Page 42 - Drug Class Review

Final Report Update 1 Drug Effectiveness Review Project

KEY QUESTION 4

Does efficacy, effectiveness, or adverse events of donepezil, galantamine,
rivastigmine, tacrine, or memantine differ in subgroups of patients with (1)

different demographic profiles (age, race, or sex), (2) Parkinsonian features or

vascular dementia, or (3) use of other commonly prescribed drugs?

A. Age

We did not identify any study specifically designed to compare the effect of donepezil, galantamine,

rivastigmine, tacrine, or memantine in a younger versus an older population.

We did find age-related information in two sources: one subgroup analysis of rivastigmine-treated
35
patients and a placebo-controlled donepezil trial conducted in a population of nursing home residents
47
who were, on average, older than the typical population for donepezil studies. The subgroup analysis
pooled data from four rivastigmine trials and reported an age-related treatment effect. Patients 75 years

and older revealed a greater benefit of rivastigmine than did patients younger than 75 years; 15% of
35
older patients and 6% of younger patients were considered responders on the ADAS-cog.

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A single trial conducted in nursing home residents with a mean age of 85 years (range 64 to 102 years)
provides indirect evidence about age effects when compared to findings from other similarly designed

trials in which the mean age was less than 75 years. 40, 41, 43-45, 48 Overall, no difference in efficacy or
adverse events was apparent in the data on the older population compared to data from the trials in
younger populations.

B. Race

We did not identify any study specifically designed to compare the effect of donepezil, galantamine,
rivastigmine, tacrine, or memantine in one racial group compared to another. In general, trials were
conducted predominantly in white populations.

Alzheimer's Drugs Page 42 of 205