Page 153 - Drug Class Review

Drug Effectiveness Review Project
In pooled ITT analysis for MMSE scores at 12 weeks, there was a 0.62 point difference in favor of
The trials involved dosages varying from 20 to 160 mg/d, varying duration of treatment (3-36 wks), and
varying times and frequencies of assessment; two studies contained more than 1 TAC group with fixed
randomization dose titration, and in the other 7 studies, patients were titrated to their best does by the
dosage regimens; in 3 of the remaining 10 studies, patients were given their “best dose” based on pre-
clinician after randomization, giving possible maximum dosages between 80 and 120 mg/d
TAC relative to placebo (95% CI: 0.23 – 1.00; P = 0.002)
1.18 – 2.11; P = 0.002) The CGIC and CIBI revealed an improvement for TAC compared to placebo: OR 1.58; 95% CI: ADAS-Noncog used as a measure of behavioral disturbance showed a 0.58 difference in favor of TAC at 12 weeks (95% CI: 0.17 – 1.00; P = 0.006) The PDS, used in 4 studies, did not differ significantly at 6 weeks between treatment and control (difference = 0.75; 95% CI: -0.43 – 1.93; P = 0.21) phase patients receiving TAC were In 5 studies with no dose titration phase prior to the main efficacy significantly more likely to withdraw (OR for withdrawal f

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NR Fair

Final Report Update 1 Authors: Qizilbash et al. Year: 1998 CHARACTERISTICS OF INTERVENTIONS: MAIN RESULTS: ADVERSE EVENTS: COMPREHENSIVE LITERATURE SEARCH STRATEGY: STANDARD METHOD OF APPRAISAL OF STUDIES: QUALITY RATING: Alzheimer's Drugs