Page 134 - Drug Class Review

Communicative Disorders and Stroke—Alzheimer Disease and Related Disorders Association with
one exception where a DSM-IV diagnosis of dementia was used for inclusion; Fourteen of 22 trials
Drug Effectiveness Review Project
Page 97 of 205
Duration of treatment varied between six weeks and three years; Number of patients included per
from analysis after randomization; In at least eight of the trials the last observation carried
“primary end points without correction for multiple comparisons. After correction, two of
probable or possible Alzheimer’s disease, according to the National Institute of Neurological and
measures any more; missing ITT analysis, as in 15 of the 22 trials patients were excluded
study varied between 27 and 978; All studies included patients with an established diagnosis of
Methodological assessment of all studies found considerable flaws: The use of several

to assess efficacy used the ADAS-cog as the primary measurement of efficacy; In 12 trials, the CIBIC-plus was used • the five trials on rivastigmine do not show any significant benefit on primary endpoint forward (LOCF) method was used to include dropouts into endpoint analyses. Donepezil, rivastigmine, and galantamine caused a broad spectrum of adverse events—nausea, vomiting, diarrhea, and weight loss were the most common.

Yes Yes Good

Final Report Update 1 Authors: Kaduszkiewicz et al. Year: 2005 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: ADVERSE EVENTS: COMPREHENSIVE LITERATURE SEARCH STRATEGY: STANDARD METHOD OF APPRAISAL OF STUDIES: QUALITY RATING: Alzheimer's Drugs