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Running vs. meds for depression: Is there a clear winner?
BARCELONA – However, running provides greater physical health benefits while adherence is greater with drug treatment.
“Both interventions helped with the depression to around the same extent,” study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam said in a release.
However, medication “generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate,” Dr. Penninx added.
The findings were presented at the annual congress of the European College of Neuropsychopharmacology and recently published in the Journal of Affective Disorders.
Research gap
Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been “poorly examined in a psychiatric population, the investigators note.
The authors note that depressive and anxiety disorders “cause immense suffering by compromising both mental and physical health,” and the need for effective treatments is “pressing.”
Although antidepressant medication is considered a “standard first-line treatment” alongside psychotherapy, the drugs are “not effective for all and [are] often associated with side effects.”
The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI).
The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy.
Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention.
A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy.
Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with U.S. Centers for Disease Control and Prevention/American College of Sports Medicine recommendations.
Physical health benefits
Treatment adherence in the antidepressant group, defined as still using treatment at the posttreatment assessment, was 82.2% vs. 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions.
Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16.
On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88).
However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006).
The investigators note the more favorable physical health changes in the running therapy group were attributable to “larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group.”
Antidepressants are generally safe and effective and work for most people, said Dr. Penninx. She also noted that untreated depression leads to worse outcomes, so “antidepressants are generally a good choice.”
Nevertheless, she said, “we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them.”
The study’s results, she added, suggest that “implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients.”
Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, said in an interview that the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health.
Dr. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications.
Overall, Dr. Cirulli said “the message should not be that everyone can be helped by running and antidepressants are bad,” but rather “these are both helpful, but not excellent, interventions against depression.”
‘Important limitations’
In a comment, Eduard Vieta, MD, PhD, chair of the department of psychiatry and psychology at the University of Barcelona Hospital Clinic, noted the study has “very important limitations.”
Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the “lack of binding and power issues” over the number of patients enrolled.
Dr. Vieta also said that the results “seem obvious, because it is known that exercise improves physical health.”
The trial therefore shows, “if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice,” he noted.
Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and “again show physical health can influence mental health.”
However, Dr. Ruhe underlined, while it is “common practice” to allow patients to follow their treatment preference and is “understandable from a pragmatic point of view,” the group comparison may be “biased,” compared with a “truly randomized study.”
“For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises,” he said. “So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly.”
Turning to the difference in adherence between the two interventions, Dr. Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill.
“This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on health care more generally, but also on psychiatric diseases,” Dr. Ruhe said.
The MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development. The study authors and clinicians interviewed for this story declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – However, running provides greater physical health benefits while adherence is greater with drug treatment.
“Both interventions helped with the depression to around the same extent,” study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam said in a release.
However, medication “generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate,” Dr. Penninx added.
The findings were presented at the annual congress of the European College of Neuropsychopharmacology and recently published in the Journal of Affective Disorders.
Research gap
Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been “poorly examined in a psychiatric population, the investigators note.
The authors note that depressive and anxiety disorders “cause immense suffering by compromising both mental and physical health,” and the need for effective treatments is “pressing.”
Although antidepressant medication is considered a “standard first-line treatment” alongside psychotherapy, the drugs are “not effective for all and [are] often associated with side effects.”
The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI).
The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy.
Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention.
A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy.
Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with U.S. Centers for Disease Control and Prevention/American College of Sports Medicine recommendations.
Physical health benefits
Treatment adherence in the antidepressant group, defined as still using treatment at the posttreatment assessment, was 82.2% vs. 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions.
Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16.
On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88).
However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006).
The investigators note the more favorable physical health changes in the running therapy group were attributable to “larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group.”
Antidepressants are generally safe and effective and work for most people, said Dr. Penninx. She also noted that untreated depression leads to worse outcomes, so “antidepressants are generally a good choice.”
Nevertheless, she said, “we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them.”
The study’s results, she added, suggest that “implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients.”
Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, said in an interview that the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health.
Dr. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications.
Overall, Dr. Cirulli said “the message should not be that everyone can be helped by running and antidepressants are bad,” but rather “these are both helpful, but not excellent, interventions against depression.”
‘Important limitations’
In a comment, Eduard Vieta, MD, PhD, chair of the department of psychiatry and psychology at the University of Barcelona Hospital Clinic, noted the study has “very important limitations.”
Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the “lack of binding and power issues” over the number of patients enrolled.
Dr. Vieta also said that the results “seem obvious, because it is known that exercise improves physical health.”
The trial therefore shows, “if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice,” he noted.
Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and “again show physical health can influence mental health.”
However, Dr. Ruhe underlined, while it is “common practice” to allow patients to follow their treatment preference and is “understandable from a pragmatic point of view,” the group comparison may be “biased,” compared with a “truly randomized study.”
“For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises,” he said. “So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly.”
Turning to the difference in adherence between the two interventions, Dr. Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill.
“This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on health care more generally, but also on psychiatric diseases,” Dr. Ruhe said.
The MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development. The study authors and clinicians interviewed for this story declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – However, running provides greater physical health benefits while adherence is greater with drug treatment.
“Both interventions helped with the depression to around the same extent,” study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam said in a release.
However, medication “generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate,” Dr. Penninx added.
The findings were presented at the annual congress of the European College of Neuropsychopharmacology and recently published in the Journal of Affective Disorders.
Research gap
Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been “poorly examined in a psychiatric population, the investigators note.
The authors note that depressive and anxiety disorders “cause immense suffering by compromising both mental and physical health,” and the need for effective treatments is “pressing.”
Although antidepressant medication is considered a “standard first-line treatment” alongside psychotherapy, the drugs are “not effective for all and [are] often associated with side effects.”
The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI).
The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy.
Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention.
A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy.
Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with U.S. Centers for Disease Control and Prevention/American College of Sports Medicine recommendations.
Physical health benefits
Treatment adherence in the antidepressant group, defined as still using treatment at the posttreatment assessment, was 82.2% vs. 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions.
Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16.
On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88).
However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006).
The investigators note the more favorable physical health changes in the running therapy group were attributable to “larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group.”
Antidepressants are generally safe and effective and work for most people, said Dr. Penninx. She also noted that untreated depression leads to worse outcomes, so “antidepressants are generally a good choice.”
Nevertheless, she said, “we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them.”
The study’s results, she added, suggest that “implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients.”
Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, said in an interview that the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health.
Dr. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications.
Overall, Dr. Cirulli said “the message should not be that everyone can be helped by running and antidepressants are bad,” but rather “these are both helpful, but not excellent, interventions against depression.”
‘Important limitations’
In a comment, Eduard Vieta, MD, PhD, chair of the department of psychiatry and psychology at the University of Barcelona Hospital Clinic, noted the study has “very important limitations.”
Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the “lack of binding and power issues” over the number of patients enrolled.
Dr. Vieta also said that the results “seem obvious, because it is known that exercise improves physical health.”
The trial therefore shows, “if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice,” he noted.
Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and “again show physical health can influence mental health.”
However, Dr. Ruhe underlined, while it is “common practice” to allow patients to follow their treatment preference and is “understandable from a pragmatic point of view,” the group comparison may be “biased,” compared with a “truly randomized study.”
“For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises,” he said. “So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly.”
Turning to the difference in adherence between the two interventions, Dr. Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill.
“This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on health care more generally, but also on psychiatric diseases,” Dr. Ruhe said.
The MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development. The study authors and clinicians interviewed for this story declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ECNP 2023
Breast reconstruction post mastectomy: What matters most to women?
TOPLINE:
, a new survey suggests.
METHODOLOGY:
- As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
- Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
- A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
- The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.
TAKEAWAY:
- Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
- Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
- Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
- Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.
IN PRACTICE:
“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”
SOURCE:
The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.
LIMITATIONS:
The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.
DISCLOSURES:
Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, a new survey suggests.
METHODOLOGY:
- As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
- Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
- A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
- The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.
TAKEAWAY:
- Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
- Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
- Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
- Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.
IN PRACTICE:
“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”
SOURCE:
The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.
LIMITATIONS:
The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.
DISCLOSURES:
Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, a new survey suggests.
METHODOLOGY:
- As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
- Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
- A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
- The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.
TAKEAWAY:
- Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
- Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
- Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
- Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.
IN PRACTICE:
“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”
SOURCE:
The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.
LIMITATIONS:
The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.
DISCLOSURES:
Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AGA patient and physician advocates visit Capitol Hill to push for prior authorization reform
In our first in-person Advocacy Day on Capitol Hill since 2019, AGA leaders and patient advocates from 22 total states met with House and Senate offices to educate members of Congress and their staff about policies affecting GI patient care such as prior authorization and step therapy. Federal research funding and Medicare reimbursement were also on the agenda.
In the meetings, the patient shared their stories of living with various gastrointestinal diseases, including ulcerative colitis and Crohn’s disease, and the struggles they’ve gone through to get treatments approved by their insurers. AGA physicians shared the provider perspective of how policies like prior authorization negatively impact practices. According to a 2023 AGA member survey, 95% of respondents say that prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes and 84% described that the burden associated with prior authorization policies have increased “significantly” or “somewhat” over the last 5 years. AGA’s advocacy day came not long after UnitedHealthcare’s announcement of a new “Gold Card” prior authorization policy to be implemented in 2024, which will impact most colonoscopies and endoscopies for its 27 million commercial beneficiaries. The group expressed serious concerns about the proposed policy to lawmakers.
“It was a wonderful and empowering experience to share my personal story with my Representative/Senator and know that they were really listening to my concerns about insurer overreach,” said Aaron Blocker, a Crohn’s disease patient and advocate. “I hope Congress acts swiftly on passing prior authorization reform, so no more patients are forced to live in pain while they wait for treatments to be approved.” As gastroenterologists, too much administrative time is spent submitting onerous prior authorization requests on a near daily basis. We hope Congress takes our concerns seriously and comes together to rein in prior authorization.
AGA thanks the patient and physician advocates who participated in this year’s Advocacy Day and looks forward to continuing our work to ensure timely access to care.
In our first in-person Advocacy Day on Capitol Hill since 2019, AGA leaders and patient advocates from 22 total states met with House and Senate offices to educate members of Congress and their staff about policies affecting GI patient care such as prior authorization and step therapy. Federal research funding and Medicare reimbursement were also on the agenda.
In the meetings, the patient shared their stories of living with various gastrointestinal diseases, including ulcerative colitis and Crohn’s disease, and the struggles they’ve gone through to get treatments approved by their insurers. AGA physicians shared the provider perspective of how policies like prior authorization negatively impact practices. According to a 2023 AGA member survey, 95% of respondents say that prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes and 84% described that the burden associated with prior authorization policies have increased “significantly” or “somewhat” over the last 5 years. AGA’s advocacy day came not long after UnitedHealthcare’s announcement of a new “Gold Card” prior authorization policy to be implemented in 2024, which will impact most colonoscopies and endoscopies for its 27 million commercial beneficiaries. The group expressed serious concerns about the proposed policy to lawmakers.
“It was a wonderful and empowering experience to share my personal story with my Representative/Senator and know that they were really listening to my concerns about insurer overreach,” said Aaron Blocker, a Crohn’s disease patient and advocate. “I hope Congress acts swiftly on passing prior authorization reform, so no more patients are forced to live in pain while they wait for treatments to be approved.” As gastroenterologists, too much administrative time is spent submitting onerous prior authorization requests on a near daily basis. We hope Congress takes our concerns seriously and comes together to rein in prior authorization.
AGA thanks the patient and physician advocates who participated in this year’s Advocacy Day and looks forward to continuing our work to ensure timely access to care.
In our first in-person Advocacy Day on Capitol Hill since 2019, AGA leaders and patient advocates from 22 total states met with House and Senate offices to educate members of Congress and their staff about policies affecting GI patient care such as prior authorization and step therapy. Federal research funding and Medicare reimbursement were also on the agenda.
In the meetings, the patient shared their stories of living with various gastrointestinal diseases, including ulcerative colitis and Crohn’s disease, and the struggles they’ve gone through to get treatments approved by their insurers. AGA physicians shared the provider perspective of how policies like prior authorization negatively impact practices. According to a 2023 AGA member survey, 95% of respondents say that prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes and 84% described that the burden associated with prior authorization policies have increased “significantly” or “somewhat” over the last 5 years. AGA’s advocacy day came not long after UnitedHealthcare’s announcement of a new “Gold Card” prior authorization policy to be implemented in 2024, which will impact most colonoscopies and endoscopies for its 27 million commercial beneficiaries. The group expressed serious concerns about the proposed policy to lawmakers.
“It was a wonderful and empowering experience to share my personal story with my Representative/Senator and know that they were really listening to my concerns about insurer overreach,” said Aaron Blocker, a Crohn’s disease patient and advocate. “I hope Congress acts swiftly on passing prior authorization reform, so no more patients are forced to live in pain while they wait for treatments to be approved.” As gastroenterologists, too much administrative time is spent submitting onerous prior authorization requests on a near daily basis. We hope Congress takes our concerns seriously and comes together to rein in prior authorization.
AGA thanks the patient and physician advocates who participated in this year’s Advocacy Day and looks forward to continuing our work to ensure timely access to care.
Proton pump inhibitors linked to increased dementia risk
TOPLINE:
and was highest among those diagnosed before age 70 years regardless of when PPI treatment was initiated.
METHODOLOGY:
- Researchers used four Danish registries to collect data on dementia diagnoses and prescription PPI use among 1,983,785 individuals aged 60-75 years between 2000 and 2018.
- The median follow-up time was 10.3 years.
TAKEAWAY:
- There were 99,384 (5.0%) cases of all-cause dementia during follow-up, with a median age of diagnosis of 79 years.
- Twenty-one-point-two percent of dementia cases and 18.9% of controls reported a history of PPI use.
- Risk for all-cause dementia before age 90 years was 36% higher with PPI use in people aged 60-69 years at baseline (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.29-1.43) and 6% higher in those who were age 80-89 years at baseline (aIRR, 1.06; 95% CI, 1.03-1.09).
- Investigators found significant increased dementia risk before age 90 years with PPI use regardless of when PPI treatment began and found no link between PPI use and dementia diagnoses after age 90 years.
IN PRACTICE:
“The association between PPI use and dementia was unambiguously largest among the youngest cases of dementia, potentially suggestive of a critical window of exposure where midlife PPI use affects dementia risk to a larger degree compared to late-life use,” the authors wrote. “Further, the finding could signify a declining impact of individual risk factors with advancing age owing to lengthy ongoing neuropathological processes.”
SOURCE:
Lead author of the study was Nelsan Pourhadi, MD, Danish Dementia Research Centre, department of neurology, Copenhagen University Hospital–Rigshospitalet. It was published online in Alzheimer’s and Dementia.
LIMITATIONS:
The study did not include data on PPI prescriptions before 1995, over-the-counter PPI use, and in-hospital intravenous use of PPI during the study period.
DISCLOSURES:
The study was funded by the Danish Ministry of Health. The authors reported no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
and was highest among those diagnosed before age 70 years regardless of when PPI treatment was initiated.
METHODOLOGY:
- Researchers used four Danish registries to collect data on dementia diagnoses and prescription PPI use among 1,983,785 individuals aged 60-75 years between 2000 and 2018.
- The median follow-up time was 10.3 years.
TAKEAWAY:
- There were 99,384 (5.0%) cases of all-cause dementia during follow-up, with a median age of diagnosis of 79 years.
- Twenty-one-point-two percent of dementia cases and 18.9% of controls reported a history of PPI use.
- Risk for all-cause dementia before age 90 years was 36% higher with PPI use in people aged 60-69 years at baseline (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.29-1.43) and 6% higher in those who were age 80-89 years at baseline (aIRR, 1.06; 95% CI, 1.03-1.09).
- Investigators found significant increased dementia risk before age 90 years with PPI use regardless of when PPI treatment began and found no link between PPI use and dementia diagnoses after age 90 years.
IN PRACTICE:
“The association between PPI use and dementia was unambiguously largest among the youngest cases of dementia, potentially suggestive of a critical window of exposure where midlife PPI use affects dementia risk to a larger degree compared to late-life use,” the authors wrote. “Further, the finding could signify a declining impact of individual risk factors with advancing age owing to lengthy ongoing neuropathological processes.”
SOURCE:
Lead author of the study was Nelsan Pourhadi, MD, Danish Dementia Research Centre, department of neurology, Copenhagen University Hospital–Rigshospitalet. It was published online in Alzheimer’s and Dementia.
LIMITATIONS:
The study did not include data on PPI prescriptions before 1995, over-the-counter PPI use, and in-hospital intravenous use of PPI during the study period.
DISCLOSURES:
The study was funded by the Danish Ministry of Health. The authors reported no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
and was highest among those diagnosed before age 70 years regardless of when PPI treatment was initiated.
METHODOLOGY:
- Researchers used four Danish registries to collect data on dementia diagnoses and prescription PPI use among 1,983,785 individuals aged 60-75 years between 2000 and 2018.
- The median follow-up time was 10.3 years.
TAKEAWAY:
- There were 99,384 (5.0%) cases of all-cause dementia during follow-up, with a median age of diagnosis of 79 years.
- Twenty-one-point-two percent of dementia cases and 18.9% of controls reported a history of PPI use.
- Risk for all-cause dementia before age 90 years was 36% higher with PPI use in people aged 60-69 years at baseline (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.29-1.43) and 6% higher in those who were age 80-89 years at baseline (aIRR, 1.06; 95% CI, 1.03-1.09).
- Investigators found significant increased dementia risk before age 90 years with PPI use regardless of when PPI treatment began and found no link between PPI use and dementia diagnoses after age 90 years.
IN PRACTICE:
“The association between PPI use and dementia was unambiguously largest among the youngest cases of dementia, potentially suggestive of a critical window of exposure where midlife PPI use affects dementia risk to a larger degree compared to late-life use,” the authors wrote. “Further, the finding could signify a declining impact of individual risk factors with advancing age owing to lengthy ongoing neuropathological processes.”
SOURCE:
Lead author of the study was Nelsan Pourhadi, MD, Danish Dementia Research Centre, department of neurology, Copenhagen University Hospital–Rigshospitalet. It was published online in Alzheimer’s and Dementia.
LIMITATIONS:
The study did not include data on PPI prescriptions before 1995, over-the-counter PPI use, and in-hospital intravenous use of PPI during the study period.
DISCLOSURES:
The study was funded by the Danish Ministry of Health. The authors reported no relevant conflicts.
A version of this article first appeared on Medscape.com.
ADHD rates holding steady in U.S. children
TOPLINE:
While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016,
METHODOLOGY:
- Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
- The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
- Information on health care provider–diagnosed ADHD was reported by a parent or guardian.
TAKEAWAY:
- A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
- The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
- There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
- The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.
IN PRACTICE:
The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.
SOURCE:
The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.
LIMITATIONS:
Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.
DISCLOSURES:
The study had no specific funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016,
METHODOLOGY:
- Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
- The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
- Information on health care provider–diagnosed ADHD was reported by a parent or guardian.
TAKEAWAY:
- A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
- The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
- There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
- The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.
IN PRACTICE:
The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.
SOURCE:
The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.
LIMITATIONS:
Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.
DISCLOSURES:
The study had no specific funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016,
METHODOLOGY:
- Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
- The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
- Information on health care provider–diagnosed ADHD was reported by a parent or guardian.
TAKEAWAY:
- A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
- The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
- There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
- The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.
IN PRACTICE:
The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.
SOURCE:
The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.
LIMITATIONS:
Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.
DISCLOSURES:
The study had no specific funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nintedanib dose reductions in IPF may do no harm
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
AT CHEST 2023
Anemia, iron deficit common in rheumatic disease pregnancy
TOPLINE:
, according to findings from a longitudinal cohort study.
METHODOLOGY:
- Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
- Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
- Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.
TAKEAWAY:
- The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
- The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
- There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
- Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).
IN PRACTICE:
“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.
SOURCE:
The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.
LIMITATIONS:
The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.
DISCLOSURES:
The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to findings from a longitudinal cohort study.
METHODOLOGY:
- Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
- Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
- Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.
TAKEAWAY:
- The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
- The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
- There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
- Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).
IN PRACTICE:
“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.
SOURCE:
The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.
LIMITATIONS:
The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.
DISCLOSURES:
The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to findings from a longitudinal cohort study.
METHODOLOGY:
- Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
- Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
- Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.
TAKEAWAY:
- The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
- The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
- There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
- Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).
IN PRACTICE:
“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.
SOURCE:
The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.
LIMITATIONS:
The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.
DISCLOSURES:
The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA denies approval for patisiran in ATTR cardiomyopathy, despite panel nod
the company has announced.
ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
In September, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy on the basis of the results of the APOLLO-B phase 3 study.
However, many panel members questioned whether the benefits are clinically meaningful – a view shared by the FDA in a complete response letter (CRL) the FDA sent to Alnylam.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have “not been established,” and therefore, the supplemental new drug application for patisiran “could not be approved in its present form.”
The FDA did not identify any issues with respect to clinical safety, study conduct, drug quality, or manufacturing.
Nonetheless, as a result of the CRL, the company said it will no longer pursue an expanded indication for patisiran in cardiomyopathy of ATTR amyloidosis in the United States.
The company said it will continue to make patisiran available for patients with cardiomyopathy of ATTR amyloidosis who are enrolled in the open-label extension period of the APOLLO-B study and the patisiran expanded access protocol.
The company also said it will continue to focus on the HELIOS-B phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy of ATTR amyloidosis.
“We remain confident in the HELIOS-B phase 3 study of vutrisiran and look forward to sharing topline results in early 2024. If successful, we believe vutrisiran will offer convenient, quarterly subcutaneous dosing with a therapeutic profile that may potentially include cardiovascular outcome benefits,” Alnylam CEO Yvonne Greenstreet, MBChB, said in the statement.
Intravenously administered patisiran is already approved in the United States and Canada for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
A version of this article first appeared on Medscape.com.
the company has announced.
ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
In September, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy on the basis of the results of the APOLLO-B phase 3 study.
However, many panel members questioned whether the benefits are clinically meaningful – a view shared by the FDA in a complete response letter (CRL) the FDA sent to Alnylam.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have “not been established,” and therefore, the supplemental new drug application for patisiran “could not be approved in its present form.”
The FDA did not identify any issues with respect to clinical safety, study conduct, drug quality, or manufacturing.
Nonetheless, as a result of the CRL, the company said it will no longer pursue an expanded indication for patisiran in cardiomyopathy of ATTR amyloidosis in the United States.
The company said it will continue to make patisiran available for patients with cardiomyopathy of ATTR amyloidosis who are enrolled in the open-label extension period of the APOLLO-B study and the patisiran expanded access protocol.
The company also said it will continue to focus on the HELIOS-B phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy of ATTR amyloidosis.
“We remain confident in the HELIOS-B phase 3 study of vutrisiran and look forward to sharing topline results in early 2024. If successful, we believe vutrisiran will offer convenient, quarterly subcutaneous dosing with a therapeutic profile that may potentially include cardiovascular outcome benefits,” Alnylam CEO Yvonne Greenstreet, MBChB, said in the statement.
Intravenously administered patisiran is already approved in the United States and Canada for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
A version of this article first appeared on Medscape.com.
the company has announced.
ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
In September, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy on the basis of the results of the APOLLO-B phase 3 study.
However, many panel members questioned whether the benefits are clinically meaningful – a view shared by the FDA in a complete response letter (CRL) the FDA sent to Alnylam.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have “not been established,” and therefore, the supplemental new drug application for patisiran “could not be approved in its present form.”
The FDA did not identify any issues with respect to clinical safety, study conduct, drug quality, or manufacturing.
Nonetheless, as a result of the CRL, the company said it will no longer pursue an expanded indication for patisiran in cardiomyopathy of ATTR amyloidosis in the United States.
The company said it will continue to make patisiran available for patients with cardiomyopathy of ATTR amyloidosis who are enrolled in the open-label extension period of the APOLLO-B study and the patisiran expanded access protocol.
The company also said it will continue to focus on the HELIOS-B phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy of ATTR amyloidosis.
“We remain confident in the HELIOS-B phase 3 study of vutrisiran and look forward to sharing topline results in early 2024. If successful, we believe vutrisiran will offer convenient, quarterly subcutaneous dosing with a therapeutic profile that may potentially include cardiovascular outcome benefits,” Alnylam CEO Yvonne Greenstreet, MBChB, said in the statement.
Intravenously administered patisiran is already approved in the United States and Canada for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
A version of this article first appeared on Medscape.com.
Illicit steroids: If MDs don’t ask, patients won’t tell
Before he attended medical school, Thomas O’Connor, MD, had a not-very-well-kept secret: As a competitive powerlifter, he had used steroids to build strength.
Now an internist and clinical instructor of medicine at the University of Connecticut, Farmington, Dr. O’Connor’s practice focuses on the needs of men taking testosterone and other anabolic steroids – a group he feels is poorly understood and largely neglected by conventional medical care, perceptions borne out by a 2020 study of steroid users he helped conduct.
“They felt discriminated against, they did not feel comfortable working with their physicians, and they felt that the doctors did not know what they were doing,” Dr. O’Connor said in an interview. His patients often express anger and frustration with doctors they had seen previously.
Patients turning to home tests
Clients can order a panel of labs designed to screen for health conditions commonly associated with use of AAS, such as dyslipidemia, renal and hepatic dysfunction, polycythemia, thrombosis, and insulin resistance. The panels also include tests for levels of different hormones.
Sales of direct-to-consumer tests topped $3.6 billion in the United States in 2022 and are predicted to grow. Some of that spending is coming from people, mostly men, using illegally obtained steroids to build muscle. Although published data on the size of the bodybuilder market are unavailable, the Internet is a ready source of relatively inexpensive tests aimed at helping individuals monitor their health.
While clinicians may have their doubts about allowing patients to pick and choose tests and interpret their results, proponents claim they empower consumers to take control of their health – and save themselves money in the process.
But a test panel designed to help the user monitor the effects of banned substances is a bit unnerving to many clinicians, including Dr. O’Connor.
“People using anabolic steroids should be aware of the health risks associated with such use and that laboratory analysis is an important step toward improving health outcomes,” he said, “I’m all about open education, but not self-diagnosis and treatment.”
Testosterone and other AAS such as nandrolone, trenbolone, and boldenone are Schedule III controlled substances that have been banned by numerous athletic governing bodies. Yet recreational users can easily obtain them from online international pharmacies without a prescription. Should they be monitoring themselves for side effects?
A basic problem is that few primary care clinicians routinely ask their patients about the use of AAS or feel competent to manage the complications or withdrawal symptoms associated with the agents. And they may have no idea what the average AAS user looks like.
The American College of Sports Medicine updated its statement on the use of AAS in 2021. The statement warned of a growing new segment of users – up to 70% of people who take the drugs do so recreationally in pursuit of a more muscular appearance, rather than competitive athletes seeking enhanced performance.
The ACSM highlighted the syndrome of muscle dysmorphia, also known as “megarexia” or “bigorexia” (think of it as “reverse anorexia”), as a major risk factor for illicit use of AAS.
Stuart Phillips, PhD, professor and director of the department of kinesiology at McMaster University, Hamilton, Ont., coauthored the ACSM guidelines.
“The prince in Snow White circa 1950s was a guy with nice hair,” said Dr. Phillips, pointing to a change in cultural expectations for the male body. “But then fast forward to the prince or hero in any other Disney movie recently – and the guy is jacked.”
Since the last guidelines were published in 1987, Dr. Phillips has seen some cultural shifts. Testosterone has gone from a banned substance no one talked about to a mainstream medical therapy for men with low androgen levels, as any television viewer of primetime sports can attest. “But the other thing that’s changed,” he added, “is that we’ve seen the proliferation of illicit anabolic steroid use solely for the purpose of aesthetics.”
As an adolescent medicine physician who specializes in eating disorders, Jason Nagata, MD, MSc, sees many young men in his practice who engage in different behaviors to increase their muscle mass – from exercising, consuming high protein diets or taking protein supplements, even injecting AAS.
“A third of teenage boys across the U.S. report they’re trying to gain weight to bulk up and gain muscle,” said Dr. Nagata, an associate professor of pediatrics at the University of California, San Francisco.
In a 2020 study published in JAMA Pediatrics, Dr. Nagata and colleagues found that use of legal performance-enhancing substances in young men aged 18-26 years was associated with a higher odds of using AAS 7 years later (adjusted odds ratio, 3.18; 95% confidence interval, 1.90-5.32). “Some of the legal performance-enhancing substances like the protein powders or creatine may serve as a gateway to use of AAS,” Dr. Nagata said.
Another important factor is exposure to AAS use on social media, where muscular influencers gain huge followings. Dr. Nagata said most of the research on eating disorders and social media has examined the role of media on weight loss in girls.
“Although there’s less research on the social media impact on boys and men, a few studies have shown links between more Instagram use and muscle dissatisfaction, as well as thinking about using steroids,” he said.
The number of people using AAS is not trivial. In a longitudinal study (led by Nagata) of young U.S. adults surveyed multiple times between 1994 and 2002, a total of 2.7% of 18- to 26-year-old men and 0.4% of women reported using AAS. In a more recent cohort of adolescents in Minnesota aged 14-22 years followed between 2010 and 2018, a total of 2.2% of males and 1% of females initiated AAS use.
The Endocrine Society has estimated that between 2.9 and 4 million Americans have used an AAS at some point in their lives. Given that use is illegal without a prescription, a limitation of any survey is that participants may not be willing to disclose their AAS habit, leading to an underestimate of the actual number.
Nor are the complications of AAS use negligible. The drugs can have wide-ranging effects on the body, potentially affecting the brain, heart, liver, kidneys, musculoskeletal system, immune system, and reproductive systems. And individuals might unknowingly expose themselves to AAS: A recent literature review found that over a quarter of dietary supplements tested were found to contain undeclared substances that are on the World Anti-Doping Agency’s list of banned agents.
Alarming mistrust of MDs
Dr. O’Connor’s study shed some light on why AAS users might resort to surfing the Internet looking for a way to diagnose their own complications from steroid use. The web-based survey of nearly 2,400 men who said they took the drugs found that participants considered physicians to be the worst source of information, ranking them below coaches, online bodybuilding forums and sites, other AAS users, and bodybuilding books or magazines. The majority (56%) did not reveal AAS use to their clinicians. Of those who did, 55% reported feeling discriminated against for the admission.
Dr. O’Connor said physicians receive scant education on the many different drugs and regimens used by bodybuilders and have no idea how to a manage withdrawal syndrome for people trying to get off steroids. He urged the medical community to develop an educational campaign for clinicians, similar to those from public health officials aimed at combating the opioid epidemic: “Let’s educate med students and the residents. Let’s put [steroid use] on our agenda.”
Consumer testing evangelist ... or physician nemesis?
Nelson Vergel, BSChE, MBA, is on a mission to make medical lab testing affordable and accessible to everyone. The chemical engineer founded Discounted Labs 8 years ago, offering commonly ordered tests, such as complete blood counts, liver function tests, and cholesterol levels.
Mr. Vergel has advocated for the use of hormones to treat HIV-wasting disease for nearly 40 years, after his own diagnosis of the infection in 1986. After losing 40 pounds, steroids saved his life, he said.
Mr. Vergel said he was shocked to learn about the lack of continuing medical education on AAS for physicians and agreed with Dr. O’Connor that more training is needed for the medical profession. He also recognized that stigma on the part of clinicians is a huge barrier for many AAS users.
“We have to accept the fact that people are using them instead of demonizing them,” Mr. Vergel said. “What I was seeing is that there was so much stigma – and patients would not even talk to their doctors about their use.”
After reviewing Google analytics for his lab’s website and seeing how often “bodybuilder” came up as a search term, he added a panel of labs a year ago that allows AAS users to monitor themselves for adverse events.
Although he doesn’t condone the use of AAS without a medical indication and advises customers to discuss their results with a doctor, “we have to make sure people are reducing their harm or risk,” he said. “That’s really my goal.”
Many health care professionals would disagree with that statement. Dr. Nagata said he was concerned that management of side effects is too complicated. “There are a lot of nuances in the interpretation of these tests.” Arriving at the correct interpretation of the results requires a clinician’s thorough review of each patient’s health history, family history, and mental health history along with lab results.
‘I’m concerned’
In a second article outlining harm-reduction strategies designed to improve care for patients using AAS, Dr. O’Connor and colleagues outlined an approach for talking with patients who are concerned about their health and are seeking guidance from a clinician.
The first step is to work on developing a rapport, and not to demand that patients stop their use of AAS. His recommended opening line is: “I want to be honest with you – I’m concerned.”
The initial interaction is an opportunity to find out why the person uses AAS, what health concerns they have at present, and why they are seeking care. Open-ended questions may reveal concerns that the patient has about fertility or side effects.
Consistent with harm-reduction approaches used for other public health epidemics – such as opioid abuse and blood-borne pathogens among people who inject drugs – follow-up visits can include nonjudgmental discussions about decreasing or stopping their use.
Ultimately, minimizing the harms of AAS use can serve as a bridge to their cessation, but the medical community needs to build up trust with a community of users who currently rely more on each other and the Internet for guidance than their primary care physicians. “We need more education. We’re going to need resources to do it,” Dr. O’Connell said. “And we’re going to have to do it.”
Dr. Phillips and Dr. Nagata have no financial disclosures. Mr. Vergel is the owner and founder of Discounted Labs but reported no other financial conflicts. Dr. O’Connor owns Anabolic Doc but has no additional financial disclosures.
A version of this article first appeared on Medscape.com.
Before he attended medical school, Thomas O’Connor, MD, had a not-very-well-kept secret: As a competitive powerlifter, he had used steroids to build strength.
Now an internist and clinical instructor of medicine at the University of Connecticut, Farmington, Dr. O’Connor’s practice focuses on the needs of men taking testosterone and other anabolic steroids – a group he feels is poorly understood and largely neglected by conventional medical care, perceptions borne out by a 2020 study of steroid users he helped conduct.
“They felt discriminated against, they did not feel comfortable working with their physicians, and they felt that the doctors did not know what they were doing,” Dr. O’Connor said in an interview. His patients often express anger and frustration with doctors they had seen previously.
Patients turning to home tests
Clients can order a panel of labs designed to screen for health conditions commonly associated with use of AAS, such as dyslipidemia, renal and hepatic dysfunction, polycythemia, thrombosis, and insulin resistance. The panels also include tests for levels of different hormones.
Sales of direct-to-consumer tests topped $3.6 billion in the United States in 2022 and are predicted to grow. Some of that spending is coming from people, mostly men, using illegally obtained steroids to build muscle. Although published data on the size of the bodybuilder market are unavailable, the Internet is a ready source of relatively inexpensive tests aimed at helping individuals monitor their health.
While clinicians may have their doubts about allowing patients to pick and choose tests and interpret their results, proponents claim they empower consumers to take control of their health – and save themselves money in the process.
But a test panel designed to help the user monitor the effects of banned substances is a bit unnerving to many clinicians, including Dr. O’Connor.
“People using anabolic steroids should be aware of the health risks associated with such use and that laboratory analysis is an important step toward improving health outcomes,” he said, “I’m all about open education, but not self-diagnosis and treatment.”
Testosterone and other AAS such as nandrolone, trenbolone, and boldenone are Schedule III controlled substances that have been banned by numerous athletic governing bodies. Yet recreational users can easily obtain them from online international pharmacies without a prescription. Should they be monitoring themselves for side effects?
A basic problem is that few primary care clinicians routinely ask their patients about the use of AAS or feel competent to manage the complications or withdrawal symptoms associated with the agents. And they may have no idea what the average AAS user looks like.
The American College of Sports Medicine updated its statement on the use of AAS in 2021. The statement warned of a growing new segment of users – up to 70% of people who take the drugs do so recreationally in pursuit of a more muscular appearance, rather than competitive athletes seeking enhanced performance.
The ACSM highlighted the syndrome of muscle dysmorphia, also known as “megarexia” or “bigorexia” (think of it as “reverse anorexia”), as a major risk factor for illicit use of AAS.
Stuart Phillips, PhD, professor and director of the department of kinesiology at McMaster University, Hamilton, Ont., coauthored the ACSM guidelines.
“The prince in Snow White circa 1950s was a guy with nice hair,” said Dr. Phillips, pointing to a change in cultural expectations for the male body. “But then fast forward to the prince or hero in any other Disney movie recently – and the guy is jacked.”
Since the last guidelines were published in 1987, Dr. Phillips has seen some cultural shifts. Testosterone has gone from a banned substance no one talked about to a mainstream medical therapy for men with low androgen levels, as any television viewer of primetime sports can attest. “But the other thing that’s changed,” he added, “is that we’ve seen the proliferation of illicit anabolic steroid use solely for the purpose of aesthetics.”
As an adolescent medicine physician who specializes in eating disorders, Jason Nagata, MD, MSc, sees many young men in his practice who engage in different behaviors to increase their muscle mass – from exercising, consuming high protein diets or taking protein supplements, even injecting AAS.
“A third of teenage boys across the U.S. report they’re trying to gain weight to bulk up and gain muscle,” said Dr. Nagata, an associate professor of pediatrics at the University of California, San Francisco.
In a 2020 study published in JAMA Pediatrics, Dr. Nagata and colleagues found that use of legal performance-enhancing substances in young men aged 18-26 years was associated with a higher odds of using AAS 7 years later (adjusted odds ratio, 3.18; 95% confidence interval, 1.90-5.32). “Some of the legal performance-enhancing substances like the protein powders or creatine may serve as a gateway to use of AAS,” Dr. Nagata said.
Another important factor is exposure to AAS use on social media, where muscular influencers gain huge followings. Dr. Nagata said most of the research on eating disorders and social media has examined the role of media on weight loss in girls.
“Although there’s less research on the social media impact on boys and men, a few studies have shown links between more Instagram use and muscle dissatisfaction, as well as thinking about using steroids,” he said.
The number of people using AAS is not trivial. In a longitudinal study (led by Nagata) of young U.S. adults surveyed multiple times between 1994 and 2002, a total of 2.7% of 18- to 26-year-old men and 0.4% of women reported using AAS. In a more recent cohort of adolescents in Minnesota aged 14-22 years followed between 2010 and 2018, a total of 2.2% of males and 1% of females initiated AAS use.
The Endocrine Society has estimated that between 2.9 and 4 million Americans have used an AAS at some point in their lives. Given that use is illegal without a prescription, a limitation of any survey is that participants may not be willing to disclose their AAS habit, leading to an underestimate of the actual number.
Nor are the complications of AAS use negligible. The drugs can have wide-ranging effects on the body, potentially affecting the brain, heart, liver, kidneys, musculoskeletal system, immune system, and reproductive systems. And individuals might unknowingly expose themselves to AAS: A recent literature review found that over a quarter of dietary supplements tested were found to contain undeclared substances that are on the World Anti-Doping Agency’s list of banned agents.
Alarming mistrust of MDs
Dr. O’Connor’s study shed some light on why AAS users might resort to surfing the Internet looking for a way to diagnose their own complications from steroid use. The web-based survey of nearly 2,400 men who said they took the drugs found that participants considered physicians to be the worst source of information, ranking them below coaches, online bodybuilding forums and sites, other AAS users, and bodybuilding books or magazines. The majority (56%) did not reveal AAS use to their clinicians. Of those who did, 55% reported feeling discriminated against for the admission.
Dr. O’Connor said physicians receive scant education on the many different drugs and regimens used by bodybuilders and have no idea how to a manage withdrawal syndrome for people trying to get off steroids. He urged the medical community to develop an educational campaign for clinicians, similar to those from public health officials aimed at combating the opioid epidemic: “Let’s educate med students and the residents. Let’s put [steroid use] on our agenda.”
Consumer testing evangelist ... or physician nemesis?
Nelson Vergel, BSChE, MBA, is on a mission to make medical lab testing affordable and accessible to everyone. The chemical engineer founded Discounted Labs 8 years ago, offering commonly ordered tests, such as complete blood counts, liver function tests, and cholesterol levels.
Mr. Vergel has advocated for the use of hormones to treat HIV-wasting disease for nearly 40 years, after his own diagnosis of the infection in 1986. After losing 40 pounds, steroids saved his life, he said.
Mr. Vergel said he was shocked to learn about the lack of continuing medical education on AAS for physicians and agreed with Dr. O’Connor that more training is needed for the medical profession. He also recognized that stigma on the part of clinicians is a huge barrier for many AAS users.
“We have to accept the fact that people are using them instead of demonizing them,” Mr. Vergel said. “What I was seeing is that there was so much stigma – and patients would not even talk to their doctors about their use.”
After reviewing Google analytics for his lab’s website and seeing how often “bodybuilder” came up as a search term, he added a panel of labs a year ago that allows AAS users to monitor themselves for adverse events.
Although he doesn’t condone the use of AAS without a medical indication and advises customers to discuss their results with a doctor, “we have to make sure people are reducing their harm or risk,” he said. “That’s really my goal.”
Many health care professionals would disagree with that statement. Dr. Nagata said he was concerned that management of side effects is too complicated. “There are a lot of nuances in the interpretation of these tests.” Arriving at the correct interpretation of the results requires a clinician’s thorough review of each patient’s health history, family history, and mental health history along with lab results.
‘I’m concerned’
In a second article outlining harm-reduction strategies designed to improve care for patients using AAS, Dr. O’Connor and colleagues outlined an approach for talking with patients who are concerned about their health and are seeking guidance from a clinician.
The first step is to work on developing a rapport, and not to demand that patients stop their use of AAS. His recommended opening line is: “I want to be honest with you – I’m concerned.”
The initial interaction is an opportunity to find out why the person uses AAS, what health concerns they have at present, and why they are seeking care. Open-ended questions may reveal concerns that the patient has about fertility or side effects.
Consistent with harm-reduction approaches used for other public health epidemics – such as opioid abuse and blood-borne pathogens among people who inject drugs – follow-up visits can include nonjudgmental discussions about decreasing or stopping their use.
Ultimately, minimizing the harms of AAS use can serve as a bridge to their cessation, but the medical community needs to build up trust with a community of users who currently rely more on each other and the Internet for guidance than their primary care physicians. “We need more education. We’re going to need resources to do it,” Dr. O’Connell said. “And we’re going to have to do it.”
Dr. Phillips and Dr. Nagata have no financial disclosures. Mr. Vergel is the owner and founder of Discounted Labs but reported no other financial conflicts. Dr. O’Connor owns Anabolic Doc but has no additional financial disclosures.
A version of this article first appeared on Medscape.com.
Before he attended medical school, Thomas O’Connor, MD, had a not-very-well-kept secret: As a competitive powerlifter, he had used steroids to build strength.
Now an internist and clinical instructor of medicine at the University of Connecticut, Farmington, Dr. O’Connor’s practice focuses on the needs of men taking testosterone and other anabolic steroids – a group he feels is poorly understood and largely neglected by conventional medical care, perceptions borne out by a 2020 study of steroid users he helped conduct.
“They felt discriminated against, they did not feel comfortable working with their physicians, and they felt that the doctors did not know what they were doing,” Dr. O’Connor said in an interview. His patients often express anger and frustration with doctors they had seen previously.
Patients turning to home tests
Clients can order a panel of labs designed to screen for health conditions commonly associated with use of AAS, such as dyslipidemia, renal and hepatic dysfunction, polycythemia, thrombosis, and insulin resistance. The panels also include tests for levels of different hormones.
Sales of direct-to-consumer tests topped $3.6 billion in the United States in 2022 and are predicted to grow. Some of that spending is coming from people, mostly men, using illegally obtained steroids to build muscle. Although published data on the size of the bodybuilder market are unavailable, the Internet is a ready source of relatively inexpensive tests aimed at helping individuals monitor their health.
While clinicians may have their doubts about allowing patients to pick and choose tests and interpret their results, proponents claim they empower consumers to take control of their health – and save themselves money in the process.
But a test panel designed to help the user monitor the effects of banned substances is a bit unnerving to many clinicians, including Dr. O’Connor.
“People using anabolic steroids should be aware of the health risks associated with such use and that laboratory analysis is an important step toward improving health outcomes,” he said, “I’m all about open education, but not self-diagnosis and treatment.”
Testosterone and other AAS such as nandrolone, trenbolone, and boldenone are Schedule III controlled substances that have been banned by numerous athletic governing bodies. Yet recreational users can easily obtain them from online international pharmacies without a prescription. Should they be monitoring themselves for side effects?
A basic problem is that few primary care clinicians routinely ask their patients about the use of AAS or feel competent to manage the complications or withdrawal symptoms associated with the agents. And they may have no idea what the average AAS user looks like.
The American College of Sports Medicine updated its statement on the use of AAS in 2021. The statement warned of a growing new segment of users – up to 70% of people who take the drugs do so recreationally in pursuit of a more muscular appearance, rather than competitive athletes seeking enhanced performance.
The ACSM highlighted the syndrome of muscle dysmorphia, also known as “megarexia” or “bigorexia” (think of it as “reverse anorexia”), as a major risk factor for illicit use of AAS.
Stuart Phillips, PhD, professor and director of the department of kinesiology at McMaster University, Hamilton, Ont., coauthored the ACSM guidelines.
“The prince in Snow White circa 1950s was a guy with nice hair,” said Dr. Phillips, pointing to a change in cultural expectations for the male body. “But then fast forward to the prince or hero in any other Disney movie recently – and the guy is jacked.”
Since the last guidelines were published in 1987, Dr. Phillips has seen some cultural shifts. Testosterone has gone from a banned substance no one talked about to a mainstream medical therapy for men with low androgen levels, as any television viewer of primetime sports can attest. “But the other thing that’s changed,” he added, “is that we’ve seen the proliferation of illicit anabolic steroid use solely for the purpose of aesthetics.”
As an adolescent medicine physician who specializes in eating disorders, Jason Nagata, MD, MSc, sees many young men in his practice who engage in different behaviors to increase their muscle mass – from exercising, consuming high protein diets or taking protein supplements, even injecting AAS.
“A third of teenage boys across the U.S. report they’re trying to gain weight to bulk up and gain muscle,” said Dr. Nagata, an associate professor of pediatrics at the University of California, San Francisco.
In a 2020 study published in JAMA Pediatrics, Dr. Nagata and colleagues found that use of legal performance-enhancing substances in young men aged 18-26 years was associated with a higher odds of using AAS 7 years later (adjusted odds ratio, 3.18; 95% confidence interval, 1.90-5.32). “Some of the legal performance-enhancing substances like the protein powders or creatine may serve as a gateway to use of AAS,” Dr. Nagata said.
Another important factor is exposure to AAS use on social media, where muscular influencers gain huge followings. Dr. Nagata said most of the research on eating disorders and social media has examined the role of media on weight loss in girls.
“Although there’s less research on the social media impact on boys and men, a few studies have shown links between more Instagram use and muscle dissatisfaction, as well as thinking about using steroids,” he said.
The number of people using AAS is not trivial. In a longitudinal study (led by Nagata) of young U.S. adults surveyed multiple times between 1994 and 2002, a total of 2.7% of 18- to 26-year-old men and 0.4% of women reported using AAS. In a more recent cohort of adolescents in Minnesota aged 14-22 years followed between 2010 and 2018, a total of 2.2% of males and 1% of females initiated AAS use.
The Endocrine Society has estimated that between 2.9 and 4 million Americans have used an AAS at some point in their lives. Given that use is illegal without a prescription, a limitation of any survey is that participants may not be willing to disclose their AAS habit, leading to an underestimate of the actual number.
Nor are the complications of AAS use negligible. The drugs can have wide-ranging effects on the body, potentially affecting the brain, heart, liver, kidneys, musculoskeletal system, immune system, and reproductive systems. And individuals might unknowingly expose themselves to AAS: A recent literature review found that over a quarter of dietary supplements tested were found to contain undeclared substances that are on the World Anti-Doping Agency’s list of banned agents.
Alarming mistrust of MDs
Dr. O’Connor’s study shed some light on why AAS users might resort to surfing the Internet looking for a way to diagnose their own complications from steroid use. The web-based survey of nearly 2,400 men who said they took the drugs found that participants considered physicians to be the worst source of information, ranking them below coaches, online bodybuilding forums and sites, other AAS users, and bodybuilding books or magazines. The majority (56%) did not reveal AAS use to their clinicians. Of those who did, 55% reported feeling discriminated against for the admission.
Dr. O’Connor said physicians receive scant education on the many different drugs and regimens used by bodybuilders and have no idea how to a manage withdrawal syndrome for people trying to get off steroids. He urged the medical community to develop an educational campaign for clinicians, similar to those from public health officials aimed at combating the opioid epidemic: “Let’s educate med students and the residents. Let’s put [steroid use] on our agenda.”
Consumer testing evangelist ... or physician nemesis?
Nelson Vergel, BSChE, MBA, is on a mission to make medical lab testing affordable and accessible to everyone. The chemical engineer founded Discounted Labs 8 years ago, offering commonly ordered tests, such as complete blood counts, liver function tests, and cholesterol levels.
Mr. Vergel has advocated for the use of hormones to treat HIV-wasting disease for nearly 40 years, after his own diagnosis of the infection in 1986. After losing 40 pounds, steroids saved his life, he said.
Mr. Vergel said he was shocked to learn about the lack of continuing medical education on AAS for physicians and agreed with Dr. O’Connor that more training is needed for the medical profession. He also recognized that stigma on the part of clinicians is a huge barrier for many AAS users.
“We have to accept the fact that people are using them instead of demonizing them,” Mr. Vergel said. “What I was seeing is that there was so much stigma – and patients would not even talk to their doctors about their use.”
After reviewing Google analytics for his lab’s website and seeing how often “bodybuilder” came up as a search term, he added a panel of labs a year ago that allows AAS users to monitor themselves for adverse events.
Although he doesn’t condone the use of AAS without a medical indication and advises customers to discuss their results with a doctor, “we have to make sure people are reducing their harm or risk,” he said. “That’s really my goal.”
Many health care professionals would disagree with that statement. Dr. Nagata said he was concerned that management of side effects is too complicated. “There are a lot of nuances in the interpretation of these tests.” Arriving at the correct interpretation of the results requires a clinician’s thorough review of each patient’s health history, family history, and mental health history along with lab results.
‘I’m concerned’
In a second article outlining harm-reduction strategies designed to improve care for patients using AAS, Dr. O’Connor and colleagues outlined an approach for talking with patients who are concerned about their health and are seeking guidance from a clinician.
The first step is to work on developing a rapport, and not to demand that patients stop their use of AAS. His recommended opening line is: “I want to be honest with you – I’m concerned.”
The initial interaction is an opportunity to find out why the person uses AAS, what health concerns they have at present, and why they are seeking care. Open-ended questions may reveal concerns that the patient has about fertility or side effects.
Consistent with harm-reduction approaches used for other public health epidemics – such as opioid abuse and blood-borne pathogens among people who inject drugs – follow-up visits can include nonjudgmental discussions about decreasing or stopping their use.
Ultimately, minimizing the harms of AAS use can serve as a bridge to their cessation, but the medical community needs to build up trust with a community of users who currently rely more on each other and the Internet for guidance than their primary care physicians. “We need more education. We’re going to need resources to do it,” Dr. O’Connell said. “And we’re going to have to do it.”
Dr. Phillips and Dr. Nagata have no financial disclosures. Mr. Vergel is the owner and founder of Discounted Labs but reported no other financial conflicts. Dr. O’Connor owns Anabolic Doc but has no additional financial disclosures.
A version of this article first appeared on Medscape.com.