Park Kee Hyung, Yang YoungSoon, Chen Christopher, Shim Yong S, Domingueze Jacqueline C, Lee Chan Nyoung, Kang Kyunghun, Kim Hee Jin, Jeong Seul Ki, Jeong Jee Hyang, Hong Zhen, Yoon Soo Jin, Zhang Zhen Xin, Kim Eun Joo, Jang Jae Won, Li Yansheng, Xu Yun, Lin Yu Te, Qu Qiumin, Hu Chaur Jong, Chou Chih Ho, Fan Dongsheng, Kandiah Nagaendran, Yang Yuan Han, Lau Chi Ieong, Chu Leung Wing, Wang Huali, Jung San, Choi Seong Hye, Kim SangYun
Department of Neurology, College of Medicine, Gachon University Gil Hospital, Incheon, Korea.
Department of Neurology, Soonchunhyang University of College of Medicine, Cheonan Hospital, Cheonan, Korea.
J Clin Neurol. 2021 Jul;17(3):376-384. doi: 10.3988/jcn.2021.17.3.376.
The rate of donepezil discontinuation and the underlying reasons for discontinuation in Asian patients with Alzheimer's disease (AD) are currently unknown. We aimed to determine the treatment discontinuation rates in AD patients who had newly been prescribed donepezil in routine clinical practice in Asia.
This 1-year observational study involved 38 institutions in seven Asian countries, and it evaluated 398 participants aged 50-90 years with a diagnosis of probable AD and on newly prescribed donepezil monotherapy. The primary endpoint was the rate of donepezil discontinuation over 1 year. Secondary endpoints included the reason for discontinuation, treatment duration, changes in cognitive function over the 1-year study period, and compliance as assessed using a clinician rating scale (CRS) and visual analog scale (VAS).
Donepezil was discontinued in 83 (20.9%) patients, most commonly due to an adverse event (43.4%). The mean treatment duration was 103.67 days in patients who discontinued. Among patients whose cognitive function was assessed at baseline and 1 year, there were no significant changes in scores on the Mini-Mental State Examination, Montreal Cognitive Assessment, and Trail-Making Test-Black and White scores, whereas the Clinical Dementia Rating score increased significantly (<0.001). Treatment compliance at 1 year was 96.8% (306/316) on the CRS and 92.6±14.1% (mean±standard deviation) on the VAS.
In patients on newly prescribed donepezil, the primary reason for discontinuation was an adverse event. Cognitive assessments revealed no significant worsening at 1 year, indicating that continuous donepezil treatment contributes to the maintenance of cognitive function.
目前尚不清楚亚洲阿尔茨海默病（AD）患者中多奈哌齐停药率及停药的潜在原因。我们旨在确定在亚洲常规临床实践中开始新使用多奈哌齐治疗的AD患者的治疗停药率。
这项为期1年的观察性研究涉及7个亚洲国家的38个机构，评估了398名年龄在50 - 90岁之间、诊断为可能的AD且开始新使用多奈哌齐单药治疗的参与者。主要终点是1年内多奈哌齐停药率。次要终点包括停药原因、治疗持续时间、1年研究期间认知功能的变化，以及使用临床医生评定量表（CRS）和视觉模拟量表（VAS）评估的依从性。
83例（20.9%）患者停用了多奈哌齐，最常见的原因是不良事件（43.4%）。停药患者的平均治疗持续时间为103.67天。在基线和1年时进行认知功能评估的患者中，简易精神状态检查表、蒙特利尔认知评估量表以及连线测验 - 黑白版得分无显著变化，而临床痴呆评定量表得分显著增加（<0.001）。1年时CRS评定的治疗依从性为96.8%（306/316），VAS评定的依从性为92.6±14.1%（平均值±标准差）。
在新使用多奈哌齐治疗的患者中，停药的主要原因是不良事件。认知评估显示1年时无显著恶化，表明持续使用多奈哌齐治疗有助于维持认知功能。
