Empagliflozin in Heart Failure with a Preserved Ejection Fraction

S.D. Anker; J. Butler; G. Filippatos; J.P. Ferreira; E. Bocchi; M. Bohm; H.P. Brunner-La Rocca; D.J. Choi; V. Chopra; E. Chuquiure-Valenzuela; N. Giannetti; J.E. Gomez-Mesa; S. Janssens; J.L. Januzzi; J.R. Gonzalez-Juanatey; B. Merkely; S.J. Nicholls; S.V. Perrone; I.L. Pina; P. Ponikowski; M. Senni; D. Sim; J. Spinar; I. Squire; S. Taddei; H. Tsutsui; S. Verma; D. Vinereanu; J. Zhang; P. Carson; C.S.P. Lam; N. Marx; C. Zeller; N. Sattar; W. Jamal; S. Schnaidt; J.M. Schnee; M. Brueckmann; S.J. Pocock; F. Zannad; M. Packer; EMPEROR-Preserved Trial Investigators

doi:10.1056/NEJMoa2107038

Empagliflozin in Heart Failure with a Preserved Ejection Fraction

S.D. Anker^*, J. Butler^*, G. Filippatos, J.P. Ferreira, E. Bocchi, M. Bohm, H.P. Brunner-La Rocca, D.J. Choi, V. Chopra, E. Chuquiure-Valenzuela, N. Giannetti, J.E. Gomez-Mesa, S. Janssens, J.L. Januzzi, J.R. Gonzalez-Juanatey, B. Merkely, S.J. Nicholls, S.V. Perrone, I.L. Pina, P. PonikowskiM. Senni, D. Sim, J. Spinar, I. Squire, S. Taddei, H. Tsutsui, S. Verma, D. Vinereanu, J. Zhang, P. Carson, C.S.P. Lam, N. Marx, C. Zeller, N. Sattar, W. Jamal, S. Schnaidt, J.M. Schnee, M. Brueckmann, S.J. Pocock, F. Zannad, M. Packer, EMPEROR-Preserved Trial Investigators

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUNDSodium-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.METHODSIn 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.RESULTSOver 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.CONCLUSIONSEmpagliflozin 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 language	English
Pages (from-to)	1451-1461
Number of pages	11
Journal	New England Journal of Medicine
Volume	385
Issue number	16
Early online date	27 Aug 2021
DOIs	https://doi.org/10.1056/NEJMoa2107038
Publication status	Published - 14 Oct 2021

Keywords

SPIRONOLACTONE

Access to Document

10.1056/NEJMoa2107038

Cite this

Anker, S. D., Butler, J., Filippatos, G., Ferreira, J. P., Bocchi, E., Bohm, M., Brunner-La Rocca, H. P., Choi, D. J., Chopra, V., Chuquiure-Valenzuela, E., Giannetti, N., Gomez-Mesa, J. E., Janssens, S., Januzzi, J. L., Gonzalez-Juanatey, J. R., Merkely, B., Nicholls, S. J., Perrone, S. V., Pina, I. L., ... EMPEROR-Preserved Trial Investigators (2021). Empagliflozin in Heart Failure with a Preserved Ejection Fraction. New England Journal of Medicine, 385(16), 1451-1461. https://doi.org/10.1056/NEJMoa2107038

@article{9e616a365e914458bf51579e80fe3c22,

title = "Empagliflozin in Heart Failure with a Preserved Ejection Fraction",

abstract = "BACKGROUNDSodium-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.METHODSIn 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.RESULTSOver 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.CONCLUSIONSEmpagliflozin 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.",

keywords = "SPIRONOLACTONE",

author = "S.D. Anker and J. Butler and G. Filippatos and J.P. Ferreira and E. Bocchi and M. Bohm and {Brunner-La Rocca}, H.P. and D.J. Choi and V. Chopra and E. Chuquiure-Valenzuela and N. Giannetti and J.E. Gomez-Mesa and S. Janssens and J.L. Januzzi and J.R. Gonzalez-Juanatey and B. Merkely and S.J. Nicholls and S.V. Perrone and I.L. Pina and P. Ponikowski and M. Senni and D. Sim and J. Spinar and I. Squire and S. Taddei and H. Tsutsui and S. Verma and D. Vinereanu and J. Zhang and P. Carson and C.S.P. Lam and N. Marx and C. Zeller and N. Sattar and W. Jamal and S. Schnaidt and J.M. Schnee and M. Brueckmann and S.J. Pocock and F. Zannad and M. Packer and {EMPEROR-Preserved Trial Investigators}",

year = "2021",

month = oct,

day = "14",

doi = "10.1056/NEJMoa2107038",

language = "English",

volume = "385",

pages = "1451--1461",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "16",

}

Anker, SD, Butler, J, Filippatos, G, Ferreira, JP, Bocchi, E, Bohm, M, Brunner-La Rocca, HP, Choi, DJ, Chopra, V, Chuquiure-Valenzuela, E, Giannetti, N, Gomez-Mesa, JE, Janssens, S, Januzzi, JL, Gonzalez-Juanatey, JR, Merkely, B, Nicholls, SJ, Perrone, SV, Pina, IL, Ponikowski, P, Senni, M, Sim, D, Spinar, J, Squire, I, Taddei, S, Tsutsui, H, Verma, S, Vinereanu, D, Zhang, J, Carson, P, Lam, CSP, Marx, N, Zeller, C, Sattar, N, Jamal, W, Schnaidt, S, Schnee, JM, Brueckmann, M, Pocock, SJ, Zannad, F, Packer, M & EMPEROR-Preserved Trial Investigators 2021, 'Empagliflozin in Heart Failure with a Preserved Ejection Fraction', New England Journal of Medicine, vol. 385, no. 16, pp. 1451-1461. https://doi.org/10.1056/NEJMoa2107038

TY - JOUR

T1 - Empagliflozin in Heart Failure with a Preserved Ejection Fraction

AU - Anker, S.D.

AU - Butler, J.

AU - Filippatos, G.

AU - Ferreira, J.P.

AU - Bocchi, E.

AU - Bohm, M.

AU - Brunner-La Rocca, H.P.

AU - Choi, D.J.

AU - Chopra, V.

AU - Chuquiure-Valenzuela, E.

AU - Giannetti, N.

AU - Gomez-Mesa, J.E.

AU - Janssens, S.

AU - Januzzi, J.L.

AU - Gonzalez-Juanatey, J.R.

AU - Merkely, B.

AU - Nicholls, S.J.

AU - Perrone, S.V.

AU - Pina, I.L.

AU - Ponikowski, P.

AU - Senni, M.

AU - Sim, D.

AU - Spinar, J.

AU - Squire, I.

AU - Taddei, S.

AU - Tsutsui, H.

AU - Verma, S.

AU - Vinereanu, D.

AU - Zhang, J.

AU - Carson, P.

AU - Lam, C.S.P.

AU - Marx, N.

AU - Zeller, C.

AU - Sattar, N.

AU - Jamal, W.

AU - Schnaidt, S.

AU - Schnee, J.M.

AU - Brueckmann, M.

AU - Pocock, S.J.

AU - Zannad, F.

AU - Packer, M.

AU - EMPEROR-Preserved Trial Investigators

PY - 2021/10/14

Y1 - 2021/10/14

N2 - BACKGROUNDSodium-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.METHODSIn 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.RESULTSOver 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.CONCLUSIONSEmpagliflozin 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 - BACKGROUNDSodium-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.METHODSIn 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.RESULTSOver 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.CONCLUSIONSEmpagliflozin 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.

KW - SPIRONOLACTONE

U2 - 10.1056/NEJMoa2107038

DO - 10.1056/NEJMoa2107038

M3 - Article

C2 - 34449189

SN - 0028-4793

VL - 385

SP - 1451

EP - 1461

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 16

ER -