Thursday April 11, 6:30 pm Eastern Time
Press Release
SOURCE: Janssen Pharmaceutica Products, L.P.
In the First Published Report of its Kind, Data Suggest Reminyl(R) Effectively Treats Dementia in Patients with Cerebrovascular Disease
Cerebrovascular Disease Plays a Role in One Out of Every Four Dementia Cases
The following is being issued today by Janssen Pharmaceutica Products L.P.
LONDON, April 11 /PRNewswire/ -- Results of a study published today in The Lancet suggest that Reminyl® (galantamine hydrobromide), the newest approved treatment for mild to moderate Alzheimer's disease, also is effective in treating a broad range of dementia symptoms in individuals with cerebrovascular disease (CVD). It is estimated that in one out of every four individuals with dementia, CVD is a primary cause or contributing factor.(1)
Reminyl is the first Alzheimer's medication for which data in this population have been presented, and now published in a peer-reviewed medical journal. The study results indicate that Reminyl can benefit these patients' cognition (memory, language and reasoning skills), ability to function (perform activities of daily living) and behavior (anxiety, delusions and agitation). The data are being submitted to health authorities worldwide to update the prescribing information; in addition, further studies of patients with vascular dementia (in which cerebrovascular disease is the primary cause of their condition) are underway.
``In the past, there has been no treatment with documented efficacy for these individuals. As a result, they often went untreated,'' says Timo Erkinjuntti, MD, lead author and a faculty member of the Memory Research Unit at the Helsinki University Central Hospital in Finland. ``Research such as this offers persuasive evidence that dementia patients can be helped, even when cerebrovascular disease -- usually one or more strokes -- is present.''
Among the risk factors that can trigger a stroke are uncontrolled diabetes, high blood pressure (hypertension) and abnormal heart rhythm (atrial fibrillation). It is estimated that cerebrovascular disease occurs in 10 to 20 percent of persons with Alzheimer's disease, and contributes to their condition (so-called ``mixed'' dementia).(2) In other individuals, cerebrovascular disease is the primary cause of the decline in their memory and intellectual abilities (vascular dementia).
``It can be very difficult to differentiate between mixed and vascular dementia, so a treatment that can potentially benefit patients with either type of disorder would have great value,'' says Dr. Erkinjuntti. ``Treatment should be initiated early, to provide benefit while diagnostic tests are conducted.''
In the six-month, double-blind, placebo-controlled study published in The Lancet, 592 patients diagnosed with vascular or mixed dementia were assigned to receive 24 mg per day of Reminyl (396) or placebo (196). When overall response to therapy was assessed using a scale called the CIBIC-plus, 75 percent of Reminyl-treated patients remained stable or improved after six months compared with 54 percent of those receiving placebo. Likewise, the proportion of study participants whose ability to think and remember improved or remained stable (as measured by the cognitive portion of the Alzheimer's Disease Assessment Scale) was significantly higher in patients receiving Reminyl than in those taking placebo (63.8 percent vs. 50.6 percent, respectively). On average, the cognitive function of patients taking Reminyl improved, whereas it deteriorated over the course of the study in individuals treated with placebo.
Potential benefit also was demonstrated using two secondary measures of effectiveness. The D.A.D (Disability Assessment in Dementia) scale showed that the ability of the Reminyl-treated group to carry out activities of daily living (such as bathing, dressing and doing housework) was maintained, while it significantly declined among individuals who received placebo. Another scale called the NPI (Neuropsychiatric Inventory) showed that the presence and severity of abnormal behaviors (such as delusions, extreme anxiety and agitation) significantly improved in the group taking Reminyl and worsened in patients who received placebo.
The most frequent side effects reported by patients in this study taking Reminyl were typical of Alzheimer's disease treatments, and included nausea, vomiting, dizziness, diarrhea and insomnia. Most were mild to moderate and short in duration.
Reminyl is thought to inhibit an enzyme that breaks down acetylcholine -- a critical chemical in the brain that plays a key role in memory and learning. In addition, it is believed that Reminyl modulates the brain's nicotinic receptors, to which acetylcholine binds. Laboratory research suggests that through this action, Reminyl stimulates greater release of the chemical. However, the significance of this finding in humans is currently unknown and further research is underway.
Reminyl was developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. Marketed in the U.S. by Janssen Pharmaceutica Products, L.P., the product is approved for the treatment of mild to moderate Alzheimer's disease in 30 countries. Reminyl also is being studied in individuals with vascular dementia and mild cognitive impairment (believed to be a precursor to Alzheimer's disease in some patients). More information on the product, including full prescribing information, can be found on reminyl.com.
Note to Editors:
Reminyl received marketing approval from the U.S. Food and Drug Administration in February 2001 for the treatment of mild to moderate Alzheimer's disease. Reminyl is available in 4 mg, 8 mg or 12 mg tablets, as well as oral solution (4mg/ml), and should be taken by patients twice a day, preferably with the morning and evening meals. The recommended starting dose is 8 mg of Reminyl per day, with an increase to 16 mg daily after four weeks. Physicians have the flexibility to increase the daily dose to 24 mg after an additional four weeks.
Reminyl was developed by Johnson & Johnson Pharmaceutical Research & Development, LLC, under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals Group plc. J&J PRD supported this study and collaborated with the authors on study design, collection of data and interpretation of the findings.
Janssen Pharmaceutica Products, L.P., is a wholly owned subsidiary of Johnson & Johnson (NYSE: JNJ - news) with a long track record in developing and marketing treatments for central nervous system disorders. Other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at us.janssen.com.
Shire Pharmaceuticals Group, plc, is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology and gastroenterology. The group has a sales-and-marketing infrastructure, with a broad portfolio of products, and its own direct-marketing capability in the United States, Canada, UK, Republic of Ireland, France, Germany, Italy and Spain, with plans to add Japan by 2004. Shire also covers the other significant pharmaceutical markets indirectly through distributors. On Dec. 11, Shire entered into an agreement to merge with BioChem Pharma Inc. to form a leading global specialty pharmaceutical company. More information on the company can be found at shire.com.
(1) Neurology in Clinical Practice, 3rd edition, Bradley WG, Daroff RB,
et al ed, page 1721.
(2) Data on file, and Kaplan & Sadock's Comprehensive Textbook of
Psychiatry (7th edition 2000).
SOURCE: Janssen Pharmaceutica Products, L.P. |
