Heart failure & cardiomyopathies

Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity

N Engl J MedPublished Randomised controlled trial

Authors' conclusion

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.

Study context

Population
Patients with HFpEF and BMI ≥30
Participants
529 patients
Comparison
Semaglutide 2.4 mg once weekly vs placebo
Primary endpoint
Dual: change from baseline in KCCQ-CSS (0–100, higher = fewer symptoms and physical limitations) and change in body weight
Follow-up
52 weeks
Methodological detailsplacebo-controlled
  • Placebo-controlled

Primary result

As reported in the abstract

Semaglutide

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) mean change
16.6 points
Body weight mean % change
−13.3%

Placebo

KCCQ-CSS mean change
8.7 points
Body weight mean % change
−2.6%

Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) mean change

Semaglutide16.6 points
Placebo8.7 points

Body weight mean % change

Semaglutide−13.3%
Placebo−2.6%
Semaglutide vs PlaceboEstimated difference, points (95% CI)P value
KCCQ-CSS
7.8(4.8–10.9)
P < 0.001
Semaglutide vs PlaceboEstimated difference, percentage points (95% CI)P value
Body weight
−10.7(−11.9 to −9.4)
P < 0.001

Secondary outcomes

Mean change, m

OutcomeSemaglutidePlaceboEstimated difference (m) (95% CI)P value
6-minute walk distance (confirmatory secondary)21.51.220.3 (8.6–32.1)P < 0.001
OutcomeWin ratio (95% CI)P value
Hierarchical composite (death, HF events, KCCQ-CSS and 6-minute walk distance change)1.72 (1.37–2.15)P < 0.001

Mean percentage change

OutcomeSemaglutidePlaceboEstimated treatment ratio (95% CI)P value
CRP level−43.5%−7.3%0.61 (0.51–0.72)P < 0.001

Safety

Serious adverse events

Original publication

Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. Published 25 August 2023. doi:10.1056/nejmoa2306963

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