中山醫學大學機構典藏 CSMUIR:Item 310902500/23717
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    jsp.display-item.identifier=請使用永久網址來引用或連結此文件: https://ir.csmu.edu.tw:8080/ir/handle/310902500/23717


    题名: Effectiveness of the 10 cm(2) Rivastigmine Patch in Taiwanese Patients with Mild-to-Moderate Alzheimer's Dementia: A 48-Week Real-World Observational Study
    作者: Chang, CC;Chan, L;Chou, HH;Yang, YW;Chen, TF;Chen, TB;Chen, CI;Yang, A;Hu, CJ
    关键词: Alzheimer's disease;Cognitive function;Rivastigmine patch
    日期: 2021
    上传时间: 2022-08-05T09:41:45Z (UTC)
    出版者: SPRINGER
    ISSN: 0741-238X
    摘要: Introduction The current study aimed to provide data on the effectiveness of the 10 cm(2) rivastigmine patch in patients with Alzheimer's disease (AD) in a real-world setting in Taiwan. Methods This was a 48-week, single-arm, open-label, observational, and post-marketing study conducted across seven centers in Taiwan between May 5, 2016 and July 10, 2017. Eligible patients (aged 55-95 years) treated with the 10 cm(2)rivastigmine patch were enrolled based on physicians' judgment and according to the Taiwan reimbursement criteria of the drug. Data were prospectively collected at Week 0 (baseline), Week 24, and Week 48. The primary endpoint was the change in the cognitive assessment screening instrument (CASI) scores at Week 48 versus baseline. The changes from baseline in clinical dementia rating (CDR), mini-mental state examination (MMSE), and neuropsychiatric inventory (NPI) scores were evaluated, as were treatment persistence and the safety profile. Results Of the 285 eligible patients [full analysis set (FAS)], 216 (75.8%) completed the study protocol while 180 (63.2%) persisted on the 10 cm(2) rivastigmine patch for the full 48 weeks. At baseline, 89.8% of patients had a CDR score of 0.5 or 1, while the change in CDR score at Week 48 was not significant. In the FAS, both the CASI and MMSE scores had numerical improvement at Week 24 but declined by 2.1 and 0.4 points, respectively, at Week 48 (p = 0.005 and p = 0.022). The increment in NPI scores was not significant. The most common drug-related adverse events (AEs) were pruritus (11.2%), nausea (3.5%), rash (3.2%), and vomiting (2.8%). Conclusions The use of the 10 cm(2) rivastigmine patch in the mild stage of AD maintained cognitive function at Week 24 and neuropsychiatric function at Week 48. The treatment persistency and safety profile support the clinical tolerability of the rivastigmine patch in the management of mild-to-moderate AD in Taiwan.
    URI: http://dx.doi.org/10.1007/s12325-021-01893-6
    https://www.webofscience.com/wos/woscc/full-record/WOS:000694791800001
    https://ir.csmu.edu.tw:8080/handle/310902500/23717
    關聯: ADVANCES IN THERAPY ,2021,v38,issue 10, P5286-5301
    显示于类别:[中山醫學大學研究成果] 期刊論文

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