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Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction

JJV. McMurray, SD. Solomon, SE. Inzucchi, L. Køber, MN. Kosiborod, FA. Martinez, P. Ponikowski, MS. Sabatine, IS. Anand, J. Bělohlávek, M. Böhm, CE. Chiang, VK. Chopra, RA. de Boer, AS. Desai, M. Diez, J. Drozdz, A. Dukát, J. Ge, JG. Howlett, T....

. 2019 ; 381 (21) : 1995-2008. [pub] 20190919

Language English Country United States

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

E-resources Online Full text

NLK ProQuest Central from 1980-01-03 to 3 months ago
Nursing & Allied Health Database (ProQuest) from 1980-01-03 to 3 months ago
Health & Medicine (ProQuest) from 1980-01-03 to 3 months ago
Family Health Database (ProQuest) from 1980-01-03 to 3 months ago
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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<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. 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. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).

2nd Department of Internal Medicine Cardiovascular Medicine General Teaching Hospital and 1st Faculty of Medicine Charles University Prague Czech Republic

5th Department of Internal Medicine Comenius University in Bratislava Bratislava Slovakia

AstraZeneca Gothenburg Sweden

Cardiovascular Division and the TIMI Study Group Brigham and Women's Hospital and Harvard Medical School Boston

Cardiovascular Division of Medicine National Cerebral and Cardiovascular Center Osaka Japan

Cardiovascular Divisionand the TIMI Study Group Brigham and Women's Hospital and Harvard Medical School Boston

Clinic of Cardiology National Cardiology Hospital Sofia Bulgaria

Cumming School of Medicine and Libin Cardiovascular Institute University of Calgary Calgary AB

Department of Biostatistics and Medical Informatics University of Wisconsin Madison

Department of Cardiology Gentofte University Hospital

Department of Cardiology Medanta Gurgaon India

Department of Cardiology Medical University of Lodz Lodz Poland

Department of Cardiology Montreal Heart Institute Montreal

Department of Cardiology Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University Shanghai China

Department of Cardiology University Medical Center and University of Groningen Groningen the Netherlands

Department of Cardiology University of Minnesota Minneapolis

Department of Internal Medicine Tan Tao University Tan Duc Vietnam

Department of Medical Sciences Cardiology Uppsala Clinical Research Center Uppsala University Uppsala Sweden

Department of Medicine Saarland University Hospital Homburg Saar Germany

Department of Molecular and Clinical Medicine and Cardiology Sahlgrenska Academy

Department of Myocardial Disease and Heart Failure National Medical Research Center of Cardiology Moscow

Division of Cardiac Surgery St Michael's Hospital University of Toronto Toronto

Division of Cardiology Instituto Cardiovascular de Buenos Aires Buenos Aires Argentina

Division of Cardiology Taipei Veterans General Hospital and National Yang Ming University Taipei Taiwan

From the BHF Cardiovascular Research Centre University of Glasgow Glasgow United Kingdom

Heart and Vascular Center Semmelweis University Budapest Hungary

Instituto do Coracao Hospital das Clinicas da Faculdade de Medicina Universidade de São Paolo São Paolo

National University of Cordoba Cordoba

Rigshospitalet Copenhagen University Hospital

Saint Luke's Mid America Heart Institute University of Missouri Kansas City

Section of Endocrinology Yale University School of Medicine New Haven CT

TIMI Study Group Brigham and Women's Hospital and Harvard Medical School Boston

Wroclaw Medical University Wroclaw

References provided by Crossref.org

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