Donepezil Hydrochloride (Page 3 of 9)

Severe Alzheimer’s Disease (Donezpezil Hydrochloride 5 mg/day and 10 mg/day)

Donepezil hydrochloride has been administered to over 600 patients with severe Alzheimer’s disease during clinical trials of at least 6 months duration, including three double-blind, placebo-controlled trials, two of which had an open label extension.

Adverse Reactions Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of donepezil hydrochloride due to adverse reactions for the donepezil hydrochloride patients were approximately 12% compared to 7% for placebo patients. The most common adverse reactions leading to discontinuation, defined as those occurring in at least 2% of donepezil hydrochloride patients and at twice or more the incidence seen in placebo, were anorexia (2% vs. 1% placebo), nausea (2% vs. < 1% placebo), diarrhea (2% vs. 0% placebo), and urinary tract infection (2% vs. 1% placebo).

Most Common Adverse Reactions

The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving donepezil hydrochloride and at twice or more the placebo rate, are largely predicted by donepezil hydrochloride’s cholinomimetic effects. These include diarrhea, anorexia, vomiting, nausea, and ecchymosis. These adverse reactions were often transient, resolving during continued donepezil hydrochloride treatment without the need for dose modification.

Table 4 lists adverse reactions that occurred in at least 2% of patients in pooled placebo-controlled trials who received donepezil hydrochloride 5 mg or 10 mg and for which the rate of occurrence was greater for patients treated with donepezil hydrochloride than with placebo.

Table 4. Adverse Reactions in Pooled Controlled Clinical Trials in Severe Alzheimer’s Disease

Body System/Adverse Reaction

Placebo (n = 392)

%

Donepezil Hydrochloride(n = 501)

%

Percent of Patients with any Adverse Reaction

73

81

Accident

12

13

Infection

9

11

Diarrhea

4

10

Anorexia

4

8

Vomiting

4

8

Nausea

2

6

Insomnia

4

5

Ecchymosis

2

5

Headache

3

4

Hypertension

2

3

Pain

2

3

Back Pain

2

3

Eczema

2

3

Hallucinations

1

3

Hostility

2

3

Increase in Creatine Phosphokinase

1

3

Nervousness

2

3

Fever

1

2

Chest Pain

< 1

2

Confusion

1

2

Dehydration

1

2

Depression

1

2

Dizziness

1

2

Emotional Lability

1

2

Hemorrhage

1

2

Hyperlipemia

< 1

2

Personality Disorder

1

2

Somnolence

1

2

Syncope

1

2

Urinary Incontinence

1

2

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