Year: 2026
Type: article
Abstract: OBJECTIVE: People receiving dialysis are at high risk of cardiovascular and all-cause mortality. Semaglutide reduces major adverse cardiovascular events (MACE) in people with type 2 diabetes (T2D) and those without T2D with obesity and high cardiovascular risk. Data to establish safety and efficacy in dialysis-dependent kidney failure are scarce. We aimed to assess the safety of semaglutide in people who initiate dialysis. RESEARCH DESIGN AND METHODS: In this post hoc analysis of four randomized, placebo-controlled trials (Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes [SUSTAIN-6], Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity [SELECT], Evaluate Renal Function With Semaglutide Once Weekly [FLOW], and Semaglutide Cardiovascular Outcomes [SOUL]), we evaluated systematically collected adverse events (AEs) from participants who initiated dialysis during study follow-up. We compared the proportion and event rates of systematically collected serious AEs (SAEs), including adjudicated MACE, and AEs leading to permanent treatment discontinuation in participants originally randomized to semaglutide or placebo who remained on treatment after dialysis initiation. RESULTS: Among 34,064 participants randomized across the trials, 307 initiated dialysis, of whom 165 participants randomized to semaglutide (n = 71) or placebo (n = 94) remained on treatment. After dialysis initiation, SAEs were reported in 32 of 71 (45%) and 54 of 94 (57%) participants, and the proportion of participants who permanently discontinued trial medication was 8.5% and 10.6% in the semaglutide and placebo groups, respectively. The MACE event rates were 9.7 and 16.1 events per 100 person-years, and all-cause mortality event rates were 13.8 and 18.1 events per 100 person-years, in the semaglutide and placebo groups, respectively. CONCLUSIONS: Although more evidence is needed, continuation of semaglutide after dialysis initiation appears safe and warrants efficacy testing regarding reduction in MACE and death.
Source: Diabetes Care
DOI: 10.2337/dc26-0112
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: American Society of Nephrology, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Alnylam Pharmaceuticals, Regeneron Pharmaceuticals, Novo Nordisk, Shionogi, National Institutes of Health, National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Advancing Translational Sciences, National Institute on Minority Health and Health Disparities
Awards: Central Hub for Kidney Precision Medicine, G4622355042, AIM-AHEAD Coordinating Center - All Four Cores, Novel Biguanides to Treat Type 2 Diabetes, North Carolina Translational and Clinical Science Institute (NC TraCS), Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease, Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices, Nephrotic Syndrome Rare Disease Clinical Research Network III, Prediction of Chronic Kidney Disease by Simulation Modeling to Improve the Health of Minority Populations, Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals with Type 2 Diabetes Mellitus and Food Insecurity, G9000009069, G9000038601, G9000179747, Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention, UT Southwestern NORC, Institute of Translational Health Sciences, Center for Identification and Study of Individuals with Atypical Diabetes Mellitus, North Carolina Diabetes Research Center, CureGN-Penn PCC, CTSA K12 Program at UNC, OTA-21-015A Post-Acute Sequelae of SARS-CoV-2 Infection Initiative: NYU Langone Health Clinical Science Core, Data Resource Core, and PASC Biorepository Core, Towards Glucose Transporter-Mediated Glucose-Responsive Insulin Delivery with Fast Response
OpenAlex ID: W7141704925