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Canadian Medical Association Journal
CMAJ - April 21, 1998 JAMC - le 21 avril 1998

Questions about donepezil

CMAJ 1998; 158:1014-5

In response to: L.M. Elie and M.G. Cole

See also comment from: S. Gauthier

The clinical evidence supporting the efficacy and safety of donepezil in patients with mild to moderate dementia of the Alzheimer's type shows a strong and consistent pattern of favourable results.

Three well-controlled clinical trials provide the core evidence. Two of these trials are phase III pivotal trials, one a 12-week study and the other a 24-week study; the third is a 14-week phase II supportive dose-finding study.

Two of the studies have now been published: the 24-week pivotal trial in January 19981 and the 14-week dose-finding trial in 1996.2 (An analysis at 98 weeks of the open-label extension of the latter study has also been published.3)

There is often a gap between the time a drug is approved and the publication of the data on which the approval is based. In the case of donepezil, the prompt acceptance of the clinical trials for publication in respected peer-reviewed journals confirms the quality of the data gathered during the development program.

During the period between approval and publication of pivotal data, the product monograph can be relied on for information, since it provides a summary of the findings as assessed by independent reviewers from the Health Protection Branch of Health Canada. The product monograph for donepezil, which includes a lengthy section on clinical trial data, has been made available to all physicians since the start of commercialization of this drug.

Notwithstanding the information provided here, we are sorry that the request to our company for the results of the 24-week study was not fulfilled, and we apologize for the inconvenience.

Bernard M. Prigent, MD
Senior Associate Medical Director
Pfizer Canada Inc.
Kirkland, Que.

References

  1. Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT, Donepezil Study Group. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Neurology 1998;50(1):136-45.
  2. Rogers S, Friedhoff L, Donepezil Study Group. The efficacy and safety of donepezil in patients with Alzheimer's disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial. Dementia 1996;7:293-303.
  3. Rogers SL, Friedhoff LT. Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: an interim analysis of the results of a US multicentre open label extension study. Eur Neuropsychopharmacol 1998;8:67-75.

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