STEP-HFpEF DM: Semaglutide beneficial in patients with HFpEF and diabetes

Significant differences in the endpoints of heart failure (HF)-related symptoms, physical limitations, and body weight marked a positive trial for semaglutide in HF with preserved ejection fraction (HFpEF) and type 2 diabetes. After 1 year, the estimated treatment differences in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and body weight were at 7.3 points and -6.4%.

The phase 3 STEP-HFpEF DM study (NCT04916470) randomised 617 adult patients with HFpEF and type-2 diabetes to receive either weekly semaglutide 2.4 mg after an escalation period of 16 weeks or matching placebo up to week 52 [1]. The dual primary endpoints, presented by Prof. Mikhail Kosiborod (Saint Luke's Mid America Heart Institute; University of Missouri, MO, USA), assessed change in body weight and modification in HF-related symptoms measured by KCCQ-CSS.

Baseline findings showed a study cohort with 44% women,  a median age of 69 years, Body Mass Index (BMI) of 37 kg/m², NT-proBNP of 493 pg/mL, and KCCQ-CSS of 59 points. One-third of participants were already treated with SGLT2 inhibitors.

At 1 year, participants in the semaglutide group achieved a significantly greater 13.7-point change in KCCQ-CSS compared with 6.4 points in the placebo arm (P<0.001). Weight loss on the study drug at week 52 was determined at -9.8%, compared with -3.4% on placebo. This difference of -6.4% was also significant: P<0.001. At week 52, results in favour of semaglutide were also found for change in 6-minute walk distance, C-reactive protein, NT-proBNP, and HF-events compared with placebo.

Safety results observed serious adverse events in 17.7% of participants on semaglutide and 28.8% on placebo (P=0.002), fewer cardiac disorders in the semaglutide group (6.1% vs 13.1%), together with no signs for increased hypoglycemia or retinal disorders.

“Collectively, the results both from STEP-HFpEF and the STEP-HFpEF type-2 diabetes trials indicate that treatment with semaglutide is a valuable treatment approach in the management of patients with obesity-related HFpEF both with and without type-2 diabetes,” Prof. Kosiborod concluded.

1. Kosiborod MN. Once-weekly semaglutide in patients with heart failure with preserved ejection fraction, obesity and type 2 diabetes: main results from the Step-HFpEF DM trial. FCR 1, Session 403, ACC 2024 Scientific Session, 6–8 April, Atlanta, USA.

 

Medical writing support was provided by Karin Drooff, MPH.
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Posted on 9 April, 20249 April, 2024