MedPageToday; June 3, 2013
A reassessment of the results of the RECORD trial by independent reviewers has turned up similar results to the initial report, possibly signaling new life for the embattled diabetes drug rosiglitazone (Avandia), according to FDA documents.
In briefing documents released ahead of a 2-day hearing on the re-adjudication of the results -- sanctioned by the FDA in 2010 -- reviewers from Duke University found similar results for overall mortality and cardiovascular mortality.
"Overall, the re-adjudication supports the previous observation that, in this trial, rosiglitazone was not associated with increased all-cause mortality or increased cardiovascular mortality," the FDA wrote in the review documents.
But critics -- namely Steve Nissen, MD, of the Cleveland Clinic, who sparked concerns about rosiglitazone in a 2007 New England Journal of Medicine meta-analysis that showed an increased risk of MI among patients on the drug -- have charged that the FDA is merely trying to wash its hands of culpability for its role in ongoing issues with the drug.
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