Semaglutide, a GLP-1 receptor originally developed to treat diabetes, is associated with weight loss and fewer adverse events among obese heart failure patients with preserved ejection fraction (HFpEF), according to new research presented at ESC Congress 2023. The study also was simultaneously published in the New England Journal of Medicine.
Novo Nordisk, which sells subcutaneous treatments of semaglutide 2.4 mg under the brand name Wegovy, recently shared new data suggesting the medication can help overweight and obese patients reduce their risk of experiencing a major adverse cardiovascular event—including a heart attack or stroke—by 20%. For this latest study, STEP-HFpEF, specialists examined data from more than 500 obese HFpEF patients who were randomized to either receive weekly semaglutide treatments or a placebo for one year. Considering the high number of HFpEF patients who are obese, interest in the potential impact of treating this patient population with semaglutide is particularly high.
The median patient age was 69 years old, median body weight was 105.1 kg and median body mass index was 37.0 kg/m2. Patients came from 13 different countries throughout North America, South America, Europe and Asia. A Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) was calculated for each participant at the beginning and end of the study.
Overall, patients from the semaglutide group saw a mean change in KCCQ-CSS score of 16.6 points, nearly double the change among patients from the placebo group. In addition, the semaglutide group was associated with a much more dramatic improvement in six-minute walk distance (21.5 m vs. 1.2 m), a greater reduction in body weight (13.3% vs. 2.6%) and a lower serious adverse event rate (13.3% vs. 26.7%) than patients in the placebo group.
“To our knowledge, this is the first trial of a pharmacologic agent to specifically target obesity as a treatment strategy for HFpEF, and the magnitude of the benefits we observed is the largest seen with any agent in HFpEF,” principal investigator Mikhail Kosiborod, MD, a cardiologist with Saint Luke’s Mid America Heart Institute in Kansas City, said in an ESC statement. “This will likely have a significant impact on clinical practice, especially since there is a dearth of efficacious therapies in this vulnerable patient group. We believe that these findings should also change the nature of the conversation about the role of obesity in HFpEF, as the STEP-HFpEF results clearly indicate that obesity is not simply a comorbidity in patients with HFpEF but a root cause and a target for therapeutic intervention.”
Novo Nordisk plans on seeking regulatory approval for semaglutide as a treatment for cardiovascular disease in the United States and Europe in the near future. For now, it has not been approved by the U.S. Food and Drug Administration for this specific indication.
Read the full study here.
ESC Congress, the annual meeting of the European Society of Cardiology, is underway in Amsterdam. Additional details about the research being presented during the four-day event are available here and here.