Daniel Einhorn, MD; John Buse, MD, PhD; Ralph DeFronzo, MD; Juan Pablo Frias, MD, and Christopher Lucci, MD, share their insights and perspectives on the connection between difficult-to control T2DM and untreated hypercortisolism:

• Almost a quarter of patients with type 2 diabetes (T2DM) require 3 or more medications to manage their disease, and even then, many patients have difficulty getting their diabetes under control¹

• Elevated cortisol activity can exacerbate the pathophysiology of T2DM and can counter the impact of traditional anti-diabetic medications, making diabetes control challenging^2-6

• Studies emerging over the last two decades suggest that up to 10% of patients with T2DM may have hypercortisolism^7-11

• Patients with treatment-resistant T2DM should therefore be evaluated for hypercortisolism

• Treating the underlying hypercortisolism is important in these patients because managing comorbidities (alone) has not significantly reduced morbidity and mortality^12,13

Daniel Einhorn, MD
Meeting Moderator
Vice President
Endocrine Strategy
Corcept Therapeutics
Menlo Park, CA

John Buse, MD, PhD
University of North Carolina
School of Medicine
UNC Diabetes and Endocrinology Clinic
Chapel Hill, NC

Ralph DeFronzo, MD
University of Texas
Health Science Center
San Antonio, TX

Juan Pablo Frias, MD
Velocity Clinical Research
Los Angeles, CA

Christopher Lucci, MD
Diabetes and Cardiovascular of Rockport
Rockport, TX

 

Click HERE to read the supplement.

References

1. Fang M, et al. N Engl J Med. 2021;384(23):2219-2228.
2. Scaroni C, et al. Endocr Rev. 2017;38(3):189-219.
3. Mazziotti G, et al. Trends Endocrinol Metab. 2011;22(12):499-506.
4. Pivonello R, et al. Neuroendocrinology. 2010;92(suppl 1):77-81.
5. Mason IC, et al. Diabetologia. 2020;63(3):462-472.
6. Thau L, et al. StatPearls [Internet]. Updated August 29, 2022. Accessed February 3, 2023. https://www.ncbi.nlm.nih.gov/books/NBK538239/
7. Chiodini I, et al. Eur J Endocrinol. 2005;153(6):837-844.
8. Catargi B, et al. J Clin Endocrinol Metab. 2003;88(12):5808-5813.
9. Costa DS, et al. J Diabetes Complications. 2016;30(6):1032-1038.
10. Leon-Justel A, et al. J Clin Endocrinol Metab. 2016;101(10):3747-3754.
11. Steffensen C, et al. Horm Metab Res. 2019;51(1):62-68.
12. Petramala L, et al. Endocrine. 2020;70(1):150-163.
13. Morelli V, et al. Front Endocrinol (Lausanne). 2022;13:898084.

©2023 Corcept Therapeutics Incorporated. All Rights Reserved. DSE-01055 SEP 2023

Daniel Einhorn, MD; John Buse, MD, PhD; Ralph DeFronzo, MD; Juan Pablo Frias, MD, and Christopher Lucci, MD, share their insights and perspectives on the connection between difficult-to control T2DM and untreated hypercortisolism:

• Almost a quarter of patients with type 2 diabetes (T2DM) require 3 or more medications to manage their disease, and even then, many patients have difficulty getting their diabetes under control¹

• Elevated cortisol activity can exacerbate the pathophysiology of T2DM and can counter the impact of traditional anti-diabetic medications, making diabetes control challenging^2-6

• Studies emerging over the last two decades suggest that up to 10% of patients with T2DM may have hypercortisolism^7-11

• Patients with treatment-resistant T2DM should therefore be evaluated for hypercortisolism

• Treating the underlying hypercortisolism is important in these patients because managing comorbidities (alone) has not significantly reduced morbidity and mortality^12,13

Daniel Einhorn, MD
Meeting Moderator
Vice President
Endocrine Strategy
Corcept Therapeutics
Menlo Park, CA

John Buse, MD, PhD
University of North Carolina
School of Medicine
UNC Diabetes and Endocrinology Clinic
Chapel Hill, NC

Ralph DeFronzo, MD
University of Texas
Health Science Center
San Antonio, TX

Juan Pablo Frias, MD
Velocity Clinical Research
Los Angeles, CA

Christopher Lucci, MD
Diabetes and Cardiovascular of Rockport
Rockport, TX

 

Click HERE to read the supplement.

References

1. Fang M, et al. N Engl J Med. 2021;384(23):2219-2228.
2. Scaroni C, et al. Endocr Rev. 2017;38(3):189-219.
3. Mazziotti G, et al. Trends Endocrinol Metab. 2011;22(12):499-506.
4. Pivonello R, et al. Neuroendocrinology. 2010;92(suppl 1):77-81.
5. Mason IC, et al. Diabetologia. 2020;63(3):462-472.
6. Thau L, et al. StatPearls [Internet]. Updated August 29, 2022. Accessed February 3, 2023. https://www.ncbi.nlm.nih.gov/books/NBK538239/
7. Chiodini I, et al. Eur J Endocrinol. 2005;153(6):837-844.
8. Catargi B, et al. J Clin Endocrinol Metab. 2003;88(12):5808-5813.
9. Costa DS, et al. J Diabetes Complications. 2016;30(6):1032-1038.
10. Leon-Justel A, et al. J Clin Endocrinol Metab. 2016;101(10):3747-3754.
11. Steffensen C, et al. Horm Metab Res. 2019;51(1):62-68.
12. Petramala L, et al. Endocrine. 2020;70(1):150-163.
13. Morelli V, et al. Front Endocrinol (Lausanne). 2022;13:898084.

©2023 Corcept Therapeutics Incorporated. All Rights Reserved. DSE-01055 SEP 2023

Daniel Einhorn, MD; John Buse, MD, PhD; Ralph DeFronzo, MD; Juan Pablo Frias, MD, and Christopher Lucci, MD, share their insights and perspectives on the connection between difficult-to control T2DM and untreated hypercortisolism:

• Almost a quarter of patients with type 2 diabetes (T2DM) require 3 or more medications to manage their disease, and even then, many patients have difficulty getting their diabetes under control¹

• Elevated cortisol activity can exacerbate the pathophysiology of T2DM and can counter the impact of traditional anti-diabetic medications, making diabetes control challenging^2-6

• Studies emerging over the last two decades suggest that up to 10% of patients with T2DM may have hypercortisolism^7-11

• Patients with treatment-resistant T2DM should therefore be evaluated for hypercortisolism

• Treating the underlying hypercortisolism is important in these patients because managing comorbidities (alone) has not significantly reduced morbidity and mortality^12,13

Daniel Einhorn, MD
Meeting Moderator
Vice President
Endocrine Strategy
Corcept Therapeutics
Menlo Park, CA

John Buse, MD, PhD
University of North Carolina
School of Medicine
UNC Diabetes and Endocrinology Clinic
Chapel Hill, NC

Ralph DeFronzo, MD
University of Texas
Health Science Center
San Antonio, TX

Juan Pablo Frias, MD
Velocity Clinical Research
Los Angeles, CA

Christopher Lucci, MD
Diabetes and Cardiovascular of Rockport
Rockport, TX

 

Click HERE to read the supplement.

References

1. Fang M, et al. N Engl J Med. 2021;384(23):2219-2228.
2. Scaroni C, et al. Endocr Rev. 2017;38(3):189-219.
3. Mazziotti G, et al. Trends Endocrinol Metab. 2011;22(12):499-506.
4. Pivonello R, et al. Neuroendocrinology. 2010;92(suppl 1):77-81.
5. Mason IC, et al. Diabetologia. 2020;63(3):462-472.
6. Thau L, et al. StatPearls [Internet]. Updated August 29, 2022. Accessed February 3, 2023. https://www.ncbi.nlm.nih.gov/books/NBK538239/
7. Chiodini I, et al. Eur J Endocrinol. 2005;153(6):837-844.
8. Catargi B, et al. J Clin Endocrinol Metab. 2003;88(12):5808-5813.
9. Costa DS, et al. J Diabetes Complications. 2016;30(6):1032-1038.
10. Leon-Justel A, et al. J Clin Endocrinol Metab. 2016;101(10):3747-3754.
11. Steffensen C, et al. Horm Metab Res. 2019;51(1):62-68.
12. Petramala L, et al. Endocrine. 2020;70(1):150-163.
13. Morelli V, et al. Front Endocrinol (Lausanne). 2022;13:898084.

©2023 Corcept Therapeutics Incorporated. All Rights Reserved. DSE-01055 SEP 2023

Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.

The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.

Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.

There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.

Duration of effectiveness in infants was one of the main questions the study sought to answer.

The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
 

Answering the ‘blunting’ question

This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.

Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
 

Best time to give mothers the vaccine

Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
 

Positive results in the United States

In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.

The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.

That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.

However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.

“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.

The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
 

Uptake low despite positive data

Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”

Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.

As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”

One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.

Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.

The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.

Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.

There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.

Duration of effectiveness in infants was one of the main questions the study sought to answer.

The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
 

Answering the ‘blunting’ question

This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.

Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
 

Best time to give mothers the vaccine

Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
 

Positive results in the United States

In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.

The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.

That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.

However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.

“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.

The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
 

Uptake low despite positive data

Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”

Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.

As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”

One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.

Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.

The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.

Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.

There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.

Duration of effectiveness in infants was one of the main questions the study sought to answer.

The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
 

Answering the ‘blunting’ question

This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.

Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
 

Best time to give mothers the vaccine

Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”

That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
 

Positive results in the United States

In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.

The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.

That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.

However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.

“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.

The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
 

Uptake low despite positive data

Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”

Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.

As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”

One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.

TOPLINE:

Individuals who visited the ER for substance-induced psychosis had a 160% greater risk of developing a schizophrenia spectrum disorder (SSD), compared with the general population, new research shows. Three years after an initial ER visit, 18.5% of those with substance-induced psychosis were diagnosed with an SSD. Cannabis-induced psychosis was associated with the greatest risk.

METHODOLOGY:

• In this retrospective, population-based cohort study, investigators evaluated the risk of transition to a diagnosis of SSD for individuals with an ER visit for substance use versus the general population.
• Investigators at The Ottawa Hospital and the Institute for Clinical Evaluative Sciences, both in Ontario, analyzed data from six linked databases containing health information on nearly 10 million Ontario residents aged 14-65 years eligible for medical coverage.
• Investigators collected the health data between January 2008 and March 2022 on residents with substance use–related ER visits with, and without, psychosis.

TAKEAWAY:

• There were nearly 408,000 individuals with an ER visit for substance use, of which 13,800 (3.4%) of the visits were for substance-induced psychosis.
• Individuals with substance-induced psychosis were at a 163-fold (age- and sex-adjusted hazard ratio, 163.2; 95% confidence interval, 156.1-170.5) increased risk of transitioning to an SSD, relative to the general population (3-year risk, 18.5% vs. 0.1%).
• Individuals with an ER visit for substance use without psychosis had a lower relative risk of transitioning (aHR, 9.8; 95% CI, 9.5-10.2; 3-year risk, 1.4%) but incurred more than three times the absolute number of transitions (9,969 vs. 3,029).
• ER visits related to cannabis use had the highest transition risk among visits with psychosis (aHR, 241.6; 95% CI, 225.5-258.9) and the third-highest risk among visits without psychosis (aHR, 14.3; 95% CI, 13.5-15.2).
• Younger age and male sex were associated with a higher risk of transition, and the risk of male sex was greater in younger, compared with older, individuals particularly for cannabis use.

IN PRACTICE:

“Primary prevention efforts aimed at reducing substance use and substance use disorders could substantially reduce the population-level burden of chronic psychoses,” the investigators write. “Our findings also highlight the need for targeted secondary prevention providing early intervention and reducing substance use in the highest-risk groups, which may delay or prevent transition to schizophrenia spectrum disorders.”

SOURCE:

Daniel T. Myran, MD, MPH, of the Ottawa Hospital Research Institute, led the study, which was funded by the Canadian Institutes of Health Research and the University of Ottawa department of family medicine. The study was published online in JAMA Psychiatry.

LIMITATIONS:

Investigators did not have access to detailed data on substance-related outpatient visits or patterns of substance use, which could provide additional prognostic information.

DISCLOSURES:

Dr. Myran reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr. Solmi reported receiving honoraria for participation on advisory boards or presentations from AbbVie, Angelini, Lundbeck, and Otsuka outside the submitted work. The remaining authors have disclosed no relevant financial relationships.

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

TOPLINE:

Individuals who visited the ER for substance-induced psychosis had a 160% greater risk of developing a schizophrenia spectrum disorder (SSD), compared with the general population, new research shows. Three years after an initial ER visit, 18.5% of those with substance-induced psychosis were diagnosed with an SSD. Cannabis-induced psychosis was associated with the greatest risk.

METHODOLOGY:

• In this retrospective, population-based cohort study, investigators evaluated the risk of transition to a diagnosis of SSD for individuals with an ER visit for substance use versus the general population.
• Investigators at The Ottawa Hospital and the Institute for Clinical Evaluative Sciences, both in Ontario, analyzed data from six linked databases containing health information on nearly 10 million Ontario residents aged 14-65 years eligible for medical coverage.
• Investigators collected the health data between January 2008 and March 2022 on residents with substance use–related ER visits with, and without, psychosis.

TAKEAWAY:

• There were nearly 408,000 individuals with an ER visit for substance use, of which 13,800 (3.4%) of the visits were for substance-induced psychosis.
• Individuals with substance-induced psychosis were at a 163-fold (age- and sex-adjusted hazard ratio, 163.2; 95% confidence interval, 156.1-170.5) increased risk of transitioning to an SSD, relative to the general population (3-year risk, 18.5% vs. 0.1%).
• Individuals with an ER visit for substance use without psychosis had a lower relative risk of transitioning (aHR, 9.8; 95% CI, 9.5-10.2; 3-year risk, 1.4%) but incurred more than three times the absolute number of transitions (9,969 vs. 3,029).
• ER visits related to cannabis use had the highest transition risk among visits with psychosis (aHR, 241.6; 95% CI, 225.5-258.9) and the third-highest risk among visits without psychosis (aHR, 14.3; 95% CI, 13.5-15.2).
• Younger age and male sex were associated with a higher risk of transition, and the risk of male sex was greater in younger, compared with older, individuals particularly for cannabis use.

IN PRACTICE:

“Primary prevention efforts aimed at reducing substance use and substance use disorders could substantially reduce the population-level burden of chronic psychoses,” the investigators write. “Our findings also highlight the need for targeted secondary prevention providing early intervention and reducing substance use in the highest-risk groups, which may delay or prevent transition to schizophrenia spectrum disorders.”

SOURCE:

Daniel T. Myran, MD, MPH, of the Ottawa Hospital Research Institute, led the study, which was funded by the Canadian Institutes of Health Research and the University of Ottawa department of family medicine. The study was published online in JAMA Psychiatry.

LIMITATIONS:

Investigators did not have access to detailed data on substance-related outpatient visits or patterns of substance use, which could provide additional prognostic information.

DISCLOSURES:

Dr. Myran reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr. Solmi reported receiving honoraria for participation on advisory boards or presentations from AbbVie, Angelini, Lundbeck, and Otsuka outside the submitted work. The remaining authors have disclosed no relevant financial relationships.

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

TOPLINE:

Individuals who visited the ER for substance-induced psychosis had a 160% greater risk of developing a schizophrenia spectrum disorder (SSD), compared with the general population, new research shows. Three years after an initial ER visit, 18.5% of those with substance-induced psychosis were diagnosed with an SSD. Cannabis-induced psychosis was associated with the greatest risk.

METHODOLOGY:

• In this retrospective, population-based cohort study, investigators evaluated the risk of transition to a diagnosis of SSD for individuals with an ER visit for substance use versus the general population.
• Investigators at The Ottawa Hospital and the Institute for Clinical Evaluative Sciences, both in Ontario, analyzed data from six linked databases containing health information on nearly 10 million Ontario residents aged 14-65 years eligible for medical coverage.
• Investigators collected the health data between January 2008 and March 2022 on residents with substance use–related ER visits with, and without, psychosis.

TAKEAWAY:

• There were nearly 408,000 individuals with an ER visit for substance use, of which 13,800 (3.4%) of the visits were for substance-induced psychosis.
• Individuals with substance-induced psychosis were at a 163-fold (age- and sex-adjusted hazard ratio, 163.2; 95% confidence interval, 156.1-170.5) increased risk of transitioning to an SSD, relative to the general population (3-year risk, 18.5% vs. 0.1%).
• Individuals with an ER visit for substance use without psychosis had a lower relative risk of transitioning (aHR, 9.8; 95% CI, 9.5-10.2; 3-year risk, 1.4%) but incurred more than three times the absolute number of transitions (9,969 vs. 3,029).
• ER visits related to cannabis use had the highest transition risk among visits with psychosis (aHR, 241.6; 95% CI, 225.5-258.9) and the third-highest risk among visits without psychosis (aHR, 14.3; 95% CI, 13.5-15.2).
• Younger age and male sex were associated with a higher risk of transition, and the risk of male sex was greater in younger, compared with older, individuals particularly for cannabis use.

IN PRACTICE:

“Primary prevention efforts aimed at reducing substance use and substance use disorders could substantially reduce the population-level burden of chronic psychoses,” the investigators write. “Our findings also highlight the need for targeted secondary prevention providing early intervention and reducing substance use in the highest-risk groups, which may delay or prevent transition to schizophrenia spectrum disorders.”

SOURCE:

Daniel T. Myran, MD, MPH, of the Ottawa Hospital Research Institute, led the study, which was funded by the Canadian Institutes of Health Research and the University of Ottawa department of family medicine. The study was published online in JAMA Psychiatry.

LIMITATIONS:

Investigators did not have access to detailed data on substance-related outpatient visits or patterns of substance use, which could provide additional prognostic information.

DISCLOSURES:

Dr. Myran reported receiving grants from the Canadian Institutes of Health Research during the conduct of the study. Dr. Solmi reported receiving honoraria for participation on advisory boards or presentations from AbbVie, Angelini, Lundbeck, and Otsuka outside the submitted work. The remaining authors have disclosed no relevant financial relationships.

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

SAN DIEGO – In a 10-year analysis, a landmark study of partial-breast and reduced-dose radiotherapy in early breast cancer continues to show that the treatments are noninferior to full-breast therapy despite reduced radiation exposure.

The follow-up analysis of the 2,016-subject IMPORT LOW study found that 10-year overall survival rates were 87.8% (95% confidence interval, 84.9-90.1) for a full-breast radiation group, 87.2% (95% CI, 84.3-89.6) for a reduced-dose group, and 90.3% (95% CI, 87.7-92.4) in a partial-breast group. Breast cancer radiotherapy specialist Anna Kirby, MB, MD (Res), MA, of the Royal Marsden and Institute of Cancer Research, London, reported the results at the annual meeting of the American Society for Radiation Oncology.

Ipsilateral breast tumor relapse was also similar in the three groups at the 10-year mark at 2.8% (95% CI, 1.8-4.5), 1.9% (95% CI, 1.1-3.4), and 2.8% (95% CI, 1.7-4.5), respectively. Moderate/marked adverse effects were deemed to be low.

Dr. Kirby said the new findings are not “practice-changing.” However, “this complementary data supporting the change in practice that happened in the UK and elsewhere following the publication back in 2017.”

The findings are “reassuring,” breast cancer radiology specialist Robert W. Mutter, MD, of the Mayo Clinic, Rochester, Minn., said in an interview after reviewing the study findings. While the outcomes and adverse events are similar between the groups, “partial-breast irradiation is attractive because it exposes less normal tissue such as the heart and lungs than whole-breast irradiation. This could lead to fewer side effects for patients later in life at a population level. Partial-breast irradiation should be considered a standard of care in selected patients.”

In a presentation at ASTRO, Dr. Kirby provided background about the motivation for the study. It was clear that radiotherapy reduces local recurrence by up to two-thirds in early breast cancer, she said. “But in a population with excellent prognosis, this translates into relatively small absolute benefits from radiotherapy for many of our lower-risk patients,” she said. “All patients treated are at risk of radiotherapy side effects, and these become the main hazard for many women. Radiotherapy that’s focused on the part of the breast that contained the tumor – the so-called tumor bed – may reduce the long-term complications from radiotherapy, particularly in the breast, and potentially in the heart and lung, whilst hopefully maintaining low local recurrence rates.”

The initial 5-year study was a randomized, multicenter, phase III trial of patients ≥ age 50 in the United Kingdom who were tracked since recruitment in 2007-2010 (median age, 63). All had undergone breast conservation surgery. The patients were assigned to the control group (n = 674, 40 Gy), reduced-dose (n = 673, 40 Gy) and partial-breast (n = 669, 40 Gy to partial breast only) in 15 daily treatment fractions. The initial results, published in The Lancet, reported noninferiority for both reduced-dose and partial-breast radiotherapy. Adverse effects were similar in the three groups except for change in breast appearance, which was better in partial-breast therapy vs. whole-breast, and breast harder or firmer, which was better in both partial- and reduced-dose groups vs. whole-breast.

Dr. Mutter described the IMPORT LOW trial as “a practice-changing study.”

The trial was unique since both the whole-breast and partial-breast arms received the same dosing schedule, he said, which “enables an unbiased assessment of the impact of target volume on treatment outcomes.” This contrasts “with other partial-breast irradiation studies where a different dosing schedule was employed for whole-breast and partial-breast irradiation.”

The new analysis tracked patients for a median of 121 months. “There is no difference in local recurrence rate across the three arms,” Dr. Kirby said. There were no differences in overall survival, breast cancer or cardiac deaths, she added, and “neither was there any difference in the time to any moderate or marked clinician-assessed breast normal tissue endpoint.”

Heart and lung outcomes may improve over time in the lower-dose groups because of less radiation exposure, “but we haven’t shown that yet with this data set.”

Dr. Mutter cautioned that “the results of this trial may not necessarily be extrapolated to other partial-breast irradiation techniques that treat a much smaller volume of breast tissue such as intracavitary brachytherapy and intraoperative radiotherapy. Whether these same excellent outcomes can be achieved with smaller treatment volumes is an area for further investigation.”

Funding information was not provided; the initial study was funded by Cancer Research UK. Dr. Kirby discloses travel costs paid by European Society of Radiotherapy and Oncology, and other authors have various disclosures including relationships with companies such as Pfizer, Seagen, AstraZeneca, Eli Lilly, Bayer, and Janssen. Dr. Mutter has no disclosures.
 

SAN DIEGO – In a 10-year analysis, a landmark study of partial-breast and reduced-dose radiotherapy in early breast cancer continues to show that the treatments are noninferior to full-breast therapy despite reduced radiation exposure.

The follow-up analysis of the 2,016-subject IMPORT LOW study found that 10-year overall survival rates were 87.8% (95% confidence interval, 84.9-90.1) for a full-breast radiation group, 87.2% (95% CI, 84.3-89.6) for a reduced-dose group, and 90.3% (95% CI, 87.7-92.4) in a partial-breast group. Breast cancer radiotherapy specialist Anna Kirby, MB, MD (Res), MA, of the Royal Marsden and Institute of Cancer Research, London, reported the results at the annual meeting of the American Society for Radiation Oncology.

Ipsilateral breast tumor relapse was also similar in the three groups at the 10-year mark at 2.8% (95% CI, 1.8-4.5), 1.9% (95% CI, 1.1-3.4), and 2.8% (95% CI, 1.7-4.5), respectively. Moderate/marked adverse effects were deemed to be low.

Dr. Kirby said the new findings are not “practice-changing.” However, “this complementary data supporting the change in practice that happened in the UK and elsewhere following the publication back in 2017.”

The findings are “reassuring,” breast cancer radiology specialist Robert W. Mutter, MD, of the Mayo Clinic, Rochester, Minn., said in an interview after reviewing the study findings. While the outcomes and adverse events are similar between the groups, “partial-breast irradiation is attractive because it exposes less normal tissue such as the heart and lungs than whole-breast irradiation. This could lead to fewer side effects for patients later in life at a population level. Partial-breast irradiation should be considered a standard of care in selected patients.”

In a presentation at ASTRO, Dr. Kirby provided background about the motivation for the study. It was clear that radiotherapy reduces local recurrence by up to two-thirds in early breast cancer, she said. “But in a population with excellent prognosis, this translates into relatively small absolute benefits from radiotherapy for many of our lower-risk patients,” she said. “All patients treated are at risk of radiotherapy side effects, and these become the main hazard for many women. Radiotherapy that’s focused on the part of the breast that contained the tumor – the so-called tumor bed – may reduce the long-term complications from radiotherapy, particularly in the breast, and potentially in the heart and lung, whilst hopefully maintaining low local recurrence rates.”

The initial 5-year study was a randomized, multicenter, phase III trial of patients ≥ age 50 in the United Kingdom who were tracked since recruitment in 2007-2010 (median age, 63). All had undergone breast conservation surgery. The patients were assigned to the control group (n = 674, 40 Gy), reduced-dose (n = 673, 40 Gy) and partial-breast (n = 669, 40 Gy to partial breast only) in 15 daily treatment fractions. The initial results, published in The Lancet, reported noninferiority for both reduced-dose and partial-breast radiotherapy. Adverse effects were similar in the three groups except for change in breast appearance, which was better in partial-breast therapy vs. whole-breast, and breast harder or firmer, which was better in both partial- and reduced-dose groups vs. whole-breast.

Dr. Mutter described the IMPORT LOW trial as “a practice-changing study.”

The trial was unique since both the whole-breast and partial-breast arms received the same dosing schedule, he said, which “enables an unbiased assessment of the impact of target volume on treatment outcomes.” This contrasts “with other partial-breast irradiation studies where a different dosing schedule was employed for whole-breast and partial-breast irradiation.”

The new analysis tracked patients for a median of 121 months. “There is no difference in local recurrence rate across the three arms,” Dr. Kirby said. There were no differences in overall survival, breast cancer or cardiac deaths, she added, and “neither was there any difference in the time to any moderate or marked clinician-assessed breast normal tissue endpoint.”

Heart and lung outcomes may improve over time in the lower-dose groups because of less radiation exposure, “but we haven’t shown that yet with this data set.”

Dr. Mutter cautioned that “the results of this trial may not necessarily be extrapolated to other partial-breast irradiation techniques that treat a much smaller volume of breast tissue such as intracavitary brachytherapy and intraoperative radiotherapy. Whether these same excellent outcomes can be achieved with smaller treatment volumes is an area for further investigation.”

Funding information was not provided; the initial study was funded by Cancer Research UK. Dr. Kirby discloses travel costs paid by European Society of Radiotherapy and Oncology, and other authors have various disclosures including relationships with companies such as Pfizer, Seagen, AstraZeneca, Eli Lilly, Bayer, and Janssen. Dr. Mutter has no disclosures.
 

SAN DIEGO – In a 10-year analysis, a landmark study of partial-breast and reduced-dose radiotherapy in early breast cancer continues to show that the treatments are noninferior to full-breast therapy despite reduced radiation exposure.

The follow-up analysis of the 2,016-subject IMPORT LOW study found that 10-year overall survival rates were 87.8% (95% confidence interval, 84.9-90.1) for a full-breast radiation group, 87.2% (95% CI, 84.3-89.6) for a reduced-dose group, and 90.3% (95% CI, 87.7-92.4) in a partial-breast group. Breast cancer radiotherapy specialist Anna Kirby, MB, MD (Res), MA, of the Royal Marsden and Institute of Cancer Research, London, reported the results at the annual meeting of the American Society for Radiation Oncology.

Ipsilateral breast tumor relapse was also similar in the three groups at the 10-year mark at 2.8% (95% CI, 1.8-4.5), 1.9% (95% CI, 1.1-3.4), and 2.8% (95% CI, 1.7-4.5), respectively. Moderate/marked adverse effects were deemed to be low.

Dr. Kirby said the new findings are not “practice-changing.” However, “this complementary data supporting the change in practice that happened in the UK and elsewhere following the publication back in 2017.”

The findings are “reassuring,” breast cancer radiology specialist Robert W. Mutter, MD, of the Mayo Clinic, Rochester, Minn., said in an interview after reviewing the study findings. While the outcomes and adverse events are similar between the groups, “partial-breast irradiation is attractive because it exposes less normal tissue such as the heart and lungs than whole-breast irradiation. This could lead to fewer side effects for patients later in life at a population level. Partial-breast irradiation should be considered a standard of care in selected patients.”

In a presentation at ASTRO, Dr. Kirby provided background about the motivation for the study. It was clear that radiotherapy reduces local recurrence by up to two-thirds in early breast cancer, she said. “But in a population with excellent prognosis, this translates into relatively small absolute benefits from radiotherapy for many of our lower-risk patients,” she said. “All patients treated are at risk of radiotherapy side effects, and these become the main hazard for many women. Radiotherapy that’s focused on the part of the breast that contained the tumor – the so-called tumor bed – may reduce the long-term complications from radiotherapy, particularly in the breast, and potentially in the heart and lung, whilst hopefully maintaining low local recurrence rates.”

The initial 5-year study was a randomized, multicenter, phase III trial of patients ≥ age 50 in the United Kingdom who were tracked since recruitment in 2007-2010 (median age, 63). All had undergone breast conservation surgery. The patients were assigned to the control group (n = 674, 40 Gy), reduced-dose (n = 673, 40 Gy) and partial-breast (n = 669, 40 Gy to partial breast only) in 15 daily treatment fractions. The initial results, published in The Lancet, reported noninferiority for both reduced-dose and partial-breast radiotherapy. Adverse effects were similar in the three groups except for change in breast appearance, which was better in partial-breast therapy vs. whole-breast, and breast harder or firmer, which was better in both partial- and reduced-dose groups vs. whole-breast.

Dr. Mutter described the IMPORT LOW trial as “a practice-changing study.”

The trial was unique since both the whole-breast and partial-breast arms received the same dosing schedule, he said, which “enables an unbiased assessment of the impact of target volume on treatment outcomes.” This contrasts “with other partial-breast irradiation studies where a different dosing schedule was employed for whole-breast and partial-breast irradiation.”

The new analysis tracked patients for a median of 121 months. “There is no difference in local recurrence rate across the three arms,” Dr. Kirby said. There were no differences in overall survival, breast cancer or cardiac deaths, she added, and “neither was there any difference in the time to any moderate or marked clinician-assessed breast normal tissue endpoint.”

Heart and lung outcomes may improve over time in the lower-dose groups because of less radiation exposure, “but we haven’t shown that yet with this data set.”

Dr. Mutter cautioned that “the results of this trial may not necessarily be extrapolated to other partial-breast irradiation techniques that treat a much smaller volume of breast tissue such as intracavitary brachytherapy and intraoperative radiotherapy. Whether these same excellent outcomes can be achieved with smaller treatment volumes is an area for further investigation.”

Funding information was not provided; the initial study was funded by Cancer Research UK. Dr. Kirby discloses travel costs paid by European Society of Radiotherapy and Oncology, and other authors have various disclosures including relationships with companies such as Pfizer, Seagen, AstraZeneca, Eli Lilly, Bayer, and Janssen. Dr. Mutter has no disclosures.
 

Among “bi-risk” patients with acute coronary syndrome (ACS) who received a stent and completed 9-12 months of dual-antiplatelet therapy (DAPT), those who de-escalated therapy to clopidogrel alone as opposed to continuing on clopidogrel and aspirin for 9 months had 25% less bleeding without increased ischemic risk.

The findings are from the OPT-BIRISK trial in more than 7,700 patients in China deemed “bi-risk” because they had both a high risk of clinically relevant bleeding and a high risk of major adverse cardiac and cerebral events (MACCE).

Yaling Han, MD, from General Hospital of Northern Theater Command in Shenyang, China, presented the trial in a hotline session at the annual congress of the  European Society of Cardiology.

The results provide evidence for this treatment strategy from “a large cohort seen in clinical practice in whom the question of continuing DAPT vs. deescalating to clopidogrel monotherapy at this time period has not previously been addressed,” Dr. Han said in an interview.

She acknowledged that the findings may not be generalizable to non-Asian cohorts. Also, these patients were event-free after 9 months on DAPT, so they were relatively stable. Moreover, the finding that clopidogrel monotherapy was superior to DAPT for MACCE is only hypothesis-generating.

Renato D. Lopes, MD, PhD, Duke University, Durham, N.C., the assigned discussant at the session, congratulated the authors “for an important trial in the understudied East Asian population. The OPT-BIRISK trial adds information to the complex puzzle of antithrombotic therapy after ACS,” he said.

However, he brought up a few points that should be taken into consideration when interpreting this trial, including the ones noted by Dr. Han.

In an interview, Dr. Lopes cautioned that OPT-BIRISK tested an antiplatelet strategy “in challenging patients at increased risk for bleeding and ischemic events, but I don’t think we can say this is truly a high-risk population.” Invited to reply, Dr. Han conceded that these patients constituted a relatively low-risk subset of bi-risk patients.
 

Double-edged sword

“Antiplatelet therapy is a double-edged sword: it reduces ischemic risk but increases bleeding risk. Optimal antiplatelet therapy for bi-risk ACS patients remains a clinical challenge, and unsolved problem for the cardiovascular physician,” Dr. Han said in a press briefing.

The rationale and design of OPT-BIRISK were published in the American Heart Journal in 2020.

Between February 2018 and December 2020, the researchers enrolled and randomly assigned 7,758 bi-risk patients in 101 centers in China who had completed 9-12 months of DAPT (aspirin plus either clopidogrel or ticagrelor) after drug-eluting stent implantation for ACS.

The patients were randomly assigned to receive either clopidogrel plus aspirin or clopidogrel plus placebo for 9 months, followed by 3 months of aspirin.

The primary endpoint was clinically relevant Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding, at 9 months after randomization.

Key secondary endpoints were MACCE (all-cause mortality, MI, stroke, or clinically driven revascularization), individual components of MACCE, any bleeding, and stent thrombosis at 9 months after randomization.

The patient criteria for having bi-risk ACS were:

• < 65 years old with at least one high-bleeding risk criterion and at least one high-ischemia risk criterion.
• 65-78 years old with at least one high-bleeding risk criterion or at least one high-ischemia risk criterion.
• > 75 years old.

The high bleeding risk criteria were female gender, iron deficiency anemia, stroke, taking a type 2 diabetes medication, and chronic kidney disease.

The high ischemic risk criteria included troponin-positive ACS, previous stent thrombosis, previous CV events (MI, stroke, peripheral artery disease [PAD], percutaneous coronary intervention [PCI]), on a type 2 diabetes medication, chronic kidney disease, and certain lesion characteristics.

The patients had a mean age of about 65 years and 41% were female. 

About half (52%) had type 2 diabetes, 18% had previous MI, and 15% had previous ischemic stroke. The ACS was mainly unstable angina (62%), followed by NSTEMI (17%) or STEMI (21%).

The patients had a mean high ischemic risk criteria of 3.2 and a mean high bleeding risk criteria of 1.4.

The initial DAPT treatment was aspirin and clopidogrel in three quarters of the patients and aspirin and ticagrelor in the remaining patients.

At 9 months, the primary endpoint of BARC type 2-5 bleeding occurred in 2.5% of patients in the clopidogrel plus placebo group and in 3.3% of patients in the clopidogrel plus aspirin group (hazard ratio, 0.75; 95% confidence interval, 0.57-0.97, P = .03).

“The bleeding results are not surprising,” Dr. Lopes said. Monotherapy vs. DAPT will cause less bleeding, Dr. Han agreed.

At 9 months, MACCE occurred in 2.6% of patients in the clopidogrel plus placebo group and in 3.5% of patients in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96, P = .02).

Interpreting this latter finding as “reduced risk” of MACCE “is a stretch,” Dr. Lopes cautioned.

A potential explanation for this finding in the trial is that in the comparison group (aspirin plus clopidogrel), when patients had bleeding, they might have stopped all antiplatelet therapy, and this may have led to more ischemic events, he speculated.

“The observed reduction in MACCE is plausible,” Dr. Han said. “However, according to study protocol, we assumed that clopidogrel monotherapy would be noninferior to DAPT on the risk of MACCE. The superiority of clopidogrel alone vs. DAPT on MACCE should therefore be hypothesis-generating.”

“The increased rate of MACCE in the clopidogrel plus aspirin group was surprising,” she said in a press release from the ESC, “and may be because hemorrhagic events, which are more common with ongoing DAPT, could be associated with an adrenergic state with increased platelet aggregation due to hypotension, remedial procedures to treat bleeding, and the cessation of anti-ischemic medications.”
 

A low-risk subset of bi-risk patients, commonly seen in clinical practice

At the time of the index ACS, more than 60% of the patients had unstable angina, Dr. Lopes observed, “and we know these patients are lower risk.” Also, more than 1,000 of the patients did not have at least one high-risk factor for bleeding or ischemia. Moreover, these patients had not had any clinical events in the past 9-12 months on DAPT, “so they were not truly high risk when they were randomized.

“Patients aged 75 years and above are definitely bi-risk (even without any bleeding/ischemic criteria), especially post ACS, according to much literature,” Dr. Han said.

“Although patients met the bi-risk criteria for increased ischemia and bleeding at the time of index ACS and PCI, they were free from major events for at least 6 months on DAPT, thus constituting a relatively low-risk subset of bi-risk patients,” she conceded.

“Nonetheless, these patients (mean age nearly 65 years, 41% female, 52% diabetes, 18% MI history and 15% ischemic stroke history in bi-risk study) represent a large cohort seen in clinical practice,” she said. And “according to a real-world, nationwide registry from China (the OPT-CAD study), unstable angina accounted for about 50% of all ACS patients.”

There have been more data with shorter times for stopping aspirin, so it’s difficult to reconcile those studies with data from OPT-BIRISK, according to Dr. Lopes.

For example, the 2019 TWILIGHT study in patients undergoing PCI at high risk for bleeding showed that it seems to be safe to stop aspirin after 3 months and continue ticagrelor, without an increase in ischemic events.

“The question is almost in the wrong time,” he said, noting that the field is moving in the direction of stopping aspirin earlier, according to five or six recently published trials.

It is hard to generalize from an Asian population, he agreed. “In the U.S., we have other data that suggests that for high-risk patients, you can stop aspirin earlier than 9 months. That’s what most practices are doing.”

“When you look at different drugs, different doses, different duration,” Dr. Lopes summarized, “you have thousands of different permutations,” for antiplatelet therapy strategies. “Every time we have some data in large studies it adds a piece to the puzzle.”

The study was funded by the National Key Research and Development Project in China, and by a grant from Sanofi-Aventis. Dr. Han reports no relevant financial relationships. Disclosures for the other coauthors can be found with the original article.

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

Among “bi-risk” patients with acute coronary syndrome (ACS) who received a stent and completed 9-12 months of dual-antiplatelet therapy (DAPT), those who de-escalated therapy to clopidogrel alone as opposed to continuing on clopidogrel and aspirin for 9 months had 25% less bleeding without increased ischemic risk.

The findings are from the OPT-BIRISK trial in more than 7,700 patients in China deemed “bi-risk” because they had both a high risk of clinically relevant bleeding and a high risk of major adverse cardiac and cerebral events (MACCE).

Yaling Han, MD, from General Hospital of Northern Theater Command in Shenyang, China, presented the trial in a hotline session at the annual congress of the  European Society of Cardiology.

The results provide evidence for this treatment strategy from “a large cohort seen in clinical practice in whom the question of continuing DAPT vs. deescalating to clopidogrel monotherapy at this time period has not previously been addressed,” Dr. Han said in an interview.

She acknowledged that the findings may not be generalizable to non-Asian cohorts. Also, these patients were event-free after 9 months on DAPT, so they were relatively stable. Moreover, the finding that clopidogrel monotherapy was superior to DAPT for MACCE is only hypothesis-generating.

Renato D. Lopes, MD, PhD, Duke University, Durham, N.C., the assigned discussant at the session, congratulated the authors “for an important trial in the understudied East Asian population. The OPT-BIRISK trial adds information to the complex puzzle of antithrombotic therapy after ACS,” he said.

However, he brought up a few points that should be taken into consideration when interpreting this trial, including the ones noted by Dr. Han.

In an interview, Dr. Lopes cautioned that OPT-BIRISK tested an antiplatelet strategy “in challenging patients at increased risk for bleeding and ischemic events, but I don’t think we can say this is truly a high-risk population.” Invited to reply, Dr. Han conceded that these patients constituted a relatively low-risk subset of bi-risk patients.
 

Double-edged sword

“Antiplatelet therapy is a double-edged sword: it reduces ischemic risk but increases bleeding risk. Optimal antiplatelet therapy for bi-risk ACS patients remains a clinical challenge, and unsolved problem for the cardiovascular physician,” Dr. Han said in a press briefing.

The rationale and design of OPT-BIRISK were published in the American Heart Journal in 2020.

Between February 2018 and December 2020, the researchers enrolled and randomly assigned 7,758 bi-risk patients in 101 centers in China who had completed 9-12 months of DAPT (aspirin plus either clopidogrel or ticagrelor) after drug-eluting stent implantation for ACS.

The patients were randomly assigned to receive either clopidogrel plus aspirin or clopidogrel plus placebo for 9 months, followed by 3 months of aspirin.

The primary endpoint was clinically relevant Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding, at 9 months after randomization.

Key secondary endpoints were MACCE (all-cause mortality, MI, stroke, or clinically driven revascularization), individual components of MACCE, any bleeding, and stent thrombosis at 9 months after randomization.

The patient criteria for having bi-risk ACS were:

• < 65 years old with at least one high-bleeding risk criterion and at least one high-ischemia risk criterion.
• 65-78 years old with at least one high-bleeding risk criterion or at least one high-ischemia risk criterion.
• > 75 years old.

The high bleeding risk criteria were female gender, iron deficiency anemia, stroke, taking a type 2 diabetes medication, and chronic kidney disease.

The high ischemic risk criteria included troponin-positive ACS, previous stent thrombosis, previous CV events (MI, stroke, peripheral artery disease [PAD], percutaneous coronary intervention [PCI]), on a type 2 diabetes medication, chronic kidney disease, and certain lesion characteristics.

The patients had a mean age of about 65 years and 41% were female. 

About half (52%) had type 2 diabetes, 18% had previous MI, and 15% had previous ischemic stroke. The ACS was mainly unstable angina (62%), followed by NSTEMI (17%) or STEMI (21%).

The patients had a mean high ischemic risk criteria of 3.2 and a mean high bleeding risk criteria of 1.4.

The initial DAPT treatment was aspirin and clopidogrel in three quarters of the patients and aspirin and ticagrelor in the remaining patients.

At 9 months, the primary endpoint of BARC type 2-5 bleeding occurred in 2.5% of patients in the clopidogrel plus placebo group and in 3.3% of patients in the clopidogrel plus aspirin group (hazard ratio, 0.75; 95% confidence interval, 0.57-0.97, P = .03).

“The bleeding results are not surprising,” Dr. Lopes said. Monotherapy vs. DAPT will cause less bleeding, Dr. Han agreed.

At 9 months, MACCE occurred in 2.6% of patients in the clopidogrel plus placebo group and in 3.5% of patients in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96, P = .02).

Interpreting this latter finding as “reduced risk” of MACCE “is a stretch,” Dr. Lopes cautioned.

A potential explanation for this finding in the trial is that in the comparison group (aspirin plus clopidogrel), when patients had bleeding, they might have stopped all antiplatelet therapy, and this may have led to more ischemic events, he speculated.

“The observed reduction in MACCE is plausible,” Dr. Han said. “However, according to study protocol, we assumed that clopidogrel monotherapy would be noninferior to DAPT on the risk of MACCE. The superiority of clopidogrel alone vs. DAPT on MACCE should therefore be hypothesis-generating.”

“The increased rate of MACCE in the clopidogrel plus aspirin group was surprising,” she said in a press release from the ESC, “and may be because hemorrhagic events, which are more common with ongoing DAPT, could be associated with an adrenergic state with increased platelet aggregation due to hypotension, remedial procedures to treat bleeding, and the cessation of anti-ischemic medications.”
 

A low-risk subset of bi-risk patients, commonly seen in clinical practice

At the time of the index ACS, more than 60% of the patients had unstable angina, Dr. Lopes observed, “and we know these patients are lower risk.” Also, more than 1,000 of the patients did not have at least one high-risk factor for bleeding or ischemia. Moreover, these patients had not had any clinical events in the past 9-12 months on DAPT, “so they were not truly high risk when they were randomized.

“Patients aged 75 years and above are definitely bi-risk (even without any bleeding/ischemic criteria), especially post ACS, according to much literature,” Dr. Han said.

“Although patients met the bi-risk criteria for increased ischemia and bleeding at the time of index ACS and PCI, they were free from major events for at least 6 months on DAPT, thus constituting a relatively low-risk subset of bi-risk patients,” she conceded.

“Nonetheless, these patients (mean age nearly 65 years, 41% female, 52% diabetes, 18% MI history and 15% ischemic stroke history in bi-risk study) represent a large cohort seen in clinical practice,” she said. And “according to a real-world, nationwide registry from China (the OPT-CAD study), unstable angina accounted for about 50% of all ACS patients.”

There have been more data with shorter times for stopping aspirin, so it’s difficult to reconcile those studies with data from OPT-BIRISK, according to Dr. Lopes.

For example, the 2019 TWILIGHT study in patients undergoing PCI at high risk for bleeding showed that it seems to be safe to stop aspirin after 3 months and continue ticagrelor, without an increase in ischemic events.

“The question is almost in the wrong time,” he said, noting that the field is moving in the direction of stopping aspirin earlier, according to five or six recently published trials.

It is hard to generalize from an Asian population, he agreed. “In the U.S., we have other data that suggests that for high-risk patients, you can stop aspirin earlier than 9 months. That’s what most practices are doing.”

“When you look at different drugs, different doses, different duration,” Dr. Lopes summarized, “you have thousands of different permutations,” for antiplatelet therapy strategies. “Every time we have some data in large studies it adds a piece to the puzzle.”

The study was funded by the National Key Research and Development Project in China, and by a grant from Sanofi-Aventis. Dr. Han reports no relevant financial relationships. Disclosures for the other coauthors can be found with the original article.

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

Among “bi-risk” patients with acute coronary syndrome (ACS) who received a stent and completed 9-12 months of dual-antiplatelet therapy (DAPT), those who de-escalated therapy to clopidogrel alone as opposed to continuing on clopidogrel and aspirin for 9 months had 25% less bleeding without increased ischemic risk.

The findings are from the OPT-BIRISK trial in more than 7,700 patients in China deemed “bi-risk” because they had both a high risk of clinically relevant bleeding and a high risk of major adverse cardiac and cerebral events (MACCE).

Yaling Han, MD, from General Hospital of Northern Theater Command in Shenyang, China, presented the trial in a hotline session at the annual congress of the  European Society of Cardiology.

The results provide evidence for this treatment strategy from “a large cohort seen in clinical practice in whom the question of continuing DAPT vs. deescalating to clopidogrel monotherapy at this time period has not previously been addressed,” Dr. Han said in an interview.

She acknowledged that the findings may not be generalizable to non-Asian cohorts. Also, these patients were event-free after 9 months on DAPT, so they were relatively stable. Moreover, the finding that clopidogrel monotherapy was superior to DAPT for MACCE is only hypothesis-generating.

Renato D. Lopes, MD, PhD, Duke University, Durham, N.C., the assigned discussant at the session, congratulated the authors “for an important trial in the understudied East Asian population. The OPT-BIRISK trial adds information to the complex puzzle of antithrombotic therapy after ACS,” he said.

However, he brought up a few points that should be taken into consideration when interpreting this trial, including the ones noted by Dr. Han.

In an interview, Dr. Lopes cautioned that OPT-BIRISK tested an antiplatelet strategy “in challenging patients at increased risk for bleeding and ischemic events, but I don’t think we can say this is truly a high-risk population.” Invited to reply, Dr. Han conceded that these patients constituted a relatively low-risk subset of bi-risk patients.
 

Double-edged sword

“Antiplatelet therapy is a double-edged sword: it reduces ischemic risk but increases bleeding risk. Optimal antiplatelet therapy for bi-risk ACS patients remains a clinical challenge, and unsolved problem for the cardiovascular physician,” Dr. Han said in a press briefing.

The rationale and design of OPT-BIRISK were published in the American Heart Journal in 2020.

Between February 2018 and December 2020, the researchers enrolled and randomly assigned 7,758 bi-risk patients in 101 centers in China who had completed 9-12 months of DAPT (aspirin plus either clopidogrel or ticagrelor) after drug-eluting stent implantation for ACS.

The patients were randomly assigned to receive either clopidogrel plus aspirin or clopidogrel plus placebo for 9 months, followed by 3 months of aspirin.

The primary endpoint was clinically relevant Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding, at 9 months after randomization.

Key secondary endpoints were MACCE (all-cause mortality, MI, stroke, or clinically driven revascularization), individual components of MACCE, any bleeding, and stent thrombosis at 9 months after randomization.

The patient criteria for having bi-risk ACS were:

• < 65 years old with at least one high-bleeding risk criterion and at least one high-ischemia risk criterion.
• 65-78 years old with at least one high-bleeding risk criterion or at least one high-ischemia risk criterion.
• > 75 years old.

The high bleeding risk criteria were female gender, iron deficiency anemia, stroke, taking a type 2 diabetes medication, and chronic kidney disease.

The high ischemic risk criteria included troponin-positive ACS, previous stent thrombosis, previous CV events (MI, stroke, peripheral artery disease [PAD], percutaneous coronary intervention [PCI]), on a type 2 diabetes medication, chronic kidney disease, and certain lesion characteristics.

The patients had a mean age of about 65 years and 41% were female. 

About half (52%) had type 2 diabetes, 18% had previous MI, and 15% had previous ischemic stroke. The ACS was mainly unstable angina (62%), followed by NSTEMI (17%) or STEMI (21%).

The patients had a mean high ischemic risk criteria of 3.2 and a mean high bleeding risk criteria of 1.4.

The initial DAPT treatment was aspirin and clopidogrel in three quarters of the patients and aspirin and ticagrelor in the remaining patients.

At 9 months, the primary endpoint of BARC type 2-5 bleeding occurred in 2.5% of patients in the clopidogrel plus placebo group and in 3.3% of patients in the clopidogrel plus aspirin group (hazard ratio, 0.75; 95% confidence interval, 0.57-0.97, P = .03).

“The bleeding results are not surprising,” Dr. Lopes said. Monotherapy vs. DAPT will cause less bleeding, Dr. Han agreed.

At 9 months, MACCE occurred in 2.6% of patients in the clopidogrel plus placebo group and in 3.5% of patients in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96, P = .02).

Interpreting this latter finding as “reduced risk” of MACCE “is a stretch,” Dr. Lopes cautioned.

A potential explanation for this finding in the trial is that in the comparison group (aspirin plus clopidogrel), when patients had bleeding, they might have stopped all antiplatelet therapy, and this may have led to more ischemic events, he speculated.

“The observed reduction in MACCE is plausible,” Dr. Han said. “However, according to study protocol, we assumed that clopidogrel monotherapy would be noninferior to DAPT on the risk of MACCE. The superiority of clopidogrel alone vs. DAPT on MACCE should therefore be hypothesis-generating.”

“The increased rate of MACCE in the clopidogrel plus aspirin group was surprising,” she said in a press release from the ESC, “and may be because hemorrhagic events, which are more common with ongoing DAPT, could be associated with an adrenergic state with increased platelet aggregation due to hypotension, remedial procedures to treat bleeding, and the cessation of anti-ischemic medications.”
 

A low-risk subset of bi-risk patients, commonly seen in clinical practice

At the time of the index ACS, more than 60% of the patients had unstable angina, Dr. Lopes observed, “and we know these patients are lower risk.” Also, more than 1,000 of the patients did not have at least one high-risk factor for bleeding or ischemia. Moreover, these patients had not had any clinical events in the past 9-12 months on DAPT, “so they were not truly high risk when they were randomized.

“Patients aged 75 years and above are definitely bi-risk (even without any bleeding/ischemic criteria), especially post ACS, according to much literature,” Dr. Han said.

“Although patients met the bi-risk criteria for increased ischemia and bleeding at the time of index ACS and PCI, they were free from major events for at least 6 months on DAPT, thus constituting a relatively low-risk subset of bi-risk patients,” she conceded.

“Nonetheless, these patients (mean age nearly 65 years, 41% female, 52% diabetes, 18% MI history and 15% ischemic stroke history in bi-risk study) represent a large cohort seen in clinical practice,” she said. And “according to a real-world, nationwide registry from China (the OPT-CAD study), unstable angina accounted for about 50% of all ACS patients.”

There have been more data with shorter times for stopping aspirin, so it’s difficult to reconcile those studies with data from OPT-BIRISK, according to Dr. Lopes.

For example, the 2019 TWILIGHT study in patients undergoing PCI at high risk for bleeding showed that it seems to be safe to stop aspirin after 3 months and continue ticagrelor, without an increase in ischemic events.

“The question is almost in the wrong time,” he said, noting that the field is moving in the direction of stopping aspirin earlier, according to five or six recently published trials.

It is hard to generalize from an Asian population, he agreed. “In the U.S., we have other data that suggests that for high-risk patients, you can stop aspirin earlier than 9 months. That’s what most practices are doing.”

“When you look at different drugs, different doses, different duration,” Dr. Lopes summarized, “you have thousands of different permutations,” for antiplatelet therapy strategies. “Every time we have some data in large studies it adds a piece to the puzzle.”

The study was funded by the National Key Research and Development Project in China, and by a grant from Sanofi-Aventis. Dr. Han reports no relevant financial relationships. Disclosures for the other coauthors can be found with the original article.

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

A disproportionate and unique number of obstacles exist in reproductive health care for patients based on race, ethnicity, geography, socioeconomic, LGBTQ+, and disability status. These barriers represent inequality in access to reproductive medical services.

These challenges are also seen in other reproductive disorders such as polycystic ovary syndrome (PCOS), fibroids, and endometriosis. It is estimated that < 25% of individuals with infertility in the United States access the resources required to have their treatment needs met (Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.113)

Fertility CARE

In 2020, the American Society for Reproductive Medicine (ASRM) created a task force on Diversity, Equity, and Inclusion (DEI) chaired by Board Member Michael A. Thomas, MD. Two years later, the ASRM elevated this task force to a committee that is now chaired by Gloria Richard-Davis, MD. As health care systems and societies increasingly recognize these obstacles to care, I invited Dr. Thomas, the current president of the ASRM, to address this vital concern. Dr. Thomas is professor and chair, department of obstetrics and gynecology, at the University of Cincinnati.
 

While not limited to reproductive health care, how prevalent is the lack of DEI and what factors contribute to this problem?

When we established the initial ASRM DEI task force, we wanted to look at DEI issues within our profession and as an access-to-care initiative. We found that ASRM and ABOG (American Board of Obstetrics and Gynecology) were not asking questions about the makeup of our REI (Reproductive Endocrinology & Infertility) providers, nursing staff, and lab personnel. We had some older data from 2018 about the REI fellowships. Since that time, there appears to be an upward trend of people of color in REI fellowships.

University of Cincinnati

We still need more data about academic, hybrid, and private REI practices when it comes to all employees. The goal would be to increase the number of people of color in all aspects of our field.

As far as access to care, we know that people of color do not have the ability to undergo ART (assisted reproductive technology) procedures at the same rate. This could be due to affordability, slower and/or later referral patterns, and personal stigma issues. Even in mandated states, people of color are seen by IVF providers in lower numbers. There is a need for a better understanding of the access-to-care issues, especially when affordability is not a problem, and the barriers to our LGBTQ+ patients.
 

Can you provide information about actions by the ASRM DEI task force and any plans for the future?

The DEI task force is now an ASRM committee. This committee is chaired by Dr. Gloria Richard-Davis and continues to work on increasing people of color in the REI workforce and understanding and decreasing access to care issues faced by people of color and members of the LGBTQ+ community.

What can physicians do at the local, state, and national level to support DEI?

All REI and ob.gyn. physicians can work with insurance companies to work on the current barriers that stand in the way of patients who want to have a family. For example, physicians can work with insurance companies to remove their definition of infertility as exposure to sperm for 1 year before fertility coverage can take effect. Also, mandated insurance coverage in all 50 states would allow even smaller companies to require this benefit to patients.

Many people of color work in smaller companies that, unfortunately, are not required to offer IVF coverage in states where mandated insurance coverage is available. As potential encouraging news, ASRM, RESOLVE (The National Infertility Association) and other patient advocacy groups are working with each state to help enact fertility mandates.
 

Which group, if any, has been most negatively affected by a lack of DEI?

People of color, LGBTQ+ communities, people with disabilities, single individuals, and those with income challenges are the most likely to be affected by adverse DEI policies.

While it is long overdue, why do you believe DEI has become such a touchstone and pervasive movement at this time?

This is the million-dollar question. After the George Floyd death, there was a global re-examination of how people of color were treated in every aspect of society. ASRM was the first to start this DEI initiative in women’s health.

ASRM and its patient advocacy partners are working with every nonmandated state toward the goal of passing infertility legislation to dramatically reduce the financial burden on all patients. We are starting to see more states either coming on board with mandates or at least discussing the possibilities. ASRM and RESOLVE have seen some recent positive outcomes with improved insurance for military families and government workers.
 

We can all agree that access to infertility treatment, particularly IVF, is not equivalent among different racial/ethnic populations. Part of the ASRM DEI task force is to evaluate research on IVF outcomes and race/ethnicity. Can you share why pregnancy outcomes would be included to potentially improve DEI?

More research needs to be done on pregnancy outcomes in women of color. We know that women of color have a decreased pregnancy rate in ART cycles even when controlling for age and other factors. We also know that birth outcomes are worse in these women. More understanding of this problem for women of color, especially African American women needs to be done.

Estimates are that more than one in eight LGBTQ+ patients live in states where physicians can refuse to treat them. Consequently, how can we improve DEI in these regions?

As someone with a number of family members in the LGBTQ+ community, this is a problem that is close to my heart. There appear to be many barriers that are being built to disenfranchise our LGBTQ+ community members. It is up to ASRM and patient advocacy groups to work with legislators to pass more inclusive laws and for insurance companies to update their definitions of infertility to be more inclusive for all.

Any final comments?

Everyone should have the right to become a parent whether they want to now or in the future!

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

A disproportionate and unique number of obstacles exist in reproductive health care for patients based on race, ethnicity, geography, socioeconomic, LGBTQ+, and disability status. These barriers represent inequality in access to reproductive medical services.

These challenges are also seen in other reproductive disorders such as polycystic ovary syndrome (PCOS), fibroids, and endometriosis. It is estimated that < 25% of individuals with infertility in the United States access the resources required to have their treatment needs met (Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.113)

Fertility CARE

In 2020, the American Society for Reproductive Medicine (ASRM) created a task force on Diversity, Equity, and Inclusion (DEI) chaired by Board Member Michael A. Thomas, MD. Two years later, the ASRM elevated this task force to a committee that is now chaired by Gloria Richard-Davis, MD. As health care systems and societies increasingly recognize these obstacles to care, I invited Dr. Thomas, the current president of the ASRM, to address this vital concern. Dr. Thomas is professor and chair, department of obstetrics and gynecology, at the University of Cincinnati.
 

While not limited to reproductive health care, how prevalent is the lack of DEI and what factors contribute to this problem?

When we established the initial ASRM DEI task force, we wanted to look at DEI issues within our profession and as an access-to-care initiative. We found that ASRM and ABOG (American Board of Obstetrics and Gynecology) were not asking questions about the makeup of our REI (Reproductive Endocrinology & Infertility) providers, nursing staff, and lab personnel. We had some older data from 2018 about the REI fellowships. Since that time, there appears to be an upward trend of people of color in REI fellowships.

University of Cincinnati

We still need more data about academic, hybrid, and private REI practices when it comes to all employees. The goal would be to increase the number of people of color in all aspects of our field.

As far as access to care, we know that people of color do not have the ability to undergo ART (assisted reproductive technology) procedures at the same rate. This could be due to affordability, slower and/or later referral patterns, and personal stigma issues. Even in mandated states, people of color are seen by IVF providers in lower numbers. There is a need for a better understanding of the access-to-care issues, especially when affordability is not a problem, and the barriers to our LGBTQ+ patients.
 

Can you provide information about actions by the ASRM DEI task force and any plans for the future?

The DEI task force is now an ASRM committee. This committee is chaired by Dr. Gloria Richard-Davis and continues to work on increasing people of color in the REI workforce and understanding and decreasing access to care issues faced by people of color and members of the LGBTQ+ community.

What can physicians do at the local, state, and national level to support DEI?

All REI and ob.gyn. physicians can work with insurance companies to work on the current barriers that stand in the way of patients who want to have a family. For example, physicians can work with insurance companies to remove their definition of infertility as exposure to sperm for 1 year before fertility coverage can take effect. Also, mandated insurance coverage in all 50 states would allow even smaller companies to require this benefit to patients.

Many people of color work in smaller companies that, unfortunately, are not required to offer IVF coverage in states where mandated insurance coverage is available. As potential encouraging news, ASRM, RESOLVE (The National Infertility Association) and other patient advocacy groups are working with each state to help enact fertility mandates.
 

Which group, if any, has been most negatively affected by a lack of DEI?

People of color, LGBTQ+ communities, people with disabilities, single individuals, and those with income challenges are the most likely to be affected by adverse DEI policies.

While it is long overdue, why do you believe DEI has become such a touchstone and pervasive movement at this time?

This is the million-dollar question. After the George Floyd death, there was a global re-examination of how people of color were treated in every aspect of society. ASRM was the first to start this DEI initiative in women’s health.

ASRM and its patient advocacy partners are working with every nonmandated state toward the goal of passing infertility legislation to dramatically reduce the financial burden on all patients. We are starting to see more states either coming on board with mandates or at least discussing the possibilities. ASRM and RESOLVE have seen some recent positive outcomes with improved insurance for military families and government workers.
 

We can all agree that access to infertility treatment, particularly IVF, is not equivalent among different racial/ethnic populations. Part of the ASRM DEI task force is to evaluate research on IVF outcomes and race/ethnicity. Can you share why pregnancy outcomes would be included to potentially improve DEI?

More research needs to be done on pregnancy outcomes in women of color. We know that women of color have a decreased pregnancy rate in ART cycles even when controlling for age and other factors. We also know that birth outcomes are worse in these women. More understanding of this problem for women of color, especially African American women needs to be done.

Estimates are that more than one in eight LGBTQ+ patients live in states where physicians can refuse to treat them. Consequently, how can we improve DEI in these regions?

As someone with a number of family members in the LGBTQ+ community, this is a problem that is close to my heart. There appear to be many barriers that are being built to disenfranchise our LGBTQ+ community members. It is up to ASRM and patient advocacy groups to work with legislators to pass more inclusive laws and for insurance companies to update their definitions of infertility to be more inclusive for all.

Any final comments?

Everyone should have the right to become a parent whether they want to now or in the future!

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

A disproportionate and unique number of obstacles exist in reproductive health care for patients based on race, ethnicity, geography, socioeconomic, LGBTQ+, and disability status. These barriers represent inequality in access to reproductive medical services.

These challenges are also seen in other reproductive disorders such as polycystic ovary syndrome (PCOS), fibroids, and endometriosis. It is estimated that < 25% of individuals with infertility in the United States access the resources required to have their treatment needs met (Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.113)

Fertility CARE

In 2020, the American Society for Reproductive Medicine (ASRM) created a task force on Diversity, Equity, and Inclusion (DEI) chaired by Board Member Michael A. Thomas, MD. Two years later, the ASRM elevated this task force to a committee that is now chaired by Gloria Richard-Davis, MD. As health care systems and societies increasingly recognize these obstacles to care, I invited Dr. Thomas, the current president of the ASRM, to address this vital concern. Dr. Thomas is professor and chair, department of obstetrics and gynecology, at the University of Cincinnati.
 

While not limited to reproductive health care, how prevalent is the lack of DEI and what factors contribute to this problem?

When we established the initial ASRM DEI task force, we wanted to look at DEI issues within our profession and as an access-to-care initiative. We found that ASRM and ABOG (American Board of Obstetrics and Gynecology) were not asking questions about the makeup of our REI (Reproductive Endocrinology & Infertility) providers, nursing staff, and lab personnel. We had some older data from 2018 about the REI fellowships. Since that time, there appears to be an upward trend of people of color in REI fellowships.

University of Cincinnati

We still need more data about academic, hybrid, and private REI practices when it comes to all employees. The goal would be to increase the number of people of color in all aspects of our field.

As far as access to care, we know that people of color do not have the ability to undergo ART (assisted reproductive technology) procedures at the same rate. This could be due to affordability, slower and/or later referral patterns, and personal stigma issues. Even in mandated states, people of color are seen by IVF providers in lower numbers. There is a need for a better understanding of the access-to-care issues, especially when affordability is not a problem, and the barriers to our LGBTQ+ patients.
 

Can you provide information about actions by the ASRM DEI task force and any plans for the future?

The DEI task force is now an ASRM committee. This committee is chaired by Dr. Gloria Richard-Davis and continues to work on increasing people of color in the REI workforce and understanding and decreasing access to care issues faced by people of color and members of the LGBTQ+ community.

What can physicians do at the local, state, and national level to support DEI?

All REI and ob.gyn. physicians can work with insurance companies to work on the current barriers that stand in the way of patients who want to have a family. For example, physicians can work with insurance companies to remove their definition of infertility as exposure to sperm for 1 year before fertility coverage can take effect. Also, mandated insurance coverage in all 50 states would allow even smaller companies to require this benefit to patients.

Many people of color work in smaller companies that, unfortunately, are not required to offer IVF coverage in states where mandated insurance coverage is available. As potential encouraging news, ASRM, RESOLVE (The National Infertility Association) and other patient advocacy groups are working with each state to help enact fertility mandates.
 

Which group, if any, has been most negatively affected by a lack of DEI?

People of color, LGBTQ+ communities, people with disabilities, single individuals, and those with income challenges are the most likely to be affected by adverse DEI policies.

While it is long overdue, why do you believe DEI has become such a touchstone and pervasive movement at this time?

This is the million-dollar question. After the George Floyd death, there was a global re-examination of how people of color were treated in every aspect of society. ASRM was the first to start this DEI initiative in women’s health.

ASRM and its patient advocacy partners are working with every nonmandated state toward the goal of passing infertility legislation to dramatically reduce the financial burden on all patients. We are starting to see more states either coming on board with mandates or at least discussing the possibilities. ASRM and RESOLVE have seen some recent positive outcomes with improved insurance for military families and government workers.
 

We can all agree that access to infertility treatment, particularly IVF, is not equivalent among different racial/ethnic populations. Part of the ASRM DEI task force is to evaluate research on IVF outcomes and race/ethnicity. Can you share why pregnancy outcomes would be included to potentially improve DEI?

More research needs to be done on pregnancy outcomes in women of color. We know that women of color have a decreased pregnancy rate in ART cycles even when controlling for age and other factors. We also know that birth outcomes are worse in these women. More understanding of this problem for women of color, especially African American women needs to be done.

Estimates are that more than one in eight LGBTQ+ patients live in states where physicians can refuse to treat them. Consequently, how can we improve DEI in these regions?

As someone with a number of family members in the LGBTQ+ community, this is a problem that is close to my heart. There appear to be many barriers that are being built to disenfranchise our LGBTQ+ community members. It is up to ASRM and patient advocacy groups to work with legislators to pass more inclusive laws and for insurance companies to update their definitions of infertility to be more inclusive for all.

Any final comments?

Everyone should have the right to become a parent whether they want to now or in the future!

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.

Thyroxine and L-thyroxine are two of the 10 most frequently prescribed medicinal products. “One large health insurance company ranks thyroid hormone at fourth place in the list of most-sold medications in the United States. It is possibly the second most commonly prescribed preparation,” said Joachim Feldkamp, MD, PhD, director of the University Clinic for General Internal Medicine, Endocrinology, Diabetology, and Infectious Diseases at Central Hospital, Bielefeld, Germany, at the online press conference for the German Society of Endocrinology’s hormone week.

The preparation is prescribed when the thyroid gland produces too little thyroid hormone. The messenger substance thyroid-stimulating hormone (TSH) is used as a screening value to assess thyroid function. An increase in TSH can indicate that too little thyroid hormone is being produced.

“But this does not mean that an underactive thyroid gland is hiding behind every elevated TSH value,” said Dr. Feldkamp. Normally, the TSH value lies between 0.3 and 4.2 mU/L. “Hypothyroidism, as it’s known, is formally present if the TSH value lies above the upper limit of 4.2 mU/L,” said Dr. Feldkamp.
 

Check again

However, not every elevated TSH value needs to be treated immediately. “From large-scale investigations, we know that TSH values are subject to fluctuations,” said Dr. Feldkamp. Individual measurements must therefore be taken with a grain of salt and almost never justify a therapeutic decision. Therefore, a slightly elevated TSH value should be checked again 2-6 months later, and the patient should be asked if they are experiencing any symptoms. “In 50%-60% of cases, the TSH value normalized at the second checkup without requiring any treatment,” Dr. Feldkamp explained.

The TSH value could be elevated for several reasons:

• Fluctuations depending on the time of day. At night and early in the morning, the TSH value is much higher than in the afternoon. An acute lack of sleep can lead to higher TSH values in the morning.
• Fluctuations depending on the time of year. In winter, TSH values are slightly higher than in the summer owing to adaptation to cooler temperatures. Researchers in the Arctic, for example, have significantly higher TSH values than people who live in warmer regions.
• Age-dependent differences. Children and adolescents have higher TSH values than adults do. The TSH values of adolescents cannot be based on those of adults because this would lead to incorrect treatment. In addition, TSH values increase with age, and slightly elevated values are initially no cause for treatment in people aged 70-80 years. Caution is advised during treatment, because overtreatment can lead to cardiac arrhythmias and a decrease in bone density.
• Sex-specific differences. The TSH values of women are generally a little higher than those in men.
• Obesity. In obesity, TSH increases and often exceeds the normal values usually recorded in persons of normal weight. The elevated values do not reflect a state of hypofunction but rather the body’s adjustment mechanism. If these patients lose weight, the TSH values will drop spontaneously. Slightly elevated TSH values in obese people should not be treated with thyroid hormones.

The nutritional supplement biotin (vitamin H or vitamin B7), which is often taken for skin, hair, and nail growth disorders, can distort measured values. In many of the laboratory methods used, the biotin competes with the test substances used. As a result, it can lead to falsely high and falsely low TSH values. At high doses of biotin (for example, 10 mg), there should be at least a 3-day pause (and ideally a pause of 1 week) before measuring TSH.
 

Hasty prescriptions

“Sometimes, because of the assumption that every high TSH value is due to sickness-related hypothyroidism, thyroid hormones can be prescribed too quickly,” said Dr. Feldkamp. This is also true for patients with thyroid nodules due to iodine deficiency, who are often still treated with thyroid hormones.

“These days, because we are generally an iodine-deficient nation, iodine would potentially be given in combination with thyroid hormones but not with thyroid hormones alone. There are lots of patients who have been taking thyroid hormones for 30 or 40 years due to thyroid nodules. That should definitely be reviewed,” said Dr. Feldkamp.
 

When to treat?

Dr. Feldkamp does not believe that standard determination of the TSH value is sensible and advises that clinicians examine patients with newly occurring symptoms, such as excess weight, impaired weight regulation despite reduced appetite, depression, or a high need for sleep.

If there are symptoms, the thyroid function must be clarified further. “This includes determination of free thyroid hormones T3 and T4; detection of antibodies against autologous thyroid tissue such as TPO-Ab [antibody against thyroid peroxidase], TG-Ab [antibody against thyroglobulin], and TRAb [antibody against TSH receptor]; and ultrasound examination of the metabolic organ,” said Dr. Feldkamp. Autoimmune-related hypothyroidism (Hashimoto’s thyroiditis) is the most common cause of an overly high TSH level.

Treatment should take place in the following situations:

• In young patients with TSH values greater than 10 mU/L;
• In young (< 65 years) symptomatic patients with TSH values of 4 to less than 10 mU/L;
• With elevated TSH values that result from thyroid surgery or radioactive iodine therapy;
• In patients with a diffuse enlarged or severely nodular thyroid gland
• In pregnant women with elevated TSH values.

This article was translated from Medscape’s German Edition and a version appeared on Medscape.com.

Thyroxine and L-thyroxine are two of the 10 most frequently prescribed medicinal products. “One large health insurance company ranks thyroid hormone at fourth place in the list of most-sold medications in the United States. It is possibly the second most commonly prescribed preparation,” said Joachim Feldkamp, MD, PhD, director of the University Clinic for General Internal Medicine, Endocrinology, Diabetology, and Infectious Diseases at Central Hospital, Bielefeld, Germany, at the online press conference for the German Society of Endocrinology’s hormone week.

The preparation is prescribed when the thyroid gland produces too little thyroid hormone. The messenger substance thyroid-stimulating hormone (TSH) is used as a screening value to assess thyroid function. An increase in TSH can indicate that too little thyroid hormone is being produced.

“But this does not mean that an underactive thyroid gland is hiding behind every elevated TSH value,” said Dr. Feldkamp. Normally, the TSH value lies between 0.3 and 4.2 mU/L. “Hypothyroidism, as it’s known, is formally present if the TSH value lies above the upper limit of 4.2 mU/L,” said Dr. Feldkamp.
 

Check again

However, not every elevated TSH value needs to be treated immediately. “From large-scale investigations, we know that TSH values are subject to fluctuations,” said Dr. Feldkamp. Individual measurements must therefore be taken with a grain of salt and almost never justify a therapeutic decision. Therefore, a slightly elevated TSH value should be checked again 2-6 months later, and the patient should be asked if they are experiencing any symptoms. “In 50%-60% of cases, the TSH value normalized at the second checkup without requiring any treatment,” Dr. Feldkamp explained.

The TSH value could be elevated for several reasons:

• Fluctuations depending on the time of day. At night and early in the morning, the TSH value is much higher than in the afternoon. An acute lack of sleep can lead to higher TSH values in the morning.
• Fluctuations depending on the time of year. In winter, TSH values are slightly higher than in the summer owing to adaptation to cooler temperatures. Researchers in the Arctic, for example, have significantly higher TSH values than people who live in warmer regions.
• Age-dependent differences. Children and adolescents have higher TSH values than adults do. The TSH values of adolescents cannot be based on those of adults because this would lead to incorrect treatment. In addition, TSH values increase with age, and slightly elevated values are initially no cause for treatment in people aged 70-80 years. Caution is advised during treatment, because overtreatment can lead to cardiac arrhythmias and a decrease in bone density.
• Sex-specific differences. The TSH values of women are generally a little higher than those in men.
• Obesity. In obesity, TSH increases and often exceeds the normal values usually recorded in persons of normal weight. The elevated values do not reflect a state of hypofunction but rather the body’s adjustment mechanism. If these patients lose weight, the TSH values will drop spontaneously. Slightly elevated TSH values in obese people should not be treated with thyroid hormones.

The nutritional supplement biotin (vitamin H or vitamin B7), which is often taken for skin, hair, and nail growth disorders, can distort measured values. In many of the laboratory methods used, the biotin competes with the test substances used. As a result, it can lead to falsely high and falsely low TSH values. At high doses of biotin (for example, 10 mg), there should be at least a 3-day pause (and ideally a pause of 1 week) before measuring TSH.
 

Hasty prescriptions

“Sometimes, because of the assumption that every high TSH value is due to sickness-related hypothyroidism, thyroid hormones can be prescribed too quickly,” said Dr. Feldkamp. This is also true for patients with thyroid nodules due to iodine deficiency, who are often still treated with thyroid hormones.

“These days, because we are generally an iodine-deficient nation, iodine would potentially be given in combination with thyroid hormones but not with thyroid hormones alone. There are lots of patients who have been taking thyroid hormones for 30 or 40 years due to thyroid nodules. That should definitely be reviewed,” said Dr. Feldkamp.
 

When to treat?

Dr. Feldkamp does not believe that standard determination of the TSH value is sensible and advises that clinicians examine patients with newly occurring symptoms, such as excess weight, impaired weight regulation despite reduced appetite, depression, or a high need for sleep.

If there are symptoms, the thyroid function must be clarified further. “This includes determination of free thyroid hormones T3 and T4; detection of antibodies against autologous thyroid tissue such as TPO-Ab [antibody against thyroid peroxidase], TG-Ab [antibody against thyroglobulin], and TRAb [antibody against TSH receptor]; and ultrasound examination of the metabolic organ,” said Dr. Feldkamp. Autoimmune-related hypothyroidism (Hashimoto’s thyroiditis) is the most common cause of an overly high TSH level.

Treatment should take place in the following situations:

• In young patients with TSH values greater than 10 mU/L;
• In young (< 65 years) symptomatic patients with TSH values of 4 to less than 10 mU/L;
• With elevated TSH values that result from thyroid surgery or radioactive iodine therapy;
• In patients with a diffuse enlarged or severely nodular thyroid gland
• In pregnant women with elevated TSH values.

This article was translated from Medscape’s German Edition and a version appeared on Medscape.com.

Thyroxine and L-thyroxine are two of the 10 most frequently prescribed medicinal products. “One large health insurance company ranks thyroid hormone at fourth place in the list of most-sold medications in the United States. It is possibly the second most commonly prescribed preparation,” said Joachim Feldkamp, MD, PhD, director of the University Clinic for General Internal Medicine, Endocrinology, Diabetology, and Infectious Diseases at Central Hospital, Bielefeld, Germany, at the online press conference for the German Society of Endocrinology’s hormone week.

The preparation is prescribed when the thyroid gland produces too little thyroid hormone. The messenger substance thyroid-stimulating hormone (TSH) is used as a screening value to assess thyroid function. An increase in TSH can indicate that too little thyroid hormone is being produced.

“But this does not mean that an underactive thyroid gland is hiding behind every elevated TSH value,” said Dr. Feldkamp. Normally, the TSH value lies between 0.3 and 4.2 mU/L. “Hypothyroidism, as it’s known, is formally present if the TSH value lies above the upper limit of 4.2 mU/L,” said Dr. Feldkamp.
 

Check again

However, not every elevated TSH value needs to be treated immediately. “From large-scale investigations, we know that TSH values are subject to fluctuations,” said Dr. Feldkamp. Individual measurements must therefore be taken with a grain of salt and almost never justify a therapeutic decision. Therefore, a slightly elevated TSH value should be checked again 2-6 months later, and the patient should be asked if they are experiencing any symptoms. “In 50%-60% of cases, the TSH value normalized at the second checkup without requiring any treatment,” Dr. Feldkamp explained.

The TSH value could be elevated for several reasons:

• Fluctuations depending on the time of day. At night and early in the morning, the TSH value is much higher than in the afternoon. An acute lack of sleep can lead to higher TSH values in the morning.
• Fluctuations depending on the time of year. In winter, TSH values are slightly higher than in the summer owing to adaptation to cooler temperatures. Researchers in the Arctic, for example, have significantly higher TSH values than people who live in warmer regions.
• Age-dependent differences. Children and adolescents have higher TSH values than adults do. The TSH values of adolescents cannot be based on those of adults because this would lead to incorrect treatment. In addition, TSH values increase with age, and slightly elevated values are initially no cause for treatment in people aged 70-80 years. Caution is advised during treatment, because overtreatment can lead to cardiac arrhythmias and a decrease in bone density.
• Sex-specific differences. The TSH values of women are generally a little higher than those in men.
• Obesity. In obesity, TSH increases and often exceeds the normal values usually recorded in persons of normal weight. The elevated values do not reflect a state of hypofunction but rather the body’s adjustment mechanism. If these patients lose weight, the TSH values will drop spontaneously. Slightly elevated TSH values in obese people should not be treated with thyroid hormones.

The nutritional supplement biotin (vitamin H or vitamin B7), which is often taken for skin, hair, and nail growth disorders, can distort measured values. In many of the laboratory methods used, the biotin competes with the test substances used. As a result, it can lead to falsely high and falsely low TSH values. At high doses of biotin (for example, 10 mg), there should be at least a 3-day pause (and ideally a pause of 1 week) before measuring TSH.
 

Hasty prescriptions

“Sometimes, because of the assumption that every high TSH value is due to sickness-related hypothyroidism, thyroid hormones can be prescribed too quickly,” said Dr. Feldkamp. This is also true for patients with thyroid nodules due to iodine deficiency, who are often still treated with thyroid hormones.

“These days, because we are generally an iodine-deficient nation, iodine would potentially be given in combination with thyroid hormones but not with thyroid hormones alone. There are lots of patients who have been taking thyroid hormones for 30 or 40 years due to thyroid nodules. That should definitely be reviewed,” said Dr. Feldkamp.
 

When to treat?

Dr. Feldkamp does not believe that standard determination of the TSH value is sensible and advises that clinicians examine patients with newly occurring symptoms, such as excess weight, impaired weight regulation despite reduced appetite, depression, or a high need for sleep.

If there are symptoms, the thyroid function must be clarified further. “This includes determination of free thyroid hormones T3 and T4; detection of antibodies against autologous thyroid tissue such as TPO-Ab [antibody against thyroid peroxidase], TG-Ab [antibody against thyroglobulin], and TRAb [antibody against TSH receptor]; and ultrasound examination of the metabolic organ,” said Dr. Feldkamp. Autoimmune-related hypothyroidism (Hashimoto’s thyroiditis) is the most common cause of an overly high TSH level.

Treatment should take place in the following situations:

• In young patients with TSH values greater than 10 mU/L;
• In young (< 65 years) symptomatic patients with TSH values of 4 to less than 10 mU/L;
• With elevated TSH values that result from thyroid surgery or radioactive iodine therapy;
• In patients with a diffuse enlarged or severely nodular thyroid gland
• In pregnant women with elevated TSH values.

This article was translated from Medscape’s German Edition and a version appeared on Medscape.com.

TOPLINE:

Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine versus NSAIDs.

METHODOLOGY:

• The researchers conducted two matched retrospective cohort studies using the U.K. Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.
• For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.
• The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.

TAKEAWAY:

• The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.
• The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.
• Compared with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.
• Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.

IN PRACTICE:

“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.

SOURCE:

First author Edward Roddy, MD, of Keele (England) University, and colleagues published their report online in BMJ’s Annals of the Rheumatic Diseases.

LIMITATIONS:

The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.

DISCLOSURES:

The study was supported by the National Institute for Health and Care Research’s Research for Patient Benefit program. The researchers had no financial conflicts to disclose.

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

TOPLINE:

Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine versus NSAIDs.

METHODOLOGY:

• The researchers conducted two matched retrospective cohort studies using the U.K. Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.
• For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.
• The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.

TAKEAWAY:

• The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.
• The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.
• Compared with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.
• Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.

IN PRACTICE:

“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.

SOURCE:

First author Edward Roddy, MD, of Keele (England) University, and colleagues published their report online in BMJ’s Annals of the Rheumatic Diseases.

LIMITATIONS:

The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.

DISCLOSURES:

The study was supported by the National Institute for Health and Care Research’s Research for Patient Benefit program. The researchers had no financial conflicts to disclose.

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

TOPLINE:

Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine versus NSAIDs.

METHODOLOGY:

• The researchers conducted two matched retrospective cohort studies using the U.K. Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.
• For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.
• The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.

TAKEAWAY:

• The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.
• The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.
• Compared with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.
• Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.

IN PRACTICE:

“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.

SOURCE:

First author Edward Roddy, MD, of Keele (England) University, and colleagues published their report online in BMJ’s Annals of the Rheumatic Diseases.

LIMITATIONS:

The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.

DISCLOSURES:

The study was supported by the National Institute for Health and Care Research’s Research for Patient Benefit program. The researchers had no financial conflicts to disclose.

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

Opposition to the current American Board of Internal Medicine’s (ABIM’s) Maintenance of Certification (MOC) process continues to gain momentum, with the latest condemnation coming from the American Society of Hematology (ASH).

ASH president Robert A. Brodsky, MD, sent a letter to ABIM’s President and Chief Executive Officer Richard Baron, MD, highlighting hematologists’ concerns about the MOC process and outlining immediate actions ABIM should take.

“ASH continues to support the importance of lifelong learning for hematologists via a program that is evidence-based, relevant to one’s practice, and transparent; however, these three basic requirements are not met by the current ABIM MOC program,” Dr. Brodsky stated in the Sept. 27 letter to Baron.

Dr. Brodsky highlighted, for instance, the fact that the Longitudinal Knowledge Assessment – the alternative to the 10-year exam – “does not reflect real life practice, nor does it target each individual’s scope of practice.” Dr. Brodsky added that, according to members of ASH, the assessment is also “creating high levels of stress and contributing to burnout.”

The letter from Dr. Brodsky urged ABIM to “establish a new MOC program” that does not involve high-stakes assessments, reduces the number of Longitudinal Knowledge Assessment questions physicians receive, and eliminates redundancy between the MOC requirement to have a current license and the requirement to report continued medical education to ABIM.

The ABIM shared a copy of the letter in a Sept. 28 blog post defending the MOC process, highlighting past collaboration with ASH that “has led to meaningful enhancements to the [MOC] program” and committing to “continue to listen to and learn from the physician community going forward.”

The recent backlash against the MOC process stemmed from a petition demanding an end to the MOC. The petition was launched in July by hematologist-oncologist Aaron Goodman, MD, from the University of California, San Diego, who has been a vocal critic of the MOC process.

The criticism largely centered around the high costs and the “complex and time-consuming process that poses significant challenges to practicing physicians,” Dr. Goodman wrote in the petition, which has garnered more than 20,700 signatures.

In August, the Society for Cardiovascular Angiography and Interventions (SCAI) published “SCAI Position on ABIM Revocation of Certification for Not Participating in MOC.” The Electrophysiology Advocacy Foundation and the Heart Rhythm Society (HRS) issued statements pushing back on the MOC as well.

On Sept. 21, the SCAI, HRS, American College of Cardiology, and the Heart Failure Society of America went a step further and announced plans to create a new certification process that is independent of the ABIM MOC system.

The American Society of Clinical Oncology (ASCO) is now also surveying members about their MOC experience. A Sept. 26 announcement encouraged recipients to check their inboxes for a link to an anonymous MOC Experience Questionnaire before Oct. 12 and thanked respondents for their “engagement as ASCO works to address this critical issue for the oncology community.”

After ASH sent its letter to ABIM, Dr. Goodman applauded the society’s stance in a post on his X (formerly Twitter) account. Vincent Rajkumar, MD, a hematologist at the Mayo Clinic in Rochester, Minn., commented on ABIM’s response to ASH’s letter via X, noting, “If I were @ASH_hematology leadership, I would take ABIM response as disrespectful. A hasty response within a day is not a sign of good faith.”

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

Opposition to the current American Board of Internal Medicine’s (ABIM’s) Maintenance of Certification (MOC) process continues to gain momentum, with the latest condemnation coming from the American Society of Hematology (ASH).

ASH president Robert A. Brodsky, MD, sent a letter to ABIM’s President and Chief Executive Officer Richard Baron, MD, highlighting hematologists’ concerns about the MOC process and outlining immediate actions ABIM should take.

“ASH continues to support the importance of lifelong learning for hematologists via a program that is evidence-based, relevant to one’s practice, and transparent; however, these three basic requirements are not met by the current ABIM MOC program,” Dr. Brodsky stated in the Sept. 27 letter to Baron.

Dr. Brodsky highlighted, for instance, the fact that the Longitudinal Knowledge Assessment – the alternative to the 10-year exam – “does not reflect real life practice, nor does it target each individual’s scope of practice.” Dr. Brodsky added that, according to members of ASH, the assessment is also “creating high levels of stress and contributing to burnout.”

The letter from Dr. Brodsky urged ABIM to “establish a new MOC program” that does not involve high-stakes assessments, reduces the number of Longitudinal Knowledge Assessment questions physicians receive, and eliminates redundancy between the MOC requirement to have a current license and the requirement to report continued medical education to ABIM.

The ABIM shared a copy of the letter in a Sept. 28 blog post defending the MOC process, highlighting past collaboration with ASH that “has led to meaningful enhancements to the [MOC] program” and committing to “continue to listen to and learn from the physician community going forward.”

The recent backlash against the MOC process stemmed from a petition demanding an end to the MOC. The petition was launched in July by hematologist-oncologist Aaron Goodman, MD, from the University of California, San Diego, who has been a vocal critic of the MOC process.

The criticism largely centered around the high costs and the “complex and time-consuming process that poses significant challenges to practicing physicians,” Dr. Goodman wrote in the petition, which has garnered more than 20,700 signatures.

In August, the Society for Cardiovascular Angiography and Interventions (SCAI) published “SCAI Position on ABIM Revocation of Certification for Not Participating in MOC.” The Electrophysiology Advocacy Foundation and the Heart Rhythm Society (HRS) issued statements pushing back on the MOC as well.

On Sept. 21, the SCAI, HRS, American College of Cardiology, and the Heart Failure Society of America went a step further and announced plans to create a new certification process that is independent of the ABIM MOC system.

The American Society of Clinical Oncology (ASCO) is now also surveying members about their MOC experience. A Sept. 26 announcement encouraged recipients to check their inboxes for a link to an anonymous MOC Experience Questionnaire before Oct. 12 and thanked respondents for their “engagement as ASCO works to address this critical issue for the oncology community.”

After ASH sent its letter to ABIM, Dr. Goodman applauded the society’s stance in a post on his X (formerly Twitter) account. Vincent Rajkumar, MD, a hematologist at the Mayo Clinic in Rochester, Minn., commented on ABIM’s response to ASH’s letter via X, noting, “If I were @ASH_hematology leadership, I would take ABIM response as disrespectful. A hasty response within a day is not a sign of good faith.”

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

Opposition to the current American Board of Internal Medicine’s (ABIM’s) Maintenance of Certification (MOC) process continues to gain momentum, with the latest condemnation coming from the American Society of Hematology (ASH).

ASH president Robert A. Brodsky, MD, sent a letter to ABIM’s President and Chief Executive Officer Richard Baron, MD, highlighting hematologists’ concerns about the MOC process and outlining immediate actions ABIM should take.

“ASH continues to support the importance of lifelong learning for hematologists via a program that is evidence-based, relevant to one’s practice, and transparent; however, these three basic requirements are not met by the current ABIM MOC program,” Dr. Brodsky stated in the Sept. 27 letter to Baron.

Dr. Brodsky highlighted, for instance, the fact that the Longitudinal Knowledge Assessment – the alternative to the 10-year exam – “does not reflect real life practice, nor does it target each individual’s scope of practice.” Dr. Brodsky added that, according to members of ASH, the assessment is also “creating high levels of stress and contributing to burnout.”

The letter from Dr. Brodsky urged ABIM to “establish a new MOC program” that does not involve high-stakes assessments, reduces the number of Longitudinal Knowledge Assessment questions physicians receive, and eliminates redundancy between the MOC requirement to have a current license and the requirement to report continued medical education to ABIM.

The ABIM shared a copy of the letter in a Sept. 28 blog post defending the MOC process, highlighting past collaboration with ASH that “has led to meaningful enhancements to the [MOC] program” and committing to “continue to listen to and learn from the physician community going forward.”

The recent backlash against the MOC process stemmed from a petition demanding an end to the MOC. The petition was launched in July by hematologist-oncologist Aaron Goodman, MD, from the University of California, San Diego, who has been a vocal critic of the MOC process.

The criticism largely centered around the high costs and the “complex and time-consuming process that poses significant challenges to practicing physicians,” Dr. Goodman wrote in the petition, which has garnered more than 20,700 signatures.

In August, the Society for Cardiovascular Angiography and Interventions (SCAI) published “SCAI Position on ABIM Revocation of Certification for Not Participating in MOC.” The Electrophysiology Advocacy Foundation and the Heart Rhythm Society (HRS) issued statements pushing back on the MOC as well.

On Sept. 21, the SCAI, HRS, American College of Cardiology, and the Heart Failure Society of America went a step further and announced plans to create a new certification process that is independent of the ABIM MOC system.

The American Society of Clinical Oncology (ASCO) is now also surveying members about their MOC experience. A Sept. 26 announcement encouraged recipients to check their inboxes for a link to an anonymous MOC Experience Questionnaire before Oct. 12 and thanked respondents for their “engagement as ASCO works to address this critical issue for the oncology community.”

After ASH sent its letter to ABIM, Dr. Goodman applauded the society’s stance in a post on his X (formerly Twitter) account. Vincent Rajkumar, MD, a hematologist at the Mayo Clinic in Rochester, Minn., commented on ABIM’s response to ASH’s letter via X, noting, “If I were @ASH_hematology leadership, I would take ABIM response as disrespectful. A hasty response within a day is not a sign of good faith.”

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

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
• Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
•  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
• Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
•  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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

TOPLINE:

Research from South Korea provides additional evidence for the connection between COVID-19 and an increased risk for autoimmune conditions post infection.

METHODOLOGY:

• In this retrospective study, researchers identified 354,527 individuals diagnosed with COVID-19 via polymerase chain reaction (PCR) testing from Oct. 8, 2020, to Dec. 31, 2021.
• Researchers compared the COVID-19 group with 6,134,940 healthy individuals who had no evidence of COVID-19 to quantify the risk for autoimmune and autoinflammatory connective tissue disorders.
• Patients were followed until diagnosis, death, or end of study period (Dec. 31, 2021).

TAKEAWAY:

• Risks for alopecia areata, alopecia totalis, antineutrophil cytoplasmic antibody–associated vasculitis, Crohn’s disease, and sarcoidosis were higher in the COVID-19 group.
• Patients with more severe COVID-19 (admitted to the ICU) were at greater risk for many autoimmune conditions, including alopecia totalis, psoriasis, vitiligo, and vasculitis.
•  

IN PRACTICE:

“Our results emphasize the need to focus on managing not only the acute stages of COVID-19 itself but also autoimmune diseases as complications of COVID-19,” the authors wrote.

SOURCE:

Sung Ha Lim, MD, of Yonsei University, Wonju, South Korea, was the first author of the study, published in JAMA Network Open.

LIMITATIONS:

The study was retrospective and was composed almost exclusively of individuals from a single ethnicity. The study could have included individuals with COVID-19 in the control group who did not undergo PCR testing. The analysis did not include detailed information on each patient, including genetic information, that could have contributed to autoimmune disease risk.

DISCLOSURES:

The study was supported by a fund from the research program of the Korea Medical Institute and by grants from the Korea Health Industry Development Institute, the Korean Ministry of Health & Welfare, and the National Research Foundation of Korea. The authors disclosed no relevant financial relationships.

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