TY - JOUR
T1 - Empagliflozin in heart failure with a preserved ejection fraction
AU - Anker, Stefan D.
AU - Butler, Javed
AU - Filippatos, Gerasimos
AU - Ferreira, João P.
AU - Bocchi, Edimar
AU - Böhm, Michael
AU - Brunner–La Rocca, Hans Peter
AU - Choi, Dong Ju
AU - Chopra, Vijay
AU - Chuquiure-Valenzuela, Eduardo
AU - Giannetti, Nadia
AU - Gomez-Mesa, Juan Esteban
AU - Janssens, Stefan
AU - Januzzi, James L.
AU - Gonzalez-Juanatey, Jose R.
AU - Merkely, Bela
AU - Nicholls, Stephen J.
AU - Perrone, Sergio V.
AU - Piña, Ileana L.
AU - Ponikowski, Piotr
AU - Senni, Michele
AU - Sim, David
AU - Spinar, Jindrich
AU - Squire, Iain
AU - Taddei, Stefano
AU - Tsutsui, Hiroyuki
AU - Verma, Subodh
AU - Vinereanu, Dragos
AU - Zhang, Jian
AU - Carson, Peter
AU - Ping Lam, Carolyn Su
AU - Marx, Nikolaus
AU - Zeller, Cordula
AU - Sattar, Naveed
AU - Jamal, Waheed
AU - Schnaidt, Sven
AU - Schnee, Janet M.
AU - Brueckmann, Martina
AU - Pocock, Stuart J.
AU - Zannad, Faiez
AU - Packer, Milton
N1 - Funding Information:
Supported by Boehringer Ingelheim and Eli Lilly. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
Publisher Copyright:
© 2021 American Society of Civil Engineers.
PY - 2021/10/14
Y1 - 2021/10/14
N2 - 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.
AB - 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.
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U2 - 10.1056/NEJMoa2107038
DO - 10.1056/NEJMoa2107038
M3 - Article
C2 - 34449189
AN - SCOPUS:85114487957
SN - 0028-4793
VL - 385
SP - 1451
EP - 1461
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 16
ER -
