Presented at the ESC Congress 2023 by:Mikhail Kosiborod, MD - Kansas City, MO, USA
A large proportion of patients with HFpEF are overweight or have obesity. It has become increasingly clear that obesity is not just a comorbidity, but plays a key role in the development and progression of HFpEF. The GLP-1RA semaglutide has previously shown to promote weight loss in patients with obesity or overweight. The current STEP HFpEF trial investigated the effects of semaglutide on symptoms, physical limitations, exercise function, and weight loss, in patients with HFpEF and obesity.
The trial randomized 529 patients (mean age 69 years, 56.1% women) with HFpEF (LVEF â¥45%), BMI â¥30 kg/m2, NYHA class IIâIV and KCCQ-CSS <90 points in a 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo for 52 weeks.
The first primary endpoint was change in KCCQ-CSS from baseline to week 52 and the second primary endpoint was change in body weight during the same time period. Confirmatory secondary endpoints were change in 6-minute walk distance (6MWD) , a hierarchical composite endpoint (consisting of death, HF events, change in KCCQ-CSS, and change in 6MWD), and change in CRP.
Dual primary outcomes
Confirmatory secondary endpoints
Exploratory outcomes
Safety results
Once-weekly semaglutide 2.4 mg improved HF-related symptoms, physical limitations and exercise function, and led to greater weight loss in patients with HFpEF and obesity, compared with placebo. Mikhail Kosiborod said âCollectively, these results indicate that treatment with semaglutide is a valuable therapeutic approach in the management of patients with HFpEF and obesityâ.
The results of this study were simultaneously published in N. Engl. J. Med. Watch the video with Mikhail Kosiborod about this trial
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