Page 190 - Drug Class Review
P. 190
Page 125 of 205
Drug Effectiveness Review Project
placebo NR 2% 7% 4% 2% 2% 1% placebo 20% 7%
donepezil 10mg NR 8% 17% 17% 10% 7% 8% Yes; DON 10 mg/d had significantly more reports of fatigue, diarrhea, nausea, vomiting and muscle Loss to follow-up differential high: No (< 15 percentage point differential) donepezil 10mg 32% 16%
donepezil 5mg NR 5% 9% 4% 3% 6% 10% cramps (P ≤ 0.05) ITT: Yes Post randomization exclusions: NR Yes NR NR Overall loss to follow-up: 22% donepezil 5mg 15% 6% Fair
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
