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The first drug to be licensed in Britain for the symptomatic treatment of mild to moderately severe Alzheimer's disease has failed to be recommended by the Drug and Therapeutics Bulletin. The report produced by the Consumers' Association concluded: "On the published evidence available we cannot recommend the use of donepezil.".
Donepezil (Aricept) is an acetylcholinesterase inhibitor that increases the concentration of acetylcholine at cholinergic synapses and so enhances chol-inergic transmission. It is the only drug licensed in Britain for the treatment of Alzheimer's disease, although tacrine, another acetylcholinesterase inhibitor, is available in the United States and France.
Only one randomised, controlled, double blind clinical trial has been published in full. This 12 week study of 161 patients with mild to moderately severe Alzheimer's disease showed that 5 mg donepezil daily improved cognitive function (Dementia 1996;7:293-303). However, the drug failed to influence day to day functioning, quality of life measures, and rating scores of overall dementia.
Dr Joe Collier, editor of the Drug and Therapeutics Bulletin, said: "The clinical significance of the changes for patients and their families or carers is therefore unclear. It is not acceptable to ask doctors to make decisions on the basis of the results of a single, clinically inconclusive trial."
But Dr Roy Jones, honorary consultant geriatrician and director of the research institute for the care of the elderly at St Martin's Hospital in Bath, said that he thought the bulletin's stance was disappointing. "No drug is registered purely on the results of the published data, and there are a lot of other data available. There is a study of 450 patients in press in Neurology and the bulletin should have waited a couple of months until this was published rather than making a statement on incomplete information."
"This is a disease for which there is no other treatment. [Donepezil] is not a miracle cure but the effect in some cases is remarkable," he said.