BACKGROUND: In the EMPA-REG OUTCOME trial, empagliflozin added to standard of care reduced cardiovascular (CV) death by 38% (HR 0.62 [95% CI 0.49, 0.77]), all-cause mortality by 32% (HR 0.68 [95% CI 0.57, 0.82]) and hospitalization for heart failure (HHF) by 35% (HR 0.65 [95% CI 0.50, 0.85]) vs placebo in patients with type 2 diabetes and established CV disease. We investigated whether a history of myocardial infarction (MI) or stroke at baseline influenced the effect of empagliflozin on these outcomes.
METHODS: Patients were randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Median observation time was 3.1 years. CV death, all-cause mortality, HHF and the composite of HHF or CV death were assessed for empagliflozin pooled vs placebo in subgroups by history MI or stroke at baseline using Cox regression analyses. P-values for treatment by subgroup interaction were obtained from tests of homogeneity of treatment group differences among subgroups with no adjustment for multiple testing.
RESULTS: Of 7020 patients treated, 65% in both treatment groups had a history of MI or stroke at baseline. Effects of empagliflozin on CV death, all-cause mortality, HHF and HHF or CV death were consistent in patients with and without MI or stroke.
CONCLUSION: Reductions in mortality and HHF with empagliflozin in patients with type 2 diabetes and established CV disease in the EMPA-REG OUTCOME trial were consistent in patients with or without a history of MI or stroke at baseline.