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New Study Supports Cardiovascular Safety of Bristol-Myers Squibb/AstraZeneca’s SGLT2 Drug Dapagliflozin in Type 2’s

Dapagliflozin, an inhibitor of SGLT2 as an adjunct to diet and exercise, is being investigated to evaluate its safety and its efficacy on blood sugar levels in adults with type 2 diabetes….

Bristol-Myers Squibb Company and AstraZeneca announced results from a pre-specified meta-analysis of cardiovascular (CV) 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 at the American Heart Association (AHA) Scientific Sessions in Orlando, FL, was conducted in accordance with the U.S. Food and Drug Administration (FDA) 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 1,941patients 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).

Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb, said, "This comprehensive analysis provides valuable information that can be used to better understand the cardiovascular safety profile of dapagliflozin as a monotherapy or as an add-on therapy to common anti-diabetic treatments." "We are pleased that the findings from this meta-analysis support the cardiovascular safety profile of dapagliflozin in adult patients with type 2 diabetes, and we look forward to conducting additional research to continue to expand our understanding of dapagliflozin."

A New Drug Application (NDA) for dapagliflozin was accepted for review by the FDA in March 2011. The FDA recently extended the Prescription Drug User Fee Act (PDUFA) date by three months, setting the new goal date at January 28, 2012.

The pre-specified meta-analysis of 14 Phase 2b/3 studies was designed to assess the CV safety of dapagliflozin relative to all comparators pooled in the clinical program. The primary endpoint was a composite endpoint of time to first event of CV death, MI, stroke or hospitalization for unstable angina.

The meta-analysis included 6,228 patients with type 2 diabetes, including 4,287 patients treated with dapagliflozin (2.5 mg, 5 mg, 10 mg doses) with or without add-on/combination anti-diabetes medication and 1,941 patients in the control group, treated with a placebo or an active comparator, with or without add-on/combination anti-diabetes medication.

The proportion of patients with at least one CV risk factor in addition to type 2 diabetes was 88.0% in both groups. The proportion of patients with at least two CV risk factors in addition to type 2 diabetes was 64.1% in the dapagliflozin group and 65.2% in the control group.

The primary endpoint was a composite endpoint of time to first event of CV death, MI, stroke or hospitalization for unstable angina. A total of 78 primary endpoint CV events were confirmed, with 48 in the dapagliflozin group (n = 4,287) and 30 in the control group (n =1,941). The relative risk between dapagliflozin and the control group, measured by hazard ratio, was 0.67 (98% CI: 0.38, 1.18).

Bristol-Myers Squibb Company and AstraZeneca. Press Release 11-16-2011