Page 144 - Drug Class Review

Page 102 of 205
Drug Effectiveness Review Project
Differences in mean change from baseline to endpoint for DON differed from placebo for both

No significant differences in CDR-SB or MMSE scores at endpoint, although significant

differences in favor of DON were observed at weeks 6, 18, 24, 36 and 42

instrumental ADL (P = 0.001) and basic ADL (P = 0.007)

placebo NR 5% 10% 7% 7% Frequency of adverse event was significantly higher in DON compared to placebo for headache, UTI, and those associated with digestive systems (anorexia, diarrhea, dyspepsia, nausea) Loss to follow-up differential high: Yes but inherent differential in study design placebo 26% 7.4%

Intermediate Outcome Measures:

donepezil NR 17% 12% 13% 12% Post randomization exclusions: Yes; 5.1% placebo and 6.5% DON Overall loss to follow-up: 27% donepezil 28% 10.7%

ITT: Yes Method NR Yes, but method NR

• • Yes Fair

Final Report Update 1 Authors: Mohs et al. Year: 2001 RESULTS: ADVERSE EVENTS: Overall adverse effects reported: Diarrhea • Agitation • Rhinitis • UTI • Significant differences in adverse events: ANALYSIS: ADEQUATE RANDOMIZATION: ADEQUATE ALLOCATION CONCEALMENT: BLINDING OF OUTCOME ASSESSORS: ATTRITION (overall): ATTRITION (treatment specific): Loss to follow-up: Withdrawals due to adverse events: QUALITY RATING: *primary outcome measures Alzheimer's Drugs