The EMPERIAL (Effect of EMPagliflozin on ExeRcise ability and HF symptoms in patients with chronic heArt faiLure) trials evaluated the effect of 10 mg empagliflozin versus placebo on exercise ability in patients with heart failure. EMPERIAL-Reduced (NCT03448419) randomized 312 patients with heart failure with reduced ejection fraction (LVEF ≤ 40%) to receive either empagliflozin or placebo. EMPERIAL-Preserved (NCT03448406) randomized 315 patients with heart failure with preserved ejection fraction (LVEF > 40%) to receive either empagliflozin or placebo. Both studies enrolled participants with and without Type 2 diabetes.
A change in the 6-minute walk test distance (6MWTD) at week 12 constituted the primary endpoint. Key secondary outcome measures included Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and the Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnoea score. The KCCQ-TSS is a 23-item questionnaire encompassing 7 domains; the CHQ-SAS encompasses 3 domains.
Both groups failed to demonstrate a change in 6MWTD after 12 weeks; i.e., the primary endpoint was not met. As a result, secondary endpoints were analyzed on an exploratory basis. The median difference in KCCQ-TSS score from Week 1 to Week 12 between the empagliflozin and placebo group was 3.13 in the EMPERIAL-Reduced trial. In the EMPERIAL-Preserved trial, this value was 2.08. The median difference in CHQ-SAS dyspnoea score between the empagliflozin and placebo group was 0.10 in the EMPERIAL-Reduced study, and -0.07 in the EMPERIAL-Preserved study. Researchers note that improvement in KCCQ-TSS scores are associated with both a lower rate of hospitalization for heart failure, and a lower risk of mortality.
There was no increase in rate of adverse events seen in patients receiving empagflizon.
Researchers concluded that results from the EMPERIAL trials support the use of sodium-glucose co-transporter 2 inhibitors in patients with chronic heart failure, both with and without type 2 diabetes.
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Author: Kelly Schoonderwoerd
Original article: Abraham et al. Eur Heart J. 2021 Feb 11;42(6):700-710.