ARTICLE | Clinical News

Jardiance empagliflozin: Additional Phase III data

September 21, 2015 7:00 AM UTC

Additional data from the double-blind, international Phase III EMPA-REG OUTCOME trial in 7,020 Type II diabetics at a high risk for CV events showed that the primary composite endpoint of CV death, non-fatal MI and non-fatal stroke occurred in 10.5% of patients receiving Jardiance plus standard of care (SOC) vs. 12.1% of patients receiving placebo plus SOC (HR=0.86, 95% CI: 0.74, 0.99, p<0.001 for non-inferiority and p=0.04 for superiority). Jardiance plus SOC was non-inferior to but not superior to placebo plus SOC on the secondary endpoint of the proportion of patients experiencing the primary composite endpoint plus hospitalization for unstable angina (12.8% vs. 14.3%, p<0.001 for non-inferiority and p=0.08 for superiority). Jardiance plus SOC also led to significantly lower rates of death from CV causes (3.7% vs. 5.9%, p<0.001), hospitalization for heart failure (2.7% vs. 4.1%, p=0.002) and death from any cause (5.7% vs. 8.3%, p<0.001) vs. placebo plus SOC. Jardiance plus SOC did not significantly reduce the incidence of non-fatal MI (4.5% vs. 5.2%, p=0.22) and fatal or non-fatal stroke (3.5% vs. 3%, p=0.26) vs. placebo plus SOC. ...