Selected Publication:

SHR Neuro Cancer Cardio Lipid Metab Microb

Kosiborod, MN; Petrie, MC; Borlaug, BA; Butler, J; Davies, MJ; Hovingh, GK; Kitzman, DW; Møller, DV; Treppendahl, MB; Verma, S; Jensen, TJ; Liisberg, K; Lindegaard, ML; Abhayaratna, W; Ahmed, FZ; Ben-Gal, T; Chopra, V; Ezekowitz, JA; Fu, M; Ito, H; Lelonek, M; Melenovský, V; Merkely, B; Núñez, J; Perna, E; Schou, M; Senni, M; Sharma, K; van, der, Meer, P; Von, Lewinski, D; Wolf, D; Shah, SJ, , STEP-HFpEF, DM, Trial, Committees, and, Investigators.
Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.
N Engl J Med. 2024; 390(15): 1394-1407. Doi: 10.1056/NEJMoa2313917
Web of Science PubMed FullText FullText_MUG

 

Co-authors Med Uni Graz

von Lewinski Dirk

Altmetrics:

Dimensions Citations:

Plum Analytics:

Scite (citation analytics):

Abstract:

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. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS: We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points 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 end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 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). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 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 with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.).

Find related publications in this database (using NLM MeSH Indexing)

Humans - administration & dosage

Diabetes Mellitus, Type 2 - drug therapy, etiology

Double-Blind Method - administration & dosage

Glucagon-Like Peptides - administration & dosage, adverse effects, therapeutic use

Heart Failure - drug therapy, etiology

Obesity - complications, drug therapy

Stroke Volume - administration & dosage

Glucagon-Like Peptide-1 Receptor Agonists - administration & dosage, adverse effects, therapeutic use

© Med Uni Graz • Imprint