Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 DiabetesMMS: Error
Diabetes Drug Reduces Cardiovascular Events, Manufacturers Announce — Physician’s First Watch
September 17, 2015
a sodium glucose cotransporter 2 inhibitor approved to treat type 2 diabetes
randomized, double-blind, placebo-controlled trial
The primary composite outcome
death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group.
The key secondary composite outcome
the primary outcome plus hospitalization for unstable angina.
P : Patients with type 2 diabetes at high risk for cardiovascular events
A total of 7020 patients were treated (median observation time, 3.1 years).
E: 10 mg or 25 mg of empagliflozin
C: placebo once daily.
The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority).
death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction)
hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction)
death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction).
secondary outcome (P=0.08 for superiority).