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EC approves new strengths of GSK's Avandamet for type 2 diabetes
London | Friday, September 10, 2004, 08:00 Hrs  [IST]

Two new dosage strengths of Avandamet (rosiglitazone maleate and metformin HCl) - a treatment for type 2 diabetes that combines two important medications in one convenient pill - has been approved by European Commission, informed GlaxoSmithKline (GSK) in a release.

The new Avandamet dosages of 1 gram metformin combined with 2 mg or 4 mg rosiglitazone will soon be available to patients in the European Union.

"GlaxoSmithKline is pleased with the European Commission's approval of the new Avandamet 1 gram tablets for the treatment of type 2 diabetes. These new dosages will offer greater dosing flexibility by providing a more comprehensive range of tablet strengths to the many type 2 diabetes patients who are currently taking Avandamet or Avandia plus metformin. The new Avandamet 1g formulation may also offer greater patient convenience by reducing the number of pills to be taken, potentially resulting in improved patient compliance," said Andrew Witty, president of GlaxoSmithKline Pharmaceuticals Europe.

"With traditional anti-diabetic agents, over 60 per cent of patients do not reach recommended treatment goals for blood glucose levels, and this can lead to serious long-term complications," said professor Stephan Matthaei, director of the Diabetes and Metabolism Centre, Quakenbruck Hospital.

"These new dosage strengths of rosiglitazone and metformin in one pill will help clinicians give their type 2 diabetes patients a more convenient way of achieving better glycaemic control," he added.

Avandamet is the first treatment that combines a thiazolidinedione - Avandia (rosiglitazone maleate) - with a leading oral diabetes therapy - metformin - in one convenient pill. Together, the two drugs help patients achieve enhanced glucose control compared to metformin alone. Good glucose control may help to reduce the risk of some long-term complications associated with type 2 diabetes. In addition, the combination of Avandia plus metformin has been shown to have a low risk of hypoglycaemia (low blood sugar), a side effect commonly seen with sulphonylureas.

Avandamet was originally approved in the European Union in October 2003 for the treatment of type 2 diabetes mellitus, particularly in overweight patients, who are uncontrolled on their maximally tolerated dose of metformin alone.

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