EMPA-REG OUTCOME

About the Trial

EMPA-REG OUTCOME randomized 7,020 type 2 diabetes patients with cardiovascular disease to the SGLT2 inhibitor empagliflozin or placebo. The drug reduced cardiovascular death by 38 percent and heart failure hospitalization by 35 percent, with a 32 percent reduction in all cause mortality. The benefit appeared within months and was too large to be explained by glucose lowering. The 2015 publication stunned cardiologists and endocrinologists, launched thousands of trials of SGLT2 inhibitors, The trial itself existed because the FDA, after safety concerns over rosiglitazone, had required cardiovascular outcome trials for new diabetes drugs since 2008. SGLT2 inhibitors later gained heart failure indications.