• DOI:10.1056/NEJMoa2022190
• Corpus ID: 221383070

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure.

@article{Packer2020CardiovascularAR,
  title={Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure.},
  author={Milton Packer and Stefan D. Anker and Javed Butler and Gerasimos Filippatos and Stuart J. Pocock and Peter E. Carson and James L. 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 Alcides Bocchi and Michael B{\"o}hm and Dong Ju Choi and Vijay K. Chopra and Eduardo Chuquiure and Nadia Giannetti and Stefan Janssens and Jian Zhang and Jos{\'e} Ram{\'o}n Gonz{\'a}lez Juanatey and Sanjay Kaul and Hans-Peter Brunner-La Rocca and B{\'e}la Merkely and Stephen J. Nicholls and Sergio V. Perrone and Ileana L. Pi{\~n}a and Piotr Ponikowski and Naveed Sattar and Michele Senni and Marie France S{\'e}ronde and Jindřich {\vS}pinar and Iain B. Squire and Stefano Taddei and Christoph Wanner and Faiez Zannad},
  journal={The New England journal of medicine},
  year={2020}
}

• M. Packer, S. Anker, +36 authors F. Zannad
• Published 28 August 2020
• Medicine
• The New England journal of medicine

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. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.).