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GlaxoSmithKline presents Avandia data to FDA
Avandia :: GlaxoSmithKline presents Avandia data to FDA
The following summarizes GlaxoSmithKline?s [NYSE: GSK] presentation of data on Avandia? (rosiglitazone maleate) to an Advisory Committee of the Food and Drug Administration (FDA) on July 30, 2007.This question was raised by different meta-analyses performed by GSK, the FDA and one published in the NEJM.
Although a meta-analysis can help raise 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.
Long-term clinical trials ? particularly those designed to test a specific outcome in patients with the disease ? are the most robust tools available to answer questions raised by meta-analyses. A 1997 published review of meta-analyses revealed 33% of the conclusions of meta-analyses are not confirmed by subsequent clinical trials.
Avandia is the most widely studied oral anti-diabetic medicine for the treatment of type 2 diabetes. The extensive data for Avandia includes:
116 clinical trials in over 52,000 patients. These include:
Three, long-term clinical trials in more than 14,000 patients: ADOPT, DREAM, RECORD, with RECORD specifically studying cardiovascular effects
A study in a high cardiovascular-risk population: PPAR
Three epidemiological studies reflecting real life use of diabetes medicines in more than 1.3 million diabetic patients.
Additionally, four other ongoing long-term studies will increase available data on the cardiovascular safety of Avandia: BARI-2D, ACCORD, VADT, APPROACH.
Across the extensive dataset for Avandia, 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.
(Avandia :: GlaxoSmithKline presents Avandia data to FDA published at SpiritIndia on Monday, July 30, 2007)
Avandia
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