Page 8 - Drug Class Review

Final Report Update 1 Drug Effectiveness Review Project

B. Scope and key questions

The purpose of this review is to help policy makers and clinicians make informed choices about the use of
the four ChEIs and memantine in the treatment of AD. We compare the efficacy, effectiveness, and
safety (adverse events) of donepezil, galantamine, rivastigmine, tacrine, and memantine in patients with

mild to severe AD. Although we will emphasize comparative head-to-head studies, the few published
ones do not allow for a comprehensive evaluation. Accordingly, we will also include supplementary data

from individual placebo-controlled trials and observational studies.

The participating organizations of the Drug Effectiveness Review Project (DERP) are responsible for
ensuring that the scope of the review reflects the populations, drugs, and outcome measures of interest to

their constituencies. The Oregon Evidence-based Practice Center initially prepared preliminary key
questions identifying the populations, interventions, and outcomes of interest, and we based the eligibility
criteria for studies on these preliminary questions. Representatives of organizations participating in the

DERP, in conjunction with experts in the fields of health policy, neurology, pharmacotherapy, and
research methods reviewed, revised, and approved the questions and outcome measures. The

participating organizations approved the following key questions:

1. How do donepezil, galantamine, rivastigmine, tacrine, and memantine or combinations of these

drugs (i.e., acetylcholinesterase inhibitor plus memantine) compare in their efficacy or
effectiveness for stabilizing symptoms and treating behavioral disturbances in patients with AD?

2. How do donepezil, galantamine, rivastigmine, tacrine, and memantine (or combinations of these
drugs) compare in their time to effect and in the time required to assess the clinical response?

3. What are the comparative incidence and severity of complications of donepezil, galantamine,
rivastigmine, tacrine, and memantine (or combinations of these drugs)?

4. Does efficacy, effectiveness, or adverse events of donepezil, galantamine, rivastigmine, tacrine,
or memantine (or combinations of these drugs) differ in subgroups of patients with (1) different

demographic profiles (age, race, or gender), (2) Parkinsonian features or vascular dementia, or (3)
use of other commonly prescribed drugs?

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