Oral semaglutide (Rybelsus) lowered the risk for major adverse cardiovascular events (MACEs) by a significant 14% compared with placebo, Novo Nordisk announced.
The topline results met the primary endpoint of the company’s multicenter, double-blinded, randomized SOUL trial of 9650 people with type 2 diabetes (T2D) and established cardiovascular disease and/or chronic kidney disease. About half of the participants also received sodium-glucose cotransporter 2 inhibitors as part of standard of care.
The primary endpoint (MACEs) was defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
Oral semaglutide appeared safe and well-tolerated during the trial.
Rybelsus is currently approved in the United States and the European Union to treat T2D as an adjunct to diet and exercise. Novo Nordisk expects to file for regulatory approval of a label expansion for MACE reduction in both the United States and European Union around the beginning of 2025 and to present the full detailed SOUL results at a scientific conference in 2025.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X: @MiriamETucker.
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Publish date : 2024-10-22 12:36:09
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