Design of a prospective patient-level pooled analysis of two parallel trials of empagliflozin in patients with established heart failure.

ABSTRACT:

Aim

The EMPEROR-Reduced trial demonstrated that empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with a reduced ejection fraction, and the EMPEROR-Preserved trial is currently evaluating the effect of the drug on the same endpoint in patients with an ejection fraction >40%. However, neither the trial was designed to have adequate statistical power to evaluate the effects of empagliflozin and dapagliflozin on major adverse renal outcomes or on mortality. Herein we describe the design of a prospective individual patient-level pooled analysis of two large-scale trials with empagliflozin (EMPEROR-Reduced and EMPEROR-Preserved) in patients with heart failure across the spectrum of ejection fraction.

Methods

The trial

SUBMITTER: Packer M 

PROVIDER: S-EPMC7898542 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature