Bristol-Myers Squibb and AstraZeneca reports dapagliflozin safety data

Bristol-Myers Squibb and AstraZeneca have reported positive findings from a new assessment of the safety performance of their diabetes therapy dapagliflozin.

Pre-specified meta-analysis of cardiovascular safety data from 14 Phase IIb/III trials of the drug has shown that the investigational compound is not associated with any unacceptable increase in heart disease risk.

This analysis takes into account clinical data collected from 6,228 patients and will help to create a comprehensive safety profile for the drug, which is currently being assessed by regulators in the US.

If approved, Bristol-Myers Squibb and AstraZeneca will conduct a further safety study to assess its long-term performance and any possible cardio-protective effect it might have.

Dr Brian Daniels, senior vice-president for global development and medical affairs at 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."

This comes after the companies published phase III data showing the efficacy of dapagliflozin in combination with metformin earlier this year.