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Newly Published Data from Large Study Support Cardiovascular Safety,of Avandia (Rosiglitazone Maleate)

Results show risk of heart attack comparable to two widely used diabetes medicines

LONDON, June 6, 2007- A study of more than 33,000 type 2 diabetes patients in a real-world setting was published today. This study shows that the incidence of hospitaliations for heart attack, and/or for a surgery known as coronary revascularization for patients on Avandia is the same as for other diabetes treatments. The study results were released in a paper titled “Coronary Heart Disease Outcomes in Patients Receiving Antidiabetic Agents” in Pharmacoepidemiology and Drug Safety.

These data, also described in a letter published online last week (May 30, 2007) in the medical journal The Lancet, are further evidence that the ischemic cardiovascular safety of Avandia is comparable to the most commonly used type 2 diabetes treatments – as evidenced in long-term prospective trials, such as ADOPT and DREAM. The findings conflict with a hypothesis generated by the recently published meta-analysis in the New England Journal of Medicine that raised concerns regarding ischemic risks with Avandia.

Based on an observational cohort study from a large U.S.managed-care database, this research was commissioned by GlaxoSmithKline as part of its commitment to the ongoing monitoring and assessment of the safety of Avandia. The study was designed to compare the risk of heart attack and coronary revascularization in type 2 diabetes patients taking Avandia, metformin or sulfonylurea – either alone, as two medicines combined and in combination with insulin. The study populations were matched to ensure that the cohort groups were similar in terms of their baseline risk factors for cardiovascular disease. Patients were followed for an avera
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