N Engl J Med

Trial evaluates semaglutide in patients with HFpEF and obesity

August 31, 2023

Compared with placebo, semaglutide (2.4 mg SC weekly) resulted in larger reductions in symptoms and physical limitations, greater improvements in exercise function, and greater weight loss.

• In the STEP-HFpEF trial, researchers randomly assigned 529 patients with HFpEF and BMI ≥30 to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. Dual primary end points: change from baseline in Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; score range, 0-100, higher scores indicating fewer symptoms and physical limitations) and change in body weight. Secondary end points: change in 6-minute walk distance; a hierarchical composite end point including death, HF events, and differences in change in KCCQ-CSS and 6-minute walk distance; and change in CRP level.
• Primary end points: Mean change in KCCQ-CSS was 16.6 points in the semaglutide group and 8.7 points in the placebo group (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; P<0.001), while mean percentage change in body weight was -13.3% with semaglutide and -2.6% with placebo (estimated difference, -10.7 percentage points; 95% CI, -11.9 to -9.4; P<0.001).
• Secondary end points: Mean change in 6-minute walk distance: 21.5 m with semaglutide and 1.2 m with placebo (estimated difference, 20.3 m; 95% CI, 8.6 to 32.1; P<0.001). Regarding the hierarchical composite end point, semaglutide was favored over placebo (win ratio, 1.72; 95% CI, 1.37 to 2.15; P<0.001). Mean percentage change in CRP level: -43.5% with semaglutide and -7.3% with placebo (estimated treatment ratio, 0.61; 95% CI, 0.51 to 0.72; P<0.001). The rate of serious adverse events was 13.3% in the semaglutide group vs. 26.7% in the placebo group.

Source:

Kosiborod MN, et al. (2023, August 25). N Engl J Med. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. https://pubmed.ncbi.nlm.nih.gov/37622681/