Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

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 Boehm; 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; EMPEROR-Reduced Trial Investigators

doi:10.1056/NEJMoa2022190

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

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 Boehm, Dong-Ju Choi, Vijay Chopra, Eduardo ChuquiureNadia 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, EMPEROR-Reduced Trial Investigators

^*Corresponding author for this work

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

Abstract

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

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.

Original language	English
Pages (from-to)	1413-1424
Number of pages	12
Journal	New England Journal of Medicine
Volume	383
Issue number	15
DOIs	https://doi.org/10.1056/NEJMoa2022190
Publication status	Published - 8 Oct 2020

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10.1056/NEJMoa2022190

Cite this

Packer, M., Anker, S. D., Butler, J., Filippatos, G., Pocock, S. J., Carson, P., Januzzi, J., Verma, S., Tsutsui, H., Brueckmann, M., Jamal, W., Kimura, K., Schnee, J., Zeller, C., Cotton, D., Bocchi, E., Boehm, M., Choi, D.-J., Chopra, V., ... EMPEROR-Reduced Trial Investigators (2020). Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. New England Journal of Medicine, 383(15), 1413-1424. https://doi.org/10.1056/NEJMoa2022190

@article{1ee4889f434a4d5fa5b3aa55812cb817,

title = "Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure",

abstract = "BACKGROUNDSodium-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.METHODSIn 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.RESULTSDuring 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; PCONCLUSIONSAmong 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.",

author = "Milton Packer and Anker, {Stefan D.} and Javed Butler and Gerasimos Filippatos and Pocock, {Stuart J.} and Peter Carson and James Januzzi and Subodh Verma and Hiroyuki Tsutsui and Martina Brueckmann and Waheed Jamal and Karen Kimura and Janet Schnee and Cordula Zeller and Daniel Cotton and Edimar Bocchi and Michael Boehm and Dong-Ju Choi and Vijay Chopra and Eduardo Chuquiure and Nadia Giannetti and Stefan Janssens and Jian Zhang and Juanatey, {Jose R. Gonzalez} and Sanjay Kaul and {Brunner-La Rocca}, Hans-Peter and Bela Merkely and Nicholls, {Stephen J.} and Sergio Perrone and Ileana Pina and Piotr Ponikowski and Naveed Sattar and Michele Senni and Marie-France Seronde and Jindrich Spinar and Iain Squire and Stefano Taddei and Christoph Wanner and Faiez Zannad and {EMPEROR-Reduced Trial Investigators}",

note = "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: {\textcopyright} 2020 Massachusetts Medical Society.",

year = "2020",

month = oct,

day = "8",

doi = "10.1056/NEJMoa2022190",

language = "English",

volume = "383",

pages = "1413--1424",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "15",

}

Packer, M, Anker, SD, Butler, J, Filippatos, G, Pocock, SJ, Carson, P, Januzzi, J, Verma, S, Tsutsui, H, Brueckmann, M, Jamal, W, Kimura, K, Schnee, J, Zeller, C, Cotton, D, Bocchi, E, Boehm, M, Choi, D-J, Chopra, V, Chuquiure, E, Giannetti, N, Janssens, S, Zhang, J, Juanatey, JRG, Kaul, S, Brunner-La Rocca, H-P, Merkely, B, Nicholls, SJ, Perrone, S, Pina, I, Ponikowski, P, Sattar, N, Senni, M, Seronde, M-F, Spinar, J, Squire, I, Taddei, S, Wanner, C, Zannad, F & EMPEROR-Reduced Trial Investigators 2020, 'Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure', New England Journal of Medicine, vol. 383, no. 15, pp. 1413-1424. https://doi.org/10.1056/NEJMoa2022190

TY - JOUR

T1 - Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

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 - Boehm, Michael

AU - Choi, Dong-Ju

AU - Chopra, Vijay

AU - Chuquiure, Eduardo

AU - Giannetti, Nadia

AU - Janssens, Stefan

AU - Zhang, Jian

AU - Juanatey, Jose R. Gonzalez

AU - Kaul, Sanjay

AU - Brunner-La Rocca, Hans-Peter

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

AU - Spinar, Jindrich

AU - Squire, Iain

AU - Taddei, Stefano

AU - Wanner, Christoph

AU - Zannad, Faiez

AU - EMPEROR-Reduced Trial Investigators

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 - BACKGROUNDSodium-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.METHODSIn 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.RESULTSDuring 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; PCONCLUSIONSAmong 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 - BACKGROUNDSodium-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.METHODSIn 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.RESULTSDuring 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; PCONCLUSIONSAmong 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.

U2 - 10.1056/NEJMoa2022190

DO - 10.1056/NEJMoa2022190

M3 - Article

C2 - 32865377

SN - 0028-4793

VL - 383

SP - 1413

EP - 1424

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 15

ER -