Two Large, Independent Outcomes Trials Offer New Important Safety Information on Cardiovascular Effects of ...(ated clinical trial analysis of 42 short...),Health

Date:6/9/2008

ated clinical trial analysis of 42 short-term clinical studies (average duration of 6 months), most of which compared AVANDIA to placebo, showed AVANDIA to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. However, the mortality results reported in the ACCORD and VADT trials are consistent with other long-term trials involving AVANDIA. Data from three other large, long-term prospective randomized controlled clinical trials with AVANDIA (DREAM, ADOPT and interim results from RECORD) included a total of 6,311 patients treated with AVANDIA, representing 21,803 patient years of experience. For these three trials, analyses were performed on major CV endpoints, including total mortality. Results from the analyses of these three other studies show there was no statistically significant difference between AVANDIA and other medications used in the trials with regard to these CV endpoints.

Diabetes and the Role of Improved Blood Glucose Control

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About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com.

Important Safety Information for AVANDIA (R) (rosiglitazone maleate)

AVANDIA, along with diet and exercise, helps improve blood sugar contro
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