Page 184 - Drug Class Review
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Drug Effectiveness Review Project
placebo 69% 8% 5% 3% 13% placebo 11 (7%) 3 (2%)
donepezil 10 mg 78% 22% 18% 13% 4% 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) donepezil 10 mg 29 (18%) 16 (10%)
donepezil 5 mg 68% 7% 8% 6% 6% Post randomization exclusions: Yes Overall loss to follow-up: 56 (12%) Loss to follow-up differential high: No donepezil 5 mg 16 (10%) 7 (4%)
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
