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

Patients with type 2 diabetes and heart failure with preserved ejection fraction (HFpEF) had significant improvements for heart failure (HF)-related symptoms, physical limitations, and body weight with semaglutide versus placebo in the phase 3 STEP-HFpEF DM trial.

“We have previously demonstrated in the STEP-HFpEF trial that semaglutide, 2.4 mg once a week, significantly reduced HF symptoms and physical limitations, as well as body weight in patients with obesity-related HFpEF who did not have diabetes,” stated Prof. Mikhail Kosiborod (Saint Luke's Mid America Heart Institute, MO, USA) [1]. Prof. Kosiborod and colleagues initiated a special investigation of this cohort after noting a high prevalence of diabetes in HFpEF patients with greater symptom burden and worse functional conditions.

The current 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. The dual primary endpoints 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, a BMI of 37 kg/m², NT-proBNP of 493 pg/mL, and KCCQ-CSS of 59 points. One-third of the 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 -6.4% difference was also significant (P<0.001). At week 52, change in 6-minute walking distance, C-reactive protein, NT-proBNP, and HF event outcomes also favoured semaglutide compared with placebo.

Serious adverse events were seen in 17.7% of participants on semaglutide and 28.8% of those on placebo (P=0.002), with fewer cardiac disorders in the semaglutide group (6.1% vs 13.1%), and no signs of increased hypoglycaemia or retinal disorders.

“Collectively, the results both from the STEP-HFpEF and STEP-HFpEF DM 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.

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Posted on 16 May 202413 June 2024