Donepezil, rivastigmine, galantamine and memantine for ...

TABLE 10 Adverse events for donepezil (note that p-values are not reported unless stated) (cont’d)
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Health Technology Assessment 2006; Vol. 10: No. 1
Burns et al., 1999 50 Adverse events experienced by at least 5% of all donepezil participants
Adverse event 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 274)
(n = 271) (n = 273)
Total participants with any
adverse event (%)
213 (79) 234 (86) 207 (76)
Digestive system 70 (26) p ≤ 0.05 a
127 (47) p ≤ 0.05 a
65 (24)
Nausea 7% p ≤ 0.05 a
24% p ≤ 0.05 a
7%
Diarrhoea 10% p ≤ 0.05 a
16% p ≤ 0.05 a
4%
Vomiting 4% p ≤ 0.05 a
16% p ≤ 0.05 a
4%
Anorexia 4% 8% 1%
Nervous system 98 (36) p ≤ 0.05 a
109 (40) p ≤ 0.05 a
80 (29)
Dizziness 5% 9% 5%
Confusion 7% 6% 6%
Insomnia 7% 8% 4%
Total participants with 19 (7) 29 (11) 25 (9)
serious adverse events
a p-Values versus placebo.
Rogers et al., 199851 Adverse events: n (%)
Adverse event 1. Donepezil 5 mg/day 2. Donepezil 10 mg/day 3. Placebo (n = 162)
(n = 154) (n = 157)
Fatigue 8 (5) 12 (8) p ≤ 0.05 a
3 (2)
Diarrhoea 14 (9) 27 (17) p ≤ 0.05 a
11 (7)
Nausea 6 (4) 26 (17) p ≤ 0.05 a
6 (4)
Vomiting 5 (3) 16 (10) p ≤ 0.05 a
3 (2)
Anorexia 3 (2) 11 (7) 3 (2)
Muscle cramps 9 (6) 12 (8) p ≤ 0.05 a
1 (1)
Dizziness 15 (10) 13 (8) p ≤ 0.05 a
Rhinitis 1 (1) 9 (6) 4 (2)
a p-Values versus placebo.
Rogers et al., 199852 Number (%) with treatment-emergent signs and symptoms (TESS)
Adverse event Donepezil 5 mg/day Donepezil 10 mg/day Placebo (n = 153)
(n = 157) (n = 158)
No. with ≥ 1 TESS 106 (68) 124 (78) 106 (69)
Nausea 11 (7) 34 (22) 12 (8)
Insomnia p < 0.001 a
13 (8) 28 (18) 8 (5)
Diarrhoea p = 0.001 a
10 (6) 21 (13) 4 (3)
Pain: p = 0.001 a
7 (4)
14 (9) 21 (13) 11 (7)
Headache 21 (13) 19 (12) 13 (8)
Dizziness 14 (9) 14 (9) 10 (7)
Muscle cramp 9 (6) 12 (8) 6 (4)
Fatigue 5 (3) 12 (8) 8 (5)
Accident 9 (6) 10 (6) 11 (7)
Agitation 7 (4) 10 (6) 11 (7)
Vomiting 5 (3) 10 (6) 7 (5)
Anorexia 6 (4) 10 (6) 4 (3)
Weight loss 3 (2) 8 (5) 3 (2)
Common cold 8 (5) 7 (4) 10 (7)
Abdominal disturbance 9 (6) 6 (4) 6 (4)
Urinary tract infection 10 (6) 6 (4) 20 (13) p = 0.009 b
Stomach upset 8 (5) 5 (3) 1 (1)
Rhinitis 8 (5) 5 (3) 6 (4)
Upper respiratory tract
infection
8 (5) 5 (3) 6 (4)
Oedema in extremities 1 (1) 4 (3) 8 (5)
Cough 2 (1) 3 (2) 8 (5)
a More frequent with donepezil (either dose).
b More frequent with placebo.
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