Oral semaglutide prevents CV events in people with diabetes and heart disease, CKD
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Key takeaways:
- Once-daily oral semaglutide reduced risk for major adverse CV events in people with diabetes and heart disease and/or kidney disease.
- The full results will be presented at a scientific conference in 2025.
Oral semaglutide demonstrated an approximately 14% reduction in major adverse CV events compared with standard care along in patients with diabetes, CVD and/or kidney disease, according to the top-line results of the phase 3 SOUL trial.
SOUL was a randomized, controlled, multicenter, double-blind, parallel-group trial designed to evaluate the effects of once-daily oral semaglutide (Rybelsus, Novo Nordisk) plus standard care on risk for major adverse CV events, defined as a composite endpoint consisting of CV death, nonfatal MI and nonfatal stroke, compared with placebo plus standard care in patients with diabetes and CVD and/or CKD.
For the SOUL trial, initiated in 2019, researchers enrolled 9,650 people. On top of standard of care, 49% of participants received SGLT2 inhibition at some point during the trial, according to a company press release.
The trial achieved its primary endpoint of significant and superior reduction in major adverse CV events in those treated with oral semaglutide compared with placebo, both in addition to standard care. Oral semaglutide appeared safe and well-tolerated, with a safety profile comparable with previous trials, according to the release.
The company announced plans to file for regulatory approval of a label expansion in both the U.S. and E.U. around the turn of the year and is expected to present the full results of the SOUL trial at a scientific conference in 2025.
"We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of standard of care,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in the release. “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions.”
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