Page 177 - Drug Class Review

Drug Effectiveness Review Project
donepezil 3mg placebo donepezil 5 mg 65% 67% 68% 5% 10% 0% 3% 10% 3% 10% 8% 3% 8% 5% 13% 5% 5% 5% 8% 3% 5% 3% 3% 3% 5% 3% 10% 3% 10% 3% placebo donepezil 5 mg donepezil 3mg 12.5% 12.8% 5% 5% 7.7% 5% Page 119 of 205

donepezil 1mg 64% 7% 0% 5% 2% 10% 10% 10% 2% 2% Post randomization exclusions: NR Method not reported but groups well balanced Method not reported Overall loss to follow-up: 12.4% Loss to follow-up differential high: No donepezil 1mg 19% 11.9%

NR ITT: Yes Yes Fair

Final Report Update 1 Authors: Rogers et al. Year: 1996 ADVERSE EVENTS: Overall adverse effects reported: Nausea/vomiting • Diarrhea • Dizziness • Nasal congestion • Common cold • Headache • Flushing • Coughing • 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