FDA Reviewer Questions Results of Key Avandia Trial

Ahead of crucial advisory panel meeting next week, official cites 'mishandling' of data for diabetes drug

By Amanda Gardner
HealthDay Reporter

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FRIDAY, July 9 (HealthDay News) -- One step ahead of a planned government review of the safety of Avandia, new doubts surfaced Friday on a key trial that helped keep the blockbuster diabetes drug on the market.

A medical reviewer for the U.S. Food and Drug Administration posted remarks on the agency's Web site Friday suggesting that drugmaker GlaxoSmithKline's "mishandling" of trial results may have masked some cardiovascular effects of Avandia (rosiglitazone).

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The official's posting was part of a safety reassessment package prepared for next week's advisory panel meeting that could determine the future of the controversial drug.

At issue in the review posting were the results of the landmark RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial, which was done by Glaxo at the FDA's request. The results, announced in June of 2009, found that Avandia raised the risk of heart failure but not to a level of statistical significance. The study also concluded that the drug did not increase the risk of cardiovascular disease or overall death.

In his posting, Thomas A. Marciniak, medical team leader of the division of cardiovascular and renal products at the FDA's Center for Drug Control and Evaluation, said that "RECORD was inadequately designed and conducted to provide any reassurance about the [cardiovascular] safety of rosiglitazone" and that "RECORD suggests the (sic) rosiglitazone increases the risk for [heart attacks]."

Last June, Glaxo used the trial results to tout the drug's safety.

"RECORD provides important and reassuring information about Avandia for physicians fighting diabetes," said Dr. Ellen Strahlman, Glaxo's chief medical officer, in a statement released at the time. "We believe that the results showed that Avandia is safe."

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