Page 115 - Drug Class Review

Drug Effectiveness Review Project
Stabilization of global function, as measured by FRS, showed significant differences in favor of
improvement in MMSE and SIB (mean treatment difference = 2.06, -4.44; P = 0.0002, 0.0026);
A subgroup analysis of patients with moderate AD (MMSE 10-17) presented significant drug-
placebo differences in CIBIC-plus scores (mean treatment difference = 0.53, P = 0.0003);
improvement on IADL+ and PSMS (P = 0.0002, 0.001)
DON (mean difference = 1.28 at 24 weeks; P = 0.0002)
Intermediate Outcome Measures (Cont’d.):

donepezil placebo 80% 83% 4.8% 12.5% 4.1% 11.8% 11.1% 11.1% Significance not reported; mild, moderate, and severe AEs were similar between treatment groups Post randomization exclusions: Unable to determine Yes (identical appearing blister packs) Overall loss to follow-up: 14.8 % Loss to follow-up differential high: No placebo donepezil 13.7% 16.0% 6% 8% Page 88 of 205
ITT: ITT/LOCF

• • Yes Yes Good

Final Report Update 1 Authors: Feldman et al. Year: 2001 RESULTS: ADVERSE EVENTS: Overall adverse effects reported: Diarrhea • Headache • Respiratory tract infection • 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