Document Type

Journal Article

Publication Date



Cardiovascular Diabetology


Volume 13

Inclusive Pages

Article number 102





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.


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


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.


EMPA-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.


Reproduced with permission of BioMed Central Cardiovascular Diabetology.

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Creative Commons License
This work is licensed under a Creative Commons Attribution 3.0 License.

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