The Rilutek® (riluzole) Global Early Access Programme:: An open-label safety evaluation in the treatment of amyotrophic lateral sclerosis
The Rilutek® (riluzole) Global Early Access Programme:: An open-label safety evaluation in the treatment of amyotrophic lateral sclerosis
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DOI：
10.1080/146608201753275508
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发表时间：
2001-09-01
影响因子：
--
通讯作者：
Truffinet, P
中科院分区：
文献类型：
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作者：
Debove, C;Zeisser, P;Truffinet, P
目的：本研究有两个主要目的：1。使以前没有参加过利鲁唑试验的肌萎缩性侧索硬化症（ALS）患者能够接受利鲁唑治疗；扩大在广大患者群体中使用该药的安全性经验。方法：这是一项利鲁唑的IIIb期多中心、多国、开放标签、非对照单治疗研究。诊断为可能或可能ALS的患者给予100mg利鲁唑/天（50mg b.i.d）。前3个月每月记录临床和实验室不良事件，之后每3个月记录一次。结果：来自44个国家的8383例患者纳入研究；有记录资料的患者中有7916人服用了研究药物。利鲁唑治疗的平均持续时间为202.1天，范围为1-630天。最常报道的严重和非严重不良事件是ALS的常见症状（呼吸系统症状和吞咽困难），只有1.9%的严重不良事件被认为与研究药物有关。结论：这一广泛人群（超过全球估计ALS人群的10%）的安全性结果与先前安慰剂对照试验报告的结果一致。未观察到不良事件的增加和意外不良事件的发生。
OBJECTIVES: This study had two main objectives: 1. To enable patients with amyotrophic lateral sclerosis (ALS) who had not participated in previous riluzole trials to receive riluzole therapy, and 2. To expand safety experience with the drug in a broad patient population.METHODS: This was a Phase IIIb multicentre, multinational, open-label, uncontrolled single treatment study of riluzole. Patients with diagnosed possible or probable ALS were administered 100 mg of riluzole/day (50 mg b.i.d.). Clinical and laboratory adverse events were recorded every month for the first 3 months and thereafter at 3-monthly intervals.RESULTS: 8383 patients from 44 countries were entered into the study; 7916 of these patients with recorded data were administered the study drug. The mean duration of riluzole treatment was 202.1 days, with a range of 1-630 days. The most frequently reported serious and non-serious adverse events were common symptoms of ALS (respiratory symptoms and dysphagia), and only 1.9% of serious adverse events were considered to be related to the study drug.CONCLUSIONS: The safety results with this broad population (over 10% of the estimated ALS population worldwide) were consistent with those previously reported from placebo-controlled trials. No increase in adverse events and no unexpected adverse events were observed.