N Engl J Med

Does oral semaglutide deliver cardiovascular benefits in type 2 diabetes patients with known ASCVD or CKD?

June 2, 2025

Oral semaglutide was linked to significantly lower major adverse cardiovascular event (MACE) risk vs. placebo, without upping serious adverse event incidence, in type 2 diabetes patients with known atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or both, in this randomized placebo-controlled trial.

• Study: 9650 adults ages 50+ years with type 2 diabetes (HbA1c, 6.5 to 10.0%) and ASCVD, CKD, or both were randomized to oral semaglutide (max dose, 14 mg once daily) vs. placebo, along with standard care. Primary outcome: MACE (composite of CV death, nonfatal MI, nonfatal stroke). Median follow-up was 49.5 months.
• Results: MACE events occurred in 12.0% of the oral semaglutide group (3.1 events/100 person-years) vs. 13.8% of the placebo group (3.7 events/100 person-years), resulting in a hazard ratio of 0.86 (P=0.006).
• Serious adverse event incidence: 47.9% for the oral semaglutide group vs. 50.3% for the placebo group. Incidence of gastrointestinal disorders was 5.0% for the semaglutide group and 4.4% for the placebo group.

Source:

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