Donepezil, rivastigmine, galantamine and memantine for ...

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Clinical effectiveness
TABLE 22 Adverse events for rivastigmine (note that p-values are not reported unless stated) (cont’d)
Corey-Bloom et al., 1998 57 Maintenance phase (%)
Adverse event Rivastigmine 1–4 mg/day Rivastigmine 6–12 mg/day Placebo
Dizziness 8 14* 4
Nausea 8* 20* 3
Vomiting 5* 16* 2
Dyspepsia 6* 5* 1
Sinusitis 1 4* 1
* p < 0.05 from placebo.
Forette et al., 199960 Incidence (%)
Adverse event Rivastigmine b.d. (n = 45) Rivastigmine t.d.s. (n = 45) Placebo (n = 24)
Nausea 58 58 8
Vomiting 38 31 4
Dizziness 27 9 0
Anorexia 18 16 0
Headache 16 20 4
Rösler et al., 199958 No. (%) of adverse events occurring at 5% more often with rivastigmine than in placebo or
occurring with an incidence significantly different from placebo
Adverse event Rivastigmine 1–4 mg/day Rivastigmine 6–12 mg/day Placebo (n = 239)
(n = 242) (1 missing) (n = 242) (1 missing)
Nausea 41 (17)* 121 (50)* 23 (10)
Vomiting 19 (8) 82 (34)* 14 (6)
Dizziness 25 (10) 48 (20)* 17 (7)
Headache 16 (7) 45 (19)* 18 (8)
Diarrhoea 23 (10) 40 (17)* 21 (9)
Anorexia 8 (3) 34 (14)* 4 (2)
Abdominal pain 11 (5) 29 (12)* 7 (3)
Fatigue 5 (2) 23 (10)* 6 (3)
Malaise 3 (1) 23 (10)* 5 (2)
* p < 0.05 from placebo.
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high-dose (6–12 mg/day) groups and the placebo
groups: Corey-Bloom and colleagues 57 reported
27% compared with 3% during the dose titration
phase and 16% compared with 2% during the
dose maintenance phase; Rösler and colleagues 58
reported vomiting rates of 28% among the highdose
group and 6% for placebo participants.
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Diarrhoea
Diarrhoea incidence was reported in only two of
the four published studies. Rösler and colleagues 58
reported a statistically significant difference
between the high-dose group (6–12 mg/day) and
placebo (17 versus 9%). Agid and colleagues 59 did
not present p-values, but reported incidence rates
of 7, 12 and 2 for the low-dose (4 mg/day), highdose
(6 mg/day) and placebo groups, respectively.
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Dizziness
All four published studies reported the incidence
of dizziness, which ranged from 0 to 13% in
placebo participants and from 6 to 27% in
treatment participants. The two studies which
presented p-values both reported statistically
significant differences between placebo
participants and participants in high-dose groups
(6–12 mg/day), with rates of 24 versus 13% being
reported by Corey-Bloom and colleagues 57 and 20
versus 7% by Rösler and colleagues. 58 However,
the incidence rates for the low-dose groups in