Washington, June 9 (ANI): A re-analysis of the data from a pivotal study of rosiglitazone found no increased risk of cardiovascular events associated with the controversial diabetes drug.
The Duke Clinical Research Institute (DCRI) study of the drug, marketed in the United States as Avandia, reassessed the original findings of a clinical trial called RECORD, which drew criticism during an advisory committee meeting of the US Food and Drug Administration in July 2010.
Rosiglitazone has not been widely marketed in the United States since 2010, when the FDA restricted its use after studies showed it was associated with a higher risk of heart attacks; it is no longer marketed in Europe.
The FDA required the new analysis, which was funded by the drug's manufacturer, GlaxoSmithKline.
"We were pleased to be chosen to perform this re-evaluation and we look forward to presenting our findings and being part of the FDA advisory committee discussion," Kenneth W. Mahaffey, M.D., associate director of the DCRI and lead author of the study, said.
The findings are published in American Heart Journal. (ANI)
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