Semaglutide continuation after dialysis initiation was safe, with fewer serious adverse events (45% vs 57%) and lower MACE rates (9.7 vs 16.1 per 100 person-years) compared to placebo.
Does semaglutide remain safe and reduce cardiovascular events in patients who initiate dialysis?
Continuation of semaglutide after dialysis initiation appears safe and is associated with numerically lower rates of serious adverse events and MACE compared to placebo.
Absolute Event Rate: 0% vs 0%
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.
Klein et al. (Fri,) reported a other. Semaglutide continuation after dialysis initiation was safe, with fewer serious adverse events (45% vs 57%) and lower MACE rates (9.7 vs 16.1 per 100 person-years) compared to placebo.