News Release

Avandia positively impacts on factors linked with insulin resistance

Peer-Reviewed Publication

MediTech Media Ltd.

Jerusalem, Israel, 18 September 2000: New studies presented at the annual conference of the European Association for the Study of Diabetes (EASD) support the suggestion that AvandiaTM (rosiglitazone) improves fat distribution and endothelial function through its impact on insulin resistance, a fundamental cause of type 2 diabetes.

Data presented by Dr David Carey, from the Wesley Research Institute, Australia, show a 30% reduction in hepatic fat with AvandiaTM therapy (8 mg/day).1 "Increased deposits of fat around the internal organs and in the liver are commonly associated with insulin resistance and are found in many type 2 diabetes patients," explained Dr Carey. "Our preliminary findings indicate that AvandiaTM helps prevent accumulation of fat around the internal organs and significantly reduces hepatic fat. Further studies, currently being undertaken, should allow us to demonstrate this important part of the drug’s profile more clearly."

Dr Carey and colleagues found that the reduction in hepatic fat was achieved with a slight increase in abdominal sub-cutaneous fat but, importantly, no increase in intra-abdominal fat1 -- the fat distribution responsible for the classic ‘apple-shape’ typical of individuals with type 2 diabetes.

In addition, studies show that AvandiaTM decreases other factors linked with insulin resistance. Dr Barry Goldstein and co-workers reported reductions in the level and activity of plasminogen activator inhibitor-1 (PAI-1) when AvandiaTM was added to sulphonylurea (SU) treatment, compared with SU monotherapy.2 PAI-1 inhibits fibrinolysis (the breakdown of blood clots) and is strongly associated with a cluster of cardiovascular risk factors.

Both studies found these changes in fat distribution and PAI-1 were in addition to substantial reductions in fasting plasma glucose and glycosylated haemoglobin (HbA1c) levels, respectively.1,2

Insulin resistance is central to a number of metabolic disturbances, which commonly manifest as hepatic and cardiovascular complications in individuals with type 2 diabetes. These latest findings highlight the potential for AvandiaTM to have a positive impact on these factors.

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SmithKline Beecham -- one of the world’s leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals and vaccines, over the counter medicines, health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com .

Note to Editors

AvandiaTM (rosiglitazone) is the first PPAR (peroxisome proliferator-activated receptor) gamma agonist (thiazolidinedione; glitazone) to receive a product licence in the EU via the centralised procedure. AvandiaTM is now available in more than 50 countries worldwide. SmithKline Beecham has committed to a programme of clinical investigations worth more than £100 million in Europe alone -- one of the biggest diabetes programmes recorded.

AvandiaTMTM is a trademark of SmithKline Beecham plc.

References

1. Carey DG, Galloway G, Dodrell D, et al. Rosiglitazone reduces hepatic fat and increases subcutaneous but not intra-abdominal fat deposits. Abstract EASD 2000.

2. Freed M, Fuell D, Menci L, et al. Effect of combination therapy with rosiglitazone and glibenclamide on PAI-1 antigen, PAI-1 activity and tPA in patients with type 2 diabetes. Abstract EASD 2000.

Press contact: Jane Nichols and Chloe Murray at MediTech Media on:
(on-site mobile) +972 (0)50 372295 or +44 [0]20 7398 0500

Graeme Holland at SmithKline Beecham on: +44 [0]1279 644369


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