Avandia provides new combination option for patients with inadequately controlled type 2 diabetes

September 17, 2000

Jerusalem, Israel, 18 September 2000: AvandiaTM (rosiglitazone), SmithKline Beecham's oral anti-diabetic agent recently approved in Europe, provides a new combination option for patients with inadequately controlled type 2 diabetes.

Previously, obese, type 2 diabetes patients unable to maintain good glycaemic control with metformin faced limited treatment options, a problem shared by patients failing on sulphonylureas where metformin is contraindicated, i.e. those with renal impairment. Yet management of these patients is critical in slowing disease progression and delaying the use of insulin.

Now, the launch of AvandiaTM provides these patients with new combination regimens. Data presented at the annual conference of the European Association for the Study of Diabetes (EASD), by Dr Tracey Jones of SmithKline Beecham, show that adding AvandiaTM (up to 8 mg/day) to metformin improves blood glucose levels in obese patients. The studies, which involved 550 type 2 diabetes patients, showed fasting plasma glucose was reduced by 3.6 mmol/l compared to baseline.1 Glycosylated haemoglobin (HbA1c) levels were also reduced by nearly 1%; importantly this reduction was maintained for at least 18 months.2 The combination of metformin and AvandiaTM was also found to improve insulin sensitivity and reduce fasting insulinaemia.

In addition, studies involving over 800 patients with type 2 diabetes show that combining AvandiaTM (4 mg/day) with a sulphonylurea in those with mild-to-moderate renal impairment decreases fasting plasma glucose by 2.1 mmol/l, compared with baseline.3 Presenting these data, Arvind Agrawal of SmithKline Beecham concluded: "AvandiaTM provides effective glycaemic control and is well tolerated in patients with renal impairment who are inadequately controlled by sulphonylurea monotherapy, offering hope to this important group of patients."

The ability of AvandiaTM to complement metformin and sulphonylurea therapy may lie with its novel mode of action. AvandiaTM addresses insulin resistance and declining ?-cell function -- two key underlying factors in type 2 diabetes.4,5 Obesity is virtually always associated with insulin resistance,6 making AvandiaTM a rational choice in combination with metformin for obese individuals with poor glycaemic control -- the patient group associated with the highest treatment costs.7 As such, AvandiaTM represents a significant advance in the choice of oral anti-diabetic agents and combination therapy regimens.
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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 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.

AvandiaTM is a trademark of SmithKline Beecham plc.

References

1. Jones T, Jones NP & Sautter M. Addition of rosiglitazone to metformin is effective in obese, insulin-resistant patients with type 2 diabetes. Abstract EASD 2000.

2. SmithKline Beecham. Data on file. 2000. ADVF0330b

3. Agrawal A, Jones NP & Sautter M. Rosiglitazone added to a sulphonylurea in patients with type 2 diabetes and mild-to-moderate renal impairment. Abstract EASD 2000.

4. Porter LE, Freed MI, Jones NP, et al. Rosiglitazone reduces proinsulin/insulin ratio and improves ?-cell function in type 2 diabetes. Abstract EASD 2000.

5. Matthews DR, Bakst A, Weston WM, Hemyari P. Rosiglitazone decreases insulin resistance and improves ?-cell function in patients with type 2 diabetes. Abstract EASD 1999.

6. Boden G. Role of fatty acids in the pathogenesis of insulin resistance and NIDDM. Diabetes 1997; 46:3--10.

7. Mera R, Wisner CL, Kirsch J, et al. The Cost Of Diabetes in Europe - Type 2 Study: poorly controlled obese diabetic patients are more costly than non-obese patients. 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


MediTech Media Ltd.

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