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Continued: FDA panel favors easing safety limits on Avandia

  • Article by: MATTHEW PERRONE , AP Health Writer
  • Last update: June 6, 2013 - 6:10 PM

That has focused the agency's attention on the RECORD trial, a six-year study of 4,400 patients that compared heart attack rates in patients taking Avandia versus metformin and sulphonylurea, a standard drug combination for diabetics. The initial results reported by Glaxo in 2009 showed no signal for heart attacks, but those findings have been questioned because of missing data and other issues.

Under instructions from the FDA, Glaxo hired Duke University to reanalyze the RECORD study, reviewing each report of heart attack or stroke at a patient-by-patient level. Duke's findings matched Glaxo's initial conclusion: Avandia did not appear to increase the risk of heart attack.

At least one FDA reviewer said this week that Duke's review was not truly independent, since the university was paid $3 million by Glaxo and relied on records provided by the drugmaker.

But FDA leadership said there was no evidence of "systematic or intentional manipulation" of the RECORD reevaluation. The agency's panelists almost unanimously backed that conclusion.

While there are well over a dozen diabetes medications on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. Both drugs increase patients' sensitivity to insulin, a key protein needed to break down carbohydrates.

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