Empagliflozin and Cardiovascular Outcomes: A Systematic Review of Randomized Controlled Trials in Populations With Diabetes and Heart Failure
Abstract
Cardiovascular disease is a principal cause of morbidity and mortality worldwide, disproportionately affecting individuals with type 2 diabetes mellitus (T2DM) and heart failure. Empagliflozin, a sodium-glucose cotransporter 2 inhibitor, has shown promising cardioprotective effects beyond its glucose-lowering properties. This systematic review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, involving a comprehensive literature search of PubMed, Scopus, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) from inception to May 2025. Randomized controlled trials evaluating empagliflozin in adult patients with T2DM or heart failure and reporting cardiovascular outcomes were included. A total of 13 RCTs comprising 21,669 participants were synthesized, encompassing a broad spectrum of populations, including high-risk T2DM, chronic heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF), and post-myocardial infarction cohorts. Empagliflozin was consistently associated with significant reductions in major adverse cardiovascular events, notably a 14-38% reduction in cardiovascular mortality and a 23-35% reduction in heart failure hospitalizations across key trials, such as EMPA-REG OUTCOME, EMPEROR-Reduced, and EMPEROR-Preserved. Smaller mechanistic studies highlighted additional benefits, including improvements in left ventricular function,…
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 21,669 participants or records.
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