Efficacy of empagliflozin in heart failure with preserved versus mid-range ejection fraction: a pre-specified analysis of EMPEROR-Preserved
Stefan D. Anker, Javed Butler, Muhammad Usman, Gerasimos Filippatos, João Pedro Ferreira, Edimar Alcides Bocchi, Michael Böhm, Hans‐Peter Brunner‐La Rocca, Dong‐Ju Choi, Vijay Chopra, Eduardo Chuquiure‐Valenzuela, Nadia Giannetti, Juan Esteban Gómez‐Mesa, Stefan Janssens, James L. Januzzi, José Ramón González‐Juanatey, Béla Merkely, Stephen J. Nicholls, Sergio V. Perrone, Ileana L. Piña, Piotr Ponikowski, Michele Senni, David Sim, Jindřich Špinar, Iain Squire, Stefano Taddei, Hiroyuki Tsutsui, Subodh Verma, Dragoş Vinereanu, Jian Zhang, Tomoko Iwata, Janet Schnee, Martina Brueckmann, Stuart Pocock, Faı̈ez Zannad
Abstract
Abstract The EMPEROR-Preserved trial showed that the sodium–glucose co-transporter 2 inhibitor empagliflozin significantly reduces the risk of cardiovascular death or hospitalization for heart failure (HHF) in heart failure patients with left ventricular ejection fraction (LVEF) > 40%. Here, we report the results of a pre-specified analysis that separately evaluates these patients stratified by LVEF: preserved (≥ 50%) ( n = 4,005; 66.9%) or mid-range (41–49%). In patients with LVEF ≥ 50%, empagliflozin reduced the risk of cardiovascular death or HHF (the primary endpoint) by 17% versus placebo (hazard ratio (HR) 0.83; 95% confidence interval (CI): 0.71–0.98, P = 0.024). For the key secondary endpoint, the HR for total HHF was 0.83 (95%CI: 0.66–1.04, P = 0.11). For patients with an LVEF of 41–49%, the HR for empagliflozin versus placebo was 0.71 (95%CI: 0.57–0.88, P = 0.002) for the primary outcome ( P interaction = 0.27), and 0.57 (95%CI: 0.42–0.79, P < 0.001) for total HHF ( P interaction = 0.06). These results, together with those from the EMPEROR-Reduced trial in patients with LVEF < 40%, support the use of empagliflozin across the full spectrum of LVEF in heart failure.