193Qualifying event proximity, cardiovascular risk, and benefit of empagliflozin in patients with type 2 diabetes and stable atherosclerosis in the EMPA-REG OUTCOME trial

Abstract

Abstract Background In type 2 diabetes, the temporal proximity of an atherosclerotic cardiovascular (CV) event can impact prognosis, but whether timing influences sodium glucose co-transporter 2 inhibitor effects is unknown. We explored the association of time from last qualifying CV event before randomisation (myocardial infarction [MI], stroke, coronary artery disease or peripheral arterial disease) with CV outcomes and benefit of empagliflozin (EMPA) in EMPA-REG OUTCOME. Methods Patients (pts) were randomised to EMPA 10 mg, 25 mg or placebo and followed for 3.1 years (median). Risk of major adverse CV events (3P MACE: CV death, MI, stroke), CV death or hospitalisation for heart failure (HHF) were evaluated using Cox regression in subgroups of ≤1/>1 year since last qualifying CV event. Qualifying event stratification was possible in 6796 (97%) pts. Results In the overall population, N=6796 (4547 EMPA and 2249 placebo pts), median (Q1, Q3) time from last CV event was 3.8 (1.5–7.6) years. Overall, 1214 (EMPA 841; placebo 373) and 5582 (EMPA 3706; placebo 1876) pts had a last qualifying CV event ≤1 and >1 year, respectively. Pts with more recent events had similar risk for CV outcomes compared with pts >1 year from qualifying event (Figure). Moreover, the benefit of EMPA on CV outcomes was consistent between pts enrolled ≤1 or >1 year from the qualifying CV event (all p-interaction >0.05; Figure). Conclusion Although most pts had a qualifying CV event >1 year before randomisation in EMPA-REG OUTCOME, the benefits of EMPA appear to extend to pts with more recent CV events. Acknowledgement/Funding Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance