Healthcare Industry News:  Alzheimer's 

Biopharmaceuticals Neurology

 News Release - July 30, 2007

Multinational study confirms positive effects of treatment with ARICEPT in patients with severe Alzheimer's disease

ARICEPT is now the first and only treatment approved in Canada for the full spectrum of Alzheimer's disease - mild, moderate and severe MONTREAL, July 30 (Healthcare Sales & Marketing Network) - A multinational study sponsored by Eisai-Pfizer Inc, co-led by a Canadian investigator and featured in the July 31 edition of the journal Neurology(1) indicates that patients entering the severe stage of Alzheimer's disease can show improvement in cognition and global function when treated with ARICEPT(TM) (donezepil HCI tablets).

These results further affirm those from a study published last year in the Lancet(2) indicating positive outcomes for nursing home patients who received treatment with ARICEPT during the severe stage of the disease.

"This study is good news for patients and their caregivers," says Dr. Sandra Black, study leader and Brill Professor of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto (Toronto). "The results provide further evidence and support for physicians that treating advanced-stage patients can make a positive difference. Caregivers who want loved ones to maintain their cognitive abilities as long as possible have a reason to continue or even initiate treatment at the severe stage of this disease."

ARICEPT was approved by Health Canada for the symptomatic treatment of severe Alzheimer's disease on June 28, 2007. For the first time, the thousands of people affected by Alzheimer's disease and the families, caregivers and healthcare professionals who care for them have a once-daily therapy to treat the symptoms in the mild, moderate and severe stages of this devastating disease.

The progress of Alzheimer's disease can vary with each patient. Those entering the severe stage of the disease require assistance to complete simple day-to-day tasks such as eating and dressing. Their ability to communicate with caregivers and families significantly declines and they may be confused and agitated.

"Our results indicated there is measurable improvement in patients who received donezepil in two key outcomes - cognition and global functioning," says Dr. Black. Two well-established diagnostic tools were used to assess baseline capacities and to monitor progress at 8, 16 and 24 weeks. Patients on ARICEPT showed significant improvement in their total scores on the Severe Impairment Battery (SIB). In the Clinical Interview Based Impression of Change - Plus (CIBIC-Plus), significantly more patients taking ARICEPT remained stable or improved compared to those on placebo.

The 24-week study included 343 men and women; 176 who were given ARICEPT (10 mg per day) and the balance received placebo. The study was conducted at 98 sites in Canada, the U.S., the UK, France and Australia in 2006. Patients were living in the community and or assisted-living settings. ARICEPT was generally well-tolerated by patients. The most common adverse effects occurring more frequently in the treatment group were diarrhea, insomnia, nausea, infection, urinary incontinence and pain.

Additional Swedish and Japanese studies affirm value of treatment with ARICPT in severe stage

The Swedish Nursing Home study involved about 200 men and women with severe Alzheimer's disease. Almost half of these patients were treated with ARICEPT for the study period. Of those receiving treatment, between 60 and 80 per cent were able to perform better when given memory, speech and practical tasks to do. Preliminary data from a third study measuring the effectiveness and safety of ARICEPT treatment for the severe stage of Alzheimer's was presented in July 2006 in Madrid. This data(3) was gathered from 66 sites in Japan. The study included 615 people, of which 325 were treated with ARICEPT and 290 were given placebo. The results showed that severe stage patients treated with ARICEPT had significant improvement in cognitive and global functional measures.

Alzheimer's disease in Canada

It is estimated that more than 450,000 Canadians over the age of 65 have Alzheimer's disease or a related dementia approximately a third of whom are in the severe stage. Alzheimer's disease is the most common form of dementia. As greater numbers of Canadians are now reaching the prime age for the onset of the disease symptoms, it is expected that by 2011 new cases of dementia, including Alzheimer's disease, will reach 111,430 per year(4). There is no cure for the disease although treatments can delay the progression of symptoms.

Symptoms of Alzheimer's disease include:

-Progressive loss of memory -Difficulty with concentration -Decrease in problem-solving skills and judgement -Confusion, hallucinations, delusions -Altered sensation of perception; impaired recognition -Impaired skilled motor function, disorientation -Impaired language skills -Personality changes About ARICEPT

ARICEPT(TM) was the first medication approved to treat the symptoms of mild to moderate AD and has been available in Canada since 1997. Today it is the first and only medication approved in Canada for the symptomatic treatment of all stages of Alzheimer's disease: mild, moderate and severe.

While there is no cure for Alzheimer's disease, ARICEPT(TM) can help slow down the progression of symptoms, including memory loss and the ability to perform daily activities. Once-a-day ARICEPT(TM) is indicated for the symptomatic treatment of patients with mild, moderate and severe dementia of the Alzheimer's type. Discovered by the Japanese pharmaceutical firm Eisai, ARICEPT(TM) is marketed in Canada by Pfizer Canada Inc.

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas, including arthritis, cardiovascular disease, endocrinology, HIV/AIDS, infectious disease, neurological disease, oncology, ophthalmology and smoking cessation. For more information, visit www.pfizer.ca.

(1) Black S, Li H, McRae T, Richardson S, et al. Donezepil Treatment of Severe Alzheimer's Disease: Results from a 24-week Multinational, Randomized, Double-Blind, Placebo-Controlled Trial, Neurology (to be confirmed)

(2) Winblad B, Kilander L, Eriksson E, et al. Donezepil in patients with severe Alzheimer's disease: double-blind, parallel-group, placebo- controlled study. Lancet 2006;367(9516): 1057-65.

(3) Homma A, ArimotoI, Daidoji K, Ohbayashi T, Ozawa H Treatment of Severe Alzheimer's Disease with Donezepil: Results from a 24-weeks, Parallel, Placebo-Controlled Study in Japan, Madrid, July 2006

(4) www.alzhiemer.ca Canadians affected by Alzheimer's disease and related dementias.


Source: Pfizer Canada

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