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Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction.

Journal article
Authors John J V McMurray
Scott D Solomon
Silvio E Inzucchi
Lars Kober
Mikhail N Kosiborod
Felipe A Martinez
Piotr Ponikowski
Marc S Sabatine
Inder S Anand
Jan Belohlavek
Michael Böhm
Chern-En Chiang
Vijay K Chopra
Rudolf A de Boer
Aksahay S Desai
Mirta Diez
Jaroslaw Drozdz
Andrej Dukát
Junbo Ge
Jonathan G Howlett
Tzvetana Katova
Masafumi Kitakaze
Charlotta Ljungman
Béla Merkely
Jose C Nicolau
Eileen O´Meara
Mark C Petrie
Pham N Vinh
Morten Schou
Sergey Tereshchenko
Subodh Verma
Claes Held
David L DeMets
Kieran F Docherty
Pardeep S Jhund
Olof Bengtsson
Mikaela Sjöstrand
Anna Maria Langkilde
Published in The New England journal of medicine
ISSN 1533-4406
Publication year 2019
Published at Institute of Medicine, Department of Molecular and Clinical Medicine
Language en
Links dx.doi.org/10.1056/NEJMoa1911303
www.ncbi.nlm.nih.gov/entrez/query.f...
Subject categories Cardiovascular medicine

Abstract

In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes.In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death.Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups.Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).

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