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Final Report Update 1 Drug Effectiveness Review Project
METHODS
A. Literature search
We searched MEDLINE, Embase, The Cochrane Library, and the International Pharmaceutical Abstracts
to identify articles relevant to each key question. We used either Medical Subject Headings (MeSH or
MH) as search terms when available or key words when appropriate. We combined terms for the selected
indication (Alzheimer’s disease), drug interactions, and adverse events with a list of five specific
Alzheimer’s drugs (donepezil, galantamine, rivastigmine, tacrine, and memantine); extended release
dosage formulations were included in this search. We limited the electronic searches to “human” and
“English language”, and searched sources from 1980 to 2005 (December) to identify literature relevant to
the scope of our topic. We used the National Library of Medicine publication type tags to identify
reviews, randomized controlled trials (RCTs), and meta-analyses. We manually searched reference lists
of pertinent and relevant review articles and letters to the editor. All citations were imported into an
electronic database (EndNote 8.0).
Additionally, we hand-searched the Center for Drug Evaluation and Research (CDER) database to
identify unpublished research submitted to the FDA. Finally, the Center for Evidence-based Policy at the
Oregon Health and Science University (OHSU) contacted pharmaceutical manufacturers and invited them
to submit dossiers, including citations, using a protocol available at www.ohsu.edu/drugeffectiveness.
We received dossiers from two pharmaceutical companies.
Our searches found 1,109 citations, unduplicated across databases. We found an additional 58 articles
from manually reviewing the reference lists of pertinent review articles. We included no studies
originating from pharmaceutical dossiers; all studies submitted from pharmaceutical dossiers were present
in our other searches. The total number of citations included in the database was 1,167.
B. Study selection
Two persons independently reviewed abstracts; if both reviewers agreed that the trial did not meet
eligibility criteria we excluded it; we obtained the full text of all remaining articles. Records were
considered for exclusion if they did not meet pre-established eligibility criteria with respect to study
design or duration, patient population, interventions, outcomes, and comparisons to Alzheimer’s
medications outside our scope of interest.
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