Some news concerning PFE's Alzheimer drug:
April 16, 1998 12:51 PM
CANADA NEWSWIRE PFIZER CANADA INC. Canadian Investigators Announce Results of Largest Single Trial of a Treatment for Alzheimer's Disease
Nine-nation study confirms ARICEPT provides
significant improvement in cognition and global functioning for those with mild to moderate Alzheimer's disease
GENEVA, (Switzerland) April 16 /CNW/ - Results
announced today from the largest single trial of an
Alzheimer's disease treatment ever conducted, confirm
the benefits of ARICEPT_ (donepezil) in the
improvement of cognition, global functioning and
activities of daily living among patients with mild to
moderate Alzheimer's disease. ARICEPT is the first and
only drug approved in Canada for the symptomatic
treatment of mild to moderate Alzheimer's disease.
The results of the study are being presented for the first
time by Canadian principal investigator, Dr. Serge G.
Gauthier, Professor at the Departments of Neurology
and Neurosurgery, Psychiatry, and Medicine, McGill
University, at the 5th International Geneva/Springfield
Symposium on Advances in Alzheimer Therapy, in
Geneva, Switzerland.
''This study documents a significant beneficial effect we
have already observed with ARICEPT in clinical
practice on the overall functioning of patients in their
everyday activities,'' said Dr. Gauthier. ''Patients treated
with a once-a-day dose of 10 mg versus placebo
showed significant improvements in the more complex
activities of daily living scores.''
The 30-week study included 82 clinical centres in nine
countries: Canada (8 centres), Australia, Belgium,
France, Germany, Ireland, New Zealand, South Africa
and the United Kingdom. In all, 818 patients were
randomized to receive placebo, 5 mg or 10 mg of
ARICEPT a day (approximately 270 per treatment
group) for 24 consecutive weeks, followed by a
six-week period during which all patients received
placebo.
All patients were assessed for cognitive function, global
function and activities of daily living. Cognitive function
was measured using the Alzheimer's Disease
Assessment Scale-Cognitive Subscale (ADAS-cog).
Global function was measured based on Clinicians
Interview-Based Impression of Change with caregiver
input (CIBIC plus) and Clinical Dementia Rating-Sum of
Boxes (CDR-SB). Activities of daily living were also
measured using the Interview for Deterioration of Daily
Living Activities in Dementia Scale (IDDD), including
Total Score, Self-Care Score and Complex Activities
Score.
Key study results at 24 weeks being presented by Dr.
Gauthier are:
- Patients in the groups receiving 5 mg or 10 mg once a day exhibited mean improvements over placebo of 1.48 and 2.92 respectively for ADAS-cog.
- Clinically and statistically significant improvements in global function were demonstrated. Twenty-one percent of the 5 mg a day and 25 percent of the 10 mg a day ARICEPT-treated patients improved (CIBIC plus < or equal 3 at endpoint) compared to 14 percent in the placebo group.
- Significant improvements were observed in the IDDDComplex Activites Scores for patients receiving 10 mg of ARICEPT a day versus placebo.
''The positive impact and benefits of ARICEPT are
demonstrated by the patients' interaction with their
caregivers and families,'' said study investigator Dr.
William D. Molloy, Director, Geriatric Research Group
and Memory Clinic, Henderson Hospital and Associate
Professor of Medicine, McMaster University, Hamilton,
Ontario.
''Seeing patients taking part again in discussions and
even decisions, is evidence of the clinical benefit on daily
living and quality of life,'' added Dr. Gauthier. ''Some
patients return to fairly complex activities they had
abandoned for over a year, including hobbies such as
knitting or playing cards.''
The study confirms that ARICEPT is well tolerated with
86 percent of ARICEPT-treated patients enrolled in the
trial having completed their participation compared to 90
percent for the placebo group. ARICEPT had no
clinically important effect on vital signs, hematology of
clinical biochemistry tests and none of the hepatotoxicity
complications observed with other agents.
''ARICEPT has a beneficial effect on the symptoms of
Alzheimer's disease,'' said Dr. Howard Feldman, an
investigator for the study and Clinical Associate
Professor of Medicine at the University of British
Columbia, Vancouver. ''When it was discontinued
during the six-week washout period, ARICEPT-treated
patients' cognitive and overall function declined to levels
close to those of placebo-treated patients. The decision
to stop treatment with ARICEPT will consequently need
to be carefully considered. How individuals will respond
to rechallenge with ARICEPT is not fully understood.''
The Geneva/Springfield Symposium on Advances in
Alzheimer Therapy, where the results are being unveiled,
is the 5th such international meeting since 1988,
organized by the School of Medicine of Southern Illinois
University, Springfield, Illinois. This year's meeting is
organized jointly with the Department of Geriatrics of the
Geneva University Hospital and the World Health
Organization (WHO), headquartered in Geneva.
Alzheimer's disease affects approximately 200,000
Canadians. By the year 2030, this is expected to rise to
half a million. Alzheimer's disease places profound
emotional and financial burdens on patients, their
caregivers and society at large. It costs the healthcare
system over $3 billion a year. While it affects primarily
the elderly, Alzheimer's disease is not a normal part of
aging. It is a progressive and ultimately fatal disease that
robs a person's memory and their ability to think,
communicate and take care of themselves.
ARICEPT has been available in Canada since August
1997 when it was approved by the Health Protection
Branch of Health Canada.
Pfizer Canada is responsible for developing and
marketing ARICEPT in Canada. ARICEPT is also
approved in the U.S., the U.K. and in other European
countries. Pfizer formed a strategic alliance with the
Japanese pharmaceutical firm Eisai Co. Ltd. to develop
ARICEPT, which was discovered by Eisai, and to
conduct further Alzheimer research.
Pfizer Canada Inc. is the Canadian operation of Pfizer
Inc, a research-based, diversified healthcare company
with global operations. Pfizer is dedicated to helping
people lead longer, healthier and more productive lives.
Pfizer Canada has over 900 employees across the
country and is headquartered in Kirkland, Quebec.
For further information: Don Sancton, Associate
Director, Corporate Affairs, Pfizer Canada Inc.,
(514) 426-7063 or Robert McCoy/Sylvie Tessier,
NATIONAL PharmaCom, (514) 843-2323/843-2051
12:36 ET
CNW 12:33E 16-APR-98 |
