Page 200 - Drug Class Review

(ITT-LOCF: -0.8 vs. -2.5 points; P = 0.02) in RIV (6-12 mg) than in placebo-treated patients. The difference
Subgroup analysis of the pooled population presented that nicotine use attenuates the dose-response curve of
Drug Effectiveness Review Project
Activity of daily living (PDS): Only RIV 6-12 mg showed a significant difference to placebo: PDS, placebo
Page 130 of 205
Subgroup analysis stratifying by disease severity (GDS) found larger treatment differences (PDS) between
RIV-treated patients experienced statistically significant better results than placebo-treated patients in:
RIV 1-4 mg/d or 6-12 mg/d (published trials) or 3 mg/d, 6 mg/d, 12 mg/d (unpublished) for 26 weeks
Cognition: ADAS-Cog, placebo -2.65; 1-4mg – 1.81; 6-12mg 0.58; P < 0.005 (observed cases)

Global function: CIBIC-plus, placebo 4.35; 1-4mg 4.17; 6-12mg 4.01; P < 0.005

-3.47; 1-4mg – 3.86; 6-12mg -0.78; P < 0.005

Authors: Schneider et al; Potkin et al.; Burns et al.
significance. RIV and placebo in patients with more severe disease, but these differences did not reach statistical RIV and older patients experienced greater benefit from RIV Retrospective subgroup analysis of patients with moderately severe AD (n = 117; MMSE 10 – 12) revealed a significantly smaller decline of ADAS-cog (ITT-LOCF: 0 vs. -6.1 points; P < 0.001) and MMSE scores in ADL did not reach statistical significance (ITT-LOCF: -2.0 vs. -6.3; P = 0.065) Not reported; Only the 3 included studies had been conducted at time of meta-analysis.

NR NR Fair

Final Report Update 1 Years: 1998; 2002; 2004 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: ADVERSE EVENTS: COMPREHENSIVE LITERATURE SEARCH STRATEGY: STANDARD METHOD OF APPRAISAL OF STUDIES: QUALITY RATING: Alzheimer's Drugs