Page 252 - Drug Class Review

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Drug Effectiveness Review Project

rivastigmine 58.2% 41.8% 23.6% 18.2% Percentage of patients experiencing at least one adverse event was lower in DON than in RIV (42.9% vs. 58.2%; P = NR); nausea, vomiting, and headache were more frequent in RIV than DON patients, ITT: No; authors note ITT was conducted but not reported because of high differential loss to follow-up rivastigmine 30.9% 21.8%

although significance NR Method not reported N/A (open-label) N/A

donepezil 42.9% 10.7% 7.1% 7.1% Post randomization exclusions: Yes Yes (ADAS-Cog); No (MMSE) Overall loss to follow-up: 20.7 % Loss to follow-up differential high: Yes (20% differential) donepezil 10.7% 10.7%

Final Report Update 1 Authors: Wilkinson et al. Year: 2002 ADVERSE EVENTS: Overall adverse effects reported: Nausea • Vomiting • Headache • 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