Skip to main content

Advertisement

Table 3 Adverse drug reactions during study period (safety population)

From: Safety and tolerability of donepezil 23 mg with or without intermediate dose titration in patients with Alzheimer’s disease taking donepezil 10 mg: a multicenter, randomized, open-label, parallel-design, three-arm, prospective trial

Variables Group 1, 15 mg (n = 51) Group 2, 10/23 mg (n = 55) Group 3, no titration (n = 54) p value
Anorexia 9/51, 17.6% 12/55, 21.8% 12/54, 22.2% 0.815
Dizziness* 4/51, 7.8% 4/55, 7.3% 12/54, 22.2% 0.029
Nausea* 4/51, 7.8% 5/55, 9.1% 13/54, 24.1% 0.025
Vomiting 4/51, 7.8% 7/55, 12.7% 9/54, 16.7% 0.392
Generalized weakness 4/51, 7.8% 8/55, 14.5% 5/54, 9.3% 0.494
Weight loss 4/51, 7.8% 4/55, 7.3% 3/54, 5.6% 0.928
Diarrhea 2/51, 3.9% 4/55, 7.3% 5/54, 9.3% 0.584
Dyspepsia 0/51, 0% 4/55, 7.3% 3/54, 5.6% 0.179
Urinary frequency 2/51, 3.9% 4/55, 7.3% 0/54, 0% 0.122
Increased neuropsychiatric sx. 0/51, 0% 1/55, 1.8% 1/54, 1.9% 1.000
Insomnia 1/51, 2.0% 2/55, 3.6% 0/54, 0% 0.537
Headache 0/51, 0% 0/55, 0% 3/54, 5.6% 0.068
Tremor 1/51, 2.0% 1/55, 1.8% 1/54, 1.9% 1.000
Cold sweating 0/51, 0% 1/55, 1.8% 0/54, 0% 1.000
Drooling 0/51, 0% 1/55, 1.8% 1/54, 1.9% 1.000
Abdominal pain 1/51, 2.0% 0/55, 0% 0/54, 0% 0.319
Unexpected nocturnal ejaculation 0/51, 0% 0/55, 0% 1/54, 1.9% 1.000
Heartburn 0/51, 0% 0/55, 0% 1/54, 1.9% 1.000
PISA syndrome 1/51, 2.0% 0/55, 0% 0/54, 0% 0.319
High BP 0/51, 0% 0/55, 0% 1/54, 1.9% 1.000
Fecal incontinence 0/51, 0% 0/55, 0% 1/54, 1.9% 1.000
  1. *Significantly different incidences (p value < 0.05) between titration and no-titration groups