Page 116 - Drug Class Review

Page 88 of 205
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)

placebo 80% 4.8% 4.1% 11.1% Significance not reported; mild, moderate, and severe AEs were similar between treatment groups placebo 13.7% 6%

Intermediate Outcome Measures (Cont’d.):

donepezil 83% 12.5% 11.8% 11.1% 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 donepezil 16.0% 8%

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