Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

Abstract

BACKGROUND 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. METHODS 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. RESULTS 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 CONCLUSIONS 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.

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Affiliated Institutions

• Brigham and Women's Hospital US
• Fudan University CN
• St. Michael's Hospital CA
• University of Wisconsin–Madison US
• Harvard University US
• Copenhagen University Hospital DK
• Comenius University Bratislava SK
• National Cerebral and Cardiovascular Center JP
• Yale University US
• Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo BR
• Montreal Heart Institute CA
• Thrombolysis in Myocardial Infarction Study Group US
• Saarland University DE
• Tân Tạo University VN
• National Medical Research Center of Cardiology RU
• University of Toronto CA
• Wroclaw Medical University PL
• University of Groningen NL
• Sun Yat-sen University CN
• University Medical Center Groningen NL
• Saint Luke's Hospital US
• Medical University of Lodz PL
• Taipei Veterans General Hospital TW
• Universidad Nacional de Córdoba AR
• Rigshospitalet DK
• University of Missouri–Kansas City US
• National Heart Hospital BG
• Instituto do Coração PT
• The First Affiliated Hospital, Sun Yat-sen University CN
• University of Glasgow GB
• University of Minnesota US
• National Yang Ming Chiao Tung University TW
• Medanta The Medicity IN
• Gentofte Hospital DK
• Charles University CZ
• Libin Cardiovascular Institute of Alberta CA
• Swedish Academy SE
• Uppsala University SE
• University of Calgary CA
• Instituto Cardiovascular de Buenos Aires AR
• Zhongshan Hospital CN
• Semmelweis University HU

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