Department of Neurology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.
Curr Med Res Opin. 2010 Feb;26(2):263-9. doi: 10.1185/03007990903434914.
To investigate the tolerability and efficacy of the rivastigmine transdermal patch in patients with mild-to-moderate Alzheimer's disease receiving concomitant memantine.
Post hoc analysis of a 25-week, randomized, prospective, open-label, parallel-group study. Patients receiving donepezil were switched to rivastigmine patches (4.6 mg/24 h) immediately or following a 7-day withdrawal for 4 weeks (core phase), before titrating up to 9.5 mg/24 h for a further 20-week extension phase. Prior memantine therapy was continued throughout.
Tolerability (adverse events [AEs], serious AEs [SAEs] and discontinuations) and efficacy (cognition, global functioning and activities of daily living [ADLs]) were assessed for the rivastigmine transdermal patch, with or without concomitant memantine.
Overall, 135 and 126 patients received rivastigmine with and without memantine, respectively. Of these, 122 (90.4%) and 118 (93.7%) patients with and without memantine, respectively, completed the core phase; 120 and 114 patients, respectively, entered the extension phase, and 90 (75.0%) and 86 (75.4%) completed the study. The incidences of AEs (73.3 vs. 67.5%) and SAEs (10.4 vs. 7.1%) were both slightly larger in patients receiving concomitant memantine, but the differences were not statistically significant (95% CIs: -5.2, 16.9 and -3.6, 10.1 for AEs and SEAs, respectively). The incidence of gastrointestinal AEs was low in both groups. Discontinuation due to AEs was higher in patients who received memantine (17.0 vs. 11.9%). Changes in cognitive and global function were similar between groups. ADL scores worsened in both groups; significantly more in those treated with memantine.
Use of the rivastigmine transdermal patch in patients on established memantine appears to be well-tolerated, with only modest, non-significant increases in AEs compared with monotherapy, and did not seem to affect cognition or global functioning adversely.
评估与盐酸美金刚合用期间，使用卡巴拉汀透皮贴剂治疗轻中度阿尔茨海默病患者的安全性和疗效。
这是一项 25 周、随机、前瞻性、开放标签、平行组研究的事后分析。接受多奈哌齐治疗的患者立即换用卡巴拉汀透皮贴剂（4.6mg/24h），或在 4 周洗脱期（核心期）后换用，在此期间患者先滴定至 9.5mg/24h，随后进入为期 20 周的扩展期。所有患者均继续接受盐酸美金刚治疗。
评估卡巴拉汀透皮贴剂（联合或不联合盐酸美金刚）的安全性（不良事件[AE]、严重不良事件[SAE]和停药）和疗效（认知功能、总体功能和日常生活活动[ADL]）。
共有 135 例和 126 例患者分别接受了联合和不联合盐酸美金刚治疗的卡巴拉汀透皮贴剂治疗。其中，分别有 122（90.4%）例和 118（93.7%）例患者完成了核心期；120 例和 114 例患者进入了扩展期，90 例（75.0%）例和 86 例（75.4%）患者完成了研究。联合盐酸美金刚治疗的患者 AE 发生率（73.3%比 67.5%）和 SAE 发生率（10.4%比 7.1%）略高，但差异无统计学意义（AE 和 SAE 的 95%CI 分别为-5.2，16.9 和-3.6，10.1）。两组胃肠道 AE 的发生率均较低。联合盐酸美金刚治疗的患者因 AE 停药率较高（17.0%比 11.9%）。两组认知和总体功能的变化相似。两组 ADL 评分均恶化；联合盐酸美金刚治疗的患者恶化更明显。
与单药治疗相比，在已接受盐酸美金刚治疗的患者中使用卡巴拉汀透皮贴剂耐受性良好，AE 仅有适度、无统计学意义的增加，且似乎不会对认知或总体功能产生不利影响。
