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Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
Article Number: SIS796408AI300425
30th April, 2025
Author(s):
D.K. McGuire et al. for the SOUL Study Group
Abstract:
Background:
The cardiovascular safety of oral semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been established in type 2 diabetes (T2D) patients with high cardiovascular risk, but its efficacy in those with atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or both remains unclear.
Methods:
In this double-blind, placebo-controlled trial, 9,650 participants aged ≥50 years with T2D (HbA1c 6.5–10.0%) and ASCVD, CKD, or both were randomized to once-daily oral semaglutide (14 mg) or placebo, added to standard care. The primary outcome was major adverse cardiovascular events (MACE: cardiovascular death, nonfatal myocardial infarction [MI], or nonfatal stroke). Confirmatory secondary outcomes included kidney disease events and major adverse limb events.
Results:
Over a median 49.5 months, MACE occurred in 12.0% of the semaglutide group vs. 13.8% with placebo (hazard ratio [HR], 0.86; 95% CI, 0.77–0.96; P=0.006). Nonfatal MI was significantly reduced (HR, 0.74; 95% CI, 0.61–0.89), but kidney outcomes did not differ (HR, 0.91; 95% CI, 0.80–1.05). Serious adverse events were lower with semaglutide (47.9% vs. 50.3%), though gastrointestinal disorders were more frequent (5.0% vs. 4.4%).
Conclusions:
Oral semaglutide reduced MACE risk in high-risk T2D patients without increasing serious adverse events, supporting its cardiovascular benefit.