Donepezil, rivastigmine, galantamine and memantine for ...

60
Clinical effectiveness
TABLE 28 CIBIC-plus for galantamine: all n (%) unless stated otherwise (cont’d)
Raskind et al. 61
1. Galantamine 2. Galantamine 3. Placebo (n = 196) p-Value vs placebo
24 mg/day (n = 186) 32 mg/day (n = 171)
1 = markedly improved 1 = markedly improved 1 = markedly improved 1. p < 0.01
3 (1.6) 2 (1.2) 1 (0.5) 2. p < 0.05
2 = moderately improved 2 = moderately improved 2 = moderately improved 1. p < 0.01
6 (3.2) 4 (2.3) 7 (3.6) 2. p < 0.05
3 = minimally improved 3 = minimally improved 3 = minimally improved 1. p < 0.01
28 (15.1) 21 (12.3) 19 (9.7) 2. p < 0.05
4 = no change 4 = no change 4 = no change 1. p < 0.01
99 (53.2) 91 (53.2) 84 (42.9) 2. p < 0.05
5 = minimally worsened 5 = minimally worsened 5 = minimally worsened 1. p < 0.01
36 (19.4) 43 (25.1) 60 (30.6) 2. p < 0.05
6 = moderately worsened 6 = moderately worsened 6 = moderately worsened 1. p < 0.01
10 (5.4) 9 (5.3) 24 (12.2) 2. p < 0.05
7 = markedly worsened 7 = markedly worsened 7 = markedly worsened 1. p < 0.01
4 (2.2) 1 (0.6) 1 (0.5) 2. p < 0.05
Wilcock et al. 64
1. Galantamine 2. Galantamine 3. Placebo (n = 203) p-Value vs placebo
24 mg/day (n = 206) 32 mg/day (n = 198) (95% CI)
1 = much improved 0 1 = much improved 0 1 = much improved 0
2 = moderately improved 2 = moderately improved 2 = moderately improved
7 (3) 9 (5) 1 (0.5)
3 = minimally improved 3 = minimally improved 3 = minimally improved
29 (14)* 39 (20)** 32 (16)
4 = no change 91 (44) 4 = no change 82 (41) 4 = no change 68 (33)
5 = minimally worsened 57 (28) 5 = minimally worsened 5 = minimally worsened
54 (27) 68 (33)
6 = moderately worsened 17(8) 6 = moderately worsened 6 = moderately worsened
14 (7) 32 (16)
7 = much worsened 5 (2) 7 = much worsened 1 (1) 7 = much worsened 2 (1)
[Commercial/academic confidential information removed]
galantamine compared with placebo, the
differences were less marked. [Commercial/
academic confidential information removed]
In a comparison of 8, 16 and 24 mg/day
galantamine with placebo, Tariot and colleagues 63
reported that statistically significantly higher
proportions of participants receiving 16 mg/day
(difference: placebo 17%; 8 mg/day 13%) or
24 mg/day (difference: placebo 15%; 8 mg/day
11%) remained stable or improved (responders)
compared with placebo or 8 mg/day. 63
*p < 0.05;
**p < 0.001
(unclear if overall or
just category 3)
Tariot et al. 63,67 Proportion of responders
1. Galantamine 2. Galantamine 3. Galantamine 4. Placebo p-Value vs placebo
8 mg/day 16 mg/day 24 mg/day (n = 255)
(n = 126) (n = 253) (n = 253)
68 (53) 169 (66) a 162 (64) b 128 (49) 1. p < 0.001
2. p < 0.001
a b p < 0.05 and p < 0.01 versus 8 mg/day galantamine group.
Wilkinson and Murray 65 reported the differences
in the proportion of participants who were
classified as either much improved, improved, no
change, worse or much worse on the CGIC scale.
Although participants on 18 and 36 mg/day
galantamine were more likely to have
improved/much improved and those on placebo
more likely to be worse/much worse, the
differences were not statistically significant.
A meta-analysis, using fixed- and random-effects
models, of the proportion of responders on the