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| |  ICVD: Exelon (Rivastigmine) Beneficial In Subcortical Vascular Dementia BASEL, SWITZERLAND -- January 28, 2002 -- Exelon® (rivastigmine) improves various aspects of mental functioning and behavior in individuals with subcortical vascular dementia, according to a study (1) presented today at the Second International Congress on Vascular Dementia in Salzburg, Austria. Exelon is currently approved for treatment of mild to moderate Alzheimer’s disease, and is under investigation for the treatment of vascular dementia. "This is the first study to evaluate the safety and efficacy of Exelon in patients with subcortical vascular dementia, a condition for which there are currently few therapeutic options," said Rita Moretti, MD, lead author of the study and a neurologist at Cattinara Hospital at the University of Trieste in Italy. "These initial findings are very promising because they showed that Exelon provided broad, significant and sustained improvements in these patients, and also reduced stress levels among the patients’ caregivers," she said. Subcortical vascular dementia is one of the major types of vascular dementia which is due to poor blood circulation in the subcortical area of the brain. It refers to a decline in mental functioning that interferes with the ability to perform routine activities. Vascular dementia is the second most common cause of dementia, accounting for about 20 percent of all cases by itself and up to another 20 percent in combination with Alzheimer’s disease. Alzheimer’s disease is the leading cause of dementia, accounting for about 50 percent of all cases. Vascular dementia usually affects people between the ages of 60 and 75 and is slightly more common in men than in women. In the study, ten men and six women diagnosed with subcortical vascular dementia were randomly assigned to be treated with either Exelon (3 mg/day, increased to 6 mg/day over four weeks) or cardioaspirin for 22 months (results after 12 months have previously been reported [2]). At the beginning and end of the study, patients were given a variety of standard tests to assess various aspects of cognitive function, the ability to perform daily living activities, behavioral symptoms (e.g., mood, delusions and hallucinations), caregiver stress level, and side effects. By the end of the study, the Exelon group showed significant improvement in "executive function," a type of cognitive function related to the ability to plan and organize, and in behavioral symptoms, compared to baseline (p < 0.01 and p < 0.05, respectively) and compared to the control group (p < 0.001 and p < 0.01, respectively). The improvements in the Exelon patients were reflected in the lower stress levels among their caregivers by the end of the study (p < 0.05 vs. baseline, p < 0.01 vs. caregivers of control patients). On average, all the other measures were maintained at baseline levels among patients given Exelon. By contrast, control patients showed no improvements on any of the tests, and showed significant deterioration over baseline in executive function and Clinical Dementia Rating (both p < 0.05). "Deterioration in executive function and behavior are cardinal features of subcortical vascular dementia," said Dr. Moretti. "Therefore, assessing them was particularly relevant in this study, and the improvements we observed suggest Exelon is beneficial in treating the disease," she said. Side effects in both groups were well tolerated, with transitory nausea the most frequently reported in both groups. No patient withdrew from either group before the end of the study and no serious adverse events were reported. No specific or organic cardiac problems were reported. Although patients were allowed to continue any previous medication, no side effects that might be related to drug interactions were reported. Although its exact causes are not understood, Alzheimer’s disease and vascular dementia are associated with a decline in the ability to transmit signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine. Exelon is unique because it works in treating Alzheimer’s disease by inhibiting the two key enzymes involved in breaking down acetylcholine - acetylcholinesterase and butyrylcholinesterase - thus preventing the breakdown of the neurotransmitter and prolonging its action. Other drugs used to treat Alzheimer’s disease, such as donepezil and galantamine, inhibit acetylcholinesterase but not butyrylcholinesterase. Recent research suggests that butyrylcholinesterase may play an increasingly important role in regulating acetylcholine levels as Alzheimer’s disease progresses, and that the dual inhibitory action of Exelon may provide greater and more sustained efficacy in treating patients with the disorder (3). References: (1) Moretti R, Torre P, Antonello RM, Cazzato G. Rivastigmine is safe and effective for at least 22 months in patients with subcortical vascular dementia. Abstract number 37. Presented at: The Second International Congress on Vascular Dementia, Salzburg, Austria, January 25, 2002. (2) Moretti R, Torre P, Antonello RM, Cazzato G. Rivastigmine. In subcortical vascular dementia: a comparison trial on efficacy and tolerability for 12 months follow up. Eur J Neurol 2001;8:361-2. (3) Ballard CG. Advances in the treatment of Alzheimer’s disease: benefits of dual cholinesterase inhibition. Eur Neurol 2002;47:64-70. SOURCE: Novartis
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