Efficacy and safety of empagliflozin in acute heart failure: a systematic review and meta-analysis.

BACKGROUND

Acute heart failure (AHF) is leading cause of hospitalization and mortality. Empagliflozin, a Sodium Glucose Co-transporter 2 inhibitor (SGLT-2i), has demonstrated benefits in HFrEF and HFpEF, but its role in AHF remains under-explored.

OBJECTIVE

Assess safety and efficacy of empagliflozin in AHF.

METHODS

A systematic review and meta-analysis adhering to PRISMA 2020 guidelines was conducted. A search on 25 February 2025, identified Phase IIb and III randomized controlled trials (RCTs) involving adults with AHF from databases like Medline®, Cochrane CENTRAL, Embase, and ClinicalTrials.gov. Outcomes included all-cause mortality, HF rehospitalization, cardiovascular deaths, and serious adverse events. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using a random-effects model. Heterogeneity was assessed with I2 and Cochrane Q-statistic.

RESULTS

Three RCTs ( = 824) were included. Empagliflozin reduced all-cause mortality (OR: 0.47, 95% CI: 0.29-0.78,  = 0.004) and cardiovascular death (OR: 0.56, 95% CI: 0.38-0.82,  = 0.003) compared to placebo. It also lowered serious adverse events risk (OR: 0.62, 95% CI: 0.44-0.87,  = 0.005) without significantly increasing adverse effects such as acute kidney injury, diabetic ketoacidosis, hypotension, or urinary tract infections. Sensitivity analyses confirmed these findings.

CONCLUSION

Empagliflozin reduces mortality in AHF with a favorable safety profile, highlighting need for further trials.