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The Pharmaceutical Journal
Vol 271 No 7266 p312
13 September 2003

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Updated glitazone licence includes oral monotherapy indication

Rosiglitazone (Avandia) and pioglitazone (Actos) can now be used as monotherapy in type 2 diabetes.

The summary of product characteristics for each drug now states that both glitazones are indicated as oral monotherapy in type 2 diabetes patients, particularly overweight patients inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance.

The new indications come just a few days after the National Institute for Clinical Excellence (NICE) released its guidance on glitazone use in type 2 diabetes (PJ, 30 August, p257). The guidance does not make recommendations about use of the drugs as monotherapy because they were not licensed for this at the time.

A NICE spokesman said: “The guidance does not override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient”. He added that when the guidance is reviewed the recommendations will take into account any extensions to the licence for the use of glitazones.

Sally Wright, from Diabetes UK, told The Journal: “Clinicians need to look closely at the full range of treatments and make sure they are putting the patients’ health first when interpreting guidelines.”

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