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Semaglutide in HFpEF across obesity class and by body weight reduction: a prespecified analysis of the STEP-HFpEF trial
BA. Borlaug, DW. Kitzman, MJ. Davies, S. Rasmussen, E. Barros, J. Butler, MN. Einfeldt, GK. Hovingh, DV. Møller, MC. Petrie, SJ. Shah, S. Verma, W. Abhayaratna, FZ. Ahmed, V. Chopra, J. Ezekowitz, M. Fu, H. Ito, M. Lelonek, V. Melenovsky, J....
Language English Country United States
Document type Journal Article, Research Support, U.S. Gov't, Non-P.H.S., Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Grant support
R01 HL162828
NHLBI NIH HHS - United States
R01 AG078153
NIA NIH HHS - United States
R01 HL140731
NHLBI NIH HHS - United States
R01 HL128526
NHLBI NIH HHS - United States
R01 HL127028
NHLBI NIH HHS - United States
R01 AG018915
NIA NIH HHS - United States
U24 AG059624
NIA NIH HHS - United States
R01 HL107577
NHLBI NIH HHS - United States
R01 HL149423
NHLBI NIH HHS - United States
P30 AG021332
NIA NIH HHS - United States
R01 AG045551
NIA NIH HHS - United States
U54 HL160273
NHLBI NIH HHS - United States
U01 HL160272
NHLBI NIH HHS - United States
U01 HL160226
NHLBI NIH HHS - United States
U01 AG076928
NIA NIH HHS - United States
- MeSH
- C-Reactive Protein MeSH
- Weight Loss MeSH
- Humans MeSH
- Obesity complications drug therapy MeSH
- Heart Failure * MeSH
- Body Weight MeSH
- Stroke Volume MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Research Support, N.I.H., Extramural MeSH
- Research Support, U.S. Gov't, Non-P.H.S. MeSH
In the STEP-HFpEF trial, semaglutide improved symptoms, physical limitations and exercise function and reduced body weight in patients with obesity phenotype of heart failure and preserved ejection fraction (HFpEF). This prespecified analysis examined the effects of semaglutide on dual primary endpoints (change in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) and body weight) and confirmatory secondary endpoints (change in 6-minute walk distance (6MWD), hierarchical composite (death, HF events, change in KCCQ-CSS and 6MWD) and change in C-reactive protein (CRP)) across obesity classes I-III (body mass index (BMI) 30.0-34.9 kg m-2, 35.0-39.9 kg m-2 and ≥40 kg m-2) and according to body weight reduction with semaglutide after 52 weeks. Semaglutide consistently improved all outcomes across obesity categories (P value for treatment effects × BMI interactions = not significant for all). In semaglutide-treated patients, improvements in KCCQ-CSS, 6MWD and CRP were greater with larger body weight reduction (for example, 6.4-point (95% confidence interval (CI): 4.1, 8.8) and 14.4-m (95% CI: 5.5, 23.3) improvements in KCCQ-CSS and 6MWD for each 10% body weight reduction). In participants with obesity phenotype of HFpEF, semaglutide improved symptoms, physical limitations and exercise function and reduced inflammation and body weight across obesity categories. In semaglutide-treated patients, the magnitude of benefit was directly related to the extent of weight loss. Collectively, these data support semaglutide-mediated weight loss as a key treatment strategy in patients with obesity phenotype of HFpEF. ClinicalTrials.gov identifier: NCT04788511 .
Cardiovascular Department ASST Papa Giovanni XXIII Hospital Bergamo Italy
Clinical Cardiology Heart Failure and Research Max Super Specialty Hospital Saket New Delhi India
College of Health and Medicine The Australian National University Canberra ACT Australia
Department of Cardiology Herlev Gentofte Hospital University of Copenhagen Herlev Denmark
Department of Cardiovascular Medicine Mayo Clinic Rochester MN USA
Department of General Internal Medicine 3 Kawasaki Medical School Okayama Japan
Department of Noninvasive Cardiology Medical University of Lodz Lodz Poland
Diabetes Research Centre University of Leicester Leicester UK
Division of Cardiology Medical University of Graz Graz Austria
Institute for Clinical and Experimental Medicine IKEM Prague Czech Republic
Instituto de Cardiologia J F Cabral Corrientes Argentina
NIHR Leicester Biomedical Research Centre Leicester UK
Novo Nordisk A S Søborg Denmark
School of Cardiovascular and Metabolic Health University of Glasgow Glasgow UK
Section of Cardiology Department of Medicine Sahlgrenska University Hospital Ostra Gothenburg Sweden
References provided by Crossref.org
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- $a In the STEP-HFpEF trial, semaglutide improved symptoms, physical limitations and exercise function and reduced body weight in patients with obesity phenotype of heart failure and preserved ejection fraction (HFpEF). This prespecified analysis examined the effects of semaglutide on dual primary endpoints (change in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) and body weight) and confirmatory secondary endpoints (change in 6-minute walk distance (6MWD), hierarchical composite (death, HF events, change in KCCQ-CSS and 6MWD) and change in C-reactive protein (CRP)) across obesity classes I-III (body mass index (BMI) 30.0-34.9 kg m-2, 35.0-39.9 kg m-2 and ≥40 kg m-2) and according to body weight reduction with semaglutide after 52 weeks. Semaglutide consistently improved all outcomes across obesity categories (P value for treatment effects × BMI interactions = not significant for all). In semaglutide-treated patients, improvements in KCCQ-CSS, 6MWD and CRP were greater with larger body weight reduction (for example, 6.4-point (95% confidence interval (CI): 4.1, 8.8) and 14.4-m (95% CI: 5.5, 23.3) improvements in KCCQ-CSS and 6MWD for each 10% body weight reduction). In participants with obesity phenotype of HFpEF, semaglutide improved symptoms, physical limitations and exercise function and reduced inflammation and body weight across obesity categories. In semaglutide-treated patients, the magnitude of benefit was directly related to the extent of weight loss. Collectively, these data support semaglutide-mediated weight loss as a key treatment strategy in patients with obesity phenotype of HFpEF. ClinicalTrials.gov identifier: NCT04788511 .
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