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Jun 03, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Avandia rosiglitazone: Phase IV data

Researchers at the Duke Clinical Research Institute conducted an independent Phase IV re-adjudication of the Phase III RECORD cardiovascular outcomes trial of Avandia showing that the diabetes drug was not associated with a significantly increased risk of cardiovascular events. The outcomes were consistent with the original analysis of the drug (see BioCentury, June 8, 2009). The re-adjudication will be the subject of a June 5-6 FDA advisory committee meeting. GSK posted a summary of the re-adjudication results in October 2012, but has not publicized their availability. GSK said it does not typically publicize data put on its clinical trial registry and added that the Duke researchers are planning to submit the data for publication. In 2010,...

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