Sodium–glucose cotransporter 2 (SGLT2) inhibitors have demonstrated clinical benefit in heart failure (HF), including during hospitalization. This prespecified analysis of the EMPULSE trial, published in the JACC: Heart Failure assessed, the efficacy, safety, and tolerability of empagliflozin in patients hospitalized with acute HF, stratified by de novo HF (NHF) and acute decompensated HF (ADHF).
Following clinical stabilization, participants were randomized in a 1:1 ratio to receive empagliflozin 10 mg once daily or placebo. The study included 175 patients with NHF and 355 with ADHF. The primary endpoint was a hierarchical composite of all-cause death, worsening HF events, or a ≥5-point difference in Kansas City Cardiomyopathy Questionnaire–Total Symptom Score (KCCQ-TSS) at 90 days, analyzed using a win ratio approach.
Baseline characteristics differed between subgroups, with NHF participants being younger, having fewer comorbidities, and demonstrating higher blood pressure, heart rate, and KCCQ-TSS.
The win ratio favored empagliflozin in both NHF (1.29; 95% CI: 0.89-1.89) and ADHF (1.39; 95% CI: 1.07-1.81), with no significant interaction between subgroups (Pinteraction=0.759).
There were no interactions between NHF and ADHF for the primary endpoint, its components, or secondary endpoints, except for diuretic response, which was greater in NHF than in ADHF from day 15 onward. Adverse events occurred less frequently with empagliflozin compared with placebo.
These findings show similar outcomes and tolerability across HF subgroups. Empagliflozin was initiated during hospitalization in this study.