Page 183 - Drug Class Review
P. 183
Drug Effectiveness Review Project
donepezil 5 mg placebo donepezil 10 mg 69% 78% 68% 8% 22% 7% 5% 18% 8% 3% 13% 6% 13% 4% 6% Nausea, insomnia and diarrhea were significantly more common in patients taking high dose DON than patients taking placebo (P < 0.001); placebo treated patients had significantly more UTI’s (P = 0.009) Post randomization exclusions: Yes Overall loss to follow-up: 56 (12%) Loss to follow-up differential high: No placebo donepezil 10 mg donepezil 5 mg 11 (7%) 29 (18%) 16 (10%) 3 (2%) 16 (10%) 7 (4%) Page 122 of 205
ITT: Yes Method not reported Yes Yes Fair
Final Report Update 1 Authors: Rogers et al. Year: 1998 ADVERSE EVENTS: Overall adverse effects reported: Nausea • Insomnia • Diarrhea • UTI • 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
