Honolulu, Hawaii (April 4, 2003) -- Severe Alzheimer's disease (AD) patients treated with ARICEPT® (donepezil HCl tablets) showed significant improvement in global function, cognition, behavior, and activities of daily living versus placebo, according to new data from a subset analysis of the Moderate to Severe Alzheimer's Disease Study (MSAD), previously published in Neurology in August 2001. These data, which were presented at the American Academy of Neurology (AAN) 55th Annual Meeting, demonstrated that ARICEPT® provided significant benefits versus placebo in everyday tasks, as well as in behavioral symptoms associated with AD. These findings suggest ARICEPT® may provide important benefits for patients with advanced AD. ARICEPT® is approved for the treatment of symptoms of mild to moderate Alzheimer's disease.
"The results of this trial indicate that the benefits of ARICEPT®, which have been reported in clinical trials of mild to moderate AD, may also extend into the severe AD stage," said Howard Feldman, MD, UBC Hospital, Clinic for Alzheimer's Disease and Related Disorders, Vancouver, British Columbia. "These findings are meaningful for patients when treatment is started even in the later stage of the disease."
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Patients receiving ARICEPT® showed statistically significant benefit in the primary outcome measure for this study, the Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus),* compared with those taking placebo. Secondary measures showing statistically significant differences between the groups in favor of ARICEPT® included: standardized Mini/Mental State Examination (sMMSE)†, Severe Impairment Battery (SIB)#, Disability Assessment for Dementia (DAD)** and the Neuropsychiatric Inventory (NPI)++.
MSAD Study Overview
In this analysis, 145 patients with severe Alzheimer's disease (sMMSE = 5-12) were randomized to receive either ARICEPT® (n=72), 5 mg once daily for the first 28 days and 10 mg once daily thereafter based on the clinicians' judgment, or placebo (n=73). Baseline demographics, including age and sex, were similar between the ARICEPT® and placebo groups. The study enrolled patients residing in the community or in assisted living settings. Patients requiring total nursing care were ineligible. The mean sMMSE score at baseline was 9.0 for the ARICEPT® group and 8.9 for the placebo group. Patients were assessed at Weeks 4, 8, 12, 18, and 24. Consistent benefits were found for ARICEPT® across the full range of measures of patient outcomes - global function, cognition, behavior, and activities of daily living -- in this 24-week, multinational, double-blind placebo-controlled trial:
- ARICEPT®-treated patients showed statistically significant improvement or remained at or near baseline throughout the study on measure of global function, while placebo-treated patients showed functional decline, as measured by the CIBIC-plus (mean difference = 0.7, p= 0.0002).
- ARICEPT®-treated patients showed statistically significant overall cognitive improvement versus placebo, as measured by the sMMSE? and SIB (mean difference = 2.0 for the sMMSE [p = 0.0022] and 7.4 for the SIB [p = 0.0017]).
- The ARICEPT®-treated group showed statistically significantly less decline compared with placebo-treated patients on activities of daily living, as measured by the DAD (mean difference = 7.2, p = 0.0082).
- The ARICEPT®-treated group showed statistically significant overall improvement versus placebo in behavioral disturbances associated with Alzheimer's, as measured by the NPI (mean difference = 6.9, p = 0.0062).
Consistent with previous ARICEPT® studies in AD, completion rates for the study were 90 percent in the ARICEPT® group and 86 percent in placebo-treated patients. The most common reason for discontinuation was adverse events (7 percent ARICEPT®, 5 percent placebo). In this analysis, the common treatment-emergent adverse events were hostility, headache, diarrhea, confusion, fecal incontinence, somnolence, vomiting, back pain, flatulence, rash, urinary tract infection. The majority of reported adverse events were rated as mild or moderate in severity.
Information About ARICEPT® (donepezil HCI tablets) Treatment in Alzheimer's Disease
While there is no cure for Alzheimer's disease, medical treatments are available to manage symptoms of the disease. Once-a-day prescription ARICEPT® is indicated for mild to moderate Alzheimer's disease. In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT® in clinical trials for Alzheimer's disease. Individual responses to treatment vary, and some patients may not respond.
ARICEPT® 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.
ARICEPT® is the number one prescribed Alzheimer's disease therapy worldwide, with more than 1 billion patient days of ARICEPT® therapy sold. More than 1.7 million people in the United States alone have begun ARICEPT® therapy.
ARICEPT® is co-promoted in the United States by Eisai Inc. and Pfizer Inc, which are dedicated to advances in Alzheimer's therapy.
For more information about managing Alzheimer's disease and about ARICEPT®, and for prescribing information on ARICEPT®, please call (888) 999-9616, or visit www.aricept.com. Full prescribing information is available at that Web site.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care company that discovers, develops, and markets products in more than 30 countries. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of more than $1 billion in fiscal year 2001 (year ending March 31, 2002). Eisai Inc. employs a total of more than 650 people at its headquarters in Teaneck, N.J., at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, N.C., and in the field. Between 1998 and 2002, Eisai Inc. moved up rapidly in the rankings of U.S. pharmaceutical companies (based on revenues) from No. 44 to 20.
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