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GSK presents Avandia data To FDA

GSK presents its data on Avandia to an FDA advisory committee in order to stay the agency's proposed market ban of the diabetes treatment

UK pharmaceutical company, GlaxoSmithKline (GSK) has presented its data on Avandia (rosiglitazone) to an FDA advisory committee.

The presentation revealed what GSK said was the weight of scientific evidence available to address a question of increased risk of cardiovascular ischemic events.

The question was raised by different meta-analyses performed by GSK, the FDA and one published in the New England Journal of Medicine (NEJM).

Although a meta-analysis can identify scientific questions for further investigation, such analyses can also have significant limitations. GSK believes a full and scientific evaluation of all the data does not confirm the safety questions originally raised by the FDA and other bodies.

GSK says that longitudinal clinical trials are the most robust tools available to answer questions raised by meta-analyses. A 1997 published review of meta-analyses revealed 33 per cent of the conclusions of meta-analyses are not confirmed by subsequent clinical trials.

The Avandia data included 116 clinical trials in over 52,000 patients. Of these, the ADOPT, DREAM and RECORD studies examine 14,000 patients. RECORD, for example specifically investigates cardiovascular effects in a high cardiovascular-risk population.

The UK's largest pharmaceutical company also presented four other ongoing long-term studies, which is says will increase available data on the cardiovascular safety of Avandia: BARI-2D, ACCORD, VADT and APPROACH.

GSK also says that there is no consistent or systematic evidence that Avandia increases the risk of heart attack or cardiovascular death in comparison to other anti-diabetic medicines.

Senior FDA officials have admitted they do not know if Avandia increases heart-attack risk and are asking the advisory panel if the drug should come off the market or stay with stronger warnings or limits.

30th July 2007

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