Introduction: In the EMPA-REG OUTCOME trial, empagliflozin (EMPA) given in addition to standard of care significantly reduced 3-point major adverse cardiovascular (CV) events (composite of CV death, non-fatal myocardial infarction, or non-fatal stroke), CV death and all-cause mortality vs placebo (PBO) in patients with type 2 diabetes (T2DM) and high CV risk.

Objective: Here we investigate the effect of age on the reduction in CV death with EMPA.

Methods: Patients in EMPA-REG OUTCOME were randomized to receive EMPA 10 mg, EMPA 25 mg or PBO. CV death was analyzed in the pooled EMPA group vs PBO in subgroups by baseline age (<65, 65 to <75, ≥75 years).

Results: A total of 7020 patients were treated. Median observation time was 3.1 years. Mean (SD) age at baseline was 63.2 (8.8) years in the PBO group and 63.1 (8.6) years in the EMPA group. The benefit of EMPA vs PBO on CV death was consistent across age categories (Figure). Across age subgroups, reported adverse events were consistent with the known safety profile of EMPA.

Conclusion: EMPA, in addition to standard of care, reduced the risk of CV death in patients with T2DM and high CV risk irrespective of age.