Demonstrating safety and efficacy, semaglutide may be a “practice-changing therapy” for patients with heart failure with preserved ejection fraction and obesity.
In patients with heart failure with preserved ejection fraction (HFpEF) and obesity, treatment with semaglutide resulted in greater weight loss and improved HF-related symptoms compared with placebo. Together with the favorable safety profile, semaglutide presents itself as a practice-changing therapy in this patient population.
The phase 3 STEP-HFpEF trial investigated the effects of 2.4 mg subcutaneously administered semaglutide once weekly on HFpEF symptoms and physical functioning in patients with the obesity HFpEF phenotype. In total, 529 adult patients were randomly assigned 1:1 to the experimental arm or to a placebo. The co-primary endpoints were the change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and the percentage change in bodyweight from baseline to week 52. These results were presented at ESC Congress 2023.
The change in KCCQ-CSS at week 52 was 16.6 points in the active treatment arm and 8.7 points in the placebo arm, representing a significant 7.8-point benefit for the semaglutide arm (95% CI, 4.8–10.9; P<0.001). Next to that, bodyweight was reduced with 13.3% in the semaglutide arm and with 2.6% in the placebo arm, meeting this second primary endpoint (95% CI, -11.9 to -9.4; P<0.001). Furthermore, participants receiving semaglutide showed a significant improvement in 6-minute walking distance compared with those receiving placebo (mean difference 20.3 m; 95% CI, 8.6–32.1; P<0.001).
Serious adverse events (AEs) were more common in the placebo arm than in the semaglutide arm (26.7% vs 13.3%; P<0.001). This effect was mainly driven by a higher rate of cardiac disorders in the placebo arm (11.3% vs 2.7%;P<0.001). The AE rate of participants discontinuing treatment appeared to be somewhat higher in the experimental arm (13.3% vs 5.3%), mainly due to a difference in gastrointestinal AEs resulting in treatment discontinuations (9.5% vs 2.6%).
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