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Randomisation phase of the DIRECT programme (DIabetic REtinopathy Candesartan Trials) completed

The randomisation of patients into the landmark DIabetic REtinopathy Candesartan Trials (DIRECT) was completed in February. A total of 5238 patients in around 300 investigational sites in 30 EU countries have now been randomised into the 3 trial/studies that comprise the DIRECT Programme. The DIRECT Programme is the first Programme designed to establish whether treatment with an angiotensin II type 1 (AT1) receptor blocker, candesartan cilexetil, targeting the renin angiotensin system (RAS), can provide effective treatment against the onset and progression of diabetic retinopathy. In this double-blind programme, patients are assigned to receive 32 mg of candesartan cilexetil or placebo.

The DIRECT programme, launched on Nov. 1, 2000, is being coordinated through EURODIAB, a European diabetes research network, based at University College, London, and Imperial College, London, and overseen by an independent Steering Committee, chaired by Professor Anne-Katrin Sjolie, University of Southern Denmark, Odense. The Steering Committee consists of leading ophthalmologists, diabetologists and epidemiologists, and has scientific responsibility for the DIRECT programme.

"We are very pleased to have completed this initial phase of the DIRECT Programme, with more patients than originally planned. DIRECT represents an important step forward in the fight against visual loss caused by diabetic retinopathy", said Professor Sjolie. "This important Programme will tell us more about the potential for using a drug such as candesartan to halt progression of, and possibly prevent, diabetic retinopathy, a common and frightening condition among people with diabetes. We look forward to the results from the DIRECT Programme, which will hopefully identify candesartan as a new addition to current treatment and help to limit retinal damage and, in some patients, preserve vision."

Retinopathy can ultimately lead to blindness in both type 1 and type 2 diabetic patients. I
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Contact: Takashi Kikuchi
Kikuchi_Takashi@takeda.co.jp
81-66-204-2258
Japan Corporate News Network
2-Mar-2004


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