Empagliflozin in heart failure with a preserved ejection fraction

Stefan D. Anker, Javed Butler, Gerasimos Filippatos, João P. Ferreira, Edimar Bocchi, Michael Böhm, Hans Peter Brunner–La Rocca, Dong Ju Choi, Vijay Chopra, Eduardo Chuquiure-Valenzuela, Nadia Giannetti, Juan Esteban Gomez-Mesa, Stefan Janssens, James L. Januzzi, Jose R. Gonzalez-Juanatey, Bela Merkely, Stephen J. Nicholls, Sergio V. Perrone, Ileana L. Piña, Piotr PonikowskiMichele Senni, David Sim, Jindrich Spinar, Iain Squire, Stefano Taddei, Hiroyuki Tsutsui, Subodh Verma, Dragos Vinereanu, Jian Zhang, Peter Carson, Carolyn Su Ping Lam, Nikolaus Marx, Cordula Zeller, Naveed Sattar, Waheed Jamal, Sven Schnaidt, Janet M. Schnee, Martina Brueckmann, Stuart J. Pocock, Faiez Zannad, Milton Packer

Research output: Contribution to journalArticlepeer-review

33 Citations (Scopus)

Abstract

BACKGROUND Sodium–glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. METHODS In this double-blind trial, we randomly assigned 5988 patients with class II–IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. RESULTS Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin. CONCLUSIONS Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes.

Original languageEnglish
Pages (from-to)1451-1461
Number of pages11
JournalNew England Journal of Medicine
Volume385
Issue number16
DOIs
Publication statusPublished - Oct 14 2021

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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