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Title: Persistent Therapy With Aricept (Donepezil HCl Tablets) Associated With Delayed Nursing Home Placement For Alzheimer's Patients

"Persistent Therapy With Aricept (Donepezil HCl Tablets) Associated With Delayed Nursing Home Placement For Alzheimer's Patients"

NEW YORK, NY -- July 1, 2003 -- Persistent treatment with the leading Alzheimer's treatment, Aricept® may help Alzheimer's patients and their families by delaying entry into a nursing home. A study published in this month's Journal of the American Geriatrics Society (JAGS) showed that dementia-related nursing home placement was delayed for nearly two years (21 months) in patients taking Aricept for at least nine months. These findings suggest that long-term treatment may help patients remain in their communities longer. Delaying nursing home placement may decrease the financial burden associated with caring for Alzheimer's disease (AD) patients. Keeping families together longer may also have important social and emotional benefits. As Alzheimer's disease progresses, patients lose their ability to perform basic functions, such as dressing and bathing, and become more dependent on their caregivers for help. As a result, caregivers often experience stress and financial strain. As these functions continue to deteriorate throughout the progression of the disease and caregiver burden increases, many patients require nursing home care. Residential care for patients with Alzheimer's disease takes a major toll on society. Total healthcare costs for Alzheimer's disease are estimated to exceed $100 billion a year in the United States. Nursing home care is the single largest component of direct AD healthcare costs, with an annual average cost estimated at more than $42,000 a year (1996 dollars) per nursing home resident. While Medicare, Medicaid and private insurance bear much of the direct cost, caregivers' expenses can still be substantial. "These study results support the importance of early, persistent use of Aricept," said David Geldmacher, MD, director, Memory Disorders Program, Department of Neurology, University of Virginia. "Many families face the difficult decision of placing a loved one in a nursing home as Alzheimer's disease progresses. Maintaining their loved ones at home for a longer time can provide real social and economic benefits for these families." Study Details Data are from two cohorts of patients in a prospective, observational follow-up of 671 AD patients from Aricept clinical trials for whom reason for and time of nursing home placement were obtained. Patients on persistent treatment received Aricept at least 9 to 12 months. Two hundred nine patients received Aricept for longer than two years. Patients on limited treatment received Aricept for six months or less. Results were adjusted for other factors that may have influenced nursing home placement: baseline MMSE*, patient age and gender, caregiver relationship to patient (spouse: yes/no), caregiver continuity and reported use of other cholinesterase inhibitors after the clinical trials. The median time for the persistent treatment group was 5.5 years versus 3.7 years for the limited treatment group. As with all studies of this type, results may be attributable to various factors. Aricept was one such factor. Other analyses (sensitivity analyses) varying the length of exposure, definition of compliance (80% and 100%) and double-blind study completion status were conducted. These results are consistent with other Aricept study findings. Information About Aricept (donepezil hydrochloride tablets) Treatment 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. 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, who are dedicated to advances in Alzheimer's therapy. For more information about managing Alzheimer's disease and about Aricept, and for prescribing information on ARCEPT, please call (888) 999-9616, or visit http://www.aricept.com. Full prescribing information is available at the Web site. * The MMSE is a brief test for measuring the cognitive state of the patient. The total score ranges from 0 to 30, with the higher score indicating a better cognitive state. SOURCE: Eisai Inc.; Pfizer Inc

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