Tirzepatide offers superior glycemic control compared with insulin, irrespective of baseline levels: Study

USA: The post hoc analyses of the SURPASS-3 and SURPASS-4 trials revealed superior glycemic control with tirzepatide compared with insulin in patients with type 2 diabetes (T2D), regardless of baseline glycemic pattern. The findings were published online in Diabetes Care on March 26, 2024

“Treatment with tirzepatide was consistently associated with more reduced postprandial glucose (PPG) levels compared with insulin treatment across subgroups, including in participants with lower baseline PPG levels, leading to greater A1c reductions,” the authors wrote.

Fasting serum glucose (FSG) and postprandial glucose levels contribute to glucose control and should be considered in type 2 diabetes management. Although basal insulins act on FSG, the effects on PPG are limited. Dulaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), showed greater effectiveness than insulin glargine on HbA1c, largely irrespective of baseline FSG and PPG levels. Although insulin dose titration was not optimal; consistent effects on PPG and FSG across baseline FSG and PPG subgroups were not observed. 

In the SURPASS-3 and SURPASS-4 trials, tirzepatide, a glucose-dependent insulinotropic polypeptide/GLP-1 RA, led to better glycemic control than insulin degludec and insulin glargine, respectively. However, the effect on FSG and postprandial glucose levels was not evaluated. Therefore, Russell J. Wiese, Eli Lilly, and Company, Indianapolis, IN, and colleagues assessed change in glycemic parameters from baseline to week 52 for tirzepatide (5, 10, 15 mg) versus insulin degludec (SURPASS-3 trial) and glargine (SURPASS-4 trial) in patients with type 2 diabetes and different baseline glycemic patterns, based on FSG and PPG values.

The patients were stratified into four groups based on the median baseline glucose values: Low FSG/low PPG, low FSG/high PPG, high FSG/low PPG, and high FSG/high PPG.

The outcomes of interest were changes in PPG, FSG, A1c, and body weight from baseline to week 52.

The study led to the following findings:

  • Tirzepatide and basal insulins effectively lowered A1c, PPG levels, and FSG levels at 52 weeks across all patient subgroups.
  • All three doses of tirzepatide resulted in greater reductions in both A1c and PPG levels than in basal insulins.
  • 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 and insulin degludec vs tirzepatide 5 mg.
  • At week 52, tirzepatide led to body weight reduction, however, insulin treatment increased body weight in all subgroups.

In conclusion, tirzepatide versus basal insulins improved A1c and postprandial glucose levels in patients with type 2 diabetes, irrespective of different baseline PPG or FSG levels.

The limitations included the study’s post hoc nature and the short treatment duration. The trials included only patients with diabetes and obesity or overweight. Therefore, the study findings may not be generalizable to other populations.

Reference:

Francesco Giorgino, Denise R. Franco, Claudia Nicolay, Andrea Hemmingway, Ángel Rodríguez, Russell J. Wiese; Effects of Tirzepatide Versus Basal Insulins in People With Type 2 Diabetes and Different Baseline Glycemic Patterns: Post Hoc Analyses of the SURPASS-3 and SURPASS-4 Trials. Diabetes Care 2024; dc232366. https://doi.org/10.2337/dc23-2366

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Dietary Fiber Intake Modulates Gut Microbiota and Metabolites to Reduce Type 2 Diabetes Risk: Study

Dietary fiber intake has long been associated with a reduced risk of type 2 diabetes (T2D), yet the underlying mechanisms remain unclear. A recent study conducted among Hispanic/Latino participants aimed to elucidate the relationship between dietary fiber intake, gut microbiota, circulating metabolites, and T2D risk. This study was published in the journal Circulation Research. The study was conducted by Zheng Wang and colleagues.

Type 2 diabetes poses a significant public health challenge globally, with dietary factors playing a crucial role in its prevention and management. The study sought to explore how dietary fiber influences gut microbiota composition, circulating metabolites, and ultimately, the risk of developing T2D.

The study included 11,394 participants from the Hispanic Community Health Study/Study of Latinos. Dietary intake was assessed using two 24-hour dietary recalls, while gut microbiome and serum metabolome were analyzed using advanced techniques. Associations between dietary fiber intake, gut microbiota composition, circulating metabolites, and incident T2D over six years were examined.

The key findings of the study were as follows:

Gut Microbiota Associations:

• Multiple bacterial genera, species, and enzymes associated with dietary fiber intake were identified.

• Bacteria such as Butyrivibrio and Faecalibacterium, along with fiber-degrading enzymes, were positively associated with fiber intake and inversely associated with prevalent T2D.

Circulating Metabolites:

• 159 metabolites were associated with fiber intake, with 47 linked to incident T2D.

• Microbial metabolites like indolepropionate and 3-phenylpropionate were inversely associated with T2D risk.

Interplay Between Microbiota and Metabolites:

• 18 of the identified metabolites were associated with fiber-related bacteria, indicating a complex interplay between gut microbiota and circulating metabolites.

• Butyrivibrio and Faecalibacterium were associated with these favorable metabolites, suggesting their potential role in T2D prevention.

The study highlights the beneficial effects of dietary fiber on gut microbiota composition and circulating metabolites, ultimately influencing T2D risk among Hispanic/Latino populations. These findings underscore the importance of dietary fiber in promoting metabolic health and preventing T2D.

Understanding the intricate relationship between dietary fiber, gut microbiota, and circulating metabolites provides valuable insights for personalized dietary interventions aimed at reducing the risk of T2D. Healthcare professionals can utilize this knowledge to develop targeted dietary strategies tailored to individual needs, ultimately improving diabetes prevention and management outcomes.

Reference:

Wang, Z., Peters, B. A., Yu, B., Grove, M. L., Wang, T., Xue, X., Thyagarajan, B., Daviglus, M. L., Boerwinkle, E., Hu, G., Mossavar-Rahmani, Y., Isasi, C. R., Knight, R., Burk, R. D., Kaplan, R. C., & Qi, Q. (2024). Gut Microbiota and blood metabolites related to fiber intake and type 2 diabetes. Circulation Research, 134(7), 842–854.https://doi.org/10.1161/circresaha.123.323634

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Among newly diagnosed type 2 diabetics who lost weight, weight gain may increase risk of complications: Study

A register-based study from Finland identified three distinct BMI trajectory groups among patients with newly diagnosed type 2 diabetes. In a four-year follow-up, most patients followed a stable trajectory without much weight change. Only 10% of patients lost weight, whereas 3% gained weight. Mean BMI exceeded the threshold of obesity in all groups at baseline. Weight loss is a central treatment goal in type 2 diabetes, but the study shows that few patients succeed in it.

The study was carried out by researchers at the University of Eastern Finland, and the results were published in Clinical Epidemiology.

Patients belonging to each trajectory group were followed up for another eight years for diabetes complications. During the follow-up, 13% of all patients developed microvascular complications, 21% developed macrovascular complications and 20% of patients deceased. The risk of microvascular complications was 2.9 times higher and the risk of macrovascular complications 2.5 times higher among patients with an increasing BMI compared to those with a stable BMI. Micro- and macrovascular complications of diabetes can include, for example, retinopathy, nephropathy and neuropathy, as well as cardiovascular diseases.

“These results underscore the significance of continuous BMI monitoring and weight management in patients with type 2 diabetes. Tailored treatments and support with lifestyle changes are crucial for efficiently preventing weight gain and reducing the risk of diabetes complications,” says Doctoral Researcher Zhiting Wang of the University of Eastern Finland.

The study was carried out in North Karelia, Finland, using electronic health records from both primary and specialised health care. The study included a total of 889 adults with newly diagnosed type 2 diabetes in 2011 or 2012. The participants were grouped based on individual BMI trajectories from the diagnosis until 2014. Risks for microvascular complications, macrovascular complications, any diabetes complications and all-cause mortality from 2015 to 2022 across BMI trajectory groups were estimated.

Reference:

Wang Z, Lavikainen P, Wikström K, Laatikainen T. Trajectories of Body Mass Index and Risk for Diabetes Complications and All-Cause Mortality in Finnish Type 2 Diabetes Patients. Clin Epidemiol. 2024;16:203-212 https://doi.org/10.2147/CLEP.S450455.

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Patients with persistently high BP within 24 hours of ischemic stroke onset at highest risk of adverse outcomes: Study

China: A recent article published in the BMJ journal Heart has reported twenty-four-hour blood pressure trajectories and clinical outcomes in patients who had an acute ischaemic stroke.

The researchers found that patients with persistently high blood pressure (BP) at 180 mm Hg within 24 hours of ischaemic stroke onset had the highest risk, while they found favorable outcomes in those maintaining stable BP at a moderate-low level (150 mm Hg) or even a low level (137 mm Hg).

The management of BP in acute ischaemic stroke remains a subject of controversy. Ruirui Wang, Suzhou Medical College of Soochow University, Suzhou, Jiangsu, China, and colleagues aimed to explore the relationship between 24-hour BP patterns following ischaemic stroke and clinical outcomes.

For this purpose, the researchers examined a cohort of 4069 patients who had an acute ischaemic stroke from 26 hospitals. Using latent mixture modeling, they identified five systolic BP trajectories: trajectory category 1 (150–130 mm Hg), trajectory category 2 (155–145 mm Hg), trajectory category 3 (170–160 mm Hg), trajectory category 4 (180–140 mm Hg), and trajectory category 5 (190–170 mm Hg).

The study’s primary outcome was a composite outcome of death and major disability at three months poststroke.

The study led to the following findings:

  • Patients with trajectory category 5 exhibited the highest risk, while those with trajectory category 1 had the lowest risk of adverse outcomes at 3-month follow-up.
  • Compared with the patients in trajectory category 5, adjusted ORs for the primary outcome were 0.79, 0.70, 0.64, and 0.47 among patients in trajectory category 4, trajectory category 3, trajectory category 2, and trajectory category 1, respectively.
  • Similar trends were observed for vascular events, death, and the composite outcome of death and vascular events.

In conclusion, the researchers identified distinctive BP trajectories within 24 hours post-stroke onset.

At the 3-month follow-up, patients in the highest trajectory category 5 (190–170 mm Hg) showed the highest risk of adverse outcomes (vascular events, death, and major disability), while those in the lowest category (150–130 mm Hg) exhibited the lowest risk. Comparatively, adjusted odds ratios reduced from 0.79 to 0.47, respectively.

Reference:

Wang R, Liu Y, Zhang Q, Zhang J, Peng H, Shi M, Peng Y, Xu T, Wang A, Xu T, Chen J, Zhang Y, He J. Twenty-four-hour blood pressure trajectories and clinical outcomes in patients who had an acute ischaemic stroke. Heart. 2024 Apr 3:heartjnl-2023-323821. doi: 10.1136/heartjnl-2023-323821. Epub ahead of print. PMID: 38569853.

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Remdesivir does not increase the risk of cardiac events in COVID-19 patients, suggests study

A recent comprehensive post-hoc safety analysis found that the antiviral drug remdesivir assure cardiac safety profile. When administered to the hospitalized patients with COVID-19, it does not elevate the risk of cardiac adverse events (AEs). These finding were published in the Clinical Infectious Diseases highlight the ongoing debate about the safety of remdesivir in the COVID-19 treatment.

The analysis focused on the cardiac health of patients and was derived from the multicenter, randomized, open-label, controlled DisCoVeRy trial that compared the effects of remdesivir with standard of care (SoC) against SoC alone in hospitalized COVID-19 patients. The study scrutinized the occurrence of any first adverse event from the time of randomization up to 29 days post-treatment in a modified intention-to-treat (mITT) population.

This trial observed cardiac adverse events in 11.2% of patients in the remdesivir group (46 out of 410) and 11.3% of patients in the control group (48 out of 423) that revealed no significant difference in cardiac risk between the two groups. This similarity held true across the various analyses that included both serious and non-serious cardiac events with arrhythmic events being the most common but generally leading to favorable outcomes.

These findings are crucial after considering the outcomes of the previous studies and analyses that hinted a potential association between remdesivir treatment and cardiac AEs. However, the data from the DisCoVeRy trial suggest that remdesivir can be administered without much added concern for cardiac safety among the hospitalized patients with moderate to severe COVID-19. This aligns with the outcomes from other randomized controlled trials and meta-analyses that further strengthens the case for the safe use of remdesivir in the fight against COVID-19.

The patients and healthcare providers have been navigating the challenges of COVID-19 treatment options, with the safety and efficacy of treatments being paramount. Overall, the contribution of DisCoVeRy trial is significant by offering a sharp reassurance about the cardiac safety profile of remdesivir where these findings are vital for informing the treatment strategies and ensuring the safety of patients.

Reference:

Terzić, V., Miantezila Basilua, J., Billard, N., de Gastines, L., Belhadi, D., Fougerou-Leurent, C., Peiffer-Smadja, N., Mercier, N., Delmas, C., Ferrane, A., Dechanet, A., Poissy, J., Espérou, H., Ader, F., Hites, M., Andrejak, C., Greil, R., Paiva, J.-A., … Staub, T. (2024). Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial. In Clinical Infectious Diseases. Oxford University Press (OUP). https://doi.org/10.1093/cid/ciae170

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Irregular sleep and late bedtimes tied to worse grades for high school students, finds research

Irregular sleep and late bedtimes are linked to worse grades and more school-related behavioral problems among teens, suggests a study funded by the National Institutes of Health (NIH). The authors stated that interventions to promote regular sleep schedules may boost adolescents’ academic performance.

The study, conducted by Gina Marie Mathew, Ph.D., and Lauren Hale, Ph.D., of Stony Brook University and colleagues, appears in Sleep. Funding was provided by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Researchers analyzed data from nearly 800 adolescents participating in a larger study(link is external). Participants provided information on grades and school-related behavioral issues. They also wore a wrist accelerometer (a device that records the wearer’s movements) for a week so that study staff could estimate their sleep patterns.

Participants with more variable bedtimes had a greater chance of receiving a D or lower during the last grading period, compared to those with more consistent bedtimes. Adolescents who went to bed later, got up later or varied the number of hours they slept per night had fewer classes in which they received an A. Adolescents were more likely to be suspended or expelled in the last two years if they got up later, varied the number of hours they slept each night or if they varied the time they went to bed each night.

The authors theorized that delayed bedtimes could result in late school arrivals, which could affect learning and behavior. In addition, many adolescents are biologically inclined to later hours, which conflict with early school start times.

Reference:

Gina Marie Mathew et al, Actigraphic sleep dimensions and associations with academic functioning among adolescents, Sleep (2024). DOI: 10.1093/sleep/zsae062.

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Ketogenic diet may improve outcomes in patients with psychiatric illness: Study

A recent pilot study published in the Psychiatry Research journal found the ketogenic diet which is traditionally used in the treatment of obesity, type 2 diabetes and epilepsy to be effective in psychiatric care. This study by Shebani Sethi and team unveiled promising results for individuals with schizophrenia or bipolar disorder with pre-existing metabolic abnormalities. This 4-month single-arm trial included a total of 23 participants which suggests the strong potential of ketogenic diet as a supplementary treatment for serious mental illnesses.

The findings of this study were significant where all participants showed marked improvements in metabolic health by effectively eliminating the criteria for metabolic syndrome by the end of the study. For the individuals who strictly adhered to the ketogenic diet, the results showed an average weight loss of 12%, a reduction in BMI of 12%, a 13% decrease in waist circumference and a substantial 36% reduction in the visceral adipose tissue. These improvements in physical health were paralleled by marked enhancements in the metabolic biomarkers which included a 27% decrease in the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and a 25% reduction in triglyceride levels.

The study illuminated the potential psychiatric advantages of the ketogenic diet beyond the metabolic benefits. The participants diagnosed with schizophrenia experienced a significant 32% decrease in their Brief Psychiatric Rating Scale scores by indicating a reduction in the severity of their symptoms. The overall Clinical Global Impression (CGI) severity score improved by an average of 31%, with a significant 79% of participants showing at least a 1-point improvement in their CGI scores that denotes a reduction in symptom severity.

The cohort reported a 17% increase in life satisfaction and a 19% improvement in sleep quality which elucidates the possible far-reaching effects on overall well-being of the diet. This pilot trial stands as a strong witness to the potential benefits of the ketogenic diet as an adjunct treatment for the individuals with serious mental illnesses. The improvements in both metabolic health and psychiatric symptoms underline the dual impact of this diet in patients who seek alternative or supplementary treatment options. Overall, these findings pave the way for further research into the role of ketogenic diet in psychiatric care that can potentially revolutionize treatment approaches for schizophrenia, bipolar disorder and much more.

Source:

Sethi, S., Wakeham, D., Ketter, T., Hooshmand, F., Bjornstad, J., Richards, B., Westman, E., Krauss, R. M., & Saslow, L. (2024). Ketogenic Diet Intervention on Metabolic and Psychiatric Health in Bipolar and Schizophrenia: A Pilot Trial. In Psychiatry Research (Vol. 335, p. 115866). Elsevier BV. https://doi.org/10.1016/j.psychres.2024.115866

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Solar-powered oxygen efficacious and cost-effective means of supplying oxygen in rural settings:Lancet

Solar-powered oxygen efficacious and cost-effective means of supplying oxygen in rural settings suggests a new study published in the Lancet.

Supplemental O2 is not always available at health facilities in low-income and middle-income countries (LMICs). Solar-powered O2 delivery can overcome gaps in O2 access, generating O2 independent of grid electricity. We hypothesized that installation of solar-powered O2 systems on the paediatrics ward of rural Ugandan hospitals would lead to a reduction in mortality among hypoxaemic children. In this pragmatic, country-wide, stepped-wedge, cluster randomised controlled trial, solar-powered O2 systems (ie, photovoltaic cells, battery bank, and O2 concentrator) were sequentially installed at 20 rural health facilities in Uganda. Sites were selected for inclusion based on the following criteria: District Hospital or Health Centre IV with paediatric inpatient services; supplemental O2 on the paediatric ward was not available or was unreliable; and adequate space to install solar panels, a battery bank, and electrical wiring. Allocation concealment was achieved for sites up to 2 weeks before installation, but the study was not masked overall.

Children younger than 5 years admitted to hospital with hypoxaemia and respiratory signs were included. The primary outcome was mortality within 48 h of detection of hypoxaemia. The statistical analysis used a linear mixed effects logistic regression model accounting for cluster as random effect and calendar time as fixed effect. Findings: Between June 28, 2019, and Nov 30, 2021, 2409 children were enrolled across 20 hospitals and, after exclusions, 2405 children were analysed. 964 children were enrolled before site randomisation and 1441 children were enrolled after site randomisation (intention to treat). There were 104 deaths, 91 of which occurred within 48 h of detection of hypoxaemia. The 48 h mortality was 49 (5·1%) of 964 children before randomisation and 42 (2·9%) of 1440 (one individual did not have vital status documented at 48 h) after randomisation (adjusted odds ratio 0·50, 95% CI 0·27-0·91, p=0·023). Results were sensitive to alternative parameterisations of the secular trend.

There was a relative risk reduction of 48·7% (95% CI 8·5-71·5), and a number needed to treat with solar-powered O2 of 45 (95% CI 28-230) to save one life. Use of O2 increased from 484 (50·2%) of 964 children before randomisation to 1424 (98·8%) of 1441 children after randomisation (p<0·0001). Adverse events were similar before and after randomisation and were not considered to be related to the intervention. The estimated cost-effectiveness was US$25 (6-505) per disability-adjusted life-year saved. This stepped-wedge, cluster randomised controlled trial shows the mortality benefit of improving O2 access with solar-powered O2. This study could serve as a model for scale-up of solar-powered O2 as one solution to O2 insecurity in LMICs.

Reference:

Conradi N, Opoka RO, Mian Q, Conroy AL, Hermann LL, Charles O, Amone J, Nabwire J, Lee BE, Saleh A, Mandhane P, Namasopo S, Hawkes MT. Solar-powered O2 delivery for the treatment of children with hypoxaemia in Uganda: a stepped-wedge, cluster randomised controlled trial. Lancet. 2024 Feb 24;403(10428):756-765. doi: 10.1016/S0140-6736(23)02502-3. Epub 2024 Feb 14. PMID: 38367643.

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FDA clears AI tool to detect heart failure with low ejection fraction

The US Food and Drug Administration (FDA) has cleared first AI tool to detect heart failure with low ejection fraction.

Eko Low Ejection Fraction Tool (ELEFT) is an algorithm intended to aid treating physicians in identifying individuals 18 years and older with left ventricular ejection fraction (LVEF) less than or equal to 40%.

For the first time, U.S. healthcare providers can now detect Low EF, a key heart failure indicator, in 15 seconds using an Eko stethoscope during a routine physical examination. This leap in early detection marks both a significant medical innovation and a new era in the detection of cardiovascular disease.

In the U.S., more than 6 million people battle heart failure, with half of them experiencing heart failure with reduced ejection fraction (HFrEF)-a condition marked by the heart’s inability to pump blood effectively. Traditional heart failure detection tools, such as echocardiography, are often unavailable in primary care settings as they are costly, require specialized training, and add significant time. As a result, many heart failure cases go undiagnosed until symptoms force a specialist or emergency hospital visit, leading to worse patient outcomes and exacerbated healthcare costs. Eko’s Low EF AI disrupts this status quo by embedding rapid and accessible low ejection fraction detection into a stethoscope exam on the front lines of care.

“The ability to identify a hidden, potentially life-threatening heart condition using a tool that primary care and subspecialist clinicians are familiar with – the stethoscope – can help us prevent hospitalizations and adverse events,” said Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester. “Importantly, since a stethoscope is small and portable, this technology can be used in urban and remote locations, and hopefully help address care in underserved areas.”

The Low EF AI will be added to Eko’s SENSORA Cardiac Early Detection Platform, the latest advancement to the platform which already features FDA-cleared algorithms to identify AFib and structural heart murmurs, often an indicator of valvular heart disease. When Low EF is detected in a primary care exam with SENSORA, access to life-extending treatment can be expedited with a referral to the cardiology department for thorough diagnostic testing and treatment evaluation.

“The stethoscope, the most recognizable symbol of healthcare, touches the lives of an estimated one billion people around the globe every year,” said Connor Landgraf, co-founder & CEO of Eko Health. “With Eko’s Low EF AI, we’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography. It’s been a privilege to work alongside Mayo Clinic in this groundbreaking endeavor.”

Clinical Development & Validation Highlights:

  • Robust AI Training & Validation: Eko’s Low EF AI was trained on a proprietary dataset of over 100,000 ECGs and echocardiogram pairs from unique patients, and was clinically validated in a multi-site, prospective clinical study of 3,456 patients, achieving an AUROC of 0.835 for detection of LVEF <40%, 74.7% sensitivity and 77.5% specificity, demonstrating a strong ability to differentiate between low and normal EF.
  • Imperial College London Independent Validation: An independent validation of the Low EF AI by the Imperial College London, published in Lancet Digital Health, reported an AUROC of 0.85 for detection of LVEF below 40%, 84.8% sensitivity, and 69.5% specificity when deployed on over 1,050 patients across multiple real-world settings. This validation prompted the UK NHS and Imperial College London to extend Eko’s deployment to over 100 clinics in London and Wales.
  • Demonstrated Impact in Pregnant Women: A clinical study led by Mayo Clinic involving nearly 1,200 pregnant women in Nigeria highlighted the AI’s effectiveness, identifying twice as many cases of pregnancy-related cardiomyopathy than standard care, with an impressive AUROC of 0.98, 100.0% sensitivity, and 79.4% specificity, underscoring its significant potential to assist in the detection and appropriate management of cardiomyopathy in pregnant women, reducing associated disease burden and risk of death.

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Patients taking semaglutide may have higher rate of “altered skin sensations” and alopecia, finds review

USA: A review of 22 articles published in the Journal of the American Academy of Dermatology found that patients taking oral semaglutide had a higher rate of “altered skin sensations” and alopecia when compared with those getting a placebo.

“Variations in administration routes and dosage could impact the types and severity of skin findings, highlighting the need for additional research,” Megan M. Tran, Warren Alpert Medical School, Brown University, Providence, Rhode Island, USA, and colleagues wrote in their study.

The MedWatch program of the US Food and Drug Administration (FDA) has not received reports of semaglutide-related safety events, and few studies have characterized skin findings associated with subcutaneous or oral semaglutide, a glucagon-like peptide 1 agonist used for obesity and type 2 diabetes treatment.

The scoping review 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, including reports of semaglutide-associated adverse dermatologic events in 255 participants.

Based on the review, the researchers reported the following findings:

  • Patients who received weekly 50 mg oral semaglutide reported a higher incidence of altered skin sensations, such as dysesthesia (1.8% versus 0%), hyperesthesia (1.2% versus 0%), skin pain (2.4% versus 0%), paresthesia (2.7% versus 0%), and sensitive skin (2.7% versus 0%), than those receiving placebo or comparator.
  • Reports of alopecia (6.9% versus 0.3%) were higher in patients who received 50 mg oral semaglutide weekly than in those on placebo, however, only 0.2% of patients on 2.4 mg of subcutaneous semaglutide reported alopecia versus 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.
  • Injection site reactions (3.5% vs 6.7%) were less common in patients on subcutaneous semaglutide than those on a placebo or comparator.

The limitation of the study is that it could not adjust for confounding factors and could not establish a direct causal association between semaglutide and the adverse reactions reported.

In conclusion, the review of 22 articles revealed that patients taking oral semaglutide had a higher rate of alopecia and “altered skin sensations” when compared with those getting a placebo.

Variations in dosage and administration routes could influence the severity and types of skin findings, underscoring the need for additional research.

Reference:

Tran, M. M., Mirza, F. N., Lee, A. C., Goldbach, H., Libby, T. J., & Wisco, O. J. (2024). Dermatologic findings associated with semaglutide use: A scoping review. Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2024.03.021

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