Semaglutide safe for dialysis patients in pooled analysis

Treatment with the GLP-1 receptor agonist semaglutide appears safe for patients initiating dialysis, as demonstrated in a pooled analysis presented at EASD 2025.

With a mean follow-up of 1.15 years from the start of dialysis, there were no significant differences between the semaglutide and placebo groups in any serious adverse events, including infections and infestations, gastrointestinal disorders, or adverse events leading to permanent discontinuation.

There were also no significant differences in major adverse cardiovascular events (MACE) or all-cause mortality. In fact, the MACE event rate was numerically lower at 9.7 per 100 person-years with semaglutide compared with 16.1 with placebo. The same was true for all-cause mortality rate, which was 13.8 per 100 person-years with semaglutide compared with 18.1 with placebo.

This finding was significant because patients on dialysis have a low median survival, mainly due to cardiovascular (CV) complications. Moreover, they are usually excluded from outcomes trials; therefore, this study represents the largest prospective cohort of individuals starting dialysis while receiving semaglutide.

“I think we can convincingly say that treatment with semaglutide was not associated with a higher proportion of serious adverse events, including MACE and all-cause mortality among those initiating dialysis,” said first author Dr Klara R. Klein from The University of North Carolina at Chapel Hill, North Carolina, US, at EASD 2025.

“Additionally, we noted a potential for CV and mortality benefits with semaglutide, necessitating further study of the potential of this agent to improve meaningful outcomes in people commencing dialysis.”

4 trials, more than 34,000 patients

The pooled analysis included 34,064 participants from four major CV outcome trials—SUSTAIN-6, SELECT, FLOW, and SOUL. Except for SELECT, the trials included a diagnosis of type 2 diabetes (T2D) as an inclusion criterion.

Among all patients, 307 started dialysis during the trial, including 141 who were randomly assigned to semaglutide and 166 to placebo. Patient characteristics were similar in both groups. The average age of the semaglutide and placebo groups was 64.4 and 65.1 years, respectively. Approximately 74 percent were male.

Seventy-one patients on semaglutide and 94 on placebo continued to receive the study medication after starting dialysis, and the results specifically pertain to these patients. The study focused on serious adverse events, adverse events leading to permanent treatment discontinuation, and MACE.

Clinical implication

According to the authors, the study’s demonstration of sustained safety after dialysis initiation could influence clinical guidelines and standard-of-care recommendations, further promoting the adoption of semaglutide. However, differences in how adverse events were collected across the trials may have made it more difficult to compare all adverse events across studies.