摘要
背景:一个24周,前瞻性,随机,平行对照,双盲研究的重度阿尔茨海默病(AD)患者的行为,通过严重障碍量表(SIB)和阿尔茨海默氏病协同的学习-活动-日常生活能力-重度损伤量表(ADCS-ADL-SIV)证明了使用卡巴拉汀片13.3毫克/24小时与4.6毫克/24小时对比下的显著疗效。总体而言, 61%的研究人群接受至少1剂量伴随美金刚,不管剂量或持续时间。本文回顾性分析了13.3毫克/24小时与4.6毫克/24小时卡巴拉汀片的有效性,安全性和耐受性伴随美金刚的影响。方法:患者根据他们是否接收伴随至少一个剂量美金刚治疗进行双盲阶段分类。根据SIB和ADCS-ADL-SIV,已治疗,汇集中心,美金刚的使用和美金刚治疗作为因素,基线作为协变量,对与基线发生的变化,利用协方差(ANCOVA)进行分析。对安全性和耐受性进行了评估。结果:美金刚治疗的患者年龄小于那些没有接受美金刚治疗的患者(平均年龄分别为75.9,78.8年),具有较低的微型精神状态检查筛选(分别为8.6和9.2)。协方差分析证实研究治疗和使用美金刚对SIB或ADCS-ADL-SIV之间没有显著的相互作用(P>0.1)。13.3毫克/24小时片剂与美金刚使用时不良反应的发生率:71.4%; 单独使用13.3毫克/24小时片剂为79.7%; 4.6毫克/24小时片剂与美金刚为74.7%;以及4.6毫克/24小时单独使用片剂为71.1%。结论:这些数据表明,13.3毫克/24小时相比4.6毫克/24小时卡巴拉汀片,都能够起效不论伴随美金刚使用。用高剂量的片剂不良反应的发生率与美金刚治疗的患者和那些没有接受美金刚治疗的相近。
关键词: 行为研究,高剂量,美金刚,利凡斯的明,重度阿尔茨海默氏病,透皮贴剂。
Current Alzheimer Research
Title:Evaluating High-Dose Rivastigmine Patch in Severe Alzheimer’s Disease: Analyses with Concomitant Memantine Usage as a Factor
Volume: 12 Issue: 1
Author(s): George T. Grossberg, Martin R. Farlow, Xiangyi Meng and Drew M. Velting
Affiliation:
关键词: 行为研究,高剂量,美金刚,利凡斯的明,重度阿尔茨海默氏病,透皮贴剂。
摘要: Background: ACTION, a 24-week, prospective, randomized, parallel-group, double-blind study in patients with severe Alzheimer’s disease (AD), demonstrated significant efficacy of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch on the Severe Impairment Battery (SIB) and Alzheimer’s Disease Cooperative Study–Activities of Daily Living scale–Severe Impairment Version (ADCS-ADL-SIV). Overall, 61% of the study population received at least 1 dose of concomitant memantine, regardless of dose or duration. This retrospective analysis investigated the effects of concomitant memantine on the efficacy, safety and tolerability of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch. Methods: Patients were stratified according to whether or not they received at least one dose of concomitant memantine during the double-blind phase. Changes from baseline on the SIB and ADCS-ADL-SIV were compared using analysis of covariance (ANCOVA) with treatment, pooled center, memantine usage and treatment-by-memantine as factors, and baseline as a covariate. Safety and tolerability were assessed. Results: Memantine-treated patients were younger than those not receiving memantine (mean 75.9 and 78.8 years, respectively), with a lower screening Mini-Mental State Examination (8.6 and 9.2, respectively). ANCOVA confirmed there was no significant interaction (p>0.1) between study treatment and memantine use on the SIB or ADCS-ADL-SIV. The incidence of adverse events was: 71.4%, 13.3 mg/24 h patch with memantine; 79.7%, 13.3 mg/24 h patch alone; 74.7%, 4.6 mg/24 h patch with memantine; and 71.1%, 4.6 mg/24 h patch alone. Conclusion: These data suggest benefit of 13.3 mg/24 h versus 4.6 mg/24 h rivastigmine patch, regardless of concomitant memantine use. The incidence of adverse events with highdose patch was similar in memantine-treated patients and those not receiving memantine.
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Cite this article as:
T. Grossberg George, R. Farlow Martin, Meng Xiangyi and M. Velting Drew, Evaluating High-Dose Rivastigmine Patch in Severe Alzheimer’s Disease: Analyses with Concomitant Memantine Usage as a Factor, Current Alzheimer Research 2015; 12 (1) . https://dx.doi.org/10.2174/1567205011666141218122835
DOI https://dx.doi.org/10.2174/1567205011666141218122835 |
Print ISSN 1567-2050 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5828 |
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