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Diabetes drugs Actos and Avandia may increase eye disorder risk

Study shows link with incidents of diabetic macular oedema

The diabetes treatments Actos (pioglitazone) and Avandia (rosiglitazone) have been linked to an increased risk of eye disorder macular oedema in patients with type 2 diabetes, according to a new report.

The study, published in the Archives of Internal Medicine, demonstrated that the level of incidence of macular oedema after one year in patients taking thiazolidinediones, such as Takeda's Actos and GlaxoSmithKline's (GSK) Avandia, was 1.3 per cent compared to 0.2 per cent among patients with type 2 diabetes not on an associated medication.

No significant difference in incidents of macular oedema, which can lead to blindness, was found between patients using Actos and those using Avandia. 

'Clinicians should be vigilant in the clinical screening for diabetic macular oedema among those patients taking thiazolidinediones', said the study's author Dr Iskandar Idris, an associate professor in diabetes medicine at the University of Nottingham.

Both Actos and Avandia have faced previous questions over their safety, with marketing of Avandia suspended in the EU and limited in the US after it was linked to an increased risk of cardiovascular incidents.

Actos has also had its cardiovascular safety called into question, although it's the drug's link to bladder cancer that has been the biggest causing for concern, with the European Medicines Agency (EMA) ordering Takeda to update the drug's label after a safety review.

The macular oedema study involving the two drugs featured an analysis of 103,368 patients with type 2 diabetes using the The Health Improvement Network (THIN) – a database that collects anonymised electronic data from a volunteer sample of general practices in the UK.

Of this population, there were 3,227 thiazolidinedione users and 100,141 patients not using the medicines after one year.

The cause of macular oedema is complex, but it is thought to be due in part to the release of signal proterin VEGF, which can disrupt the blood-retinal barrier and cause chronic leakage of fluid that collects under the eye's macula.

According to the researchers from Nottingham, thiazolidinediones can increase the permeability of VEGF, which might be a reason for the increased risk of macular oedema.

A definitive reason was not possible, however, with the study concluding: “A larger and more detailed meta-analysis of randomised controlled trials (ideally in high-risk patients) will be needed to clearly establish the risk-benefit profile of thiazolidinediones in patients with, or at risk of, diabetic macular oedema.”

14th June 2012


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