Rivastigmine Transdermal Patch Skin Tolerability Results of a 1-Year Clinical Trial in Patients with Mild-to-Moderate Alzheimer's Disease
Rivastigmine Transdermal Patch Skin Tolerability Results of a 1-Year Clinical Trial in Patients with Mild-to-Moderate Alzheimer's Disease
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DOI：
10.2165/11531270-000000000-00000
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发表时间：
2010-01-01
影响因子：
3.2
通讯作者：
Olin, Jason T.
中科院分区：
文献类型：
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作者：
Cummings, Jeffrey L.;Farlow, Martin R.;Olin, Jason T.
背景和目的：透皮贴剂提供了非侵入性、持续的药物释放，与口服治疗相比具有显著的潜在优势。对于所有的经皮治疗，一定比例的患者会经历某种形式的皮肤反应。自2007年7月以来，里瓦斯明贴片已在美国被批准用于治疗轻至中度阿尔茨海默病(AD)。本试验的主要目的是评价利凡斯明透皮贴剂对轻中度AD患者的皮肤耐受性。方法：对1195例轻中度AD患者进行为期24周的随机、双盲、安慰剂对照的多中心试验，评价利凡斯明贴剂的皮肤耐受性。紧随其后的是28周的开放标签延期。虽然不是前瞻性地定义为二次评估，但在研究的两个阶段，患者在应用部位的皮肤状况都进行了评估。结果：在24周的双盲期研究中，99.6%的目标9.5 mg/24小时贴片治疗组的患者在其最严重的涂抹部位反应中记录到没有、轻微或轻微的体征或症状。红斑和瘙痒是最常见的反应。任何贴片治疗组的患者均未发生严重不良反应。在9.5 mg/24小时治疗组中，2.4%的患者因涂抹部位的反应而停止治疗。在28周的开放标签延长期间，皮肤耐受性与双盲阶段相似。总体而言，3.7%的患者因涂抹部位的皮肤反应而停止治疗。没有迹象表明皮肤反应的严重程度随着时间的推移而增加。结论：总体而言，数据支持利瓦斯明透皮贴剂的良好皮肤耐受性，并保证利瓦斯明贴剂治疗AD患者的益处不会因严重的皮肤刺激问题而混淆。然而，应注意遵循制造商关于贴剂应用的建议，例如每日轮换贴片部位，以将皮肤反应的风险降至最低。
Background and Objectives: Transdermal patches provide non-invasive, continuous drug delivery, and offer significant potential advantages over oral treatments. With all transdermal treatments a proportion of patients will experience some form of skin reaction. The rivastigmine patch has been approved for the treatment of mild-to-moderate Alzheimer's disease (AD) since July 2007 in the US. The aim of the component of the trial reported here was to evaluate the skin tolerability of the rivastigmine transdermal patch in patients with mild-to-moderate AD.Methods: The pivotal IDEAL trial was a 24-week, randomized, double-blind, placebo-controlled, multicentre trial of the efficacy and tolerability of the rivastigmine transdermal patch in 1195 patients with mild-to-moderate AD. This was followed by a 28-week open-label extension. Although not prospectively defined as a secondary assessment, during both phases of the study the condition of the patients' skin at the application site was evaluated. These data are reviewed in this article.Results: During the 24-week, double-blind phase of the study, 89.6% of patients in the target 9.5 mg/24 h patch treatment group had recorded 'no, slight or mild' signs or symptoms for their most severe application-site reaction. Erythema and pruritus were the most commonly reported reactions. No patient in any patch treatment group experienced a skin reaction that was reported as a serious adverse event. In the 9.5 mg/24 h treatment group, 2.4% of patients discontinued treatment due to an application-site reaction. During the 28-week open-label extension, the skin tolerability profile was similar to that seen in the double-blind phase. Overall, 3.7% of patients discontinued treatment due to application-site skin reactions. There was no indication that the severity of the skin reactions increased over time.Conclusion: Overall, the data support a favourable skin tolerability profile for the rivastigmine transdermal patch, and provide reassurance that the benefits of rivastigmine patch therapy for patients with AD are not confounded by significant skin irritation problems. Nevertheless, care should be taken to follow manufacturer's advice about patch application, such as daily rotation of the application site, to minimize the risk of skin reactions.