N Engl J Med

ACC 2025: Oral semaglutide reduces cardiovascular events in high-risk T2DM

April 2, 2025

Oral semaglutide significantly reduced the risk of major adverse cardiovascular events in high-risk T2DM patients without increasing serious adverse events. These findings, presented at American College of Cardiology (ACC).25, support the use of oral semaglutide for cardiovascular risk reduction in this patient population.

Study details: The double-blind SOUL trial evaluated the cardiovascular efficacy of oral semaglutide in 9,650 participants aged ≥50 years with T2DM and known atherosclerotic cardiovascular disease, chronic kidney disease, or both. Participants were randomized to receive either once-daily oral semaglutide (up to 14 mg) or placebo, in addition to standard care. The primary outcome was the time to first major adverse cardiovascular event (MACE), including cardiovascular death, nonfatal MI, or nonfatal stroke.

Results: Over a mean follow-up of 47.5 months, the incidence of primary outcome events was significantly lower in the oral semaglutide group (12.0%; incidence, 3.1 events per 100 person-years) compared with the placebo group (13.8%; incidence, 3.7 events per 100 person-years) with a hazard ratio of 0.86 (95% confidence interval [CI], 0.77 - 0.96; P=0.006). The incidence of serious adverse events was similar between groups, with GI disorders being slightly more common in the semaglutide group (5.0% vs. 4.4%).

Source:

McGuire DK, et al; SOUL Study Group. (2025, March 29). N Engl J Med. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. https://pubmed.ncbi.nlm.nih.gov/40162642/