Page 75 - Drug Class Review
P. 75
Drug Effectiveness Review Project
DON given at any dose for more than one day with parallel concomitant placebo group; outcome measures
included: Global assessment (CIBIC-plus, GBS, MENFIS, CDR-SB, ADAS-Cog, MMSE); ADL’s (PDS,
DAD, IADL, PSMS, CMCS); behavioral disturbances; QOL; caregiver stress; side effects
Quality of life No significant difference between DON and placebo for QOL and behavioral disturbance • Activities of daily living Pooled data from 2 studies provided evidence of benefit of DON at 12 and 24 weeks (P < 0.01) • Global assessment The CIBIC-plus scale was dichotomized into those showing no change or decline against those • showing improvement; overall there are benefits associated with 5 and 10 mg/d DON compared with placebo at 12 and 24 weeks (P < 0.005) as shown by the ITT-LOC analyses: 24 weeks, 10 mg/d: OR 2.18; 95% CI: 1.53 – 3.11; P < 0
Final Report Update 1 Authors: Birks et al. Year: 2004 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: Alzheimer's Drugs