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GlaxoSmithKline Responds to JAMA Articles
Date:9/11/2007

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comparators (HR 0.96). In all of these analyses, the Avandia and the

Actos hazard ratios (HR 0.82 for Actos in Nissen meta-analysis) do not

suggest an increased risk versus the comparators.

-- No long-term, head-to-head clinical trial data specifically evaluates

cardiovascular risk between Avandia and Actos; however, the

head-to-head data that does exist, and the overwhelming majority of

comparative observational data, show no significant differences in CV

events.

The JAMA article on Avandia is yet another iteration of previously analyzed data, and offers no new information on the safety of Avandia. The suggested increase in heart attack cited comes from a selective re-analyses of previously published and highly selective data from only four of 116 available studies, and reflects a difference of only 11 events in 14,291 patients between Avandia and control. In this limited meta-analysis, in the context of all the other evidence, we believe it is inappropriate for the author to advise doctors to disregard the FDA's advice which is to keep patients who are effectively controlling their diabetes on Avandia. These data have been presented to an expert advisory panel of the FDA, which voted to keep Avandia available to patients -- a vote that reflects the role of this medicine as an important treatment option to help diabetes patients control their blood sugar.

The conclusions of these meta-analyses conflict with the wealth of accumulated data on Avandia -- including 116 clinical trials in more than 52,000 patients and epidemiological studies of databases in over 1 million patients. Analyzed studies show no difference in the ischemic cardiovascular effects of Avandia versus other oral anti-diabetic medicines, including Actos.

1. Across this extensive data set, the number of heart attacks is small,

and Avandia is shown to have a comparable cardiovascular profile to the<
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SOURCE GlaxoSmithKline
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