Semaglutide in Heart Failure with Preserved Ejection Fraction and Obesity PDF

new england journal of medicine The established in 1812 September 21, 2023 vol. 389 no. 12 Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity M.N. Kosiborod, S.Z. Abildstrøm, B.A. Borlaug, J. Butler, S. Rasmussen, M. Davies, G.K. Hovingh, D.W. Kitzman, M.L. Linde...

new england journal of medicine The established in 1812 September 21, 2023 vol. 389 no. 12 Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity M.N. Kosiborod, S.Z. Abildstrøm, B.A. Borlaug, J. Butler, S. Rasmussen, M. Davies, G.K. Hovingh, D.W. Kitzman, M.L. Lindegaard, D.V. Møller, S.J. Shah, M.B. Treppendahl, S. Verma, W. Abhayaratna, F.Z. Ahmed, V. Chopra, J. Ezekowitz, M. Fu, H. Ito, M. Lelonek, V. Melenovsky, B. Merkely, J. Núñez, E. Perna, M. Schou, M. Senni, K. Sharma, P. Van der Meer, D. von Lewinski, D. Wolf, and M.C Petrie, for the STEP-HFpEF Trial Committees and Investigators*​​ a bs t r ac t BACKGROUND Heart failure with preserved ejection fraction is increasing in prevalence and is associated with a high symptom burden and functional impairment, especially in persons with obesity. No therapies have been approved to target obesity-related heart failure with preserved ejection fraction. METHODS We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The dual 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 the 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. The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Dr. Kosiborod can be contacted at ­mkosiborod@​­saint-lukes​.­org or at Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd., Kansas City, MO 64111. *A list of the STEP HFpEF trial committees and investigators is provided in the Supplementary Appendix, available at NEJM.org. This article was published on August 25, 2023, at NEJM.org. N Engl J Med 2023;389:1069-84. DOI: 10.1056/NEJMoa2306963 Copyright © 2023 Massachusetts Medical Society. CME at NEJM.org RESULTS The mean change in the KCCQ-CSS was 16.6 points with semaglutide and 8.7 points with placebo (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; P