonize and bring uniformity to the language applied,” writing committee chair H.V. “Skip” Anderson, MD, with UT Health Science Center, Houston, told this news organization.

“You want heart attack to mean the same thing in Miami Beach as in Western Pennsylvania, as in Oregon and Washington and every place in between,” Dr. Anderson explained. “You want everybody to be using the same language, so that’s what these data standards are meant to do.”

In the document, data elements are grouped into three broad categories: chest pain, myocardial injury, and MI.

“We deliberately followed the plans contained in the new guideline and focused on potentially serious cardiovascular causes of chest pain as might be encountered in emergency departments,” the writing group notes in the document.

The terms “typical” and “atypical” as descriptors of chest pain or anginal syndromes are not used in the new document, in line with the 2021 guidance to abandon these terms.

Instead, the new document divides chest pain syndromes into three categories: “cardiac,” “possible cardiac,” and “noncardiac” – again, in keeping with the chest pain guideline.

The document also includes data elements for risk stratification scoring according to several common risk scoring algorithms and for procedure-related myocardial injury and procedure-related MI.

Each year, chest pain sends more than 7 million adults to the emergency department in the United States. Although noncardiac causes of chest pain make up a large majority of these cases, there are several life-threatening causes of chest pain that must be identified and treated promptly.

Distinguishing between serious and nonserious causes of chest pain is an urgent imperative, the writing group says.

Overall, they say this new clinical lexicon and set of data standards should be “broadly applicable” in various settings, including clinical trials and observational studies, patient care, electronic health records (EHRs), quality and performance improvement initiatives, registries, and public reporting programs.

The 2022 ACC/AHA Key Data Elements and Definitions for Chest Pain and Acute Myocardial Infarction was simultaneously published online in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.

It was developed in collaboration with the American College of Emergency Physicians and the Society for Cardiac Angiography and Interventions and endorsed by the Society for Academic Emergency Medicine.

Dr. Anderson noted that “almost all of the guidelines that come out now, certainly in the last few years, have been followed after a certain interval by a set of data standards applicable to the guidelines.”

“It would be really great if it could actually be attached as an appendix, but the nature of the development of these things is such that there will always be a bit of a time lag between the writing group that develops the guidelines and the work group that develops the data standards; you can’t really have them working in parallel at the same time,” Dr. Anderson said in an interview.

This research had no commercial funding. The authors have no relevant disclosures.

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

The American College of Cardiology/American Heart Association have issued a set of data standards for chest pain and acute myocardial infarction to accompany the 2021 guidelines for evaluation and diagnosis of chest pain.

In October 2021, the AHA/ACC issued a joint clinical practice guideline encouraging clinicians to use standardized risk assessments, clinical pathways, and tools to evaluate and communicate with patients who present with chest pain, as reported by this news organization.

The writing group underscored the need to reach a consensus for the definitions of chest pain. The new document standardizes related data elements for consistent reporting on chest pain syndromes.

“This is an appendix to the guidelines and a planned effort to try to harmonize and bring uniformity to the language applied,” writing committee chair H.V. “Skip” Anderson, MD, with UT Health Science Center, Houston, told this news organization.

“You want heart attack to mean the same thing in Miami Beach as in Western Pennsylvania, as in Oregon and Washington and every place in between,” Dr. Anderson explained. “You want everybody to be using the same language, so that’s what these data standards are meant to do.”

In the document, data elements are grouped into three broad categories: chest pain, myocardial injury, and MI.

“We deliberately followed the plans contained in the new guideline and focused on potentially serious cardiovascular causes of chest pain as might be encountered in emergency departments,” the writing group notes in the document.

The terms “typical” and “atypical” as descriptors of chest pain or anginal syndromes are not used in the new document, in line with the 2021 guidance to abandon these terms.

Instead, the new document divides chest pain syndromes into three categories: “cardiac,” “possible cardiac,” and “noncardiac” – again, in keeping with the chest pain guideline.

The document also includes data elements for risk stratification scoring according to several common risk scoring algorithms and for procedure-related myocardial injury and procedure-related MI.

Each year, chest pain sends more than 7 million adults to the emergency department in the United States. Although noncardiac causes of chest pain make up a large majority of these cases, there are several life-threatening causes of chest pain that must be identified and treated promptly.

Distinguishing between serious and nonserious causes of chest pain is an urgent imperative, the writing group says.

Overall, they say this new clinical lexicon and set of data standards should be “broadly applicable” in various settings, including clinical trials and observational studies, patient care, electronic health records (EHRs), quality and performance improvement initiatives, registries, and public reporting programs.

The 2022 ACC/AHA Key Data Elements and Definitions for Chest Pain and Acute Myocardial Infarction was simultaneously published online in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.

It was developed in collaboration with the American College of Emergency Physicians and the Society for Cardiac Angiography and Interventions and endorsed by the Society for Academic Emergency Medicine.

Dr. Anderson noted that “almost all of the guidelines that come out now, certainly in the last few years, have been followed after a certain interval by a set of data standards applicable to the guidelines.”

“It would be really great if it could actually be attached as an appendix, but the nature of the development of these things is such that there will always be a bit of a time lag between the writing group that develops the guidelines and the work group that develops the data standards; you can’t really have them working in parallel at the same time,” Dr. Anderson said in an interview.

This research had no commercial funding. The authors have no relevant disclosures.

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

The American College of Cardiology/American Heart Association have issued a set of data standards for chest pain and acute myocardial infarction to accompany the 2021 guidelines for evaluation and diagnosis of chest pain.

In October 2021, the AHA/ACC issued a joint clinical practice guideline encouraging clinicians to use standardized risk assessments, clinical pathways, and tools to evaluate and communicate with patients who present with chest pain, as reported by this news organization.

The writing group underscored the need to reach a consensus for the definitions of chest pain. The new document standardizes related data elements for consistent reporting on chest pain syndromes.

“This is an appendix to the guidelines and a planned effort to try to harmonize and bring uniformity to the language applied,” writing committee chair H.V. “Skip” Anderson, MD, with UT Health Science Center, Houston, told this news organization.

“You want heart attack to mean the same thing in Miami Beach as in Western Pennsylvania, as in Oregon and Washington and every place in between,” Dr. Anderson explained. “You want everybody to be using the same language, so that’s what these data standards are meant to do.”

In the document, data elements are grouped into three broad categories: chest pain, myocardial injury, and MI.

“We deliberately followed the plans contained in the new guideline and focused on potentially serious cardiovascular causes of chest pain as might be encountered in emergency departments,” the writing group notes in the document.

The terms “typical” and “atypical” as descriptors of chest pain or anginal syndromes are not used in the new document, in line with the 2021 guidance to abandon these terms.

Instead, the new document divides chest pain syndromes into three categories: “cardiac,” “possible cardiac,” and “noncardiac” – again, in keeping with the chest pain guideline.

The document also includes data elements for risk stratification scoring according to several common risk scoring algorithms and for procedure-related myocardial injury and procedure-related MI.

Each year, chest pain sends more than 7 million adults to the emergency department in the United States. Although noncardiac causes of chest pain make up a large majority of these cases, there are several life-threatening causes of chest pain that must be identified and treated promptly.

Distinguishing between serious and nonserious causes of chest pain is an urgent imperative, the writing group says.

Overall, they say this new clinical lexicon and set of data standards should be “broadly applicable” in various settings, including clinical trials and observational studies, patient care, electronic health records (EHRs), quality and performance improvement initiatives, registries, and public reporting programs.

The 2022 ACC/AHA Key Data Elements and Definitions for Chest Pain and Acute Myocardial Infarction was simultaneously published online in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.

It was developed in collaboration with the American College of Emergency Physicians and the Society for Cardiac Angiography and Interventions and endorsed by the Society for Academic Emergency Medicine.

Dr. Anderson noted that “almost all of the guidelines that come out now, certainly in the last few years, have been followed after a certain interval by a set of data standards applicable to the guidelines.”

“It would be really great if it could actually be attached as an appendix, but the nature of the development of these things is such that there will always be a bit of a time lag between the writing group that develops the guidelines and the work group that develops the data standards; you can’t really have them working in parallel at the same time,” Dr. Anderson said in an interview.

This research had no commercial funding. The authors have no relevant disclosures.

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

Certain ultraprocessed foods – especially candy, prepackaged pastries, and frozen desserts – could be “gateway foods” for adolescents, leading them to increase their intake of other unhealthy foods, a new study suggests.

“For teens, gateway ultraprocessed foods (candy, store pastries, frozen desserts) should be prioritized for preventive dietary interventions as they increase intake across all other UPFs,” lead researcher Maria Balhara said in an interview.

“The good news,” said Ms. Balhara, is that even small changes, such as reducing how often gateway foods are consumed, may reduce overall intake of unhealthy foods and have a “big impact” on overall health.

Ms. Balhara has a unique perspective on adolescent eating habits: She’s 16 years old, from Florida, and conducted the study while dual-enrolled at Broward College and Cooper City High School.

Her study was released Sept. 7 ahead of presentation at the American Heart Association Hypertension Scientific Sessions 2022 in San Diego.
 

Blame the pandemic?

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including weight gain, hypertension, and increased risk for heart disease and premature death.

For her research, Ms. Balhara asked 315 teenagers (42% male) from 12 high schools in South Florida how often they consumed UPFs over two time periods – before COVID in 2019 and after COVID restrictions were eased in 2022 – using a survey that she developed called the Processed Intake Evaluation (PIE).

More than 2 in 5 teens (43%) increased their consumption of UPFs between 2019 and 2022.

During this time, increased consumption of frozen desserts was associated with an 11% increase in consumption of all other UPFs, whereas increased consumption of prepackaged pastries and candy was associated with a 12% and 31%, respectively, increase in consumption of all other UPFs, Ms. Balhara found.

Encouragingly, 57% of teens decreased their consumption of UPFs between 2019 and 2022.

During this time, decreased consumption of processed meats was associated with an 8% decrease in consumption of all other UPFs, whereas decreased consumption of white bread and biscuits was associated with a 9% and 10%, respectively, decrease in consumption of all other UPFs.

The results provide initial evidence for a new “gateway food model,” Ms. Balhara told this news organization, in which certain UPFs, when increased, drive overall consumption of all UPFs among teens.

Limitations of the study include the self-reported dietary data and the fact that the PIE survey has not been validated.
 

Not all UPFs are bad

“I commend Ms. Balhara for her project, which highlights the importance of establishing good dietary patterns early in life,” Donna K. Arnett, PhD, past president of the AHA, said in a news release.

“The relationship between poor dietary quality and cardiovascular risk factors is well-established. While this is a small, preliminary study, it’s an important topic to continue to investigate and help us understand ways we can influence dietary behaviors to promote optimal cardiovascular health for all ages,” said Dr. Arnett, executive vice president for academic affairs and provost at the University of South Carolina, Columbia.

Offering perspective on the study, Taylor C. Wallace, PhD, with the department of nutrition and food studies, George Mason University, Fairfax, Va., made the point that “food processing and ultraprocessed foods aren’t the problem. The problem is the types of ultraprocessed foods on the market that people consume.”

“Remember, non-fat, vitamin D fortified yogurt is also ‘ultra-processed,’ and it’s very healthy,” he told this news organization.

Dr. Wallace said that it’s no surprise that teens increased their intake of UPFs during the pandemic.

“Of course, people increased processed food intake during the pandemic. Processed foods are shelf stable at a time when grocery stores were running out of things and supply chains weren’t able to keep up. Also, many were depressed and use food to indulge,” he noted.

The study had no funding. Ms. Balhara has no relevant disclosures. Dr. Wallace is principal and CEO of Think Healthy Group; chief food and nutrition scientist with Produce for Better Health Foundation; editor, Journal of Dietary Supplements; deputy editor, Journal of the American College of Nutrition; nutrition section editor, Annals of Medicine; and an advisory board member with Forbes Health.

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

Certain ultraprocessed foods – especially candy, prepackaged pastries, and frozen desserts – could be “gateway foods” for adolescents, leading them to increase their intake of other unhealthy foods, a new study suggests.

“For teens, gateway ultraprocessed foods (candy, store pastries, frozen desserts) should be prioritized for preventive dietary interventions as they increase intake across all other UPFs,” lead researcher Maria Balhara said in an interview.

“The good news,” said Ms. Balhara, is that even small changes, such as reducing how often gateway foods are consumed, may reduce overall intake of unhealthy foods and have a “big impact” on overall health.

Ms. Balhara has a unique perspective on adolescent eating habits: She’s 16 years old, from Florida, and conducted the study while dual-enrolled at Broward College and Cooper City High School.

Her study was released Sept. 7 ahead of presentation at the American Heart Association Hypertension Scientific Sessions 2022 in San Diego.
 

Blame the pandemic?

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including weight gain, hypertension, and increased risk for heart disease and premature death.

For her research, Ms. Balhara asked 315 teenagers (42% male) from 12 high schools in South Florida how often they consumed UPFs over two time periods – before COVID in 2019 and after COVID restrictions were eased in 2022 – using a survey that she developed called the Processed Intake Evaluation (PIE).

More than 2 in 5 teens (43%) increased their consumption of UPFs between 2019 and 2022.

During this time, increased consumption of frozen desserts was associated with an 11% increase in consumption of all other UPFs, whereas increased consumption of prepackaged pastries and candy was associated with a 12% and 31%, respectively, increase in consumption of all other UPFs, Ms. Balhara found.

Encouragingly, 57% of teens decreased their consumption of UPFs between 2019 and 2022.

During this time, decreased consumption of processed meats was associated with an 8% decrease in consumption of all other UPFs, whereas decreased consumption of white bread and biscuits was associated with a 9% and 10%, respectively, decrease in consumption of all other UPFs.

The results provide initial evidence for a new “gateway food model,” Ms. Balhara told this news organization, in which certain UPFs, when increased, drive overall consumption of all UPFs among teens.

Limitations of the study include the self-reported dietary data and the fact that the PIE survey has not been validated.
 

Not all UPFs are bad

“I commend Ms. Balhara for her project, which highlights the importance of establishing good dietary patterns early in life,” Donna K. Arnett, PhD, past president of the AHA, said in a news release.

“The relationship between poor dietary quality and cardiovascular risk factors is well-established. While this is a small, preliminary study, it’s an important topic to continue to investigate and help us understand ways we can influence dietary behaviors to promote optimal cardiovascular health for all ages,” said Dr. Arnett, executive vice president for academic affairs and provost at the University of South Carolina, Columbia.

Offering perspective on the study, Taylor C. Wallace, PhD, with the department of nutrition and food studies, George Mason University, Fairfax, Va., made the point that “food processing and ultraprocessed foods aren’t the problem. The problem is the types of ultraprocessed foods on the market that people consume.”

“Remember, non-fat, vitamin D fortified yogurt is also ‘ultra-processed,’ and it’s very healthy,” he told this news organization.

Dr. Wallace said that it’s no surprise that teens increased their intake of UPFs during the pandemic.

“Of course, people increased processed food intake during the pandemic. Processed foods are shelf stable at a time when grocery stores were running out of things and supply chains weren’t able to keep up. Also, many were depressed and use food to indulge,” he noted.

The study had no funding. Ms. Balhara has no relevant disclosures. Dr. Wallace is principal and CEO of Think Healthy Group; chief food and nutrition scientist with Produce for Better Health Foundation; editor, Journal of Dietary Supplements; deputy editor, Journal of the American College of Nutrition; nutrition section editor, Annals of Medicine; and an advisory board member with Forbes Health.

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

Certain ultraprocessed foods – especially candy, prepackaged pastries, and frozen desserts – could be “gateway foods” for adolescents, leading them to increase their intake of other unhealthy foods, a new study suggests.

“For teens, gateway ultraprocessed foods (candy, store pastries, frozen desserts) should be prioritized for preventive dietary interventions as they increase intake across all other UPFs,” lead researcher Maria Balhara said in an interview.

“The good news,” said Ms. Balhara, is that even small changes, such as reducing how often gateway foods are consumed, may reduce overall intake of unhealthy foods and have a “big impact” on overall health.

Ms. Balhara has a unique perspective on adolescent eating habits: She’s 16 years old, from Florida, and conducted the study while dual-enrolled at Broward College and Cooper City High School.

Her study was released Sept. 7 ahead of presentation at the American Heart Association Hypertension Scientific Sessions 2022 in San Diego.
 

Blame the pandemic?

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including weight gain, hypertension, and increased risk for heart disease and premature death.

For her research, Ms. Balhara asked 315 teenagers (42% male) from 12 high schools in South Florida how often they consumed UPFs over two time periods – before COVID in 2019 and after COVID restrictions were eased in 2022 – using a survey that she developed called the Processed Intake Evaluation (PIE).

More than 2 in 5 teens (43%) increased their consumption of UPFs between 2019 and 2022.

During this time, increased consumption of frozen desserts was associated with an 11% increase in consumption of all other UPFs, whereas increased consumption of prepackaged pastries and candy was associated with a 12% and 31%, respectively, increase in consumption of all other UPFs, Ms. Balhara found.

Encouragingly, 57% of teens decreased their consumption of UPFs between 2019 and 2022.

During this time, decreased consumption of processed meats was associated with an 8% decrease in consumption of all other UPFs, whereas decreased consumption of white bread and biscuits was associated with a 9% and 10%, respectively, decrease in consumption of all other UPFs.

The results provide initial evidence for a new “gateway food model,” Ms. Balhara told this news organization, in which certain UPFs, when increased, drive overall consumption of all UPFs among teens.

Limitations of the study include the self-reported dietary data and the fact that the PIE survey has not been validated.
 

Not all UPFs are bad

“I commend Ms. Balhara for her project, which highlights the importance of establishing good dietary patterns early in life,” Donna K. Arnett, PhD, past president of the AHA, said in a news release.

“The relationship between poor dietary quality and cardiovascular risk factors is well-established. While this is a small, preliminary study, it’s an important topic to continue to investigate and help us understand ways we can influence dietary behaviors to promote optimal cardiovascular health for all ages,” said Dr. Arnett, executive vice president for academic affairs and provost at the University of South Carolina, Columbia.

Offering perspective on the study, Taylor C. Wallace, PhD, with the department of nutrition and food studies, George Mason University, Fairfax, Va., made the point that “food processing and ultraprocessed foods aren’t the problem. The problem is the types of ultraprocessed foods on the market that people consume.”

“Remember, non-fat, vitamin D fortified yogurt is also ‘ultra-processed,’ and it’s very healthy,” he told this news organization.

Dr. Wallace said that it’s no surprise that teens increased their intake of UPFs during the pandemic.

“Of course, people increased processed food intake during the pandemic. Processed foods are shelf stable at a time when grocery stores were running out of things and supply chains weren’t able to keep up. Also, many were depressed and use food to indulge,” he noted.

The study had no funding. Ms. Balhara has no relevant disclosures. Dr. Wallace is principal and CEO of Think Healthy Group; chief food and nutrition scientist with Produce for Better Health Foundation; editor, Journal of Dietary Supplements; deputy editor, Journal of the American College of Nutrition; nutrition section editor, Annals of Medicine; and an advisory board member with Forbes Health.

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

A new study has found no convincing evidence to suggest a causal relationship between nonsteroidal anti-inflammatory drug (NSAID) use and inflammatory bowel disease (IBD) exacerbations.

Rather, the study suggests that observed associations between IBD exacerbation and NSAID exposure may be explained by preexisting underlying risks for IBD flares, residual confounding, and reverse causality.

“We hope these study findings will aid providers in better directing IBD patients on their risk for IBD exacerbation with NSAID use,” write Shirley Cohen-Mekelburg, MD, with University of Michigan Medicine, Ann Arbor, and colleagues.

“This may guide therapy for both IBD and non-IBD related pain management, and the comfort of patients with IBD and the clinicians who treat them when considering NSAIDs as a non-opioid treatment option,” they add.

The study was published online in the American Journal of Gastroenterology.
 

Taking a second look

Patients with IBD (Crohn’s disease and ulcerative colitis) are prone to both inflammatory and noninflammatory pain, and there has been long-standing concern that NSAIDs may play a role in disease flare-ups.

To see whether a true association exists, Dr. Cohen-Mekelburg and colleagues conducted a series of studies that involved roughly 35,000 patients with IBD.

First, they created a propensity-matched cohort of 15,705 patients who had received NSAIDs and 19,326 who had not taken NSAIDs. Findings from a Cox proportional hazards model suggested a higher likelihood of IBD exacerbation in the group that had taken NSAIDs (hazard ratio, 1.24; 95% confidence interval, 1.16-1.33), after adjusting for age, gender, race, Charlson comorbidity index, smoking status, IBD type, and use of immunomodulator or biologic medications.

However, those who received NSAIDs were already at increased risk of experiencing a disease flare. And the prior event rate ratio for IBD exacerbation, as determined by dividing the adjusted HR after NSAID exposure by the adjusted HR for pre-NSAID exposure, was 0.95 (95% CI, 0.89-1.01).

The researchers used a self-controlled case series to verify their findings and to adjust for other immeasurable patient-level confounders. In this analysis, which involved 3,968 patients, the risk of IBD flare did not increase in the period from 2 weeks to 6 months after exposure to an NSAID.

The incidence of IBD exacerbations was higher in the 0- to 2-week transition period after an NSAID was prescribed, but it dropped after the 2-week “risk” window. This suggests that these short-term flares may be secondary to residual confounding related to reverse causality, rather than the NSAIDs themselves, the researchers say.

While NSAIDs represent the most common first-line analgesic, their use for patients with IBD is variable, in part due to the suspected risk of IBD exacerbation “despite inconclusive evidence of harm to date,” Dr. Cohen-Mekelburg and colleagues note.

They also note that about 36% of patients with IBD in their cohort received at least one NSAID prescription, and three-quarters of these patients did not experience an IBD exacerbation during an average of 5.9 years of follow-up.
 

Good study, reassuring data

“This is a good study trying to understand the potential sources of bias in associations,” Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.

Overall, he said the study “provides reassurance that cautious, short-duration or low-dose use is likely well tolerated in most patients with IBD. But more work is needed to understand the impact of higher dose or more frequent use.”

Also weighing in, Adam Steinlauf, MD, with Mount Sinai Health System and Icahn School of Medicine at Mount Sinai in New York, noted that patients with IBD experience pain throughout the course of their disease, both intestinal and extraintestinal.

“Treating the underlying IBD is important, but medications used to treat joint pain and inflammation specifically are few,” said Dr. Steinlauf, who wasn’t involved in the new study.

“Sulfasalazine has been used with success, but it does not work in everyone, and many are allergic to the sulfa component, limiting its use. Narcotics are often reluctantly used for these issues as well. Medical marijuana has emerged on the scene to control both types of pain, but to date, there is inconclusive evidence that it significantly treats both pain and underlying inflammation,” Dr. Steinlauf pointed out.

NSAIDs, on the other hand, are “excellent” choices for treating joint pain and inflammation, but gastroenterologists often try to avoid these medications, given the fear of triggering flares of underlying IBD, Dr. Steinlauf told this news organization.

In his view, this new study is “important in that it quite elegantly challenges the notion that gastroenterologists should avoid NSAIDs in patients with IBD.”

Although more data are clearly needed, Dr. Steinlauf said this study “should give practitioners a bit more confidence in prescribing NSAIDs for their patients with IBD if absolutely necessary to control pain and inflammation and improve quality of life when other standard treatments fail.

“The association of NSAIDs with subsequent flares, of which we are all so well aware of and afraid of, may in fact be related more to our patients’ underlying risks for IBD and reverse causality rather than the NSAIDs themselves. Future studies should further clarify this notion,” Dr. Steinlauf said.

The study received no commercial funding. Dr. Cohen-Mekelburg, Dr. Ananthakrishnan, and Dr. Steinlauf have disclosed no relevant financial relationships.

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

A new study has found no convincing evidence to suggest a causal relationship between nonsteroidal anti-inflammatory drug (NSAID) use and inflammatory bowel disease (IBD) exacerbations.

Rather, the study suggests that observed associations between IBD exacerbation and NSAID exposure may be explained by preexisting underlying risks for IBD flares, residual confounding, and reverse causality.

“We hope these study findings will aid providers in better directing IBD patients on their risk for IBD exacerbation with NSAID use,” write Shirley Cohen-Mekelburg, MD, with University of Michigan Medicine, Ann Arbor, and colleagues.

“This may guide therapy for both IBD and non-IBD related pain management, and the comfort of patients with IBD and the clinicians who treat them when considering NSAIDs as a non-opioid treatment option,” they add.

The study was published online in the American Journal of Gastroenterology.
 

Taking a second look

Patients with IBD (Crohn’s disease and ulcerative colitis) are prone to both inflammatory and noninflammatory pain, and there has been long-standing concern that NSAIDs may play a role in disease flare-ups.

To see whether a true association exists, Dr. Cohen-Mekelburg and colleagues conducted a series of studies that involved roughly 35,000 patients with IBD.

First, they created a propensity-matched cohort of 15,705 patients who had received NSAIDs and 19,326 who had not taken NSAIDs. Findings from a Cox proportional hazards model suggested a higher likelihood of IBD exacerbation in the group that had taken NSAIDs (hazard ratio, 1.24; 95% confidence interval, 1.16-1.33), after adjusting for age, gender, race, Charlson comorbidity index, smoking status, IBD type, and use of immunomodulator or biologic medications.

However, those who received NSAIDs were already at increased risk of experiencing a disease flare. And the prior event rate ratio for IBD exacerbation, as determined by dividing the adjusted HR after NSAID exposure by the adjusted HR for pre-NSAID exposure, was 0.95 (95% CI, 0.89-1.01).

The researchers used a self-controlled case series to verify their findings and to adjust for other immeasurable patient-level confounders. In this analysis, which involved 3,968 patients, the risk of IBD flare did not increase in the period from 2 weeks to 6 months after exposure to an NSAID.

The incidence of IBD exacerbations was higher in the 0- to 2-week transition period after an NSAID was prescribed, but it dropped after the 2-week “risk” window. This suggests that these short-term flares may be secondary to residual confounding related to reverse causality, rather than the NSAIDs themselves, the researchers say.

While NSAIDs represent the most common first-line analgesic, their use for patients with IBD is variable, in part due to the suspected risk of IBD exacerbation “despite inconclusive evidence of harm to date,” Dr. Cohen-Mekelburg and colleagues note.

They also note that about 36% of patients with IBD in their cohort received at least one NSAID prescription, and three-quarters of these patients did not experience an IBD exacerbation during an average of 5.9 years of follow-up.
 

Good study, reassuring data

“This is a good study trying to understand the potential sources of bias in associations,” Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.

Overall, he said the study “provides reassurance that cautious, short-duration or low-dose use is likely well tolerated in most patients with IBD. But more work is needed to understand the impact of higher dose or more frequent use.”

Also weighing in, Adam Steinlauf, MD, with Mount Sinai Health System and Icahn School of Medicine at Mount Sinai in New York, noted that patients with IBD experience pain throughout the course of their disease, both intestinal and extraintestinal.

“Treating the underlying IBD is important, but medications used to treat joint pain and inflammation specifically are few,” said Dr. Steinlauf, who wasn’t involved in the new study.

“Sulfasalazine has been used with success, but it does not work in everyone, and many are allergic to the sulfa component, limiting its use. Narcotics are often reluctantly used for these issues as well. Medical marijuana has emerged on the scene to control both types of pain, but to date, there is inconclusive evidence that it significantly treats both pain and underlying inflammation,” Dr. Steinlauf pointed out.

NSAIDs, on the other hand, are “excellent” choices for treating joint pain and inflammation, but gastroenterologists often try to avoid these medications, given the fear of triggering flares of underlying IBD, Dr. Steinlauf told this news organization.

In his view, this new study is “important in that it quite elegantly challenges the notion that gastroenterologists should avoid NSAIDs in patients with IBD.”

Although more data are clearly needed, Dr. Steinlauf said this study “should give practitioners a bit more confidence in prescribing NSAIDs for their patients with IBD if absolutely necessary to control pain and inflammation and improve quality of life when other standard treatments fail.

“The association of NSAIDs with subsequent flares, of which we are all so well aware of and afraid of, may in fact be related more to our patients’ underlying risks for IBD and reverse causality rather than the NSAIDs themselves. Future studies should further clarify this notion,” Dr. Steinlauf said.

The study received no commercial funding. Dr. Cohen-Mekelburg, Dr. Ananthakrishnan, and Dr. Steinlauf have disclosed no relevant financial relationships.

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

A new study has found no convincing evidence to suggest a causal relationship between nonsteroidal anti-inflammatory drug (NSAID) use and inflammatory bowel disease (IBD) exacerbations.

Rather, the study suggests that observed associations between IBD exacerbation and NSAID exposure may be explained by preexisting underlying risks for IBD flares, residual confounding, and reverse causality.

“We hope these study findings will aid providers in better directing IBD patients on their risk for IBD exacerbation with NSAID use,” write Shirley Cohen-Mekelburg, MD, with University of Michigan Medicine, Ann Arbor, and colleagues.

“This may guide therapy for both IBD and non-IBD related pain management, and the comfort of patients with IBD and the clinicians who treat them when considering NSAIDs as a non-opioid treatment option,” they add.

The study was published online in the American Journal of Gastroenterology.
 

Taking a second look

Patients with IBD (Crohn’s disease and ulcerative colitis) are prone to both inflammatory and noninflammatory pain, and there has been long-standing concern that NSAIDs may play a role in disease flare-ups.

To see whether a true association exists, Dr. Cohen-Mekelburg and colleagues conducted a series of studies that involved roughly 35,000 patients with IBD.

First, they created a propensity-matched cohort of 15,705 patients who had received NSAIDs and 19,326 who had not taken NSAIDs. Findings from a Cox proportional hazards model suggested a higher likelihood of IBD exacerbation in the group that had taken NSAIDs (hazard ratio, 1.24; 95% confidence interval, 1.16-1.33), after adjusting for age, gender, race, Charlson comorbidity index, smoking status, IBD type, and use of immunomodulator or biologic medications.

However, those who received NSAIDs were already at increased risk of experiencing a disease flare. And the prior event rate ratio for IBD exacerbation, as determined by dividing the adjusted HR after NSAID exposure by the adjusted HR for pre-NSAID exposure, was 0.95 (95% CI, 0.89-1.01).

The researchers used a self-controlled case series to verify their findings and to adjust for other immeasurable patient-level confounders. In this analysis, which involved 3,968 patients, the risk of IBD flare did not increase in the period from 2 weeks to 6 months after exposure to an NSAID.

The incidence of IBD exacerbations was higher in the 0- to 2-week transition period after an NSAID was prescribed, but it dropped after the 2-week “risk” window. This suggests that these short-term flares may be secondary to residual confounding related to reverse causality, rather than the NSAIDs themselves, the researchers say.

While NSAIDs represent the most common first-line analgesic, their use for patients with IBD is variable, in part due to the suspected risk of IBD exacerbation “despite inconclusive evidence of harm to date,” Dr. Cohen-Mekelburg and colleagues note.

They also note that about 36% of patients with IBD in their cohort received at least one NSAID prescription, and three-quarters of these patients did not experience an IBD exacerbation during an average of 5.9 years of follow-up.
 

Good study, reassuring data

“This is a good study trying to understand the potential sources of bias in associations,” Ashwin Ananthakrishnan, MD, MPH, with Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the study, told this news organization.

Overall, he said the study “provides reassurance that cautious, short-duration or low-dose use is likely well tolerated in most patients with IBD. But more work is needed to understand the impact of higher dose or more frequent use.”

Also weighing in, Adam Steinlauf, MD, with Mount Sinai Health System and Icahn School of Medicine at Mount Sinai in New York, noted that patients with IBD experience pain throughout the course of their disease, both intestinal and extraintestinal.

“Treating the underlying IBD is important, but medications used to treat joint pain and inflammation specifically are few,” said Dr. Steinlauf, who wasn’t involved in the new study.

“Sulfasalazine has been used with success, but it does not work in everyone, and many are allergic to the sulfa component, limiting its use. Narcotics are often reluctantly used for these issues as well. Medical marijuana has emerged on the scene to control both types of pain, but to date, there is inconclusive evidence that it significantly treats both pain and underlying inflammation,” Dr. Steinlauf pointed out.

NSAIDs, on the other hand, are “excellent” choices for treating joint pain and inflammation, but gastroenterologists often try to avoid these medications, given the fear of triggering flares of underlying IBD, Dr. Steinlauf told this news organization.

In his view, this new study is “important in that it quite elegantly challenges the notion that gastroenterologists should avoid NSAIDs in patients with IBD.”

Although more data are clearly needed, Dr. Steinlauf said this study “should give practitioners a bit more confidence in prescribing NSAIDs for their patients with IBD if absolutely necessary to control pain and inflammation and improve quality of life when other standard treatments fail.

“The association of NSAIDs with subsequent flares, of which we are all so well aware of and afraid of, may in fact be related more to our patients’ underlying risks for IBD and reverse causality rather than the NSAIDs themselves. Future studies should further clarify this notion,” Dr. Steinlauf said.

The study received no commercial funding. Dr. Cohen-Mekelburg, Dr. Ananthakrishnan, and Dr. Steinlauf have disclosed no relevant financial relationships.

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

Researchers have identified genetic variants in 10 genes that increase susceptibility to Crohn’s disease (CD), a form of inflammatory bowel disease (IBD). Some of the variants had not previously been connected to CD.

Because they’re so common, most people will have some of the genetic variants that increase susceptibility to IBD, first author Aleksejs Sazonovs, PhD, research associate at the Wellcome Sanger Institute, Hinxton, United Kingdom, said in a news release.

“These common variants may increase a person’s risk by 10%, for example, but this increased risk doesn’t necessarily lead to disease,” Dr. Sazonovs explains.

However, some rare variants can render an individual four or five times more likely to develop IBD, “so it’s especially important to locate these and understand the biological processes they disrupt,” Dr. Sazonovs adds.

The study was published online in Nature Genetics.

Genome-wide association studies (GWASs) of CD, and of IBD more generally, have identified more than 200 loci that contribute to disease risk.

To complement GWAS data and to better define actionable biological targets in protein-coding genes, the researchers analyzed large-scale exome sequencing data from more than 30,000 patients with CD and 80,000 control persons from more than 35 centers in the International IBD Genetics Consortium.

Their findings, they say, “directly implicate” genetic variants in 10 genes in general-onset CD, four of which lie within established CD GWAS loci.

They also implicate genetic variation in six genes in regions of the genome that had not previously been connected to CD.

Of note, say the researchers, many of these newly associated genes appear to be linked to the roles that mesenchymal cells (MCs) play in intestinal homeostasis, “a pathway not previously implicated by genetic studies.”

“In addition to reiterating the central role of innate and adaptive immune cells, as well as autophagy in CD pathogenesis, these newly associated genes highlight the emerging role of mesenchymal cells in the development and maintenance of intestinal inflammation,” they add.

The researchers note that previous studies have demonstrated that the biology of MCs is disrupted in IBD. The current findings of coding variants in these genes demonstrate that these cells and functions “causally contribute to disease susceptibility,” they write.

The association of these pathways with CD pathogenesis provides a rationale for developing therapeutic modalities that can “reestablish the balance to the mesenchymal niche, as it is believed that genetic evidence for a drug target has a measurable impact on drug development,” they add.

The researchers plan to extend this research to ulcerative colitis and to increase the scale of sampling.

“We’ve already begun working on our next study, which will use exome sequence data from more than 650,000 individuals and give us unprecedented ability to derive insights into the aberrant biology underpinning inflammatory bowel disease,” Carl Anderson, PhD, senior investigator at the Wellcome Sanger Institute, says in the release.

Support for the study was funded by the National Institutes of Health, the Wellcome Trust, and the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Sazonovs reports no relevant financial relationships. Dr. Anderson has received consultancy fees from Genomics PLC and BridgeBio and lecture fees from GlaxoSmithKline.

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

Researchers have identified genetic variants in 10 genes that increase susceptibility to Crohn’s disease (CD), a form of inflammatory bowel disease (IBD). Some of the variants had not previously been connected to CD.

Because they’re so common, most people will have some of the genetic variants that increase susceptibility to IBD, first author Aleksejs Sazonovs, PhD, research associate at the Wellcome Sanger Institute, Hinxton, United Kingdom, said in a news release.

“These common variants may increase a person’s risk by 10%, for example, but this increased risk doesn’t necessarily lead to disease,” Dr. Sazonovs explains.

However, some rare variants can render an individual four or five times more likely to develop IBD, “so it’s especially important to locate these and understand the biological processes they disrupt,” Dr. Sazonovs adds.

The study was published online in Nature Genetics.

Genome-wide association studies (GWASs) of CD, and of IBD more generally, have identified more than 200 loci that contribute to disease risk.

To complement GWAS data and to better define actionable biological targets in protein-coding genes, the researchers analyzed large-scale exome sequencing data from more than 30,000 patients with CD and 80,000 control persons from more than 35 centers in the International IBD Genetics Consortium.

Their findings, they say, “directly implicate” genetic variants in 10 genes in general-onset CD, four of which lie within established CD GWAS loci.

They also implicate genetic variation in six genes in regions of the genome that had not previously been connected to CD.

Of note, say the researchers, many of these newly associated genes appear to be linked to the roles that mesenchymal cells (MCs) play in intestinal homeostasis, “a pathway not previously implicated by genetic studies.”

“In addition to reiterating the central role of innate and adaptive immune cells, as well as autophagy in CD pathogenesis, these newly associated genes highlight the emerging role of mesenchymal cells in the development and maintenance of intestinal inflammation,” they add.

The researchers note that previous studies have demonstrated that the biology of MCs is disrupted in IBD. The current findings of coding variants in these genes demonstrate that these cells and functions “causally contribute to disease susceptibility,” they write.

The association of these pathways with CD pathogenesis provides a rationale for developing therapeutic modalities that can “reestablish the balance to the mesenchymal niche, as it is believed that genetic evidence for a drug target has a measurable impact on drug development,” they add.

The researchers plan to extend this research to ulcerative colitis and to increase the scale of sampling.

“We’ve already begun working on our next study, which will use exome sequence data from more than 650,000 individuals and give us unprecedented ability to derive insights into the aberrant biology underpinning inflammatory bowel disease,” Carl Anderson, PhD, senior investigator at the Wellcome Sanger Institute, says in the release.

Support for the study was funded by the National Institutes of Health, the Wellcome Trust, and the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Sazonovs reports no relevant financial relationships. Dr. Anderson has received consultancy fees from Genomics PLC and BridgeBio and lecture fees from GlaxoSmithKline.

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

Researchers have identified genetic variants in 10 genes that increase susceptibility to Crohn’s disease (CD), a form of inflammatory bowel disease (IBD). Some of the variants had not previously been connected to CD.

Because they’re so common, most people will have some of the genetic variants that increase susceptibility to IBD, first author Aleksejs Sazonovs, PhD, research associate at the Wellcome Sanger Institute, Hinxton, United Kingdom, said in a news release.

“These common variants may increase a person’s risk by 10%, for example, but this increased risk doesn’t necessarily lead to disease,” Dr. Sazonovs explains.

However, some rare variants can render an individual four or five times more likely to develop IBD, “so it’s especially important to locate these and understand the biological processes they disrupt,” Dr. Sazonovs adds.

The study was published online in Nature Genetics.

Genome-wide association studies (GWASs) of CD, and of IBD more generally, have identified more than 200 loci that contribute to disease risk.

To complement GWAS data and to better define actionable biological targets in protein-coding genes, the researchers analyzed large-scale exome sequencing data from more than 30,000 patients with CD and 80,000 control persons from more than 35 centers in the International IBD Genetics Consortium.

Their findings, they say, “directly implicate” genetic variants in 10 genes in general-onset CD, four of which lie within established CD GWAS loci.

They also implicate genetic variation in six genes in regions of the genome that had not previously been connected to CD.

Of note, say the researchers, many of these newly associated genes appear to be linked to the roles that mesenchymal cells (MCs) play in intestinal homeostasis, “a pathway not previously implicated by genetic studies.”

“In addition to reiterating the central role of innate and adaptive immune cells, as well as autophagy in CD pathogenesis, these newly associated genes highlight the emerging role of mesenchymal cells in the development and maintenance of intestinal inflammation,” they add.

The researchers note that previous studies have demonstrated that the biology of MCs is disrupted in IBD. The current findings of coding variants in these genes demonstrate that these cells and functions “causally contribute to disease susceptibility,” they write.

The association of these pathways with CD pathogenesis provides a rationale for developing therapeutic modalities that can “reestablish the balance to the mesenchymal niche, as it is believed that genetic evidence for a drug target has a measurable impact on drug development,” they add.

The researchers plan to extend this research to ulcerative colitis and to increase the scale of sampling.

“We’ve already begun working on our next study, which will use exome sequence data from more than 650,000 individuals and give us unprecedented ability to derive insights into the aberrant biology underpinning inflammatory bowel disease,” Carl Anderson, PhD, senior investigator at the Wellcome Sanger Institute, says in the release.

Support for the study was funded by the National Institutes of Health, the Wellcome Trust, and the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Sazonovs reports no relevant financial relationships. Dr. Anderson has received consultancy fees from Genomics PLC and BridgeBio and lecture fees from GlaxoSmithKline.

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

The U.S. Food and Drug Administration has approved daxibotulinumtoxinA-lanm injection (Daxxify) for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults.

According to a company news release, Daxxify, an acetylcholine release inhibitor and neuromuscular blocking agent, is the first peptide-formulated, long-acting neuromodulator approved for this indication.

The approval of Daxxify, manufactured by Revance Therapeutics, was based on the data from the SAKURA phase 3 clinical trial program, which included more than 2,700 adults who received roughly 4,200 treatments, according to the company.

About three-quarters of participants achieved at least a two-grade improvement in glabellar lines at week 4 as judged by both investigator and patient, and 98% achieved “none or mild wrinkle severity” at week 4 per investigator assessment, the company said.

The median duration of treatment effect was 6 months, with some patients maintaining treatment results at 9 months, compared with a 3- to 4-month duration of treatment effect with conventional neuromodulators.

“Compelling data from the largest phase 3 clinical program ever conducted for glabellar lines demonstrated that Daxxify was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction,” SAKURA investigator Jeffrey Dover, MD, co-director of SkinCare Physicians, Chestnut Hill, Mass., said in the news release.

“Notably,” said Dr. Dover, “Daxxify was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines.”

Daxxify has a safety profile in line with other currently available neuromodulators in the aesthetics market, the company said, with no serious treatment-related adverse events reported in clinical trial participants.

The most common treatment-related adverse events in the pivotal studies were headache (6%), eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).

Daxxify is contraindicated in adults with hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection sites. 

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved daxibotulinumtoxinA-lanm injection (Daxxify) for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults.

According to a company news release, Daxxify, an acetylcholine release inhibitor and neuromuscular blocking agent, is the first peptide-formulated, long-acting neuromodulator approved for this indication.

The approval of Daxxify, manufactured by Revance Therapeutics, was based on the data from the SAKURA phase 3 clinical trial program, which included more than 2,700 adults who received roughly 4,200 treatments, according to the company.

About three-quarters of participants achieved at least a two-grade improvement in glabellar lines at week 4 as judged by both investigator and patient, and 98% achieved “none or mild wrinkle severity” at week 4 per investigator assessment, the company said.

The median duration of treatment effect was 6 months, with some patients maintaining treatment results at 9 months, compared with a 3- to 4-month duration of treatment effect with conventional neuromodulators.

“Compelling data from the largest phase 3 clinical program ever conducted for glabellar lines demonstrated that Daxxify was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction,” SAKURA investigator Jeffrey Dover, MD, co-director of SkinCare Physicians, Chestnut Hill, Mass., said in the news release.

“Notably,” said Dr. Dover, “Daxxify was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines.”

Daxxify has a safety profile in line with other currently available neuromodulators in the aesthetics market, the company said, with no serious treatment-related adverse events reported in clinical trial participants.

The most common treatment-related adverse events in the pivotal studies were headache (6%), eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).

Daxxify is contraindicated in adults with hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection sites. 

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved daxibotulinumtoxinA-lanm injection (Daxxify) for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults.

According to a company news release, Daxxify, an acetylcholine release inhibitor and neuromuscular blocking agent, is the first peptide-formulated, long-acting neuromodulator approved for this indication.

The approval of Daxxify, manufactured by Revance Therapeutics, was based on the data from the SAKURA phase 3 clinical trial program, which included more than 2,700 adults who received roughly 4,200 treatments, according to the company.

About three-quarters of participants achieved at least a two-grade improvement in glabellar lines at week 4 as judged by both investigator and patient, and 98% achieved “none or mild wrinkle severity” at week 4 per investigator assessment, the company said.

The median duration of treatment effect was 6 months, with some patients maintaining treatment results at 9 months, compared with a 3- to 4-month duration of treatment effect with conventional neuromodulators.

“Compelling data from the largest phase 3 clinical program ever conducted for glabellar lines demonstrated that Daxxify was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction,” SAKURA investigator Jeffrey Dover, MD, co-director of SkinCare Physicians, Chestnut Hill, Mass., said in the news release.

“Notably,” said Dr. Dover, “Daxxify was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines.”

Daxxify has a safety profile in line with other currently available neuromodulators in the aesthetics market, the company said, with no serious treatment-related adverse events reported in clinical trial participants.

The most common treatment-related adverse events in the pivotal studies were headache (6%), eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).

Daxxify is contraindicated in adults with hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection sites. 

Full prescribing information is available online.

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

Clinicians in Portugal say a 31-year-old man with confirmed monkeypox developed acute myocarditis roughly 1 week after the eruption of the characteristic skin lesions of the disease.

“This case highlights cardiac involvement as a potential complication associated with monkeypox infection,” Ana Isabel Pinho, MD, department of cardiology, São João University Hospital Centre, Porto, Portugal, said in a news release.

“We believe that reporting this potential causal relationship can raise more awareness of the scientific community and health professionals for acute myocarditis as a possible complication associated with monkeypox and might be helpful for close monitoring of affected patients for further recognition of other complications in the future,” Dr. Pinho adds.

Dr. Pinho and colleagues describe the case in a report published in JACC: Case Reports.
 

Case details

The patient presented with a 5-day history of malaise, myalgias, and fever followed by the eruption of multiple swollen skin lesions on his face, hands, and genitalia.

Monkeypox was confirmed by positive polymerase chain reaction assay of a swab sample from a skin lesion.

Three days later, the patient developed chest tightness that radiated through the left arm and which awoke him during the night. He was admitted to an intensive care unit with clinical suspicion of acute myocarditis.

The patient’s initial electrocardiogram showed sinus rhythm with nonspecific ventricular repolarization abnormalities.

On chest x-ray, the cardiothoracic index was normal, with no interstitial infiltrates, pleural effusion, or masses. On transthoracic echocardigraphy, biventricular systolic function was preserved, and there was no pericardial effusion.

Routine laboratory tests revealed elevated levels of C-reactive protein, creatine phosphokinase, high-sensitivity troponin I, and brain natriuretic peptide, suggesting stress injury to the heart.

Findings on cardiac magnetic resonance were consistent with myocardial inflammation and acute myocarditis.

The patient was treated with supportive care, and he made a full clinical recovery. He was discharged after 1 week. On discharge, cardiac enzymes were within the normal range. The patient showed sustained electric and hemodynamic stability, and the skin lesions had healed.

“Through this important case study, we are developing a deeper understanding of monkeypox, viral myocarditis, and how to accurately diagnose and manage this disease,” Julia Grapsa, MD, PhD, editor-in-chief of JACC: Case Reports, commented in the news release.

“I commend the authors on this valuable clinical case during a critical time as monkeypox continues to spread globally,” Dr. Grapsa added.

The researchers say further research is needed to identify the pathologic mechanism underlying monkeypox-associated cardiac injury.
 

By the numbers

According to the latest data, California has reported 3,629 cases, followed closely by New York with 3,367 cases, Florida with 1,957 cases, Texas with 1,698, Georgia with 1,418, and Illinois with 1,081. The other states have reported fewer than 600 cases.

The CDC says that globally, more than 52,000 monkeypox cases have been reported.

Monkeypox case counts appear to be slowing in the United States and globally.

Last week, the World Health Organization said the number of new cases worldwide declined by 21% between Aug. 15 and 21 after increasing for 4 straight weeks.

The research had no funding. Dr. Pinho and colleagues have disclosed no relevant financial relationships.

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

Clinicians in Portugal say a 31-year-old man with confirmed monkeypox developed acute myocarditis roughly 1 week after the eruption of the characteristic skin lesions of the disease.

“This case highlights cardiac involvement as a potential complication associated with monkeypox infection,” Ana Isabel Pinho, MD, department of cardiology, São João University Hospital Centre, Porto, Portugal, said in a news release.

“We believe that reporting this potential causal relationship can raise more awareness of the scientific community and health professionals for acute myocarditis as a possible complication associated with monkeypox and might be helpful for close monitoring of affected patients for further recognition of other complications in the future,” Dr. Pinho adds.

Dr. Pinho and colleagues describe the case in a report published in JACC: Case Reports.
 

Case details

The patient presented with a 5-day history of malaise, myalgias, and fever followed by the eruption of multiple swollen skin lesions on his face, hands, and genitalia.

Monkeypox was confirmed by positive polymerase chain reaction assay of a swab sample from a skin lesion.

Three days later, the patient developed chest tightness that radiated through the left arm and which awoke him during the night. He was admitted to an intensive care unit with clinical suspicion of acute myocarditis.

The patient’s initial electrocardiogram showed sinus rhythm with nonspecific ventricular repolarization abnormalities.

On chest x-ray, the cardiothoracic index was normal, with no interstitial infiltrates, pleural effusion, or masses. On transthoracic echocardigraphy, biventricular systolic function was preserved, and there was no pericardial effusion.

Routine laboratory tests revealed elevated levels of C-reactive protein, creatine phosphokinase, high-sensitivity troponin I, and brain natriuretic peptide, suggesting stress injury to the heart.

Findings on cardiac magnetic resonance were consistent with myocardial inflammation and acute myocarditis.

The patient was treated with supportive care, and he made a full clinical recovery. He was discharged after 1 week. On discharge, cardiac enzymes were within the normal range. The patient showed sustained electric and hemodynamic stability, and the skin lesions had healed.

“Through this important case study, we are developing a deeper understanding of monkeypox, viral myocarditis, and how to accurately diagnose and manage this disease,” Julia Grapsa, MD, PhD, editor-in-chief of JACC: Case Reports, commented in the news release.

“I commend the authors on this valuable clinical case during a critical time as monkeypox continues to spread globally,” Dr. Grapsa added.

The researchers say further research is needed to identify the pathologic mechanism underlying monkeypox-associated cardiac injury.
 

By the numbers

According to the latest data, California has reported 3,629 cases, followed closely by New York with 3,367 cases, Florida with 1,957 cases, Texas with 1,698, Georgia with 1,418, and Illinois with 1,081. The other states have reported fewer than 600 cases.

The CDC says that globally, more than 52,000 monkeypox cases have been reported.

Monkeypox case counts appear to be slowing in the United States and globally.

Last week, the World Health Organization said the number of new cases worldwide declined by 21% between Aug. 15 and 21 after increasing for 4 straight weeks.

The research had no funding. Dr. Pinho and colleagues have disclosed no relevant financial relationships.

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

Clinicians in Portugal say a 31-year-old man with confirmed monkeypox developed acute myocarditis roughly 1 week after the eruption of the characteristic skin lesions of the disease.

“This case highlights cardiac involvement as a potential complication associated with monkeypox infection,” Ana Isabel Pinho, MD, department of cardiology, São João University Hospital Centre, Porto, Portugal, said in a news release.

“We believe that reporting this potential causal relationship can raise more awareness of the scientific community and health professionals for acute myocarditis as a possible complication associated with monkeypox and might be helpful for close monitoring of affected patients for further recognition of other complications in the future,” Dr. Pinho adds.

Dr. Pinho and colleagues describe the case in a report published in JACC: Case Reports.
 

Case details

The patient presented with a 5-day history of malaise, myalgias, and fever followed by the eruption of multiple swollen skin lesions on his face, hands, and genitalia.

Monkeypox was confirmed by positive polymerase chain reaction assay of a swab sample from a skin lesion.

Three days later, the patient developed chest tightness that radiated through the left arm and which awoke him during the night. He was admitted to an intensive care unit with clinical suspicion of acute myocarditis.

The patient’s initial electrocardiogram showed sinus rhythm with nonspecific ventricular repolarization abnormalities.

On chest x-ray, the cardiothoracic index was normal, with no interstitial infiltrates, pleural effusion, or masses. On transthoracic echocardigraphy, biventricular systolic function was preserved, and there was no pericardial effusion.

Routine laboratory tests revealed elevated levels of C-reactive protein, creatine phosphokinase, high-sensitivity troponin I, and brain natriuretic peptide, suggesting stress injury to the heart.

Findings on cardiac magnetic resonance were consistent with myocardial inflammation and acute myocarditis.

The patient was treated with supportive care, and he made a full clinical recovery. He was discharged after 1 week. On discharge, cardiac enzymes were within the normal range. The patient showed sustained electric and hemodynamic stability, and the skin lesions had healed.

“Through this important case study, we are developing a deeper understanding of monkeypox, viral myocarditis, and how to accurately diagnose and manage this disease,” Julia Grapsa, MD, PhD, editor-in-chief of JACC: Case Reports, commented in the news release.

“I commend the authors on this valuable clinical case during a critical time as monkeypox continues to spread globally,” Dr. Grapsa added.

The researchers say further research is needed to identify the pathologic mechanism underlying monkeypox-associated cardiac injury.
 

By the numbers

According to the latest data, California has reported 3,629 cases, followed closely by New York with 3,367 cases, Florida with 1,957 cases, Texas with 1,698, Georgia with 1,418, and Illinois with 1,081. The other states have reported fewer than 600 cases.

The CDC says that globally, more than 52,000 monkeypox cases have been reported.

Monkeypox case counts appear to be slowing in the United States and globally.

Last week, the World Health Organization said the number of new cases worldwide declined by 21% between Aug. 15 and 21 after increasing for 4 straight weeks.

The research had no funding. Dr. Pinho and colleagues have disclosed no relevant financial relationships.

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

Reduced physical function is an independent risk factor for composite and individual cardiovascular events, including coronary heart disease (CHD), stroke, and heart failure (HF) in older adults, according to new observational data from the Atherosclerosis Risk in Communities (ARIC) study.

“We found that physical function in older adults predicts future cardiovascular disease (CVD) beyond traditional heart disease risk factors, regardless of whether an individual has a history of cardiovascular disease,” senior author Kunihiro Matsushita, MD, PhD, division of cardiology, Johns Hopkins University, Baltimore, said in a news release.

The study was published online in the Journal of the American Heart Association.
 

Keeping fit with age

The researchers analyzed health data collected between 2011 and 2013 for 5,570 ARIC participants (mean age, 75 years; 58% women, 22% Black persons). They assessed physical function using the Short Physical Performance Battery (SPPB), which measures walking speed, leg strength, and balance.

On the basis of the results, participants were categorized into three physical function groups: low (score, 0-6; 13% of the cohort), intermediate (score, 7-9; 30%) and high (score, 10-12; 57%).

During a median follow up of 7 years, there were 930 composite CVD events (386 CHD, 251 stroke, and 529 HF).

Adults with lower SPPB scores had a higher cumulative incidence of composite CVD outcomes.

The 5-year cumulative incidence of the composite CVD outcome in the low- and intermediate-SPPB categories was about three times (23.4%) and two times (15.3%) higher than in the high-SPPB category (8.6%), the researchers reported.

In addition, continuous SPPB scores showed significant associations with composite and individual CVD outcomes in all models. A 1-point lower SPPB score was associated with 6%-10% higher risk for CVD events after adjusting for potential confounders.

In the fully adjusted model, the risk for composite CVD outcomes was 47% higher (hazard ratio, 1.47; 95% confidence interval, 1.20-1.79) in those with low physical function and 25% higher in those with intermediate physical function (HR, 1.25; 95% CI, 1.07-1.46) compared with peers with high physical function.

For the individual outcomes, low physical function was associated with higher risk for stroke (HR, 1.81; 95% CI, 1.24-2.64) and HF (HR, 1.33; 95% CI, 1.02-1.73), whereas the association for CHD was not significant.

The associations were largely consistent across subgroups, including those with CVD at baseline.

The addition of SPPB scores significantly improved risk prediction of CVD events beyond traditional CVD risk factors in adults regardless of prior CVD history, suggesting that this tool may be useful for classifying CVD risk in older adults, the researchers said.
 

Meaningful impact on care?

“Our findings highlight the value of assessing the physical function level of older adults in clinical practice,” lead author Xiao Hu, MHS, with the department of epidemiology at Johns Hopkins, said in the news release. “In addition to heart health, older adults are at higher risk for falls and disability. The assessment of physical function may also inform the risk of these concerning conditions in older adults.”

Weighing in on the study, Jonathan Halperin, MD, cardiologist at Mount Sinai Heart and professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai, both in New York, said that “It’s known that cardiorespiratory fitness is an important predictor of cardiovascular risk, but it is one of the few physiological risk factors that are subjectively queried but not objectively assessed in routine clinical practice.”

In this study, Dr. Halperin noted, the investigators found that a battery of physical performance assessments, including a walk test, chair standing, and balance testing, improved cardiovascular risk prediction.

Dr. Halperin cautioned, however, that “since even the short sequence of tests takes time to perform and interpret, and is not currently reimbursed under most health insurance policies, it is not clear whether the report will have a meaningful impact on patient care.”

This research was funded by the National Institutes of Health. Dr. Matsushita and Dr. Halperin have no relevant disclosures.

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

Reduced physical function is an independent risk factor for composite and individual cardiovascular events, including coronary heart disease (CHD), stroke, and heart failure (HF) in older adults, according to new observational data from the Atherosclerosis Risk in Communities (ARIC) study.

“We found that physical function in older adults predicts future cardiovascular disease (CVD) beyond traditional heart disease risk factors, regardless of whether an individual has a history of cardiovascular disease,” senior author Kunihiro Matsushita, MD, PhD, division of cardiology, Johns Hopkins University, Baltimore, said in a news release.

The study was published online in the Journal of the American Heart Association.
 

Keeping fit with age

The researchers analyzed health data collected between 2011 and 2013 for 5,570 ARIC participants (mean age, 75 years; 58% women, 22% Black persons). They assessed physical function using the Short Physical Performance Battery (SPPB), which measures walking speed, leg strength, and balance.

On the basis of the results, participants were categorized into three physical function groups: low (score, 0-6; 13% of the cohort), intermediate (score, 7-9; 30%) and high (score, 10-12; 57%).

During a median follow up of 7 years, there were 930 composite CVD events (386 CHD, 251 stroke, and 529 HF).

Adults with lower SPPB scores had a higher cumulative incidence of composite CVD outcomes.

The 5-year cumulative incidence of the composite CVD outcome in the low- and intermediate-SPPB categories was about three times (23.4%) and two times (15.3%) higher than in the high-SPPB category (8.6%), the researchers reported.

In addition, continuous SPPB scores showed significant associations with composite and individual CVD outcomes in all models. A 1-point lower SPPB score was associated with 6%-10% higher risk for CVD events after adjusting for potential confounders.

In the fully adjusted model, the risk for composite CVD outcomes was 47% higher (hazard ratio, 1.47; 95% confidence interval, 1.20-1.79) in those with low physical function and 25% higher in those with intermediate physical function (HR, 1.25; 95% CI, 1.07-1.46) compared with peers with high physical function.

For the individual outcomes, low physical function was associated with higher risk for stroke (HR, 1.81; 95% CI, 1.24-2.64) and HF (HR, 1.33; 95% CI, 1.02-1.73), whereas the association for CHD was not significant.

The associations were largely consistent across subgroups, including those with CVD at baseline.

The addition of SPPB scores significantly improved risk prediction of CVD events beyond traditional CVD risk factors in adults regardless of prior CVD history, suggesting that this tool may be useful for classifying CVD risk in older adults, the researchers said.
 

Meaningful impact on care?

“Our findings highlight the value of assessing the physical function level of older adults in clinical practice,” lead author Xiao Hu, MHS, with the department of epidemiology at Johns Hopkins, said in the news release. “In addition to heart health, older adults are at higher risk for falls and disability. The assessment of physical function may also inform the risk of these concerning conditions in older adults.”

Weighing in on the study, Jonathan Halperin, MD, cardiologist at Mount Sinai Heart and professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai, both in New York, said that “It’s known that cardiorespiratory fitness is an important predictor of cardiovascular risk, but it is one of the few physiological risk factors that are subjectively queried but not objectively assessed in routine clinical practice.”

In this study, Dr. Halperin noted, the investigators found that a battery of physical performance assessments, including a walk test, chair standing, and balance testing, improved cardiovascular risk prediction.

Dr. Halperin cautioned, however, that “since even the short sequence of tests takes time to perform and interpret, and is not currently reimbursed under most health insurance policies, it is not clear whether the report will have a meaningful impact on patient care.”

This research was funded by the National Institutes of Health. Dr. Matsushita and Dr. Halperin have no relevant disclosures.

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

Reduced physical function is an independent risk factor for composite and individual cardiovascular events, including coronary heart disease (CHD), stroke, and heart failure (HF) in older adults, according to new observational data from the Atherosclerosis Risk in Communities (ARIC) study.

“We found that physical function in older adults predicts future cardiovascular disease (CVD) beyond traditional heart disease risk factors, regardless of whether an individual has a history of cardiovascular disease,” senior author Kunihiro Matsushita, MD, PhD, division of cardiology, Johns Hopkins University, Baltimore, said in a news release.

The study was published online in the Journal of the American Heart Association.
 

Keeping fit with age

The researchers analyzed health data collected between 2011 and 2013 for 5,570 ARIC participants (mean age, 75 years; 58% women, 22% Black persons). They assessed physical function using the Short Physical Performance Battery (SPPB), which measures walking speed, leg strength, and balance.

On the basis of the results, participants were categorized into three physical function groups: low (score, 0-6; 13% of the cohort), intermediate (score, 7-9; 30%) and high (score, 10-12; 57%).

During a median follow up of 7 years, there were 930 composite CVD events (386 CHD, 251 stroke, and 529 HF).

Adults with lower SPPB scores had a higher cumulative incidence of composite CVD outcomes.

The 5-year cumulative incidence of the composite CVD outcome in the low- and intermediate-SPPB categories was about three times (23.4%) and two times (15.3%) higher than in the high-SPPB category (8.6%), the researchers reported.

In addition, continuous SPPB scores showed significant associations with composite and individual CVD outcomes in all models. A 1-point lower SPPB score was associated with 6%-10% higher risk for CVD events after adjusting for potential confounders.

In the fully adjusted model, the risk for composite CVD outcomes was 47% higher (hazard ratio, 1.47; 95% confidence interval, 1.20-1.79) in those with low physical function and 25% higher in those with intermediate physical function (HR, 1.25; 95% CI, 1.07-1.46) compared with peers with high physical function.

For the individual outcomes, low physical function was associated with higher risk for stroke (HR, 1.81; 95% CI, 1.24-2.64) and HF (HR, 1.33; 95% CI, 1.02-1.73), whereas the association for CHD was not significant.

The associations were largely consistent across subgroups, including those with CVD at baseline.

The addition of SPPB scores significantly improved risk prediction of CVD events beyond traditional CVD risk factors in adults regardless of prior CVD history, suggesting that this tool may be useful for classifying CVD risk in older adults, the researchers said.
 

Meaningful impact on care?

“Our findings highlight the value of assessing the physical function level of older adults in clinical practice,” lead author Xiao Hu, MHS, with the department of epidemiology at Johns Hopkins, said in the news release. “In addition to heart health, older adults are at higher risk for falls and disability. The assessment of physical function may also inform the risk of these concerning conditions in older adults.”

Weighing in on the study, Jonathan Halperin, MD, cardiologist at Mount Sinai Heart and professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai, both in New York, said that “It’s known that cardiorespiratory fitness is an important predictor of cardiovascular risk, but it is one of the few physiological risk factors that are subjectively queried but not objectively assessed in routine clinical practice.”

In this study, Dr. Halperin noted, the investigators found that a battery of physical performance assessments, including a walk test, chair standing, and balance testing, improved cardiovascular risk prediction.

Dr. Halperin cautioned, however, that “since even the short sequence of tests takes time to perform and interpret, and is not currently reimbursed under most health insurance policies, it is not clear whether the report will have a meaningful impact on patient care.”

This research was funded by the National Institutes of Health. Dr. Matsushita and Dr. Halperin have no relevant disclosures.

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

The U.S. Food and Drug Administration has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company that manufactures the drug has announced.

Until this approval, “there were no FDA-approved options to treat patients experiencing a GPP flare,” Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told this news organization. The approval “is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease,” he said. Treatment with spesolimab “rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares,” noted Dr. Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim, is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the United States.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Dr. Lebwohl is a paid consultant to Boehringer Ingelheim.

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

This article was updated 9/6/22.

The U.S. Food and Drug Administration has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company that manufactures the drug has announced.

Until this approval, “there were no FDA-approved options to treat patients experiencing a GPP flare,” Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told this news organization. The approval “is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease,” he said. Treatment with spesolimab “rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares,” noted Dr. Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim, is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the United States.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Dr. Lebwohl is a paid consultant to Boehringer Ingelheim.

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

This article was updated 9/6/22.

The U.S. Food and Drug Administration has approved the biologic agent spesolimab (Spevigo) for the treatment of flares in adults with generalized pustular psoriasis (GPP), the company that manufactures the drug has announced.

Until this approval, “there were no FDA-approved options to treat patients experiencing a GPP flare,” Mark Lebwohl, MD, principal investigator in the pivotal spesolimab trial, told this news organization. The approval “is a turning point for dermatologists and clinicians who treat patients living with this devastating and debilitating disease,” he said. Treatment with spesolimab “rapidly improves the clinical symptoms of GPP flares and will greatly improve our ability to help our patients manage painful flares,” noted Dr. Lebwohl, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York.

Spesolimab, manufactured by Boehringer Ingelheim, is a novel, selective monoclonal antibody that blocks interleukin-36 signaling known to be involved in GPP. It received priority review and had orphan drug and breakthrough therapy designation.

GPP affects an estimated 1 of every 10,000 people in the United States.

Though rare, GPP is a potentially life-threatening disease that is distinct from plaque psoriasis. GPP is caused by the accumulation of neutrophils in the skin. Throughout the course of the disease, patients may suffer recurring episodes of widespread eruptions of painful, sterile pustules across all parts of the body.

Spesolimab was evaluated in a global, 12-week, placebo-controlled clinical trial that involved 53 adults experiencing a GPP flare. After 1 week, significantly more patients treated with spesolimab than placebo showed no visible pustules (54% vs 6%), according to the company.

The most common adverse reactions, seen in at least 5% of patients treated with spesolimab, were asthenia and fatigue; nausea and vomiting; headache; pruritus and prurigo; hematoma and bruising at the infusion site; and urinary tract infection.

Dr. Lebwohl is a paid consultant to Boehringer Ingelheim.

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

This article was updated 9/6/22.

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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