User login
Study supports lower starting dose of lenvatinib for endometrial cancer
The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.
“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.
Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).
This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.
Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.
“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
Study rationale
Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.
However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.
MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.
“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.
The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
Results and implications
Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.
In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.
There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).
However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).
The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.
Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).
There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.
The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).
Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.
In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.
“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”
This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.
The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.
“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.
Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).
This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.
Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.
“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
Study rationale
Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.
However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.
MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.
“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.
The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
Results and implications
Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.
In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.
There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).
However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).
The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.
Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).
There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.
The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).
Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.
In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.
“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”
This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.
The study included 70 patients who received lenvatinib in combination with pembrolizumab. Patients who were started on 14 mg of lenvatinib per day had fewer dose reductions and a longer time to the first dose reduction, compared with patients who were started on the recommended 20-mg dose. There were no significant differences in response, progression-free survival, or overall survival between the two dose groups.
“Published studies and these results may support using lenvatinib at a starting dose of 14 mg daily in clinical practice,” said Jeffrey How, MD, a gynecologic oncology fellow at MD Anderson Cancer Center in Houston.
Dr. How presented the results at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 10775).
This is not the first time a recommended starting dose has been deemed too high to use in practice, according to Carol Aghajanian, MD, chief of gynecologic medical oncology at Memorial Sloan Kettering Cancer Center in New York and a panelist for the session where Dr. How presented his research.
Dr. Aghajanian noted that pegylated liposomal doxorubicin and topotecan are “rarely, if ever” started at the labeling doses for recurrent ovarian cancer. Those doses proved to be too high for general practice and “not tolerable with multicycle treatment,” she said.
“We may again be experiencing the effect of single-cycle, dose-limiting toxicity information not guiding us well in how to treat patients over time,” she added.
Study rationale
Based on a 38% overall response rate in the phase 2 KEYNOTE-146 trial, lenvatinib plus pembrolizumab was approved in September 2019 to treat patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair deficient who have progressed on systemic therapy and are not candidates for curative surgery or radiation.
However, the rate of grade 3/4 adverse events with the combination was 66.9% in the trial, leading to dose interruptions or reductions and a discontinuation rate of 17.7%.
MD Anderson oncologists noticed similar toxicity rates at the approved lenvatinib dose of 20 mg per day when they started using the combination in October 2019. It raised a question about the feasibility of implementing the regimen in general practice as well as concerns about compliance, Dr. How said.
“As a consequence, our team started patients on a reduced dose of lenvatinib to improve safety and tolerability,” he added.
The mean dose intensity in the phase 2 trial was 14.4 mg/day, so the team began to start patients on 14 mg daily.
Results and implications
Of the 70 patients studied, 16 were started at 20 mg, and 54 were started at 14 mg. There were no significant differences between the two groups at baseline.
In the entire cohort, the median age was 65.5 years, and patients had received a median of two prior lines of therapy (range, one to nine). Most patients (90%) had a performance status of 0 or 1, 92.9% had microsatellite stable tumors, and 27.1% each had endometrioid or serous histology.
There was no significant difference between the dose groups with regard to any hospitalization (P = .46), hospitalization due to treatment-related adverse events (P = .55), dose interruption (P = .18), or treatment discontinuation due to treatment-related adverse events (P = .54).
However, the average number of dose reductions per patient was higher in the 20-mg group than in the 14-mg group – 1.1 and 0.4, respectively (P = .003).
The increased dose reductions with the higher starting dose were due mostly to gastrointestinal and hematologic adverse events as well as fatigue and anorexia, all of which were far more common in patients started at 20 mg.
Patients in the 14-mg group had a longer time to the first dose reduction or discontinuation due to toxicity – 107 days vs. 42 days in the 20-mg group (P = .001).
There was no significant difference in response rates between the 14-mg and 20-mg groups – 38.2% and 28.6%, respectively (P = .51) – and no significant difference in clinical benefit rates – 72.3% and 57.1%, respectively.
The median progression-free survival was 3.2 months in the 20-mg group and 5.5 months in the 14-mg group (P = .25). The median overall survival was 8.6 months and 10.3 months, respectively (P = .95).
Dr. How noted that this study was limited by its retrospective nature, and the small number of women started at 20 mg may have limited the ability to detect differences with a lower starting dose. Still, these results seem to support a starting dose of 14 mg, he concluded.
In a discussion after Dr. How’s presentation, panelist Judith Smith, PharmD, of UT Health in Houston, noted that her practice is starting women on lenvatinib at 12 mg per day.
“You can use the 14-mg convenience pack, but, from a cost perspective ... we have to be cognizant of the financial toxicity,” she said. “[Combining the] 10-mg and 4-mg tablets is going to be more expensive, so we’ve been using the 4-mg tablets [three per day] and starting at 12 mg.”
This study was funded by MD Anderson and the National Institutes of Health. Dr. How reported having no conflicts of interest. Dr. Aghajanian and Dr. Smith did not provide disclosures.
FROM SGO 2021
Oral sarecycline promising for papulopustular rosacea
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
Linda Stein Gold, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The oral broad-spectrum second-generation tetracyclines doxycycline and minocycline have long been considered first-line therapy for papulopustular rosacea that isn’t cleared using topical agents. But the widespread use of these oral tetracyclines has encouraged the development of antimicrobial resistance. In contrast, sarecycline (Seysara) is a third-generation, narrow-spectrum tetracycline designed to minimize antibiotic resistance. The Food and Drug Administration approved the drug for treatment of moderate to severe acne vulgaris in 2018.
At the meeting, Dr. Stein Gold, director of dermatology clinical research at the Henry Ford Health System in Detroit, highlighted a recent pilot study of oral sarecycline for papulopustular rosacea carried out by James Q. Del Rosso, DO, of Las Vegas and coinvestigators. Although she wasn’t involved in the study, she is a veteran clinical trialist with vast experience leading studies of new therapies for rosacea, acne, and other major dermatologic disorders.
The 12-week, prospective, investigator-blinded study included 97 adults with moderate to severe papulopustular rosacea; 72 were randomized to weight-based dosing of once-daily sarecycline, while the 25 controls took a daily oral vitamin.
One coprimary endpoint was achievement of an Investigator Global Assessment score of 0 or 1, meaning clear or almost clear skin, at week 12. The rates were 75% in the sarecycline group and 16% in controls. The other coprimary endpoint was the percent reduction from baseline to week 12 in inflammatory lesion count. Here again, there was a statistically significant difference in favor of the third-generation tetracycline derivative, which achieved an 80% reduction, compared with 50% in the control group.
Of note, the difference was already significant at the first evaluation at week 4, with a 58% reduction in inflammatory lesions in the sarecycline group versus 31% decrease in controls, Dr. Stein Gold observed at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
Also at week 12, 96% of patients on sarecycline reported having no or only trace symptoms of facial burning, 63% had no or only trace facial erythema, and 94% had no or trace facial itch, compared with 76%, 12%, and 76% of controls, respectively. The sarecycline group was also significantly more likely to report no or trace skin dryness and oiliness.
The side-effect profile was favorable and the same as encountered with the use of sarecycline for acne: no major photosensitivity issues, no serious adverse events, and only 2 of the original 75 patients in the active-treatment arm discontinued sarecycline for treatment-emergent headache or gastroenteritis considered “probably” related to the study drug. The investigators deemed further studies of sarecycline for rosacea to be warranted as a potential expanded indication.
Aiming for clear skin rather than ‘almost clear’
Dr. Stein Gold shared her mantra for rosacea therapy: “Always aim for clear skin.”
She cited a study led by Guy Webster, MD, professor of dermatology, Thomas Jefferson University, Philadelphia, in which he and his coinvestigators looked at the durability of treatment response in a pooled analysis of 1,366 rosacea patients in four clinical trials. If patients improved to “almost clear” after treatment, their median time to relapse was 3 months; if they reached “clear,” it was more than 8 months. Also, more clear patients rated their outcomes as excellent and reported that their skin disease no longer had any effect on their quality of life.
“That’s more than a 5-month difference,” Dr. Stein Gold noted. “It shows the importance of really striving to get that skin completely clear.”
The sarecycline study was funded by Almirall, which markets the antibiotic. Dr. Stein Gold, who has no financial relationship with Almirall, has received research funding from and/or served as a consultant to roughly a dozen other pharmaceutical companies. MedscapeLIVE! and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
National Psoriasis Foundation recommends some stop methotrexate for 2 weeks after J&J vaccine
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
AI system beats endoscopists for detecting early neoplasia in Barrett’s
One of the top publications in gastroenterology in 2020 was a Dutch study demonstrating that a computer-aided system suitable for real-time use in clinical practice detected early neoplasia in patients with Barrett’s esophagus with impressively greater accuracy than did a group of general endoscopists, according to Douglas A. Corley, MD, PhD.
It’s not just his personal opinion that this was one of the major studies of the past year, either. Analytic tools showed the Dutch report was one of the most frequently downloaded studies in 2020 by both clinical gastroenterologists and researchers, said Dr. Corley, director of delivery science and applied research at Kaiser Permanente of Northern California, Oakland, and a faculty gastroenterologist at the University of California, San Francisco.
The deep-learning system developed, evaluated, and externally validated by the Dutch investigators is designed to reduce the rate of failed detection of high-grade dysplasia and early adenocarcinoma in patients undergoing surveillance by general practice gastrointestinal endoscopists. The false-negative rate in looking for the sometimes subtle mucosal surface abnormalities indicative of early neoplasia is known to be higher among these general endoscopists than that among expert endoscopists, and yet it’s the general endoscopists who perform the majority of cancer surveillance in patients with Barrett’s esophagus.
The Dutch group developed the computer-aided detection system by applying artificial intelligence methods to analyze nearly one half-million endoscopic images of confirmed early neoplasia. Once the system was ready to go, they compared its diagnostic accuracy in 80 patients to that of 53 general, nonexpert endoscopists. The deep-learning system had 93% sensitivity and 83% specificity for identification of early neoplasia, significantly better than the 72% sensitivity and 74% specificity for the general endoscopists. The overall accuracy of the computer-assisted detection system was 88%, compared to 73% for the general endoscopists. Moreover, the deep-learning system achieved greater accuracy than did any single one of the endoscopists.
“I think this will be a really helpful addition, the equivalent of a second endoscopist raising a yellow flag to take a closer look at a particular area. It’ll be complementary,” Dr. Corley said at the Gastroenterology Updates, IBD, Liver Disease Conference.
An audience member said he’s aware that other computer-assisted detection systems have also shown outstanding performance for the detection of early neoplasia in Barrett’s esophagus. He asked, why aren’t these being deployed yet in routine clinical practice?
Two reasons, Dr. Corley replied. One is that some of those systems aren’t capable of working during real-time endoscopy. Also, industry seems to be taking a wait-and-see approach. The field of applied artificial intelligence is moving incredibly rapidly, and none of the endoscopic equipment manufacturers wants to incorporate a computer-assisted detection system into their gear when rumor has it that an even better system is going to be announced 6 months later. The manufacturers want to make sure they’re operationalizing the right one.
He suspects the major players in the endoscopic imaging industry are waiting to find a computer-assisted detection system that’s been published and widely accepted as clearly a winner. Then they’ll introduce it into their equipment.
“I do think we’re probably going to be seeing these increasingly. Some computer-assisted detection systems for colon cancer are starting to be put into equipment,” he observed.
Dr. Corley reported having no financial conflicts regarding his presentation.
This article was updated March 31, 2021.
One of the top publications in gastroenterology in 2020 was a Dutch study demonstrating that a computer-aided system suitable for real-time use in clinical practice detected early neoplasia in patients with Barrett’s esophagus with impressively greater accuracy than did a group of general endoscopists, according to Douglas A. Corley, MD, PhD.
It’s not just his personal opinion that this was one of the major studies of the past year, either. Analytic tools showed the Dutch report was one of the most frequently downloaded studies in 2020 by both clinical gastroenterologists and researchers, said Dr. Corley, director of delivery science and applied research at Kaiser Permanente of Northern California, Oakland, and a faculty gastroenterologist at the University of California, San Francisco.
The deep-learning system developed, evaluated, and externally validated by the Dutch investigators is designed to reduce the rate of failed detection of high-grade dysplasia and early adenocarcinoma in patients undergoing surveillance by general practice gastrointestinal endoscopists. The false-negative rate in looking for the sometimes subtle mucosal surface abnormalities indicative of early neoplasia is known to be higher among these general endoscopists than that among expert endoscopists, and yet it’s the general endoscopists who perform the majority of cancer surveillance in patients with Barrett’s esophagus.
The Dutch group developed the computer-aided detection system by applying artificial intelligence methods to analyze nearly one half-million endoscopic images of confirmed early neoplasia. Once the system was ready to go, they compared its diagnostic accuracy in 80 patients to that of 53 general, nonexpert endoscopists. The deep-learning system had 93% sensitivity and 83% specificity for identification of early neoplasia, significantly better than the 72% sensitivity and 74% specificity for the general endoscopists. The overall accuracy of the computer-assisted detection system was 88%, compared to 73% for the general endoscopists. Moreover, the deep-learning system achieved greater accuracy than did any single one of the endoscopists.
“I think this will be a really helpful addition, the equivalent of a second endoscopist raising a yellow flag to take a closer look at a particular area. It’ll be complementary,” Dr. Corley said at the Gastroenterology Updates, IBD, Liver Disease Conference.
An audience member said he’s aware that other computer-assisted detection systems have also shown outstanding performance for the detection of early neoplasia in Barrett’s esophagus. He asked, why aren’t these being deployed yet in routine clinical practice?
Two reasons, Dr. Corley replied. One is that some of those systems aren’t capable of working during real-time endoscopy. Also, industry seems to be taking a wait-and-see approach. The field of applied artificial intelligence is moving incredibly rapidly, and none of the endoscopic equipment manufacturers wants to incorporate a computer-assisted detection system into their gear when rumor has it that an even better system is going to be announced 6 months later. The manufacturers want to make sure they’re operationalizing the right one.
He suspects the major players in the endoscopic imaging industry are waiting to find a computer-assisted detection system that’s been published and widely accepted as clearly a winner. Then they’ll introduce it into their equipment.
“I do think we’re probably going to be seeing these increasingly. Some computer-assisted detection systems for colon cancer are starting to be put into equipment,” he observed.
Dr. Corley reported having no financial conflicts regarding his presentation.
This article was updated March 31, 2021.
One of the top publications in gastroenterology in 2020 was a Dutch study demonstrating that a computer-aided system suitable for real-time use in clinical practice detected early neoplasia in patients with Barrett’s esophagus with impressively greater accuracy than did a group of general endoscopists, according to Douglas A. Corley, MD, PhD.
It’s not just his personal opinion that this was one of the major studies of the past year, either. Analytic tools showed the Dutch report was one of the most frequently downloaded studies in 2020 by both clinical gastroenterologists and researchers, said Dr. Corley, director of delivery science and applied research at Kaiser Permanente of Northern California, Oakland, and a faculty gastroenterologist at the University of California, San Francisco.
The deep-learning system developed, evaluated, and externally validated by the Dutch investigators is designed to reduce the rate of failed detection of high-grade dysplasia and early adenocarcinoma in patients undergoing surveillance by general practice gastrointestinal endoscopists. The false-negative rate in looking for the sometimes subtle mucosal surface abnormalities indicative of early neoplasia is known to be higher among these general endoscopists than that among expert endoscopists, and yet it’s the general endoscopists who perform the majority of cancer surveillance in patients with Barrett’s esophagus.
The Dutch group developed the computer-aided detection system by applying artificial intelligence methods to analyze nearly one half-million endoscopic images of confirmed early neoplasia. Once the system was ready to go, they compared its diagnostic accuracy in 80 patients to that of 53 general, nonexpert endoscopists. The deep-learning system had 93% sensitivity and 83% specificity for identification of early neoplasia, significantly better than the 72% sensitivity and 74% specificity for the general endoscopists. The overall accuracy of the computer-assisted detection system was 88%, compared to 73% for the general endoscopists. Moreover, the deep-learning system achieved greater accuracy than did any single one of the endoscopists.
“I think this will be a really helpful addition, the equivalent of a second endoscopist raising a yellow flag to take a closer look at a particular area. It’ll be complementary,” Dr. Corley said at the Gastroenterology Updates, IBD, Liver Disease Conference.
An audience member said he’s aware that other computer-assisted detection systems have also shown outstanding performance for the detection of early neoplasia in Barrett’s esophagus. He asked, why aren’t these being deployed yet in routine clinical practice?
Two reasons, Dr. Corley replied. One is that some of those systems aren’t capable of working during real-time endoscopy. Also, industry seems to be taking a wait-and-see approach. The field of applied artificial intelligence is moving incredibly rapidly, and none of the endoscopic equipment manufacturers wants to incorporate a computer-assisted detection system into their gear when rumor has it that an even better system is going to be announced 6 months later. The manufacturers want to make sure they’re operationalizing the right one.
He suspects the major players in the endoscopic imaging industry are waiting to find a computer-assisted detection system that’s been published and widely accepted as clearly a winner. Then they’ll introduce it into their equipment.
“I do think we’re probably going to be seeing these increasingly. Some computer-assisted detection systems for colon cancer are starting to be put into equipment,” he observed.
Dr. Corley reported having no financial conflicts regarding his presentation.
This article was updated March 31, 2021.
FROM GUILD 2021
Use of complimentary and alternative medicine common in diabetes patients
An updated worldwide estimate of complementary and alternative medicine (CAM) use among individuals with diabetes found widespread use, though it varied greatly by region and is sometimes hard to define.
The report is the first literature review of the subject since 2007. The researchers looked at CAM use by region, as well as by patient categories such as those with advanced diabetes and by length of time since diagnosis. The most commonly reported CAMs in use were herbal medicine, acupuncture, homeopathy, and spiritual healing.
Only about one-third of patients disclosed their CAM use to their physician or health care provider. “We suggest that health care professionals should carefully anticipate the likelihood of their [patients’] diabetic CAM use in order to enhance treatment optimization and promote medication adherence, as well as to provide a fully informed consultation,” said first author Abdulaziz S. Alzahrani, a PhD student at the University of Birmingham (England). The study was published March 8, 2021, in the European Journal of Clinical Pharmacology.
Patients also have a responsibility, said Gregory Rhee, PhD, assistant professor of public health sciences at the University of Connecticut, Farmington. He was the lead author of a 2018 survey of CAM use in adults aged 65 years and older with diabetes in the United States using data from the 2012 National Health Interview Survey, and found that 25% had used CAM in some form in the prior year. “They need to be more up front, more proactive talking about CAM use with their doctors, and the second part is the physician. They also should be better educated in terms of CAM use. Traditionally, the physician in Western societies have pretty much ignored CAM use. But they are getting aware of CAM use and also we know that people are coming from multiple cultural backgrounds. The physicians and other health care providers should be better informed about CAM, and they should be better educated about it to provide patients better practice,” said Dr. Rhee.
He also distinguished between approaches like yoga or Tai Chi, which are physically oriented and not particularly controversial, and herbal medicines or dietary supplements. “Those can be controversial because we do not have strong scientific evidence to support those modalities for effectiveness on diabetes management,” Dr. Rhee added.
Mr. Alzahrani and colleagues conducted a meta-analysis of 38 studies, which included data from 25 countries. The included studies varied in their approach. For example, 16 studies focused exclusively on herbal and nutritional supplements. The most commonly mentioned CAMs were acupuncture and mind-body therapies (each named in six studies), religious and spiritual healing (five studies), and homeopathy (four studies). Among 31 studies focusing on herbal and nutritional supplements, the most common herbs mentioned were cinnamon and fenugreek (mentioned in 18 studies), garlic (17 studies), aloe vera (14 studies), and black seed (12 studies).
Prevalence of CAM use varied widely, ranging from 17% in Jordan to 89% in India and in a separate study in Jordan. The pooled prevalence of CAM use was 51% (95% confidence interval, 43%-59%). Subgroup analyses found the highest rate of CAM use in Europe (76%) and Africa (55%), and the lowest in North America (45%).
When the researchers examined patient characteristics, they found no significant relationship between CAM use and established ethnicity groups, or between type 1 and type 2 diabetes. The prevalence ratio was lower among men (PR, 0.86; 95% CI, 0.81-0.91). PRs for CAM use were lower among those with diabetic complications (PR, 0.81; 95% CI, 0.66-0.99). Individuals with diabetes of at least 5 years’ duration were more likely to use CAM than those with shorter duration of illness (PR, 1.71; 95% CI, 1.04-1.32).
Most (78%) CAM users employed it as an addition to their treatment regimen (95% CI, 56-94%), while 21% used it as an alternative to prescribed medicine (95% CI, 12-31%). More than two-thirds (67%) of individuals did not disclose CAM use to health care professionals (95% CI, 58-76%).
Although CAM use can be a source of friction between patients and physicians, Dr. Rhee also sees it as an opportunity. Patients from diverse backgrounds may be using CAM, often as a result of different cultural backgrounds. He cited the belief in some Asian countries that the balance of Yin and Yang is key to health, which many patients believe can be addressed through CAM. “If we want to promote cultural diversity, if we really care about patient diversity, I think CAM is one of the potential sources where the doctors should know [more about] the issue,” said Dr. Rhee.
The study was funded by the University of Birmingham. Dr. Rhee and Mr. Alzahrani have no relevant financial disclosures.
An updated worldwide estimate of complementary and alternative medicine (CAM) use among individuals with diabetes found widespread use, though it varied greatly by region and is sometimes hard to define.
The report is the first literature review of the subject since 2007. The researchers looked at CAM use by region, as well as by patient categories such as those with advanced diabetes and by length of time since diagnosis. The most commonly reported CAMs in use were herbal medicine, acupuncture, homeopathy, and spiritual healing.
Only about one-third of patients disclosed their CAM use to their physician or health care provider. “We suggest that health care professionals should carefully anticipate the likelihood of their [patients’] diabetic CAM use in order to enhance treatment optimization and promote medication adherence, as well as to provide a fully informed consultation,” said first author Abdulaziz S. Alzahrani, a PhD student at the University of Birmingham (England). The study was published March 8, 2021, in the European Journal of Clinical Pharmacology.
Patients also have a responsibility, said Gregory Rhee, PhD, assistant professor of public health sciences at the University of Connecticut, Farmington. He was the lead author of a 2018 survey of CAM use in adults aged 65 years and older with diabetes in the United States using data from the 2012 National Health Interview Survey, and found that 25% had used CAM in some form in the prior year. “They need to be more up front, more proactive talking about CAM use with their doctors, and the second part is the physician. They also should be better educated in terms of CAM use. Traditionally, the physician in Western societies have pretty much ignored CAM use. But they are getting aware of CAM use and also we know that people are coming from multiple cultural backgrounds. The physicians and other health care providers should be better informed about CAM, and they should be better educated about it to provide patients better practice,” said Dr. Rhee.
He also distinguished between approaches like yoga or Tai Chi, which are physically oriented and not particularly controversial, and herbal medicines or dietary supplements. “Those can be controversial because we do not have strong scientific evidence to support those modalities for effectiveness on diabetes management,” Dr. Rhee added.
Mr. Alzahrani and colleagues conducted a meta-analysis of 38 studies, which included data from 25 countries. The included studies varied in their approach. For example, 16 studies focused exclusively on herbal and nutritional supplements. The most commonly mentioned CAMs were acupuncture and mind-body therapies (each named in six studies), religious and spiritual healing (five studies), and homeopathy (four studies). Among 31 studies focusing on herbal and nutritional supplements, the most common herbs mentioned were cinnamon and fenugreek (mentioned in 18 studies), garlic (17 studies), aloe vera (14 studies), and black seed (12 studies).
Prevalence of CAM use varied widely, ranging from 17% in Jordan to 89% in India and in a separate study in Jordan. The pooled prevalence of CAM use was 51% (95% confidence interval, 43%-59%). Subgroup analyses found the highest rate of CAM use in Europe (76%) and Africa (55%), and the lowest in North America (45%).
When the researchers examined patient characteristics, they found no significant relationship between CAM use and established ethnicity groups, or between type 1 and type 2 diabetes. The prevalence ratio was lower among men (PR, 0.86; 95% CI, 0.81-0.91). PRs for CAM use were lower among those with diabetic complications (PR, 0.81; 95% CI, 0.66-0.99). Individuals with diabetes of at least 5 years’ duration were more likely to use CAM than those with shorter duration of illness (PR, 1.71; 95% CI, 1.04-1.32).
Most (78%) CAM users employed it as an addition to their treatment regimen (95% CI, 56-94%), while 21% used it as an alternative to prescribed medicine (95% CI, 12-31%). More than two-thirds (67%) of individuals did not disclose CAM use to health care professionals (95% CI, 58-76%).
Although CAM use can be a source of friction between patients and physicians, Dr. Rhee also sees it as an opportunity. Patients from diverse backgrounds may be using CAM, often as a result of different cultural backgrounds. He cited the belief in some Asian countries that the balance of Yin and Yang is key to health, which many patients believe can be addressed through CAM. “If we want to promote cultural diversity, if we really care about patient diversity, I think CAM is one of the potential sources where the doctors should know [more about] the issue,” said Dr. Rhee.
The study was funded by the University of Birmingham. Dr. Rhee and Mr. Alzahrani have no relevant financial disclosures.
An updated worldwide estimate of complementary and alternative medicine (CAM) use among individuals with diabetes found widespread use, though it varied greatly by region and is sometimes hard to define.
The report is the first literature review of the subject since 2007. The researchers looked at CAM use by region, as well as by patient categories such as those with advanced diabetes and by length of time since diagnosis. The most commonly reported CAMs in use were herbal medicine, acupuncture, homeopathy, and spiritual healing.
Only about one-third of patients disclosed their CAM use to their physician or health care provider. “We suggest that health care professionals should carefully anticipate the likelihood of their [patients’] diabetic CAM use in order to enhance treatment optimization and promote medication adherence, as well as to provide a fully informed consultation,” said first author Abdulaziz S. Alzahrani, a PhD student at the University of Birmingham (England). The study was published March 8, 2021, in the European Journal of Clinical Pharmacology.
Patients also have a responsibility, said Gregory Rhee, PhD, assistant professor of public health sciences at the University of Connecticut, Farmington. He was the lead author of a 2018 survey of CAM use in adults aged 65 years and older with diabetes in the United States using data from the 2012 National Health Interview Survey, and found that 25% had used CAM in some form in the prior year. “They need to be more up front, more proactive talking about CAM use with their doctors, and the second part is the physician. They also should be better educated in terms of CAM use. Traditionally, the physician in Western societies have pretty much ignored CAM use. But they are getting aware of CAM use and also we know that people are coming from multiple cultural backgrounds. The physicians and other health care providers should be better informed about CAM, and they should be better educated about it to provide patients better practice,” said Dr. Rhee.
He also distinguished between approaches like yoga or Tai Chi, which are physically oriented and not particularly controversial, and herbal medicines or dietary supplements. “Those can be controversial because we do not have strong scientific evidence to support those modalities for effectiveness on diabetes management,” Dr. Rhee added.
Mr. Alzahrani and colleagues conducted a meta-analysis of 38 studies, which included data from 25 countries. The included studies varied in their approach. For example, 16 studies focused exclusively on herbal and nutritional supplements. The most commonly mentioned CAMs were acupuncture and mind-body therapies (each named in six studies), religious and spiritual healing (five studies), and homeopathy (four studies). Among 31 studies focusing on herbal and nutritional supplements, the most common herbs mentioned were cinnamon and fenugreek (mentioned in 18 studies), garlic (17 studies), aloe vera (14 studies), and black seed (12 studies).
Prevalence of CAM use varied widely, ranging from 17% in Jordan to 89% in India and in a separate study in Jordan. The pooled prevalence of CAM use was 51% (95% confidence interval, 43%-59%). Subgroup analyses found the highest rate of CAM use in Europe (76%) and Africa (55%), and the lowest in North America (45%).
When the researchers examined patient characteristics, they found no significant relationship between CAM use and established ethnicity groups, or between type 1 and type 2 diabetes. The prevalence ratio was lower among men (PR, 0.86; 95% CI, 0.81-0.91). PRs for CAM use were lower among those with diabetic complications (PR, 0.81; 95% CI, 0.66-0.99). Individuals with diabetes of at least 5 years’ duration were more likely to use CAM than those with shorter duration of illness (PR, 1.71; 95% CI, 1.04-1.32).
Most (78%) CAM users employed it as an addition to their treatment regimen (95% CI, 56-94%), while 21% used it as an alternative to prescribed medicine (95% CI, 12-31%). More than two-thirds (67%) of individuals did not disclose CAM use to health care professionals (95% CI, 58-76%).
Although CAM use can be a source of friction between patients and physicians, Dr. Rhee also sees it as an opportunity. Patients from diverse backgrounds may be using CAM, often as a result of different cultural backgrounds. He cited the belief in some Asian countries that the balance of Yin and Yang is key to health, which many patients believe can be addressed through CAM. “If we want to promote cultural diversity, if we really care about patient diversity, I think CAM is one of the potential sources where the doctors should know [more about] the issue,” said Dr. Rhee.
The study was funded by the University of Birmingham. Dr. Rhee and Mr. Alzahrani have no relevant financial disclosures.
FROM THE EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Many unknowns on fertility preservation in transgender patients
Unknowns around the long-term effects of gender-affirming hormonal treatment on fertility in transgender individuals, especially adolescents, and what this means for fertility preservation, should be red flags for clinicians, according to one expert addressing the issue at the recent virtual ENDO 2021 meeting.
“One of the main concerns regarding fertility preservation in this population is that the decision to seek gender-affirming therapy is often made early in the reproductive lifespan, and for many patients this is well before the consideration of … child-bearing,” remarked Marie Menke, MD, an ob/gyn from University of Michigan, Ann Arbor, presenting in a session dedicated to state-of-the-art approaches to gamete preservation.
“These patients need to consider simultaneously their desire for gender-affirming therapy and their desire for child-bearing,” she added, explaining that gender-affirming therapy typically requires suppression of the hormonal axis that supports reproduction.
“This level of shared decision-making requires time and multidisciplinary involvement in the face of … limited data, and even with the best of counseling it can be quite overwhelming,” Dr. Menke stressed.
Specifically, the effects of gender-affirming therapy on both fertility and fertility preservation options in transgender individuals in comparison to the general population are areas that require much more research, she emphasized.
On the topic of adolescents specifically, she said they are “a special population,” as many seeking medical therapy for gender dysphoria have never considered long-term fertility goals or desires. Reports of such discussions during pediatric gender care vary greatly depending on the age of the patient and their geographic location.
And where such conversations have happened, “often there is no recollection by patients of such discussion prior to referral to endocrinology,” she emphasized.
Session co-moderator Irene Su, MD, a reproductive endocrinologist at the University of California, San Diego, said shared decisions with patients have to be made every day, even though data are limited.
“Little is known about both the adverse medical impact of gender-affirming hormonal therapy on fertility potential, as well as the psychosocial impact of interrupting/reversing gender-affirming hormonal therapy in the future to attempt fertility,” she told this news organization.
However, “because there are reasons to be concerned about an adverse impact on fertility, transgender individuals need access to fertility risk and preservation counseling,” she stressed.
Dr. Su has a special interest in improving reproductive health in young cancer survivors, and this involves similar discussions around fertility preservation – a medical subspecialty known as “oncofertility.”
There is a greater pool of knowledge in this field compared with fertility preservation and family planning in transgender patients, Dr. Su noted.
“While we need similar data in transgender individuals, what we’ve learned from the cancer survivor population is that they and their families want to know about known and unknown fertility risks and options, even if they ultimately do not choose to undertake fertility preservation procedures,” she explains.
Desire for future kids, but <10% currently preserve fertility
Dr. Menke said the estimated prevalence of individuals who identify as transgender is around 0.7% of the U.S. population, and she observed that, “by and large, fertility management involves tissue cryopreservation.”
She presented survey data showing that between 33%-54% of transgender and nonbinary individuals report a desire to have biological children currently, or in the future, and 94.6% are also strongly in support of transgender people having access to fertility preservation procedures.
Likewise, an online cross-sectional survey of over 1,100 people in the general population found that 76.2% agree that transgender individuals should be offered fertility preservation, and 60% support fertility preservation in minors.
Multiple professional societies support counseling in regard to options for fertility preservation and recommend that it should be offered to transgender individuals.
The American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), the World Professional Association for Transgender Health (WPATH), and the Endocrine Society all advocate that individuals seeking gender-affirming medical treatment should receive multidisciplinary counseling regarding fertility preservation prior to puberty suppression in adolescents, and prior to cross-sex hormone treatment in both adolescents and adults.
But despite all of these recommendations and the survey findings, fertility preservation rates in transgender patients are low, “at less than 10%,” reported Dr. Menke.
Fertility preservation counseling and management ideally needs to begin prior to initiation of hormone therapy, stressed Dr. Menke.
Given the limited data on the long-term effects of gender-affirming therapy on fertility and its preservation, such counseling often leads to a myriad of questions, she further explained.
“Patients ask ‘What are the chances of having biological children if I don’t pursue fertility preservation?’, and ‘How likely am I to have a biological child if I do pursue fertility preservation?’, as well as issues around access to care, with patients asking, ‘Will I be able to pursue this option [of fertility preservation]?’”
“The chance of having a biological child if fertility preservation is pursued is similar to those [patients with cancer] who receive ‘oncofertility’ care, which has a good prognosis,” she explained.
However, issues around access to care, and the cost of it, can be barriers.
What does a transgender male, born female, need to do?
For transgender males, options for fertility preservation include the recommended option of cryopreservation of the eggs (oocytes), although freezing of embryos and/or ovarian tissue are also possible.
The latter would be required in a prepubertal individual if they wanted to start puberty blockers and then go straight onto cross-sex hormones, Dr. Menke noted, although she said it’s not definitively known if prepubertal ovarian tissue is capable of being stimulated in the future to produce viable mature oocytes.
In someone who has gone through puberty, the ideal time to freeze eggs is before beginning gender-affirming hormone therapy, Dr. Menke explained. This is because it is not known whether testosterone has any adverse impact on oocyte development.
“We just don’t have definitive data that long-term testosterone isn’t gonadotoxic,” she said in response to a question about this after her talk.
Assessment of the reproductive consequences of gender-affirming therapy in transgender males can also be complicated by coexisting conditions, Dr. Menke explained.
For example, up to 58% of transgender males have polycystic ovary syndrome (PCOS) prior to transitioning, she noted. PCOS itself, and/or the gender-affirming therapy, may cause histologic changes of the ovarian tissue – for example, hyperplasia of ovarian stroma – and it’s not yet known to what extent this may impact future fertility, if present, she noted.
For oocyte preservation in female-to-male transgender individuals, stimulation with gonadotropins for 2-3 weeks is needed, and the procedure is invasive, requiring repeated vaginal ultrasounds. During this period, estradiol levels are supraphysiologic, and there is potential for breast development and vaginal bleeding post-retrieval, which individuals will need to be counseled about, Dr. Menke noted.
The cost of this also needs to be factored into the equation. Depending on insurance coverage, costs may be covered – and where there is no precedent, individuals can try referring their insurance companies to the ‘oncofertility consortium access-to-care model’, Dr. Menke advised.
If there is no coverage, the average cost for one egg-freezing cycle ranges from $10,000-$17,000 in the U.S., and often two to three cycles are needed to generate sufficient oocytes to be sure of a pregnancy. In addition, there are storage costs. Plus, there will be the cost of any future intervention to achieve a pregnancy, she stressed.
How long frozen oocytes remain viable is also still a matter of scientific debate, although “as the technology changes from slow-freeze to vitrification,” this time period should lengthen, Dr. Menke said.
In transgender males who have not preserved oocytes or embryos prior to transitioning, it’s necessary to stop testosterone to have the best chance of harvesting viable gametes, Dr. Menke said. Furthermore, individuals undertaking this procedure need to take into account all of the above-mentioned side effects of egg harvesting.
Although there have been reports of successful pregnancies with eggs retrieved from transgender males who have temporarily stopped testosterone, fertilization and embryo development following discontinuation of testosterone still require “additional investigation,” she observed.
Furthermore, “there are case reports of oocyte stimulation and retrieval of mature oocytes while patients continue testosterone therapy, and this may be an option in the future,” she noted, again stressing that it’s not known if excess testosterone is gonadotoxic.
Other options for fertility preservation in the transgender male include embryo cryopreservation, but this still involves hormonal stimulation and invasive procedures and would require the use of a sperm donor in a person who doesn’t currently have a partner (or who has one, but not necessarily one with whom they want to create a child).
For transgender males there is also the possibility of using a surrogate mother for the pregnancy, she noted.
What about transgender women, assigned male at birth?
For those assigned male at birth who wish to take puberty blockers, fertility preservation would require cryopreservation of testicular tissue, although Dr. Menke stressed that this is still considered “experimental.”
In the postpubertal period, the simplest option is to cryopreserve semen, with this ideally being performed prior to the individual commencing gender-affirming hormone therapy, Dr. Menke said.
If this is not done prior to beginning hormonal treatment, estrogen will need to be discontinued for fertility preservation, she noted.
Return of sperm function following cessation of estrogen may be limited – “expect at least 3 months before return of reproductive function,” Dr. Menke said. And even this may not be sufficient to restore normal spermatogenesis, she cautioned. “Absent or reduced spermatogenesis or morphological changes to Sertoli cells [have been reported in transgender women].”
Also, “there are needs for multiple attempts at ejaculation and storage requirements” for this approach. Cost for freezing sperm in the U.S., if not covered by insurance, is around $400, she noted, with storage costs ranging from $100 to up to $800 a year.
“Case reports using cryopreserved sperm [in transgender individuals] are promising overall … with clinical pregnancy rates following [in vitro fertilization] (IVF) with cryopreserved sperm … equivalent to patients without evidence of male factor fertility,” Dr. Menke reported.
However, she emphasized the fact that IVF, or intracytoplasmic sperm injection (ICSI), will still be necessary for conception, with potential additional costs.
Some individuals may also need to undergo surgical removal of sperm postpuberty; this is typically performed where there is evidence of male factor infertility, for example.
Embryo cryopreservation requires a partner or use of donor oocytes and, again, will have cost implications.
In conclusion, Dr. Menke reiterated that the use of fertility preservation techniques among transgender people is low, and it is more frequently accessed by transgender females. Among the identified barriers to fertility preservation are cost, lack of information, invasiveness of procedures, and desire not to delay medical transition.
Dr. Menke has disclosed no relevant financial relationships. Dr. Su has received a speaker honorarium from Ferring Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Unknowns around the long-term effects of gender-affirming hormonal treatment on fertility in transgender individuals, especially adolescents, and what this means for fertility preservation, should be red flags for clinicians, according to one expert addressing the issue at the recent virtual ENDO 2021 meeting.
“One of the main concerns regarding fertility preservation in this population is that the decision to seek gender-affirming therapy is often made early in the reproductive lifespan, and for many patients this is well before the consideration of … child-bearing,” remarked Marie Menke, MD, an ob/gyn from University of Michigan, Ann Arbor, presenting in a session dedicated to state-of-the-art approaches to gamete preservation.
“These patients need to consider simultaneously their desire for gender-affirming therapy and their desire for child-bearing,” she added, explaining that gender-affirming therapy typically requires suppression of the hormonal axis that supports reproduction.
“This level of shared decision-making requires time and multidisciplinary involvement in the face of … limited data, and even with the best of counseling it can be quite overwhelming,” Dr. Menke stressed.
Specifically, the effects of gender-affirming therapy on both fertility and fertility preservation options in transgender individuals in comparison to the general population are areas that require much more research, she emphasized.
On the topic of adolescents specifically, she said they are “a special population,” as many seeking medical therapy for gender dysphoria have never considered long-term fertility goals or desires. Reports of such discussions during pediatric gender care vary greatly depending on the age of the patient and their geographic location.
And where such conversations have happened, “often there is no recollection by patients of such discussion prior to referral to endocrinology,” she emphasized.
Session co-moderator Irene Su, MD, a reproductive endocrinologist at the University of California, San Diego, said shared decisions with patients have to be made every day, even though data are limited.
“Little is known about both the adverse medical impact of gender-affirming hormonal therapy on fertility potential, as well as the psychosocial impact of interrupting/reversing gender-affirming hormonal therapy in the future to attempt fertility,” she told this news organization.
However, “because there are reasons to be concerned about an adverse impact on fertility, transgender individuals need access to fertility risk and preservation counseling,” she stressed.
Dr. Su has a special interest in improving reproductive health in young cancer survivors, and this involves similar discussions around fertility preservation – a medical subspecialty known as “oncofertility.”
There is a greater pool of knowledge in this field compared with fertility preservation and family planning in transgender patients, Dr. Su noted.
“While we need similar data in transgender individuals, what we’ve learned from the cancer survivor population is that they and their families want to know about known and unknown fertility risks and options, even if they ultimately do not choose to undertake fertility preservation procedures,” she explains.
Desire for future kids, but <10% currently preserve fertility
Dr. Menke said the estimated prevalence of individuals who identify as transgender is around 0.7% of the U.S. population, and she observed that, “by and large, fertility management involves tissue cryopreservation.”
She presented survey data showing that between 33%-54% of transgender and nonbinary individuals report a desire to have biological children currently, or in the future, and 94.6% are also strongly in support of transgender people having access to fertility preservation procedures.
Likewise, an online cross-sectional survey of over 1,100 people in the general population found that 76.2% agree that transgender individuals should be offered fertility preservation, and 60% support fertility preservation in minors.
Multiple professional societies support counseling in regard to options for fertility preservation and recommend that it should be offered to transgender individuals.
The American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), the World Professional Association for Transgender Health (WPATH), and the Endocrine Society all advocate that individuals seeking gender-affirming medical treatment should receive multidisciplinary counseling regarding fertility preservation prior to puberty suppression in adolescents, and prior to cross-sex hormone treatment in both adolescents and adults.
But despite all of these recommendations and the survey findings, fertility preservation rates in transgender patients are low, “at less than 10%,” reported Dr. Menke.
Fertility preservation counseling and management ideally needs to begin prior to initiation of hormone therapy, stressed Dr. Menke.
Given the limited data on the long-term effects of gender-affirming therapy on fertility and its preservation, such counseling often leads to a myriad of questions, she further explained.
“Patients ask ‘What are the chances of having biological children if I don’t pursue fertility preservation?’, and ‘How likely am I to have a biological child if I do pursue fertility preservation?’, as well as issues around access to care, with patients asking, ‘Will I be able to pursue this option [of fertility preservation]?’”
“The chance of having a biological child if fertility preservation is pursued is similar to those [patients with cancer] who receive ‘oncofertility’ care, which has a good prognosis,” she explained.
However, issues around access to care, and the cost of it, can be barriers.
What does a transgender male, born female, need to do?
For transgender males, options for fertility preservation include the recommended option of cryopreservation of the eggs (oocytes), although freezing of embryos and/or ovarian tissue are also possible.
The latter would be required in a prepubertal individual if they wanted to start puberty blockers and then go straight onto cross-sex hormones, Dr. Menke noted, although she said it’s not definitively known if prepubertal ovarian tissue is capable of being stimulated in the future to produce viable mature oocytes.
In someone who has gone through puberty, the ideal time to freeze eggs is before beginning gender-affirming hormone therapy, Dr. Menke explained. This is because it is not known whether testosterone has any adverse impact on oocyte development.
“We just don’t have definitive data that long-term testosterone isn’t gonadotoxic,” she said in response to a question about this after her talk.
Assessment of the reproductive consequences of gender-affirming therapy in transgender males can also be complicated by coexisting conditions, Dr. Menke explained.
For example, up to 58% of transgender males have polycystic ovary syndrome (PCOS) prior to transitioning, she noted. PCOS itself, and/or the gender-affirming therapy, may cause histologic changes of the ovarian tissue – for example, hyperplasia of ovarian stroma – and it’s not yet known to what extent this may impact future fertility, if present, she noted.
For oocyte preservation in female-to-male transgender individuals, stimulation with gonadotropins for 2-3 weeks is needed, and the procedure is invasive, requiring repeated vaginal ultrasounds. During this period, estradiol levels are supraphysiologic, and there is potential for breast development and vaginal bleeding post-retrieval, which individuals will need to be counseled about, Dr. Menke noted.
The cost of this also needs to be factored into the equation. Depending on insurance coverage, costs may be covered – and where there is no precedent, individuals can try referring their insurance companies to the ‘oncofertility consortium access-to-care model’, Dr. Menke advised.
If there is no coverage, the average cost for one egg-freezing cycle ranges from $10,000-$17,000 in the U.S., and often two to three cycles are needed to generate sufficient oocytes to be sure of a pregnancy. In addition, there are storage costs. Plus, there will be the cost of any future intervention to achieve a pregnancy, she stressed.
How long frozen oocytes remain viable is also still a matter of scientific debate, although “as the technology changes from slow-freeze to vitrification,” this time period should lengthen, Dr. Menke said.
In transgender males who have not preserved oocytes or embryos prior to transitioning, it’s necessary to stop testosterone to have the best chance of harvesting viable gametes, Dr. Menke said. Furthermore, individuals undertaking this procedure need to take into account all of the above-mentioned side effects of egg harvesting.
Although there have been reports of successful pregnancies with eggs retrieved from transgender males who have temporarily stopped testosterone, fertilization and embryo development following discontinuation of testosterone still require “additional investigation,” she observed.
Furthermore, “there are case reports of oocyte stimulation and retrieval of mature oocytes while patients continue testosterone therapy, and this may be an option in the future,” she noted, again stressing that it’s not known if excess testosterone is gonadotoxic.
Other options for fertility preservation in the transgender male include embryo cryopreservation, but this still involves hormonal stimulation and invasive procedures and would require the use of a sperm donor in a person who doesn’t currently have a partner (or who has one, but not necessarily one with whom they want to create a child).
For transgender males there is also the possibility of using a surrogate mother for the pregnancy, she noted.
What about transgender women, assigned male at birth?
For those assigned male at birth who wish to take puberty blockers, fertility preservation would require cryopreservation of testicular tissue, although Dr. Menke stressed that this is still considered “experimental.”
In the postpubertal period, the simplest option is to cryopreserve semen, with this ideally being performed prior to the individual commencing gender-affirming hormone therapy, Dr. Menke said.
If this is not done prior to beginning hormonal treatment, estrogen will need to be discontinued for fertility preservation, she noted.
Return of sperm function following cessation of estrogen may be limited – “expect at least 3 months before return of reproductive function,” Dr. Menke said. And even this may not be sufficient to restore normal spermatogenesis, she cautioned. “Absent or reduced spermatogenesis or morphological changes to Sertoli cells [have been reported in transgender women].”
Also, “there are needs for multiple attempts at ejaculation and storage requirements” for this approach. Cost for freezing sperm in the U.S., if not covered by insurance, is around $400, she noted, with storage costs ranging from $100 to up to $800 a year.
“Case reports using cryopreserved sperm [in transgender individuals] are promising overall … with clinical pregnancy rates following [in vitro fertilization] (IVF) with cryopreserved sperm … equivalent to patients without evidence of male factor fertility,” Dr. Menke reported.
However, she emphasized the fact that IVF, or intracytoplasmic sperm injection (ICSI), will still be necessary for conception, with potential additional costs.
Some individuals may also need to undergo surgical removal of sperm postpuberty; this is typically performed where there is evidence of male factor infertility, for example.
Embryo cryopreservation requires a partner or use of donor oocytes and, again, will have cost implications.
In conclusion, Dr. Menke reiterated that the use of fertility preservation techniques among transgender people is low, and it is more frequently accessed by transgender females. Among the identified barriers to fertility preservation are cost, lack of information, invasiveness of procedures, and desire not to delay medical transition.
Dr. Menke has disclosed no relevant financial relationships. Dr. Su has received a speaker honorarium from Ferring Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Unknowns around the long-term effects of gender-affirming hormonal treatment on fertility in transgender individuals, especially adolescents, and what this means for fertility preservation, should be red flags for clinicians, according to one expert addressing the issue at the recent virtual ENDO 2021 meeting.
“One of the main concerns regarding fertility preservation in this population is that the decision to seek gender-affirming therapy is often made early in the reproductive lifespan, and for many patients this is well before the consideration of … child-bearing,” remarked Marie Menke, MD, an ob/gyn from University of Michigan, Ann Arbor, presenting in a session dedicated to state-of-the-art approaches to gamete preservation.
“These patients need to consider simultaneously their desire for gender-affirming therapy and their desire for child-bearing,” she added, explaining that gender-affirming therapy typically requires suppression of the hormonal axis that supports reproduction.
“This level of shared decision-making requires time and multidisciplinary involvement in the face of … limited data, and even with the best of counseling it can be quite overwhelming,” Dr. Menke stressed.
Specifically, the effects of gender-affirming therapy on both fertility and fertility preservation options in transgender individuals in comparison to the general population are areas that require much more research, she emphasized.
On the topic of adolescents specifically, she said they are “a special population,” as many seeking medical therapy for gender dysphoria have never considered long-term fertility goals or desires. Reports of such discussions during pediatric gender care vary greatly depending on the age of the patient and their geographic location.
And where such conversations have happened, “often there is no recollection by patients of such discussion prior to referral to endocrinology,” she emphasized.
Session co-moderator Irene Su, MD, a reproductive endocrinologist at the University of California, San Diego, said shared decisions with patients have to be made every day, even though data are limited.
“Little is known about both the adverse medical impact of gender-affirming hormonal therapy on fertility potential, as well as the psychosocial impact of interrupting/reversing gender-affirming hormonal therapy in the future to attempt fertility,” she told this news organization.
However, “because there are reasons to be concerned about an adverse impact on fertility, transgender individuals need access to fertility risk and preservation counseling,” she stressed.
Dr. Su has a special interest in improving reproductive health in young cancer survivors, and this involves similar discussions around fertility preservation – a medical subspecialty known as “oncofertility.”
There is a greater pool of knowledge in this field compared with fertility preservation and family planning in transgender patients, Dr. Su noted.
“While we need similar data in transgender individuals, what we’ve learned from the cancer survivor population is that they and their families want to know about known and unknown fertility risks and options, even if they ultimately do not choose to undertake fertility preservation procedures,” she explains.
Desire for future kids, but <10% currently preserve fertility
Dr. Menke said the estimated prevalence of individuals who identify as transgender is around 0.7% of the U.S. population, and she observed that, “by and large, fertility management involves tissue cryopreservation.”
She presented survey data showing that between 33%-54% of transgender and nonbinary individuals report a desire to have biological children currently, or in the future, and 94.6% are also strongly in support of transgender people having access to fertility preservation procedures.
Likewise, an online cross-sectional survey of over 1,100 people in the general population found that 76.2% agree that transgender individuals should be offered fertility preservation, and 60% support fertility preservation in minors.
Multiple professional societies support counseling in regard to options for fertility preservation and recommend that it should be offered to transgender individuals.
The American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), the World Professional Association for Transgender Health (WPATH), and the Endocrine Society all advocate that individuals seeking gender-affirming medical treatment should receive multidisciplinary counseling regarding fertility preservation prior to puberty suppression in adolescents, and prior to cross-sex hormone treatment in both adolescents and adults.
But despite all of these recommendations and the survey findings, fertility preservation rates in transgender patients are low, “at less than 10%,” reported Dr. Menke.
Fertility preservation counseling and management ideally needs to begin prior to initiation of hormone therapy, stressed Dr. Menke.
Given the limited data on the long-term effects of gender-affirming therapy on fertility and its preservation, such counseling often leads to a myriad of questions, she further explained.
“Patients ask ‘What are the chances of having biological children if I don’t pursue fertility preservation?’, and ‘How likely am I to have a biological child if I do pursue fertility preservation?’, as well as issues around access to care, with patients asking, ‘Will I be able to pursue this option [of fertility preservation]?’”
“The chance of having a biological child if fertility preservation is pursued is similar to those [patients with cancer] who receive ‘oncofertility’ care, which has a good prognosis,” she explained.
However, issues around access to care, and the cost of it, can be barriers.
What does a transgender male, born female, need to do?
For transgender males, options for fertility preservation include the recommended option of cryopreservation of the eggs (oocytes), although freezing of embryos and/or ovarian tissue are also possible.
The latter would be required in a prepubertal individual if they wanted to start puberty blockers and then go straight onto cross-sex hormones, Dr. Menke noted, although she said it’s not definitively known if prepubertal ovarian tissue is capable of being stimulated in the future to produce viable mature oocytes.
In someone who has gone through puberty, the ideal time to freeze eggs is before beginning gender-affirming hormone therapy, Dr. Menke explained. This is because it is not known whether testosterone has any adverse impact on oocyte development.
“We just don’t have definitive data that long-term testosterone isn’t gonadotoxic,” she said in response to a question about this after her talk.
Assessment of the reproductive consequences of gender-affirming therapy in transgender males can also be complicated by coexisting conditions, Dr. Menke explained.
For example, up to 58% of transgender males have polycystic ovary syndrome (PCOS) prior to transitioning, she noted. PCOS itself, and/or the gender-affirming therapy, may cause histologic changes of the ovarian tissue – for example, hyperplasia of ovarian stroma – and it’s not yet known to what extent this may impact future fertility, if present, she noted.
For oocyte preservation in female-to-male transgender individuals, stimulation with gonadotropins for 2-3 weeks is needed, and the procedure is invasive, requiring repeated vaginal ultrasounds. During this period, estradiol levels are supraphysiologic, and there is potential for breast development and vaginal bleeding post-retrieval, which individuals will need to be counseled about, Dr. Menke noted.
The cost of this also needs to be factored into the equation. Depending on insurance coverage, costs may be covered – and where there is no precedent, individuals can try referring their insurance companies to the ‘oncofertility consortium access-to-care model’, Dr. Menke advised.
If there is no coverage, the average cost for one egg-freezing cycle ranges from $10,000-$17,000 in the U.S., and often two to three cycles are needed to generate sufficient oocytes to be sure of a pregnancy. In addition, there are storage costs. Plus, there will be the cost of any future intervention to achieve a pregnancy, she stressed.
How long frozen oocytes remain viable is also still a matter of scientific debate, although “as the technology changes from slow-freeze to vitrification,” this time period should lengthen, Dr. Menke said.
In transgender males who have not preserved oocytes or embryos prior to transitioning, it’s necessary to stop testosterone to have the best chance of harvesting viable gametes, Dr. Menke said. Furthermore, individuals undertaking this procedure need to take into account all of the above-mentioned side effects of egg harvesting.
Although there have been reports of successful pregnancies with eggs retrieved from transgender males who have temporarily stopped testosterone, fertilization and embryo development following discontinuation of testosterone still require “additional investigation,” she observed.
Furthermore, “there are case reports of oocyte stimulation and retrieval of mature oocytes while patients continue testosterone therapy, and this may be an option in the future,” she noted, again stressing that it’s not known if excess testosterone is gonadotoxic.
Other options for fertility preservation in the transgender male include embryo cryopreservation, but this still involves hormonal stimulation and invasive procedures and would require the use of a sperm donor in a person who doesn’t currently have a partner (or who has one, but not necessarily one with whom they want to create a child).
For transgender males there is also the possibility of using a surrogate mother for the pregnancy, she noted.
What about transgender women, assigned male at birth?
For those assigned male at birth who wish to take puberty blockers, fertility preservation would require cryopreservation of testicular tissue, although Dr. Menke stressed that this is still considered “experimental.”
In the postpubertal period, the simplest option is to cryopreserve semen, with this ideally being performed prior to the individual commencing gender-affirming hormone therapy, Dr. Menke said.
If this is not done prior to beginning hormonal treatment, estrogen will need to be discontinued for fertility preservation, she noted.
Return of sperm function following cessation of estrogen may be limited – “expect at least 3 months before return of reproductive function,” Dr. Menke said. And even this may not be sufficient to restore normal spermatogenesis, she cautioned. “Absent or reduced spermatogenesis or morphological changes to Sertoli cells [have been reported in transgender women].”
Also, “there are needs for multiple attempts at ejaculation and storage requirements” for this approach. Cost for freezing sperm in the U.S., if not covered by insurance, is around $400, she noted, with storage costs ranging from $100 to up to $800 a year.
“Case reports using cryopreserved sperm [in transgender individuals] are promising overall … with clinical pregnancy rates following [in vitro fertilization] (IVF) with cryopreserved sperm … equivalent to patients without evidence of male factor fertility,” Dr. Menke reported.
However, she emphasized the fact that IVF, or intracytoplasmic sperm injection (ICSI), will still be necessary for conception, with potential additional costs.
Some individuals may also need to undergo surgical removal of sperm postpuberty; this is typically performed where there is evidence of male factor infertility, for example.
Embryo cryopreservation requires a partner or use of donor oocytes and, again, will have cost implications.
In conclusion, Dr. Menke reiterated that the use of fertility preservation techniques among transgender people is low, and it is more frequently accessed by transgender females. Among the identified barriers to fertility preservation are cost, lack of information, invasiveness of procedures, and desire not to delay medical transition.
Dr. Menke has disclosed no relevant financial relationships. Dr. Su has received a speaker honorarium from Ferring Pharmaceuticals.
A version of this article first appeared on Medscape.com.
‘Striking’ increase in childhood obesity during pandemic
Obesity rates among children jumped substantially in the first months of the COVID-19 pandemic, according to a study published online in Pediatrics. Experts worry the excess weight will be a continuing problem for these children.
“Across the board in the span of a year, there has been a 2% increase in obesity, which is really striking,” lead author Brian P. Jenssen, MD, said in an interview.
The prevalence of obesity in a large pediatric primary care network increased from 13.7% to 15.4%.
Preexisting disparities by race or ethnicity and socioeconomic status worsened, noted Dr. Jenssen, a primary care pediatrician affiliated with Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania, Philadelphia.
Dr. Jenssen and colleagues compared the average obesity rate from June to December 2020 with the rate from June to December 2019 among patients in the CHOP Care Network, which includes 29 urban, suburban, and semirural clinics in the Philadelphia region. In June 2020, the volume of patient visits “returned to near-normal” after a dramatic decline in March 2020, the study authors wrote.
The investigators examined body mass index at all visits for patients aged 2-17 years for whom height and weight were documented. Patients with a BMI at or above the 95th percentile were classified as obese. The analysis included approximately 169,000 visits in 2019 and about 145,000 in 2020.
The average age of the patients was 9.2 years, and 48.9% were girls. In all, 21.4% were non-Hispanic Black, and about 30% were publicly insured.
Increases in obesity rates were more pronounced among patients aged 5-9 years and among patients who were Hispanic/Latino, non-Hispanic Black, publicly insured, or from lower-income neighborhoods.
Whereas the obesity rate increased 1% for patients aged 13-17 years, the rate increased 2.6% for patients aged 5-9 years.
Nearly 25% of Hispanic/Latino or non-Hispanic Black patients seen during the pandemic were obese, compared with 11.3% of non-Hispanic White patients. Before the pandemic, differences by race or ethnicity had been about 10%-11%.
Limiting the analysis to preventive visits did not meaningfully change the results, wrote Dr. Jenssen and colleagues.
“Having any increase in the obesity rates is alarming,” said Sandra Hassink, MD, medical director for the American Academy of Pediatrics’ (AAP’s) Institute for Healthy Childhood Weight. “I think what we’re seeing is what we feared.”
Before the pandemic, children received appropriately portioned breakfasts and lunches at school, but during the pandemic, they had less access to such meals, the academy noted. Disruptions to schooling, easier access to unhealthy snacks, increased screen time, and economic issues such as parents’ job losses were further factors, Hassink said.
Tackling the weight gain
In December 2020, the AAP issued two clinical guidance documents to highlight the importance of addressing obesity during the pandemic. Recommendations included physician counseling of families about maintaining healthy nutrition, minimizing sedentary time, and getting enough sleep and physical activity, as well as the assessment of all patients for onset of obesity and the maintenance of obesity treatment for patients with obesity.
In addition to clinical assessments and guidance, Dr. Jenssen emphasized that a return to routines may be crucial. Prepandemic studies have shown that many children, especially those insured by Medicaid, gain more weight during the summer when they are out of school, he noted. Many of the same factors are present during the pandemic, he said.
“One solution, and probably the most important solution, is getting kids back in school,” Dr. Jenssen said. School disruptions also have affected children’s learning and mental health, but those effects may be harder to quantify than BMI, he said.
Dr. Jenssen suggests that parents do their best to model good routines and habits. For example, they might decide that they and their children will stop drinking soda as a family, or opt for an apple instead of a bag of chips. They can walk around the house or up and down stairs when talking. “Those sorts of little things can make a big difference in the long run,” Dr. Jenssen said.
Clinicians should address obesity in a compassionate and caring way, be aware of community resources to help families adopt healthy lifestyles, and “look for the comorbidities of obesity,” such as type 2 diabetes, liver disease, sleep apnea, knee problems, and hypertension, Dr. Hassink said.
Policies that address other factors, such as the cost of healthy foods and the marketing of unhealthy foods, may also be needed, Dr. Hassink said.
“I’ve always thought of obesity as kind of the canary in the coal mine,” Dr. Hassink said. “It is important to keep our minds on the fact that it is a chronic disease. But it also indicates a lot of things about how we are able to support a healthy population.”
Potato chips, red meat, and sugary drinks
Other researchers have assessed how healthy behaviors tended to take a turn for the worse when routines were disrupted during the pandemic. Steven B. Heymsfield, MD, a professor in the metabolism and body composition laboratory at Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, and collaborators documented how diet and activity changed for children during the pandemic.
Dr. Heymsfield worked with researchers in Italy to examine changes in behavior among 41 children and adolescents with obesity in Verona, Italy, during an early lockdown.
As part of a longitudinal observational study, they had baseline data about diet and physical activity from interviews conducted from May to July 2019. They repeated the interviews 3 weeks after a mandatory quarantine.
Intake of potato chips, red meat, and sugary drinks had increased, time spent in sports activities had decreased by more than 2 hours per week, and screen time had increased by more than 4 hours per day, the researchers found. Their study was published in Obesity.
Unpublished follow-up data indicate that “there was further deterioration in the diets and activity patterns” for some but not all of the participants, Dr. Heymsfield said.
He said he was hopeful that children who experienced the onset of obesity during the pandemic may lose weight when routines return to normal, but added that it is unclear whether that will happen.
“My impression from the limited written literature on this question is that for some kids who gain weight during the lockdown or, by analogy, the summer months, the weight doesn’t go back down again. It is not universal, but it is a known phenomenon that it is a bit of a ratchet,” he said. “They just sort of slowly ratchet their weights up, up to adulthood.”
Recognizing weight gain during the pandemic may be an important first step.
“The first thing is not to ignore it,” Dr. Heymsfield said. “Anything that can be done to prevent excess weight gain during childhood – not to promote anorexia or anything like that, but just being careful – is very important, because these behaviors are formed early in life, and they persist.”
CHOP supported the research. Dr. Jenssen and Dr. Hassink have disclosed no relevant financial relationships. Dr. Heymsfield is a medical adviser for Medifast, a weight loss company.
A version of this article first appeared on Medscape.com.
Obesity rates among children jumped substantially in the first months of the COVID-19 pandemic, according to a study published online in Pediatrics. Experts worry the excess weight will be a continuing problem for these children.
“Across the board in the span of a year, there has been a 2% increase in obesity, which is really striking,” lead author Brian P. Jenssen, MD, said in an interview.
The prevalence of obesity in a large pediatric primary care network increased from 13.7% to 15.4%.
Preexisting disparities by race or ethnicity and socioeconomic status worsened, noted Dr. Jenssen, a primary care pediatrician affiliated with Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania, Philadelphia.
Dr. Jenssen and colleagues compared the average obesity rate from June to December 2020 with the rate from June to December 2019 among patients in the CHOP Care Network, which includes 29 urban, suburban, and semirural clinics in the Philadelphia region. In June 2020, the volume of patient visits “returned to near-normal” after a dramatic decline in March 2020, the study authors wrote.
The investigators examined body mass index at all visits for patients aged 2-17 years for whom height and weight were documented. Patients with a BMI at or above the 95th percentile were classified as obese. The analysis included approximately 169,000 visits in 2019 and about 145,000 in 2020.
The average age of the patients was 9.2 years, and 48.9% were girls. In all, 21.4% were non-Hispanic Black, and about 30% were publicly insured.
Increases in obesity rates were more pronounced among patients aged 5-9 years and among patients who were Hispanic/Latino, non-Hispanic Black, publicly insured, or from lower-income neighborhoods.
Whereas the obesity rate increased 1% for patients aged 13-17 years, the rate increased 2.6% for patients aged 5-9 years.
Nearly 25% of Hispanic/Latino or non-Hispanic Black patients seen during the pandemic were obese, compared with 11.3% of non-Hispanic White patients. Before the pandemic, differences by race or ethnicity had been about 10%-11%.
Limiting the analysis to preventive visits did not meaningfully change the results, wrote Dr. Jenssen and colleagues.
“Having any increase in the obesity rates is alarming,” said Sandra Hassink, MD, medical director for the American Academy of Pediatrics’ (AAP’s) Institute for Healthy Childhood Weight. “I think what we’re seeing is what we feared.”
Before the pandemic, children received appropriately portioned breakfasts and lunches at school, but during the pandemic, they had less access to such meals, the academy noted. Disruptions to schooling, easier access to unhealthy snacks, increased screen time, and economic issues such as parents’ job losses were further factors, Hassink said.
Tackling the weight gain
In December 2020, the AAP issued two clinical guidance documents to highlight the importance of addressing obesity during the pandemic. Recommendations included physician counseling of families about maintaining healthy nutrition, minimizing sedentary time, and getting enough sleep and physical activity, as well as the assessment of all patients for onset of obesity and the maintenance of obesity treatment for patients with obesity.
In addition to clinical assessments and guidance, Dr. Jenssen emphasized that a return to routines may be crucial. Prepandemic studies have shown that many children, especially those insured by Medicaid, gain more weight during the summer when they are out of school, he noted. Many of the same factors are present during the pandemic, he said.
“One solution, and probably the most important solution, is getting kids back in school,” Dr. Jenssen said. School disruptions also have affected children’s learning and mental health, but those effects may be harder to quantify than BMI, he said.
Dr. Jenssen suggests that parents do their best to model good routines and habits. For example, they might decide that they and their children will stop drinking soda as a family, or opt for an apple instead of a bag of chips. They can walk around the house or up and down stairs when talking. “Those sorts of little things can make a big difference in the long run,” Dr. Jenssen said.
Clinicians should address obesity in a compassionate and caring way, be aware of community resources to help families adopt healthy lifestyles, and “look for the comorbidities of obesity,” such as type 2 diabetes, liver disease, sleep apnea, knee problems, and hypertension, Dr. Hassink said.
Policies that address other factors, such as the cost of healthy foods and the marketing of unhealthy foods, may also be needed, Dr. Hassink said.
“I’ve always thought of obesity as kind of the canary in the coal mine,” Dr. Hassink said. “It is important to keep our minds on the fact that it is a chronic disease. But it also indicates a lot of things about how we are able to support a healthy population.”
Potato chips, red meat, and sugary drinks
Other researchers have assessed how healthy behaviors tended to take a turn for the worse when routines were disrupted during the pandemic. Steven B. Heymsfield, MD, a professor in the metabolism and body composition laboratory at Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, and collaborators documented how diet and activity changed for children during the pandemic.
Dr. Heymsfield worked with researchers in Italy to examine changes in behavior among 41 children and adolescents with obesity in Verona, Italy, during an early lockdown.
As part of a longitudinal observational study, they had baseline data about diet and physical activity from interviews conducted from May to July 2019. They repeated the interviews 3 weeks after a mandatory quarantine.
Intake of potato chips, red meat, and sugary drinks had increased, time spent in sports activities had decreased by more than 2 hours per week, and screen time had increased by more than 4 hours per day, the researchers found. Their study was published in Obesity.
Unpublished follow-up data indicate that “there was further deterioration in the diets and activity patterns” for some but not all of the participants, Dr. Heymsfield said.
He said he was hopeful that children who experienced the onset of obesity during the pandemic may lose weight when routines return to normal, but added that it is unclear whether that will happen.
“My impression from the limited written literature on this question is that for some kids who gain weight during the lockdown or, by analogy, the summer months, the weight doesn’t go back down again. It is not universal, but it is a known phenomenon that it is a bit of a ratchet,” he said. “They just sort of slowly ratchet their weights up, up to adulthood.”
Recognizing weight gain during the pandemic may be an important first step.
“The first thing is not to ignore it,” Dr. Heymsfield said. “Anything that can be done to prevent excess weight gain during childhood – not to promote anorexia or anything like that, but just being careful – is very important, because these behaviors are formed early in life, and they persist.”
CHOP supported the research. Dr. Jenssen and Dr. Hassink have disclosed no relevant financial relationships. Dr. Heymsfield is a medical adviser for Medifast, a weight loss company.
A version of this article first appeared on Medscape.com.
Obesity rates among children jumped substantially in the first months of the COVID-19 pandemic, according to a study published online in Pediatrics. Experts worry the excess weight will be a continuing problem for these children.
“Across the board in the span of a year, there has been a 2% increase in obesity, which is really striking,” lead author Brian P. Jenssen, MD, said in an interview.
The prevalence of obesity in a large pediatric primary care network increased from 13.7% to 15.4%.
Preexisting disparities by race or ethnicity and socioeconomic status worsened, noted Dr. Jenssen, a primary care pediatrician affiliated with Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania, Philadelphia.
Dr. Jenssen and colleagues compared the average obesity rate from June to December 2020 with the rate from June to December 2019 among patients in the CHOP Care Network, which includes 29 urban, suburban, and semirural clinics in the Philadelphia region. In June 2020, the volume of patient visits “returned to near-normal” after a dramatic decline in March 2020, the study authors wrote.
The investigators examined body mass index at all visits for patients aged 2-17 years for whom height and weight were documented. Patients with a BMI at or above the 95th percentile were classified as obese. The analysis included approximately 169,000 visits in 2019 and about 145,000 in 2020.
The average age of the patients was 9.2 years, and 48.9% were girls. In all, 21.4% were non-Hispanic Black, and about 30% were publicly insured.
Increases in obesity rates were more pronounced among patients aged 5-9 years and among patients who were Hispanic/Latino, non-Hispanic Black, publicly insured, or from lower-income neighborhoods.
Whereas the obesity rate increased 1% for patients aged 13-17 years, the rate increased 2.6% for patients aged 5-9 years.
Nearly 25% of Hispanic/Latino or non-Hispanic Black patients seen during the pandemic were obese, compared with 11.3% of non-Hispanic White patients. Before the pandemic, differences by race or ethnicity had been about 10%-11%.
Limiting the analysis to preventive visits did not meaningfully change the results, wrote Dr. Jenssen and colleagues.
“Having any increase in the obesity rates is alarming,” said Sandra Hassink, MD, medical director for the American Academy of Pediatrics’ (AAP’s) Institute for Healthy Childhood Weight. “I think what we’re seeing is what we feared.”
Before the pandemic, children received appropriately portioned breakfasts and lunches at school, but during the pandemic, they had less access to such meals, the academy noted. Disruptions to schooling, easier access to unhealthy snacks, increased screen time, and economic issues such as parents’ job losses were further factors, Hassink said.
Tackling the weight gain
In December 2020, the AAP issued two clinical guidance documents to highlight the importance of addressing obesity during the pandemic. Recommendations included physician counseling of families about maintaining healthy nutrition, minimizing sedentary time, and getting enough sleep and physical activity, as well as the assessment of all patients for onset of obesity and the maintenance of obesity treatment for patients with obesity.
In addition to clinical assessments and guidance, Dr. Jenssen emphasized that a return to routines may be crucial. Prepandemic studies have shown that many children, especially those insured by Medicaid, gain more weight during the summer when they are out of school, he noted. Many of the same factors are present during the pandemic, he said.
“One solution, and probably the most important solution, is getting kids back in school,” Dr. Jenssen said. School disruptions also have affected children’s learning and mental health, but those effects may be harder to quantify than BMI, he said.
Dr. Jenssen suggests that parents do their best to model good routines and habits. For example, they might decide that they and their children will stop drinking soda as a family, or opt for an apple instead of a bag of chips. They can walk around the house or up and down stairs when talking. “Those sorts of little things can make a big difference in the long run,” Dr. Jenssen said.
Clinicians should address obesity in a compassionate and caring way, be aware of community resources to help families adopt healthy lifestyles, and “look for the comorbidities of obesity,” such as type 2 diabetes, liver disease, sleep apnea, knee problems, and hypertension, Dr. Hassink said.
Policies that address other factors, such as the cost of healthy foods and the marketing of unhealthy foods, may also be needed, Dr. Hassink said.
“I’ve always thought of obesity as kind of the canary in the coal mine,” Dr. Hassink said. “It is important to keep our minds on the fact that it is a chronic disease. But it also indicates a lot of things about how we are able to support a healthy population.”
Potato chips, red meat, and sugary drinks
Other researchers have assessed how healthy behaviors tended to take a turn for the worse when routines were disrupted during the pandemic. Steven B. Heymsfield, MD, a professor in the metabolism and body composition laboratory at Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, and collaborators documented how diet and activity changed for children during the pandemic.
Dr. Heymsfield worked with researchers in Italy to examine changes in behavior among 41 children and adolescents with obesity in Verona, Italy, during an early lockdown.
As part of a longitudinal observational study, they had baseline data about diet and physical activity from interviews conducted from May to July 2019. They repeated the interviews 3 weeks after a mandatory quarantine.
Intake of potato chips, red meat, and sugary drinks had increased, time spent in sports activities had decreased by more than 2 hours per week, and screen time had increased by more than 4 hours per day, the researchers found. Their study was published in Obesity.
Unpublished follow-up data indicate that “there was further deterioration in the diets and activity patterns” for some but not all of the participants, Dr. Heymsfield said.
He said he was hopeful that children who experienced the onset of obesity during the pandemic may lose weight when routines return to normal, but added that it is unclear whether that will happen.
“My impression from the limited written literature on this question is that for some kids who gain weight during the lockdown or, by analogy, the summer months, the weight doesn’t go back down again. It is not universal, but it is a known phenomenon that it is a bit of a ratchet,” he said. “They just sort of slowly ratchet their weights up, up to adulthood.”
Recognizing weight gain during the pandemic may be an important first step.
“The first thing is not to ignore it,” Dr. Heymsfield said. “Anything that can be done to prevent excess weight gain during childhood – not to promote anorexia or anything like that, but just being careful – is very important, because these behaviors are formed early in life, and they persist.”
CHOP supported the research. Dr. Jenssen and Dr. Hassink have disclosed no relevant financial relationships. Dr. Heymsfield is a medical adviser for Medifast, a weight loss company.
A version of this article first appeared on Medscape.com.
New guidelines on the diagnosis and treatment of adults with CAP
Background: More than a decade has passed since the last CAP guidelines. Since then there have been new trials and epidemiological studies. There have also been changes to the process for guideline development. This guideline has moved away from the narrative style of guidelines to the GRADE format and PICO framework with hopes of answering specific questions by looking at the quality of evidence.
Study design: Multidisciplinary panel conducted pragmatic systemic reviews of high-quality studies.
Setting: The panel revised and built upon the 2007 guidelines, addressing 16 clinical questions to be used in immunocompetent patients with radiographic evidence of CAP in the United States with no recent foreign travel.
Synopsis: Changes from the 2007 guidelines are as follows: Sputum and blood cultures, previously recommended only in patients with severe CAP, are now also recommended for inpatients being empirically treated for Pseudomonas or methicillin-resistant Staphylococcus aureus (MRSA) and for those who have received IV antibiotics in the previous 90 days; use of procalcitonin is not recommended to decide whether to withhold antibiotics; steroids are not recommended unless being used for shock; HCAP categorization should be abandoned and need for empiric coverage of MRSA and Pseudomonas should be based on local epidemiology and local validated risk factors; B-lactam/macrolide is favored over fluoroquinolone for severe CAP therapy; and routine follow-up chest x-ray is not recommended.
Other recommendations include not routinely testing for urine pneumococcal or legionella antigens in nonsevere CAP; using PSI over CURB-65, in addition to clinical judgment, to determine need for inpatient care; using severe CAP criteria and clinical judgment for determining ICU need; not adding anaerobic coverage for aspiration pneumonia; and treating most cases of CAP that are clinically stable and uncomplicated for 5-7 days.
Bottom line: Given new data, updated recommendations have been made to help optimize CAP therapy.
Citation: Metlay JP et al. Diagnosis and treatment of adults with community-acquired pneumonia: An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-67.
Dr. Horton is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.
Background: More than a decade has passed since the last CAP guidelines. Since then there have been new trials and epidemiological studies. There have also been changes to the process for guideline development. This guideline has moved away from the narrative style of guidelines to the GRADE format and PICO framework with hopes of answering specific questions by looking at the quality of evidence.
Study design: Multidisciplinary panel conducted pragmatic systemic reviews of high-quality studies.
Setting: The panel revised and built upon the 2007 guidelines, addressing 16 clinical questions to be used in immunocompetent patients with radiographic evidence of CAP in the United States with no recent foreign travel.
Synopsis: Changes from the 2007 guidelines are as follows: Sputum and blood cultures, previously recommended only in patients with severe CAP, are now also recommended for inpatients being empirically treated for Pseudomonas or methicillin-resistant Staphylococcus aureus (MRSA) and for those who have received IV antibiotics in the previous 90 days; use of procalcitonin is not recommended to decide whether to withhold antibiotics; steroids are not recommended unless being used for shock; HCAP categorization should be abandoned and need for empiric coverage of MRSA and Pseudomonas should be based on local epidemiology and local validated risk factors; B-lactam/macrolide is favored over fluoroquinolone for severe CAP therapy; and routine follow-up chest x-ray is not recommended.
Other recommendations include not routinely testing for urine pneumococcal or legionella antigens in nonsevere CAP; using PSI over CURB-65, in addition to clinical judgment, to determine need for inpatient care; using severe CAP criteria and clinical judgment for determining ICU need; not adding anaerobic coverage for aspiration pneumonia; and treating most cases of CAP that are clinically stable and uncomplicated for 5-7 days.
Bottom line: Given new data, updated recommendations have been made to help optimize CAP therapy.
Citation: Metlay JP et al. Diagnosis and treatment of adults with community-acquired pneumonia: An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-67.
Dr. Horton is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.
Background: More than a decade has passed since the last CAP guidelines. Since then there have been new trials and epidemiological studies. There have also been changes to the process for guideline development. This guideline has moved away from the narrative style of guidelines to the GRADE format and PICO framework with hopes of answering specific questions by looking at the quality of evidence.
Study design: Multidisciplinary panel conducted pragmatic systemic reviews of high-quality studies.
Setting: The panel revised and built upon the 2007 guidelines, addressing 16 clinical questions to be used in immunocompetent patients with radiographic evidence of CAP in the United States with no recent foreign travel.
Synopsis: Changes from the 2007 guidelines are as follows: Sputum and blood cultures, previously recommended only in patients with severe CAP, are now also recommended for inpatients being empirically treated for Pseudomonas or methicillin-resistant Staphylococcus aureus (MRSA) and for those who have received IV antibiotics in the previous 90 days; use of procalcitonin is not recommended to decide whether to withhold antibiotics; steroids are not recommended unless being used for shock; HCAP categorization should be abandoned and need for empiric coverage of MRSA and Pseudomonas should be based on local epidemiology and local validated risk factors; B-lactam/macrolide is favored over fluoroquinolone for severe CAP therapy; and routine follow-up chest x-ray is not recommended.
Other recommendations include not routinely testing for urine pneumococcal or legionella antigens in nonsevere CAP; using PSI over CURB-65, in addition to clinical judgment, to determine need for inpatient care; using severe CAP criteria and clinical judgment for determining ICU need; not adding anaerobic coverage for aspiration pneumonia; and treating most cases of CAP that are clinically stable and uncomplicated for 5-7 days.
Bottom line: Given new data, updated recommendations have been made to help optimize CAP therapy.
Citation: Metlay JP et al. Diagnosis and treatment of adults with community-acquired pneumonia: An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-67.
Dr. Horton is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.