ARICEPT®(donepezil hydrochloride) may reduce caregiver burden

Stockholm, Sweden, 25 February 2001--Caregivers of patients treated with ARICEPT® reported less time spent assisting patients with mild to moderate Alzheimer's disease, compared to caregivers of placebo-treated patients.

These data from a 1-year, placebo-controlled study were presented today at the American Association for Geriatric Psychiatry's (AAGP) 14th annual meeting.

ARICEPT®, the no. 1 prescribed Alzheimer’s medication, is a clinically proven, well-tolerated, once-daily treatment for mild to moderate Alzheimer's disease.

“We’ve long known that the devastating effects of Alzheimer’s are not limited to patients; they take a tremendous toll on caregivers as well,” said Dr. Bengt Winblad, MD, department of clinical neuroscience and family medicine, Karolinska Institute, Sweden. “Our findings suggest that the intellectual and functional benefits experienced by Ariceptâ-treated patients may lessen the burden of caregiving.”

In the double-blind study, Dr. Winblad followed ARICEPT®- and placebo-treated patients for one year to determine the effects of therapy on patients' cognition and ability to perform both basic activities of daily living (ADLs), such as toileting, dressing and bathing, and their ability to perform instrumental activities of daily living (IADLs), such as using the telephone, shopping, engaging in hobbies and managing money.

Treatment with ARICEPT® had beneficial effects on global and cognitive functioning over 1 year. This study also found that ARICEPT®-treated patients gained significant functional benefits relative to placebo during the study, as assessed by the Progressive Deterioration Scale (PDS) at week 52 (p<0.05). Subdomain analyses of the PDS at week 52 demonstrated that ARICEPT®-treated patients relative to placebo-treated patients showed benefits on 9 of the 10 domains on the PDS of which telephone (p=0.009), memory (p=0.003) and selfcare (p=0.042) were statistically significant.

Researchers also found that caregivers in the ARICEPT®-treated group spent less time providing care compared with those in the placebo-treated group, and less time assisting patients with both instrumental and basic ADLs. Study investigators suggest this time savings may be attributed to the functional benefits patients experienced by taking ARICEPTâ.

In this trial, conducted in Northern Europe, 286 patients with mild to moderate Alzheimer’s disease were randomized to receive either ARICEPT® (donepezil hydrochloride) or placebo. Assessment measures included the Progressive Deterioration Scale (PDS), the IADL scale and the Physical Self-maintenance Scale (PSMS). The amount of time caregivers spent assisting patients with basic and instrumental ADLs and the total time spent caring for patients also were collected.

Over 52 weeks, it was calculated that caregivers in the ARICEPT®-treated group spent an average of 400 hours less providing care, the equivalent of 10 work weeks, compared with caregivers in the placebo-treated group.

In addition, caregivers of patients receiving ARICEPT®, compared to those receiving placebo, spent less time assisting patients with both basic (2.4 vs. 3.7 hours per day (P=NS)) and instrumental ADLs (7.7 vs. 8.3 hours per day (P=NS)).

Further, more caregivers of placebo-treated patients compared with ARICEPT®-treated patients reported spending most of each day (at least 16 hours a day) caring for patients at weeks 12 (2% vs. 1% (p=.34); 24 (3% vs. 0%; p<0.05); 36 (5% vs. 0%; p<0.05) and 52 (6% vs. 2%; p=0.1).

“The impact of an hour a day may be lost on someone not in a similar situation,” said Dr. Winblad. “But in a caregiver’s day, any alleviation of the daily workload, no matter how slight, may be meaningful.”

In this one-year study, the most frequent treatment-emergent adverse events for ARICEPTâ vs. placebo were asthenia or fatigue (8% vs. 4%), syncope or fainting (6% vs. 3%), and vertigo (8% vs. 2%).

Although Alzheimer’s disease is incurable, medical treatment is available to manage some of the symptoms. Once-a-day ARICEPT® (donepezil hydrochloride) tablets can improve cognition and maintain patient function in people with mild-to-moderate Alzheimer’s disease.

In this multinational 1-year placebo-controlled clinical 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® 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 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 450 million days of patient use worldwide, and more than 1.4 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.

The study was funded by Eisai and Pfizer Inc. Full prescribing information is available upon request from Melissa Furrie of Porter Novelli or Celeste Torello of Pfizer Inc.

ARICEPT® is a registered trademark of Eisai Co., Ltd.

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