Donepezil, rivastigmine, galantamine and memantine for ...

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Clinical effectiveness
difference of 3.38 points between the 6–12 mg/day
rivastigmine participants and the placebo group,
but Rösler and colleagues 58 did not find a
statistically significant difference. The low-dose
group in the study by Corey-Bloom and
colleagues 57 showed a lower score change than
placebo participants, with a mean change of –5.19,
but this was not statistically significant. High-dose
participants in the study by Rösler and colleagues
showed a clinical improvement, with an average
improvement of 0.05 compared with the mean
change of –2.18 in the placebo group. Again,
changes were smaller in the low-dose group, with a
mean of –3.37.
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The study by Rösler and colleagues 58 also
reported the number and percentage of
participants in each group who showed an
improvement of at least 10%. A statistically
significantly higher proportion of participants in
the high-dose group compared with those in the
placebo group demonstrated this level of
improvement (29 versus 19%). In the low-dose
group, 19% of participants showed an
improvement of at least 10%.
Summary: participants treated with 6–12 mg/day
rivastigmine demonstrated statistically significantly better
functional outcomes than placebo participants, based on
TABLE 21 NOSGER for rivastigmine
Agid et al., 1998 59
the PDS measure discussed here.
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Behaviour and mood measures
NOSGER
Two published studies reported the Nurses
Observation Scale for Geriatric Participants
(NOSGER). Changes from baseline are shown in
Table 21. Agid and colleagues 59 compared two
different dose treatment groups with placebo.
No p-values were reported for this outcome
measure, but the high-dose rivastigmine group
(6–12 mg/day) seemed to show an average
improvement in memory and IADL performance
(mean differences of –0.2 and –0.5, respectively).
Forette and colleagues 60 compared twice
daily/three-times daily doses of rivastigmine with
placebo. This study reported a statistically
significant improvement in memory assessment
for both treatment groups compared with placebo
(mean difference between high-dose group and
placebo was 2.3, mean difference between lowdose
group and placebo was 2.0). No statistically
significant differences were reported for other
components of the NOSGER assessment, i.e. those
assessing mood and behaviour.
Summary: on measures of behaviour and mood no
statistically significant benefit was demonstrated in the
rivastigmine-treated groups compared to the placebo
groups.
1. Rivastigmine 4 mg/day 2. Rivastigmine 6 mg/day 3. Placebo (n = 117) p-Value versus
(n = 111) (n = 103) placebo
Memory: 0.7 ± 2.8 Memory: –0.2 ± 2.4 Memory: 0.0 ± 3.4 Not reported
IADL: 0.0 ± 3.3 IADL: –0.7 ± 3.5 IADL: –0.2 ± 3.3 Not reported
Self-care: 0.2 ± 2.8 Self-care: –0.1 ± 2.1 Self-care: 0.1 ± 2.7 Not reported
Mood: 0.2 ± 2.8 Mood: 0.1 ± 2.5 Mood: 0.1 ± 3.1 Not reported
Social behaviour: –0.3 ± 3.1 Social behaviour: –0.5 ± 3.0 Social behaviour: 0.0 ± 3.6 Not reported
Disturbing behaviour: 0.2 ± 2.2 Disturbing behaviour: –0.5 ± 2.3 Disturbing behaviour: –0.0 ± 2.1 Not reported
Forette et al., 1999 60
1. Rivastigmine b.d. (n = 23) 2. Rivastigmine t.d.s. (n = 27) 3. Placebo (n = 19) p-Value versus
placebo
Memory: –0.7 ± 2.9 Memory: –1.0 ± 2.7 Memory: 1.3 ± 3.7 1. p = 0.037
2. p = 0.014
IADL: 0.4 ± 3.1 IADL: –0.7 ± 4.0 IADL: 0.8 ± 4.0 Not reported
Self-care: –0.4 ± 2.0 Self-care: –0.6 ± 2.4 Self-care: –0.3 ± 2.5 Not reported
Mood: 0.7 ± 3.0 Mood: –0.4 ± 3.4 Mood: –0.6 ± 3.2 Not reported
Social behaviour: 0.0 ± 2.6 Social behaviour: –1.1 ± 3.8 Social behaviour: 0.3 ± 3.3 Not reported
Disturbing behaviour: –0.3 ± 2.1 Disturbing behaviour: –0.7 ± 3.4 Disturbing behaviour: 0.1 ± 3.1 Not reported