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Data support Avandia (rosiglitazone maleate) cardiovascular safety profile

Posted by dlife on Wed, Feb 01, 12, 07:01 AM 0 Comment

July 9, 2010 (GlaxoSmithKline) - The U.S. Food and Drug Administration (FDA) today posted a comprehensive review conducted by GlaxoSmithKline (GSK) of the cardiovascular safety data on Avandia (rosiglitazone maleate). GSKs review supports the overall positive benefit-risk profile of rosiglitazone as an important medicine for patients with type 2 diabetes.

The data in GSKs review come from meta-analyses, observational studies and large controlled clinical trials that have become available since July 2007, when the FDA convened advisory committees to review the efficacy and safety of rosiglitazone. The FDAs Endocrinologic and Metabolic Drugs, and the Drug Safety and Risk Management Advisory Committees will review these data at a meeting on 13-14 July 2010.

Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death, said Dr. Murray Stewart, Vice President for Clinical Development at GSK. We also know that Avandia lowers glucose levels in both the short- and long-term and is the only oral anti-diabetic medicine that has been shown to sustain blood sugar control for up to five years.[1] We look forward to presenting these data and participating in a rigorous scientific discussion with the advisory committees.

About nine percent of adults in the U.S. have type 2 diabetes, which has increased from five percent in 1997 (Ref CDC website). Type 2 diabetes is characterised by high blood sugar levels and it represents a major health risk with complications that can include blindness, kidney failure, amputations, heart attack and stroke.

A three-page executive summary of GSKs briefing document for the FDA meeting and a copy of the complete briefing document is posted on the FDAs website.

[1] Kahn SE, Haffner SM, Heise MA et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355(23):2427-2443.

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