Donepezil, rivastigmine, galantamine and memantine for ...

Three trials 41,44,54 were two-arm comparisons,
three were three-arm comparisons 50–52 and one
was a four-arm comparison. 53 Change from
baseline scores for each individual trial can be
seen in Tables 7 and 8. The summary that follows
will predominantly discuss comparisons between
5 mg donepezil and placebo and 10 mg donepezil
and placebo, regardless of the number of arms in
TABLE 8 CIBIC-plus for donepezil
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Health Technology Assessment 2006; Vol. 10: No. 1
the individual trial. The one study 41 where the
intervention dose of donepezil was 5 mg/day for
28 days followed by 10 mg/day until study
completion will be treated as having a 10 mg/day
dose.
Donepezil 5 mg/day versus placebo. Six trials
included an intervention group with a daily dose
Gauthier et al., 200241 CIBIC-plus least-squares mean scores Numbers estimated from figure
Donepezil 10 mg/day (n = 98) Placebo (n = 105) p-Value versus placebo
4.0 4.5 p = 0.0003
Gauthier et al., 200241 % participants rated as improved or no change (≤ 4)
Donepezil 10 mg/day (n = 98) Placebo (n = 105) p-Value versus placebo
70% 47% p = 0.0007
Burns et al., 199950 Mean change from baseline ± SE Numbers estimated from figures
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 274) p-Value versus placebo
(n = 271) (n = 273)
4.23 ± 0.06 4.13 ± 0.06 4.52 ± 0.06 1. p = 0.0072
2. p < 0.0002
Burns et al., 199950 % participants rated as improved (CIBIC-plus scores ≤ 3 at endpoint)
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 274) p-Value versus placebo
(n = 271) (n = 273)
21 25 14 Not reported
Burns et al., 199950 % treatment failures (CIBIC-plus scores ≥ 5 at endpoint)
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 274) p-Value versus placebo
(n = 271) (n = 273)
43 37 51 Not reported
Rogers et al., 199851 Mean change from baseline ± SE
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 152) p-Value versus placebo
(n = 149) (n = 149)
4.15 ± 0.09 4.07 ± 0.07 4.51 ± 0.08 1. p = 0.0047
2. p < 0.0001
Rogers et al., 199851 % participants rated as ‘improved’ (CIBIC-plus scores ≤ 3)
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 152) p-Value versus placebo
(n = 149) (n = 149)
26 25 11
Rogers et al., 199852 Least-squares mean ± SEM change
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 150) p-Value versus placebo
(n = 156) (n = 155)
3.9 ± 0.08 3.8 ± 0.08 4.2 ± 0.07 1. p = 0.03
2. p = 0.08
Rogers et al., 199852 % participants rated as ‘improved’ (CIBIC-plus scores ≤ 3)
1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 150) p-Value versus placebo
(n = 156 ) (n = 155)
32 38 18
25