Page 143 - Drug Class Review

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)
Intermediate Outcome Measures:

donepezil placebo NR NR 5% 17% 10% 12% 7% 13% 7% 12% 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) Post randomization exclusions: Yes; 5.1% placebo and 6.5% DON Overall loss to follow-up: 27% Loss to follow-up differential high: Yes but inherent differential in study design placebo donepezil 26% 28% 7.4% 10.7% Page 102 of 205

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