New results of a subanalysis of the EMPA-REG OUTCOME® trial show that, in patients with type 2 diabetes at high risk for cardiovascular events (CV), the reduction in the risk of hospitalization for heart failure or cardiovascular death with empagliflozin compared to placebo – when added to standard therapy – it has been consistent for all subgroups analyzed, including patients with and without heart failure at baseline.
These results were presented on behalf of Boehringer Ingelheim and Eli Lilly and Company at the 2015 Congress of the American Heart Association (AHA) going to Orlando. The data are part of an analysis of the pre-determined secondary endpoints of the study. People with diabetes have a risk two / three times more likely to develop heart failure, compared to non-diabetics. In other new findings, also presented at AHA Congress, empagliflozin shows that, in patients with type 2 diabetes at high risk for cardiovascular events, reduces by 39% the risk for the composite endpoint of hospitalization for heart failure or death from congestive heart failure as compared to placebo, when added to standard therapy. EMPA-REG OUTCOME® is a long-term, multicenter, randomized, double-blind, placebo control group, involving over 7,000 patients with type 2 diabetes at high risk for cardiovascular events in 42 countries. The study was designed to evaluate the effect of empagliflozin (10 mg or 25 mg once/day) added to standard therapy, compared to placebo added to standard therapy. Standard therapy included diabetes medications and cardiovascular drugs (including antihypertensive and lipid-lowering). The primary endpoint was the time elapsed until the occurrence of the first of the following events: death from cardiovascular causes or nonfatal myocardial infarction or nonfatal stroke. In a median time of 3.1 years empagliflozin significantly reduced, by 14% versus placebo, the risk of death from cardiovascular causes or nonfatal myocardial infarction or nonfatal stroke. Treatment with empagliflozin also led to the reduction in the risk of mortality from all causes by 32% and the risk of hospitalization for heart failure by 35% .The overall safety profile of empagliflozin was in line with that seen in previous studies. The incidence of diabetic ketoacidosis was equal to or less than 0.1% and similar in all treatment groups. Empagliflozin is an inhibitor of the sodium-glucose co-transporter type 2 (SGLT2) oral, highly selective, once-daily, approved in Europe, the United States and other countries for the treatment of adults with type 2 diabetes.