Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOMETM)
Background:
Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOMETM trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on microvascular outcomes.
Methods:
Patients who were drug-naive (HbA1c >=7.0% and =7.0% and =691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of
Source: Cardiovascular Diabetology - Category: Cardiology Authors: Bernard ZinmanSilvio InzucchiJohn LachinChristoph WannerRoberto FerrariDavid FitchettErich BluhmkiStefan HantelJoan Kempthorne-RawsonJennifer NewmanOdd JohansenHans WoerleUli Broedl Source Type: research
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