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| |  AAN: Alzheimer's patients taking Aricept (donepezil) maintained daily activities longer SAN DIEGO, CA -- May 5, 2000 -- Aricept(R) (donepezil hydrochloride) treatment maintained function longer compared with placebo in patients with mild-to-moderate Alzheimer's disease, according to one-year data presented today at the American Academy of Neurology's 52nd annual meeting. Aricept, the number one Alzheimer's medication prescribed worldwide, is a clinically proven, once-daily treatment for mild-to-moderate Alzheimer's disease. Results of this study confirmed that patients treated with Aricept for up to one year were more likely to maintain their ability to perform activities of daily living such as dressing, eating meals, handling money, grasping situations or explanations, handling personal mail, using the telephone and doing household tasks. Aricept is the only Alzheimer's disease drug in the cholinesterase inhibitor class with two one-year, placebo-controlled trials. "These findings provide evidence that median time to functional loss is longer in patients who are treated with Aricept than those treated with placebo in a one-year clinical trial," said John C. Morris, MD, professor of neurology, Washington University School of Medicine in St. Louis. "For patients, this means that they are more likely to be able to continue to enjoy everyday activities longer than without medication." During the double-blind, placebo-controlled study, researchers evaluated the time to reach clinically significant decline in function in patients with Alzheimer's disease taking Aricept (donepezil hydrochloride) compared with placebo. Patients who met predetermined criteria for clinically significant decline in function were discontinued from the study and were given the option to receive open-label Aricept. These criteria included a decline in the patient's ability to perform one or more basic activities of daily living; a reduction of 20 percent in ability to perform one or more instrumental activities of daily living, such as preparing meals and using household appliances; or a one-point increase in the global Clinical Dementia Rating, a clinically validated measure of disease severity. Of the 431 patients, 214 took 10 mg of Aricept once daily, and the other 217 patients took placebo. Assessments of patient function were conducted at baseline and at six-week intervals for 54 weeks. At 48 weeks, patients taking Aricept had a 51 percent likelihood of maintaining function compared with a 35 percent likelihood for those on placebo. In addition, the estimated time it took for half of the patients on Aricept(R) to lose function (median time = 357 days) was 72 percent longer than the time it took for half of those on placebo (median time = 208 days). "This study shows that treatment with Aricept may help maintain function in patients with mild-to-moderate Alzheimer's disease," said Dr. Morris. "In general, people should be proactive and see a doctor when they see signs of increased forgetfulness, trouble finding words and asking repeated questions in a friend or family member." In this one-year study, the most frequent treatment-emergent adverse events for Aricept(donepezil hydrochloride) versus placebo included: headache (9 percent vs 3 percent for placebo); abrasion (8 percent vs 3 percent); accidental injury (6 percent vs 3 percent); diarrhea (17 percent vs 5 percent); dyspepsia (6 percent vs 1 percent); nausea (9 percent vs 4 percent); anorexia (6 percent vs 2 percent); insomnia (8 percent vs 3 percent); urinary tract infection (13 percent vs 6 percent). Results of this study were originally presented in London at the 12th European College of Neuropsychopharmacology Congress in September 1999. These findings complement data from another one-year trial (referred to as the Nordic Study, see AAN oral presentation S79.006). Results of that randomized double-blind, placebo-controlled trial demonstrated that Aricept's beneficial effects on cognition are maintained over one year in patients with mild-to-moderate Alzheimer's disease. Although Alzheimer's disease is incurable, medical treatment is available to manage some of the symptoms. Once-daily Aricept tablets, for example, can improve cognition and maintain patient function in people with mild-to-moderate Alzheimer's disease. In controlled clinical trials of up to six months, more than 80 percent of patients taking Aricept experienced a best change score of improved cognition or no further decline compared with 58 percent of patients on placebo. These findings are based on the best score achieved on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) for each patient from week 12 through week 24 of the study. In a progressively degenerative disease such as Alzheimer's, no further decline or a less than expected decline is considered a favorable response. Improvement, stabilization, and decline have been observed in patients treated with Aricept (donepezil hydrochloride) in clinical trials. Individual responses to Aricept treatment may vary. To date, more than one million people in the United States have received a prescription for Aricept, contributing to a total of 314 million days of patient use worldwide. Aricept is well tolerated with a low incidence of side effects, offers convenient once-daily dosing, and can be taken with or without food. In pivotal controlled clinical trials, the most common side effects experienced with Aricept included nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia. These effects were often mild, transient, and resolved with continued treatment. Clinical trials of Aricept have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Nevertheless, cholinesterase inhibitors may be expected to increase gastric acid secretion. Therefore, patients (especially those at increased risk for developing ulcers -- e.g., having a history of ulcer disease, receiving concurrent nonsteriodal anti-inflammatory drugs) should be monitored closely for gastrointestinal bleeding. In pivotal clinical trials, syncopal (fainting) episodes have been reported in association with Aricept (2 percent vs 1 percent for placebo). Aricept is clinically effective at the starting dose of 5-mg/day, and the dose can be escalated to 10-mg/day after four to six weeks if clinically indicated. Currently, Aricept is available by prescription in more than 43 countries. In November 1994, Eisai Co., Ltd. and Pfizer Inc announced the formation of a strategic alliance for the promotion of Aricept (donepezil hydrochloride) and development of new treatments for Alzheimer's disease and other cognitive disorders. First launched in the United States in February 1997, Aricept has been well received in the Alzheimer's disease community and currently is the most widely prescribed Alzheimer's disease medication in the world. Related Link: Aricept (donepezil hydrochloride).
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