Page 65 - Drug Class Review

Drug Effectiveness Review Project

donepezil placebo NR NR NR NR Significantly more DON than placebo-treated patients withdrew because of adverse events after 12 weeks (13% vs. 7%; P = 0.02) and between 13 and 60 weeks (7% vs. 3%; P = 0.05) Post randomization exclusions: Yes (at least 1) Overall loss to follow-up: 17% after 60 weeks of treatment Loss to follow-up differential high: No placebo donepezil 18% 17% 3% 7% Page 63 of 205

ITT: Yes Yes Yes Yes Fair

Final Report Update 1 Authors: AD2000 Collaborative Group Year: 2004 ADVERSE EVENTS: Overall adverse effects reported: Specific adverse effects reported: Significant differences in adverse events: ANALYSIS: ADEQUATE RANDOMIZATION: ADEQUATE ALLOCATION CONCEALMENT: BLINDING OF OUTCOME ASSESSORS: ATTRITION (overall): ATTRITION (treatment specific): Loss to follow-up (60 weeks): Withdrawals due to adverse events: QUALITY RATING: *primary outcome measures Alzheimer's Drugs