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
The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee.
The trial will continue until =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
Results:
Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia).
At baseline, the mean age was 63 +/- 9 years, BMI 30.6 +/- 5.3 kg/m2, HbA1c 8.1 +/- 0.8%, and eGFR 74 +/- 21 ml/min/1.73 m2. The study is expected to report in 2015.DiscussionEMPA-REG OUTCOMETM will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.Trial registration: Clinicaltrials.gov NCT01131676
Author: Bernard ZinmanSilvio E InzucchiJohn M LachinChristoph WannerRoberto FerrariDavid FitchettErich BluhmkiStefan HantelJoan Kempthorne-RawsonJennifer NewmanOdd Erik JohansenHans Juergen WoerleUli C Broedl
Credits/Source: Cardiovascular Diabetology
Published on: 2014-06-19
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