FDA批准更大剂量AD治疗药艾斯能贴片

圣路易斯(MD Consult)——2012年9月4日，诺华公司宣布，美国食品药品管理局(FDA)已核准更大剂量的艾斯能贴片(卡巴拉汀经皮给药系统)用于治疗轻至中度阿尔茨海默病(AD)。这种新核准的药物剂量为13.3 mg/24 h。在此之前，9.5 mg/24 h和4.6 mg/24 h规格的贴片已通过核准。

FDA之所以批准规格为13.3 mg/24 h的艾斯能贴片，是基于一项对照试验的48周双盲阶段数据，该研究中纳入符合预定功能和认知减退标准并正在接受9.5 mg/24 h剂量贴片治疗的轻至中度AD患者。在48周时，工具性日常生活活动量表的评估显示，与9.5 mg/24 h贴片相比，使用13.3 mg/24 h贴片者的总体功能(联合主要终点之一)有显著改善(P＜0.05)。与较小剂量相比，第24周时认知功能有显著改善，但48周时的结果无统计学意义(也是联合重要终点之一)。

在48周剂量比较阶段，未报告任何预期之外的导致退出试验的不良事件(AEs)，较大剂量贴片的安全性与之前核准剂量的艾斯能贴片一致。总体上，13.3 mg/24 h组因AE导致退出试验的患者百分率低于9.5 mg/24 h组(9.6% vs. 12.7%)。

这项试验报告的最常见不良反应中，艾斯能贴片13.3 mg/24 h组最常见的事件为恶心、呕吐、跌倒、体重减轻、用药部位红斑、食欲减退、腹泻和泌尿系感染。13.3 mg/24 h组发生上述事件的患者百分率高于9.5mg/24 h组。在艾斯能贴片治疗期间，应监测体重变化。

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ST LOUIS (MD Consult) - On September 4, 2012, Novartis announced that the US Food and Drug Administration (FDA) has approved a higher dose of Exelon Patch (rivastigmine transdermal system) for the treatment of mild to moderate Alzheimer's disease (AD). The newly approved dosage is 13.3 mg/24 h. The patch has been previously approved in 9.5 mg/24 h and 4.6 mg/24 h strengths.

The FDA approval of Exelon Patch 13.3 mg/24 h was granted on the basis of data from a 48-week double-blind phase of a controlled trial that included patients with mild to moderate AD who met the predefined criteria for functional and cognitive decline while receiving the 9.5mg/24 h dose of the patch. Patients treated with the 13.3 mg/24 h patch experienced statistically significant (P < .05) improvement in their overall function compared with use of the 9.5 mg/24 h patch as measured by the instrumental activities of daily living scale at week 48 (a co-primary end point). Improvement in cognition compared with the lower dose was nominally statistically significant at 24 weeks but not at 48 weeks (also a co-primary end point).

During the 48-week dose-comparison phase of the trial, no unexpected adverse events (AEs) leading to discontinuation were reported, and the safety profile of the higher dose was consistent with that of the previously approved doses of Exelon Patch. Overall, the percentage of patients with AEs leading to discontinuation was lower in the 13.3 mg/24 h group compared with the 9.5 mg/24 h group (9.6% vs 12.7%, respectively).

Of the commonly reported adverse reactions in the 48-week clinical trial, the most frequent events in the Exelon Patch 13.3 mg/24 h group were nausea, vomiting, fall, weight decrease, application-site erythema, decreased appetite, diarrhea, and urinary tract infection. The percentage of these patients with these events was higher in the 13.3 mg/24 h group than in the 9.5mg/24 h group. Weight should be monitored during therapy with the Exelon Patch.