Novo Nordisk’s Rybelsus lowers MACE risk in Type 2 Diabetes patients with CKD

DENMARK—Novo Nordisk, a leading pharmaceutical company based in Denmark, has unveiled promising results from the SOUL cardiovascular outcomes trial.

The study demonstrated that Rybelsus® (oral semaglutide) significantly lowers the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who also have cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

This announcement builds on findings from another trial, STRIDE, which investigated the effects of once-weekly Ozempic® (semaglutide 1.0 mg) injections in adults with type 2 diabetes and peripheral artery disease (PAD).

The SOUL trial, recently presented at the late-breaking clinical session during the American College of Cardiology’s Annual Scientific Session and Expo in Chicago, was also featured in The New England Journal of Medicine.

It achieved its primary goal by showing a 14% reduction in MACE risk for patients treated with Rybelsus compared to those receiving a placebo.

MACE includes cardiovascular death, nonfatal heart attacks, and nonfatal strokes, all of which contributed to the observed risk reduction.

Dr. Darren McGuire, co-chair of the SOUL steering committee and professor at the University of Texas Southwestern Medical Center, emphasized the importance of these findings.

 He noted that heart attacks and strokes are leading causes of disability and death among people with type 2 diabetes.

The SOUL trial highlights oral semaglutide as an effective treatment option that can significantly reduce these risks while offering patients a convenient oral alternative to enhance their health outcomes.

Cardiometabolic diseases, which encompass conditions like CVD, PAD, type 2 diabetes, and CKD, remain the leading cause of death globally.

 Type 2 diabetes not only increases the risk of developing these interconnected conditions but also accelerates other cardiovascular risk factors.

Nearly one-third of adults with type 2 diabetes have CVD.

 Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, shared that the company’s focus is expanding beyond diabetes and obesity to address a broader range of metabolic and cardiovascular health challenges.

He highlighted the comprehensive benefits of semaglutide as a strong option for healthcare professionals managing these conditions.

The safety profile of Rybelsus in the SOUL trial was consistent with previous studies, showing no new safety concerns.

Serious adverse events were less frequent among participants receiving Rybelsus®, primarily due to fewer cardiovascular events and infections compared to the placebo group.

Based on these findings, Novo Nordisk has submitted applications for label extensions for Rybelsus to regulatory agencies in Europe and the United States, with decisions expected in 2025.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and beyond. Also, follow us on our WhatsApp channel for updates.