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5TH YEAR MILESTONE FOR FIRST ALZHEIMER DRUG APPROVED IN CANADA

Standard of care, once-a-day ARICEPT heralded new era in the treatment of Alzheimer's Disease in 1997

Montreal, Quebec - August 21, 2002


With the introduction of ARICEPT™ (donepezil) in August of 1997, a new era began in the treatment of Alzheimer’s disease (AD) in Canada. Until that time, no specific therapy was available to alleviate the devastating impact of AD on patients and their caregivers. The first of its new class of medication known as cholinesterase inhibitors, ARICEPT is indicated for the symptomatic treatment of mild to moderate AD.

Today, ARICEPT is the number one prescribed AD medication in the world with a total of over 717 million patient days of use. In Canada, it remains the standard of care in the treatment of mild to moderate Alzheimer’s disease and the total number of days of treatment with ARICEPT has reached more than 34 million.

Eight Years of Studies
ARICEPT has been the subject of clinical studies for over eight years and has been assessed among a population of over 7,800 AD patients around the world. Many of the multinational studies involved Canadian researchers and centres. To date, some 1,200 Canadian AD patients have taken part in such clinical trials.

ARICEPT is the only prescription drug of its class with cumulative published trial data for up to almost five years; patients in some of the clinical trials have been followed for more than five years. It is also the only approved AD prescription drug with published data on safety in long term use in two (2) one-year placebo-controlled studies1,2 showing that its clinical benefits in terms of global function, cognition and activities of daily living are sustained over time and that it is well tolerated by patients in long-term treatment.

Data from three open-label trials including a 98-week open-label extension study with 133 patients3, a 144-week open-label extension study with 763 patients with mild to moderate AD4 and a 152-week open-label study5 with 579 patients indicated that patients maintained benefit with long-term use as measured by function and cognition.

A Success story for Quality of Life
“ARICEPT has not only been shown to slow the progression of AD patients’ symptoms, it has been shown to delay their need for transfer to institutional care,” says Dr. Serge Gauthier, McGill Centre of Studies in Aging, Montreal, Quebec. “It has also had an impact on symptoms such as cognition and everyday function for periods of up to three or more years. That is where the success story lies and it is certainly a great contribution to improving quality of life for the patients, their caregivers and families,” he adds.

Science behind Canadian Guidelines
“Canada was one of the first countries in the world to have clinical practice guidelines for the treatment of AD,” recalls Dr. Gauthier. “ARICEPT data presented the basis of evidence that helped the Canadian Consensus Conference on Dementia develop its recommendations for family physicians in 1998. The recommendations published in the Canadian Medical Association Journal 6, included a trial course of ARICEPT to be prescribed to informed and willing patients with mild to moderate dementia due to probable AD.

“These guidelines were key at the time and were certainly instrumental in ensuring more consistent and improved care of persons with dementia by physicians across Canada.”

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