The present study aimed to examine the long-term efficacy and safety of rotigotine treatment for restless legs syndrome (RLS), as well as the rate of clinically significant augmentation, in a 1-year open-label study of Japanese subjects. Japanese patients with RLS who had been treated with rotigotine or placebo in a double-blind trial were enrolled in a 1-year, open-label, uncontrolled extension study and treated with rotigotine at a dose of up to 3 mg/24 h after an 8-week titration phase. Outcomes included International Restless Legs Syndrome Study Group rating scale (IRLS scale), Pittsburgh Sleep Quality Index (PSQI), safety, and investigator-/expert panel-assessed augmentation (including Augmentation Severity Rating Scale). Overall, 185 patients entered the open-label study and 133 completed the study. IRLS and PSQI total scores improved throughout the 52-week treatment period (IRLS, from 23.2±5.1 to 7.8±7.6 and PSQI, from 8.0±3.1 to 5.0±2.9). Treatment-emergent adverse events were mild to moderate in severity, and included application site reactions (52.4%) and nausea (28.6%). Clinically significant augmentation occurred in five patients (2.7%). These results indicate a good long-term efficacy of rotigotine for treating RLS, with a relatively low risk of clinically significant augmentation.

译文

:本研究旨在对日本受试者进行为期1年的开放标签研究,以探讨罗替戈汀治疗躁动性腿综合征(RLS)的长期疗效和安全性,以及临床显着性增高的比率。曾在一项双盲试验中接受过罗替戈汀或安慰剂治疗的日本RLS患者参加了为期1年的开放标签,非对照扩展研究,并在接受罗格替汀治疗后3毫克/ 24小时内接受了剂量8周的滴定阶段。结果包括国际躁动腿综合症研究组评分量表(IRLS量表),匹兹堡睡眠质量指数(PSQI),安全性以及研究者/专家小组评估的增强(包括增强严重度评分量表)。总体而言,有185位患者进入了开放标签研究,其中133位完成了研究。在整个52周的治疗期间,IRLS和PSQI总分有所改善(IRLS从23.2±5.1降低到7.8±7.6,PSQI从8.0±3.1降低到5.0±2.9)。突发性治疗不良事件的严重程度为轻度至中度,包括应用部位反应(52.4%)和恶心(28.6%)。有五名患者(2.7%)发生了临床上明显的增强。这些结果表明罗替戈汀治疗RLS具有良好的长期疗效,临床上显着增强的风险相对较低。

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