Drug news

Potential role for dapagliflozin (BMS/AstraZeneca)in Cardioprotection

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Last updated:19th Nov 2011

Published:19th Nov 2011

Source: Pharmawand

A pre-specified meta-analysis of cardiovascular safety data from 14 Phase IIb/III trials in adult patients treated with dapagliflozin (BMS/AstraZeneca) with Type 2 Diabetes, was conducted in accordance with FDA guidelines for the assessment of cardiovascular safety in new antidiabetic treatments. The results were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, Florida and showed that the compound was not associated with an unacceptable increase in CV risk relative to all comparators pooled in the clinical programme. AstraZeneca and BMS plan a trial to test the cardiovascular protective effect of the drug which is to be reviewed by the FDA on 18 January 2011.The FDA has expressed concerns about the safety profile of dapagliflozin.

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