Abstract 16903: Consistent Effect of Empagliflozin on Cardiovascular Death in Subgroups by Type of Cardiovascular Disease: Results From EMPA-REG OUTCOME

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 (3-point MACE: composite of CV death, non-fatal myocardial infarction, non-fatal stroke) in patients with type 2 diabetes (T2DM) and high CV risk. CV death and all-cause mortality were reduced by 38% and 32%, respectively, with EMPA vs placebo (PBO). We conducted a subgroup analysis to determine the association between the reduction in CV death with EMPA and type of CV disease at baseline. Methods: Patients with high CV risk were randomized (1:1:1) to receive EMPA 10 mg, EMPA 25 mg, or PBO in addition to standard of care. Risk of CV death was compared between the pooled EMPA group and PBO in subgroups by type of CV disease at baseline using Cox regression analyses. Results: A total of 7020 patients were treated. Median observation time was 3.1 years. The effect of EMPA vs PBO on CV death was consistent across subgroups of patients by type of CV disease at baseline (Figure). Conclusion: The reduction in CV death observed with EMPA in patients with T2DM and high CV risk in the EMPA-REG OUTCOME trial was observed irrespective of type of CV disease at baseline.