Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
Last week, we reported on a study presented at the European Society of Cardiology Congress 2023 and simultaneously published in the New England Journal of Medicine that aimed to test the hypothesis that treatment with semaglutide 2.4 mg could substantially improve symptoms, physical limitations, and exercise function, in addition to promoting weight loss, in patients with heart failure with preserved ejection fraction (HFpEF) and obesity.
The phase 3 STEP-HFpEF (Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects with Obesity-related Heart Failure with Preserved Ejection Fraction) clinical trial was a randomized, double-blind, placebo-controlled study conducted at 96 sites in 13 countries in Asia, Europe, and North and South America.
For study inclusion participants were required to have HFpEF (LVEF ≥45%), body mass index (BMI) ≥30 kg/m2, heart failure symptoms and functional limitations (New York Heart Association functional class II–IV and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score [KCCQ-CSS] <90 points). Potential participants were excluded for a self-reported change in body weight of >5 kg within 90 days of screening or a history of diabetes.
Participants were assigned randomly in a 1:1 ratio to receive treatment with semaglutide 2.4 mg or placebo for 52 weeks. Investigators defined dual primary endpoints: change from baseline to week 52 in KCCQ-CSS (range, 0 to 100) and change in body weight.
The final cohort numbered 529 participants; 263 were randomly assigned to receive semaglutide 2.4 mg and 266 to receive placebo.
The mean change in KCCQ-CSS from baseline to week 52 was 16.6 points with semaglutide versus 8.7 points with placebo (estimated treatment difference [ETD], 7.8 points; 95% CI, 4.8 to 10.9; P<.001). The observed mean change in bodyweight was also statistically significant, recorded from baseline to week 52 at -13.3% with semaglutide vs -2.6% with placebo (ETD, -10.7%; 95% CI -11.9% to -9.4%; P<.001).
"In patients with heart failure with preserved ejection fraction and obesity, treatment with semaglutide (2.4 mg) led to larger reductions in symptoms and physical limitations, greater improvements in exercise function, and greater weight loss than placebo."