Clinical Trial Insights

Novo Nordisk recently announced positive results from a late-stage trial of its diabetes medication, Rybelsus, at the American College of Cardiology’s Annual Scientific Session in Chicago. The study demonstrated that Rybelsus reduced the risk of cardiovascular-related events—such as death, heart attack, and stroke—by 14% compared to a placebo group over an average period of four years.

Rybelsus and Cardiovascular Health

The trial involved over 9,600 patients aged 50 and older, all of whom had diabetes and established heart disease, with many also experiencing chronic kidney disease. Among the participants, 12% in the Rybelsus group experienced cardiovascular-related death, heart attack, or stroke, against 13.8% in the placebo group, evidencing the pill’s potential in mitigating serious health risks associated with these conditions.

Broader Implications for Diabetes Treatment

Currently, Rybelsus is already approved for managing Type 2 diabetes. Novo Nordisk has sought to extend this approval to include the reduction of cardiovascular risks. Stephen Gough, the company’s global chief medical officer, emphasized the importance of providing options for patients who may be reluctant to receive injections due to fear or discomfort.

This oral alternative could offer a more accessible treatment route, especially for those who prefer pills over injections, as Gough noted: “We provide that option, that you can have one or the other, depending on what the patients and the healthcare professional think is right in that joint discussion.”

Comparing Rybelsus to Other Treatments

Rybelsus is an oral formulation of semaglutide, the same active ingredient found in Novo Nordisk’s Ozempic injections, which are administered weekly. In addition, the company’s weight loss injection, Wegovy, recently gained U.S. approval for reducing the risk of major cardiovascular events in individuals with cardiovascular disease who are overweight or obese. This expanding range of treatment options could potentially cater to various patient preferences.

Efficacy and Side Effects

The trial results affirmed that Rybelsus also significantly reduced the risk of non-fatal heart attacks by 26% and non-fatal strokes by 12%, alongside a 7% reduction in cardiovascular-related deaths. While there was no noteworthy impact on kidney function in either treatment group, Gough clarified that the trial primarily assessed cardiovascular outcomes.

Common side effects reported included gastrointestinal issues such as nausea, diarrhea, and constipation, which were consistent with the known side effects of injectable semaglutide. Importantly, these gastrointestinal symptoms led to few participants discontinuing the medication.

Patient Satisfaction and Administration

Notably, Rybelsus must be consumed on an empty stomach with a small amount of water, at least 30 minutes prior to breakfast. Despite these requirements, Dr. Darren McGuire, the study’s first author, expressed confidence that the study reassured that patients adhered to the regimen and derived cardiovascular benefits.