Trial Subanalysis Finds Empagliflozin Can Reduce Risk of Cardiovascular Death in Patients With Type 2 Diabetes and PAD


November 21, 2017—Data from the EMPA-REG OUTCOME trial showed that empagliflozin reduced the risk of cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and peripheral artery disease (PAD). These data were presented by Subodh Verma, MD, at the American Heart Association Scientific Sessions 2017 held November 11–15 in Anaheim, California, and were simultaneously published online in Circulation.

Empagliflozin is marketed by Boehringer Ingelheim and Eli Lilly and Company as Jardiance. According to the companies’ joint announcement, empagliflozin is an oral, once-daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor.

At baseline, 20.8% of the 7,020 trial participants had PAD. Subanalysis of this patient population found that when compared with placebo, empagliflozin reduced the risk of cardiovascular death by 43% (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.37–0.88) in conjunction with standard of care.

The risk for the composite primary endpoint of cardiovascular death, nonfatal heart attack, or nonfatal stroke was reduced by 16% (HR, 0.84; 95% CI, 0.62–1.14). Death from any cause was reduced by 38% (HR, 0.62; 95% CI, 0.44–0.88) and hospitalization for heart failure decreased by 44% (HR, 0.56; 95% CI, 0.35–0.92).

Overall adverse effects and serious adverse effects were similar between groups with and without PAD. Among those with PAD, lower limb amputations were lower in those treated with empagliflozin compared with placebo group (5.5% vs 6.3%; HR, 0.84; CI, 0.54–1.32). In patients without PAD, lower limb amputations occurred in 0.9% of those treated with empagliflozin compared with 0.7% of those treated with placebo (HR, 1.30; 95% CI, 0.69–2.46).

“[PAD], one of the most common cardiovascular complications associated with type 2 diabetes, increases the risk of death from cardiovascular causes,” commented Dr. Verma in the companies’ announcement. “There is an urgent need for treatment options that can improve cardiovascular-related outcomes in people with type 2 diabetes and [PAD].” Dr. Verma is a cardiac surgeon-scientist at St. Michael’s Hospital and Professor at the University of Toronto.

Empagliflozin is approved for use in Europe, the United States, and other markets around the world for the treatment of adults with type 2 diabetes.


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