Empagliflozin associated with reduced mortality risk in patients with cardiovascular disease
Patients with type 2 diabetes and cardiovascular disease who received empagliflozin had lower rates of cardiovascular-related and all-cause mortality than those on placebo, an industry-funded study found.
Patients with type 2 diabetes and cardiovascular disease who received empagliflozin had lower rates of cardiovascular-related and all-cause mortality than those on placebo, an industry-funded study found.
Researchers conducted a randomized, double-blind trial to assess the effect of once-daily empagliflozin, at a dose of either 10 mg or 25 mg, on cardiovascular events in adults at 590 sites in 42 countries. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was the primary outcome plus hospitalization for unstable angina.
Patients had a baseline HbA1c between 7% and 10% and underwent a 2-week, open-label, placebo run-in period in which glucose-lowering therapy was unchanged, and then were randomly assigned in a 1:1:1 ratio to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The study was funded by Boehringer Ingelheim and Eli Lilly. The trial was designed and overseen by a steering committee that included academic investigators and employees of Boehringer Ingelheim. Results appeared Sept. 17 in the New England Journal of Medicine.
Among 7,020 patients, the primary outcome occurred in 490 of 4,687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2,333 placebo patients (12.1%) (hazard ratio [HR], 0.86; 95.02% CI, 0.74 to 0.99; P=0.04). There were no significant between-group differences in the rates of myocardial infarction or stroke, but the empagliflozin group had significantly lower rates of death from cardiovascular causes (3.7% vs. 5.9%; HR, 0.62; 95% CI, 0.49 to 0.77; P<0.001), hospitalization for heart failure (2.7% vs. 4.1%; HR, 0.65; 95% CI, 0.50 to 0.85; P=0.002), and death from any cause (5.7% vs. 8.3%; HR, 0.68; 95% CI, 0.57 to 0.82; P<0.001).
Hospitalization for unstable angina occurred in 133 of 4,687 patients (2.8%) in the empagliflozin group and 66 of 2,333 patients (2.8%) in the placebo group (HR, 0.99; 95% CI, 0.74 to 1.34; P=0.97).
The researchers wrote, “Although a small dose-response effect for the 10-mg dose of empagliflozin versus placebo and the 25-mg dose versus placebo has been documented for metabolic responses, in our study the 2 dose groups had similar hazard ratios for cardiovascular outcomes. Thus, in clinical practice, the choice of the empagliflozin dose will probably depend primarily on the achievement of metabolic targets and the occurrence of adverse events.”