Efficacy And Safety Of Aricept Questioned

29 October 1997

Eisai/Pfizer's acetylcholinesterase inhibitor Aricept (donepezil) waslicensed in the UK earlier this year for the symptomatic treatment of mild-to-moderately severe Alzheimer's dementia (Marketletter March 3). However, its efficacy and safety has been questioned in a report published in the Drugs and Therapeutics Bulletin (October issue).

The article says that as donepezil increases cholinergic transmission, then its therapeutic benefits "must depend on the presence of functioning cholinergic neurones." In that case, the therapeutic effects of an acetylcholinesterase inhibitor must diminish during the course of the disease as the number of cholinergic neurones decreases.

Data Not Fully Published The report goes on to say that only one trial, including 161 patients with mild-to-moderately-severe Alzheimer's disease, has been published in full; data from an open-label study looking at long-term treatment with donepezil has been published in abstract form only, as have the results from a Phase III, 450-patient trial.

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