Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
Milton Packer, Stefan D. Anker, Javed Butler, Gerasimos Filippatos, Stuart Pocock, Peter E. Carson, James L. Januzzi, Subodh Verma, Hiroyuki Tsutsui, Martina Brueckmann, Waheed Jamal, Karen Kimura, Janet Schnee, Cordula Zeller, Daniel Cotton, Edimar Alcides Bocchi, Michael Böhm, Dong‐Ju Choi, Vijay Chopra, Eduardo Chuquiure‐Valenzuela, Nadia Giannetti, Stefan Janssens, Jian Zhang, José Ramón González‐Juanatey, Sanjay Kaul, Hans‐Peter Brunner‐La Rocca, Béla Merkely, Stephen J. Nicholls, Sergio V. Perrone, Ileana L. Piña, Piotr Ponikowski, Naveed Sattar, Michele Senni, Marie‐France Seronde, Jindřich Špinar, Iain Squire, Stefano Taddei, Christoph Wanner, Faı̈ez Zannad
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: 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.).