Empagliflozin, used to treat type 2 diabetes, reduces the risk for heart failure, cardiovascular death, and all-cause mortality, according to a new landmark study published in The New England Journal of Medicine. Empagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that lowers blood sugar by enhancing renal excretion. Some 7000 high-risk type 2 diabetics were randomized to receive 10 mg or 25 mg of empagliflozin or placebo daily along with standard care for just over 3 years. The primary composite endpoint was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. A secondary outcome was hospitalization for unstable angina. The primary outcome occurred in 10.5% of the pooled empagliflozin group and 12.1% of the placebo group (hazard ratio, 0.86; 95.02% confidence interval, 0.74-0.99; P = 0.04 for superiority). There were no significant differences in the rate of myocardial infarction or stroke, but the empagliflozin group had significantly lower rates of death from cardiovascular causes (3.7% vs 5.9%; 38% relative risk [RR] reduction), hospitalization for heart failure (2.7% vs 4.1%; 35% RR reduction), and death from any cause (5.7% vs 8.3%; 32% RR reduction). There was no significant difference in hospitalization for unstable angina. Genital infections were more common in the treatment group. The rate of acute renal failure was lower in the empagliflozin group. The authors concluded that patients with type 2 diabetes at high risk for cardiovascular disease who received empagliflozin had significantly lower rates of the composite cardiac vascular outcome and death from any cause compared to those in the placebo group (N Eng J Med published online Sept. 17, 2015; doi: 10.1056/NEJMoa1504720). Empagliflozin is marketed by Boehringer Ingelheim as Jardiance. This is the first of the “new generation” diabetes drugs to show cardiovascular risk benefit. It is unclear whether the other SGLT2 inhibitors (dapagliflozin [Farxiga] or canagliflozin [Invokana]) have similar benefits.
