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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....
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
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
Psychology Database (ProQuest)
from 1980-01-03 to 3 months ago
Health Management Database (ProQuest)
from 1980-01-03 to 3 months ago
Public Health Database (ProQuest)
from 1980-01-03 to 3 months ago
PubMed
31535829
DOI
10.1056/nejmoa1911303
Knihovny.cz E-resources
- MeSH
- Benzhydryl Compounds adverse effects therapeutic use MeSH
- Diabetes Mellitus, Type 2 blood complications drug therapy MeSH
- Ventricular Dysfunction, Left complications drug therapy MeSH
- Sodium-Glucose Transporter 2 Inhibitors adverse effects therapeutic use MeSH
- Glucosides adverse effects therapeutic use MeSH
- Glycated Hemoglobin analysis MeSH
- Hospitalization MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Agents therapeutic use MeSH
- Cardiovascular Diseases mortality MeSH
- Drug Therapy, Combination MeSH
- Combined Modality Therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Heart Failure complications drug therapy MeSH
- Stroke Volume drug effects MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.).
5th Department of Internal Medicine Comenius University in Bratislava Bratislava Slovakia
Cardiovascular Division of Medicine National Cerebral and Cardiovascular Center Osaka Japan
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 University of Minnesota Minneapolis
Department of Internal Medicine Tan Tao University Tan Duc Vietnam
Department of Medicine Saarland University Hospital Homburg Saar Germany
Department of Molecular and Clinical Medicine and Cardiology Sahlgrenska Academy
Division of Cardiac Surgery St Michael's Hospital University of Toronto Toronto
Division of Cardiology Instituto Cardiovascular de Buenos Aires Buenos Aires Argentina
From the BHF Cardiovascular Research Centre University of Glasgow Glasgow United Kingdom
Heart and Vascular Center Semmelweis University Budapest Hungary
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
References provided by Crossref.org
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