Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

摘要: Evidence concerning the importance of glucose lowering in prevention cardiovascular (CV) outcomes remains controversial. Given multi-faceted pathogenesis atherosclerosis diabetes, it is likely that any intervention to mitigate this risk must address CV factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves control, body weight and blood pressure when used as monotherapy or add-on other antihyperglycemic agents patients with type 2 diabetes. aim ongoing EMPA-REG OUTCOME™ trial determine long-term safety empagliflozin, well investigating potential benefits on macro-/microvascular outcomes. Patients who were drug-naive (HbA1c ≥7.0% ≤9.0%), background glucose-lowering therapy ≤10.0%), at high events, randomized (1:1:1) treated 10 mg, 25 mg, placebo (double blind, double dummy) superimposed upon standard care. primary outcome time first occurrence death, non-fatal myocardial infarction, stroke. events will be prospectively adjudicated by an independent Clinical Events Committee. continue until ≥691 confirmed have occurred, providing a power 90% yield upper limit adjusted 95% CI for hazard ratio <1.3 one-sided α 0.025, assuming equal risks between (both doses pooled). Hierarchical testing superiority follow key secondary (time stroke hospitalization unstable angina pectoris) where non-inferiority achieved. Between Sept 2010 April 2013, 592 clinical sites 7034 (41% from Europe, 20% North America, 19% Asia). At baseline, mean age was 63 ± 9 years, BMI 30.6 ± 5.3 kg/m2, HbA1c 8.1 ± 0.8%, eGFR 74 ± 21 ml/min/1.73 m2. study expected report 2015. cohort diabetes risk, show cardioprotection. Clinicaltrials.gov NCT01131676