Novo Nordisk’s diabetes pill Rybelsus has demonstrated significant cardiovascular benefits in a late-stage trial, potentially broadening its therapeutic scope. The study revealed a 14% reduction in the risk of cardiovascular-related death, heart attack, and stroke over an average of four years compared to a placebo in patients with diabetes and established heart disease. The results, presented at the American College of Cardiology’s Annual Scientific Session, suggest that Rybelsus could soon become a more accessible alternative for individuals hesitant to use injectable treatments. Novo Nordisk has already applied for regulatory approval in the U.S. and EU to expand Rybelsus’ indications to include reducing major cardiovascular complications.
Rybelsus is the once-daily oral formulation of semaglutide, the active ingredient in Novo Nordisk’s popular diabetes injection Ozempic and weight-loss drug Wegovy. While Wegovy recently gained approval for lowering cardiovascular risk in overweight and obese adults with heart disease, the new data on Rybelsus highlights its potential as a convenient oral treatment for those reluctant to use injections. The late-stage trial, involving over 9,600 participants aged 50 and older, found that 12% of Rybelsus users experienced cardiovascular events compared to 13.8% in the placebo group, reflecting a notable reduction in risk.
A key finding was a 26% reduction in non-fatal heart attacks among Rybelsus users, which significantly contributed to the overall cardiovascular benefits. Additionally, the pill lowered the risk of non-fatal strokes by 12% and cardiovascular-related deaths by 7%. Although the study did not show significant kidney-related benefits, the trial primarily focused on cardiovascular outcomes.
Like its injectable counterparts, Rybelsus works by mimicking gut hormones to regulate blood sugar and appetite while also reducing inflammation. Common side effects included mild gastrointestinal symptoms, such as nausea, diarrhea, and constipation, which rarely led to treatment discontinuation. Despite requiring patients to take it on an empty stomach at least 30 minutes before eating, the study confirmed that adherence was high, leading to consistent cardiovascular benefits across all patient subgroups. As competition in the oral GLP-1 space grows, Novo Nordisk’s findings position Rybelsus as a promising option for diabetes and heart disease management.
READ MORE: