Drug for Alzheimer's disease is of little benefit, study shows
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《英国医生杂志》
Donepezil (Aricept), a cholinesterase inhibitor approved by the National Institute for Clinical Excellence (NICE) for the treatment of Alzheimer's disease, neither slows the onset of the disease nor delays the need for patients to be taken into care, a study published in the Lancet has found (2004;363; 2105-15).
The five year, double blind, randomised controlled trial conducted by the University of Birmingham and funded by the NHS concluded that routine prescribing of the drug is a waste of scarce resources.
Currently 39 000 people in the United Kingdom are taking the drug, which costs about ￡1000 ($1825; 1500) per person per year.
The study, called AD2000, recruited 565 patients with mild to moderate Alzheimer's disease who were living in the community. The patients were randomly assigned to either donepezil or a placebo.
It found only a marginal improvement in the mental state and functional ability of patients who took the drug. The researchers tested for cognition, using the MMSE (mini-mental state examination) and for functionality using the BADLS (Bristol activities of daily living) scales.
Those on donepezil averaged only 0.8 MMSE points better than those on the placebo (95% CI 0.5-1.2). The mini-mental state exam is a test out of 30.
Those on donepezil scored 1.0 BADLS points better (95% CI 0.5-1.6) with donepezil over the first two years. The BADLS test has a 60 point scale.
Donepezil increases functional ability only marginally in patients with Alzheimer's disease
Credit: BSIP/MENDIL/SPL
Investing in better social support for patients and their carers would be wiser than prescribing these expensive drugs, argues the team responsible for the study.
Eisai and Pfizer UK, the companies that make donepezil, said that the study recruited too few patients for the results to be dependable and said that patients have seen benefits from the drugs.
A review of NICE's 2001 recommendations for cholinesterase inhibitors and Alzheimer's disease is under way and is due for publication in May 2005.(Debashis Singh)
The five year, double blind, randomised controlled trial conducted by the University of Birmingham and funded by the NHS concluded that routine prescribing of the drug is a waste of scarce resources.
Currently 39 000 people in the United Kingdom are taking the drug, which costs about ￡1000 ($1825; 1500) per person per year.
The study, called AD2000, recruited 565 patients with mild to moderate Alzheimer's disease who were living in the community. The patients were randomly assigned to either donepezil or a placebo.
It found only a marginal improvement in the mental state and functional ability of patients who took the drug. The researchers tested for cognition, using the MMSE (mini-mental state examination) and for functionality using the BADLS (Bristol activities of daily living) scales.
Those on donepezil averaged only 0.8 MMSE points better than those on the placebo (95% CI 0.5-1.2). The mini-mental state exam is a test out of 30.
Those on donepezil scored 1.0 BADLS points better (95% CI 0.5-1.6) with donepezil over the first two years. The BADLS test has a 60 point scale.
Donepezil increases functional ability only marginally in patients with Alzheimer's disease
Credit: BSIP/MENDIL/SPL
Investing in better social support for patients and their carers would be wiser than prescribing these expensive drugs, argues the team responsible for the study.
Eisai and Pfizer UK, the companies that make donepezil, said that the study recruited too few patients for the results to be dependable and said that patients have seen benefits from the drugs.
A review of NICE's 2001 recommendations for cholinesterase inhibitors and Alzheimer's disease is under way and is due for publication in May 2005.(Debashis Singh)