Page 97 - Drug Class Review

Drug Effectiveness Review Project

donepezil 5 mg placebo donepezil 10 mg 76% 86% 79% 7% 24% 7% 4% 16% 10% 4% 16% 4% 29% 40% 36% Patients taking DON had significantly more adverse digestive and nervous system events (dizziness, confusion, insomnia: incidence < 10%) than placebo; P < 0.05 Post randomization exclusions: NR Overall loss to follow-up: 132 (24%) Loss to follow-up differential high: No placebo donepezil 10 mg donepezil 5 mg 20% 26% 22% 10% 18% 9% Page 79 of 205

ITT: Yes NR NR NR Fair

Final Report Update 1 Authors: Burns et al. Year: 1999 ADVERSE EVENTS: Overall adverse effects reported: Nausea • Diarrhea • Vomiting • Nervous system • 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