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Patients With Dementia Following Stroke Improved When Treated With Aricept (Donepezil)

MONTREAL, QC -- August 26, 2003 -- Treatment with Aricept™ (donepezil) significantly improved memory, thinking and global function in patients with vascular dementia (VaD), compared with placebo, according to an article published in this month's issue of the peer-reviewed journal Neurology(1). VaD, a loss of cognitive abilities caused by a single, localized stroke, or series of strokes, is the second most common form of dementia in Canada(2).

The study examined the efficacy and safety of the number one prescribed Alzheimer's disease (AD) treatment in patients with VaD. In Canada Aricept is indicated for the treatment of mild to moderate AD. There are no approved treatments for VaD.

"Stroke patients often have other complicated medical problems and physicians tend to focus on treating those underlying conditions rather than memory and thinking," said Dr. Alain Robillard, Director, Memory Clinic at Hôpital Maisonneuve-Rosemont in Montreal, and one of the principal investigators of the study. "This study shows promising results in this patient population and that Aricept was efficacious in treating the cognitive symptoms of VaD."

VaD is directly correlated with risk factors for stroke, including high blood pressure, diabetes, elevated cholesterol levels and smoking(3). Patients with VaD typically experience a step by step decline in function, in contrast to patients with AD, who often experience a gradual, progressive decline(4),(5). With AD, patients experience memory loss, such as misplacing items, getting lost in familiar places and trouble having conversations(6). VaD patients experience impairment in executive function, such as making decisions or judgments or solving problems(7).

Globally, 5.5 million people are affected by VaD and mixed dementias (a combination of AD and VaD)(8). By the year 2050, it is estimated that the population aged 60 years and older will reach 2 billion(9). This will make VaD an even greater health issue than it is today, as the risk of dementia increases with age, affecting more than 15 per cent of people over age 65(10).

Study Details
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This 24-week, double-blind, randomized, placebo-controlled study, included 616 patients who received daily doses of either 5 or 10 mg of Aricept, or placebo. The study excluded those patients with a diagnosis of AD. Patients were selected using research criteria specifically designed to identify patients with VaD developed by the National Institute of Neurological Disorders and Stroke (NINDS) with support from the Associate Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN). Patients were also required to have neuroimaging evidence of cerebrovascular disease obtained by a computed tomography (CT) scan or magnetic resonance imaging (MRI).

The majority of participants had a history of stroke. Virtually all of the participants took one or more additional medications, most frequently to prevent cardiovascular risk factors, with over 80 per cent receiving some form of medication to prevent strokes.

Study Results
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- Patients showed significant improvement in their cognitive function compared to those taking placebo (p = 0.003 for the 5 mg dose; p = 0.0002 for the 10 mg dose), as measured by the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog) and measured by the Mini-Mental State Examination (MMSE) (p (equal sign) 0.0004 for the 5 mg dose; p = 0.0003 for the 10 mg dose), for both dosages.

- Greater improvements in global function were observed in patients at both donepezil doses, compared to patients who received placebo (p = 0.004 for the 5 mg dose; p = 0.047 for the 10 mg dose; p = 0.008, overall), as measured by the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC-plus). A trend toward slowing functional deterioration was observed in patients treated with both doses of donepezil compared with placebo dose (p = 0.109 for the 5 mg dose; p = 0.054 for the 10 mg dose), as measured by the Alzheimer's Disease Functional Assessment and Change Scale (ADFACS).

The overall safety profile of Aricept in this study was consistent with the clinical experience in patients with AD. Nearly 80 per cent of all patients completed the study, demonstrating that donepezil is well tolerated, even in a population of elderly patients who are simultaneously being treated for cerebrovascular disease. Overall adverse events did not differ significantly in frequency between patients receiving Aricept (90.4 per cent for 5 mg patients; 91.6 per cent for 10 mg patients) and those on placebo (86.5 per cent). Rates of cardiovascular events were also similar among all study participants (19 percent for 5 mg; 20 per cent for 10 mg group; 22 per cent for placebo). Other adverse events that occurred significantly more often in Aricept- treated patients were accidental injury, insomnia, leg cramps, rhinitis, and abnormal dreams. No deaths were considered to be related to Aricept.

Canada's first and longest available treatment for AD
Aricept was approved by Health Canada in 1997 for the treatment of mild to moderate AD and is the number one prescribed Alzheimer's medication in the world. It is available by prescription in 44 countries, including Canada, the United States, the United Kingdom and other European countries. To date, the number of patient days has surpassed one billion worldwide.

Discovered by the Japanese pharmaceutical firm Eisai, Aricept is marketed in Canada by Pfizer Canada Inc.

Aricept is a trademark of Eisai Co., Ltd. Pfizer Canada Inc., licensee.

References:

1. Wilkinson, D. et al. Donepezil in vascular dementia: a randomized, placebo-controlled study.

2. Dubois MF, Hébert R. The Incidence of Vascular Dementia in Canada: A Comparison with Europe and East Asia Neuroepidemiology 2001;20:179-187

3. National Stroke Association. Recovery & Rehab: Vascular Dementia and Stroke Fact Sheet. Available at http://www.stroke.org/recov_rehab.cfm. 4. Roman GC, Tatemichi TK, Erkinjuntti T et al. Vascular dementia: Diagnostic criteria for research studies. Report of the NINDS-AIREN International Workshop. Neurology 1993;43:250-260.

5. Alzheimer Society, Alzheimer Disease 'What is Alzheimer Disease'. Available at http://www.alzheimer.ca/english/disease/whatisit- intro.htm

6. Alzheimer Society, Alzheimer Disease '10 Warning Signs'. Available at http://www.alzheimer.ca/english/disease/warningsigns.htm

7. Roman GC, Royall DR. Executive control function: A rational basis for the diagnosis of vascular dementia. Alzheimer Dis Assoc Dosird 1999; 13 (Suppl 3): S69-S80.

8. Datamonitor: Strategic Perspectives 2001: Dementia

9. World Population Prospects: The 2002 Revision. United Nations Report. Presented at Second World Assembly on Ageing - Madrid, Spain 8 - 12 April 2002

10.Merck Manual of Diagnostics and Therapy. Delirium and Dementia. Available at http://www.merck.com/pubs/mmanual/section14/chapter171/171c.htm.


SOURCE: Pfizer Canada Inc

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