大剂量艾斯能贴剂获准用于治疗重度阿尔茨海默病

圣路易斯(MD Consult)——2013年6月27日，诺华公司宣布，美国食品药品管理局(FDA)扩大了艾斯能贴剂（卡巴拉汀经皮治疗系统）的适应证，将治疗重度阿尔茨海默病(AD)纳入其中。这一批准令增加了大剂量(13.3 mg/24 h)艾斯能贴剂在这一人群中的适用范围。艾斯能贴剂是目前唯一获准用于所有阶段AD患者的经皮治疗产品。

对于艾斯能贴剂用于重度AD患者的批准是基于一项关键、随机、双盲研究的结果。该研究24周时显示，与接受艾斯能贴剂4.6 mg/24 h治疗的患者相比，接受13.3 mg/24 h治疗者的整体认知和功能均显著改善，并具有统计学意义。

临床试验中最常见的不良反应包括用药部位红斑、跌倒、失眠、呕吐、腹泻、体重减轻和恶心。艾斯能贴剂13.3 mg/24 h治疗组发生上述反应的患者百分率高于艾斯能贴剂4.6 mg/24 h治疗组。

艾斯能贴剂使用错误可导致严重不良反应；一些病例可能需要住院治疗，甚至可导致极少数病例死亡。多数用药错误与使用新贴剂时未除去旧贴剂而引起同时使用多份贴剂有关。每次仅允许使用一片艾斯能贴剂。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On June 27, 2013, Novartis announced that the US Food and Drug Administration (FDA) has expanded its approval of Exelon Patch (rivastigmine transdermal system) to include the treatment of persons with severe Alzheimer's disease (AD). This approval adds use of the high-dose (13.3 mg/24 h) Exelon Patch for this population. Exelon Patch is now the only transdermal therapy approved to treat all stages of AD.

The approval of Exelon Patch for severe AD was granted on the basis of data from a pivotal randomized, double-blind study. At week 24, patients in the study who received Exelon Patch at the 13.3 mg/24 h dose demonstrated statistically significant improvement in overall cognition and function versus patients who received the 4.6 mg/24 h dose.

The most commonly observed adverse reactions in the clinical trial included application-site erythema, fall, insomnia, vomiting, diarrhea, weight loss, and nausea. These reactions were observed in a higher percentage of patients in the Exelon Patch 13.3 mg/24 h group than in the Exelon Patch 4.6 mg/24 h group.

Mistakes in using Exelon Patch have resulted in serious adverse effects; some cases have required hospitalization, and rarely, led to death. Most mistakes have involved not removing the old patch when applying a new one and the use of multiple patches at one time. Only one Exelon Patch should be worn at a time.