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Empagliflozin, cardiovascular outcomes and all-cause death in T2D

In the first reported cardiovascular outcome study for the sodium–glucose cotransporter 2 inhibitor class of drugs, empagliflozin, in addition to standard care, was examined for its impact on cardiovascular morbidity and mortality in people with type 2 diabetes at high cardiovascular risk. Participants taking empagliflozin, as compared with placebo, had a lower rate of the primary composite endpoint of cardiovascular outcomes, and also of death from any cause.

By Colin Kenny, GP, Dromore

In the EMPA-REG OUTCOME study, 7020 people with type 2 diabetes and established cardiovascular disease (prior myocardial infarction, coronary artery disease, unstable angina, stroke or occlusive peripheral arterial disease), and who had an estimated glomerular filtration rate of at least 30 mL/min/1.73 m2, were randomised on a 1:1:1 basis to empagliflozin 10 mg daily, empagliflozin 25 mg daily or placebo, on top of standard care. The study continued for a median observation time of 3.1 years, and the primary outcome was a composite cardiovascular endpoint – death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke.

The outcomes for the two empagliflozin groups were pooled, and the results showed that the primary outcome occurred less frequently in this pooled empagliflozin group compared with placebo recipients (hazard ratio, 0.86; P=0.04). Empagliflozin did not reduce the rate of non-fatal MI or non-fatal stroke; the difference in the primary endpoint was mainly driven by the 38% relative risk reduction in cardiovascular death and 32% relative risk reduction in death from any cause.


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