The Pharmaceutical Journal
Vol 279 No 7464 p148
11 August 2007

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Donepezil shown to help severe Alzheimer’s patients

Acetylcholinesterase inhibitor donepezil can improve cognition and global function for people with severe Alzheimer's disease, a recently published study suggests (Neurology 2007;69:459). The study comes ahead of the outcome of a high court challenge of the National Institute for Health and Clinical Excellence’s appraisal processes for anticholinesterase drugs.

Researchers randomised 343 patients with severe Alzheimer’s disease to receive donepezil (5mg daily for the first six weeks then 10mg daily thereafter) or placebo for 24 weeks. By the end of the study, donepezil was shown to be better than placebo for change in “severe impairment battery” scores (P=0.0001) and “clinician’s interview-based impression of change plus caregiver input” scores (P=0.0473), the primary outcome measures.

However, aside from mini-mental state examination scores, which were improved in the donepezil group (P=0.0267), other secondary measures, such as those of daily living, caregiver burden and care resource utilisation, were not significantly different between groups.

Last year, NICE restricted the use of anticholinesterase drugs, including donepezil, to patients with Alzheimer’s disease of moderate severity only (PJ, 25 November 2006, p625). NICE’s decision-making process has been challenged by Eisai and Pfizer — manufacturers of donepezil (Aricept) — in a judicial review, the judgment of which was scheduled for 10 August 2007, after The Journal went to press.

The authors of the study (supported by Eisai and Pfizer) say that the effectiveness of donepezil for preserving cognitive and global function in severe Alzheimer’s disease is encouraging. They suggest that donepezil may be considered beneficial throughout the course of the disease.