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Dapagliflozin in patients with heart failure and reduced ejection fraction
McMurray, John J. V. Solomon, Scott D. Inzucchi, Silvio E. Kober, Lars Kosiborod, Mikhail N. Martinez, Felipe A. Ponikowski, Piotr Sabatine, Marc S. Anand, Inder S. Belohlavek, J.
McMurray, John J. V.
Solomon, Scott D.
Inzucchi, Silvio E.
Kober, Lars
Kosiborod, Mikhail N.
Martinez, Felipe A.
Ponikowski, Piotr
Sabatine, Marc S.
Anand, Inder S.
Belohlavek, J.
Author
McMurray, John J. V.
Solomon, Scott D.
Inzucchi, Silvio E.
Kober, Lars
Kosiborod, Mikhail N.
Martinez, Felipe A.
Ponikowski, Piotr
Sabatine, Marc S.
Anand, Inder S.
Belohlavek, J.
Bohm, Michael
Chiang, C.-E.
Chopra, Vijay K.
de Boer, Rudolf A.
Desai, Akshay S.
Diez, M.
Drozdz, J.
Dukat, Andrej
Ge, Junbo
Howlett, Jonathan G.
Katova, Tz
Kitakaze, M.
Ljungman, C. E. A.
Merkely, Bela
Nicolau, J. C.
O'Meara, Eileen
Petrie, Mark C.
Vinh, P. N.
Schou, Morten
Solomon, Scott D.
Inzucchi, Silvio E.
Kober, Lars
Kosiborod, Mikhail N.
Martinez, Felipe A.
Ponikowski, Piotr
Sabatine, Marc S.
Anand, Inder S.
Belohlavek, J.
Bohm, Michael
Chiang, C.-E.
Chopra, Vijay K.
de Boer, Rudolf A.
Desai, Akshay S.
Diez, M.
Drozdz, J.
Dukat, Andrej
Ge, Junbo
Howlett, Jonathan G.
Katova, Tz
Kitakaze, M.
Ljungman, C. E. A.
Merkely, Bela
Nicolau, J. C.
O'Meara, Eileen
Petrie, Mark C.
Vinh, P. N.
Schou, Morten
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<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.
Keywords
Date
2019
Type
Journal article
Journal
New England Journal of Medicine
Book
Volume
381
Issue
21
Page Range
1995-2008
Article Number
ACU Department
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