Diabetes Drug Cuts Cardiovascular Mortality in High-Risk Adults

By Amy Orciari Herman

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

Empagliflozin — a sodium glucose cotransporter 2 inhibitor approved to treat type 2 diabetes — lowers the risk for cardiovascular death among high-risk patients, according to an international, manufacturer-conducted study. The findings were presented on Thursday at the annual meeting of the European Association for the Study of Diabetes and published in the New England Journal of Medicine.

Some 7000 adults with type 2 diabetes and cardiovascular disease were randomized to receive daily empagliflozin (10 or 25 mg) or placebo in addition to standard care. Participants were treated for roughly 2.5 years and were observed for about 3 years.

The primary outcome — a composite of stroke, myocardial infarction, or cardiovascular death — occurred significantly less often with empagliflozin than with placebo (10.5% vs. 12.1%). The difference between groups was due to a significant reduction in cardiovascular death with empagliflozin (3.7% vs. 5.9%). The drug was also associated with significant reductions in overall mortality (5.7% vs. 8.3%) and heart failure hospitalization (2.7% vs. 4.1%). Findings were similar with the 10- and 25-mg doses.

Genital infections occurred about three times more often with empagliflozin than with placebo.

Dr. Harlan Krumholz, editor-in-chief of NEJM Journal Watch Cardiology, said: "It's great to see this historic trial, with evidence of outcomes benefit, in print. I would love to see further validation of the findings, but the benefit occurred early and is meaningful, and this drug now has evidentiary support that other strategies lack."