Department of Neurology, Inha University School of Medicine, Incheon, South Korea.
Curr Med Res Opin. 2011 Jul;27(7):1375-83. doi: 10.1185/03007995.2011.582484. Epub 2011 May 12.
To compare the tolerability and efficacy of combination therapy of memantine plus rivastigmine patch with rivastigmine patch monotherapy in patients with mild to moderate Alzheimer's disease (AD).
In this multicenter, randomized, open-label study, patients entered an 8-week run-in period (a 5 cm 2 rivastigmine patch for 4 weeks, then a 10 cm(2) patch for 4 weeks) followed by 16 weeks of memantine plus rivastigmine patch or rivastigmine patch monotherapy. The primary outcome measure was the retention rate at the end of the trial.
clinicaltrials.gov. NCT01025466.
Overall, 88 and 84 patients received rivastigmine patch with and without memantine, respectively, and of these, 77 (87.5%) and 70 (83.3%) patients completed the study. The difference in retention rate was not significant (95% confidence interval: -6.3-14.7%). The incidence of adverse events (AEs) (53.4 vs. 50.6%) and discontinuation due to AEs (6.8 vs. 4.8%) were not different between patients with and without memantine. The most frequent AEs were skin irritation in patients with and without memantine (42.0 vs. 34.9%, p = 0.71), but discontinuation due to skin irritation was rare (4.5 vs. 2.4%, p = 0.74). The incidence of gastrointestinal AEs was very low in patients with and without memantine (nausea, 2.3 vs. 1.2%; vomiting, 1.1 vs. 1.2%). The Korean Version of the Cohen Mansfield Agitation Inventory scores favored rivastigmine patch monotherapy at the end of treatment (p = 0.01). Changes in other efficacy measures were similar between the groups.
There were no significant differences in tolerability and safety between the treatment groups. The combination therapy of memantine plus rivastigmine patch did not show an advantage over rivastigmine patch monotherapy on efficacy analyses. The sample size for comparing tolerability may have been too small to detect a difference of efficacy between the two groups.
比较盐酸美金刚与利斯的明透皮贴剂联合治疗与利斯的明透皮贴剂单药治疗轻中度阿尔茨海默病（AD）患者的耐受性和疗效。
在这项多中心、随机、开放标签研究中，患者先进入 8 周的导入期（4 周使用 5cm²利斯的明贴剂，4 周使用 10cm²贴剂），然后进入 16 周的盐酸美金刚与利斯的明透皮贴剂联合治疗或利斯的明透皮贴剂单药治疗。主要终点是试验结束时的保留率。
clinicaltrials.gov。NCT01025466。
共有 88 例和 84 例患者分别接受了利斯的明贴剂联合美金刚和利斯的明贴剂单药治疗，其中 77 例（87.5%）和 70 例（83.3%）患者完成了研究。保留率差异无统计学意义（95%置信区间：-6.3%至 14.7%）。有和美金刚的患者中不良反应（AE）发生率（53.4% vs. 50.6%）和因 AE 停药率（6.8% vs. 4.8%）无差异。最常见的 AE 是有和美金刚的患者中的皮肤刺激（42.0% vs. 34.9%，p=0.71），但因皮肤刺激而停药的情况很少见（4.5% vs. 2.4%，p=0.74）。有和美金刚的患者中胃肠道 AE 的发生率很低（恶心，2.3% vs. 1.2%；呕吐，1.1% vs. 1.2%）。治疗结束时，韩国版科恩-曼斯菲尔德激越量表评分更倾向于利斯的明透皮贴剂单药治疗（p=0.01）。两组间其他疗效指标的变化相似。
两组的耐受性和安全性无显著差异。美金刚与利斯的明透皮贴剂联合治疗在疗效分析中并未显示优于利斯的明透皮贴剂单药治疗。比较两组间耐受性的样本量可能太小，无法检测出疗效差异。
