Background In EMPEROR-Preserved, empagliflozin reduced the composite primary endpoint of cardiovascular (CV) death/hospitalisation for heart failure (HHF) in patients with heart failure (HF) with left ventricular ejection fraction (LVEF) >40%. We assessed the effect of empagliflozin in patients with a preserved LVEF ≥50% (considered ‘true HFpEF’ by many clinicians) and contrasted it with HF patients with mildly-reduced LVEF of 41–49% (i.e., <50%).
Methods Of 5,988 randomised patients, 1,983 had LVEF <50% and 4,005 had LVEF ≥50%. The outcomes included (1) the primary endpoint, (2) first and total HHF, (3) change in KCCQ-Clinical Summary Score (CSS), and (4) NYHA class at Week 52.
Results Patients with LVEF ≥50% (vs LVEF <50%) were more frequently women and were older; they had median NT-proBNP 946 pg/mL, and mean eGFR 59 mL/min; approximately half had atrial fibrillation or diabetes at baseline. In patients with LVEF ≥50%, empagliflozin reduced the risk of CV death/HHF by 17% (p=0.024), driven by a reduction in HHF (see table). Time-to-first-event of HHF was reduced by 22% (p=0.013) and total HHF by 17% (p=0.113). Empagliflozin produced meaningful improvements in KCCQ-CSS and NYHA class at Week 52. Compared with placebo, empagliflozin increased KCCQ-CSS in patients with LVEF ≥50% by 1.46 points (0.42–2.51; p=0.006); these empagliflozin-treated patients were 34% more likely to be in a lower NYHA class (p<0.001).
Conclusion In EMPEROR-Preserved, empagliflozin significantly improved CV death/HHF in patients with LVEF ≥50% by 17%, driven by reductions in HHF. This is the first large-scale study documenting event reductions and quality-of-life benefits in patients with true HFpEF.
Conflict of Interest Received consultancy fees/lecture honoraria/research funding from the following: Boehringer Ingelheim, Eli Lilly, AstraZeneca, Novartis, BMS, Servier, Medtronic, and Novo Nordisc.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.