Researchers have reported that Empagliflozin (Jardiance) has become the first type-2 diabetes drug that has shown a significant cardiovascular benefit in a safety trial. The trial included over 7,000 patients.

At a session here at the 51st annual meeting of the European Association for the Study of Diabetes, study co-author Bernard Zinman, MD, of Lunenfeld-Tanenbaum Research Institute in Toronto, reported that the primary composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke was met by 10.5% of patients on empagliflozin and regular care as compared to 12.1% of patients in the placebo group.

In the three-year-long study, researchers saw the benefit in significant reduction in cardiovascular mortality, overall mortality, and heart failure hospitalizations because there were no differences between the group on the drug, a once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of type-2 diabetes, and the control group in terms of rates of myocardial infarction or stroke.

Zinman said treatment of 39 patients with empagliflozin for three years would prevent one cardiovascular death, which is pretty good.

The rate of cardiovascular death was 3.7% compared to 5.9% in controls, which was a relative risk reduction of 38%, in the treatment group. Admission in hospital due to heart failure was 2.7% versus 4.1% for a relative risk reduction of 35%, and death because of any cause was 5.7% versus 8.3%, which worked out to a relative risk reduction of 32%. The study results were simultaneously published in the New England Journal of Medicine.

Zinman called the results dramatic and exciting, and told MedPage Today that they have quite clearly met the safety criteria of non-inferiority.