On Saturday, Novo Nordisk announced that its innovative diabetes pill, Rybelsus, demonstrated significant cardiovascular benefits in a late-stage clinical trial. This breakthrough could potentially position Rybelsus as a new treatment option for individuals living with both diabetes and heart disease. The study indicated that Rybelsus reduced the risk of cardiovascular-related death, heart attacks, and strokes by 14% compared to a placebo over an average follow-up period of four years.
The data from the trial, presented at the American College of Cardiology's Annual Scientific Session in Chicago, revealed that Rybelsus was effective among patients diagnosed with diabetes and established heart disease, regardless of whether they also had chronic kidney disease. Stephen Gough, the global chief medical officer of Novo Nordisk, indicated that the company has already submitted applications in the U.S. and EU to broaden the approval of Rybelsus to include the reduction of serious cardiovascular complications.
Rybelsus is the oral formulation of Novo Nordisk's successful diabetes injection, Ozempic, which is administered weekly. Both Rybelsus and Ozempic, along with the weekly weight loss injection Wegovy, contain the active ingredient semaglutide. Notably, Wegovy recently received U.S. approval in March 2024 for its efficacy in reducing the risk of major cardiovascular events in adults who are obese or overweight and have cardiovascular disease.
The findings are particularly promising for patients who are reluctant to use injections, such as those with a fear of needles. “We know not everybody wants an injection, whether it is painful or not; they want the option of an oral medication,” Gough explained in an interview with CNBC. This flexibility provides patients and healthcare professionals the opportunity to decide together which treatment option suits their needs best.
The phase three trial involved over 9,600 participants aged 50 years and older, who were randomly assigned to receive either Rybelsus or a placebo alongside their standard treatment regimen for an average duration of just under four years. Almost half of the participants were administered SGLT2 inhibitors, medications primarily used to lower blood sugar levels in adults with Type 2 diabetes, during the trial.
By the conclusion of the study, 12% of participants taking Rybelsus and 13.8% of those on placebo experienced cardiovascular-related events. This outcome underscores a 14% overall lower risk for those who received Rybelsus. Researchers noted that these results align with the cardiovascular benefits previously observed in eight prior trials involving injectable GLP-1 medications, including semaglutide, which mimics gut hormones to suppress appetite and regulate blood sugar while also reducing inflammation.
Rybelsus was shown to decrease the risk of non-fatal heart attacks by 26% compared to placebo, which was the primary factor contributing to the overall reduction in cardiovascular complications. Additionally, the risk of non-fatal strokes was reduced by 12%, and cardiovascular-related death was decreased by 7%. Importantly, there were no significant differences in kidney function outcomes between the Rybelsus and placebo groups, although the trial was primarily focused on cardiovascular benefits, as noted by Gough. Ozempic remains approved for treating chronic kidney disease in diabetes patients.
The most prevalent side effects reported during the study were gastrointestinal issues, including nausea, diarrhea, and constipation. Fortunately, these side effects rarely led to participants discontinuing Rybelsus, which is consistent with the side effects associated with injectable semaglutide. The trial also indicated similar results across various patient demographics, including variations in age, sex, and pre-existing health conditions.
Unlike injectable alternatives, Rybelsus must be taken on an empty stomach at least 30 minutes before breakfast, accompanied by a small amount of water. Despite these requirements, the study reinforced that patients adhered to the medication regimen and experienced cardiovascular health benefits, according to Dr. Darren McGuire, a professor of medicine at UT Southwestern Medical Center and the lead author of the study.
