Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction

Solomon, S. D. et al. (2022) Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. New England Journal of Medicine, 387(12), pp. 1089-1098. (doi: 10.1056/NEJMoa2206286) (PMID:36027570)

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Abstract

Background: Sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain. Methods: We randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis. Results: Over a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P<0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups. Conclusions: Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.).

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Jhund, Professor Pardeep and McMurray, Professor John
Authors: Solomon, S. D., McMurray, J. J.V., Claggett, B., de Boer, R. A., DeMets, D., Hernandez, A. F., Inzucchi, S. E., Kosiborod, M. N., Lam, C. S.P., Martinez, F., Shah, S. J., Desai, A. S., Jhund, P. S., Belohlavek, J., Chiang, C.-E., Borleffs, C. J. W., Comin-Colet, J., Dobreanu, D., Drozdz, J., Fang, J. C., Alcocer-Gamba, M. A., Al Habeeb, W., Han, Y., Cabrera Honorio, J. W., Janssens, S. P., Katova, T., Kitakaze, M., Merkely, B., O’Meara, E., Saraiva, J. F. K., Tereshchenko, S. N., Thierer, J., Vaduganathan, M., Vardeny, O., Verma, S., Pham, V. N., Wilderäng, U., Zaozerska, N., Bachus, E., Lindholm, D., Petersson, M., and Langkilde, A. M.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:New England Journal of Medicine
Publisher:Massachusetts Medical Society
ISSN:0028-4793
ISSN (Online):1533-4406
Published Online:27 August 2022
Copyright Holders:Copyright © 2022 Massachusetts Medical Society
First Published:First published in New England Journal of Medicine 387(12): 1089-1098
Publisher Policy:Reproduced in accordance with the publisher copyright policy
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