New Diabetes Drug Lowers Heart Complication Risk by 14%: Study

Novo Nordisk has made the complete SOUL results presentation today, the results from a 3-phase cardiovascular outcomes study indicated that oral semaglutide significantly decreased the risk of major adverse cardiovascular events in adults with type 2 diabetes possessing CVD and/or CKD.

On account of the Late-breaking Clinical Trials session of the Annual Scientific Session and Expo of the American College of Cardiology in Chicago; simultaneous release was effected to the New England Journal of Medicine.

"In an important news from the SOUL trial, oral semaglutide has shown it can reduce the risk of major adverse cardiovascular events (MACE), regardless of whether participants were already using sodium-glucose cotransporter-2 inhibitor (SGLT2i). The benefits were consistent for everyone—those on SGLT2i and those without—during the trial", said Dr AG Unnikrishnan, CEO and Chief of Endocrinology at the Chellaram Diabetes Institute, Pune.

He added, "What is even better is that combining these two treatments was a safe approach, opening the door to a more comprehensive, all-rounded approach to managing type 2 diabetes. This breakthrough not only transforms care for people living with type 2 diabetes but also sets a new standard for management of type 2 diabetes and cardiovascular management".

The SOUL comprised a positive primary endpoint of 14% relative risk reduction of MACE with treatment compared to placebo, which encompassed a 26% relative risk reduction in nonfatal myocardial infarctions, an additional 12% reduction in nonfatal strokes, and a 7% reduction in cardiovascular death. However, the benefit appeared to be stronger in Asian participants, who saw a 27% relative risk reduction in MACE.

Martin Holst Lange, Executive Vice President for Development at Novo Nordisk said, "Novo Nordisk continues to evolve its focus beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health. These data, alongside our other data being presented at ACC, reinforce the comprehensive set of health benefits of semaglutide, making it a strong option for healthcare professionals addressing the spectrum of metabolic and cardiovascular health – and our continued leadership in the space".

Cardiometabolic diseases including type 2 diabetes, CVD, peripheral artery disease, and CKD are still the leading causes of death in the world. In this context, the SOUL trial brings new evidence supporting oral semaglutide's cardiovascular benefits in these related disease states.

Oral semaglutide's safety profile was as expected in the SOUL trial. The data did not reveal any newly identified safety concerns for oral semaglutide. Overall, these findings solidify the proven safety and tolerability of the drug, with evidence already accumulated from over 33 million patient years of use.

Novo Nordisk applied for the extension of the oral semaglutide label to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) based on the results, with expected decisions in 2025.