To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Canada Approves Reminyl (Galantamine) For Alzheimer's Disease URL: http://www.pslgroup.com/dg/202726.htm Doctor's Guide August 1, 2001
TORONTO, ON -- August 1, 2001 -- The Therapeutic Products Directorate of Health Canada has approved Reminyl™ (galantamine hydrobromide), for treatment of the symptoms of mild to moderate Alzheimer's disease. This neurological disorder affects more than 238,000 Canadians over age 65(1). Clinical trials have consistently shown that galantamine, derived from daffodil bulbs, produces significant and sustained benefits in global functioning and cognition (memory, attention and decision making abilities). It has been shown to reduce caregiver burden and may keep patients in their homes longer(2,3). It is also the first new treatment shown to delay the emergence of behavioural disturbances in mild to moderate Alzheimer's disease(4).
Galantamine is postulated to have a dual mechanism of action. Like other treatments available, galantamine inhibits the enzyme acetylcholinesterase, which is responsible for the breakdown of the neurotransmitter acetylcholine, a brain chemical believed to be critical to memory and learning(5). This helps to compensate for the lower levels of acetylcholine in Alzheimer's disease.
Unlike other treatments, however, Reminyl also appears to enhance the response of nicotinic receptors to acetylcholine(6,7,8). It is thought that by acting on these receptors, Reminyl increases the release of acetylcholine(6,7,8).
"We are very pleased that, for the first time, doctors will be able to offer a new approach that appears to target the nicotinic receptors, while improving memory, learning, attention and concentration," said Dr. Alain Robillard, MD, Neurologist at Maisonneuve-Rosemont Hospital in Montreal." Galantamine offers new hope for improving the quality of life for patients, their families and caregivers."
Dr. Jane Rylett, a leading researcher on cholinergic neurobiology and a professor of physiology, pharmacology and toxicology at the University of Western Ontario, adds: "Identifying the brain's nicotinic receptors as a potential therapeutic target in the treatment of Alzheimer's disease marks an exciting new milestone in Alzheimer's disease research. Unlike other treatments currently available, galantamine is believed to have an effect on the nicotinic receptors. It is thought that this causes the release of more acetylcholine, which we know is important for learning and memory."
Research published in Neurology and the British Medical Journal has demonstrated that galantamine may benefit cognition and activities of daily living (including patients' abilities to wash, feed and dress themselves)(3,4,12). In fact, research has shown that these benefits can be sustained for at least one year (3). As a result, galantamine-treated patients may be better able to maintain language use, attention span and short- term memory recall, as well as to understand their surroundings.
"The goal of therapy is to maintain the level of functioning that an Alzheimer's patient has at the time of diagnosis," said Sandra E. Black, MD, head of neurology at Sunnybrook and Women's College Health Sciences Centre in Toronto.
Clinical trials show that galantamine may delay the emergence of behavioural disturbances associated with Alzheimer's disease, including apathy, agitation, aggression, delusions, hallucinations and lack of inhibition (4).
"The behavioural disturbances associated with the progression of Alzheimer's disease are not always emphasized enough, despite being common," said Dr. Black. "In fact, over 90 per cent of patients may experience behavioural disturbances, such as apathy, aggression and agitation at some point during their illness."
"Behavioural symptoms associated with Alzheimer's disease can cause caregiver distress and are a primary contributor to the decision to admit loved ones to institutional care," added Dr. Black. "Galantamine's impact on cognitive and behavioural symptoms may relieve caregiver burden and help keep patients in their homes."
Caregiver burden is a term used to describe the physical, emotional and social costs of caring for an elderly person with long-term health problems or physical limitations. These may include fatigue, stress-related physical health complaints and depression (9).
Results of a placebo-controlled, double-blind trial (presented at the 7th International World Alzheimer Congress, Washington, DC, July 9 - 18, 2000) showed that over a six-month period, when compared to placebo, galantamine reduced the time that caregivers needed to spend supervising patients or assisting them with activities of daily living by up to one hour per day (2).
Reminyl will be available nationwide in September 2001.
References:
2. Wilcock G, Gaens E, Walschap Y, et al. Efficacy, tolerability and safety of galantamine 12 and 16 mg b.i.d. versus placebo in the treatment of Alzheimer's Disease. Janssen Clinical Research Report N134124 (GAL-INT-1), January 999.
3. Raskind M A, et al. Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. Neurology 2000; 54:2261-2268.
4. Tariot P N, et al. A 5-month, randomized, placebo-controlled trial of galantamine in AD Neurology 2000; 54:2269-2276
5. A definition for acetylcholine can be found on the following website: http://www.alz.org/glossary.htm.
6. Schrattenholz A, et al. Agonist Responses of Neuronal Nicotinic Acetylcholine Receptors Are Potentiated by Novel Class of Allosterically Acting Ligands. Molecular Pharmacology
7. 1996; 49:1-6.
8. Maelicke A, et al. Allosteric modulation of nicotinic acetylcholine receptors as a treatment strategy for Alzheimer's disease. European Journal of Pharmacology 2000; 393:165-170.
9. Based on in vitro data; clinical relevance unknown.
10. Chwallsz K. Perceived Stress and Caregiver Burden after Brain Injury: A Theoretical Integration. Rehabilitation Psychology 1992; 37 (3):189-203.
11. The Aluminum Association Alzheimer's Disease Survey, Public Opinion Strategies, 1997.
12. Ostbye T and Crosse E. Net economic costs of dementia in Canada. Can Med Assoc J 1994; 151 (10):1457-64.
13. Wilcock GK, et al. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. British Medical Journal 2000; 321:1-7.