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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