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Aricept

Donepezil, marketed under the trade name AriceptĀ® (Eisai), is a centrally acting reversible acetyl cholinesterase inhibitor. Its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. It is well absorbed in the gut with an oral bioavailability of 100% and easily crosses the blood-brain barrier. Because it has a half life of about 70 hours, it can be taken once a day. Initial dose is 5 mg per day, which can be increased to 10 mg per day after an adjustment period of at least 4 weeks. more...

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The clinical utility of donepezil is controversial. Presently, there is no proof that use of donepezil or other similar agents alters the course or progression of Alzheimer's disease. However, controlled studies have shown modest benefits in cognition and behavior with this and similar agents. Therefore, many neurologists, psychiatrists, and primary care physicians use donepezil in patients with Alzheimer's disease. As of the 22 March 2005, the UK National Institute for Clinical Excellence (NICE) withdrew its recommendation for use of the drug for mild-to-moderate AD, on the basis that there is no significant improvement in functional outcome; of quality of life or of behavioral symptoms. However, these data conflict with those of other reports, as is often the case in medicine.

Donepezil is sometimes used in combination with Memantine, a new agent for Alzheimer's disease which is in the same chemical class. The response to both together is superior to either alone.

Donepezil has been tested in other disorders which cause dementia including Lewy body dementia and Vascular dementia, but it is not currently approved for these indications.

Sources

  • Brenner, G. M. (2000). Pharmacology. Philadelphia, PA: W.B. Saunders Company. ISBN 0-7216-7757-6
  • Canadian Pharmacists Association (2000). Compendium of Pharmaceuticals and Specialties (25th ed.). Toronto, ON: Webcom. ISBN 0-919115-76-4

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Marketing Aricept for Alzheimer's - Shorts - Brief Article
From Townsend Letter for Doctors and Patients, 7/1/02 by Jule Klotter

Aricept, a FDA-approved drug to alleviate the symptoms of mild to moderate Alzheimer's, is being promoted as having an effect on late-stages of the disease as well, according to a Wall Street Journal (January 7, 2002) article by Ann Davis. Aricept and similar drugs block the action of cholinesterase, an enzyme that breaks down acetyicholine. The drug's marketers, Pfizer Inc. and Eisai Co. (Tokyo, Japan) have sponsored post-marketing studies to encourage long-term use of the drug. Some insurers and European governments that pay for medicines have objected to the long-term cost of Aricept, which sells for $4 or more per day. The post-marketing studies are published in professional journals and promoted at conventions.

The promotion of these studies, which are often small and poorly designed, does not always reflect the actual outcome. In one study, for example, 208 nursing-home patients (only one-fourth of whom had severe Alzheimer's) were given Aricept; and their behavior problems (delusions, anxiety, irritability, depression, and nighttime wandering) were monitored. The outcome showed no significant difference between patients receiving Aricept and those who did not. Yet, doctors involved in the study, which was published in the Journal of the American Geriatrics Society, have maintained that Aricept has a beneficial effect. Another study sponsored by Aricept's marketers, published in Neurology (August 2001), found that the drug improved cognition, behavior, and daily activity in 290 Alzheimer's patients. The study was promoted as looking at Aricept's effect on people with moderate to severe Alzheimer's, but only 80 of the 290 had severe dementia. The drug's effect on those 80 was inconclusive, according to one of the re searchers involved in the study. "Zaven Khachaturian, former head of Alzheimer's research for the National Institutes of Health, says that given the modest effects of the Alzheimer's drugs and the difficulty of measuring symptoms, any study with fewer than several hundred to 1,000 people would be problematic," reporter Ann Davis explains. Exelon, made by Novartis, and Reminyl, made by Johnson & Johnson's Janssen Pharmaceutica, have also been the subjects of small, company-sponsored, post-marketing studies.

According to FDA regulations, companies cannot promote their drugs for off-label use (for purposes other than those for which they received FDA approval) by providing doctors or researchers with scripts to use at conferences or professional gatherings. The companies are, however, allowed to sponsor conferences where post-marketing and preliminary studies for off-label uses are discussed. In an effort to encourage the use of Aricept, Pfizer-Eisai's public relations firm, Hill & Knowlton, has recruited doctors to talk to news media about Alzheimer's and Aricept and coached them on how to be effective 'spokesdoctors' for the drug.

Davis, Ann. Tactic of Drug Makers Is Raising Questions About Use of Research. The Wall Street Journal 2002 January 7; p A1.

COPYRIGHT 2002 The Townsend Letter Group
COPYRIGHT 2002 Gale Group

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