OBJECTIVES:  The EMPA-REG OUTCOME trial was a randomised, double-blind, placebo-controlled, cardiovascular (CV) safety trial which examined the long-term effects of empagliflozin versus placebo, in addition to standard of care (SoC), on CV morbidity and mortality in patients with T2DM and a high risk of CV events. Empagliflozin showed 38% reduction in CV death (95% CI: 0.49-0.77, p<0.001) and a 35% reduction in hospitalisation for heart failure (95% CI: 0.50-0.85, p=0.002). A post-hoc analysis showed a 39% reduction in nephropathy (95% CI: 0.53-0.70, p<0.001) and a 55% reduction in renal replacement therapy (95% CI: 0.21-0.97, p=0.04). The objective was to quantify the clinical and economic outcomes of empagliflozin for treatment of patients with T2DM at increased CV risk based on the EMPA-REG OUTCOME™ study. METHODS:  An economic model was created to simulate profiles of patients treated with empagliflozin versus patients treated with placebo, both added to SoC, over a lifetime horizon. Time-dependent survival regression analysis was performed on the EMPA REG OUTCOMES trial data to model event rates over time and the interaction between events. Model outcomes included costs incurred, life years (LY) and quality-adjusted life-years (QALYs). Future costs and QALYs were discounted at a 3.5% annual rate. RESULTS:  Empagliflozin was predicted to result in longer survival (15.0 LY vs. 13.0 LY with SoC). This was attributable to both a direct treatment effect on CV mortality and an indirect effect via reductions in other CV events, particularly heart failure hospitalisation. This results in a predicted 0.9 incremental QALYs with empagliflozin at an incremental cost of £3,971 per patient and an incremental cost-effectiveness ratio of £4,365/QALY. This is well below the common threshold for cost-effectiveness in the UK (£20,000/QALY). CONCLUSIONS: Empagliflozin is a cost-effective option for the treatment of T2DM patients at a high risk of CV events.