Page 98 - Drug Class Review
P. 98
Page 79 of 205
Drug Effectiveness Review Project
placebo 76% 7% 4% 4% 29% placebo 20% 10%
donepezil 10 mg 86% 24% 16% 16% 40% Patients taking DON had significantly more adverse digestive and nervous system events (dizziness, donepezil 10 mg 26% 18%
donepezil 5 mg 79% 7% 10% 4% 36% 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 donepezil 5 mg 22% 9%
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
