Study Results Show That Time to Nursing Home Placement Was Delayed for Close to 2 Years in Alzheimer's Patients Treated with ARICEPT(R) (Donepezil Hydrochloride)

Apr 04, 2001, 01:00 ET from Eisai Inc. and Pfizer Inc

    NEW YORK, April 4 /PRNewswire/ -- Persistent treatment with ARICEPT(R)
 (donepezil hydrochloride) may have delayed dementia-related nursing home
 placement for Alzheimer's patients for close to 2 years (21 months), according
 to a new study.  These results were presented recently at the 14th annual
 meeting of the American Association for Geriatric Psychiatry.
     Delaying nursing home placement for any reason may have benefits to
 families and society by lessening emotional and financial burdens associated
 with caring for Alzheimer's disease patients.
     "As Alzheimer's disease progresses, the burdens of caregiving may simply
 become too great, and families may be faced with the difficult decision to
 place their loved one in a nursing home," said David Geldmacher, M.D.,
 Clinical Director, University Alzheimer Center, University Hospitals of
 Cleveland and Case Western Reserve University.  "This study showed that
 persistent treatment with ARICEPT(R) may have allowed patients to stay at home
 with their families longer before requiring the skilled care and full-time
 supervision of a nursing home."
     "Also, these findings reinforce the importance of beginning treatment with
 ARICEPT(R) as early as possible in the disease process and maintaining that
 treatment for long-term benefits, as medically appropriate," Dr. Geldmacher
 continued.
     ARICEPT(R), the no. 1 prescribed Alzheimer's medication, is a clinically
 proven, well-tolerated, once-daily treatment for mild to moderate Alzheimer's
 disease.
     "Our doctor put my husband on ARICEPT(R) (as part of a clinical trial)
 shortly after he was diagnosed in 1994, and he has been on treatment ever
 since," said caregiver Janet Farr.  "Early treatment bought us more quality
 time at home together, and we're both very grateful for that."
     Alzheimer's disease exacts a major toll on society, with direct dollar
 costs estimated at  $29 billion a year in the U.S., with most of these costs
 related to nursing home care.  The average annual costs of nursing home care
 are estimated at more than $42,000 a year (1996 costs) per person.  While
 Medicare, Medicaid, and private insurance bear much of the direct cost,
 caregivers' costs can still be substantial.
 
     Information About the Delay to Nursing Home Placement Study
     In this study, the time to placement in a nursing home was analyzed for
 671 patients with mild to moderate Alzheimer's disease who had participated in
 1 of 3 clinical trials with ARICEPT(R) versus a sugar pill, followed by
 studies where everyone took ARICEPT(R).  Patients' caregivers were interviewed
 to obtain information on the dates and reasons for nursing home placements
 that lasted for two weeks or more.  Patients were categorized according to the
 length of effective treatment (5 mg or 10 mg a day) with ARICEPT(R) (donepezil
 hydrochloride) during the clinical trials and follow-up studies.
     Using statistical analyses, times to nursing home placement for
 dementia-related reasons were estimated based on different periods of drug
 treatment.  These time estimates took into account each patient's age, gender,
 and severity of illness as measured by Mini-Mental State Examination (MMSE)
 scores at entry into a clinical trial, as well as change in caregiver and the
 patient's use of other cholinesterase-inhibiting drugs after completing
 participation in the ARICEPT(R) (donepezil hydrochloride) clinical trials.
     This study showed that patients who received ARICEPT(R) for longer periods
 (an effective dose of at least 5 mg a day for at least 9 to 12 months) had a
 21-month longer delay in nursing home placement than patients who received no
 or limited ARICEPT(R) (sugar pill, or less than 5 mg a day, or at least 5 mg a
 day for less than 80 percent of the time during a clinical trial).
 
     Table 1: Times to nursing home placement for patients who received limited
              as compared to persistent ARICEPT(R) treatment.
 
                                      Time to First
                                      Dementia-Related Nursing
     Drug Treatment Group             Home Placement                  Delay
 
     No or limited ARICEPT(R)
     treatment                          45 months                       --
 
     Persistent ARICEPT(R)
     treatment (an effective dose
     -- at least 5 mg/day for at
     least 9-12 months)                 66 months                   21 months
 
     While there is no cure for Alzheimer's disease, medical treatments are
 available to manage symptoms of the disease.  Once-a-day prescription
 ARICEPT(R) (donepezil hydrochloride) can improve cognition and maintain
 patient function in people with mild to moderate Alzheimer's disease.  In a
 progressively degenerative disease such as Alzheimer's, improvement,
 stabilization or a less-than-expected decline is considered a positive
 response to treatment.  These types of responses have been observed in
 patients treated with ARICEPT(R) in clinical trials.  Individual responses to
 treatment may vary.
     ARICEPT(R) (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(R) (donepezil
 hydrochloride) may experience fainting.  People at risk for ulcers should tell
 their doctors because their condition may get worse.
     It is estimated that 1 in 10 individuals older than age 65 has Alzheimer's
 disease.  Approximately 4 million Americans are thought to have Alzheimer's
 disease; by the year 2050, it is estimated that nearly 14 million Americans
 will suffer from the disease.
     To date, more than 1.4 million people in the United States have received a
 prescription for ARICEPT(R) contributing to a total of 450 million days of
 patient use worldwide.
     For more information about managing Alzheimer's disease and about
 ARICEPT(R), please call the Eisai Inc.- and Pfizer Inc-sponsored toll-free
 number, 888-999-9616, or see http://www.aricept.com.
     Eisai Inc. and Pfizer Inc. are dedicated to advances in Alzheimer's
 therapy.
     Full prescribing information attached and available at
 http://www.aricept.com.
 
     ARICEPT(R) is a registered trademark of Eisai Co., Ltd.
     News Source: Eisai Inc. and Pfizer Inc
 
     * MMSE - A clinically validated measure of cognition.
 
 

SOURCE Eisai Inc. and Pfizer Inc
    NEW YORK, April 4 /PRNewswire/ -- Persistent treatment with ARICEPT(R)
 (donepezil hydrochloride) may have delayed dementia-related nursing home
 placement for Alzheimer's patients for close to 2 years (21 months), according
 to a new study.  These results were presented recently at the 14th annual
 meeting of the American Association for Geriatric Psychiatry.
     Delaying nursing home placement for any reason may have benefits to
 families and society by lessening emotional and financial burdens associated
 with caring for Alzheimer's disease patients.
     "As Alzheimer's disease progresses, the burdens of caregiving may simply
 become too great, and families may be faced with the difficult decision to
 place their loved one in a nursing home," said David Geldmacher, M.D.,
 Clinical Director, University Alzheimer Center, University Hospitals of
 Cleveland and Case Western Reserve University.  "This study showed that
 persistent treatment with ARICEPT(R) may have allowed patients to stay at home
 with their families longer before requiring the skilled care and full-time
 supervision of a nursing home."
     "Also, these findings reinforce the importance of beginning treatment with
 ARICEPT(R) as early as possible in the disease process and maintaining that
 treatment for long-term benefits, as medically appropriate," Dr. Geldmacher
 continued.
     ARICEPT(R), the no. 1 prescribed Alzheimer's medication, is a clinically
 proven, well-tolerated, once-daily treatment for mild to moderate Alzheimer's
 disease.
     "Our doctor put my husband on ARICEPT(R) (as part of a clinical trial)
 shortly after he was diagnosed in 1994, and he has been on treatment ever
 since," said caregiver Janet Farr.  "Early treatment bought us more quality
 time at home together, and we're both very grateful for that."
     Alzheimer's disease exacts a major toll on society, with direct dollar
 costs estimated at  $29 billion a year in the U.S., with most of these costs
 related to nursing home care.  The average annual costs of nursing home care
 are estimated at more than $42,000 a year (1996 costs) per person.  While
 Medicare, Medicaid, and private insurance bear much of the direct cost,
 caregivers' costs can still be substantial.
 
     Information About the Delay to Nursing Home Placement Study
     In this study, the time to placement in a nursing home was analyzed for
 671 patients with mild to moderate Alzheimer's disease who had participated in
 1 of 3 clinical trials with ARICEPT(R) versus a sugar pill, followed by
 studies where everyone took ARICEPT(R).  Patients' caregivers were interviewed
 to obtain information on the dates and reasons for nursing home placements
 that lasted for two weeks or more.  Patients were categorized according to the
 length of effective treatment (5 mg or 10 mg a day) with ARICEPT(R) (donepezil
 hydrochloride) during the clinical trials and follow-up studies.
     Using statistical analyses, times to nursing home placement for
 dementia-related reasons were estimated based on different periods of drug
 treatment.  These time estimates took into account each patient's age, gender,
 and severity of illness as measured by Mini-Mental State Examination (MMSE)
 scores at entry into a clinical trial, as well as change in caregiver and the
 patient's use of other cholinesterase-inhibiting drugs after completing
 participation in the ARICEPT(R) (donepezil hydrochloride) clinical trials.
     This study showed that patients who received ARICEPT(R) for longer periods
 (an effective dose of at least 5 mg a day for at least 9 to 12 months) had a
 21-month longer delay in nursing home placement than patients who received no
 or limited ARICEPT(R) (sugar pill, or less than 5 mg a day, or at least 5 mg a
 day for less than 80 percent of the time during a clinical trial).
 
     Table 1: Times to nursing home placement for patients who received limited
              as compared to persistent ARICEPT(R) treatment.
 
                                      Time to First
                                      Dementia-Related Nursing
     Drug Treatment Group             Home Placement                  Delay
 
     No or limited ARICEPT(R)
     treatment                          45 months                       --
 
     Persistent ARICEPT(R)
     treatment (an effective dose
     -- at least 5 mg/day for at
     least 9-12 months)                 66 months                   21 months
 
     While there is no cure for Alzheimer's disease, medical treatments are
 available to manage symptoms of the disease.  Once-a-day prescription
 ARICEPT(R) (donepezil hydrochloride) can improve cognition and maintain
 patient function in people with mild to moderate Alzheimer's disease.  In a
 progressively degenerative disease such as Alzheimer's, improvement,
 stabilization or a less-than-expected decline is considered a positive
 response to treatment.  These types of responses have been observed in
 patients treated with ARICEPT(R) in clinical trials.  Individual responses to
 treatment may vary.
     ARICEPT(R) (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(R) (donepezil
 hydrochloride) may experience fainting.  People at risk for ulcers should tell
 their doctors because their condition may get worse.
     It is estimated that 1 in 10 individuals older than age 65 has Alzheimer's
 disease.  Approximately 4 million Americans are thought to have Alzheimer's
 disease; by the year 2050, it is estimated that nearly 14 million Americans
 will suffer from the disease.
     To date, more than 1.4 million people in the United States have received a
 prescription for ARICEPT(R) contributing to a total of 450 million days of
 patient use worldwide.
     For more information about managing Alzheimer's disease and about
 ARICEPT(R), please call the Eisai Inc.- and Pfizer Inc-sponsored toll-free
 number, 888-999-9616, or see http://www.aricept.com.
     Eisai Inc. and Pfizer Inc. are dedicated to advances in Alzheimer's
 therapy.
     Full prescribing information attached and available at
 http://www.aricept.com.
 
     ARICEPT(R) is a registered trademark of Eisai Co., Ltd.
     News Source: Eisai Inc. and Pfizer Inc
 
     * MMSE - A clinically validated measure of cognition.
 
 SOURCE  Eisai Inc. and Pfizer Inc