Aricept - Side Effects & Drug Interactions

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titrated to 10 mg/day over 1 and 6 weeks

No titration

One week titration

Six week titration

Adverse Event

Placebo (n=315)

5 mg/day (n=311)

10 mg/day (n=315)

10 mg/day (n=269)

Nausea

6%

5%

19%

6%

Diarrhea

5%

8%

15%

9%

Insomnia

6%

6%

14%

6%

Fatigue

3%

4%

8%

3%

Vomiting

3%

3%

8%

5%

Muscle cramps

2%

6%

8%

3%

Anorexia

2%

3%

7%

3%

Adverse Events Reported in Controlled Trials

The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in placebo-controlled trials who received ARICEPT® and for which the rate of occurrence was greater for ARICEPT®-assigned than placebo-assigned patients. In general, adverse events occurred more frequently in female patients and with advancing age.

Table 3. Adverse Events Reported in Controlled Clinical Trials

in at Least 2% of Patients Receiving ARICEPT® and at a Higher Frequency than Placebo-treated Patients

Body System/Adverse Event

Placebo

(n=355)

ARICEPT®

(n=747)

Percent of Patients with any Adverse Event

72

74

Body as a Whole

Headache

9

10

Pain, various locations

8

9

Accident

6

7

Fatigue

3

5

Cardiovascular System

Syncope

1

2

Digestive System

Nausea

6

11

Diarrhea

5

10

Vomiting

3

5

Anorexia

2

4

Hemic and Lymphatic System

Ecchymosis

3

4

Metabolic and Nutritional Systems

Weight Decrease

1

3

Musculoskeletal System

Muscle Cramps

2

6

Arthritis

1

2

Nervous System

Insomnia

6

9

Dizziness

6

8

Depression

<1

3

Abnormal Dreams

0

3

Somnolence

<1

2

Urogenital System

Frequent Urination

1

2

Other Adverse Events Observed During Clinical Trials

ARICEPT® has been administered to over 1,700 individuals during clinical trials worldwide. Approximately 1,200 of these patients have been treated for at least 3 months and more than 1,000 patients have been treated for at least 6 months. Controlled and uncontrolled trials in the United States included approximately 900 patients. In regards to the highest dose of 10 mg/day, this population includes 650 patients treated for 3 months, 475 patients treated for 6 months and 116 patients treated for over 1 year. The range of patient exposure is from 1 to 1,214 days.