TY - JOUR
T1 - Cardiovascular and renal outcomes with empagliflozin in heart failure
AU - The EMPEROR-Reduced Trial Investigators
AU - Packer, Milton
AU - Anker, Stefan D.
AU - Butler, Javed
AU - Filippatos, Gerasimos
AU - Pocock, Stuart J.
AU - Carson, Peter
AU - Januzzi, James
AU - Verma, Subodh
AU - Tsutsui, Hiroyuki
AU - Brueckmann, Martina
AU - Jamal, Waheed
AU - Kimura, Karen
AU - Schnee, Janet
AU - Zeller, Cordula
AU - Cotton, Daniel
AU - Bocchi, Edimar
AU - Bohm, Michael
AU - Choi, Dong‑Ju J.
AU - Chopra, Vijay
AU - Chuquiure, Eduardo
AU - Giannetti, Nadia
AU - Janssens, Stefan
AU - Zhang, Jian
AU - Gonzalez Juanatey, Jose R.
AU - Kaul, Sanjay
AU - Brunner‑La Rocca, Hans‑Peter ‑P
AU - Merkely, Bela
AU - Nicholls, Stephen J.
AU - Perrone, Sergio
AU - Pina, Ileana
AU - Ponikowski, Piotr
AU - Sattar, Naveed
AU - Senni, Michele
AU - Seronde, Marie‑France ‑F
AU - Spinar, Jindrich
AU - Squire, Iain
AU - Taddei, Stefano
AU - Wanner, Christoph
AU - Zannad, Faiez
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:
© 2020 Massachusetts Medical Society.
PY - 2020/10/8
Y1 - 2020/10/8
N2 - 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.
AB - 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.
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U2 - 10.1056/NEJMoa2022190
DO - 10.1056/NEJMoa2022190
M3 - Article
C2 - 32865377
AN - SCOPUS:85090992310
SN - 0028-4793
VL - 383
SP - 1413
EP - 1424
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 15
ER -
