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Teen depression and dyslipidemia: New data

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Fri, 06/16/2023 - 17:24

 

TOPLINE

Mean lipid levels are similar among adolescents with and without major depressive disorder (MDD), as is the proportion of adolescents with borderline-high lipid levels.

METHODOLOGY

Teen depression is associated with an increased likelihood of experiencing cardiovascular (CV) events, with dyslipidemia being a potentially modifiable risk factor.

Only a few studies have examined the association between depression and lipids during adolescence, when confounding comorbidities such as obesity and diabetes are less common.

The study included 243 adolescents (186 with MDD and 57 healthy controls [HCs]) who were mostly female and had a mean age of 15 years.

Researchers assessed CV risk factors including body mass index (BMI), blood pressure, smoking status, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride (TG), which were classified as acceptable or borderline high.

Dyslipidemia was defined as having concentration of at least one lipid outside the acceptable range.
 

TAKEAWAY

Most participants in both groups had lipid concentrations within the acceptable range.

There were no differences between study groups in mean lipid levels after adjusting for age, sex, and standardized BMI.

There were also no differences in the proportion of adolescents with borderline-high lipid concentrations.

Among youth with MDD, greater depressive symptoms were associated with higher HDL levels and a lower TG:HDL ratio after adjusting for sex, age, and standardized BMI.
 

IN PRACTICE

“Taken together, results of the current study support the need for further examination of the relationship between gender, depression, and cholesterol,” the authors write.

STUDY DETAILS

The study was conducted by Anisa F. Khalfan, Neurosciences and Mental Health research program, SickKids Research Institute, Toronto, Canada, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS

The HC group was relatively small, which might have contributed to the null findings. The mean Center for Epidemiologic Studies Depression Scale for Children (CES-DC) score was 8.3 among healthy youth, compared with 37.5 among MDD youth, limiting detection of an association related to depression severity.

DISCLOSURES

The study was supported by the Lunenfeld Summer Studentship. The authors report no relevant financial relationships.

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

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TOPLINE

Mean lipid levels are similar among adolescents with and without major depressive disorder (MDD), as is the proportion of adolescents with borderline-high lipid levels.

METHODOLOGY

Teen depression is associated with an increased likelihood of experiencing cardiovascular (CV) events, with dyslipidemia being a potentially modifiable risk factor.

Only a few studies have examined the association between depression and lipids during adolescence, when confounding comorbidities such as obesity and diabetes are less common.

The study included 243 adolescents (186 with MDD and 57 healthy controls [HCs]) who were mostly female and had a mean age of 15 years.

Researchers assessed CV risk factors including body mass index (BMI), blood pressure, smoking status, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride (TG), which were classified as acceptable or borderline high.

Dyslipidemia was defined as having concentration of at least one lipid outside the acceptable range.
 

TAKEAWAY

Most participants in both groups had lipid concentrations within the acceptable range.

There were no differences between study groups in mean lipid levels after adjusting for age, sex, and standardized BMI.

There were also no differences in the proportion of adolescents with borderline-high lipid concentrations.

Among youth with MDD, greater depressive symptoms were associated with higher HDL levels and a lower TG:HDL ratio after adjusting for sex, age, and standardized BMI.
 

IN PRACTICE

“Taken together, results of the current study support the need for further examination of the relationship between gender, depression, and cholesterol,” the authors write.

STUDY DETAILS

The study was conducted by Anisa F. Khalfan, Neurosciences and Mental Health research program, SickKids Research Institute, Toronto, Canada, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS

The HC group was relatively small, which might have contributed to the null findings. The mean Center for Epidemiologic Studies Depression Scale for Children (CES-DC) score was 8.3 among healthy youth, compared with 37.5 among MDD youth, limiting detection of an association related to depression severity.

DISCLOSURES

The study was supported by the Lunenfeld Summer Studentship. The authors report no relevant financial relationships.

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

 

TOPLINE

Mean lipid levels are similar among adolescents with and without major depressive disorder (MDD), as is the proportion of adolescents with borderline-high lipid levels.

METHODOLOGY

Teen depression is associated with an increased likelihood of experiencing cardiovascular (CV) events, with dyslipidemia being a potentially modifiable risk factor.

Only a few studies have examined the association between depression and lipids during adolescence, when confounding comorbidities such as obesity and diabetes are less common.

The study included 243 adolescents (186 with MDD and 57 healthy controls [HCs]) who were mostly female and had a mean age of 15 years.

Researchers assessed CV risk factors including body mass index (BMI), blood pressure, smoking status, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride (TG), which were classified as acceptable or borderline high.

Dyslipidemia was defined as having concentration of at least one lipid outside the acceptable range.
 

TAKEAWAY

Most participants in both groups had lipid concentrations within the acceptable range.

There were no differences between study groups in mean lipid levels after adjusting for age, sex, and standardized BMI.

There were also no differences in the proportion of adolescents with borderline-high lipid concentrations.

Among youth with MDD, greater depressive symptoms were associated with higher HDL levels and a lower TG:HDL ratio after adjusting for sex, age, and standardized BMI.
 

IN PRACTICE

“Taken together, results of the current study support the need for further examination of the relationship between gender, depression, and cholesterol,” the authors write.

STUDY DETAILS

The study was conducted by Anisa F. Khalfan, Neurosciences and Mental Health research program, SickKids Research Institute, Toronto, Canada, and colleagues. It was published online in the Journal of Affective Disorders.

LIMITATIONS

The HC group was relatively small, which might have contributed to the null findings. The mean Center for Epidemiologic Studies Depression Scale for Children (CES-DC) score was 8.3 among healthy youth, compared with 37.5 among MDD youth, limiting detection of an association related to depression severity.

DISCLOSURES

The study was supported by the Lunenfeld Summer Studentship. The authors report no relevant financial relationships.

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

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Alcohol dependence in teens tied to subsequent depression

Article Type
Changed
Tue, 06/13/2023 - 09:02

 

TOPLINE

Alcohol dependence, but not consumption, at age 18 years increases the risk for depression at age 24 years.

METHODOLOGY

  • The study included 3,902 mostly White adolescents, about 58% female, born in England from April 1991 to December 1992, who were part of the Avon Longitudinal Study of Parents and Children (ALSPAC) that examined genetic and environmental determinants of health and development.
  • Participants completed the self-report Alcohol Use Disorders Identification Test (AUDIT) between the ages of 16 and 23 years, a period when average alcohol use increases rapidly.
  • The primary outcome was probability for depression at age 24 years, using the Clinical Interview Schedule Revised (CIS-R), a self-administered computerized clinical assessment of common mental disorder symptoms during the past week.
  • Researchers assessed frequency and quantity of alcohol consumption as well as alcohol dependence.
  • Confounders included sex, housing type, maternal education and depressive symptoms, parents’ alcohol use, conduct problems at age 4 years, being bullied, and smoking status.

TAKEAWAYS

  • After adjustments, alcohol dependence at age 18 years was associated with depression at age 24 years (unstandardized probit coefficient 0.13; 95% confidence interval, 0.02-0.25; P = .019)
  • The relationship appeared to persist for alcohol dependence at each age of the growth curve (17-22 years).
  • There was no evidence that frequency or quantity of alcohol consumption at age 18 was significantly associated with depression at age 24, suggesting these factors may not increase the risk for later depression unless there are also features of dependency.

IN PRACTICE

“Our findings suggest that preventing alcohol dependence during adolescence, or treating it early, could reduce the risk of depression,” which could have important public health implications, the researchers write.

STUDY DETAILS

The study was carried out by researchers at the University of Bristol; University College London; Critical Thinking Unit, Public Health Directorate, NHS; University of Nottingham, all in the United Kingdom. It was published online in Lancet Psychiatry

LIMITATIONS

There was substantial attrition in the ALSPAC cohort from birth to age 24 years. The sample was recruited from one U.K. region and most participants were White. Measures of alcohol consumption and dependence excluded some features of abuse. And as this is an observational study, the possibility of residual confounding can’t be excluded.

DISCLOSURES

The investigators report no relevant disclosures. The study received support from the UK Medical Research Council and Alcohol Research UK.

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

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TOPLINE

Alcohol dependence, but not consumption, at age 18 years increases the risk for depression at age 24 years.

METHODOLOGY

  • The study included 3,902 mostly White adolescents, about 58% female, born in England from April 1991 to December 1992, who were part of the Avon Longitudinal Study of Parents and Children (ALSPAC) that examined genetic and environmental determinants of health and development.
  • Participants completed the self-report Alcohol Use Disorders Identification Test (AUDIT) between the ages of 16 and 23 years, a period when average alcohol use increases rapidly.
  • The primary outcome was probability for depression at age 24 years, using the Clinical Interview Schedule Revised (CIS-R), a self-administered computerized clinical assessment of common mental disorder symptoms during the past week.
  • Researchers assessed frequency and quantity of alcohol consumption as well as alcohol dependence.
  • Confounders included sex, housing type, maternal education and depressive symptoms, parents’ alcohol use, conduct problems at age 4 years, being bullied, and smoking status.

TAKEAWAYS

  • After adjustments, alcohol dependence at age 18 years was associated with depression at age 24 years (unstandardized probit coefficient 0.13; 95% confidence interval, 0.02-0.25; P = .019)
  • The relationship appeared to persist for alcohol dependence at each age of the growth curve (17-22 years).
  • There was no evidence that frequency or quantity of alcohol consumption at age 18 was significantly associated with depression at age 24, suggesting these factors may not increase the risk for later depression unless there are also features of dependency.

IN PRACTICE

“Our findings suggest that preventing alcohol dependence during adolescence, or treating it early, could reduce the risk of depression,” which could have important public health implications, the researchers write.

STUDY DETAILS

The study was carried out by researchers at the University of Bristol; University College London; Critical Thinking Unit, Public Health Directorate, NHS; University of Nottingham, all in the United Kingdom. It was published online in Lancet Psychiatry

LIMITATIONS

There was substantial attrition in the ALSPAC cohort from birth to age 24 years. The sample was recruited from one U.K. region and most participants were White. Measures of alcohol consumption and dependence excluded some features of abuse. And as this is an observational study, the possibility of residual confounding can’t be excluded.

DISCLOSURES

The investigators report no relevant disclosures. The study received support from the UK Medical Research Council and Alcohol Research UK.

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

 

TOPLINE

Alcohol dependence, but not consumption, at age 18 years increases the risk for depression at age 24 years.

METHODOLOGY

  • The study included 3,902 mostly White adolescents, about 58% female, born in England from April 1991 to December 1992, who were part of the Avon Longitudinal Study of Parents and Children (ALSPAC) that examined genetic and environmental determinants of health and development.
  • Participants completed the self-report Alcohol Use Disorders Identification Test (AUDIT) between the ages of 16 and 23 years, a period when average alcohol use increases rapidly.
  • The primary outcome was probability for depression at age 24 years, using the Clinical Interview Schedule Revised (CIS-R), a self-administered computerized clinical assessment of common mental disorder symptoms during the past week.
  • Researchers assessed frequency and quantity of alcohol consumption as well as alcohol dependence.
  • Confounders included sex, housing type, maternal education and depressive symptoms, parents’ alcohol use, conduct problems at age 4 years, being bullied, and smoking status.

TAKEAWAYS

  • After adjustments, alcohol dependence at age 18 years was associated with depression at age 24 years (unstandardized probit coefficient 0.13; 95% confidence interval, 0.02-0.25; P = .019)
  • The relationship appeared to persist for alcohol dependence at each age of the growth curve (17-22 years).
  • There was no evidence that frequency or quantity of alcohol consumption at age 18 was significantly associated with depression at age 24, suggesting these factors may not increase the risk for later depression unless there are also features of dependency.

IN PRACTICE

“Our findings suggest that preventing alcohol dependence during adolescence, or treating it early, could reduce the risk of depression,” which could have important public health implications, the researchers write.

STUDY DETAILS

The study was carried out by researchers at the University of Bristol; University College London; Critical Thinking Unit, Public Health Directorate, NHS; University of Nottingham, all in the United Kingdom. It was published online in Lancet Psychiatry

LIMITATIONS

There was substantial attrition in the ALSPAC cohort from birth to age 24 years. The sample was recruited from one U.K. region and most participants were White. Measures of alcohol consumption and dependence excluded some features of abuse. And as this is an observational study, the possibility of residual confounding can’t be excluded.

DISCLOSURES

The investigators report no relevant disclosures. The study received support from the UK Medical Research Council and Alcohol Research UK.

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

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Suicidality risk in youth at highest at night

Article Type
Changed
Wed, 06/07/2023 - 14:32

Suicide risk in young people appears to follow a diurnal pattern, increasing at night, new research shows.

Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.

“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.

The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
 

Urgent need

Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.

“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.

The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.

More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).

They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.

They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.

As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).

There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
 

True variation or mechanics?

Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”

Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”

The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.

“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
 

 

 

A vulnerable time

Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.

Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.

“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.

Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.

“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.

These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.

“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.

The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.

Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.

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

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Suicide risk in young people appears to follow a diurnal pattern, increasing at night, new research shows.

Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.

“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.

The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
 

Urgent need

Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.

“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.

The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.

More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).

They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.

They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.

As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).

There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
 

True variation or mechanics?

Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”

Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”

The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.

“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
 

 

 

A vulnerable time

Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.

Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.

“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.

Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.

“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.

These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.

“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.

The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.

Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.

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

Suicide risk in young people appears to follow a diurnal pattern, increasing at night, new research shows.

Investigators found that suicidal ideation and attempts were lowest in the mornings and highest in the evenings, particularly among youth with higher levels of self-critical rumination.

“These are preliminary findings, and there is a need for more data, but they signal potentially that there’s a need for support, particularly at nighttime, and that there might be a potential of targeting self-critical rumination in daily lives of youth,” said lead researcher Anastacia Kudinova, PhD, with the department of psychiatry and human behavior, Alpert Medical School of Brown University, Providence, R.I.

The findings were presented at the late-breaker session at the annual meeting of the Associated Professional Sleep Societies.
 

Urgent need

Suicidal ideation (SI) is a “robust” predictor of suicidal behavior and, “alarmingly,” both suicidal ideation and suicidal behavior have been increasing, Dr. Kudinova said.

“There is an urgent need to describe proximal time-period risk factors for suicide so that we can identify who is at a greater suicide risk on the time scale of weeks, days, or even hours,” she told attendees.

The researchers asked 165 psychiatrically hospitalized youth aged 11-18 (72% female) about the time of day of their most recent suicide attempt.

More than half (58%) said it occurred in the evenings and nights, followed by daytime (35%) and mornings (7%).

They also assessed the timing of suicidal ideation at home in 61 youth aged 12-15 (61% female) who were discharged after a partial hospitalization program.

They did this using ecological momentary assessments (EMAs) three times a day over 2 weeks. EMAs study people’s thoughts and behavior in their daily lives by repeatedly collecting data in an individual’s normal environment at or close to the time they carry out that behavior.

As in the other sample, youth in this sample also experienced significantly more frequent suicidal ideation later in the day (P < .01).

There was also a significant moderating effect of self-criticism (P < .01), such that more self-critical youth evidenced the highest levels of suicidal ideation later in the day.
 

True variation or mechanics?

Reached for comment, Paul Nestadt, MD, with Johns Hopkins Bloomberg School of Public Health, Baltimore, noted that EMA is becoming “an interesting way to track high-resolution temporal variation in suicidal ideation and other psych symptoms.”

Dr. Nestadt, who was not involved in the study, said that “it’s not surprising” that the majority of youth attempted suicide in evenings and nights, “as adolescents are generally being supervised in a school setting during daytime hours. It may not be the fluctuation in suicidality that impacts attempt timing so much as the mechanics – it is very hard to attempt suicide in math class.”

The same may be true for the youth in the second sample who were in the partial hospital program. “During the day, they were in therapy groups where feelings of suicidal ideation would have been solicited and addressed in real time,” Dr. Nestadt noted.

“Again, suicidal ideation later in the day may be a practical effect of how they are occupied in the partial hospital program, as opposed to some inherent suicidal ideation increase linked to something endogenous, such as circadian rhythm or cortisol level rises. That said, we do often see more attempts in the evenings in adults as well,” he added.
 

 

 

A vulnerable time

Also weighing in, Casey O’Brien, PsyD, a psychologist in the department of psychiatry at Columbia University Irving Medical Center, New York, said the findings in this study “track” with what she sees in the clinic.

Teens often report in session that the “unstructured time of night – especially the time when they usually should be getting to bed but are kind of staying up – tends to be a very vulnerable time for them,” Dr. O’Brien said in an interview.

“It’s really nice to have research confirm a lot of what we see reported anecdotally from the teens we work with,” said Dr. O’Brien.

Dr. O’Brien heads the intensive adolescent dialectical behavior therapy (DBT) program at Columbia for young people struggling with mental health issues.

“Within the DBT framework, we try to really focus on accepting that this is a vulnerable time and then planning ahead for what the strategies are that they can use to help them transition to bed quickly and smoothly,” Dr. O’Brien said.

These strategies may include spending time with their parents before bed, reading, or building into their bedtime routines things that they find soothing and comforting, like taking a longer shower or having comfortable pajamas to change into, she explained.

“We also work a lot on sleep hygiene strategies to help develop a regular bedtime and have a consistent sleep-wake cycle. We also will plan ahead for using distress tolerance skills during times of emotional vulnerability,” Dr. O’Brien said.

The Columbia DBT program also offers phone coaching “so teens can reach out to a therapist for help using skills outside of a therapeutic hour, and we do find that we get more coaching calls closer to around bedtime,” Dr. O’Brien said.

Support for the study was provided by the National Institute of Mental Health and Bradley Hospital COBRE Center. Dr. Kudinova, Dr. Nestadt, and Dr. O’Brien have disclosed no relevant financial relationships.

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

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APA launches online eating disorder assessment tool

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Fri, 06/02/2023 - 12:08

The American Psychiatric Association has released an online screening and assessment tool for eating disorders.

“People with eating disorders have a high rate of mortality and [the disorder is] growing in prevalence among young adults and adolescents,” APA CEO and medical director Saul Levin, MD, MPA, said in a news release.

“It is vital that we equip our clinicians, especially primary care clinicians, with the latest evidence from the APA to empower their decision-making and improve care for their patients,” Dr. Levin added.

The clinical decision support tool was developed by the APA’s guideline writing group in collaboration with AvoMD, a software company that translates clinical evidence into the workflow.

The tool guides clinicians through the screening, assessing, diagnosing, and treatment planning of patients with anorexia nervosa, bulimia nervosa, binge-eating disorder, and other eating disorders.

It’s available free in the electronic health record, on the APA website, and on the AvoMD mobile app.

The tool is based on the APA’s updated practice guidelines for the management of eating disorders, which were released in March.

The tool incorporates guidance on screening tools, levels of care, nutrition, exercise, psychotherapy, and more. Additionally, the tool provides a summary of responses that can be leveraged for easy documentation.

It is intended for use by pediatricians, family physicians, and other primary care and mental health clinicians, including psychiatrists and therapists.

Data published earlier this year show that more than 1 in 5 children worldwide are at risk of developing an eating disorder. Girls are significantly more likely than boys to have disordered eating.

Early diagnosis and treatment are associated with a higher rate of recovery, and extended illness is associated with potentially devastating consequences, the APA notes.

“As an internal medicine physician myself, I see a wide variety of patients and clinical issues,” Joongheum Park, MD, head of product and engineering at AvoMD, said in the release.

“Easy access to the expertise in me and my peers’ workflow is essential to ensuring high-quality care, and partnering with the leading authority on eating disorders to provide this tool will improve clinician efficiency and most importantly, patient outcomes,” Dr. Park added.

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

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The American Psychiatric Association has released an online screening and assessment tool for eating disorders.

“People with eating disorders have a high rate of mortality and [the disorder is] growing in prevalence among young adults and adolescents,” APA CEO and medical director Saul Levin, MD, MPA, said in a news release.

“It is vital that we equip our clinicians, especially primary care clinicians, with the latest evidence from the APA to empower their decision-making and improve care for their patients,” Dr. Levin added.

The clinical decision support tool was developed by the APA’s guideline writing group in collaboration with AvoMD, a software company that translates clinical evidence into the workflow.

The tool guides clinicians through the screening, assessing, diagnosing, and treatment planning of patients with anorexia nervosa, bulimia nervosa, binge-eating disorder, and other eating disorders.

It’s available free in the electronic health record, on the APA website, and on the AvoMD mobile app.

The tool is based on the APA’s updated practice guidelines for the management of eating disorders, which were released in March.

The tool incorporates guidance on screening tools, levels of care, nutrition, exercise, psychotherapy, and more. Additionally, the tool provides a summary of responses that can be leveraged for easy documentation.

It is intended for use by pediatricians, family physicians, and other primary care and mental health clinicians, including psychiatrists and therapists.

Data published earlier this year show that more than 1 in 5 children worldwide are at risk of developing an eating disorder. Girls are significantly more likely than boys to have disordered eating.

Early diagnosis and treatment are associated with a higher rate of recovery, and extended illness is associated with potentially devastating consequences, the APA notes.

“As an internal medicine physician myself, I see a wide variety of patients and clinical issues,” Joongheum Park, MD, head of product and engineering at AvoMD, said in the release.

“Easy access to the expertise in me and my peers’ workflow is essential to ensuring high-quality care, and partnering with the leading authority on eating disorders to provide this tool will improve clinician efficiency and most importantly, patient outcomes,” Dr. Park added.

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

The American Psychiatric Association has released an online screening and assessment tool for eating disorders.

“People with eating disorders have a high rate of mortality and [the disorder is] growing in prevalence among young adults and adolescents,” APA CEO and medical director Saul Levin, MD, MPA, said in a news release.

“It is vital that we equip our clinicians, especially primary care clinicians, with the latest evidence from the APA to empower their decision-making and improve care for their patients,” Dr. Levin added.

The clinical decision support tool was developed by the APA’s guideline writing group in collaboration with AvoMD, a software company that translates clinical evidence into the workflow.

The tool guides clinicians through the screening, assessing, diagnosing, and treatment planning of patients with anorexia nervosa, bulimia nervosa, binge-eating disorder, and other eating disorders.

It’s available free in the electronic health record, on the APA website, and on the AvoMD mobile app.

The tool is based on the APA’s updated practice guidelines for the management of eating disorders, which were released in March.

The tool incorporates guidance on screening tools, levels of care, nutrition, exercise, psychotherapy, and more. Additionally, the tool provides a summary of responses that can be leveraged for easy documentation.

It is intended for use by pediatricians, family physicians, and other primary care and mental health clinicians, including psychiatrists and therapists.

Data published earlier this year show that more than 1 in 5 children worldwide are at risk of developing an eating disorder. Girls are significantly more likely than boys to have disordered eating.

Early diagnosis and treatment are associated with a higher rate of recovery, and extended illness is associated with potentially devastating consequences, the APA notes.

“As an internal medicine physician myself, I see a wide variety of patients and clinical issues,” Joongheum Park, MD, head of product and engineering at AvoMD, said in the release.

“Easy access to the expertise in me and my peers’ workflow is essential to ensuring high-quality care, and partnering with the leading authority on eating disorders to provide this tool will improve clinician efficiency and most importantly, patient outcomes,” Dr. Park added.

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

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Significant increase in vitamin D deficiency in kids with major depressive disorder

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During the pandemic, there was a significant increase in vitamin D deficiency in pediatric patients with major depressive disorder, according to new findings that suggest spending more time indoors may have fueled this uptick.

“We suspect that this may be due to the COVID lockdowns and kids schooling from home and having less time outside,” study investigator Oluwatomiwa Babade, MD, MPH, with Virginia Tech Carilion School of Medicine, Roanoke, Va., said in an interview.

The study was presented at the annual meeting of the American Psychiatric Association.
 

Anecdotal observation confirmed

During the pandemic, investigators noticed an uptick in the number of children and adolescents attending their clinic for psychiatric hospitalization who had low vitamin D levels.

To investigate, they analyzed the records of all patients aged 6-17 years with psychiatric diagnoses and vitamin D level assessment who were admitted into the inpatient psychiatry unit from March 18, 2020, to June 30, 2021.

Among 599 unique patients, 275 (83% female) had a diagnosis of MDD and 226 of these patients were vitamin D deficient (< 30 ng/mL) – a prevalence rate of roughly 82%. Among 246 patients with psychiatric disorders other than MDD, the prevalence of vitamin D deficiency was 76%.

“This was very surprising and much higher than prior to the pandemic. Prior to COVID, the prevalence of vitamin D deficiency was around 14% in similar patients,” Dr. Babade said.

“Now that we are post-lockdown, it would be good to repeat the study. I think the prevalence should drop. That’s my guess,” he added.
 

Important research, no surprises

In a comment, Cemre Robinson, MD, director of the Mount Sinai Pediatric Bone Health and Calcium Metabolism Clinic, New York, said that although the study’s findings aren’t surprising, “it’s important to present such data in adolescents with major depression.”

“These findings reiterate the importance of screening for vitamin D deficiency in children and adolescents, with or without depression, particularly during winter, which is associated with less sun exposure,” Dr. Robinson, assistant professor of pediatrics, endocrinology, and diabetes at Icahn School of Medicine at Mount Sinai, said.

She noted that vitamin D deficiency is prevalent in the general population, and it can be easily corrected with supplementation.

“Vitamin D is important for bone growth, mineralization, and accretion as well as calcium absorption. Adolescence, in particular, is a period of rapid physical, cognitive, and psychosocial growth,” Dr. Robinson said.

“The requirement of all minerals and vitamins changes in this phase of life. Therefore, it is important to have sufficient vitamin D levels during adolescence for several health benefits,” she noted.

Dr. Robinson said that “more research is needed to validate the present findings in adolescents with major depression, and larger studies, including randomized control trials, are required to establish a causal association between MDD and vitamin D deficiency.”

The study had no specific funding. Dr. Babade and Dr. Robinson report no relevant financial relationships.

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

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During the pandemic, there was a significant increase in vitamin D deficiency in pediatric patients with major depressive disorder, according to new findings that suggest spending more time indoors may have fueled this uptick.

“We suspect that this may be due to the COVID lockdowns and kids schooling from home and having less time outside,” study investigator Oluwatomiwa Babade, MD, MPH, with Virginia Tech Carilion School of Medicine, Roanoke, Va., said in an interview.

The study was presented at the annual meeting of the American Psychiatric Association.
 

Anecdotal observation confirmed

During the pandemic, investigators noticed an uptick in the number of children and adolescents attending their clinic for psychiatric hospitalization who had low vitamin D levels.

To investigate, they analyzed the records of all patients aged 6-17 years with psychiatric diagnoses and vitamin D level assessment who were admitted into the inpatient psychiatry unit from March 18, 2020, to June 30, 2021.

Among 599 unique patients, 275 (83% female) had a diagnosis of MDD and 226 of these patients were vitamin D deficient (< 30 ng/mL) – a prevalence rate of roughly 82%. Among 246 patients with psychiatric disorders other than MDD, the prevalence of vitamin D deficiency was 76%.

“This was very surprising and much higher than prior to the pandemic. Prior to COVID, the prevalence of vitamin D deficiency was around 14% in similar patients,” Dr. Babade said.

“Now that we are post-lockdown, it would be good to repeat the study. I think the prevalence should drop. That’s my guess,” he added.
 

Important research, no surprises

In a comment, Cemre Robinson, MD, director of the Mount Sinai Pediatric Bone Health and Calcium Metabolism Clinic, New York, said that although the study’s findings aren’t surprising, “it’s important to present such data in adolescents with major depression.”

“These findings reiterate the importance of screening for vitamin D deficiency in children and adolescents, with or without depression, particularly during winter, which is associated with less sun exposure,” Dr. Robinson, assistant professor of pediatrics, endocrinology, and diabetes at Icahn School of Medicine at Mount Sinai, said.

She noted that vitamin D deficiency is prevalent in the general population, and it can be easily corrected with supplementation.

“Vitamin D is important for bone growth, mineralization, and accretion as well as calcium absorption. Adolescence, in particular, is a period of rapid physical, cognitive, and psychosocial growth,” Dr. Robinson said.

“The requirement of all minerals and vitamins changes in this phase of life. Therefore, it is important to have sufficient vitamin D levels during adolescence for several health benefits,” she noted.

Dr. Robinson said that “more research is needed to validate the present findings in adolescents with major depression, and larger studies, including randomized control trials, are required to establish a causal association between MDD and vitamin D deficiency.”

The study had no specific funding. Dr. Babade and Dr. Robinson report no relevant financial relationships.

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

During the pandemic, there was a significant increase in vitamin D deficiency in pediatric patients with major depressive disorder, according to new findings that suggest spending more time indoors may have fueled this uptick.

“We suspect that this may be due to the COVID lockdowns and kids schooling from home and having less time outside,” study investigator Oluwatomiwa Babade, MD, MPH, with Virginia Tech Carilion School of Medicine, Roanoke, Va., said in an interview.

The study was presented at the annual meeting of the American Psychiatric Association.
 

Anecdotal observation confirmed

During the pandemic, investigators noticed an uptick in the number of children and adolescents attending their clinic for psychiatric hospitalization who had low vitamin D levels.

To investigate, they analyzed the records of all patients aged 6-17 years with psychiatric diagnoses and vitamin D level assessment who were admitted into the inpatient psychiatry unit from March 18, 2020, to June 30, 2021.

Among 599 unique patients, 275 (83% female) had a diagnosis of MDD and 226 of these patients were vitamin D deficient (< 30 ng/mL) – a prevalence rate of roughly 82%. Among 246 patients with psychiatric disorders other than MDD, the prevalence of vitamin D deficiency was 76%.

“This was very surprising and much higher than prior to the pandemic. Prior to COVID, the prevalence of vitamin D deficiency was around 14% in similar patients,” Dr. Babade said.

“Now that we are post-lockdown, it would be good to repeat the study. I think the prevalence should drop. That’s my guess,” he added.
 

Important research, no surprises

In a comment, Cemre Robinson, MD, director of the Mount Sinai Pediatric Bone Health and Calcium Metabolism Clinic, New York, said that although the study’s findings aren’t surprising, “it’s important to present such data in adolescents with major depression.”

“These findings reiterate the importance of screening for vitamin D deficiency in children and adolescents, with or without depression, particularly during winter, which is associated with less sun exposure,” Dr. Robinson, assistant professor of pediatrics, endocrinology, and diabetes at Icahn School of Medicine at Mount Sinai, said.

She noted that vitamin D deficiency is prevalent in the general population, and it can be easily corrected with supplementation.

“Vitamin D is important for bone growth, mineralization, and accretion as well as calcium absorption. Adolescence, in particular, is a period of rapid physical, cognitive, and psychosocial growth,” Dr. Robinson said.

“The requirement of all minerals and vitamins changes in this phase of life. Therefore, it is important to have sufficient vitamin D levels during adolescence for several health benefits,” she noted.

Dr. Robinson said that “more research is needed to validate the present findings in adolescents with major depression, and larger studies, including randomized control trials, are required to establish a causal association between MDD and vitamin D deficiency.”

The study had no specific funding. Dr. Babade and Dr. Robinson report no relevant financial relationships.

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

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JAK-inhibitor safety in adolescents with AD: Long-term analyses reported

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Tue, 05/30/2023 - 10:59

WASHINGTON – Abrocitinib demonstrated an acceptable long-term safety profile in adolescents with moderate to severe atopic dermatitis (AD) in an integrated safety analysis of 635 adolescents and over 1,000 patient-years of exposure, Lawrence F. Eichenfield, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.

In March 2023, the oral Janus kinase 1 (JAK1) inhibitor was approved by the Food and Drug Administration for treating adolescents aged 12-17 with refractory moderate to severe AD – an expanded indication from the approval in adults in 2022.

University of California, San Diego
Dr. Lawrence F. Eichenfield

The new analysis evaluated data from patients who participated in the phase 3 JADE clinical trials – MONO-1, MONO-2, TEEN, and REGIMEN – and were subsequently enrolled in the ongoing phase 3 extension trial JADE EXTEND. Compared with a previous post hoc analysis in which adolescent patients had approximately 1 year of exposure, this updated analysis includes a sizable portion of patients with more than 96 weeks of exposure.

“We’re starting to get good numbers of [adolescents] who’ve had about 2 years of exposure,” said Dr. Eichenfield, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego, during a late-breaking research session.

With a data cut for this analysis of September 2021, “we haven’t seen additive long-term [adverse] effects” with longer exposures, he said. In addition, “there were no unique safety concerns related to adolescents compared to the findings observed [in an] integrated safety analysis using the same data cut in which most patients were adults.”

(The analysis in adults covered 3,802 patients with over 5,000 patient-years of exposure, and was presented at the annual American Academy of Dermatology meeting in March 2023.)

Dr. Christopher G. Bunick

Also presented in the late-breaking abstract session at RAD 2023 was a long-term safety study of upadacitinib (Rinvoq), the other JAK1 inhibitor approved for adolescents with AD – approved by the FDA for both adolescents and adults with moderate to severe AD in 2022. The new analysis captures exposure of up to 4 years and shows no “worsening or accumulation of events,” compared with 1-year data, reported Christopher G. Bunick, MD, PhD, of the department of dermatology and the program in translational biomedicine at Yale University, New Haven, Conn.
 

Abrocitinib in adolescents

For the safety analysis of abrocitinib (Cibinqo), data were pooled into two cohorts: A consistent-dose cohort of 490 adolescents who received the same dose (200 mg or 100 mg) during the entire duration of the qualifying JADE trials, and a variable-dose cohort of 145 adolescents who received different doses (200 mg or 100 mg) during the JADE REGIMEN qualifying trial.

Duration of exposure was 96 weeks or more in 37%-38% of the consistent-dose cohort and 68% of the variable-dose cohort.

In the consistent-dose cohort, adverse events occurred in 243 (84%) and 153 (76%) of patients receiving 200-mg doses and 100-mg doses, respectively. Incidence rates for severe adverse events were 5.87 per 100 patient-years at both doses, and rates for adverse events leading to study discontinuation were 6.96/100 patient-years at 200 mg and 5.13/100 patient-years at 100 mg.

“No meaningful dose-response relationship was observed for serious adverse events, or adverse events leading to discontinuation, or adverse events of special interest,” said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.



The IRs of adverse events of special interest were 1.84/100 patient-years and 1.28/100 patient-years for serious infection; 2.11/100 patient-years, and 1.62/100 patient-years for all herpes zoster infections; and 0.69/100 patient-years and 0.32/100 patient-years for opportunistic herpes zoster infections in the 200-mg and 100-mg arms, respectively.

“Other than herpes zoster, there were no opportunistic infections observed and no tuberculosis cases,” he said. “There was one nonfatal venous thromboembolism in an adolescent who had a very strong family history of [pulmonary embolism], one retinal detachment [with a concurrent diagnosis of cataracts and of left eyebrow folliculitis], and no events of nonmelanoma skin cancer or other malignancies, major adverse cardiovascular events, or deaths.” The thromboembolism case was reported in the previous post hoc analysis.

In the variable-dose cohort, data were similar, Dr. Eichenfield said. The IRs for severe adverse events, adverse events leading to study withdrawal, and adverse events of special interest were consistent with those in the other cohort. And similarly, there were no reports of tuberculosis or other opportunistic infections (excluding herpes zoster), and no reports of nonmelanoma skin cancer (NMSC) or other malignancies, major adverse cardiovascular events (MACE), or death. In this cohort, there were no venous thromboembolism (VTE) reports.

 

 

Upadacitinib in adolescents, adults

The new analysis looked at up to 4 years of upadacitinib treatment in almost 2,700 adolescents and adults– and over 6,200 patient-years – using integrated data from three ongoing pivotal phase 3 studies: Measure Up 1, Measure Up 2, and AD Up. (Of these patients, 539 were adolescents, Dr. Bunick said after the meeting.)

In the Measure Up studies, patients were randomized 1:1:1 to receive a 15-mg dose, a 30-mg dose, or placebo once daily. In AD Up, patients in each arm received concomitant topical corticosteroids. At week 16, patients receiving the drug continued their assigned treatment during the ongoing blinded extension period, and those receiving placebo were rerandomized to upadacitinib 15 mg or 30 mg.

The exposure-adjusted event rates for any adverse event leading to discontinuation were 4.1/100 patient-years and 4.7/100 patient-years in patients receiving 15 mg and 30 mg, respectively, and the rates of any serious adverse event were 6.5/100 patient-years and 7.5/100 patient-years, Dr. Bunick reported. Three deaths occurred in the 30-mg group; all deaths were related to COVID infection and occurred in adults with cardiovascular risk factors.

Incidence rates of adverse events of special interest were similar to those in a previous 1-year analysis. The rate of serious infections per 100 patient years, for instance, was 2.3 and 2.8 in the 15-mg and 30-mg groups, respectively, compared with 2.2 and 2.8 in the 1-year analysis.

The rate of opportunistic infections, including eczema herpeticum (and excluding TB and herpes zoster), saw a slight bump in the new analysis to 2.4/100 patient-years with the 30-mg dose. Other event rates, across both dosages and durations, were less than 0.1/100 patient-years for active TB; 0.3-0.4/100 patient-years for NMSC, and 0.1/100 patient-years or below for other malignancies, MACE, and VTE. Herpes zoster had the highest event rate in both the 1- and 4-year analyses of between 3.1/100 patient-years and 5.8/100 patient-years, Dr. Bunick reported.

The adverse event rates for adolescents and adults “show consistency and are very low,” Dr. Bunick said. At 4 years, no new safety risks were identified.
 

‘The more data ... the better’

Data on the safety of new medications in children and adolescents is always important, and with systemic JAK inhibitors in particular, “the more data we can accumulate in [younger] patients with AD ... the better,” said Robert Sidbury, MD, MPH, professor in the department of pediatrics at the University of Washington, Seattle, and chief of the division of dermatology at Seattle Children’s Hospital, who was asked to comment on the two studies.

Dr. Robert Sidbury

Dermatologists have taken comfort in the fact that the “daunting” boxed warning on JAK inhibitors “was generated in a very different population than we generally propose to treat, certainly when talking about children and adolescents,” said Dr. Sidbury, who was not involved in either of the new safety analyses.

The JAK inhibitor boxed warning “reflects a study of tofacitinib – a different JAK inhibitor with arguably more risk of adverse effects – in adults over the age of 50 with rheumatoid arthritis and multiple risk factors for comorbidities included in the boxed warning,” he said.

“This allows dermatologists to reasonably conclude that the boxed warning – while critical to discuss and consider in every patient – is likely less concerning than might otherwise by implied.”

With more patient experience, “the more our assessment of risk, and of the ‘legitimacy’ of the boxed warning in our patient population, becomes evidence-based as opposed to extrapolation,” Dr. Sidbury said.

The two studies reported, he said, “detail an experience that is not adverse effect free –I have yet to find that medication – but is a reasonable profile considering the robust efficacy results they accompany.”

The abrocitinib safety analysis was sponsored by Pfizer. Regarding the study of upadacitinib, AbbVie contributed to the design of the safety analysis and participated in data collection. No honoria or payments were made to the authors, according to the study abstract. Dr. Eichenfield is a consultant/advisory board member for Pfizer and other companies, and has served on the speakers bureau/received honoria for Pfizer and other companies. Dr. Bunick is a consultant for AbbVie and other companies, and has served as an speaker/received honoraria or served as an investigator for several companies. Dr. Sidbury disclosed being a consultant/advisory board member for Lilly and Leo and serving on the speakers bureau/honoraria for Beiersdorf. All reported receiving grant/research support from various companies.
 

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WASHINGTON – Abrocitinib demonstrated an acceptable long-term safety profile in adolescents with moderate to severe atopic dermatitis (AD) in an integrated safety analysis of 635 adolescents and over 1,000 patient-years of exposure, Lawrence F. Eichenfield, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.

In March 2023, the oral Janus kinase 1 (JAK1) inhibitor was approved by the Food and Drug Administration for treating adolescents aged 12-17 with refractory moderate to severe AD – an expanded indication from the approval in adults in 2022.

University of California, San Diego
Dr. Lawrence F. Eichenfield

The new analysis evaluated data from patients who participated in the phase 3 JADE clinical trials – MONO-1, MONO-2, TEEN, and REGIMEN – and were subsequently enrolled in the ongoing phase 3 extension trial JADE EXTEND. Compared with a previous post hoc analysis in which adolescent patients had approximately 1 year of exposure, this updated analysis includes a sizable portion of patients with more than 96 weeks of exposure.

“We’re starting to get good numbers of [adolescents] who’ve had about 2 years of exposure,” said Dr. Eichenfield, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego, during a late-breaking research session.

With a data cut for this analysis of September 2021, “we haven’t seen additive long-term [adverse] effects” with longer exposures, he said. In addition, “there were no unique safety concerns related to adolescents compared to the findings observed [in an] integrated safety analysis using the same data cut in which most patients were adults.”

(The analysis in adults covered 3,802 patients with over 5,000 patient-years of exposure, and was presented at the annual American Academy of Dermatology meeting in March 2023.)

Dr. Christopher G. Bunick

Also presented in the late-breaking abstract session at RAD 2023 was a long-term safety study of upadacitinib (Rinvoq), the other JAK1 inhibitor approved for adolescents with AD – approved by the FDA for both adolescents and adults with moderate to severe AD in 2022. The new analysis captures exposure of up to 4 years and shows no “worsening or accumulation of events,” compared with 1-year data, reported Christopher G. Bunick, MD, PhD, of the department of dermatology and the program in translational biomedicine at Yale University, New Haven, Conn.
 

Abrocitinib in adolescents

For the safety analysis of abrocitinib (Cibinqo), data were pooled into two cohorts: A consistent-dose cohort of 490 adolescents who received the same dose (200 mg or 100 mg) during the entire duration of the qualifying JADE trials, and a variable-dose cohort of 145 adolescents who received different doses (200 mg or 100 mg) during the JADE REGIMEN qualifying trial.

Duration of exposure was 96 weeks or more in 37%-38% of the consistent-dose cohort and 68% of the variable-dose cohort.

In the consistent-dose cohort, adverse events occurred in 243 (84%) and 153 (76%) of patients receiving 200-mg doses and 100-mg doses, respectively. Incidence rates for severe adverse events were 5.87 per 100 patient-years at both doses, and rates for adverse events leading to study discontinuation were 6.96/100 patient-years at 200 mg and 5.13/100 patient-years at 100 mg.

“No meaningful dose-response relationship was observed for serious adverse events, or adverse events leading to discontinuation, or adverse events of special interest,” said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.



The IRs of adverse events of special interest were 1.84/100 patient-years and 1.28/100 patient-years for serious infection; 2.11/100 patient-years, and 1.62/100 patient-years for all herpes zoster infections; and 0.69/100 patient-years and 0.32/100 patient-years for opportunistic herpes zoster infections in the 200-mg and 100-mg arms, respectively.

“Other than herpes zoster, there were no opportunistic infections observed and no tuberculosis cases,” he said. “There was one nonfatal venous thromboembolism in an adolescent who had a very strong family history of [pulmonary embolism], one retinal detachment [with a concurrent diagnosis of cataracts and of left eyebrow folliculitis], and no events of nonmelanoma skin cancer or other malignancies, major adverse cardiovascular events, or deaths.” The thromboembolism case was reported in the previous post hoc analysis.

In the variable-dose cohort, data were similar, Dr. Eichenfield said. The IRs for severe adverse events, adverse events leading to study withdrawal, and adverse events of special interest were consistent with those in the other cohort. And similarly, there were no reports of tuberculosis or other opportunistic infections (excluding herpes zoster), and no reports of nonmelanoma skin cancer (NMSC) or other malignancies, major adverse cardiovascular events (MACE), or death. In this cohort, there were no venous thromboembolism (VTE) reports.

 

 

Upadacitinib in adolescents, adults

The new analysis looked at up to 4 years of upadacitinib treatment in almost 2,700 adolescents and adults– and over 6,200 patient-years – using integrated data from three ongoing pivotal phase 3 studies: Measure Up 1, Measure Up 2, and AD Up. (Of these patients, 539 were adolescents, Dr. Bunick said after the meeting.)

In the Measure Up studies, patients were randomized 1:1:1 to receive a 15-mg dose, a 30-mg dose, or placebo once daily. In AD Up, patients in each arm received concomitant topical corticosteroids. At week 16, patients receiving the drug continued their assigned treatment during the ongoing blinded extension period, and those receiving placebo were rerandomized to upadacitinib 15 mg or 30 mg.

The exposure-adjusted event rates for any adverse event leading to discontinuation were 4.1/100 patient-years and 4.7/100 patient-years in patients receiving 15 mg and 30 mg, respectively, and the rates of any serious adverse event were 6.5/100 patient-years and 7.5/100 patient-years, Dr. Bunick reported. Three deaths occurred in the 30-mg group; all deaths were related to COVID infection and occurred in adults with cardiovascular risk factors.

Incidence rates of adverse events of special interest were similar to those in a previous 1-year analysis. The rate of serious infections per 100 patient years, for instance, was 2.3 and 2.8 in the 15-mg and 30-mg groups, respectively, compared with 2.2 and 2.8 in the 1-year analysis.

The rate of opportunistic infections, including eczema herpeticum (and excluding TB and herpes zoster), saw a slight bump in the new analysis to 2.4/100 patient-years with the 30-mg dose. Other event rates, across both dosages and durations, were less than 0.1/100 patient-years for active TB; 0.3-0.4/100 patient-years for NMSC, and 0.1/100 patient-years or below for other malignancies, MACE, and VTE. Herpes zoster had the highest event rate in both the 1- and 4-year analyses of between 3.1/100 patient-years and 5.8/100 patient-years, Dr. Bunick reported.

The adverse event rates for adolescents and adults “show consistency and are very low,” Dr. Bunick said. At 4 years, no new safety risks were identified.
 

‘The more data ... the better’

Data on the safety of new medications in children and adolescents is always important, and with systemic JAK inhibitors in particular, “the more data we can accumulate in [younger] patients with AD ... the better,” said Robert Sidbury, MD, MPH, professor in the department of pediatrics at the University of Washington, Seattle, and chief of the division of dermatology at Seattle Children’s Hospital, who was asked to comment on the two studies.

Dr. Robert Sidbury

Dermatologists have taken comfort in the fact that the “daunting” boxed warning on JAK inhibitors “was generated in a very different population than we generally propose to treat, certainly when talking about children and adolescents,” said Dr. Sidbury, who was not involved in either of the new safety analyses.

The JAK inhibitor boxed warning “reflects a study of tofacitinib – a different JAK inhibitor with arguably more risk of adverse effects – in adults over the age of 50 with rheumatoid arthritis and multiple risk factors for comorbidities included in the boxed warning,” he said.

“This allows dermatologists to reasonably conclude that the boxed warning – while critical to discuss and consider in every patient – is likely less concerning than might otherwise by implied.”

With more patient experience, “the more our assessment of risk, and of the ‘legitimacy’ of the boxed warning in our patient population, becomes evidence-based as opposed to extrapolation,” Dr. Sidbury said.

The two studies reported, he said, “detail an experience that is not adverse effect free –I have yet to find that medication – but is a reasonable profile considering the robust efficacy results they accompany.”

The abrocitinib safety analysis was sponsored by Pfizer. Regarding the study of upadacitinib, AbbVie contributed to the design of the safety analysis and participated in data collection. No honoria or payments were made to the authors, according to the study abstract. Dr. Eichenfield is a consultant/advisory board member for Pfizer and other companies, and has served on the speakers bureau/received honoria for Pfizer and other companies. Dr. Bunick is a consultant for AbbVie and other companies, and has served as an speaker/received honoraria or served as an investigator for several companies. Dr. Sidbury disclosed being a consultant/advisory board member for Lilly and Leo and serving on the speakers bureau/honoraria for Beiersdorf. All reported receiving grant/research support from various companies.
 

WASHINGTON – Abrocitinib demonstrated an acceptable long-term safety profile in adolescents with moderate to severe atopic dermatitis (AD) in an integrated safety analysis of 635 adolescents and over 1,000 patient-years of exposure, Lawrence F. Eichenfield, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.

In March 2023, the oral Janus kinase 1 (JAK1) inhibitor was approved by the Food and Drug Administration for treating adolescents aged 12-17 with refractory moderate to severe AD – an expanded indication from the approval in adults in 2022.

University of California, San Diego
Dr. Lawrence F. Eichenfield

The new analysis evaluated data from patients who participated in the phase 3 JADE clinical trials – MONO-1, MONO-2, TEEN, and REGIMEN – and were subsequently enrolled in the ongoing phase 3 extension trial JADE EXTEND. Compared with a previous post hoc analysis in which adolescent patients had approximately 1 year of exposure, this updated analysis includes a sizable portion of patients with more than 96 weeks of exposure.

“We’re starting to get good numbers of [adolescents] who’ve had about 2 years of exposure,” said Dr. Eichenfield, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego, during a late-breaking research session.

With a data cut for this analysis of September 2021, “we haven’t seen additive long-term [adverse] effects” with longer exposures, he said. In addition, “there were no unique safety concerns related to adolescents compared to the findings observed [in an] integrated safety analysis using the same data cut in which most patients were adults.”

(The analysis in adults covered 3,802 patients with over 5,000 patient-years of exposure, and was presented at the annual American Academy of Dermatology meeting in March 2023.)

Dr. Christopher G. Bunick

Also presented in the late-breaking abstract session at RAD 2023 was a long-term safety study of upadacitinib (Rinvoq), the other JAK1 inhibitor approved for adolescents with AD – approved by the FDA for both adolescents and adults with moderate to severe AD in 2022. The new analysis captures exposure of up to 4 years and shows no “worsening or accumulation of events,” compared with 1-year data, reported Christopher G. Bunick, MD, PhD, of the department of dermatology and the program in translational biomedicine at Yale University, New Haven, Conn.
 

Abrocitinib in adolescents

For the safety analysis of abrocitinib (Cibinqo), data were pooled into two cohorts: A consistent-dose cohort of 490 adolescents who received the same dose (200 mg or 100 mg) during the entire duration of the qualifying JADE trials, and a variable-dose cohort of 145 adolescents who received different doses (200 mg or 100 mg) during the JADE REGIMEN qualifying trial.

Duration of exposure was 96 weeks or more in 37%-38% of the consistent-dose cohort and 68% of the variable-dose cohort.

In the consistent-dose cohort, adverse events occurred in 243 (84%) and 153 (76%) of patients receiving 200-mg doses and 100-mg doses, respectively. Incidence rates for severe adverse events were 5.87 per 100 patient-years at both doses, and rates for adverse events leading to study discontinuation were 6.96/100 patient-years at 200 mg and 5.13/100 patient-years at 100 mg.

“No meaningful dose-response relationship was observed for serious adverse events, or adverse events leading to discontinuation, or adverse events of special interest,” said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.



The IRs of adverse events of special interest were 1.84/100 patient-years and 1.28/100 patient-years for serious infection; 2.11/100 patient-years, and 1.62/100 patient-years for all herpes zoster infections; and 0.69/100 patient-years and 0.32/100 patient-years for opportunistic herpes zoster infections in the 200-mg and 100-mg arms, respectively.

“Other than herpes zoster, there were no opportunistic infections observed and no tuberculosis cases,” he said. “There was one nonfatal venous thromboembolism in an adolescent who had a very strong family history of [pulmonary embolism], one retinal detachment [with a concurrent diagnosis of cataracts and of left eyebrow folliculitis], and no events of nonmelanoma skin cancer or other malignancies, major adverse cardiovascular events, or deaths.” The thromboembolism case was reported in the previous post hoc analysis.

In the variable-dose cohort, data were similar, Dr. Eichenfield said. The IRs for severe adverse events, adverse events leading to study withdrawal, and adverse events of special interest were consistent with those in the other cohort. And similarly, there were no reports of tuberculosis or other opportunistic infections (excluding herpes zoster), and no reports of nonmelanoma skin cancer (NMSC) or other malignancies, major adverse cardiovascular events (MACE), or death. In this cohort, there were no venous thromboembolism (VTE) reports.

 

 

Upadacitinib in adolescents, adults

The new analysis looked at up to 4 years of upadacitinib treatment in almost 2,700 adolescents and adults– and over 6,200 patient-years – using integrated data from three ongoing pivotal phase 3 studies: Measure Up 1, Measure Up 2, and AD Up. (Of these patients, 539 were adolescents, Dr. Bunick said after the meeting.)

In the Measure Up studies, patients were randomized 1:1:1 to receive a 15-mg dose, a 30-mg dose, or placebo once daily. In AD Up, patients in each arm received concomitant topical corticosteroids. At week 16, patients receiving the drug continued their assigned treatment during the ongoing blinded extension period, and those receiving placebo were rerandomized to upadacitinib 15 mg or 30 mg.

The exposure-adjusted event rates for any adverse event leading to discontinuation were 4.1/100 patient-years and 4.7/100 patient-years in patients receiving 15 mg and 30 mg, respectively, and the rates of any serious adverse event were 6.5/100 patient-years and 7.5/100 patient-years, Dr. Bunick reported. Three deaths occurred in the 30-mg group; all deaths were related to COVID infection and occurred in adults with cardiovascular risk factors.

Incidence rates of adverse events of special interest were similar to those in a previous 1-year analysis. The rate of serious infections per 100 patient years, for instance, was 2.3 and 2.8 in the 15-mg and 30-mg groups, respectively, compared with 2.2 and 2.8 in the 1-year analysis.

The rate of opportunistic infections, including eczema herpeticum (and excluding TB and herpes zoster), saw a slight bump in the new analysis to 2.4/100 patient-years with the 30-mg dose. Other event rates, across both dosages and durations, were less than 0.1/100 patient-years for active TB; 0.3-0.4/100 patient-years for NMSC, and 0.1/100 patient-years or below for other malignancies, MACE, and VTE. Herpes zoster had the highest event rate in both the 1- and 4-year analyses of between 3.1/100 patient-years and 5.8/100 patient-years, Dr. Bunick reported.

The adverse event rates for adolescents and adults “show consistency and are very low,” Dr. Bunick said. At 4 years, no new safety risks were identified.
 

‘The more data ... the better’

Data on the safety of new medications in children and adolescents is always important, and with systemic JAK inhibitors in particular, “the more data we can accumulate in [younger] patients with AD ... the better,” said Robert Sidbury, MD, MPH, professor in the department of pediatrics at the University of Washington, Seattle, and chief of the division of dermatology at Seattle Children’s Hospital, who was asked to comment on the two studies.

Dr. Robert Sidbury

Dermatologists have taken comfort in the fact that the “daunting” boxed warning on JAK inhibitors “was generated in a very different population than we generally propose to treat, certainly when talking about children and adolescents,” said Dr. Sidbury, who was not involved in either of the new safety analyses.

The JAK inhibitor boxed warning “reflects a study of tofacitinib – a different JAK inhibitor with arguably more risk of adverse effects – in adults over the age of 50 with rheumatoid arthritis and multiple risk factors for comorbidities included in the boxed warning,” he said.

“This allows dermatologists to reasonably conclude that the boxed warning – while critical to discuss and consider in every patient – is likely less concerning than might otherwise by implied.”

With more patient experience, “the more our assessment of risk, and of the ‘legitimacy’ of the boxed warning in our patient population, becomes evidence-based as opposed to extrapolation,” Dr. Sidbury said.

The two studies reported, he said, “detail an experience that is not adverse effect free –I have yet to find that medication – but is a reasonable profile considering the robust efficacy results they accompany.”

The abrocitinib safety analysis was sponsored by Pfizer. Regarding the study of upadacitinib, AbbVie contributed to the design of the safety analysis and participated in data collection. No honoria or payments were made to the authors, according to the study abstract. Dr. Eichenfield is a consultant/advisory board member for Pfizer and other companies, and has served on the speakers bureau/received honoria for Pfizer and other companies. Dr. Bunick is a consultant for AbbVie and other companies, and has served as an speaker/received honoraria or served as an investigator for several companies. Dr. Sidbury disclosed being a consultant/advisory board member for Lilly and Leo and serving on the speakers bureau/honoraria for Beiersdorf. All reported receiving grant/research support from various companies.
 

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Talking tobacco with youth? Ask the right questions

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Talking tobacco with youth? Ask the right questions

There is good news and bad news regarding the use of tobacco products by young people in the United States, according to the recently released findings from the 2021 Youth Risk Behavior Survey (YRBS).1 The use of cigarettes among high school students declined from 36.4% in 1997 to 6.0% in 2019.2 However, young people have replaced cigarettes with other tobacco products, including electronic vapor products (EVPs). So we need to ask specifically about these products.

Known by many names. EVPs are referred to as e-cigarettes, vapes, hookah pens, and mods. They usually contain nicotine, which is highly addictive, can affect brain development, and may lead to smoking of cigarettes.3 The most common reasons young people say they use EVPs are feelings of anxiety, stress, and depression, as well as the “high” associated with nicotine use.4

Use of EVPs among youth. The YRBS, which includes a representative sample of public and private school students in grades 9 to 12 in the 50 states, categorizes the use of EVPs as

  • ever use
  • current use (≥ 1 use during the 30 days before the survey), and
  • daily use (during the 30 days before the survey).

In 2021, 36.2% of young people reported ever use of EVPs (40.9% of females; 32.1% of males), 18% reported current use (21.4% of females; 14.9% of males), and 5% reported daily use (5.6% of females; 4.5% of males). Differences between racial and ethnic groups were minor, except for markedly lower rates in Asian youth (19.5% ever use, 5.5% current use, and 1.2% daily use).5

Current recommendations. The US Preventive Services Task Force (USPSTF) recommends education and brief counseling for school-age children and adolescents to prevent them from starting to use tobacco (including use of EVPs).6 The USPSTF also recommends tobacco cessation using behavioral interventions and/or pharmacotherapy for those ages 18 years and older.7

The USPSTF makes no recommendation on cessation for those younger than 18 years, citing weak evidence. However, it would be reasonable to offer behavioral interventions to younger current users. (Pharmacotherapy is not approved for use in children and adolescents.)

The take-home message. When we ask children and adolescents about use of tobacco products, we need to specifically mention EVPs and advise against their use.

References

1. CDC. Youth Risk Behavior Surveillance—United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72(suppl 1):1-93. Accessed May 24, 2023. www.cdc.gov/mmwr/volumes/72/su/pdfs/su7201-h.pdf

2. Creamer MR, Everett Jones S, Gentzke AS, et al. Tobacco product use among high school students—Youth Risk Behavior Survey, United States, 2019. MMWR Morb Mortal Wkly Rep. 2020;69(suppl 1):56-63. doi: 10.15585/mmwr.su6901a7

3. National Academies of Sciences, Engineering, and Medicine. Public Health Consequences of E-Cigarettes. Washington, DC: National Academies Press; 2018. Accessed May 24, 2023. https://nap.nationalacademies.org/catalog/24952/public-health-consequences-of-e-cigarettes

4. Gentzke AS, Wang TW, Cornelius M, et al. Tobacco product use and associated factors among middle and high school students—National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ. 2022;71(no. SS-5):1-29. doi: 10.15585/mmwr.ss7105a1

5. Oliver BE, Jones SE, Hops ED, et al. Electronic vapor product use among high school students—Youth Risk Behavior Survey, United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72(suppl 1):93-99. doi: 10.15585/mmwr.su7201a11

6. USPSTF. Tobacco use in children and adolescents: primary care interventions. Final recommendation statement. Published April 28, 2020. Accessed May 24, 2023. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions

7. USPSTF. Tobacco smoking cessation in adults, including pregnant persons: interventions. Final recommendation statement. Published January 19, 2021. Accessed May 24, 2023. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author reported no potential conflicts of interest relevant to this article.

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Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author reported no potential conflicts of interest relevant to this article.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author reported no potential conflicts of interest relevant to this article.

There is good news and bad news regarding the use of tobacco products by young people in the United States, according to the recently released findings from the 2021 Youth Risk Behavior Survey (YRBS).1 The use of cigarettes among high school students declined from 36.4% in 1997 to 6.0% in 2019.2 However, young people have replaced cigarettes with other tobacco products, including electronic vapor products (EVPs). So we need to ask specifically about these products.

Known by many names. EVPs are referred to as e-cigarettes, vapes, hookah pens, and mods. They usually contain nicotine, which is highly addictive, can affect brain development, and may lead to smoking of cigarettes.3 The most common reasons young people say they use EVPs are feelings of anxiety, stress, and depression, as well as the “high” associated with nicotine use.4

Use of EVPs among youth. The YRBS, which includes a representative sample of public and private school students in grades 9 to 12 in the 50 states, categorizes the use of EVPs as

  • ever use
  • current use (≥ 1 use during the 30 days before the survey), and
  • daily use (during the 30 days before the survey).

In 2021, 36.2% of young people reported ever use of EVPs (40.9% of females; 32.1% of males), 18% reported current use (21.4% of females; 14.9% of males), and 5% reported daily use (5.6% of females; 4.5% of males). Differences between racial and ethnic groups were minor, except for markedly lower rates in Asian youth (19.5% ever use, 5.5% current use, and 1.2% daily use).5

Current recommendations. The US Preventive Services Task Force (USPSTF) recommends education and brief counseling for school-age children and adolescents to prevent them from starting to use tobacco (including use of EVPs).6 The USPSTF also recommends tobacco cessation using behavioral interventions and/or pharmacotherapy for those ages 18 years and older.7

The USPSTF makes no recommendation on cessation for those younger than 18 years, citing weak evidence. However, it would be reasonable to offer behavioral interventions to younger current users. (Pharmacotherapy is not approved for use in children and adolescents.)

The take-home message. When we ask children and adolescents about use of tobacco products, we need to specifically mention EVPs and advise against their use.

There is good news and bad news regarding the use of tobacco products by young people in the United States, according to the recently released findings from the 2021 Youth Risk Behavior Survey (YRBS).1 The use of cigarettes among high school students declined from 36.4% in 1997 to 6.0% in 2019.2 However, young people have replaced cigarettes with other tobacco products, including electronic vapor products (EVPs). So we need to ask specifically about these products.

Known by many names. EVPs are referred to as e-cigarettes, vapes, hookah pens, and mods. They usually contain nicotine, which is highly addictive, can affect brain development, and may lead to smoking of cigarettes.3 The most common reasons young people say they use EVPs are feelings of anxiety, stress, and depression, as well as the “high” associated with nicotine use.4

Use of EVPs among youth. The YRBS, which includes a representative sample of public and private school students in grades 9 to 12 in the 50 states, categorizes the use of EVPs as

  • ever use
  • current use (≥ 1 use during the 30 days before the survey), and
  • daily use (during the 30 days before the survey).

In 2021, 36.2% of young people reported ever use of EVPs (40.9% of females; 32.1% of males), 18% reported current use (21.4% of females; 14.9% of males), and 5% reported daily use (5.6% of females; 4.5% of males). Differences between racial and ethnic groups were minor, except for markedly lower rates in Asian youth (19.5% ever use, 5.5% current use, and 1.2% daily use).5

Current recommendations. The US Preventive Services Task Force (USPSTF) recommends education and brief counseling for school-age children and adolescents to prevent them from starting to use tobacco (including use of EVPs).6 The USPSTF also recommends tobacco cessation using behavioral interventions and/or pharmacotherapy for those ages 18 years and older.7

The USPSTF makes no recommendation on cessation for those younger than 18 years, citing weak evidence. However, it would be reasonable to offer behavioral interventions to younger current users. (Pharmacotherapy is not approved for use in children and adolescents.)

The take-home message. When we ask children and adolescents about use of tobacco products, we need to specifically mention EVPs and advise against their use.

References

1. CDC. Youth Risk Behavior Surveillance—United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72(suppl 1):1-93. Accessed May 24, 2023. www.cdc.gov/mmwr/volumes/72/su/pdfs/su7201-h.pdf

2. Creamer MR, Everett Jones S, Gentzke AS, et al. Tobacco product use among high school students—Youth Risk Behavior Survey, United States, 2019. MMWR Morb Mortal Wkly Rep. 2020;69(suppl 1):56-63. doi: 10.15585/mmwr.su6901a7

3. National Academies of Sciences, Engineering, and Medicine. Public Health Consequences of E-Cigarettes. Washington, DC: National Academies Press; 2018. Accessed May 24, 2023. https://nap.nationalacademies.org/catalog/24952/public-health-consequences-of-e-cigarettes

4. Gentzke AS, Wang TW, Cornelius M, et al. Tobacco product use and associated factors among middle and high school students—National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ. 2022;71(no. SS-5):1-29. doi: 10.15585/mmwr.ss7105a1

5. Oliver BE, Jones SE, Hops ED, et al. Electronic vapor product use among high school students—Youth Risk Behavior Survey, United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72(suppl 1):93-99. doi: 10.15585/mmwr.su7201a11

6. USPSTF. Tobacco use in children and adolescents: primary care interventions. Final recommendation statement. Published April 28, 2020. Accessed May 24, 2023. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions

7. USPSTF. Tobacco smoking cessation in adults, including pregnant persons: interventions. Final recommendation statement. Published January 19, 2021. Accessed May 24, 2023. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions

References

1. CDC. Youth Risk Behavior Surveillance—United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72(suppl 1):1-93. Accessed May 24, 2023. www.cdc.gov/mmwr/volumes/72/su/pdfs/su7201-h.pdf

2. Creamer MR, Everett Jones S, Gentzke AS, et al. Tobacco product use among high school students—Youth Risk Behavior Survey, United States, 2019. MMWR Morb Mortal Wkly Rep. 2020;69(suppl 1):56-63. doi: 10.15585/mmwr.su6901a7

3. National Academies of Sciences, Engineering, and Medicine. Public Health Consequences of E-Cigarettes. Washington, DC: National Academies Press; 2018. Accessed May 24, 2023. https://nap.nationalacademies.org/catalog/24952/public-health-consequences-of-e-cigarettes

4. Gentzke AS, Wang TW, Cornelius M, et al. Tobacco product use and associated factors among middle and high school students—National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ. 2022;71(no. SS-5):1-29. doi: 10.15585/mmwr.ss7105a1

5. Oliver BE, Jones SE, Hops ED, et al. Electronic vapor product use among high school students—Youth Risk Behavior Survey, United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72(suppl 1):93-99. doi: 10.15585/mmwr.su7201a11

6. USPSTF. Tobacco use in children and adolescents: primary care interventions. Final recommendation statement. Published April 28, 2020. Accessed May 24, 2023. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-and-nicotine-use-prevention-in-children-and-adolescents-primary-care-interventions

7. USPSTF. Tobacco smoking cessation in adults, including pregnant persons: interventions. Final recommendation statement. Published January 19, 2021. Accessed May 24, 2023. www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions

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Youth-led sexual health program improves teen knowledge, autonomy

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A youth-led discussion and education program, facilitated by experts during monthly meetings, significantly increased teen participants’ knowledge and self-efficacy around sexual and reproductive health, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.

Ms. Sao
Saumya Sao

“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”

Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.

Dr. Friedman
Dr. Jaime Friedman


“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”

Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.

The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).

The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.

The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.

For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.

The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).

Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.

“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”

Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.

“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”

Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.

“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.

Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.

“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”

But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.

“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.” 

Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.

“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.

Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.

“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”

Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.

No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.

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A youth-led discussion and education program, facilitated by experts during monthly meetings, significantly increased teen participants’ knowledge and self-efficacy around sexual and reproductive health, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.

Ms. Sao
Saumya Sao

“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”

Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.

Dr. Friedman
Dr. Jaime Friedman


“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”

Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.

The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).

The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.

The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.

For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.

The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).

Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.

“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”

Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.

“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”

Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.

“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.

Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.

“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”

But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.

“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.” 

Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.

“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.

Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.

“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”

Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.

No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.

A youth-led discussion and education program, facilitated by experts during monthly meetings, significantly increased teen participants’ knowledge and self-efficacy around sexual and reproductive health, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

While the small pilot study focused primarily on assessing feasibility and effectiveness, the results suggest potential for scaling the program up to reach a larger audience and assessing the knowledge disseminated from direct youth participants.

Ms. Sao
Saumya Sao

“The good thing about this subject is that not a lot of it has to be context-specific,” Saumya Sao, a clinical researcher in gynecology and obstetrics at the Johns Hopkins University, Baltimore, and the study’s lead author, said in an interview. “A lot of it is just baseline information that everybody needs and doesn’t get.”

Jaime Friedman, MD, a pediatrician and director of marketing at Children’s Primary Care Medical Group in San Diego, was not involved in the study but was impressed with the program’s objectives and results so far.

Dr. Friedman
Dr. Jaime Friedman


“While education is massively important, teens don’t always want to hear it from their parents or other adults,” Dr. Friedman said in an interview. “Learning from their peers is one way to overcome this hurdle.”

Given the high rate of sexually transmitted infections and unintended pregnancies in youth, paired with low sexual and reproductive health literacy in this population, the researchers sought to learn whether a program focused on peer-to-peer health education on these topics was feasible. The goal was to increase youth sexual and reproductive health knowledge, self-efficacy, and autonomy using a youth-led intervention.

The researchers hosted nine monthly, interactive, youth-led sessions that lasted 2 hours over Zoom or in person. Incorporated into the meetings were principles from Youth Participatory Action Research (YPAR) and Positive Youth Development (PYD).

The major topics included the following: Use of social media, values and goal-setting, anatomy and menstrual health, risk factors of sexual activities , STI and HIV prevention, contraceptive methods, healthy relationships and consent, practice responding to unhealthy behavior, gender and sexuality, and social media and body image.

The 24 participants were provided with transportation to the study site at the researchers’ institution and received financial compensation for their participation. They were an average 15.8 years old, lived in the greater Baltimore area, and mostly self-identified as female. Eight percent identified as non-binary and half (50%) identified as LGBTQIA+. Just over half the participants (52%) were Black/African American, 28% were Asian/Asian American, 12% were White, and 8% were Hispanic. The participants attended an average 88% of the sessions throughout the full intervention.

For each of the nine sessions, more than 50% of participants reported that they “learned a lot,” and only one participant reported for one session (session 5) that they “didn’t learn” anything. The researchers assessed participants’ knowledge, self-efficacy, and sense of autonomy at baseline and after completion of the intervention. Significant improvements occurred across all areas.

The average score improved by 31% in sexual and reproductive health knowledge (P < .001), 33% in sexual and reproductive health services awareness (P = .002), 46% in advocacy and empowerment (P < .001), 16% in general perceived efficacy (P = .002), and 22% personal sexuality empowerment (P = .006).

Ms. Sao said she was very pleased to see that the improvements were significant in every domain they measured, which she attributed largely to the incorporation of YPAR and PYD into the program.

“We approached it using these two frameworks that really do focus on involving youth in the teaching themselves, so I think that’s what increased their general perceived efficacy and advocacy empowerment without us necessarily having to emphasize, ‘You are advocates,’” Ms. Sao said. “Those frameworks ask the youth for their opinions and then give the youth an opportunity in every single session to be teachers themselves, and I think that lends itself well to all of the domains.”

Ms. Sao was also pleasantly surprised at the high level of retention across the 9 months.

“Every single session was slotted for 2 hours, but they would want to stay for 3 hours. Eventually, we actually started meeting with them twice a month, just adding an extra session,” she said. “As they gained confidence, they were so excited to be peer educators and realized, ‘I can really do this. I can teach my peers. We’re not getting this from anywhere else.’ ”

Ms. Sao and another study author, Maclaine Barré-Quick, an undergraduate research assistant at Johns Hopkins University, said the participants quickly discovered how easy it was to have a non-stigmatizing conversation about many of the topics once a subject was brought up.

“They’re actively looking for that opportunity,” Ms. Barré-Quick said in an interview.

Dr. Friedman agreed that this type of program provides what many adolescents need in a way that they may welcome more than through other methods.

“Adolescents’ bodies are approaching adulthood and function like adults, but their brains are still developing. They don’t have the worldly experience and education of adults, but they think they know everything,” Dr. Friedman said. “They are a population known for their high risk behavior due to their natural impulsivity. This can be a scary combination, especially when it comes to sexual health.”

But if teens don’t want to hear some of the information they need from adults, they may be more open to hearing it from other teens, Dr. Friedman said.

“Using an evidence-based approach ensures the desired outcome of healthier habits, decreased STIs and decreased teen pregnancy,” Dr. Friedman said. “It also adds weight to the argument against abstinence-only education. Teens deserve accurate and evidence-based education about their own bodies.” 

Ms. Sao said the next steps will be exploring ways to scale the program up, such as putting the curriculum resources into a bundle available to other educators. They’re also looking at ways to put it into an online platform that’s self-paced, though that requires solving the challenge of having synchronous meetings for youth-led discussion.

“There are certain kinks that we have to work out because there were some activities where I think the students really benefited from having those open discussions with each other, so [we need to determine] how to replicate that in an online format,” Ms. Sao said.

Dr. Friedman agreed that scalability appears to be the biggest challenge, along with funding programs. But if those obstacles can be overcome, such programs would complement and expand on the education she does currently with families.

“I don’t have time for a full sex ed course at each visit,” Dr. Friedman said. “I would like to be able to direct them to a program that I know works and would be easy for them to complete. Even better, this would be an amazing program to ‘sell’ to practices interested in hosting these sessions themselves.”

Ms. Sao said they also hope to assess the impact of the intervention on the participants’ peers to see how well the knowledge and self-efficacy spread through the youths’ teaching.

No external funding was noted. One author reported research support from Hologic and Merck. Dr. Friedman had no disclosures.

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The family firearm often used in youth suicide

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SAN FRANCISCO – Young people who commit suicide using a gun are often introduced to guns through family traditions and use the family gun to commit suicide, according to results of a novel “psychological autopsy study” of loved ones of youth who died by gun-related suicide.

Yet, families don’t always recognize the danger firearms pose to a young person with suicide risk factors, even when there is a young person in the house with a mental health condition, the data show.

Perhaps most importantly, many parents indicated that they would have removed firearms from the home if it had been suggested by their health care professionals.

The study was presented at the American Psychiatric Association annual meeting. 

The message is very clear: Clinicians need to ask about guns and gun safety with patients and families, said study investigator Paul Nestadt, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore.

“It’s never illegal to ask about gun access and it’s medically relevant. Just do it,” he said during a briefing with reporters.
 

Grim statistics

Suicide rates have been climbing in the United States for the majority of the past 20 years. Suicide is the second most common cause of death among youth.

Dr. Paul Nestadt

Dr. Nestadt noted that overall about 8% of suicide attempts result in death, but when an attempt involves a firearm the percentage jumps astronomically to 90%.

Research has shown that for every 10% increase in household firearms in a given community there is a 27% increase in youth suicide deaths.

“In the world of public health and mental health, we think about having access to firearms as an important risk factor for completed suicide. But in the United States, guns have become an important part of how many Americans see themselves,” Dr. Nestadt told reporters.

Research has shown that half of gun owners say owning a gun is central to their identity and three quarters say it’s essential to their freedom, he noted.

To explore these attitudes further, Dr. Nestadt and colleagues did 11 “psychological autopsy interviews” with the loved ones of nine young people aged 17-21 who died by gun-related suicide. They interviewed six mothers, three fathers, one sibling, and one close friend.

Most of the families had some level of “familial engagement” with firearms, Dr. Nestadt reported.

In more than two-thirds of the families, the youth used a family-owned firearm to commit suicide.

Notably, more than three-quarters of the youth had received mental health care before taking their lives, with many receiving care in the weeks prior to their suicide; 44% had made a prior suicide attempt.

In many cases, parents shared that they had not considered their family-owned firearms to be sources of danger and indicated that had their clinicians expressed concern about the gun in the home, they may have acted to reduce the risk by removing it.

Several also shared that they would have considered using Maryland’s Extreme Risk Protective Order Law if it had existed at the time and they had been made aware of it.

Extreme risk protection order (ERPO) laws, or “red flag laws,” prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm.

Dr. Nestadt said youth suicide interventions “must acknowledge culturally embedded roots of identity formation while rescripting firearms from expressions of family cohesion to instruments that may undermine that cohesion.”
 

 

 

‘Courageous study’

Dr. Nestadt noted that while this study was challenging on many fronts, it took no convincing to get these grieving families to participate.

“They wanted to talk to us, especially because they were hopeful that our work could help prevent future suicides, but also they wanted to talk about their loved ones,” he said. 

“When you lose someone to cancer, people give you hugs and flowers. When you lose someone to suicide, people don’t discuss it. Suicide has a stigma to it.”

Briefing moderator Howard Liu, MD, MBA, chair of the department of psychiatry, University of Nebraska Medical Center, Omaha, praised the study team for a “courageous study that really required a tremendous amount of vulnerability from the research team and clearly from the survivors as well.”

Dr. Howard Liu


This is an “important and timely public health discussion,” said Dr. Liu, chair of the APA Council on Communications.

“We’re all facing this challenge of how do we reduce suicide across all ages, from youth to adults as well. This is a really vital discussion and such an important clue about access and trying to reduce access in a moment of impulsivity,” he added.

The study had no commercial funding. Dr. Nestadt and Dr. Liu report no relevant financial relationships.
 

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

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SAN FRANCISCO – Young people who commit suicide using a gun are often introduced to guns through family traditions and use the family gun to commit suicide, according to results of a novel “psychological autopsy study” of loved ones of youth who died by gun-related suicide.

Yet, families don’t always recognize the danger firearms pose to a young person with suicide risk factors, even when there is a young person in the house with a mental health condition, the data show.

Perhaps most importantly, many parents indicated that they would have removed firearms from the home if it had been suggested by their health care professionals.

The study was presented at the American Psychiatric Association annual meeting. 

The message is very clear: Clinicians need to ask about guns and gun safety with patients and families, said study investigator Paul Nestadt, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore.

“It’s never illegal to ask about gun access and it’s medically relevant. Just do it,” he said during a briefing with reporters.
 

Grim statistics

Suicide rates have been climbing in the United States for the majority of the past 20 years. Suicide is the second most common cause of death among youth.

Dr. Paul Nestadt

Dr. Nestadt noted that overall about 8% of suicide attempts result in death, but when an attempt involves a firearm the percentage jumps astronomically to 90%.

Research has shown that for every 10% increase in household firearms in a given community there is a 27% increase in youth suicide deaths.

“In the world of public health and mental health, we think about having access to firearms as an important risk factor for completed suicide. But in the United States, guns have become an important part of how many Americans see themselves,” Dr. Nestadt told reporters.

Research has shown that half of gun owners say owning a gun is central to their identity and three quarters say it’s essential to their freedom, he noted.

To explore these attitudes further, Dr. Nestadt and colleagues did 11 “psychological autopsy interviews” with the loved ones of nine young people aged 17-21 who died by gun-related suicide. They interviewed six mothers, three fathers, one sibling, and one close friend.

Most of the families had some level of “familial engagement” with firearms, Dr. Nestadt reported.

In more than two-thirds of the families, the youth used a family-owned firearm to commit suicide.

Notably, more than three-quarters of the youth had received mental health care before taking their lives, with many receiving care in the weeks prior to their suicide; 44% had made a prior suicide attempt.

In many cases, parents shared that they had not considered their family-owned firearms to be sources of danger and indicated that had their clinicians expressed concern about the gun in the home, they may have acted to reduce the risk by removing it.

Several also shared that they would have considered using Maryland’s Extreme Risk Protective Order Law if it had existed at the time and they had been made aware of it.

Extreme risk protection order (ERPO) laws, or “red flag laws,” prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm.

Dr. Nestadt said youth suicide interventions “must acknowledge culturally embedded roots of identity formation while rescripting firearms from expressions of family cohesion to instruments that may undermine that cohesion.”
 

 

 

‘Courageous study’

Dr. Nestadt noted that while this study was challenging on many fronts, it took no convincing to get these grieving families to participate.

“They wanted to talk to us, especially because they were hopeful that our work could help prevent future suicides, but also they wanted to talk about their loved ones,” he said. 

“When you lose someone to cancer, people give you hugs and flowers. When you lose someone to suicide, people don’t discuss it. Suicide has a stigma to it.”

Briefing moderator Howard Liu, MD, MBA, chair of the department of psychiatry, University of Nebraska Medical Center, Omaha, praised the study team for a “courageous study that really required a tremendous amount of vulnerability from the research team and clearly from the survivors as well.”

Dr. Howard Liu


This is an “important and timely public health discussion,” said Dr. Liu, chair of the APA Council on Communications.

“We’re all facing this challenge of how do we reduce suicide across all ages, from youth to adults as well. This is a really vital discussion and such an important clue about access and trying to reduce access in a moment of impulsivity,” he added.

The study had no commercial funding. Dr. Nestadt and Dr. Liu report no relevant financial relationships.
 

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

SAN FRANCISCO – Young people who commit suicide using a gun are often introduced to guns through family traditions and use the family gun to commit suicide, according to results of a novel “psychological autopsy study” of loved ones of youth who died by gun-related suicide.

Yet, families don’t always recognize the danger firearms pose to a young person with suicide risk factors, even when there is a young person in the house with a mental health condition, the data show.

Perhaps most importantly, many parents indicated that they would have removed firearms from the home if it had been suggested by their health care professionals.

The study was presented at the American Psychiatric Association annual meeting. 

The message is very clear: Clinicians need to ask about guns and gun safety with patients and families, said study investigator Paul Nestadt, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore.

“It’s never illegal to ask about gun access and it’s medically relevant. Just do it,” he said during a briefing with reporters.
 

Grim statistics

Suicide rates have been climbing in the United States for the majority of the past 20 years. Suicide is the second most common cause of death among youth.

Dr. Paul Nestadt

Dr. Nestadt noted that overall about 8% of suicide attempts result in death, but when an attempt involves a firearm the percentage jumps astronomically to 90%.

Research has shown that for every 10% increase in household firearms in a given community there is a 27% increase in youth suicide deaths.

“In the world of public health and mental health, we think about having access to firearms as an important risk factor for completed suicide. But in the United States, guns have become an important part of how many Americans see themselves,” Dr. Nestadt told reporters.

Research has shown that half of gun owners say owning a gun is central to their identity and three quarters say it’s essential to their freedom, he noted.

To explore these attitudes further, Dr. Nestadt and colleagues did 11 “psychological autopsy interviews” with the loved ones of nine young people aged 17-21 who died by gun-related suicide. They interviewed six mothers, three fathers, one sibling, and one close friend.

Most of the families had some level of “familial engagement” with firearms, Dr. Nestadt reported.

In more than two-thirds of the families, the youth used a family-owned firearm to commit suicide.

Notably, more than three-quarters of the youth had received mental health care before taking their lives, with many receiving care in the weeks prior to their suicide; 44% had made a prior suicide attempt.

In many cases, parents shared that they had not considered their family-owned firearms to be sources of danger and indicated that had their clinicians expressed concern about the gun in the home, they may have acted to reduce the risk by removing it.

Several also shared that they would have considered using Maryland’s Extreme Risk Protective Order Law if it had existed at the time and they had been made aware of it.

Extreme risk protection order (ERPO) laws, or “red flag laws,” prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm.

Dr. Nestadt said youth suicide interventions “must acknowledge culturally embedded roots of identity formation while rescripting firearms from expressions of family cohesion to instruments that may undermine that cohesion.”
 

 

 

‘Courageous study’

Dr. Nestadt noted that while this study was challenging on many fronts, it took no convincing to get these grieving families to participate.

“They wanted to talk to us, especially because they were hopeful that our work could help prevent future suicides, but also they wanted to talk about their loved ones,” he said. 

“When you lose someone to cancer, people give you hugs and flowers. When you lose someone to suicide, people don’t discuss it. Suicide has a stigma to it.”

Briefing moderator Howard Liu, MD, MBA, chair of the department of psychiatry, University of Nebraska Medical Center, Omaha, praised the study team for a “courageous study that really required a tremendous amount of vulnerability from the research team and clearly from the survivors as well.”

Dr. Howard Liu


This is an “important and timely public health discussion,” said Dr. Liu, chair of the APA Council on Communications.

“We’re all facing this challenge of how do we reduce suicide across all ages, from youth to adults as well. This is a really vital discussion and such an important clue about access and trying to reduce access in a moment of impulsivity,” he added.

The study had no commercial funding. Dr. Nestadt and Dr. Liu report no relevant financial relationships.
 

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

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Half of teens drop below obesity cutoff with semaglutide

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Tue, 05/23/2023 - 09:30

Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Dr. Aaron S. Kelly


“In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery,” remarked Aaron S. Kelly, MD, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, who presented the latest data at this year’s European Congress on Obesity.

“There was a 22.7-higher odds of dropping below the obesity threshold if assigned to semaglutide versus odds on placebo (P < .0001), and a 23.5-fold higher odds of dropping BMI by one category if on semaglutide (P < .0001),” he reported.

This analysis follows the 2022 publication of the main results of STEP TEENS published in the New England Journal of Medicine, which showed semaglutide helped adolescents lose weight. The drug was subsequently approved by the U.S. Food and Drug Administration for the treatment of obesity in those aged 12 and over in January of this year.

The new analysis was presented at ECO and simultaneously published in Obesity.

Grace O’Malley, PhD, Child & Adolescent Obesity Service, Children’s Health Ireland, Dublin, commented on the findings, noting that adolescents’ access to comprehensive health care is essential for the proper treatment of obesity.

“Treatment requires a long-term, multidisciplinary chronic-care approach, and usually, when treatment stops, the biological mechanisms driving the obesity begin again to drive the build-up of adipose tissue,” she said. This means that “long-term treatment including nutrition therapy, exercise ... behavioral support, and sleep therapy needs to be available to families in combination with pharmacotherapy and surgical intervention where required.”

“The results of the STEP TEENS study represent a promising development for the treatment of adolescent obesity and for associated complications related to liver function,” she added. “The observed improvements in obesity category and [liver enzyme] alanine transaminase will help clinicians plan more tailored care for adolescents with obesity,” she noted.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

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Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Dr. Aaron S. Kelly


“In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery,” remarked Aaron S. Kelly, MD, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, who presented the latest data at this year’s European Congress on Obesity.

“There was a 22.7-higher odds of dropping below the obesity threshold if assigned to semaglutide versus odds on placebo (P < .0001), and a 23.5-fold higher odds of dropping BMI by one category if on semaglutide (P < .0001),” he reported.

This analysis follows the 2022 publication of the main results of STEP TEENS published in the New England Journal of Medicine, which showed semaglutide helped adolescents lose weight. The drug was subsequently approved by the U.S. Food and Drug Administration for the treatment of obesity in those aged 12 and over in January of this year.

The new analysis was presented at ECO and simultaneously published in Obesity.

Grace O’Malley, PhD, Child & Adolescent Obesity Service, Children’s Health Ireland, Dublin, commented on the findings, noting that adolescents’ access to comprehensive health care is essential for the proper treatment of obesity.

“Treatment requires a long-term, multidisciplinary chronic-care approach, and usually, when treatment stops, the biological mechanisms driving the obesity begin again to drive the build-up of adipose tissue,” she said. This means that “long-term treatment including nutrition therapy, exercise ... behavioral support, and sleep therapy needs to be available to families in combination with pharmacotherapy and surgical intervention where required.”

“The results of the STEP TEENS study represent a promising development for the treatment of adolescent obesity and for associated complications related to liver function,” she added. “The observed improvements in obesity category and [liver enzyme] alanine transaminase will help clinicians plan more tailored care for adolescents with obesity,” she noted.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

Nearly half (45%) of adolescents assigned to semaglutide (Wegovy), a once-weekly glucagon-like peptide-1 (GLP-1) agonist, managed to lose enough weight to drop below the clinical threshold for obesity, according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
 

By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.

The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.

Dr. Aaron S. Kelly


“In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery,” remarked Aaron S. Kelly, MD, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, who presented the latest data at this year’s European Congress on Obesity.

“There was a 22.7-higher odds of dropping below the obesity threshold if assigned to semaglutide versus odds on placebo (P < .0001), and a 23.5-fold higher odds of dropping BMI by one category if on semaglutide (P < .0001),” he reported.

This analysis follows the 2022 publication of the main results of STEP TEENS published in the New England Journal of Medicine, which showed semaglutide helped adolescents lose weight. The drug was subsequently approved by the U.S. Food and Drug Administration for the treatment of obesity in those aged 12 and over in January of this year.

The new analysis was presented at ECO and simultaneously published in Obesity.

Grace O’Malley, PhD, Child & Adolescent Obesity Service, Children’s Health Ireland, Dublin, commented on the findings, noting that adolescents’ access to comprehensive health care is essential for the proper treatment of obesity.

“Treatment requires a long-term, multidisciplinary chronic-care approach, and usually, when treatment stops, the biological mechanisms driving the obesity begin again to drive the build-up of adipose tissue,” she said. This means that “long-term treatment including nutrition therapy, exercise ... behavioral support, and sleep therapy needs to be available to families in combination with pharmacotherapy and surgical intervention where required.”

“The results of the STEP TEENS study represent a promising development for the treatment of adolescent obesity and for associated complications related to liver function,” she added. “The observed improvements in obesity category and [liver enzyme] alanine transaminase will help clinicians plan more tailored care for adolescents with obesity,” she noted.

Semaglutide shifts BMI category

In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.

The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).

After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.

Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.

At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.

“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.

Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”

Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.

For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.

In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.

“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”

Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”

Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”

Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.

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

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