Page 189 - Drug Class Review
P. 189
Drug Effectiveness Review Project
donepezil 5mg placebo donepezil 10mg NR NR NR 2% 8% 5% 7% 17% 9% 4% 17% 4% 2% 10% 3% 2% 7% 6% 1% 8% 10% Yes; DON 10 mg/d had significantly more reports of fatigue, diarrhea, nausea, vomiting and muscle cramps (P ≤ 0.05) ITT: Yes Post randomization exclusions: NR Yes NR NR Overall loss to follow-up: 22% Loss to follow-up differential high: No (< 15 percentage point differential) placebo donepezil 10mg donepezil 5mg 20% 32% 15% 7% 16% 6% Fair Page 125 of 205
Final Report Update 1 Authors: Rogers et al. Year:1998 ADVERSE EVENTS: Overall adverse effects reported: Fatigue • Diarrhea • Nausea • Vomiting • Muscle cramps • Dizziness • 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
