Summary:
In adults aged 18 years or older with obesity-related heart failure with preserved ejection fraction (HFpEF), characterized by a BMI ≥30 kg/m², left ventricular ejection fraction ≥45%, and New York Heart Association class II-IV symptoms, semaglutide 2.4 mg administered once weekly for 52 weeks significantly improved heart failure symptoms (mean KCCQ-CSS score increase of 7.5 points, 95% CI 5.3 to 9.8, p<0.0001) and reduced body weight by 8.4% (95% CI -9.2 to -7.5, p<0.0001) compared to matched placebo administered once weekly under identical conditions. Additional benefits included improved 6-minute walk distance (+17.1 meters, p<0.0001), reduced C-reactive protein (treatment ratio 0.64, p<0.0001), and fewer serious adverse events (161 vs. 301).
PICO | Description |
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Population | Adults aged 18 years or older with obesity-related heart failure with preserved ejection fraction (HFpEF), characterized by a BMI ≥30 kg/m², left ventricular ejection fraction ≥45%, and New York Heart Association class II-IV symptoms. The analysis included 1145 participants pooled from the STEP-HFpEF and STEP-HFpEF DM trials. |
Intervention | Administration of semaglutide 2.4 mg once weekly for 52 weeks. The dual primary endpoints were improvements in heart failure-related symptoms (Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score, KCCQ-CSS) and bodyweight reduction. |
Comparison | Matched placebo administered once weekly for 52 weeks under identical trial conditions. |
Outcome | Semaglutide significantly improved heart failure symptoms with a mean KCCQ-CSS score increase of 7.5 points (95% CI 5.3 to 9.8; p<0.0001) and reduced bodyweight by 8.4% (95% CI -9.2 to -7.5; p<0.0001) compared to placebo. Additional benefits included improved 6-min walk distance (+17.1 meters, p<0.0001), reduced C-reactive protein (treatment ratio 0.64, p<0.0001), and fewer serious adverse events (161 vs. 301). |
Source: Javed Butler, et al. “Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.” Lancet, 2024. Read article here.