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Honolulu, Hawaii (April 4, 2003) -- The leading Alzheimer's treatment, ARICEPT® (donepezil HCl tablets), may also benefit patients with vascular dementia (VaD), according to a study analysis presented at the American Academy of Neurology (AAN) 55th Annual Meeting. There are no medications approved to treat VaD, which affects approximately 1.3 million Americans. VaD is caused by a single, localized stroke or series of strokes. A supplemental New Drug Application (sNDA) is under review by the U.S. Food and Drug Administration for the treatment of VaD with ARICEPT. ARICEPT® is indicated for the treatment of mild to moderate AD.
This study analysis presented at AAN compared treated and untreated Alzheimer's disease (AD) and VaD patients. In these distinct populations, patients treated with ARICEPT® demonstrated significant improvements in cognition, behavior, and activities of daily living, compared to those receiving placebo. There were important differences in the treatment response between AD and VaD patients. This study suggests that for VaD patients an important measure of treatment success is the improvement of symptoms. Treatment success for AD patients includes improvement, stabilization or a less-than-expected decline.
A collaboration dedicated to advances in Alzheimer's therapy.
"Currently, more than 60 percent of VaD patients are undiagnosed," said Dr. Stephen Salloway, director of Neurology and The Memory Disorders Program and associate professor of Clinical Neurosciences at Brown Medical School, Providence, Rhode Island. "This analysis supports the need for physicians to diagnose, as well as treat, their VaD patients. As the population ages and more people are at risk for VaD, treatment will become more critical than ever to address this growing health care issue."
Study Details
The research is a post-hoc analysis of 12 prospective studies, including two 24-week, double-blind, randomized, placebo-controlled studies of 1,219 patients with probable or possible VaD and 10 studies of 2,376 patients with probable AD. VaD patients were eligible for enrollment based upon research criteria developed NINDS-AIREN (National Institute of Neurological Disorders and Stroke-Associate Internationale pour la Recherche et l'Enseignment en Neurosciences).
Patients were randomized to receive ARICEPT® 5 mg/day (VaD patients n= 406; AD patients n=821), ARICEPT® 10 mg/day (VaD patients n=421; AD patients n=662), or placebo (VaD patients n=392; AD patients n=893). Patients in this study were evaluated using the Clinician's Interview-based Impression of Change-Plus version (CIBIC-plus).* These analyses are based on observed cases of patients who had a final evaluation at Week 24.
- A greater proportion of ARICEPT®-treated patients showed improvement in cognition, behavior, and activities of daily living compared to those taking placebo, both in VaD (placebo, 29%; ARICEPT® 5 mg/day, 41%, p=0.003; ARICEPT® 10 mg/day, 33%, p=0.072; overall treatment, p=0.001), and in AD (placebo, 16%; ARICEPT® 5 mg/day, 31%, p<0.0001; ARICEPT® 10 mg/day, 27%, p<0.0001; overall treatment, p<0.0001).
- Fewer ARICEPT®-treated patients compared to those on placebo showed decline, both in VaD (placebo, 30%; ARICEPT® 5 mg/day, 21%; ARICEPT® 10 mg/day, 27%), and in AD (placebo, 49%; ARICEPT® 5 mg/day, 37%; ARICEPT® 10 mg/day, 35%).
Information About ARICEPT® (donepezil hydrochloride 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 dementia 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 No. 20.
About Pfizer Inc
Pfizer Inc. discovers, develops, manufactures, and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer products.