Page 206 - Drug Class Review

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Drug Effectiveness Review Project

placebo 65% 9% 4% 2% 0% 2% 0% 0% Significantly more donepezil patients experienced abnormal dreams (P = 0.03) placebo 19% 9%

donepezil 70% 20% 10% 9% 9% 8% 6% 5% Post randomization exclusions: No Overall loss to follow-up: 24% Loss to follow-up differential high: No donepezil 27% 16%

ITT: Yes Method not reported Method not reported Yes Fair

Final Report Update 1 Authors: Seltzer et al. Year: 2004 ADVERSE EVENTS: Overall adverse effects reported: Diarrhea • Nausea • Asthenia • Abnormal Dreams • Dizziness • Injury • Insomnia • 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