- Question
- Does adding empagliflozin to standard care reduce cardiovascular events and mortality in patients with type 2 diabetes at high cardiovascular risk?
- Design
- Phase 3, multicenter, international, randomized, double-blind, placebo-controlled trial with 7020 treated patients and a median observation time of 3.1 years.
- Population
- Patients with type 2 diabetes at high risk of cardiovascular events who were receiving standard care.
- Intervention
- Empagliflozin 10 mg or 25 mg orally once daily added to standard care; both doses were analyzed pooled.
- Control
- Placebo once daily added to standard care.
- Primary outcome
- Composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, analyzed in the pooled empagliflozin group versus placebo.
- Results
- The primary outcome occurred in 490 of 4687 patients (10.5%) on empagliflozin and 282 of 2333 (12.1%) on placebo (HR 0.86; 95.02% CI 0.74 to 0.99; P=0.04 for superiority). Cardiovascular death was lower with empagliflozin (3.7% vs. 5.9%; 38% relative risk reduction), as were all-cause death (5.7% vs. 8.3%; 32% reduction) and hospitalization for heart failure (2.7% vs. 4.1%; 35% reduction). There were no significant differences in myocardial infarction or stroke.
- Safety
- Genital infections were more frequent with empagliflozin, with no increase in other adverse events.
- Conclusion
- In patients with type 2 diabetes at high cardiovascular risk, empagliflozin added to standard care lowered the primary composite cardiovascular outcome and all-cause mortality compared with placebo.
- Why it matters
- It was the first trial to show that a glucose-lowering drug reduced cardiovascular and total mortality in type 2 diabetes, shifting treatment toward agents with proven cardiovascular benefit and highlighting a marked effect on heart failure.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026