Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone

An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result.

The re-adjudication of RECORD will be the subject of an extraordinary two-day FDA advisory committee meeting next week on June 5 and 6. GlaxoSmithKline posted a summary of the results (PDF) on its website last October, but its presence was not generally known until the publication of an article in BioCentury on Tuesday.

The FDA also required GSK to commission the independent re-adjudication of RECORD that has now resides on the GSK website. The re-adjudciation was performed by the Duke Clinical Research Institute. According to BioCentury, “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.”

Here is the conclusion of the DCRI re-adjudciation:

Click here to read the full post on Forbes.

 

 

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