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Differences in the endpoints of HF-related symptoms, physical limitations, and body weight shown in trial for semaglutide for patients with HFpEF and T2D.
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 T2D. After one 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) randomized 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 Mikhail Kosiborod, MD, assessed change in body weight and modification in HF-related symptoms measured by KCCQ-CSS.
Baseline findings showed a study cohort with 44% women, median age of 69 years, BMI of 37 kg/m2, N-terminal pro-B-type natriuretic peptide level (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 difference of -6.4% was also significant: P<0.001. At week 52, results also favored semaglutide 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,” Dr. Kosiborod concluded.
Medical writing support was provided by Karin Drooff, MPH.
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