Page 84 - Drug Class Review

Withdrawals by week 26 for adverse events showed no significant differences between the 1-4 mg/d
there are significant differences for the 6-12 mg/d group in favor of placebo at 12, 18 and 26 weeks;
Meta-analyses overall adverse event rates show no significant differences by the end of the titration
differences between withdrawals in the 1-4 mg/d RIV group and placebo group at 12 and 26 weeks;
Drug Effectiveness Review Project
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1.31); the same is true at 26 weeks (509/644 vs 518/646; OR 0.93; 95% CI: 0.71 – 1.23); however,
significantly from the placebo group, but there were significant differences between 6-12 mg/d and
1.88; 95% CI: 1.39 – 2.55) and by 26 weeks 166/1052 vs. 114/868 (OR 1.29; 95% CI: 1.00 –1.67)
period between 1-4 mg/d RIV and placebo groups (440/644 vs. 437/646; OR 1.04; 95% CI: 0.82 –
(20/133 vs. 8/133, 16/45 vs. 2/24, 367/1052 vs. 145/868; OR 2.60; 95% CI: 1.19 – 5.68; OR 4.02;
latter by the end of the titration period (920/1071 vs. 584/878; OR 2.98; 95% CI: 2.40 – 3.70) and
placebo groups in favor of the latter; results for the titration period were 130/1052 vs. 61/868; OR
significant differences between the 6-12 mg/d and placebo groups in favor of the latter (257/1052
there were significant differences between the 6-12 mg/d RIV and placebo groups in favor of the
by 26 weeks (960/1052 vs 687/868; OR 2.67; 95% CI: 2.05 – 3.46); the pattern is similar for the
RIV and placebo groups (55/645 vs. 54/646; OR 1.01; 95% CI: 0.75 – 1.34); however, there are
There are significant differences in favor of placebo for number of patients suffering nausea,
number of patients with at least one severe adverse event; the 1-4 mg/d group did not differ

• Withdrawals for any reason before the end of treatment show that there are no significant 95% CI: 1.31 – 12.32; OR 2.40; 95% CI: 1.95 – 2.96) • vs. 74/868; OR 2.97; 95% CI: 2.33 – 3.79) • • vomiting, diarrhea, anorexia, headache, syncope, abdominal pain and dizziness;

Final Report Update 1 Authors: Birks et al. Year: 2004 ADVERSE EVENTS: Alzheimer's Drugs