Avandia targets both fundamental causes of type 2 diabetes – offering new hope for delaying disease progression

Jerusalem, Israel, 18 September 2000: Addressing insulin resistance and declining beta-cell function may be the key to delaying the progression of type 2 diabetes, according to experts at the annual conference of the European Association for the Study of Diabetes (EASD).

A new treatment, Avandia ^TM (rosiglitazone), is now available in Europe that may address this dual therapeutic need. Unlike conventional oral anti-diabetic therapies, Avandia ^TM targets both fundamental causes of type 2 diabetes; reducing insulin resistance and potentially improving beta-cell function. ¹ ^, ² By doing this, Avandia ^TM provides enhanced and sustained glycaemic control ³ ^, ⁴ ^, ⁵ ^, ⁶ and may have the potential to alter disease outcomes and delay disease progression.

Data show a 23% improvement in beta-cell function when Avandia ^TM (8 mg/day) is added to metformin therapy in a Homeostasis Model Assessment (HOMA) study*. ⁷ This may reflect Avandia ^TM ’s ability to reduce elevated blood glucose and free fatty acid levels,7 factors characteristic of type 2 diabetes that appear to be toxic to the pancreatic beta-cells. ⁸ ^, ⁹

Significantly, a preclinical study showed that Avandia ^TM may have a protective effect on the beta-cells. ¹⁰ "In animal studies, we found that Avandia ^TM prevented the loss of â-cell mass in rats treated before the development of diabetes," reported Dr Diane Finegood, lead investigator of the study. "Maintenance of â-cell mass was associated with less â-cell death as compared to untreated animals. This suggests that, in this model, the progression to type 2 diabetes can be delayed."

As type 2 diabetes progresses insulin resistance increases and the beta-cells can no longer compensate, so it becomes harder to maintain good glycaemic control -- even with combination therapy. This may be due, in part, to the fact that conventional oral anti-diabetics do not directly treat the underlying causes of the disease, particularly insulin resistance. ¹

Avandia ^TM (8 mg/day) in combination with metformin therapy was also shown to reduce insulin resistance by 20% compared to baseline. ² Furthermore, adding Avandia ^TM (4 mg/day) to sulphonylurea treatment decreased insulin resistance by 17% compared to baseline. ²

Importantly, the effects of Avandia ^TM , in combination with metformin, on insulin resistance and beta-cell function are maintained for at least 2 years. ⁷ ^, ¹¹ This may account for the sustained improvements in glycaemic control seen with Avandia ^TM treatment and suggests that it may delay disease progression.

At present, the ability of treatments to maintain effective glycaemic control declines markedly with time; approximately half of patients on monotherapy must progress to combination therapy within 3 years. ¹² Through its novel mode of action, Avandia ^TM has the potential to substantially improve the management of type 2 diabetes in patients with unmet medical needs.

* Homeostasis Model Assessment (HOMA) is a method for estimating insulin resistance and beta-cell function in patients with type 2 diabetes.

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:

Avandia ^TM (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. Avandia ^TM 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.

Avandia targets both fundamental causes of type 2 diabetes – offering new hope for delaying disease progression

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