Weight Loss Interventions Improve Key Features of PCOS

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Wed, 11/06/2024 - 10:06

 

TOPLINE:

Weight loss interventions using medication or behavioral changes can improve insulin resistance, hormonal markers, and menstrual frequency in women with polycystic ovary syndrome (PCOS), according to a new meta-analysis. Losing weight may not significantly reduce hirsutism or improve quality of life in women with the condition, however.

METHODOLOGY:

  • Researchers systematically reviewed randomized controlled trials comparing weight loss interventions to usual care in women with PCOS.
  • They focused on 12 studies with behavioral interventions (mainly diets with modest energy deficits), nine trials that used glucagon-like peptide 1 (GLP-1) receptor agonists, and eight studies using other weight loss medications.
  • A total of 1529 participants were included in the analysis.
  • The investigators synthesized the data using a random-effects meta-analysis with Knapp-Hartung adjustment to examine pooled mean differences.

TAKEAWAY:

  • Menstrual frequency increased by 2.64 menses per year (95% CI, 0.65-4.63) with weight loss interventions.
  • “To our knowledge, this is the first review to show a clinically significant association in improvement in menstrual frequency with weight loss interventions, an important indicator of subsequent fertility and an important outcome for women,” the researchers wrote.
  • Glycemic control also improved, with a mean reduction in homeostatic model assessment of insulin resistance of 0.45 (95% CI, –0.75 to –0.15).
  • Free androgen index decreased by an average of 2.03 (95% CI, –3.0 to –1.07).

IN PRACTICE:

“Clinicians may use these findings to counsel women with PCOS on the expected improvements in PCOS markers after weight loss and direct patients toward interventions,” the authors of the study wrote. “Because weight loss programs are cost-effective interventions to improve cardiometabolic risk, they may be particularly valuable for this population at elevated risk.”

SOURCE:

The study was led by Jadine Scragg, PhD, with the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England. It was published online in Annals of Internal Medicine.

LIMITATIONS:

Interventions using GLP-1 agonists were dosed for glycemic control rather than weight management. The studies in the meta-analysis were relatively few and heterogeneous. Data were insufficient to assess ovulation and acne.

DISCLOSURES:

The meta-analysis was supported by grants from the National Institute for Health and Care Research School for Primary Care Research. Authors disclosed ties to Nestlé Health Science and Second Nature.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Weight loss interventions using medication or behavioral changes can improve insulin resistance, hormonal markers, and menstrual frequency in women with polycystic ovary syndrome (PCOS), according to a new meta-analysis. Losing weight may not significantly reduce hirsutism or improve quality of life in women with the condition, however.

METHODOLOGY:

  • Researchers systematically reviewed randomized controlled trials comparing weight loss interventions to usual care in women with PCOS.
  • They focused on 12 studies with behavioral interventions (mainly diets with modest energy deficits), nine trials that used glucagon-like peptide 1 (GLP-1) receptor agonists, and eight studies using other weight loss medications.
  • A total of 1529 participants were included in the analysis.
  • The investigators synthesized the data using a random-effects meta-analysis with Knapp-Hartung adjustment to examine pooled mean differences.

TAKEAWAY:

  • Menstrual frequency increased by 2.64 menses per year (95% CI, 0.65-4.63) with weight loss interventions.
  • “To our knowledge, this is the first review to show a clinically significant association in improvement in menstrual frequency with weight loss interventions, an important indicator of subsequent fertility and an important outcome for women,” the researchers wrote.
  • Glycemic control also improved, with a mean reduction in homeostatic model assessment of insulin resistance of 0.45 (95% CI, –0.75 to –0.15).
  • Free androgen index decreased by an average of 2.03 (95% CI, –3.0 to –1.07).

IN PRACTICE:

“Clinicians may use these findings to counsel women with PCOS on the expected improvements in PCOS markers after weight loss and direct patients toward interventions,” the authors of the study wrote. “Because weight loss programs are cost-effective interventions to improve cardiometabolic risk, they may be particularly valuable for this population at elevated risk.”

SOURCE:

The study was led by Jadine Scragg, PhD, with the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England. It was published online in Annals of Internal Medicine.

LIMITATIONS:

Interventions using GLP-1 agonists were dosed for glycemic control rather than weight management. The studies in the meta-analysis were relatively few and heterogeneous. Data were insufficient to assess ovulation and acne.

DISCLOSURES:

The meta-analysis was supported by grants from the National Institute for Health and Care Research School for Primary Care Research. Authors disclosed ties to Nestlé Health Science and Second Nature.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Weight loss interventions using medication or behavioral changes can improve insulin resistance, hormonal markers, and menstrual frequency in women with polycystic ovary syndrome (PCOS), according to a new meta-analysis. Losing weight may not significantly reduce hirsutism or improve quality of life in women with the condition, however.

METHODOLOGY:

  • Researchers systematically reviewed randomized controlled trials comparing weight loss interventions to usual care in women with PCOS.
  • They focused on 12 studies with behavioral interventions (mainly diets with modest energy deficits), nine trials that used glucagon-like peptide 1 (GLP-1) receptor agonists, and eight studies using other weight loss medications.
  • A total of 1529 participants were included in the analysis.
  • The investigators synthesized the data using a random-effects meta-analysis with Knapp-Hartung adjustment to examine pooled mean differences.

TAKEAWAY:

  • Menstrual frequency increased by 2.64 menses per year (95% CI, 0.65-4.63) with weight loss interventions.
  • “To our knowledge, this is the first review to show a clinically significant association in improvement in menstrual frequency with weight loss interventions, an important indicator of subsequent fertility and an important outcome for women,” the researchers wrote.
  • Glycemic control also improved, with a mean reduction in homeostatic model assessment of insulin resistance of 0.45 (95% CI, –0.75 to –0.15).
  • Free androgen index decreased by an average of 2.03 (95% CI, –3.0 to –1.07).

IN PRACTICE:

“Clinicians may use these findings to counsel women with PCOS on the expected improvements in PCOS markers after weight loss and direct patients toward interventions,” the authors of the study wrote. “Because weight loss programs are cost-effective interventions to improve cardiometabolic risk, they may be particularly valuable for this population at elevated risk.”

SOURCE:

The study was led by Jadine Scragg, PhD, with the Nuffield Department of Primary Care Health Sciences at the University of Oxford in England. It was published online in Annals of Internal Medicine.

LIMITATIONS:

Interventions using GLP-1 agonists were dosed for glycemic control rather than weight management. The studies in the meta-analysis were relatively few and heterogeneous. Data were insufficient to assess ovulation and acne.

DISCLOSURES:

The meta-analysis was supported by grants from the National Institute for Health and Care Research School for Primary Care Research. Authors disclosed ties to Nestlé Health Science and Second Nature.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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‘Small Increase’ in Breast Cancer With Levonorgestrel IUD?

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Changed
Mon, 10/28/2024 - 14:08

 

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

  • The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
  • They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
  • Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
  • The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

  • Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
  • The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

  • The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
  • They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
  • Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
  • The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

  • Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
  • The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

  • The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
  • They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
  • Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
  • The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

  • Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
  • The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Industry Payments to Peer Reviewers Scrutinized at Four Major Medical Journals

Article Type
Changed
Thu, 10/24/2024 - 09:35

 

TOPLINE: 

More than half of the US peer reviewers for four major medical journals received industry payments between 2020-2022, new research shows. Altogether they received more than $64 million in general, non-research payments, with a median payment per physician of $7614. Research payments — including money paid directly to physicians as well as funds related to research for which a physician was registered as a principal investigator — exceeded $1 billion.

METHODOLOGY:

  • Researchers identified peer reviewers in 2022 for The BMJJAMAThe Lancet, and The New England Journal of Medicine using each journal’s list of reviewers for that year. They included 1962 US-based physicians in their analysis.
  • General and research payments made to the peer reviewers between 2020-2022 were extracted from the Open Payments database.

TAKEAWAY:

  • Nearly 59% of the peer reviewers received industry payments between 2020-2022.
  • Payments included $34.31 million in consulting fees and $11.8 million for speaking compensation unrelated to continuing medical education programs.
  • Male reviewers received a significantly higher median total payment than did female reviewers ($38,959 vs $19,586). General payments were higher for men as well ($8663 vs $4183).
  • For comparison, the median general payment to all physicians in 2018 was $216, the researchers noted.

IN PRACTICE:

“Additional research and transparency regarding industry payments in the peer review process are needed,” the authors of the study wrote.

SOURCE:

Christopher J. D. Wallis, MD, PhD, with the division of urology at the University of Toronto, Canada, was the corresponding author for the study. The article was published online October 10 in JAMA.

LIMITATIONS: 

Whether the financial ties were relevant to any of the papers that the peer reviewers critiqued is not known. Some reviewers might have received additional payments from insurance and technology companies that were not captured in this study. The findings might not apply to other journals, the researchers noted. 

DISCLOSURES:

Wallis disclosed personal fees from Janssen Oncology, Nanostics, Precision Point Specialty, Sesen Bio, AbbVie, Astellas, AstraZeneca, Bayer, EMD Serono, Knight Therapeutics, Merck, Science and Medicine Canada, TerSera, and Tolmar. He and some coauthors also disclosed support and grants from foundations and government institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE: 

More than half of the US peer reviewers for four major medical journals received industry payments between 2020-2022, new research shows. Altogether they received more than $64 million in general, non-research payments, with a median payment per physician of $7614. Research payments — including money paid directly to physicians as well as funds related to research for which a physician was registered as a principal investigator — exceeded $1 billion.

METHODOLOGY:

  • Researchers identified peer reviewers in 2022 for The BMJJAMAThe Lancet, and The New England Journal of Medicine using each journal’s list of reviewers for that year. They included 1962 US-based physicians in their analysis.
  • General and research payments made to the peer reviewers between 2020-2022 were extracted from the Open Payments database.

TAKEAWAY:

  • Nearly 59% of the peer reviewers received industry payments between 2020-2022.
  • Payments included $34.31 million in consulting fees and $11.8 million for speaking compensation unrelated to continuing medical education programs.
  • Male reviewers received a significantly higher median total payment than did female reviewers ($38,959 vs $19,586). General payments were higher for men as well ($8663 vs $4183).
  • For comparison, the median general payment to all physicians in 2018 was $216, the researchers noted.

IN PRACTICE:

“Additional research and transparency regarding industry payments in the peer review process are needed,” the authors of the study wrote.

SOURCE:

Christopher J. D. Wallis, MD, PhD, with the division of urology at the University of Toronto, Canada, was the corresponding author for the study. The article was published online October 10 in JAMA.

LIMITATIONS: 

Whether the financial ties were relevant to any of the papers that the peer reviewers critiqued is not known. Some reviewers might have received additional payments from insurance and technology companies that were not captured in this study. The findings might not apply to other journals, the researchers noted. 

DISCLOSURES:

Wallis disclosed personal fees from Janssen Oncology, Nanostics, Precision Point Specialty, Sesen Bio, AbbVie, Astellas, AstraZeneca, Bayer, EMD Serono, Knight Therapeutics, Merck, Science and Medicine Canada, TerSera, and Tolmar. He and some coauthors also disclosed support and grants from foundations and government institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE: 

More than half of the US peer reviewers for four major medical journals received industry payments between 2020-2022, new research shows. Altogether they received more than $64 million in general, non-research payments, with a median payment per physician of $7614. Research payments — including money paid directly to physicians as well as funds related to research for which a physician was registered as a principal investigator — exceeded $1 billion.

METHODOLOGY:

  • Researchers identified peer reviewers in 2022 for The BMJJAMAThe Lancet, and The New England Journal of Medicine using each journal’s list of reviewers for that year. They included 1962 US-based physicians in their analysis.
  • General and research payments made to the peer reviewers between 2020-2022 were extracted from the Open Payments database.

TAKEAWAY:

  • Nearly 59% of the peer reviewers received industry payments between 2020-2022.
  • Payments included $34.31 million in consulting fees and $11.8 million for speaking compensation unrelated to continuing medical education programs.
  • Male reviewers received a significantly higher median total payment than did female reviewers ($38,959 vs $19,586). General payments were higher for men as well ($8663 vs $4183).
  • For comparison, the median general payment to all physicians in 2018 was $216, the researchers noted.

IN PRACTICE:

“Additional research and transparency regarding industry payments in the peer review process are needed,” the authors of the study wrote.

SOURCE:

Christopher J. D. Wallis, MD, PhD, with the division of urology at the University of Toronto, Canada, was the corresponding author for the study. The article was published online October 10 in JAMA.

LIMITATIONS: 

Whether the financial ties were relevant to any of the papers that the peer reviewers critiqued is not known. Some reviewers might have received additional payments from insurance and technology companies that were not captured in this study. The findings might not apply to other journals, the researchers noted. 

DISCLOSURES:

Wallis disclosed personal fees from Janssen Oncology, Nanostics, Precision Point Specialty, Sesen Bio, AbbVie, Astellas, AstraZeneca, Bayer, EMD Serono, Knight Therapeutics, Merck, Science and Medicine Canada, TerSera, and Tolmar. He and some coauthors also disclosed support and grants from foundations and government institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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These Patients May Be Less Adherent to nAMD Treatment

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Wed, 10/23/2024 - 08:29

 

TOPLINE:

— Patients who receive a diagnosis of neovascular age-related macular degeneration (nAMD) from their primary care clinician may be less likely to adhere to treatment than those who receive the diagnosis from a specialist who provides anti–vascular endothelial growth factor (anti-VEGF) therapy, according to global survey results presented at the European Society of Retina Specialists (EURETINA) 2024. Likewise, patients who self-pay for the medication or who have bilateral nAMD may be less adherent to therapy, researchers found.

METHODOLOGY:

  • Researchers analyzed data from 4558 patients with nAMD who participated in the Barometer Global Survey, which involved 77 clinics in 24 countries, including Canada, Mexico, Brazil, Germany, and France.
  • The survey included multiple-choice questions on personal characteristics, disease awareness, experiences with treatment, and logistical challenges with getting to appointments.
  • An exploratory statistical analysis identified 19 variables that influenced patient adherence to anti-VEGF therapy.
  • The researchers classified 670 patients who missed two or more appointments during a 12-month period as nonadherent.

TAKEAWAY:

  • Patients with nAMD diagnosed by their family doctor or general practitioner had a threefold higher risk for nonadherence than those diagnosed by the physician treating their nAMD.
  • Self-pay was associated with more than twice the odds of nonadherence compared with having insurance coverage (odds ratio [OR], 2.5).
  • Compared with unilateral nAMD, bilateral nAMD was associated with higher odds of multiple missed appointments (OR, 1.7).
  • Nonadherence increased with the number of anti-VEGF injections, which may show that “longer treatment durations could permit more opportunities for absenteeism,” the investigators noted.

IN PRACTICE:

“Identifying patient characteristics and challenges that may be associated with nonadherence allows clinicians to recognize patients at risk for nonadherence and provide further support before these patients begin to miss appointments,” the study authors wrote.

SOURCE:

This study was led by Laurent Kodjikian, MD, PhD, with Croix-Rousse University Hospital and the University of Lyon in France. The findings were presented in a poster at EURETINA 2024 (September 19-22).

LIMITATIONS:

The survey relied on participant responses using Likert scales and single-choice questions. Patients from the United States were not included in the study. 

DISCLOSURES:

The survey and medical writing support for the study were funded by Bayer Consumer Care. Kodjikian and co-authors disclosed consulting work for Bayer and other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

— Patients who receive a diagnosis of neovascular age-related macular degeneration (nAMD) from their primary care clinician may be less likely to adhere to treatment than those who receive the diagnosis from a specialist who provides anti–vascular endothelial growth factor (anti-VEGF) therapy, according to global survey results presented at the European Society of Retina Specialists (EURETINA) 2024. Likewise, patients who self-pay for the medication or who have bilateral nAMD may be less adherent to therapy, researchers found.

METHODOLOGY:

  • Researchers analyzed data from 4558 patients with nAMD who participated in the Barometer Global Survey, which involved 77 clinics in 24 countries, including Canada, Mexico, Brazil, Germany, and France.
  • The survey included multiple-choice questions on personal characteristics, disease awareness, experiences with treatment, and logistical challenges with getting to appointments.
  • An exploratory statistical analysis identified 19 variables that influenced patient adherence to anti-VEGF therapy.
  • The researchers classified 670 patients who missed two or more appointments during a 12-month period as nonadherent.

TAKEAWAY:

  • Patients with nAMD diagnosed by their family doctor or general practitioner had a threefold higher risk for nonadherence than those diagnosed by the physician treating their nAMD.
  • Self-pay was associated with more than twice the odds of nonadherence compared with having insurance coverage (odds ratio [OR], 2.5).
  • Compared with unilateral nAMD, bilateral nAMD was associated with higher odds of multiple missed appointments (OR, 1.7).
  • Nonadherence increased with the number of anti-VEGF injections, which may show that “longer treatment durations could permit more opportunities for absenteeism,” the investigators noted.

IN PRACTICE:

“Identifying patient characteristics and challenges that may be associated with nonadherence allows clinicians to recognize patients at risk for nonadherence and provide further support before these patients begin to miss appointments,” the study authors wrote.

SOURCE:

This study was led by Laurent Kodjikian, MD, PhD, with Croix-Rousse University Hospital and the University of Lyon in France. The findings were presented in a poster at EURETINA 2024 (September 19-22).

LIMITATIONS:

The survey relied on participant responses using Likert scales and single-choice questions. Patients from the United States were not included in the study. 

DISCLOSURES:

The survey and medical writing support for the study were funded by Bayer Consumer Care. Kodjikian and co-authors disclosed consulting work for Bayer and other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

— Patients who receive a diagnosis of neovascular age-related macular degeneration (nAMD) from their primary care clinician may be less likely to adhere to treatment than those who receive the diagnosis from a specialist who provides anti–vascular endothelial growth factor (anti-VEGF) therapy, according to global survey results presented at the European Society of Retina Specialists (EURETINA) 2024. Likewise, patients who self-pay for the medication or who have bilateral nAMD may be less adherent to therapy, researchers found.

METHODOLOGY:

  • Researchers analyzed data from 4558 patients with nAMD who participated in the Barometer Global Survey, which involved 77 clinics in 24 countries, including Canada, Mexico, Brazil, Germany, and France.
  • The survey included multiple-choice questions on personal characteristics, disease awareness, experiences with treatment, and logistical challenges with getting to appointments.
  • An exploratory statistical analysis identified 19 variables that influenced patient adherence to anti-VEGF therapy.
  • The researchers classified 670 patients who missed two or more appointments during a 12-month period as nonadherent.

TAKEAWAY:

  • Patients with nAMD diagnosed by their family doctor or general practitioner had a threefold higher risk for nonadherence than those diagnosed by the physician treating their nAMD.
  • Self-pay was associated with more than twice the odds of nonadherence compared with having insurance coverage (odds ratio [OR], 2.5).
  • Compared with unilateral nAMD, bilateral nAMD was associated with higher odds of multiple missed appointments (OR, 1.7).
  • Nonadherence increased with the number of anti-VEGF injections, which may show that “longer treatment durations could permit more opportunities for absenteeism,” the investigators noted.

IN PRACTICE:

“Identifying patient characteristics and challenges that may be associated with nonadherence allows clinicians to recognize patients at risk for nonadherence and provide further support before these patients begin to miss appointments,” the study authors wrote.

SOURCE:

This study was led by Laurent Kodjikian, MD, PhD, with Croix-Rousse University Hospital and the University of Lyon in France. The findings were presented in a poster at EURETINA 2024 (September 19-22).

LIMITATIONS:

The survey relied on participant responses using Likert scales and single-choice questions. Patients from the United States were not included in the study. 

DISCLOSURES:

The survey and medical writing support for the study were funded by Bayer Consumer Care. Kodjikian and co-authors disclosed consulting work for Bayer and other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Cannabis Linked to Bulging Eyes in Graves’ Disease

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Fri, 09/27/2024 - 15:38

 

TOPLINE:

Among patients with autoimmune hyperthyroidism, those who use cannabis are 1.9 times more likely to develop exophthalmos — eyes that appear to bulge from the face — within 1 year of diagnosis, than those who do not use the drug. However, the added risk may wane over time.

METHODOLOGY:

  • Researchers analyzed data from TriNetX, an electronic health record platform, for more than 36,000 patients with autoimmune hyperthyroidism between 2003 and 2023.
  • The dataset included cannabis users (n = 783), nicotine users (n = 17,310), and control individuals (n = 18,093) who did not use either substance.
  • Primary outcomes included presentations of thyroid eye disease (TED) and the use of treatments for the condition, such as teprotumumab, steroids, eyelid retraction repair, tarsorrhaphy, strabismus surgery, or orbital decompression.
  • The investigators used propensity matching to control for characteristics such as age, sex, race, and prior thyroidectomy or radio ablation.

TAKEAWAY:

  • The incidence of exophthalmos at 1 year was 4.1% among nicotine users, 4.1% among cannabis users, and 2.2% among controls.
  • Cannabis users were 1.9 times more likely than controls to develop exophthalmos within 1 year (P = .03).
  • At 2 years, the researchers identified a trend toward more TED in cannabis users than in controls, but the difference was no longer statistically significant.
  • Cannabis users were about 2.5 times more likely than controls to be prescribed steroids throughout the 2-year follow-up period.

IN PRACTICE:

“These findings altogether suggest that cannabis usage may be associated with earlier progression or increased short-term severity of TED symptoms,” the authors of the study wrote. The mechanisms may be like those for cigarette smoking and could include inflammation and vascular congestion, they added.

SOURCE:

The study was conducted by Amanda M. Zong and Anne Barmettler, MD, with Albert Einstein College of Medicine in New York City. It was published online in Ophthalmic Plastic and Reconstructive Surgery.

LIMITATIONS:

The number of cannabis users was relatively small and included only patients who had received a diagnosis of a cannabis-usage disorder prior to the diagnosis of autoimmune hyperthyroidism, the researchers noted. TED lacks a specific International Classification of Diseases–10 code, which necessitated the use of indirect measures. “Furthermore, the mode of administration, duration, and frequency of cannabis and nicotine usage were not available in the dataset used, limiting analysis of degree of association and modifiable risk,” they wrote.

DISCLOSURES:

The researchers disclosed no relevant financial relationships.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Among patients with autoimmune hyperthyroidism, those who use cannabis are 1.9 times more likely to develop exophthalmos — eyes that appear to bulge from the face — within 1 year of diagnosis, than those who do not use the drug. However, the added risk may wane over time.

METHODOLOGY:

  • Researchers analyzed data from TriNetX, an electronic health record platform, for more than 36,000 patients with autoimmune hyperthyroidism between 2003 and 2023.
  • The dataset included cannabis users (n = 783), nicotine users (n = 17,310), and control individuals (n = 18,093) who did not use either substance.
  • Primary outcomes included presentations of thyroid eye disease (TED) and the use of treatments for the condition, such as teprotumumab, steroids, eyelid retraction repair, tarsorrhaphy, strabismus surgery, or orbital decompression.
  • The investigators used propensity matching to control for characteristics such as age, sex, race, and prior thyroidectomy or radio ablation.

TAKEAWAY:

  • The incidence of exophthalmos at 1 year was 4.1% among nicotine users, 4.1% among cannabis users, and 2.2% among controls.
  • Cannabis users were 1.9 times more likely than controls to develop exophthalmos within 1 year (P = .03).
  • At 2 years, the researchers identified a trend toward more TED in cannabis users than in controls, but the difference was no longer statistically significant.
  • Cannabis users were about 2.5 times more likely than controls to be prescribed steroids throughout the 2-year follow-up period.

IN PRACTICE:

“These findings altogether suggest that cannabis usage may be associated with earlier progression or increased short-term severity of TED symptoms,” the authors of the study wrote. The mechanisms may be like those for cigarette smoking and could include inflammation and vascular congestion, they added.

SOURCE:

The study was conducted by Amanda M. Zong and Anne Barmettler, MD, with Albert Einstein College of Medicine in New York City. It was published online in Ophthalmic Plastic and Reconstructive Surgery.

LIMITATIONS:

The number of cannabis users was relatively small and included only patients who had received a diagnosis of a cannabis-usage disorder prior to the diagnosis of autoimmune hyperthyroidism, the researchers noted. TED lacks a specific International Classification of Diseases–10 code, which necessitated the use of indirect measures. “Furthermore, the mode of administration, duration, and frequency of cannabis and nicotine usage were not available in the dataset used, limiting analysis of degree of association and modifiable risk,” they wrote.

DISCLOSURES:

The researchers disclosed no relevant financial relationships.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Among patients with autoimmune hyperthyroidism, those who use cannabis are 1.9 times more likely to develop exophthalmos — eyes that appear to bulge from the face — within 1 year of diagnosis, than those who do not use the drug. However, the added risk may wane over time.

METHODOLOGY:

  • Researchers analyzed data from TriNetX, an electronic health record platform, for more than 36,000 patients with autoimmune hyperthyroidism between 2003 and 2023.
  • The dataset included cannabis users (n = 783), nicotine users (n = 17,310), and control individuals (n = 18,093) who did not use either substance.
  • Primary outcomes included presentations of thyroid eye disease (TED) and the use of treatments for the condition, such as teprotumumab, steroids, eyelid retraction repair, tarsorrhaphy, strabismus surgery, or orbital decompression.
  • The investigators used propensity matching to control for characteristics such as age, sex, race, and prior thyroidectomy or radio ablation.

TAKEAWAY:

  • The incidence of exophthalmos at 1 year was 4.1% among nicotine users, 4.1% among cannabis users, and 2.2% among controls.
  • Cannabis users were 1.9 times more likely than controls to develop exophthalmos within 1 year (P = .03).
  • At 2 years, the researchers identified a trend toward more TED in cannabis users than in controls, but the difference was no longer statistically significant.
  • Cannabis users were about 2.5 times more likely than controls to be prescribed steroids throughout the 2-year follow-up period.

IN PRACTICE:

“These findings altogether suggest that cannabis usage may be associated with earlier progression or increased short-term severity of TED symptoms,” the authors of the study wrote. The mechanisms may be like those for cigarette smoking and could include inflammation and vascular congestion, they added.

SOURCE:

The study was conducted by Amanda M. Zong and Anne Barmettler, MD, with Albert Einstein College of Medicine in New York City. It was published online in Ophthalmic Plastic and Reconstructive Surgery.

LIMITATIONS:

The number of cannabis users was relatively small and included only patients who had received a diagnosis of a cannabis-usage disorder prior to the diagnosis of autoimmune hyperthyroidism, the researchers noted. TED lacks a specific International Classification of Diseases–10 code, which necessitated the use of indirect measures. “Furthermore, the mode of administration, duration, and frequency of cannabis and nicotine usage were not available in the dataset used, limiting analysis of degree of association and modifiable risk,” they wrote.

DISCLOSURES:

The researchers disclosed no relevant financial relationships.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Can Antihistamines Trigger Seizures in Young Kids?

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Changed
Tue, 09/10/2024 - 14:59

 

TOPLINE:

First-generation antihistamines are linked to a 22% higher risk for seizures in children, new research shows. The risk appears to be most pronounced in children aged 6-24 months.

METHODOLOGY:

  • Researchers in Korea used a self-controlled case-crossover design to assess the risk for seizures associated with prescriptions of first-generation antihistamines.
  • They analyzed data from 11,729 children who had a seizure event (an emergency department visit with a diagnosis of epilepsy, status epilepticus, or convulsion) and had previously received a prescription for a first-generation antihistamine, including chlorpheniramine maleate, mequitazine, oxatomide, piprinhydrinate, or hydroxyzine hydrochloride.
  • Prescriptions during the 15 days before a seizure were considered to have been received during a hazard period, whereas earlier prescriptions were considered to have been received during a control period.
  • The researchers excluded patients with febrile seizures.

TAKEAWAY:

  • In an adjusted analysis, a prescription for an antihistamine during the hazard period was associated with a 22% higher risk for seizures in children (adjusted odds ratio, 1.22; 95% CI, 1.13-1.31).
  • The seizure risk was significant in children aged 6-24 months, with an adjusted odds ratio of 1.49 (95% CI, 1.31-1.70).
  • For older children, the risk was not statistically significant.

IN PRACTICE:

“The study underscores a substantial increase in seizure risk associated with antihistamine prescription among children aged 6-24 months,” the authors of the study wrote. “We are not aware of any other studies that have pointed out the increased risk of seizures with first-generation antihistamines in this particular age group. ... The benefits and risks of antihistamine use should always be carefully considered, especially when prescribing H1 antihistamines to vulnerable infants.”

The findings raise a host of questions for clinicians, including how a “relatively small risk” should translate into practice, and whether the risk may be attenuated with newer antihistamines, wrote Frank Max Charles Besag, MB, ChB, with East London NHS Foundation Trust in England, in an editorial accompanying the study. “It would be reasonable to inform families that at least one study has suggested a relatively small increase in the risk of seizures with first-generation antihistamines, adding that there are still too few data to draw any firm conclusions and also providing families with the information on what to do if the child were to have a seizure.” 
 

SOURCE:

Seonkyeong Rhie, MD, and Man Yong Han, MD, both with the Department of Pediatrics at CHA University School of Medicine, in Seongnam, South Korea, were the corresponding authors on the study. The research was published online in JAMA Network Open.

LIMITATIONS:

The researchers did not have details about seizure symptoms, did not include children seen in outpatient clinics, and were unable to verify the actual intake of the prescribed antihistamines. Although second-generation antihistamines may be less likely to cross the blood-brain barrier, one newer medication, desloratadine, has been associated with seizures.

DISCLOSURES:

The study was supported by grants from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, the Ministry of Health and Welfare, Republic of Korea.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

First-generation antihistamines are linked to a 22% higher risk for seizures in children, new research shows. The risk appears to be most pronounced in children aged 6-24 months.

METHODOLOGY:

  • Researchers in Korea used a self-controlled case-crossover design to assess the risk for seizures associated with prescriptions of first-generation antihistamines.
  • They analyzed data from 11,729 children who had a seizure event (an emergency department visit with a diagnosis of epilepsy, status epilepticus, or convulsion) and had previously received a prescription for a first-generation antihistamine, including chlorpheniramine maleate, mequitazine, oxatomide, piprinhydrinate, or hydroxyzine hydrochloride.
  • Prescriptions during the 15 days before a seizure were considered to have been received during a hazard period, whereas earlier prescriptions were considered to have been received during a control period.
  • The researchers excluded patients with febrile seizures.

TAKEAWAY:

  • In an adjusted analysis, a prescription for an antihistamine during the hazard period was associated with a 22% higher risk for seizures in children (adjusted odds ratio, 1.22; 95% CI, 1.13-1.31).
  • The seizure risk was significant in children aged 6-24 months, with an adjusted odds ratio of 1.49 (95% CI, 1.31-1.70).
  • For older children, the risk was not statistically significant.

IN PRACTICE:

“The study underscores a substantial increase in seizure risk associated with antihistamine prescription among children aged 6-24 months,” the authors of the study wrote. “We are not aware of any other studies that have pointed out the increased risk of seizures with first-generation antihistamines in this particular age group. ... The benefits and risks of antihistamine use should always be carefully considered, especially when prescribing H1 antihistamines to vulnerable infants.”

The findings raise a host of questions for clinicians, including how a “relatively small risk” should translate into practice, and whether the risk may be attenuated with newer antihistamines, wrote Frank Max Charles Besag, MB, ChB, with East London NHS Foundation Trust in England, in an editorial accompanying the study. “It would be reasonable to inform families that at least one study has suggested a relatively small increase in the risk of seizures with first-generation antihistamines, adding that there are still too few data to draw any firm conclusions and also providing families with the information on what to do if the child were to have a seizure.” 
 

SOURCE:

Seonkyeong Rhie, MD, and Man Yong Han, MD, both with the Department of Pediatrics at CHA University School of Medicine, in Seongnam, South Korea, were the corresponding authors on the study. The research was published online in JAMA Network Open.

LIMITATIONS:

The researchers did not have details about seizure symptoms, did not include children seen in outpatient clinics, and were unable to verify the actual intake of the prescribed antihistamines. Although second-generation antihistamines may be less likely to cross the blood-brain barrier, one newer medication, desloratadine, has been associated with seizures.

DISCLOSURES:

The study was supported by grants from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, the Ministry of Health and Welfare, Republic of Korea.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

First-generation antihistamines are linked to a 22% higher risk for seizures in children, new research shows. The risk appears to be most pronounced in children aged 6-24 months.

METHODOLOGY:

  • Researchers in Korea used a self-controlled case-crossover design to assess the risk for seizures associated with prescriptions of first-generation antihistamines.
  • They analyzed data from 11,729 children who had a seizure event (an emergency department visit with a diagnosis of epilepsy, status epilepticus, or convulsion) and had previously received a prescription for a first-generation antihistamine, including chlorpheniramine maleate, mequitazine, oxatomide, piprinhydrinate, or hydroxyzine hydrochloride.
  • Prescriptions during the 15 days before a seizure were considered to have been received during a hazard period, whereas earlier prescriptions were considered to have been received during a control period.
  • The researchers excluded patients with febrile seizures.

TAKEAWAY:

  • In an adjusted analysis, a prescription for an antihistamine during the hazard period was associated with a 22% higher risk for seizures in children (adjusted odds ratio, 1.22; 95% CI, 1.13-1.31).
  • The seizure risk was significant in children aged 6-24 months, with an adjusted odds ratio of 1.49 (95% CI, 1.31-1.70).
  • For older children, the risk was not statistically significant.

IN PRACTICE:

“The study underscores a substantial increase in seizure risk associated with antihistamine prescription among children aged 6-24 months,” the authors of the study wrote. “We are not aware of any other studies that have pointed out the increased risk of seizures with first-generation antihistamines in this particular age group. ... The benefits and risks of antihistamine use should always be carefully considered, especially when prescribing H1 antihistamines to vulnerable infants.”

The findings raise a host of questions for clinicians, including how a “relatively small risk” should translate into practice, and whether the risk may be attenuated with newer antihistamines, wrote Frank Max Charles Besag, MB, ChB, with East London NHS Foundation Trust in England, in an editorial accompanying the study. “It would be reasonable to inform families that at least one study has suggested a relatively small increase in the risk of seizures with first-generation antihistamines, adding that there are still too few data to draw any firm conclusions and also providing families with the information on what to do if the child were to have a seizure.” 
 

SOURCE:

Seonkyeong Rhie, MD, and Man Yong Han, MD, both with the Department of Pediatrics at CHA University School of Medicine, in Seongnam, South Korea, were the corresponding authors on the study. The research was published online in JAMA Network Open.

LIMITATIONS:

The researchers did not have details about seizure symptoms, did not include children seen in outpatient clinics, and were unable to verify the actual intake of the prescribed antihistamines. Although second-generation antihistamines may be less likely to cross the blood-brain barrier, one newer medication, desloratadine, has been associated with seizures.

DISCLOSURES:

The study was supported by grants from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, the Ministry of Health and Welfare, Republic of Korea.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Revamped Antibiotic May Treat Deadly Eye Infection

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Changed
Thu, 05/09/2024 - 13:54

The relatively new antibiotic cefiderocol given in the form of eye drops may be a way to combat a type of ocular infection that broke out in the United States last year, according to research presented at the 2024 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).

The infections, linked to contaminated bottles of artificial tearswere detected in 81 patients in 18 states. The outbreak led to loss of vision in 14 patients, surgical removal of the eyeball in four patients, and four deaths, according to health officials. 

An extensively drug-resistant strain of Pseudomonas aeruginosa that had not previously been reported in the country caused the infections. Scientists cautioned last year that the bacteria potentially could spread from person to person

At ARVO on May 6, Eric G. Romanowski, MS, research director of the Charles T. Campbell Ophthalmic Microbiology Laboratory at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, described studies that his lab conducted evaluating topical cefiderocol as a potential treatment option for these infections (Abstract 2095).

Investigators had found that the bacterial strain was susceptible to this medication, which was approved by the US Food and Drug Administration in 2019 as a treatment for complicated urinary tract infections. But the antibiotic had not been tested as an eye drop.

“We showed that the ‘Trojan-horse’ antibiotic, cefiderocol … was non-toxic and effective against the highly resistant outbreak strain in an experimental model of infection,” Dr. Romanowski and co–lead investigator Robert M. Q. Shanks, PhD, said in a statement about their research. “These results demonstrate that topical cefiderocol could be a new weapon in the ophthalmologist’s arsenal for the treatment of corneal infections caused by highly antibiotic-resistant Pseudomonas aeruginosa.”
 

Experimental Models

Dr. Romanowski’s group, with colleagues at the Geisel School of Medicine at Dartmouth University, Hanover, New Hampshire, used minimum inhibitory concentration testing to evaluate the effectiveness of cefiderocol against 135 isolates from eye infections. They also tested ocular toxicity and antibiotic efficacy of cefiderocol eye drops in a rabbit model of keratitis caused by the bacterial strain.

Cefiderocol was “well tolerated on rabbit corneas,” they reported. It also was effective in vitro against the isolates and in vivo in the rabbit model of keratitis.

They first published their findings as a preprint in September 2023 and then in Ophthalmology Science in December.

 

A ‘Duty to the Profession’

Their paper noted that “there is no current consensus as to the most effective antimicrobial strategy to deal with” extensively drug-resistant keratitis.

During the outbreak, clinicians tried various treatment regimens, with mixed results. In one case, a combination of intravenous cefiderocol and other topical and oral medications appeared to be successful.

Dr. Romanowski’s team decided to test cefiderocol drops with their own resources “as a duty to the profession,” he said. “Not many labs do these types of studies.”

“We would like to see further development of this antibiotic for potential use,” Dr. Romanowski added. “It would be up to any individual clinician to determine whether to use this antibiotic in an emergency situation.”

A version of this article appeared on Medscape.com.

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The relatively new antibiotic cefiderocol given in the form of eye drops may be a way to combat a type of ocular infection that broke out in the United States last year, according to research presented at the 2024 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).

The infections, linked to contaminated bottles of artificial tearswere detected in 81 patients in 18 states. The outbreak led to loss of vision in 14 patients, surgical removal of the eyeball in four patients, and four deaths, according to health officials. 

An extensively drug-resistant strain of Pseudomonas aeruginosa that had not previously been reported in the country caused the infections. Scientists cautioned last year that the bacteria potentially could spread from person to person

At ARVO on May 6, Eric G. Romanowski, MS, research director of the Charles T. Campbell Ophthalmic Microbiology Laboratory at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, described studies that his lab conducted evaluating topical cefiderocol as a potential treatment option for these infections (Abstract 2095).

Investigators had found that the bacterial strain was susceptible to this medication, which was approved by the US Food and Drug Administration in 2019 as a treatment for complicated urinary tract infections. But the antibiotic had not been tested as an eye drop.

“We showed that the ‘Trojan-horse’ antibiotic, cefiderocol … was non-toxic and effective against the highly resistant outbreak strain in an experimental model of infection,” Dr. Romanowski and co–lead investigator Robert M. Q. Shanks, PhD, said in a statement about their research. “These results demonstrate that topical cefiderocol could be a new weapon in the ophthalmologist’s arsenal for the treatment of corneal infections caused by highly antibiotic-resistant Pseudomonas aeruginosa.”
 

Experimental Models

Dr. Romanowski’s group, with colleagues at the Geisel School of Medicine at Dartmouth University, Hanover, New Hampshire, used minimum inhibitory concentration testing to evaluate the effectiveness of cefiderocol against 135 isolates from eye infections. They also tested ocular toxicity and antibiotic efficacy of cefiderocol eye drops in a rabbit model of keratitis caused by the bacterial strain.

Cefiderocol was “well tolerated on rabbit corneas,” they reported. It also was effective in vitro against the isolates and in vivo in the rabbit model of keratitis.

They first published their findings as a preprint in September 2023 and then in Ophthalmology Science in December.

 

A ‘Duty to the Profession’

Their paper noted that “there is no current consensus as to the most effective antimicrobial strategy to deal with” extensively drug-resistant keratitis.

During the outbreak, clinicians tried various treatment regimens, with mixed results. In one case, a combination of intravenous cefiderocol and other topical and oral medications appeared to be successful.

Dr. Romanowski’s team decided to test cefiderocol drops with their own resources “as a duty to the profession,” he said. “Not many labs do these types of studies.”

“We would like to see further development of this antibiotic for potential use,” Dr. Romanowski added. “It would be up to any individual clinician to determine whether to use this antibiotic in an emergency situation.”

A version of this article appeared on Medscape.com.

The relatively new antibiotic cefiderocol given in the form of eye drops may be a way to combat a type of ocular infection that broke out in the United States last year, according to research presented at the 2024 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).

The infections, linked to contaminated bottles of artificial tearswere detected in 81 patients in 18 states. The outbreak led to loss of vision in 14 patients, surgical removal of the eyeball in four patients, and four deaths, according to health officials. 

An extensively drug-resistant strain of Pseudomonas aeruginosa that had not previously been reported in the country caused the infections. Scientists cautioned last year that the bacteria potentially could spread from person to person

At ARVO on May 6, Eric G. Romanowski, MS, research director of the Charles T. Campbell Ophthalmic Microbiology Laboratory at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, described studies that his lab conducted evaluating topical cefiderocol as a potential treatment option for these infections (Abstract 2095).

Investigators had found that the bacterial strain was susceptible to this medication, which was approved by the US Food and Drug Administration in 2019 as a treatment for complicated urinary tract infections. But the antibiotic had not been tested as an eye drop.

“We showed that the ‘Trojan-horse’ antibiotic, cefiderocol … was non-toxic and effective against the highly resistant outbreak strain in an experimental model of infection,” Dr. Romanowski and co–lead investigator Robert M. Q. Shanks, PhD, said in a statement about their research. “These results demonstrate that topical cefiderocol could be a new weapon in the ophthalmologist’s arsenal for the treatment of corneal infections caused by highly antibiotic-resistant Pseudomonas aeruginosa.”
 

Experimental Models

Dr. Romanowski’s group, with colleagues at the Geisel School of Medicine at Dartmouth University, Hanover, New Hampshire, used minimum inhibitory concentration testing to evaluate the effectiveness of cefiderocol against 135 isolates from eye infections. They also tested ocular toxicity and antibiotic efficacy of cefiderocol eye drops in a rabbit model of keratitis caused by the bacterial strain.

Cefiderocol was “well tolerated on rabbit corneas,” they reported. It also was effective in vitro against the isolates and in vivo in the rabbit model of keratitis.

They first published their findings as a preprint in September 2023 and then in Ophthalmology Science in December.

 

A ‘Duty to the Profession’

Their paper noted that “there is no current consensus as to the most effective antimicrobial strategy to deal with” extensively drug-resistant keratitis.

During the outbreak, clinicians tried various treatment regimens, with mixed results. In one case, a combination of intravenous cefiderocol and other topical and oral medications appeared to be successful.

Dr. Romanowski’s team decided to test cefiderocol drops with their own resources “as a duty to the profession,” he said. “Not many labs do these types of studies.”

“We would like to see further development of this antibiotic for potential use,” Dr. Romanowski added. “It would be up to any individual clinician to determine whether to use this antibiotic in an emergency situation.”

A version of this article appeared on Medscape.com.

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FDA Approves New Antibiotic for Uncomplicated UTIs

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Mon, 05/06/2024 - 16:59

 



The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

 



The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

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Ocular Microbiome May Be Dry Eye Culprit

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Wed, 04/24/2024 - 10:10

 

A mix of microbes may help explain why some people develop dry eye disease, new research showed.

This finding suggests that bacteria may cause dry eye and could someday point to new treatments for the condition and related disorders, which affect an estimated 27 million Americans, according to researchers.

Current treatments aim to preserve and enhance tears and tear production to ease the grittiness and itchiness that accompany dry eye disease. 

To examine the role of the ocular microbiome in dry eye disease, scientists in Texas analyzed swab samples from 30 men and women, nine of whom had dry eye.

They found Streptococcus and Pedobacter species were the most common bacteria in healthy eyes.

In people with dry eye, however, more Acinetobacter species were detected.

“We think the metabolites produced by these bacteria are responsible for dry eye conditions,” study coauthor Pallavi Sharma said in a news release about the findings. 

Sharma, a graduate student at Stephen F. Austin State University in Nacogdoches, Texas, presented this research last month at the annual meeting of the American Society for Biochemistry and Molecular Biology. The research team was led by Alexandra Van Kley, PhD, a professor of biology at the university.

“Once we understand the eye microbiota properly, it will improve disease diagnosis at an early stage,” Van Kley predicted in the news release. “This knowledge can also serve as a catalyst for developing innovative therapies aimed at preventing and treating ocular disease as well as those that affect the central microbiome site: The gut.”

Investigators in Australia have conducted similar experiments in patients with meibomian gland dysfunction, a condition marked by underproduction of key oils in the eye.

One group reported in August 2023 the finding of “detectable differences in the bacterial richness, diversity, and community structure of the conjunctiva and eyelid margin between individuals with meibomian gland dysfunction with and without lacrimal dysfunction, as well as to healthy controls.”

More research is needed to confirm and understand the findings, though, and “to determine if manipulating the microbiome could be a potential treatment for the condition,” they wrote.

A version of this article appeared on Medscape.com.

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A mix of microbes may help explain why some people develop dry eye disease, new research showed.

This finding suggests that bacteria may cause dry eye and could someday point to new treatments for the condition and related disorders, which affect an estimated 27 million Americans, according to researchers.

Current treatments aim to preserve and enhance tears and tear production to ease the grittiness and itchiness that accompany dry eye disease. 

To examine the role of the ocular microbiome in dry eye disease, scientists in Texas analyzed swab samples from 30 men and women, nine of whom had dry eye.

They found Streptococcus and Pedobacter species were the most common bacteria in healthy eyes.

In people with dry eye, however, more Acinetobacter species were detected.

“We think the metabolites produced by these bacteria are responsible for dry eye conditions,” study coauthor Pallavi Sharma said in a news release about the findings. 

Sharma, a graduate student at Stephen F. Austin State University in Nacogdoches, Texas, presented this research last month at the annual meeting of the American Society for Biochemistry and Molecular Biology. The research team was led by Alexandra Van Kley, PhD, a professor of biology at the university.

“Once we understand the eye microbiota properly, it will improve disease diagnosis at an early stage,” Van Kley predicted in the news release. “This knowledge can also serve as a catalyst for developing innovative therapies aimed at preventing and treating ocular disease as well as those that affect the central microbiome site: The gut.”

Investigators in Australia have conducted similar experiments in patients with meibomian gland dysfunction, a condition marked by underproduction of key oils in the eye.

One group reported in August 2023 the finding of “detectable differences in the bacterial richness, diversity, and community structure of the conjunctiva and eyelid margin between individuals with meibomian gland dysfunction with and without lacrimal dysfunction, as well as to healthy controls.”

More research is needed to confirm and understand the findings, though, and “to determine if manipulating the microbiome could be a potential treatment for the condition,” they wrote.

A version of this article appeared on Medscape.com.

 

A mix of microbes may help explain why some people develop dry eye disease, new research showed.

This finding suggests that bacteria may cause dry eye and could someday point to new treatments for the condition and related disorders, which affect an estimated 27 million Americans, according to researchers.

Current treatments aim to preserve and enhance tears and tear production to ease the grittiness and itchiness that accompany dry eye disease. 

To examine the role of the ocular microbiome in dry eye disease, scientists in Texas analyzed swab samples from 30 men and women, nine of whom had dry eye.

They found Streptococcus and Pedobacter species were the most common bacteria in healthy eyes.

In people with dry eye, however, more Acinetobacter species were detected.

“We think the metabolites produced by these bacteria are responsible for dry eye conditions,” study coauthor Pallavi Sharma said in a news release about the findings. 

Sharma, a graduate student at Stephen F. Austin State University in Nacogdoches, Texas, presented this research last month at the annual meeting of the American Society for Biochemistry and Molecular Biology. The research team was led by Alexandra Van Kley, PhD, a professor of biology at the university.

“Once we understand the eye microbiota properly, it will improve disease diagnosis at an early stage,” Van Kley predicted in the news release. “This knowledge can also serve as a catalyst for developing innovative therapies aimed at preventing and treating ocular disease as well as those that affect the central microbiome site: The gut.”

Investigators in Australia have conducted similar experiments in patients with meibomian gland dysfunction, a condition marked by underproduction of key oils in the eye.

One group reported in August 2023 the finding of “detectable differences in the bacterial richness, diversity, and community structure of the conjunctiva and eyelid margin between individuals with meibomian gland dysfunction with and without lacrimal dysfunction, as well as to healthy controls.”

More research is needed to confirm and understand the findings, though, and “to determine if manipulating the microbiome could be a potential treatment for the condition,” they wrote.

A version of this article appeared on Medscape.com.

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FDA OKs Benralizumab for Asthma in Children as Young as 6 Years

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Fri, 04/12/2024 - 12:08

Benralizumab is now approved by the US Food and Drug Administration (FDA) for the treatment of asthma in children older than 6 years. 

Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older. The drug is approved as a maintenance add-on for patients with severe eosinophilic asthma. 

AstraZeneca, which markets the drug, announced the approval for younger patients on April 11. 

The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said. 

For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh < 35 kg, a new 10-mg dose will be available, according to the announcement. 

The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.

Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
 

A version of this article appeared on Medscape.com.

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Benralizumab is now approved by the US Food and Drug Administration (FDA) for the treatment of asthma in children older than 6 years. 

Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older. The drug is approved as a maintenance add-on for patients with severe eosinophilic asthma. 

AstraZeneca, which markets the drug, announced the approval for younger patients on April 11. 

The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said. 

For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh < 35 kg, a new 10-mg dose will be available, according to the announcement. 

The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.

Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
 

A version of this article appeared on Medscape.com.

Benralizumab is now approved by the US Food and Drug Administration (FDA) for the treatment of asthma in children older than 6 years. 

Marketed as Fasenra, the medication first was approved in 2017 for patients aged 12 years or older. The drug is approved as a maintenance add-on for patients with severe eosinophilic asthma. 

AstraZeneca, which markets the drug, announced the approval for younger patients on April 11. 

The expanded indication was supported by a study that showed that the drug functions in the same way with younger children and their adolescent peers. The safety and tolerability were also consistent with the known profile of the medicine, the company said. 

For children who weigh ≥ 35 kg, the recommended dose is 30 mg. For patients aged 6-11 years who weigh < 35 kg, a new 10-mg dose will be available, according to the announcement. 

The drug, a monoclonal antibody that depletes eosinophils by binding to interleukin 5 receptor alpha on eosinophils, is administered by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks.

Benralizumab should not be used to treat acute asthma symptoms. Hypersensitivity reasons have occurred after administration of the drug. The most common adverse reactions include headache and pharyngitis.
 

A version of this article appeared on Medscape.com.

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