ARICEPT better tolerated than Exelon in patients with mild to moderate Alzheimer's disease

September 26, 2000

First head-to-head study of ARICEPT® (donepezil hydrochloride) and Exelon® (rivastigmine tartrate) offers comparative information of clinical use to physicians

Study patients treated according to approved product labeling

NEW YORK, SEPTEMBER 27, 2000 - Results from the first head-to-head study between ARICEPT® (donepezil hydrochloride) (Eisai and Pfizer Inc) and Exelon® (rivastigmine tartrate) (Novartis Pharma AG) showed that in this open-label study ARICEPT® was better tolerated than Exelon® in patients with mild to moderate Alzheimer's disease. Data were presented at a scientific conference earlier this month in Munich, Germany.

"Despite the often devastating nature of the disease, tolerability is still very important to patients with Alzheimer's disease," said David Wilkinson, MD, director of the Memory Assessment and Research Centre, Moorgreen Hospital, Southampton, England, and an investigator in the study. "Patients tend to be elderly and often have other medical conditions that can make treating Alzheimer's disease more complex. It is therefore important to treat patients with medications that are well tolerated and easy to use, such as ARICEPT®."

The multinational, head-to-head, open-label study was designed to compare the tolerability and ease of use of ARICEPT® to Exelon® in 111 patients with mild to moderate Alzheimer's disease.

The two treatment groups had similar improvements from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) scores throughout the 12-week treatment period. ADAS-cog is a clinically validated measure of cognitive function. Testing was administered by independent raters who were blinded to study medication.

Key study findings: During the 12-week, open-label trial, 111 patients (59% female) with an average age of 74.5 years (51-90 years) were randomized and treated with either ARICEPT® or Exelon® for 12 weeks. Patients were dosed according to the approved product labeling for each medication.

Patients in the ARICEPT® study arm received 5 mg once daily for 4 weeks and 10 mg once daily thereafter, if tolerated. Patients in the Exelon® study arm received 1.5 mg twice daily for 2 weeks with dose increases of 1.5 mg twice daily every 2 weeks until reaching 12 mg (6 mg twice daily), if tolerated. Patients who could not tolerate higher doses were allowed to continue in the study at the next lower tolerated dose. Patients who could not tolerate at least 5 mg daily of ARICEPT® (donepezil hydrochloride) or 6 mg daily (3 mg twice daily) of Exelon® (rivastigmine tartrate) were discontinued from the study.

In this study, the most frequent treatment-emergent adverse events for ARICEPT® versus Exelon® included: nausea (10.7% vs 41.8%); vomiting (7.1% vs 23.6%); headache (7.1% vs 18.2%); anorexia (1.8% vs 9.1%); abnormal dreams (7.1% vs 1.8%); back pain (7.1% vs 0.0%); somnolence (1.8% vs 5.5%); and urinary tract infection (5.4% vs 0.0%).

Other data presented at the symposium included results from two 1-year, placebo-controlled clinical studies with ARICEPT®. In the 1-year US study, patients treated with ARICEPT® maintained function significantly longer (median time about 5 months longer) than those treated with placebo. In the multinational 1-year study, cognition was maintained at or near baseline for 1 year as measured by the Mini Mental State Examination (MMSE) in patients treated with ARICEPT®.

Alzheimer's disease, which is a progressive and degenerative brain disorder, impairs cognition and the ability to perform such daily living activities as handling money, using the telephone, grooming, etc. Approximately 15 million people suffer from AD worldwide.

ARICEPT® (donepezil hydrochloride) is well tolerated but may not be for everyone. Some people may experience nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, or loss of appetite. In studies, these side effects were usually mild and temporary. Some people taking ARICEPT® may experience fainting. People at risk for ulcers should tell their doctors because their condition may get worse. In a progressively degenerative disease such as Alzheimer's, no further decline or a less than expected decline is considered a favorable response. Improvement, stabilization and decline have been observed in patients treated with ARICEPT® in clinical trials. Individual responses to treatment may vary.

ARICEPT® is available by prescription in more than 40 countries. In November 1994, Eisai Co., Ltd., and Pfizer Inc. announced the formation of a strategic alliance for the promotion of ARICEPT® and development of new treatments for Alzheimer's disease and other cognitive disorders. ARICEPT® is the lead compound in this alliance. First launched in the United States in February 1997, ARICEPT® has been well received in the Alzheimer's disease community with more than 394 million days of patient use worldwide, and more than 1.2 million people in the United States have received a prescription for ARICEPT®.

Eisai Co., Ltd., and Pfizer Inc are committed to a collaboration dedicated to advances in Alzheimer's therapy. These studies were funded by Eisai and Pfizer Inc.

_________________________ Physician's Satisfaction Questionnaire: When surveyed on overall satisfaction with ARICEPT® for each patient, physicians who participated in the study reported "very satisfied" for 46.4% of patients; "satisfied" for 48.2% of patients; "neither satisfied nor dissatisfied" for 1.8% of patients; "dissatisfied" for 0.0% of patients; "very dissatisfied" for 3.6% of patients.

Physician's Satisfaction Questionnaire: When surveyed on overall satisfaction with Exelon® for each patient, physicians who participated in the study reported "very satisfied" for 18.9% of patients; "satisfied" for 49.1% of patients; "neither satisfied nor dissatisfied" for 17% of patients; "dissatisfied" for 11.3% of patients; "very dissatisfied" for 3.8% of patients.

Approved product labeling for ARICEPT® is the same with regard to dosage and administration in the EU and the USA. Approved product labeling for Exelon® is the same with regard to dosage and administration in the EU and the USA.

These treatment-emergent adverse events occurred in greater than or equal to 5% of patients and at least twice as frequently in either treatment group (all causalities).
-end-
Full prescribing information is available upon request from Melissa Furrie of Porter Novelli or Celeste Torello of Pfizer Inc (see contact information above). ARICEPT® is a registered trademark of Eisai Co., Ltd. Exelon® is a registered trademark of Novartis. News Source: Eisai Ltd. (European Office) and Pfizer Inc.

Porter Novelli

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