Page 43 - Drug Class Review

Final Report Update 1 Drug Effectiveness Review Project

One study used pooled data from 2,126 patients in three placebo-controlled rivastigmine trials to analyze
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differences in efficacy among racial subgroups. The pooled population was 93.6% white, 4.4% black,
and 2% other races. Treatment response did not differ across racial subgroups.

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One donepezil trial was conducted in a Japanese population and one tacrine trial was conducted in a
Chinese population. Overall, effect sizes observed in these trials are similar to effect sizes reported in
trials conducted predominantly in non-Asian populations. However, the trial conducted in the Japanese

population presented treatment effects on low-dose donepezil, which suggests ethnic differences in major
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enzymes that metabolize ChEIs. This finding was supported by a meta-analysis of ChEIs.

C. Sex

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

rivastigmine, tacrine, or memantine in females compared to males. On average, study populations
comprised more females than males; this fact reflects population and disease demographics and does not
provide insight into treatment differences.

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One review of pooled data from rivastigmine trials conducted a subgroup analysis by sex but reported
no differences. No other indirect evidence suggests that effectiveness or adverse events differ between
females and males.

D. Parkinsonian features

Dementia with Parkinsonian features, or dementia with Lewy bodies (DLB), is characterized by abnormal
protein inclusions (Lewy bodies) in selected areas of the brain. Because these structures, and many of the

symptoms of dementia with Lewy bodies, are associated with Parkinson’s and Alzheimer’s diseases, it
remains unclear whether DLB is a distinct clinical entity or perhaps a variant of Alzheimer’s or
Parkinson’s disease.

We did not identify any trial conducted in patients with AD that compared effectiveness or adverse events

in a population with Parkinsonian features to a population without Parkinsonian features. Although some
trials specifically excluded patients with suspected PD, trials that did not specifically exclude patients
with Parkinsonian features did not report differences among these patients.

Alzheimer's Drugs Page 43 of 205