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FDA OKs dostarlimab plus chemo for endometrial cancer
The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).
The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.
MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.
“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”
that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.
Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.
Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.
The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.
Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).
The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.
MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.
“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”
that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.
Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.
Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.
The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.
Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).
The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.
MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.
“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”
that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.
Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.
Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.
The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.
Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.
A version of this article first appeared on Medscape.com.
Cognitive problems transient after AFib ablation
Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.
Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.
The study was published online in the July issue of JACC: Clinical Electrophysiology.
Important pillar
Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.
Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.
The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.
Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).
Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.
AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.
Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).
Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.
The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
More research needed
Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.
At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)
But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).
Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).
When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.
At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).
Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).
As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).
“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.
They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
‘Reassuring’ findings
In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.
Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.
Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.
Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”
Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”
The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.
A version of this article first appeared on Medscape.com.
Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.
Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.
The study was published online in the July issue of JACC: Clinical Electrophysiology.
Important pillar
Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.
Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.
The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.
Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).
Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.
AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.
Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).
Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.
The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
More research needed
Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.
At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)
But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).
Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).
When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.
At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).
Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).
As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).
“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.
They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
‘Reassuring’ findings
In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.
Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.
Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.
Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”
Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”
The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.
A version of this article first appeared on Medscape.com.
Investigators randomly assigned 100 patients with symptomatic AFib who had failed at least one anti-arrhythmic drug (AAD) to ongoing therapy or to AFib catheter ablation. Patients were followed for 1 year, and changes in cognitive performance were assessed at baseline and at 3, 6, and 12 months.
Although patients in the ablation arm initially showed more cognitive dysfunction than those in the medical arm, at 6 months, the gap was smaller, and at 12 months, no patients in the ablation arm showed signs of cognitive dysfunction. In fact, more than 1 in 10 showed signs of cognitive improvement, compared with no patients in the medical arm.
The study was published online in the July issue of JACC: Clinical Electrophysiology.
Important pillar
Previous research has shown that AFib is associated with cognitive dysfunction independently of stroke, “suggesting that AFib is an additional risk factor for cognitive impairment,” the authors write.
Catheter ablation is an “important pillar” in the management of patients with AFib that is refractory to medical therapy, but postoperative cognitive dysfunction (POCD) may occur in the immediate aftermath of the procedure, they note. Little is known about whether these cognitive changes persist long term, and no randomized studies have investigated this issue.
The researchers randomly assigned 100 patients with symptomatic paroxysmal or persistent AFib who had failed greater than or equal to 1 AAD to receive either medical management or catheter ablation. The mean age of the patients was 59 plus or minus 12 years, 32% were women, and 46% had persistent AFib.
Medical management consisted of optimization of AADs to maintain sinus rhythm. For those who underwent ablation, AADs were discontinued five half-lives prior to the procedure (with the exception of amiodarone).
Participants were followed for 12 months after enrollment. Clinical reviews and cognitive testing were performed at 3, 6, and 12 months during that time.
AADs and oral anticoagulation were weaned and were discontinued 3 months after the procedure, depending on each patient’s individual risk profile.
Cognitive testing included the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) Auditory Verbal Learning Test and Semantic Fluency test; the Controlled Oral Word Association test; and the Trail Making Task (parts A and B).
Participants also completed the University of Toronto AFib Symptom Severity Scale at baseline and at all follow-up visits.
The primary endpoint was prevalence of new-onset cognitive dysfunction. Main secondary endpoints included improvement in cognitive function during follow-up; AFib recurrence and AFib function during follow-up; AAD use during follow-up; and changes to AFib symptom severity assessment scores during follow-up.
More research needed
Of the 100 participants, 96 completed the study protocol (52 in the ablation group and 48 in the medical management group). There were no significant differences between the groups regarding baseline demographics, clinical AFib risk factors, and echocardiographic parameters.
At 3 months, new-onset cognitive dysfunction was detected across a wide range of the neuropsychological tests in 14% of participants in the ablation arm, versus 2% of participants in the medical arm (P = .03)
But at 6 months, only 4% of patients in the ablation arm displayed cognitive dysfunction, compared again with 2% in the medical arm (P = .60). And by 12 months, there were no patients with detectable cognitive dysfunction in the ablation arm, compared with the same patient who showed cognitive impairment in the medical arm (P = .30).
Longer ablation time was an independent predictor of new-onset cognitive dysfunction (odds ratio, 1.30; 95% CI, 1.01-1.60; P = .003).
When patients with and those without new-onset cognitive dysfunction were compared, no differences were found in arrhythmia recurrence or AFib burden post ablation.
At 12 months, 14% of those in the ablation arm showed improvement in cognitive performance, compared with no participants in the medical arm (P = .007).
Compared with participants who had no change in cognitive performance, those who had a significant improvement had a trend toward lower AFib recurrence rates (29% vs. 48%; P = .30). However, both groups were found to have a low AFib burden over the 12 months. And the use of AADs at the 12-month mark was significantly lower among those with versus those without cognitive improvement (0% vs. 38%; P = .04).
As early as 3 months post procedure and then at 12 months, participants in the ablation group had significant improvement in AFib-related symptoms, compared with those in the medical arm (for both, P < .001).
“Among a contemporary cohort of symptomatic paroxysmal and persistent AFib patients, catheter ablation was associated with a transient decline in cognitive function in the short-term, followed by recovery at 12 months,” the authors conclude.
They note that further large studies “are required to determine with AFib ablation may prevent the longer-term neurocognitive decline and dementia development associated with AFib.”
‘Reassuring’ findings
In a comment, Andrea Natale, MD, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, said POCD is “very likely due to the vulnerable state of mind and the stress that the patients encounter while undergoing the cardiac procedure,” as well as postsurgical inflammation, which “can cause brief functional alterations in the brain, leading to temporary cognitive impairment.” Inadequate preprocedural anticoagulation may also play a role.
Dr. Natale, co-author of an accompanying editorial, said it’s “prudent” when evaluating cognitive function to use questionnaires that are “sensitive to mild cognitive impairment,” such as the Montreal Cognitive Assessment or the Mini-Mental State Examination.
Additionally, “post-ablation cognitive function should be assessed way after the blanking period to avoid any plausible impact of inflammation, medications, the feeling of being overwhelmed, and the stress of undergoing a cardiac procedure,” advised Dr. Natale, who was not involved with the study.
Also commenting, Matthew Hyman, MD, PhD, an electrophysiologist and assistant professor of medicine at the Hospital of the University of Pennsylvania, called it a “well-done and very reassuring study.”
Dr. Hyman, who was also not part of the research team, added that previous work has shown an association between AFib and dementia, “and it remains to be seen if patients with rhythm control over longer durations than the current studies have the best outcomes.”
The authors of the study are supported by the National Health and Medical Research Council research scholarship. One author of the study is supported by a practitioner fellowship from the National Health and Medical Research Council; has received research support from Biosense Webster, Boston Scientific, Abbott, and Medtronic; and has served on the advisory board of Boston Scientific and Biosense Webster. Dr. Natale is a consultant for Abbott, Baylis, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr. Hyman is a consultant/speaker for Abbott, Biosense Webster and Boston Scientific.
A version of this article first appeared on Medscape.com.
FROM JACC: CLINICAL ELECTROPHYSIOLOGY
Free teledermatology clinic helps underserved patients initiate AD care
A in other underserved areas in the United States.
Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.
Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.
Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.
Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.
The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.
The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.
Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.
Patients deem clinic ‘extremely’ helpful
As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.
One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.
Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.
However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.
Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”
About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.
Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.
For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
Alopecia areata
The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.
Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
Building partnerships, earning trust
Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”
Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)
In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.
Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)
In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.
Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.
“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).
The GWU program, she said, “is a great start.”
Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”
Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.
A in other underserved areas in the United States.
Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.
Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.
Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.
Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.
The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.
The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.
Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.
Patients deem clinic ‘extremely’ helpful
As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.
One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.
Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.
However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.
Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”
About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.
Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.
For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
Alopecia areata
The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.
Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
Building partnerships, earning trust
Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”
Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)
In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.
Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)
In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.
Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.
“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).
The GWU program, she said, “is a great start.”
Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”
Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.
A in other underserved areas in the United States.
Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.
Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.
Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.
Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.
The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.
The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.
Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.
Patients deem clinic ‘extremely’ helpful
As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.
One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.
Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.
However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.
Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”
About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.
Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.
For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
Alopecia areata
The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.
Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
Building partnerships, earning trust
Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”
Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)
In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.
Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)
In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.
Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.
“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).
The GWU program, she said, “is a great start.”
Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”
Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.
Heat waves plus air pollution tied to doubling of fatal MI
, a study from China suggests.
The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).
“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.
There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.
The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.
The study was published online in Circulation.
Intensity and duration matter
The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.
They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.
Among the key findings:
- The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
- The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
- The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m3. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
- Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m3).
- The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.
The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.
Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.
“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.
In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.
This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a study from China suggests.
The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).
“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.
There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.
The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.
The study was published online in Circulation.
Intensity and duration matter
The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.
They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.
Among the key findings:
- The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
- The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
- The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m3. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
- Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m3).
- The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.
The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.
Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.
“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.
In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.
This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, a study from China suggests.
The researchers estimate that up to 3% of all deaths due to MI could be attributed to the combination of extreme temperatures and high levels of ambient fine particulate matter (PM2.5).
“Our findings provide evidence that reducing exposure to both extreme temperatures and fine particulate pollution may be useful to prevent premature deaths from heart attack,” senior author Yuewei Liu, MD, PhD, with Sun Yat-sen University in Guangzhou, China, said in a statement.
There is “long-standing evidence” of the harmful cardiovascular effects of air pollution, Jonathan Newman, MD, MPH, cardiologist at NYU Langone Heart in New York, who wasn’t involved in the study, said in an interview.
The added value of this study was finding an interaction between extreme hot temperatures and air pollution, “which is worrisome with global warming,” said Dr. Newman, assistant professor, department of medicine, the Leon H. Charney Division of Cardiology at NYU Langone Health.
The study was published online in Circulation.
Intensity and duration matter
The researchers analyzed data on 202,678 adults (mean age, 77.6 years; 52% male) who suffered fatal MI between 2015 and 2020 in Jiangsu province, a region with four distinct seasons and a wide range of temperatures and ambient PM2.5.
They evaluated the association of exposure to extreme temperature events, including both hot and cold spells, and PM2.5 with MI mortality, and their interactive effects.
Among the key findings:
- The risk of fatal MI was 18% higher during 2-day heat waves with heat indexes at or above the 90th percentile (ranging from 82.6° to 97.9° F) and 74% higher during 4-day heat waves with heat indexes at or above the 97.5th percentile (ranging from 94.8° to 109.4° F), compared with control days.
- The risk of fatal MI was 4% higher during 2-day cold snaps with temperatures at or below the 10th percentile (ranging from 33.3° to 40.5° F) and 12% higher during 3-day cold snaps with temperatures at or below the 2.5th percentile (ranging from 27.0° to 37.2° F).
- The risk of fatal MI was twice as high during 4-day heat waves that had PM2.5 above 37.5 mcg/m3. Days with high levels of PM2.5 during cold snaps did not have an equivalent increase in the risk of fatal MI.
- Up to 2.8% of MI deaths during the 5-year study period may be attributable to the combination of extreme temperature exposure and PM2.5 at levels exceeding World Health Organization air quality guidelines (37.5 mcg/m3).
- The risk of fatal MI was generally higher among women than men during heat waves and was higher among adults 80 years old and older than in younger adults during heat waves, cold snaps, or days with high levels of PM2.5.
The finding that adults over age 80 are particularly susceptible to the effects of heat and air pollution and the interaction of the two is “notable and particularly relevant given the aging of the population,” Dr. Newman told this news organization.
Mitigating both extreme temperature events and PM2.5 exposures “may bring health cobenefits in preventing premature deaths from MI,” the researchers write.
“To improve public health, it is important to take fine particulate pollution into consideration when providing extreme temperature warnings to the public,” Dr. Liu adds in the statement.
In an earlier study, Dr. Liu and colleagues showed that exposure to both large and small particulate matter, as well as nitrogen dioxide, was significantly associated with increased odds of death from MI.
This study was funded by China’s Ministry of Science and Technology. The authors and Dr. Newman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION
Fatalities from breast cancer have ‘improved substantially’
Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.
Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.
“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.
The study was published online in the BMJ.
Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.
The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.
The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.
The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).
Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.
The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.
Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.
Overall, the annual case fatality rates decreased over time in nearly every patient group.
While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.
“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.
Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.
While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.
“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”
The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”
The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.
A version of this article first appeared on Medscape.com.
Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.
Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.
“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.
The study was published online in the BMJ.
Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.
The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.
The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.
The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).
Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.
The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.
Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.
Overall, the annual case fatality rates decreased over time in nearly every patient group.
While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.
“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.
Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.
While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.
“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”
The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”
The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.
A version of this article first appeared on Medscape.com.
Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.
Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.
“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.
The study was published online in the BMJ.
Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.
The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.
The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.
The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).
Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.
The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.
Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.
Overall, the annual case fatality rates decreased over time in nearly every patient group.
While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.
“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.
Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.
While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.
“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”
The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”
The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.
A version of this article first appeared on Medscape.com.
FROM THE BMJ
Kombucha benefits type 2 diabetes, study suggests
TOPLINE:
The sample size was too small for statistical significance.
METHODOLOGY:
- Prospective, randomized, double-blinded, crossover study at a single-center urban hospital system.
- A total of 12 participants with type 2 diabetes were randomly assigned to consume 240 mL of either a kombucha product or placebo daily with dinner for 4 weeks.
- After an 8-week washout, they were switched to the other product for another 4 weeks.
- Fasting blood glucose levels were self-determined at baseline and at 1 and 4 weeks, and questionnaires were used to assess secondary health outcomes.
- Questionnaire data were analyzed for all 12 participants, but only 7 who completed the study were included in the analysis of fasting blood glucose.
TAKEAWAY:
- Kombucha significantly lowered average fasting blood glucose levels at week 4, compared with baseline (164 vs. 116 mg/dL; P = .035), while the placebo was not associated with statistically significant change (162 vs. 141 mg/dL; P = .078).
- Among just the five participants with baseline fasting glucose > 130 mg/dL, kombucha consumption was associated with a mean fasting blood glucose decrease of 74.3 mg/dL, significantly greater than the 15.9 mg/dL drop with placebo (P = .017).
- On cultural enumeration, the kombucha contained mostly lactic acid bacteria, acetic acid bacteria, and yeast, with molds present.
IN PRACTICE:
“Kombucha is a growing part of the beverage market in the United States and the world, driven, in part, by the wide range of suggested health benefits. However, nearly all of these benefits are based on in vitro or animal studies, and human clinical trials are needed to validate biological outcomes.”
SOURCE:
The study was conducted by Chagai Mendelson, of MedStar Georgetown University Hospital, Washington, and colleagues. It was published in Frontiers in Nutrition.
LIMITATIONS:
- The number of participants was small, and attrition was high.
- Glucose levels were self-reported.
- Only one kombucha was studied.
DISCLOSURES:
One author is a cofounder of Synbiotic Health and another has a financial interest in the company. The other authors have no disclosures. Kombucha and placebo drinks were donated by Craft Kombucha, but the company did not have access to the data, and no authors have financial ties with that company.
A version of this article first appeared on Medscape.com.
TOPLINE:
The sample size was too small for statistical significance.
METHODOLOGY:
- Prospective, randomized, double-blinded, crossover study at a single-center urban hospital system.
- A total of 12 participants with type 2 diabetes were randomly assigned to consume 240 mL of either a kombucha product or placebo daily with dinner for 4 weeks.
- After an 8-week washout, they were switched to the other product for another 4 weeks.
- Fasting blood glucose levels were self-determined at baseline and at 1 and 4 weeks, and questionnaires were used to assess secondary health outcomes.
- Questionnaire data were analyzed for all 12 participants, but only 7 who completed the study were included in the analysis of fasting blood glucose.
TAKEAWAY:
- Kombucha significantly lowered average fasting blood glucose levels at week 4, compared with baseline (164 vs. 116 mg/dL; P = .035), while the placebo was not associated with statistically significant change (162 vs. 141 mg/dL; P = .078).
- Among just the five participants with baseline fasting glucose > 130 mg/dL, kombucha consumption was associated with a mean fasting blood glucose decrease of 74.3 mg/dL, significantly greater than the 15.9 mg/dL drop with placebo (P = .017).
- On cultural enumeration, the kombucha contained mostly lactic acid bacteria, acetic acid bacteria, and yeast, with molds present.
IN PRACTICE:
“Kombucha is a growing part of the beverage market in the United States and the world, driven, in part, by the wide range of suggested health benefits. However, nearly all of these benefits are based on in vitro or animal studies, and human clinical trials are needed to validate biological outcomes.”
SOURCE:
The study was conducted by Chagai Mendelson, of MedStar Georgetown University Hospital, Washington, and colleagues. It was published in Frontiers in Nutrition.
LIMITATIONS:
- The number of participants was small, and attrition was high.
- Glucose levels were self-reported.
- Only one kombucha was studied.
DISCLOSURES:
One author is a cofounder of Synbiotic Health and another has a financial interest in the company. The other authors have no disclosures. Kombucha and placebo drinks were donated by Craft Kombucha, but the company did not have access to the data, and no authors have financial ties with that company.
A version of this article first appeared on Medscape.com.
TOPLINE:
The sample size was too small for statistical significance.
METHODOLOGY:
- Prospective, randomized, double-blinded, crossover study at a single-center urban hospital system.
- A total of 12 participants with type 2 diabetes were randomly assigned to consume 240 mL of either a kombucha product or placebo daily with dinner for 4 weeks.
- After an 8-week washout, they were switched to the other product for another 4 weeks.
- Fasting blood glucose levels were self-determined at baseline and at 1 and 4 weeks, and questionnaires were used to assess secondary health outcomes.
- Questionnaire data were analyzed for all 12 participants, but only 7 who completed the study were included in the analysis of fasting blood glucose.
TAKEAWAY:
- Kombucha significantly lowered average fasting blood glucose levels at week 4, compared with baseline (164 vs. 116 mg/dL; P = .035), while the placebo was not associated with statistically significant change (162 vs. 141 mg/dL; P = .078).
- Among just the five participants with baseline fasting glucose > 130 mg/dL, kombucha consumption was associated with a mean fasting blood glucose decrease of 74.3 mg/dL, significantly greater than the 15.9 mg/dL drop with placebo (P = .017).
- On cultural enumeration, the kombucha contained mostly lactic acid bacteria, acetic acid bacteria, and yeast, with molds present.
IN PRACTICE:
“Kombucha is a growing part of the beverage market in the United States and the world, driven, in part, by the wide range of suggested health benefits. However, nearly all of these benefits are based on in vitro or animal studies, and human clinical trials are needed to validate biological outcomes.”
SOURCE:
The study was conducted by Chagai Mendelson, of MedStar Georgetown University Hospital, Washington, and colleagues. It was published in Frontiers in Nutrition.
LIMITATIONS:
- The number of participants was small, and attrition was high.
- Glucose levels were self-reported.
- Only one kombucha was studied.
DISCLOSURES:
One author is a cofounder of Synbiotic Health and another has a financial interest in the company. The other authors have no disclosures. Kombucha and placebo drinks were donated by Craft Kombucha, but the company did not have access to the data, and no authors have financial ties with that company.
A version of this article first appeared on Medscape.com.
FROM FRONTIERS IN NUTRITION
The four questions you should ask about sexual health
This transcript has been edited for clarity.
When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.
What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.
As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.
Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.
Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.
We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.
Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.
Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.
Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.
Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.
Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.
What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.
As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.
Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.
Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.
We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.
Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.
Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.
Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.
Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.
Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
When I went to med school, we were taught to take a sexual history. Do you smoke? Do you drink? Do you do drugs? Do you have sex? Men, women, or both? And that was it. We’re telling patients that sex is a vice, something that is dangerous and that you should feel bad about. But sex is how we’re all here and how we even continue as a species. We must get comfortable as doctors talking to our patients about sexual medicine.
What if we move away from sex being in the vice category – the part of the social history that’s the bad stuff you shouldn’t be doing? Maybe we should bring it into the review of systems.
As a very basic first step, I like to ask patients four things. As a sexual medicine doctor, I deal with these four things: libido, arousal, orgasm, and pain.
Why are these important? These are the things our patients really care about; 2.3 of every 1,000 people got divorced in 2021.
Libido. Women who have distressing low sexual desire have sex on average two and a half times per month. We call this mercy sex or duty sex. I don’t know what the half time per month looks like, but people genuinely care about desire and their doctors don’t really know that.
We have a biopsychosocial toolbox to help our patients. Let me give you an example: Antidepressants can have sexual side effects. Could there be medications in our toolbox that can help our patients? Of course there can, and there are. What about education or talk therapy? We should be asking our patients what they care about and why they care about it so we can help them achieve their quality-of-life goals.
Arousal. What about arousal? Did you know that erections are a marker of cardiovascular disease in men? We know this to be true for men, and I’m certain the research would be no different for women. We know that there are many biological causes for decrease in arousal, including sleep apnea, diabetes, hypertension, and smoking. I can convince a lot of men to quit smoking because I tell them it’s bad for their penis. We have to understand what our patients care about and then advise them on why we think we can help improve these issues.
Orgasm. How about orgasm? Have you ever been asked whether you can orgasm? Have you ever been asked whether you have questions about orgasm? About 15%-20% of women report having an orgasm disorder, and we rarely talk about this in an exam room. I’ve certainly never been asked, and everybody knows what I do for a living. Not to mention all the men that I and my colleagues see who have really distressing premature ejaculation or delayed orgasm. This is pathophysiology at its finest and most complex. It is so interesting, and we have so much to learn and understand about orgasm in general.
Pain. Finally, ask about pain. It seems obvious that we should be asking our patients about their pain, which includes pelvic pain, but oftentimes we avoid talking about private parts. Pain affects not just our patients, but also their partners and their families, when our patients can’t sit without discomfort, if they can’t go and perform the daily activities that bring them joy and belonging. We have to really work with our toolbox in a biopsychosocial manner to help our patients. I often use the incredible rehabilitation specialists called pelvic floor physical therapists.
Remember, we’re talking about libido, arousal, orgasm, and pain. Sex is important to us as a species. It’s important to our patients. Ask nonjudgmental and open-ended questions. You actually may be the only doctor to ever do so.
Dr. Rubin is an assistant clinical professor, department of urology, Georgetown University, Washington. She reported conflicts of interest with Sprout, Maternal Medical, Absorption Pharmaceuticals, GSK, and Endo.
A version of this article first appeared on Medscape.com.
New and emerging options for treating recurrent C. difficile
This transcript has been edited for clarity.
Clostridioides difficile is a toxin-based infection that takes up residence in the colon due to disturbed normal bowel flora, usually after antibiotics.
Recurrent C. difficile can happen in up to a quarter of patients who receive oral vancomycin as a treatment for their infection. It can also occur with treatment with the newer agent, fidaxomicin, although possibly in fewer patients. In general, relapses are indeed common.
When I trained at Johns Hopkins under John Bartlett, he took the approach that after the second – and always after the third – relapse, an extended course of oral therapy with vancomycin could help get patients out of trouble. He used the so-called extended pulse method, where patients would take the drug for approximately 4-6 weeks and gradually reduce the dose.
This approach can also be done with fidaxomicin. However, I’m not sure it works much better than vancomycin, and there are often hurdles to using fidaxomicin because of insurers not approving it because of the expense.
What other therapies are there?
There is bezlotoxumab, which is a human monoclonal antibody targeting C. difficile toxin B. I’ve used it a few times. It is given as a one-time infusion, and there are challenges regarding cost, the logistics of setting up the infusion, and insurance approval.
Fecal microbiota transplant
In recent years, fecal microbiota transplants (FMT) have received a lot of attention as a different avenue of treatment that could lower the potential for relapses, with success rates usually around 80%-90%. However, in the past few years, there have been some serious safety signals because of possible transmission of dangerous pathogens, often with drug resistance, with FMT.
I’m therefore pleased to say that newer fecal microbiota products are coming in fast and furious. I thought I’d spend a few minutes speaking about these.
OpenBiome, an organization dedicated to microbiome research, offers an investigational product from screened donors that has not received Food and Drug Administration approval. It’s been around for some time. It can be used in either upper or lower GI applications, and the organization cites about an 84% success rate using this product.
There are also two new FDA-approved products I think are worth knowing about. They’ve just been approved recently and we’re a little uncertain of where they’re going to end up in the treatment landscape.
The first is from Ferring, and it goes by fecal microbiota, live-jslm (Rebyota). This is a product from qualified and screened donors, the main component of which is Bacteroides, which is given as a single dose by enema.
The company did a phase 3 trial with a Bayesian primary analysis, which I think convinced the FDA to approve this product. The success rate in people with multiple relapses was 70.6%, compared with 57.5% with placebo. The estimated treatment effect was 13.1%. Of those who did respond, over 90% were kept free of relapse over a 6-month period.
The other product, also FDA approved, is from Seres. It was previously called SER-109, and is now called fecal microbiota spores, live-brpk (Vowst). Unlike the previous product, this is orally administered, with patients taking four capsules daily for 3 days. Again, these donor-derived firmicutes have been appropriately screened and are free of potential pathogens.
The phase 3 randomized clinical trial results were published in the New England Journal of Medicine. They showed that 12% of those taking this product had a relapse, compared with 40% of those taking placebo, which is about the range we tend to see in people who have had multiple relapses. The safety profile was similar to placebo.
So, how will people use these treatments?
I think the FDA imprimatur will be attractive to people, but the products, I believe, will be priced fairly expensively, in the under $10,000 range. The first (Rebyota) is a rectal infusion; it is a one-and-done treatment but creates logistical issues. Interestingly, it could be a billable procedure for infectious disease clinicians. The ease of oral administration for Vowst, no doubt, will be very appealing. Both of these are given after completing a course of treatment with vancomycin or fidaxomicin so as not to interfere with the microbiome product.
I’ll also briefly mention a paper published in JAMA on yet another microbiome product, called VE303. This product was based on eight commensal strains of Clostridia and was given orally in a phase 2 trial. Interestingly, this worked about the same as the oral product that is already FDA approved. The study showed a recurrence rate of 13.8% in the high-dose group, compared with 45.5% in the placebo group.
I think this is exciting. And, of course, there is the expense.
But anything that can be done to help improve these patients is welcome, as once they get into the multiple-relapse phase, it is challenging to turn around. These commercialized products will hopefully become a bit more mainstream. Certainly, we’ll see how these will be utilized in the coming months and over the next few years.
Dr. Auwaerter is Clinical Director, Division of Infectious Diseases, Johns Hopkins University, Baltimore. He reported conflicts of interest with Gilead, Shionogi, and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Clostridioides difficile is a toxin-based infection that takes up residence in the colon due to disturbed normal bowel flora, usually after antibiotics.
Recurrent C. difficile can happen in up to a quarter of patients who receive oral vancomycin as a treatment for their infection. It can also occur with treatment with the newer agent, fidaxomicin, although possibly in fewer patients. In general, relapses are indeed common.
When I trained at Johns Hopkins under John Bartlett, he took the approach that after the second – and always after the third – relapse, an extended course of oral therapy with vancomycin could help get patients out of trouble. He used the so-called extended pulse method, where patients would take the drug for approximately 4-6 weeks and gradually reduce the dose.
This approach can also be done with fidaxomicin. However, I’m not sure it works much better than vancomycin, and there are often hurdles to using fidaxomicin because of insurers not approving it because of the expense.
What other therapies are there?
There is bezlotoxumab, which is a human monoclonal antibody targeting C. difficile toxin B. I’ve used it a few times. It is given as a one-time infusion, and there are challenges regarding cost, the logistics of setting up the infusion, and insurance approval.
Fecal microbiota transplant
In recent years, fecal microbiota transplants (FMT) have received a lot of attention as a different avenue of treatment that could lower the potential for relapses, with success rates usually around 80%-90%. However, in the past few years, there have been some serious safety signals because of possible transmission of dangerous pathogens, often with drug resistance, with FMT.
I’m therefore pleased to say that newer fecal microbiota products are coming in fast and furious. I thought I’d spend a few minutes speaking about these.
OpenBiome, an organization dedicated to microbiome research, offers an investigational product from screened donors that has not received Food and Drug Administration approval. It’s been around for some time. It can be used in either upper or lower GI applications, and the organization cites about an 84% success rate using this product.
There are also two new FDA-approved products I think are worth knowing about. They’ve just been approved recently and we’re a little uncertain of where they’re going to end up in the treatment landscape.
The first is from Ferring, and it goes by fecal microbiota, live-jslm (Rebyota). This is a product from qualified and screened donors, the main component of which is Bacteroides, which is given as a single dose by enema.
The company did a phase 3 trial with a Bayesian primary analysis, which I think convinced the FDA to approve this product. The success rate in people with multiple relapses was 70.6%, compared with 57.5% with placebo. The estimated treatment effect was 13.1%. Of those who did respond, over 90% were kept free of relapse over a 6-month period.
The other product, also FDA approved, is from Seres. It was previously called SER-109, and is now called fecal microbiota spores, live-brpk (Vowst). Unlike the previous product, this is orally administered, with patients taking four capsules daily for 3 days. Again, these donor-derived firmicutes have been appropriately screened and are free of potential pathogens.
The phase 3 randomized clinical trial results were published in the New England Journal of Medicine. They showed that 12% of those taking this product had a relapse, compared with 40% of those taking placebo, which is about the range we tend to see in people who have had multiple relapses. The safety profile was similar to placebo.
So, how will people use these treatments?
I think the FDA imprimatur will be attractive to people, but the products, I believe, will be priced fairly expensively, in the under $10,000 range. The first (Rebyota) is a rectal infusion; it is a one-and-done treatment but creates logistical issues. Interestingly, it could be a billable procedure for infectious disease clinicians. The ease of oral administration for Vowst, no doubt, will be very appealing. Both of these are given after completing a course of treatment with vancomycin or fidaxomicin so as not to interfere with the microbiome product.
I’ll also briefly mention a paper published in JAMA on yet another microbiome product, called VE303. This product was based on eight commensal strains of Clostridia and was given orally in a phase 2 trial. Interestingly, this worked about the same as the oral product that is already FDA approved. The study showed a recurrence rate of 13.8% in the high-dose group, compared with 45.5% in the placebo group.
I think this is exciting. And, of course, there is the expense.
But anything that can be done to help improve these patients is welcome, as once they get into the multiple-relapse phase, it is challenging to turn around. These commercialized products will hopefully become a bit more mainstream. Certainly, we’ll see how these will be utilized in the coming months and over the next few years.
Dr. Auwaerter is Clinical Director, Division of Infectious Diseases, Johns Hopkins University, Baltimore. He reported conflicts of interest with Gilead, Shionogi, and Medscape.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Clostridioides difficile is a toxin-based infection that takes up residence in the colon due to disturbed normal bowel flora, usually after antibiotics.
Recurrent C. difficile can happen in up to a quarter of patients who receive oral vancomycin as a treatment for their infection. It can also occur with treatment with the newer agent, fidaxomicin, although possibly in fewer patients. In general, relapses are indeed common.
When I trained at Johns Hopkins under John Bartlett, he took the approach that after the second – and always after the third – relapse, an extended course of oral therapy with vancomycin could help get patients out of trouble. He used the so-called extended pulse method, where patients would take the drug for approximately 4-6 weeks and gradually reduce the dose.
This approach can also be done with fidaxomicin. However, I’m not sure it works much better than vancomycin, and there are often hurdles to using fidaxomicin because of insurers not approving it because of the expense.
What other therapies are there?
There is bezlotoxumab, which is a human monoclonal antibody targeting C. difficile toxin B. I’ve used it a few times. It is given as a one-time infusion, and there are challenges regarding cost, the logistics of setting up the infusion, and insurance approval.
Fecal microbiota transplant
In recent years, fecal microbiota transplants (FMT) have received a lot of attention as a different avenue of treatment that could lower the potential for relapses, with success rates usually around 80%-90%. However, in the past few years, there have been some serious safety signals because of possible transmission of dangerous pathogens, often with drug resistance, with FMT.
I’m therefore pleased to say that newer fecal microbiota products are coming in fast and furious. I thought I’d spend a few minutes speaking about these.
OpenBiome, an organization dedicated to microbiome research, offers an investigational product from screened donors that has not received Food and Drug Administration approval. It’s been around for some time. It can be used in either upper or lower GI applications, and the organization cites about an 84% success rate using this product.
There are also two new FDA-approved products I think are worth knowing about. They’ve just been approved recently and we’re a little uncertain of where they’re going to end up in the treatment landscape.
The first is from Ferring, and it goes by fecal microbiota, live-jslm (Rebyota). This is a product from qualified and screened donors, the main component of which is Bacteroides, which is given as a single dose by enema.
The company did a phase 3 trial with a Bayesian primary analysis, which I think convinced the FDA to approve this product. The success rate in people with multiple relapses was 70.6%, compared with 57.5% with placebo. The estimated treatment effect was 13.1%. Of those who did respond, over 90% were kept free of relapse over a 6-month period.
The other product, also FDA approved, is from Seres. It was previously called SER-109, and is now called fecal microbiota spores, live-brpk (Vowst). Unlike the previous product, this is orally administered, with patients taking four capsules daily for 3 days. Again, these donor-derived firmicutes have been appropriately screened and are free of potential pathogens.
The phase 3 randomized clinical trial results were published in the New England Journal of Medicine. They showed that 12% of those taking this product had a relapse, compared with 40% of those taking placebo, which is about the range we tend to see in people who have had multiple relapses. The safety profile was similar to placebo.
So, how will people use these treatments?
I think the FDA imprimatur will be attractive to people, but the products, I believe, will be priced fairly expensively, in the under $10,000 range. The first (Rebyota) is a rectal infusion; it is a one-and-done treatment but creates logistical issues. Interestingly, it could be a billable procedure for infectious disease clinicians. The ease of oral administration for Vowst, no doubt, will be very appealing. Both of these are given after completing a course of treatment with vancomycin or fidaxomicin so as not to interfere with the microbiome product.
I’ll also briefly mention a paper published in JAMA on yet another microbiome product, called VE303. This product was based on eight commensal strains of Clostridia and was given orally in a phase 2 trial. Interestingly, this worked about the same as the oral product that is already FDA approved. The study showed a recurrence rate of 13.8% in the high-dose group, compared with 45.5% in the placebo group.
I think this is exciting. And, of course, there is the expense.
But anything that can be done to help improve these patients is welcome, as once they get into the multiple-relapse phase, it is challenging to turn around. These commercialized products will hopefully become a bit more mainstream. Certainly, we’ll see how these will be utilized in the coming months and over the next few years.
Dr. Auwaerter is Clinical Director, Division of Infectious Diseases, Johns Hopkins University, Baltimore. He reported conflicts of interest with Gilead, Shionogi, and Medscape.
A version of this article first appeared on Medscape.com.
FDA clears AI-assisted colonoscopy device
, according to the Israeli-based manufacturer of the same name.
The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.
The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.
In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.
In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”
The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”
As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.
Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.
“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.
According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.
A version of this article first appeared on Medscape.com.
, according to the Israeli-based manufacturer of the same name.
The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.
The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.
In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.
In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”
The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”
As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.
Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.
“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.
According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.
A version of this article first appeared on Medscape.com.
, according to the Israeli-based manufacturer of the same name.
The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.
The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.
In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.
In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”
The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”
As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.
Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.
“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.
According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.
A version of this article first appeared on Medscape.com.
Injecting long-acting antiretrovirals into clinic care
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
FROM IAS 2023