Controversial Analysis Of Disputed Trial Finds Avandia Is Safe, After All

File this under ‘what a surprise!’ Next month, the FDA will hold a two-day meeting to discuss a reassessment of a hotly contested clinical trial that was the focus of a contentious 2010 FDA panel meeting held to review the controversial Avandia diabetes pill (back story). And now, the results are out. The re-adjudication of the RECORD trial shows the drug was not associated with a significantly increased risk of cardiovascular events and the outcomes were consistent with the original analysis of the GlaxoSmithKline (GSK) pill. Although the FDA restricted Avandia use to only Type 2 diabetes who are unable to benefit from other diabetes medications, the agency ordered Glaxo to convene an independent group of scientists to review the trial, which was skewered by an FDA medical reviewer during the 2010 committee meeting. The re-adjudication was conducted by the Duke Clinical Research Instituted and Glaxo posted a summary of the results on its web site last October, although the drugmaker did not publicize the availability and its existence was first reported by BioCentury. This is what the Duke researchers say: “As concluded by the independent DCRI RECORD CEC group, there was no evidence of treatment effect on all-cause mortality or cardiovascular plus unknown mortality. The results of the primary analyses and extensive sensitivity analyses using the re-adjudicated outcomes were consistent with the original RECORD results and did not show statistically significant differenc...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs