Empagliflozin in De Novo vs Acute Decompensated Chronic Heart Failure

BACKGROUND: In EMPULSE (A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure), the sodium-glucose cotransporter 2 inhibitor empagliflozin improved clinical outcomes in patients hospitalized for heart failure (HF). OBJECTIVES: This prespecified analysis examined efficacy, safety, and tolerability of empagliflozin in subgroups with de novo heart failure (NHF) vs acute decompensated heart failure (ADHF). METHODS: After stabilization, participants were randomized 1:1 to empagliflozin 10 mg/d or placebo, stratified by HF status (NHF: n = 175; ADHF: n = 355). The primary endpoint was a hierarchical composite of death, worsening HF, or ≥5-point difference in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) change at day 90, assessed using a win ratio. RESULTS: = 0.017), with even greater between-group differences at days 30 and 90. Frequencies of adverse events were consistently lower with empagliflozin vs placebo. CONCLUSIONS: In-hospital initiation of empagliflozin produced similar clinical benefits in NHF and ADHF despite the reduced diuretic response in participants with ADHF and was well tolerated. This supports in-hospital initiation of empagliflozin in all patients with acute HF (A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure [EMPULSE]; NCT04157751).