Clinical question: Does initiation of empagliflozin in hospitalized patients with acute decompensated heart failure improve clinical outcomes and symptom burden?
Background: Studies have outlined the clinical benefit of empagliflozin and sodium-glucose cotransporter-2 inhibitors in the ambulatory setting. However, little is known about initiation in hospitalized patients with acute decompensated heart failure and its impact on both clinical and symptomatic outcomes.
Study design: Randomized, double-blinded, placebo-controlled trial
Setting: 118 centers across 15 countries
Synopsis: 530 hospitalized patients were randomized to empagliflozin 10 mg versus placebo. Kansas City Cardiomyopathy Questionnaire with Total Symptom Score (KCCQ-TSS) was obtained at baseline and on days 15, 30, and 90. The primary clinical benefit endpoint was defined as the hierarchical composite of all-cause death, heart failure events, and a five-point or greater KCCQ-TSS change from baseline to 90 days. In a post-hoc analysis, patients were then assigned to tertiles based upon baseline KCCQ-TSS ranging from (1) <27.1, (2) ≥27.1 to <52.1, and (3) ≥52.1 points.
Independent of baseline symptom burden, patients treated with empagliflozin experienced an improvement in KCCQ-TSS, quality of life, clinical summary, and overall summary. Symptomatic improvement by KCCQ-TSS was seen as early as 15 days in the empagliflozin-treated group (placebo-adjusted mean difference, 5.35 [95% CI, 1.51–9.19] points; P<0.01).
Primary results of the empagliflozin in patients hospitalized with acute heart failure who have been stabilized (EMPULSE) trial, performed by win-ratio analysis, showed clinical benefit in empagliflozin-treated patients at 53.9% versus 39.7% in the placebo group (P=0.0054).
Bottom line: Initiation of empagliflozin in patients hospitalized with acute decompensated heart failure shows both clinical and symptomatic benefit at 90 days regardless of baseline symptom burden.
Citation: Kosiborod MN, et al. Effects of empagliflozin on symptoms, physical limitations, and quality of life in patients hospitalized for acute heart failure: Results from the EMPULSE trial. Circulation. 2022;146(4):279-88.
Dr. Kerley is an assistant professor of medicine at the University of Virginia School of Medicine, Charlottesville, Va.