Bristol-Myers Squibb and AstraZeneca Announce Meta-Analysis of Clinical Data on Cardiovascular Safety Presented for Investigational Compound Dapagliflozin in Adult Patients with Type 2 Diabetes

Bristol-Myers Squibb Company BMY and AstraZeneca AZN today announced results from a pre-specified meta-analysis of cardiovascular safety data from 14 Phase 2b/3 trials in adult patients with type 2 diabetes, which showed that the investigational compound dapagliflozin was not associated with an unacceptable increase in CV risk relative to all comparators pooled in the clinical program. The meta-analysis, presented today at the American Heart Association Scientific Sessions in Orlando, FL, was conducted in accordance with the U.S. Food and Drug Administration guidelines for the assessment of CV safety in new anti-diabetic treatments. The meta-analysis included 6,228 patients, with 4,287 patients in the dapagliflozin group and 1,941 patients in the control group. The primary endpoint was a composite endpoint of time to first event of CV death, myocardial infarction (MI), stroke or hospitalization for unstable angina. The relative risk between dapagliflozin and the control group, measured by hazard ratio, was 0.67 (98% CI: 0.38, 1.18).