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The FDA approved Novo Nordisk’s oral semaglutide (Rybelsus) for cardiovascular (CV) risk reduction in adults with type 2 diabetes (T2D) who are at high CV risk, whether or not they’ve had a prior CV event.
Once-daily oral semaglutide 7 mg and 14 mg tablets were initially approved for the treatment of T2D along with diet and exercise in September 2019.
The new indication is based on results from the double-blind SOUL trial of 9650 aged patients 50 years or older with T2D who had coronary artery disease, cerebrovascular disease, symptomatic peripheral arterial disease, or chronic kidney disease. The 14 mg dose reduced major adverse CV events (a three-point composite of CV death, nonfatal myocardial infarction, or nonfatal stroke) by 14% compared to placebo (12.0% vs 13.8%, P = .006) at 4 years.
The overall safety profile was consistent with that seen in previous trials. Gastrointestinal adverse events were more common with oral semaglutide vs placebo (5.0% vs 4.4%) as were adverse events leading to discontinuation (15.5% vs 11.6%).
Novo Nordisk is awaiting an FDA decision on its application for once-daily oral semaglutide for treating obesity, under the trade name Wegovy, expected later this year.
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 and BlueSky @miriametucker.bsky.social.
