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Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

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posted on 2020-09-18, 14:07 authored by Milton Packer, Stefan D Anker, Javed Butler, Gerasimos Filippatos, Stuart J Pocock, Peter Carson, James Januzzi, Subodh Verma, Hiroyuki Tsutsui, Martina Brueckmann, Waheed Jamal, Karen Kimura, Janet Schnee, Cordula Zeller, Daniel Cotton, Edimar Bocchi, Michael Böhm, Dong-Ju Choi, Vijay Chopra, Eduardo Chuquiure, Nadia Giannetti, Stefan Janssens, Jian Zhang, Jose R Gonzalez Juanatey, Sanjay Kaul, Hans-Peter Brunner-La Rocca, Bela Merkely, Stephen J Nicholls, Sergio Perrone, Ileana Pina, Piotr Ponikowski, Naveed Sattar, Michele Senni, Marie-France Seronde, Jindrich Spinar, Iain Squire, Stefano Taddei, Christoph Wanner, Faiez Zannad
BACKGROUND
Sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.

METHODS
In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.

RESULTS
During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (–0.55 vs. –2.28 ml per minute per 1.73 m2 of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin.

CONCLUSIONS
Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977. opens in new tab.)

Funding

Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977

History

Citation

New England Journal of Medicine, 2020, https://doi.org/10.1056/NEJMoa2022190

Author affiliation

Department of Cardiovascular Sciences

Version

  • VoR (Version of Record)

Published in

New England Journal of Medicine

Publisher

Massachusetts Medical Society

issn

0028-4793

eissn

1533-4406

Copyright date

2020

Available date

2021-02-28

Language

en

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