Key message:
In this randomized clinical trial, the efficacy of semaglutide was evaluated in individuals with type 2 diabetes and obesity-related heart failure and preserved ejection fraction (HFpEF). The results revealed a notable reduction in heart failure-related symptoms and physical limitations, along with greater weight loss, among participants receiving semaglutide compared to those receiving placebo after one year. Additionally, the semaglutide group showed a lower incidence of serious adverse events compared to the placebo group. These findings underscore the cardiovascular benefits of semaglutide, complementing its weight loss effects, in individuals with obesity-related HFpEF and type 2 diabetes.
Summary:
Background:
Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. There are no approved therapies that specifically target obesity-related heart failure with preserved ejection fraction in people with type 2 diabetes.
Methods:
We randomly assigned patients who had heart failure with preserved ejection fraction, a body mass index (weight in kilograms divided by the square of height in meters) of 30 or more, and type 2 diabetes to receive semaglutide once a week. (2.4 mg) or placebo for 52 weeks. The primary endpoints were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary endpoints included change in 6-minute walk distance; a hierarchical composite endpoint that included death, heart failure events, and differences in change in the KCCQ-CSS and 6-minute walk distance; and the change in the level of C-reactive protein (CRP).
Results:
A total of 616 participants underwent randomization. The mean change on the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [IC], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001 ). Results for confirmatory secondary endpoints favored semaglutide over placebo (estimated difference between groups in change in 6-minute walk distance, 14.3 m [IC del 95%, 3.7 a 24.9; P=0.008]; gain ratio for hierarchical composite endpoint, 1.58 [IC del 95%, 1.29 a 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [IC del 95%, 0.55 a 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group.
Conclusions:
Among patients with obesity-related heart failure and preserved ejection fraction and type 2 diabetes, semaglutide led to greater reductions in heart failure-related symptoms and physical limitations, as well as greater weight loss than placebo. 1 year.
Fountain: BioPress
