Page 257 - Drug Class Review

Drug Effectiveness Review Project

donepezil placebo 75.7% 81.7% 9.0% 11.3% 7.6% 11.3% 5.6% 10.6% Post randomization exclusions: NR Overall loss to follow-up: 32.9% Loss to follow-up differential high: No placebo donepezil 32.6% 33.1% 6.3% 7% Page 159 of 205

ITT: Yes

NR Yes NR NR Fair

Final Report Update 1 Authors: Winblad et al. 2001 Year: 2001 ADVERSE EVENTS: Overall adverse effects reported: Nausea • Depression • Anxiety • 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