Data support Avandia (rosiglitazone maleate) cardiovascular safety profile

Issued: London UK 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). GSK’s review supports the overall positive benefit-risk profile of rosiglitazone as an important medicine for patients with type 2 diabetes. The data in GSK’s 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 FDA’s 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 GSK’s briefing document for the FDA meeting and a copy of the complete briefing document is posted on the FDA’s 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. 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 further information please visit www.gsk.com or the Avandia resource centre. GlaxoSmithKline Enquiries: UK Media enquiries: Philip Thomson Claire Brough Stephen Rea Alexandra Harrison Jo Revill (020) 8047 5502 (020) 8047 5502 (020) 8047 5502 (020) 8047 5502 (020) 8047 5502 US Media enquiries: Nancy Pekarek Mary Anne Rhyne Kevin Colgan Sarah Alspach (919) 483 2839 (919) 483 2839 (919) 483 2839 (919) 483 2839 European Analyst/ Investor enquiries: David Mawdsley Sally Ferguson Gary Davies (020) 8047 5564 (020) 8047 5543 (020) 8047 5503 US Analyst/ Investor enquiries: Tom Curry Jen Hill Baxter (215) 751 5419 (215) 751 7002 Gsk Logo This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our location selector. © 2001-2026 GSK plc. All rights reserved. Trade marks are owned by or licensed to the GSK group of companies. GSK plc. Registered in England and Wales No. 3888792. Registered office: 79 New Oxford Street, London. United Kingdom. WC1A 1DG > Modern Slavery Act Statement 2025 (PDF - 187.7KB) GSK websites Locations selector Social media directory GSKPro for healthcare professionals GSK study register Supplier website ViiV Healthcare Quick links Behind the Science magazine Company Innovation Products Responsibility Investors Media Careers Get in touch Contact us Partnerships Report a possible side effect GSK Speak up Follow us on: Accessibility Digital sustainability Terms of use Cookie policy Privacy notice Sitemap

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