Alva G, Cummings J L, Galvin J E, Meng X, Velting D M
ATP Clinical Research, Costa Mesa, CA, USA.
Int J Clin Pract. 2015 May;69(5):518-30. doi: 10.1111/ijcp.12621. Epub 2015 Feb 16.
Rivastigmine patch is approved for the treatment of all stages of Alzheimer's disease (AD). Application site reactions may be a concern to clinicians and we used two large clinical trial databases to investigate the incidence of skin reactions in patients receiving rivastigmine patch.
Data from a 24-week, randomised, double-blind (DB) evaluation of 13.3 vs. 4.6 mg/24 h rivastigmine patch in severe AD (ACTION) and a 72- to 96-week study comprising an initial open-label (IOL) phase followed by a 48-week randomised, DB phase (13.3 vs. 9.5 mg/24 h rivastigmine patch) in declining patients with mild-to-moderate AD (OPTIMA) were analyzed. The incidence, frequency, severity, management and predictors of application site reactions were assessed.
Application site reactions were mostly mild or moderate in severity and reported by similar proportions in each treatment group (
13.3 mg/24 h, 24.5% and 4.6 mg/24 h, 24.2%; OPTIMA: IOL 9.5 mg/24 h, 22.9%; DB 13.3 mg/24 h, 11.4% and 9.5 mg/24 h, 12.0%); none were rated serious. In both studies, <9% of patients required treatment for application site reactions. Application site reactions led to discontinuation of 1.7% and 2.5% of the 13.3 mg/24 h and 4.6 mg/24 h groups, respectively, in ACTION, 8.7% in OPTIMA IOL and 1.8% and 3.5% of the 13.3 mg/24 h and 9.5 mg/24 h groups, respectively, in OPTIMA DB.
Application site reactions were experienced by <25% of patients in both studies, with no notable effect of dose. No reactions qualified as serious and skin reactions were uncommon as a reason for study discontinuation.
卡巴拉汀透皮贴剂已被批准用于治疗各阶段的阿尔茨海默病（AD）。应用部位反应可能是临床医生关注的问题，我们使用两个大型临床试验数据库来调查接受卡巴拉汀透皮贴剂治疗的患者皮肤反应的发生率。
分析了一项针对重度AD患者的24周随机双盲（DB）评估数据（ACTION研究，比较13.3与4.6mg/24h卡巴拉汀透皮贴剂），以及一项针对轻度至中度AD病情逐渐恶化患者的72至96周研究数据（OPTIMA研究，包括初始开放标签（IOL）阶段，随后是48周随机双盲阶段，比较13.3与9.5mg/24h卡巴拉汀透皮贴剂）。评估了应用部位反应的发生率、频率、严重程度、处理方法及预测因素。
应用部位反应大多为轻度或中度，各治疗组报告的比例相似（ACTION研究：13.3mg/24h组为24.5%，4.6mg/24h组为24.2%；OPTIMA研究：IOL阶段9.5mg/24h组为22.9%；DB阶段13.3mg/24h组为11.4%，9.5mg/24h组为12.0%）；均无严重等级的反应。在两项研究中，<9%的患者因应用部位反应需要治疗。在ACTION研究中，应用部位反应导致13.3mg/24h组和4.6mg/24h组分别有1.7%和2.5%的患者停药；在OPTIMA研究的IOL阶段为8.7%，在OPTIMA研究的DB阶段，13.3mg/24h组和9.5mg/24h组分别有1.8%和3.5%的患者停药。
两项研究中<25%的患者出现应用部位反应，剂量无显著影响。没有反应被判定为严重，皮肤反应作为研究停药原因并不常见。
