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Botulinum Toxin, Dermal Fillers Safe in Skin of Color Patients, Review Finds
TOPLINE:
, and more data on Black and Latinx populations are needed, according to a literature review.
METHODOLOGY:
- Understanding the efficacy and safety of cosmetic injectables in diverse skin types is important because individuals identifying as racial and ethnic minorities accounted for 18% of neuromodulator procedures and 22% of soft tissue augmentation procedures in 2020 in the United States.
- Researchers reviewed available literature on the usability and efficacy of neuromodulators and soft tissue augmentation in individuals with SOC because of the limited data available in these populations, particularly non-Asian, SOC populations.
- Overall, 88 studies in English were included, which were either dedicated to discussing safety and/or efficacy of injectables in SOC populations or enrolled more than 20% of participants from SOC populations.
- High-quality level I and II evidence was found in 50 studies, and 9940 patients were analyzed in this review.
TAKEAWAY:
- Studies considered high quality indicated that botulinum toxin is safe and effective for treating glabellar lines in Asians; tailored guidelines recommended specific strategies; and adverse events, such as eyelid issues, were more common in Asians.
- Hyaluronic acid fillers showed significant improvement in moderate to severe cases of nasolabial folds in Asians, and adverse effects like swelling and pain were mild to moderate — some cases of granuloma formation and vascular compromise have been reported.
- In Black individuals, botulinum toxin was well tolerated; hyaluronic acid fillers showed favorable safety, with mild to moderate adverse events; and measures like slower injections and subdermal techniques minimized risks.
- In Latinx populations, there was a lack of robust study data on safety and efficacy of botulinum toxin, whereas hyaluronic acid and poly-L-lactic acid fillers were well tolerated.
IN PRACTICE:
“Neuromodulators and dermal fillers are useful and safe as cosmetic and antiaging treatments in SOC populations, with the greatest amount of data supporting its use in Asian populations,” although more data on Black and Latinx populations are needed, the authors concluded. “During cosmetic consultations, physicians should consider the impact of different cultural beauty norms on the aesthetic goals of diverse patient populations,” they added.
SOURCE:
This study led by Shanice McKenzie, MD, from the Department of Dermatology, University of Southern California, Los Angeles, California, was published online in the Journal of Cosmetic Dermatology.
LIMITATIONS:
Most of the recent data and formal consensus guidelines on injectables in the review came from Asian countries, and there was “a relative paucity of research on Black and Latinx populations,” the authors noted.
DISCLOSURES:
The study did not receive any funding. Two authors declared serving as a consultant, investigator, and/or speaker for various companies; the rest had no disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
, and more data on Black and Latinx populations are needed, according to a literature review.
METHODOLOGY:
- Understanding the efficacy and safety of cosmetic injectables in diverse skin types is important because individuals identifying as racial and ethnic minorities accounted for 18% of neuromodulator procedures and 22% of soft tissue augmentation procedures in 2020 in the United States.
- Researchers reviewed available literature on the usability and efficacy of neuromodulators and soft tissue augmentation in individuals with SOC because of the limited data available in these populations, particularly non-Asian, SOC populations.
- Overall, 88 studies in English were included, which were either dedicated to discussing safety and/or efficacy of injectables in SOC populations or enrolled more than 20% of participants from SOC populations.
- High-quality level I and II evidence was found in 50 studies, and 9940 patients were analyzed in this review.
TAKEAWAY:
- Studies considered high quality indicated that botulinum toxin is safe and effective for treating glabellar lines in Asians; tailored guidelines recommended specific strategies; and adverse events, such as eyelid issues, were more common in Asians.
- Hyaluronic acid fillers showed significant improvement in moderate to severe cases of nasolabial folds in Asians, and adverse effects like swelling and pain were mild to moderate — some cases of granuloma formation and vascular compromise have been reported.
- In Black individuals, botulinum toxin was well tolerated; hyaluronic acid fillers showed favorable safety, with mild to moderate adverse events; and measures like slower injections and subdermal techniques minimized risks.
- In Latinx populations, there was a lack of robust study data on safety and efficacy of botulinum toxin, whereas hyaluronic acid and poly-L-lactic acid fillers were well tolerated.
IN PRACTICE:
“Neuromodulators and dermal fillers are useful and safe as cosmetic and antiaging treatments in SOC populations, with the greatest amount of data supporting its use in Asian populations,” although more data on Black and Latinx populations are needed, the authors concluded. “During cosmetic consultations, physicians should consider the impact of different cultural beauty norms on the aesthetic goals of diverse patient populations,” they added.
SOURCE:
This study led by Shanice McKenzie, MD, from the Department of Dermatology, University of Southern California, Los Angeles, California, was published online in the Journal of Cosmetic Dermatology.
LIMITATIONS:
Most of the recent data and formal consensus guidelines on injectables in the review came from Asian countries, and there was “a relative paucity of research on Black and Latinx populations,” the authors noted.
DISCLOSURES:
The study did not receive any funding. Two authors declared serving as a consultant, investigator, and/or speaker for various companies; the rest had no disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
, and more data on Black and Latinx populations are needed, according to a literature review.
METHODOLOGY:
- Understanding the efficacy and safety of cosmetic injectables in diverse skin types is important because individuals identifying as racial and ethnic minorities accounted for 18% of neuromodulator procedures and 22% of soft tissue augmentation procedures in 2020 in the United States.
- Researchers reviewed available literature on the usability and efficacy of neuromodulators and soft tissue augmentation in individuals with SOC because of the limited data available in these populations, particularly non-Asian, SOC populations.
- Overall, 88 studies in English were included, which were either dedicated to discussing safety and/or efficacy of injectables in SOC populations or enrolled more than 20% of participants from SOC populations.
- High-quality level I and II evidence was found in 50 studies, and 9940 patients were analyzed in this review.
TAKEAWAY:
- Studies considered high quality indicated that botulinum toxin is safe and effective for treating glabellar lines in Asians; tailored guidelines recommended specific strategies; and adverse events, such as eyelid issues, were more common in Asians.
- Hyaluronic acid fillers showed significant improvement in moderate to severe cases of nasolabial folds in Asians, and adverse effects like swelling and pain were mild to moderate — some cases of granuloma formation and vascular compromise have been reported.
- In Black individuals, botulinum toxin was well tolerated; hyaluronic acid fillers showed favorable safety, with mild to moderate adverse events; and measures like slower injections and subdermal techniques minimized risks.
- In Latinx populations, there was a lack of robust study data on safety and efficacy of botulinum toxin, whereas hyaluronic acid and poly-L-lactic acid fillers were well tolerated.
IN PRACTICE:
“Neuromodulators and dermal fillers are useful and safe as cosmetic and antiaging treatments in SOC populations, with the greatest amount of data supporting its use in Asian populations,” although more data on Black and Latinx populations are needed, the authors concluded. “During cosmetic consultations, physicians should consider the impact of different cultural beauty norms on the aesthetic goals of diverse patient populations,” they added.
SOURCE:
This study led by Shanice McKenzie, MD, from the Department of Dermatology, University of Southern California, Los Angeles, California, was published online in the Journal of Cosmetic Dermatology.
LIMITATIONS:
Most of the recent data and formal consensus guidelines on injectables in the review came from Asian countries, and there was “a relative paucity of research on Black and Latinx populations,” the authors noted.
DISCLOSURES:
The study did not receive any funding. Two authors declared serving as a consultant, investigator, and/or speaker for various companies; the rest had no disclosures to report.
A version of this article appeared on Medscape.com.
Too Little Sleep Raises Health Risks for Teens With T1D
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
Sugar Substitutes Satisfy Appetite, Blunt Insulin Response
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
TOPLINE:
but decrease post-meal insulin and glucose levels in adults with overweight or obesity.
METHODOLOGY:
- In 2023, the World Health Organization issued a conditional recommendation that S&SE should not be used for weight control, apparently due to a lack of evidence for a clear benefit and weak evidence linking S&SE intake with excess weight and poorer health outcomes.
- This randomized crossover trial, conducted in England and France between 2021 and 2022, evaluated the acute (1 day) and repeated (daily for 2 weeks) effects of S&SEs vs sucrose in solid food on appetite and endocrine responses in adults with overweight or obesity.
- Overall, 53 adults (33 women, 20 men; aged 18-60 years) with overweight or obesity consumed biscuits with fruit filling containing either sucrose or reformulated with the S&SEs StRebM or neotame, daily for three 2-week intervention periods separated by a washout period of 14-21 days.
- Participants were required to fast for 12 hours before attending a laboratory session at the beginning (day 1) and end (day 14) of each consumption period.
- The primary endpoint was the composite appetite score, while secondary endpoints included food preferences, postprandial glucose and insulin response, and other satiety-related peptides, such as ghrelin, glucagon-like peptide 1, and pancreatic polypeptide.
TAKEAWAY:
- The composite appetite scores were comparable between the sucrose, StRebM, and neotame groups, with lower appetite suppression observed on day 14 than on day 1 for all three formulations.
- Neotame (P < .001) and StRebM (P < .001) lowered postprandial insulin levels compared with sucrose, while glucose levels saw a decline only with StRebM (and not with neotame) compared with sucrose (P < .05).
- The S&SEs had no effect on satiety levels, as any acute or repeated exposures to StRebM or neotame vs sucrose did not affect the ghrelin and glucagon-like peptide-1 responses.
- Gastrointestinal issues were more frequently reported in the neotame and StRebM groups than in the sucrose group.
IN PRACTICE:
“There is no detrimental impact of replacing sugar with S&SE in these endpoints,” the authors wrote. “Additionally, glucose and insulin responses were blunted after acute and repeated consumption of S&SE-reformulated biscuits, which may confer a benefit for blood glucose control, for example, in individuals at risk of developing type 2 diabetes.”
SOURCE:
This study was led by Catherine Gibbons, School of Psychology, Faculty of Medicine and Health, University of Leeds, England. It was published online in eBioMedicine.
LIMITATIONS:
The reformulated products required the addition of polyol bulking agents (8% maltitol and 8% sorbitol) to match the biscuits in sensory qualities as closely as possible. Gastrointestinal symptoms (initial bloating and flatulence) in the neotame and StRebM formulations may be due to the polyols, classed as low-digestible carbohydrates.
DISCLOSURES:
This study received funding from a European Union Horizon 2020 program, SWEET (Sweeteners and sweetness enhancers: Impact on health, obesity, safety, and sustainability). The authors reported receiving funding and honoraria from the food and beverage industry and trade groups from various entities.
A version of this article appeared on Medscape.com.
Endoscopic Sleeve Gastroplasty More Cost-Effective Long Term Than Semaglutide for Treating Obesity
TOPLINE:
Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.
METHODOLOGY:
- Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
- A 45-year-old patient with a BMI of 37 was included as the base case in this study.
- The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
- The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
- Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
TAKEAWAY:
- ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
- The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
- The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.
IN PRACTICE:
“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.
SOURCE:
Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.
LIMITATIONS:
The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.
DISCLOSURES:
This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.
A version of this article appeared on Medscape.com.
TOPLINE:
Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.
METHODOLOGY:
- Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
- A 45-year-old patient with a BMI of 37 was included as the base case in this study.
- The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
- The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
- Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
TAKEAWAY:
- ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
- The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
- The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.
IN PRACTICE:
“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.
SOURCE:
Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.
LIMITATIONS:
The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.
DISCLOSURES:
This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.
A version of this article appeared on Medscape.com.
TOPLINE:
Endoscopic sleeve gastroplasty (ESG) is more cost-effective, and achieves and sustains greater weight loss, than semaglutide over a 5-year period in patients with class II obesity.
METHODOLOGY:
- Researchers used a Markov cohort model to assess the cost-effectiveness of semaglutide vs ESG over 5 years in people with class II obesity (body mass index [BMI], 35-39.9), with the model costs based on the US healthcare system.
- A 45-year-old patient with a BMI of 37 was included as the base case in this study.
- The model simulated hypothetical patients with class II obesity who received ESG, semaglutide, or no treatment (reference group with zero treatment costs).
- The model derived clinical data for the first year from two randomized clinical trials, STEP 1 (semaglutide) and MERIT (ESG); for the following years, data were derived from published studies and publicly available data sources.
- Study outcomes were total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
TAKEAWAY:
- ESG led to better weight loss outcomes (BMI, 31.7 vs 33.0) and added 0.06 more QALYs relative to semaglutide in the modelled patients over the 5-year time horizon; about 20% of the patients receiving semaglutide dropped out owing to medication intolerance or other reasons.
- The semaglutide treatment was $33,583 more expensive than the ESG treatment over the 5-year period.
- The annual price of semaglutide would need to be reduced from $13,618 to $3591 to achieve nondominance compared with ESG.
IN PRACTICE:
“The strategic choice of cost saving yet effective treatment such as ESG compared with semaglutide for specific patient groups could help alleviate the potential budget strain expected from the use of semaglutide,” the authors wrote.
SOURCE:
Muhammad Haseeb, MD, MSc, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, led this study, which was published online on April 12, 2024, in JAMA Network Open.
LIMITATIONS:
The study did not look at benefits associated with improvements in comorbidities from either treatment strategy, and the model used did not account for any microlevel follow-up costs such as routine clinic visits. The authors acknowledged that semaglutide’s prices may fall in the future when more anti-obesity drugs get approved.
DISCLOSURES:
This study was supported in part by the National Institutes of Health. Some authors declared receiving personal fees, royalty payments, and/or grants and having other ties with several sources.
A version of this article appeared on Medscape.com.
Parotid and Labial Gland Biopsies Provide Similar Help in Diagnosing Sjögren Syndrome
TOPLINE:
Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.
METHODOLOGY:
- While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
- In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
- Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
- FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
- On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.
TAKEAWAY:
- The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
- However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
- In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm2, and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.
IN PRACTICE:
“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.
SOURCE:
This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).
LIMITATIONS:
This study did not discuss any limitations.
DISCLOSURES:
This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.
A version of this article appeared on Medscape.com.
TOPLINE:
Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.
METHODOLOGY:
- While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
- In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
- Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
- FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
- On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.
TAKEAWAY:
- The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
- However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
- In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm2, and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.
IN PRACTICE:
“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.
SOURCE:
This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).
LIMITATIONS:
This study did not discuss any limitations.
DISCLOSURES:
This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.
A version of this article appeared on Medscape.com.
TOPLINE:
Both labial and parotid salivary glands can be used for the diagnosis of Sjögren syndrome (SjS), as their biopsies show largely similar histopathologic features in patients with sicca complaints suspected of having SjS.
METHODOLOGY:
- While a labial gland biopsy is the conventional method for diagnosing SjS, a biopsy of the parotid gland is preferable, as it allows for repeat measurements and increases the possibility of finding a mucosa-associated lymphoid tissue lymphoma.
- In this prospective study, researchers compared the focus score (FS) and other histopathologic features of SjS between paired labial and parotid salivary gland biopsies in a diagnostic cohort of patients with sicca suspected of having SjS.
- Labial and parotid gland biopsies were simultaneously obtained under local infiltration anesthesia in 99 patients with oral and/or ocular sicca complaints at the University Medical Center Groningen, Groningen, the Netherlands, between 2014 and 2017.
- FS is defined as the number of foci per 4 mm2 of salivary gland tissue. An FS ≥ 1 indicates a positive diagnosis of SjS.
- On the basis of an expert opinion of three experienced rheumatologists, 36 patients were diagnosed with SjS, and 63 were diagnosed with non-SjS sicca.
TAKEAWAY:
- The absolute agreement of various histopathologic features was high between labial and parotid biopsies, with values being 80% for FS, 89% for germinal centers, 84% for the immunoglobulin (Ig) A/IgG plasma cell shift, and 93% for pre-lymphoepithelial lesions.
- However, an FS ≥ 1 was more frequently seen in labial glands than in parotid glands (P = .012) in both the SjS and non-SjS sicca populations, indicating that labial gland biopsies show more inflammation irrespective of the presence of SjS.
- In patients with SjS, the absolute B-lymphocyte count, the number of germinal centers per mm2, and the severity of pre-lymphoepithelial lesions were higher in parotid glands than in labial glands, revealing evident histopathologic signs of B-lymphocyte hyperactivity.
IN PRACTICE:
“The results of this study offer novel insights into the pathophysiology of pSS [primary Sjögren syndrome] and can be incorporated into guidelines for the histopathological analysis of salivary gland biopsies,” the authors wrote.
SOURCE:
This study, led by Uzma Nakshbandi, MD, Department of Reumatology & Clinical Immunology, University Medical Center Groningen, Groningen, the Netherlands, was published online in Rheumatology (Oxford).
LIMITATIONS:
This study did not discuss any limitations.
DISCLOSURES:
This study was funded by the National Institutes of Health. One of the authors disclosed serving as a consultant and scientific advisory board member for several pharmaceutical companies, as well as receiving speaker’s fees from some of them.
A version of this article appeared on Medscape.com.
Bone Infections Increase After S. aureus Bacteremia in Patients With Rheumatoid Arthritis
TOPLINE:
After Staphylococcus aureus bacteremia, patients with rheumatoid arthritis (RA) face nearly double the risk for osteoarticular infections compared with those without RA, with similar mortality risks in both groups.
METHODOLOGY:
- The contraction of S aureus bacteremia is linked to poor clinical outcomes in patients with RA; however, no well-sized studies have evaluated the risk for osteoarticular infections and mortality outcomes in patients with RA following S aureus bacteremia.
- This Danish nationwide cohort study aimed to explore whether the cumulative incidence of osteoarticular infections and death would be higher in patients with RA than in those without RA after contracting S aureus bacteremia.
- The study cohort included 18,274 patients with a first episode of S aureus bacteremia between 2006 and 2018, of whom 367 had been diagnosed with RA before contracting S aureus bacteremia.
- The RA cohort had more women (62%) and a higher median age of participants (73 years) than the non-RA cohort (37% women; median age of participants, 70 years).
TAKEAWAY:
- The 90-day cumulative incidence of osteoarticular infections (septic arthritis, spondylitis, osteomyelitis, psoas muscle abscess, or prosthetic joint infection) was nearly double in patients with RA compared with in those without RA (23.1% vs 12.5%; hazard ratio [HR], 1.93; 95% CI, 1.54-2.41).
- In patients with RA, the risk for osteoarticular infections increased with tumor necrosis factor inhibitor use (HR, 2.27; 95% CI, 1.29-3.98) and orthopedic implants (HR, 1.75; 95% CI, 1.08-2.85).
- Moreover, 90-day all-cause mortality was comparable in the RA (35.4%) and non-RA cohorts (33.9%).
IN PRACTICE:
“Our findings stress the need for vigilance in patients with RA who present with S aureus bacteremia to ensure timely identification and treatment of osteoarticular infections, especially in current TNFi [tumor necrosis factor inhibitor] users and patients with orthopedic implants,” the authors wrote.
SOURCE:
This study, led by Sabine S. Dieperink, MD, of the Centre of Head and Orthopaedics, Copenhagen University Rigshospitalet Glostrup, Denmark, was published online March 9 in Rheumatology (Oxford).
LIMITATIONS:
There might have been chances of misclassification of metastatic S aureus infections owing to the lack of specificity in diagnoses or procedure codes. This study relied on administrative data to record osteoarticular infections, which might have led investigators to underestimate the true cumulative incidence of osteoarticular infections. Also, some patients might have passed away before being diagnosed with osteoarticular infection owing to the high mortality.
DISCLOSURES:
This work was supported by grants from The Danish Rheumatism Association and Beckett Fonden. Some of the authors, including the lead author, declared receiving grants from various funding agencies and other sources, including pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
After Staphylococcus aureus bacteremia, patients with rheumatoid arthritis (RA) face nearly double the risk for osteoarticular infections compared with those without RA, with similar mortality risks in both groups.
METHODOLOGY:
- The contraction of S aureus bacteremia is linked to poor clinical outcomes in patients with RA; however, no well-sized studies have evaluated the risk for osteoarticular infections and mortality outcomes in patients with RA following S aureus bacteremia.
- This Danish nationwide cohort study aimed to explore whether the cumulative incidence of osteoarticular infections and death would be higher in patients with RA than in those without RA after contracting S aureus bacteremia.
- The study cohort included 18,274 patients with a first episode of S aureus bacteremia between 2006 and 2018, of whom 367 had been diagnosed with RA before contracting S aureus bacteremia.
- The RA cohort had more women (62%) and a higher median age of participants (73 years) than the non-RA cohort (37% women; median age of participants, 70 years).
TAKEAWAY:
- The 90-day cumulative incidence of osteoarticular infections (septic arthritis, spondylitis, osteomyelitis, psoas muscle abscess, or prosthetic joint infection) was nearly double in patients with RA compared with in those without RA (23.1% vs 12.5%; hazard ratio [HR], 1.93; 95% CI, 1.54-2.41).
- In patients with RA, the risk for osteoarticular infections increased with tumor necrosis factor inhibitor use (HR, 2.27; 95% CI, 1.29-3.98) and orthopedic implants (HR, 1.75; 95% CI, 1.08-2.85).
- Moreover, 90-day all-cause mortality was comparable in the RA (35.4%) and non-RA cohorts (33.9%).
IN PRACTICE:
“Our findings stress the need for vigilance in patients with RA who present with S aureus bacteremia to ensure timely identification and treatment of osteoarticular infections, especially in current TNFi [tumor necrosis factor inhibitor] users and patients with orthopedic implants,” the authors wrote.
SOURCE:
This study, led by Sabine S. Dieperink, MD, of the Centre of Head and Orthopaedics, Copenhagen University Rigshospitalet Glostrup, Denmark, was published online March 9 in Rheumatology (Oxford).
LIMITATIONS:
There might have been chances of misclassification of metastatic S aureus infections owing to the lack of specificity in diagnoses or procedure codes. This study relied on administrative data to record osteoarticular infections, which might have led investigators to underestimate the true cumulative incidence of osteoarticular infections. Also, some patients might have passed away before being diagnosed with osteoarticular infection owing to the high mortality.
DISCLOSURES:
This work was supported by grants from The Danish Rheumatism Association and Beckett Fonden. Some of the authors, including the lead author, declared receiving grants from various funding agencies and other sources, including pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
After Staphylococcus aureus bacteremia, patients with rheumatoid arthritis (RA) face nearly double the risk for osteoarticular infections compared with those without RA, with similar mortality risks in both groups.
METHODOLOGY:
- The contraction of S aureus bacteremia is linked to poor clinical outcomes in patients with RA; however, no well-sized studies have evaluated the risk for osteoarticular infections and mortality outcomes in patients with RA following S aureus bacteremia.
- This Danish nationwide cohort study aimed to explore whether the cumulative incidence of osteoarticular infections and death would be higher in patients with RA than in those without RA after contracting S aureus bacteremia.
- The study cohort included 18,274 patients with a first episode of S aureus bacteremia between 2006 and 2018, of whom 367 had been diagnosed with RA before contracting S aureus bacteremia.
- The RA cohort had more women (62%) and a higher median age of participants (73 years) than the non-RA cohort (37% women; median age of participants, 70 years).
TAKEAWAY:
- The 90-day cumulative incidence of osteoarticular infections (septic arthritis, spondylitis, osteomyelitis, psoas muscle abscess, or prosthetic joint infection) was nearly double in patients with RA compared with in those without RA (23.1% vs 12.5%; hazard ratio [HR], 1.93; 95% CI, 1.54-2.41).
- In patients with RA, the risk for osteoarticular infections increased with tumor necrosis factor inhibitor use (HR, 2.27; 95% CI, 1.29-3.98) and orthopedic implants (HR, 1.75; 95% CI, 1.08-2.85).
- Moreover, 90-day all-cause mortality was comparable in the RA (35.4%) and non-RA cohorts (33.9%).
IN PRACTICE:
“Our findings stress the need for vigilance in patients with RA who present with S aureus bacteremia to ensure timely identification and treatment of osteoarticular infections, especially in current TNFi [tumor necrosis factor inhibitor] users and patients with orthopedic implants,” the authors wrote.
SOURCE:
This study, led by Sabine S. Dieperink, MD, of the Centre of Head and Orthopaedics, Copenhagen University Rigshospitalet Glostrup, Denmark, was published online March 9 in Rheumatology (Oxford).
LIMITATIONS:
There might have been chances of misclassification of metastatic S aureus infections owing to the lack of specificity in diagnoses or procedure codes. This study relied on administrative data to record osteoarticular infections, which might have led investigators to underestimate the true cumulative incidence of osteoarticular infections. Also, some patients might have passed away before being diagnosed with osteoarticular infection owing to the high mortality.
DISCLOSURES:
This work was supported by grants from The Danish Rheumatism Association and Beckett Fonden. Some of the authors, including the lead author, declared receiving grants from various funding agencies and other sources, including pharmaceutical companies.
A version of this article appeared on Medscape.com.
Study Highlights Some Semaglutide-Associated Skin Effects
TOPLINE:
.
METHODOLOGY:
- The Food and Drug Administration’s has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
- In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.
TAKEAWAY:
- Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
- Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
- Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
- On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.
IN PRACTICE:
“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.
SOURCE:
Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.
DISCLOSURES:
This study did not report any funding sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- The Food and Drug Administration’s has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
- In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.
TAKEAWAY:
- Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
- Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
- Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
- On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.
IN PRACTICE:
“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.
SOURCE:
Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.
DISCLOSURES:
This study did not report any funding sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- The Food and Drug Administration’s has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with oral or subcutaneous semaglutide, a glucagon-like peptide 1 agonist used to treat obesity and type 2 diabetes.
- In this scoping review, researchers included 22 articles (15 clinical trials, six case reports, and one retrospective cohort study), published through January 2024, of patients receiving either semaglutide or a placebo or comparator, which included reports of semaglutide-associated adverse dermatologic events in 255 participants.
TAKEAWAY:
- Patients who received 50 mg oral semaglutide weekly reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% vs 0%), hyperesthesia (1.2% vs 0%), skin pain (2.4% vs 0%), paresthesia (2.7% vs 0%), and sensitive skin (2.7% vs 0%), than those receiving placebo or comparator.
- Reports of alopecia (6.9% vs 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, but only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia vs 0.5% of those on placebo.
- Unspecified dermatologic reactions (4.1% vs 1.5%) were reported in more patients on subcutaneous semaglutide than those on a placebo or comparator. Several case reports described isolated cases of severe skin-related adverse effects, such as bullous pemphigoid, eosinophilic fasciitis, and leukocytoclastic vasculitis.
- On the contrary, injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide compared with in those on a placebo or comparator.
IN PRACTICE:
“Variations in dosage and administration routes could influence the types and severity of skin findings, underscoring the need for additional research,” the authors wrote.
SOURCE:
Megan M. Tran, BS, from the Warren Alpert Medical School, Brown University, Providence, Rhode Island, led this study, which was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
This study could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.
DISCLOSURES:
This study did not report any funding sources. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
Tirzepatide Offers Better Glucose Control, Regardless of Baseline Levels
TOPLINE:
Tirzepatide vs basal insulins led to greater improvements in A1c and postprandial glucose (PPG) levels in patients with type 2 diabetes (T2D), regardless of different baseline PPG or fasting serum glucose (FSG) levels.
METHODOLOGY:
- Tirzepatide led to better glycemic control than insulin degludec and insulin glargine in the SURPASS-3 and SURPASS-4 trials, respectively, but the effect on FSG and PPG levels was not evaluated.
- In this post hoc analysis, the researchers assessed changes in various glycemic parameters in 3314 patients with T2D who were randomly assigned to receive tirzepatide (5, 10, or 15 mg), insulin degludec, or insulin glargine.
- Based on the median baseline glucose values, the patients were stratified into four subgroups: Low FSG/low PPG, low FSG/high PPG, high FSG/low PPG, and high FSG/high PPG.
- The outcomes of interest were changes in FSG, PPG, A1c, and body weight from baseline to week 52.
TAKEAWAY:
- Tirzepatide and basal insulins effectively lowered A1c, PPG levels, and FSG levels at 52 weeks across all patient subgroups (all P < .05).
- All three doses of tirzepatide resulted in greater reductions in both A1c and PPG levels than in basal insulins (all P < .05).
- In the high FSG/high PPG subgroup, a greater reduction in FSG levels was observed with tirzepatide 10- and 15-mg doses vs insulin glargine (both P < .05) and insulin degludec vs tirzepatide 5 mg (P < .001).
- Furthermore, at week 52, tirzepatide led to body weight reduction (P < .05), but insulin treatment led to an increase in body weight (P < .05) in all subgroups.
IN PRACTICE:
“Treatment with tirzepatide was consistently associated with more reduced PPG levels compared with insulin treatment across subgroups, including in participants with lower baseline PPG levels, in turn leading to greater A1c reductions,” the authors wrote.
SOURCE:
This study was led by Francesco Giorgino, MD, PhD, of the Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy, and was published online in Diabetes Care.
LIMITATIONS:
The limitations include post hoc nature of the study and the short treatment duration. The trials included only patients with diabetes and overweight or obesity, and therefore, the study findings may not be generalizable to other populations.
DISCLOSURES:
This study and the SURPASS trials were funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company. The other authors declared having several ties with various sources, including Eli Lilly and Company.
A version of this article appeared on Medscape.com.
TOPLINE:
Tirzepatide vs basal insulins led to greater improvements in A1c and postprandial glucose (PPG) levels in patients with type 2 diabetes (T2D), regardless of different baseline PPG or fasting serum glucose (FSG) levels.
METHODOLOGY:
- Tirzepatide led to better glycemic control than insulin degludec and insulin glargine in the SURPASS-3 and SURPASS-4 trials, respectively, but the effect on FSG and PPG levels was not evaluated.
- In this post hoc analysis, the researchers assessed changes in various glycemic parameters in 3314 patients with T2D who were randomly assigned to receive tirzepatide (5, 10, or 15 mg), insulin degludec, or insulin glargine.
- Based on the median baseline glucose values, the patients were stratified into four subgroups: Low FSG/low PPG, low FSG/high PPG, high FSG/low PPG, and high FSG/high PPG.
- The outcomes of interest were changes in FSG, PPG, A1c, and body weight from baseline to week 52.
TAKEAWAY:
- Tirzepatide and basal insulins effectively lowered A1c, PPG levels, and FSG levels at 52 weeks across all patient subgroups (all P < .05).
- All three doses of tirzepatide resulted in greater reductions in both A1c and PPG levels than in basal insulins (all P < .05).
- In the high FSG/high PPG subgroup, a greater reduction in FSG levels was observed with tirzepatide 10- and 15-mg doses vs insulin glargine (both P < .05) and insulin degludec vs tirzepatide 5 mg (P < .001).
- Furthermore, at week 52, tirzepatide led to body weight reduction (P < .05), but insulin treatment led to an increase in body weight (P < .05) in all subgroups.
IN PRACTICE:
“Treatment with tirzepatide was consistently associated with more reduced PPG levels compared with insulin treatment across subgroups, including in participants with lower baseline PPG levels, in turn leading to greater A1c reductions,” the authors wrote.
SOURCE:
This study was led by Francesco Giorgino, MD, PhD, of the Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy, and was published online in Diabetes Care.
LIMITATIONS:
The limitations include post hoc nature of the study and the short treatment duration. The trials included only patients with diabetes and overweight or obesity, and therefore, the study findings may not be generalizable to other populations.
DISCLOSURES:
This study and the SURPASS trials were funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company. The other authors declared having several ties with various sources, including Eli Lilly and Company.
A version of this article appeared on Medscape.com.
TOPLINE:
Tirzepatide vs basal insulins led to greater improvements in A1c and postprandial glucose (PPG) levels in patients with type 2 diabetes (T2D), regardless of different baseline PPG or fasting serum glucose (FSG) levels.
METHODOLOGY:
- Tirzepatide led to better glycemic control than insulin degludec and insulin glargine in the SURPASS-3 and SURPASS-4 trials, respectively, but the effect on FSG and PPG levels was not evaluated.
- In this post hoc analysis, the researchers assessed changes in various glycemic parameters in 3314 patients with T2D who were randomly assigned to receive tirzepatide (5, 10, or 15 mg), insulin degludec, or insulin glargine.
- Based on the median baseline glucose values, the patients were stratified into four subgroups: Low FSG/low PPG, low FSG/high PPG, high FSG/low PPG, and high FSG/high PPG.
- The outcomes of interest were changes in FSG, PPG, A1c, and body weight from baseline to week 52.
TAKEAWAY:
- Tirzepatide and basal insulins effectively lowered A1c, PPG levels, and FSG levels at 52 weeks across all patient subgroups (all P < .05).
- All three doses of tirzepatide resulted in greater reductions in both A1c and PPG levels than in basal insulins (all P < .05).
- In the high FSG/high PPG subgroup, a greater reduction in FSG levels was observed with tirzepatide 10- and 15-mg doses vs insulin glargine (both P < .05) and insulin degludec vs tirzepatide 5 mg (P < .001).
- Furthermore, at week 52, tirzepatide led to body weight reduction (P < .05), but insulin treatment led to an increase in body weight (P < .05) in all subgroups.
IN PRACTICE:
“Treatment with tirzepatide was consistently associated with more reduced PPG levels compared with insulin treatment across subgroups, including in participants with lower baseline PPG levels, in turn leading to greater A1c reductions,” the authors wrote.
SOURCE:
This study was led by Francesco Giorgino, MD, PhD, of the Section of Internal Medicine, Endocrinology, Andrology, and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy, and was published online in Diabetes Care.
LIMITATIONS:
The limitations include post hoc nature of the study and the short treatment duration. The trials included only patients with diabetes and overweight or obesity, and therefore, the study findings may not be generalizable to other populations.
DISCLOSURES:
This study and the SURPASS trials were funded by Eli Lilly and Company. Four authors declared being employees and shareholders of Eli Lilly and Company. The other authors declared having several ties with various sources, including Eli Lilly and Company.
A version of this article appeared on Medscape.com.
The ED Sailed Smoothly in the Early COVID-19 Days
TOPLINE:
There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.
METHODOLOGY:
- This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
- The possibility of infected ED personnel reporting to work
- The burden of COVID-19 symptoms on an ED personnel’s work status
- The association between SARS-CoV-2 infection levels and ED staffing
- Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
- The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
- Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.
TAKEAWAY:
- Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
- Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
- The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
- During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.
IN PRACTICE:
“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.
SOURCE:
This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.
LIMITATIONS:
Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.
DISCLOSURES:
This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.
METHODOLOGY:
- This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
- The possibility of infected ED personnel reporting to work
- The burden of COVID-19 symptoms on an ED personnel’s work status
- The association between SARS-CoV-2 infection levels and ED staffing
- Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
- The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
- Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.
TAKEAWAY:
- Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
- Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
- The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
- During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.
IN PRACTICE:
“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.
SOURCE:
This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.
LIMITATIONS:
Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.
DISCLOSURES:
This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.
METHODOLOGY:
- This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
- The possibility of infected ED personnel reporting to work
- The burden of COVID-19 symptoms on an ED personnel’s work status
- The association between SARS-CoV-2 infection levels and ED staffing
- Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
- The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
- Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.
TAKEAWAY:
- Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
- Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
- The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
- During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.
IN PRACTICE:
“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.
SOURCE:
This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.
LIMITATIONS:
Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.
DISCLOSURES:
This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.
A version of this article appeared on Medscape.com.
A Prescription Checklist for Older Adults in ED
TOPLINE:
The geriatric emergency medication safety recommendations (GEMS-Rx) is the first expert consensus-based list identifying high-risk medication classes that should not be prescribed to older patients visiting the emergency department (ED).
METHODOLOGY:
- The American Geriatrics Society (AGS) has already established guidelines to identify potentially inappropriate medications in older adults; however, the criteria are centered on chronic conditions and long-term medication use and are unsuitable for managing ED prescriptions.
- In this study, the GEMS-Rx high-risk prescription list was prepared with a panel of 10 ED physicians with expertise in geriatrics and quality measurement and a pharmacist with expertise in geriatric pharmacotherapy and emergency medicine.
- They reviewed over 30 medication classes from the 2019 AGS Beers Criteria that were deemed inappropriate for use in older patients. Despite their not being included in the Beers list, the use of short- and long-acting opioids was also discussed.
- After three rounds of review and discussion, the panelists ranked each class of medication on a 5-point Likert scale, with a score of 1 indicating the lowest and 5 indicating the greatest need for avoiding a drug in an ED prescription.
TAKEAWAY:
- The first round suggested that first-generation antihistamines, metoclopramide, short-acting opioids, antipsychotics, barbiturates, skeletal muscle relaxants, and benzodiazepines should be avoided, with mean Likert scores ranging from 3.7 to 4.6.
- Although nonbenzodiazepine and benzodiazepine receptor agonist hypnotics (“Z-drugs”) were not initially considered owing to their low frequency of prescription in ED settings, the panelists finally included “Z” drugs and sulfonylureas in the GEMS-Rx list after the second and third rounds.
- The final list of high-risk medications to be avoided in ED settings that were prioritized included benzodiazepines, skeletal muscle relaxants, barbiturates, first-generation antipsychotics, first-generation antihistamines, “Z” drugs, metoclopramide, and sulfonylureas.
- However, seizure disorders, benzodiazepine withdrawal, ethanol withdrawal, severe generalized anxiety disorder, end-of-life care, allergic reactions, and ED visits for prescription refilling were deemed exceptional cases in which these high-risk medications could be prescribed.
IN PRACTICE:
“By combining expert consensus and evidence-based criteria, this list can serve as a resource to guide prescribing decisions and mitigate potential risks associated with medications at this crucial care transition. The incorporation of this emergency medicine-specific geriatric prescription list in a national quality measure has the potential to improve patient safety and enhance the quality of care for the millions of older adults who seek care in EDs each year,” the authors said.
SOURCE:
This study was led by Rachel M. Skains, MD, MSPH, Department of Emergency Medicine, University of Alabama at Birmingham, and published online in Annals of Emergency Medicine.
LIMITATIONS:
The GEMS-Rx list was prepared by physicians and pharmacists and may not have fully captured data regarding individual patient preferences, comorbidities, or other contextual factors. During the meetings, the panelists’ identities were not concealed from one another, which may have affected the conversations owing to response and social desirability bias. Furthermore, this list may not be generalizable to other settings because it was produced and intended for usage in US EDs.
DISCLOSURES:
This work was supported by the American College of Emergency Physicians. Some of the authors, including the lead author, declared being supported by various funding agencies. Few authors also declared serving in leadership positions for several sources.
A version of this article appeared on Medscape.com.
TOPLINE:
The geriatric emergency medication safety recommendations (GEMS-Rx) is the first expert consensus-based list identifying high-risk medication classes that should not be prescribed to older patients visiting the emergency department (ED).
METHODOLOGY:
- The American Geriatrics Society (AGS) has already established guidelines to identify potentially inappropriate medications in older adults; however, the criteria are centered on chronic conditions and long-term medication use and are unsuitable for managing ED prescriptions.
- In this study, the GEMS-Rx high-risk prescription list was prepared with a panel of 10 ED physicians with expertise in geriatrics and quality measurement and a pharmacist with expertise in geriatric pharmacotherapy and emergency medicine.
- They reviewed over 30 medication classes from the 2019 AGS Beers Criteria that were deemed inappropriate for use in older patients. Despite their not being included in the Beers list, the use of short- and long-acting opioids was also discussed.
- After three rounds of review and discussion, the panelists ranked each class of medication on a 5-point Likert scale, with a score of 1 indicating the lowest and 5 indicating the greatest need for avoiding a drug in an ED prescription.
TAKEAWAY:
- The first round suggested that first-generation antihistamines, metoclopramide, short-acting opioids, antipsychotics, barbiturates, skeletal muscle relaxants, and benzodiazepines should be avoided, with mean Likert scores ranging from 3.7 to 4.6.
- Although nonbenzodiazepine and benzodiazepine receptor agonist hypnotics (“Z-drugs”) were not initially considered owing to their low frequency of prescription in ED settings, the panelists finally included “Z” drugs and sulfonylureas in the GEMS-Rx list after the second and third rounds.
- The final list of high-risk medications to be avoided in ED settings that were prioritized included benzodiazepines, skeletal muscle relaxants, barbiturates, first-generation antipsychotics, first-generation antihistamines, “Z” drugs, metoclopramide, and sulfonylureas.
- However, seizure disorders, benzodiazepine withdrawal, ethanol withdrawal, severe generalized anxiety disorder, end-of-life care, allergic reactions, and ED visits for prescription refilling were deemed exceptional cases in which these high-risk medications could be prescribed.
IN PRACTICE:
“By combining expert consensus and evidence-based criteria, this list can serve as a resource to guide prescribing decisions and mitigate potential risks associated with medications at this crucial care transition. The incorporation of this emergency medicine-specific geriatric prescription list in a national quality measure has the potential to improve patient safety and enhance the quality of care for the millions of older adults who seek care in EDs each year,” the authors said.
SOURCE:
This study was led by Rachel M. Skains, MD, MSPH, Department of Emergency Medicine, University of Alabama at Birmingham, and published online in Annals of Emergency Medicine.
LIMITATIONS:
The GEMS-Rx list was prepared by physicians and pharmacists and may not have fully captured data regarding individual patient preferences, comorbidities, or other contextual factors. During the meetings, the panelists’ identities were not concealed from one another, which may have affected the conversations owing to response and social desirability bias. Furthermore, this list may not be generalizable to other settings because it was produced and intended for usage in US EDs.
DISCLOSURES:
This work was supported by the American College of Emergency Physicians. Some of the authors, including the lead author, declared being supported by various funding agencies. Few authors also declared serving in leadership positions for several sources.
A version of this article appeared on Medscape.com.
TOPLINE:
The geriatric emergency medication safety recommendations (GEMS-Rx) is the first expert consensus-based list identifying high-risk medication classes that should not be prescribed to older patients visiting the emergency department (ED).
METHODOLOGY:
- The American Geriatrics Society (AGS) has already established guidelines to identify potentially inappropriate medications in older adults; however, the criteria are centered on chronic conditions and long-term medication use and are unsuitable for managing ED prescriptions.
- In this study, the GEMS-Rx high-risk prescription list was prepared with a panel of 10 ED physicians with expertise in geriatrics and quality measurement and a pharmacist with expertise in geriatric pharmacotherapy and emergency medicine.
- They reviewed over 30 medication classes from the 2019 AGS Beers Criteria that were deemed inappropriate for use in older patients. Despite their not being included in the Beers list, the use of short- and long-acting opioids was also discussed.
- After three rounds of review and discussion, the panelists ranked each class of medication on a 5-point Likert scale, with a score of 1 indicating the lowest and 5 indicating the greatest need for avoiding a drug in an ED prescription.
TAKEAWAY:
- The first round suggested that first-generation antihistamines, metoclopramide, short-acting opioids, antipsychotics, barbiturates, skeletal muscle relaxants, and benzodiazepines should be avoided, with mean Likert scores ranging from 3.7 to 4.6.
- Although nonbenzodiazepine and benzodiazepine receptor agonist hypnotics (“Z-drugs”) were not initially considered owing to their low frequency of prescription in ED settings, the panelists finally included “Z” drugs and sulfonylureas in the GEMS-Rx list after the second and third rounds.
- The final list of high-risk medications to be avoided in ED settings that were prioritized included benzodiazepines, skeletal muscle relaxants, barbiturates, first-generation antipsychotics, first-generation antihistamines, “Z” drugs, metoclopramide, and sulfonylureas.
- However, seizure disorders, benzodiazepine withdrawal, ethanol withdrawal, severe generalized anxiety disorder, end-of-life care, allergic reactions, and ED visits for prescription refilling were deemed exceptional cases in which these high-risk medications could be prescribed.
IN PRACTICE:
“By combining expert consensus and evidence-based criteria, this list can serve as a resource to guide prescribing decisions and mitigate potential risks associated with medications at this crucial care transition. The incorporation of this emergency medicine-specific geriatric prescription list in a national quality measure has the potential to improve patient safety and enhance the quality of care for the millions of older adults who seek care in EDs each year,” the authors said.
SOURCE:
This study was led by Rachel M. Skains, MD, MSPH, Department of Emergency Medicine, University of Alabama at Birmingham, and published online in Annals of Emergency Medicine.
LIMITATIONS:
The GEMS-Rx list was prepared by physicians and pharmacists and may not have fully captured data regarding individual patient preferences, comorbidities, or other contextual factors. During the meetings, the panelists’ identities were not concealed from one another, which may have affected the conversations owing to response and social desirability bias. Furthermore, this list may not be generalizable to other settings because it was produced and intended for usage in US EDs.
DISCLOSURES:
This work was supported by the American College of Emergency Physicians. Some of the authors, including the lead author, declared being supported by various funding agencies. Few authors also declared serving in leadership positions for several sources.
A version of this article appeared on Medscape.com.