The authors of the BCMJ theme issue “The new era of treatable Alzheimer disease” (September 2004;:332-347) strongly condone the efficacy of cholinesterase inhibitors such as donepezil (Aricept) in the treatment of Alzheimer dementia.
Three months earlier in June 2004 and published in the Lancet were the findings of the AD 2000 Collaborative Group conducting an RCT on donepezil treatment in 565 patients (Lancet 363:2105-2115). The authors were at great pains to remove bias: the partaking physicians had to be uncertain that a patient would benefit from donepezil before randomization, and unlike previous major studies, AD 2000 was undertaken independently of any commercial interests and at arm’s length from the pharmaceutical industry. The study period was four times longer than in previous trials.
The AD 2000 study agreed with previous ones to the effect that donepezil produces small improvements in cognition and ADL in patients with mild to moderate Alzheimer’s. Cognitive improvement in the donepezil-treated patients was by less than one point on the MMSE scale. Compared to controls there were no significant differences in behavioral symptoms, well-being, or caregiver time, and no differences in the two primary end points of the study, namely rate of institutionalization and progress of disability. Worrisome potential findings of serious adverse events were recorded. An editorial comment (pages 2100 to 2101) in the same issue of the Lancet read, “the AD 2000 results are incompatible with many drug-company-sponsored observational studies.”
Many BCMJ readers (including presumably those close to the topic) will have learned of AD 2000 in the lay press during May. Because of the publication time line of the BCMJ theme issue it may not have been possible for the BCMJ authors to incorporate into their texts the AD 2000 findings. However, the last article of the theme issue, that pertaining to the TREAD conference, was able to incorporate reference number 5 accessed in June 2004. Was it not possible for the authors to produce an addendum acknowledging the existence of AD 2000, which despite imperfections was arguably the best-conducted study to have appeared so far on this matter?
—Peter Rees, PhD, FRCPC
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Halpern SD, Ubel PA, Caplan AL, Marion DW, Palmer AM, Schiding JK, et al. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7.
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