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| |  IPA CONGRESS: Aricept Effective, Well-Tolerated For Long-Term Alzheimer's Treatment VANCOUVER, BC -- Aug. 17, 1999 -- Study results evaluating patients with mild to moderately-severe Alzheimer's disease (AD) found that Eisai Co., Ltd.’s and Pfizer Inc.’s once-daily treatment, Aricept(R) (donepezil hydrochloride) had beneficial effects on global and cognitive functioning and activities of daily living over one year. Researchers presented the results of this randomised, double-blind, placebo-controlled trial today at a poster presentation at the ninth congress of the International Psychogeriatric Association. "This is good news for Alzheimer's disease patients and their caregivers world-wide," said Bengt Winblad, M.D., department of clinical neuroscience and family medicine, Karolinska Institute, Sweden. "Aricept offers hope to those looking for well-tolerated and effective, long-term treatment." Patients treated with Aricept showed statistically significant results in global functioning. The Aricept-treated group's mean change from baseline on the Gottfries, Brane and Steen scale (GBS) total score were statistically significantly better at Weeks 24, 36 and 52 compared to the placebo-treated group. Patients treated with Aricept also showed statistically-significant improvement in cognition and activities of daily living compared to placebo. When compared to the placebo-treated group's scores, the Aricept-treated group's average changes from baseline on the Mini-Mental State Examination (MMSE) were statistically significant at Weeks 24, 36 and 52 and Progressive Deterioration Scale (PDS) total scores at Week 52, respectively. This study evaluated the long-term clinical efficacy and tolerability of donepezil versus placebo over one year in patients (average age 72.5 years) with mild to moderately severe Alzheimer's disease (AD). The study recruited 286 patients with possible or probable AD from 28 sites in five Northern European countries (Denmark, Finland, The Netherlands, Norway and Sweden). They were randomised to receive either Aricept or placebo for one year. In this trial, 66.9 percent of Aricept- and 67.4 percent of placebo-treated patients completed the one-year study. Only seven percent of Aricept- and 6.3 percent of placebo-treated patients discontinued due to adverse events. Alzheimer's disease is a progressive, degenerative brain disease that results in cognitive decline, impaired memory, thinking, behaviour changes, loss of language, motor skills and activities of daily living (or self- Aricept is indicated for the symptomatic treatment of mild to moderately-severe dementia of the Alzheimer's type. 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 controlled trials that supported the approval of Aricept, it was found that the drug's most common side effects include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue and anorexia. These effects were often mild, transient and resolved with continued treatment. People at risk for ulcers should inform their doctor when taking Aricept. In clinical trials, syncopal episodes have been reported in patients taking Aricept (two percent versus one 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.
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