Han S-H, Lee J-H, Kim S Y, Park K W, Chen C, Tripathi M, Dash A, Kubota N
Department of Neurology, Konkuk University Hospital, Seoul, South Korea.
Department of Neurology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Acta Neurol Scand. 2017 Feb;135(2):252-256. doi: 10.1111/ane.12571. Epub 2016 Feb 29.
Ethnic diversity between different populations may affect treatment safety and efficacy.
A subanalysis to a global trial (study 326) was carried out to ascertain the safety and efficacy of donepezil 23 mg/day compared with donepezil 10 mg/day in Asian patients with moderate-to-severe Alzheimer's disease. Changes in cognition and global functioning were measured by the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), respectively, at week 24.
Cognitive improvement measured by SIB score was greater with donepezil 23 mg than with donepezil 10 mg (+1.36 vs -1.56]; difference, 2.92). There was no difference between the groups in global function measured by the CIBIC-Plus (3.94 and 3.95, respectively). Overall, 119 patients (82.1%) receiving donepezil 23 mg and 56 (71.8%) receiving donepezil 10 mg experienced ≥1 treatment emergent adverse events (TEAEs). In the donepezil 23 mg group, the incidence of TEAEs was higher among patients of lower weight (<55 kg) at baseline than in those of higher weight (64 of 75 patients [85.3%] vs 55 of 70 patients [78.5%]).
The benefits and risks associated with donepezil 23 mg in Asian patients are comparable to those of the global study population.
不同人群之间的种族差异可能会影响治疗的安全性和有效性。
对一项全球试验（研究326）进行亚组分析，以确定每日23毫克多奈哌齐与每日10毫克多奈哌齐相比，在亚洲中重度阿尔茨海默病患者中的安全性和有效性。在第24周时，分别通过严重损害量表（SIB）和基于临床医生访谈的变化印象加照顾者意见（CIBIC-Plus）来测量认知和整体功能的变化。
用SIB评分衡量，23毫克多奈哌齐组的认知改善程度大于10毫克多奈哌齐组（分别为+1.36和 -1.56；差异为2.92）。两组在通过CIBIC-Plus测量的整体功能方面没有差异（分别为3.94和3.95）。总体而言，接受23毫克多奈哌齐治疗的119名患者（82.1%）和接受10毫克多奈哌齐治疗的56名患者（71.8%）经历了≥1次治疗中出现的不良事件（TEAE）。在23毫克多奈哌齐组中，基线体重较低（<55千克）的患者中TEAE的发生率高于体重较高的患者（75名患者中的64名[85.3%]对70名患者中的55名[78.5%]）。
在亚洲患者中，23毫克多奈哌齐的获益和风险与全球研究人群相当。
