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.
The GSK presentation demonstrates the weight of scientific evidence available to address a question of increased risk of cardiovascular ischemic events.
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.