التفاصيل البيبلوغرافية
| العنوان: |
Efficacy and Safety of Sustained Release Donepezil High Dose versus Immediate Release Donepezil Standard Dose in Japanese Patients with Severe Alzheimer's Disease: A Randomized, Double-Blind Trial. |
| المؤلفون: |
Akira Homma, Hirotsugu Atarashi, Naoki Kubota, Kenya Nakai, Takao Takase, Homma, Akira, Atarashi, Hirotsugu, Kubota, Naoki, Nakai, Kenya, Takase, Takao |
| المصدر: |
Journal of Alzheimer's Disease; 2016, Vol. 52 Issue 1, p345-357, 13p |
| مصطلحات موضوعية: |
DONEPEZIL, ALZHEIMER'S disease risk factors, JAPANESE people, CHOLINESTERASE inhibitors, ENZYME inhibitors, DISEASES, ALZHEIMER'S disease, COMPARATIVE studies, CONTROLLED release preparations, HYDROCARBONS, NEUROPSYCHOLOGICAL tests, RESEARCH methodology, MEDICAL cooperation, NOOTROPIC agents, PIPERIDINE, PSYCHOLOGICAL tests, RESEARCH, EVALUATION research, TREATMENT effectiveness, BLIND experiment, SEVERITY of illness index |
| مصطلحات جغرافية: |
JAPAN |
| مستخلص: |
Background: Donepezil is an established treatment for mild, moderate, and severe Alzheimer's disease (AD). An international study demonstrated superior efficacy of sustained release (SR) 23 mg/day donepezil over immediate release (IR) 10 mg/day donepezil for cognitive function, but not global function in moderate-to-severe AD.Objective: To demonstrate the superiority of SR 23 mg/day donepezil over IR 10 mg/day donepezil in Japanese patients with severe AD (SAD).Methods: In this multicenter, randomized, double-blind, parallel-group study, Japanese outpatients with SAD were randomly assigned to continue IR 10 mg/day or switch to SR 23 mg/day for 24 weeks. Endpoints included the Severe Impairment Battery (SIB), Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus), and safety.Results: Overall, 166 and 185 patients were randomized to receive IR 10 mg/day and SR 23 mg/day, respectively. SR 23 mg/day was not statistically superior to IR 10 mg/day by SIB (least squares mean difference [LSMD]: 0.0; 95% confidence interval [CI]: -1.7, 1.8; p = 0.981) or CIBIC-plus (LSMD: 0.2; 95% CI: 0.0, 0.4; p = 0.080). Common adverse events in the SR 23 mg group were decreased appetite, vomiting, diarrhea, and contusion. Safety findings were consistent with known safety profiles of donepezil.Conclusion: SR 23 mg/day donepezil was not superior to IR 10 mg/day donepezil regarding the efficacy endpoints for Japanese SAD. Considering that a 10 mg/day dose is approved for SAD in Japan, the present findings suggest that IR 10 mg/day donepezil is the optimal dosage for Japanese patients with SAD. [ABSTRACT FROM AUTHOR] |
|
Copyright of Journal of Alzheimer's Disease is the property of IOS Press and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
