See Table 2 for a comparison of the most common adverse events following one and six week titration regimens. Table 2. Comparison of rates of adverse events in patients 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 ARICEPTŪ and for which the rate of occurrence was greater for ARICEPTŪ-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 ARICEPTŪ and at a Higher Frequency than Placebo-treated Patients Body System/Adverse Event Placebo (n=355) ARICEPTŪ (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 | ||||
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