The EMPEROR-Preserved trial: Empagliflozin in heart failure [Classics Series]

1. The present study demonstrated that patients with heart failure with preserved ejection fraction (HFpEF) are less likely to experience a composite outcome of cardiovascular death or hospitalization for heart failure if they received empagliflozin (13.8%) as compared to placebo (17.1%).

2. Presence or absence of type 2 diabetes had no impact on the differences in outcomes between groups.

Original Date of Publication: October 2021

This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials, 2e (The Classics Series).

Study Rundown: The Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Preserved Ejection Fraction (EMPEROR-Preserved) trial compared cardiovascular outcomes in individuals with HFpEF who were randomized to empagliflozin or placebo. Participants in the empagliflozin group had significantly lower rates of cardiovascular death or hospitalization related to heart failure, regardless of diabetes status. The number of all-cause hospitalizations were also lower in the empagliflozin group, although mortality rates did not differ. The major limitation of the EMPEROR-Preserved trial was a 23% overall dropout rate, although the rate was not significantly different between groups. Overall, the EMPEROR-Preserved trial demonstrated that in patients with HFpEF, empagliflozin reduces risk of cardiovascular death and heart failure hospitalization.

Please click to read study in NEJM

In-Depth [randomized controlled trial]: In the double-blinded EMPEROR-Preserved trial, patients with a New York Heart Association class of II to IV and ejection fraction > 40% were randomized to receive either a placebo (n = 2991) or empagliflozin (n = 2997). Endpoints were assessed by a blinded clinical events committee. The main composite endpoint of cardiovascular mortality and hospitalization due to heart failure was significantly reduced in participants who were randomized to empagliflozin (HR 0.79; 95%CI 0.69-0.90). Empagliflozin was still superior to placebo in diabetes subgroup analysis. All-cause hospitalization (p < 0.001) and glomerular filtration rate decline (p < 0.001) were also lower with empagliflozin as compared to placebo. Although, differences in all-cause mortality were not significant between groups (HR 1.00; 95%CI 0.87-1.15).

Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Böhm M, Brunner–La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N. Empagliflozin in heart failure with a preserved ejection fraction. New England Journal of Medicine. 2021 Oct 14;385(16):1451-61.

© 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.