Giladi Nir, Ghys Liesbet, Surmann Erwin, Boroojerdi Babak, Jankovic Joseph
Department of Neurology, Tel-Aviv University, Tel-Aviv, Israel; Sago School of Neuroscience, Tel-Aviv University, Tel-Aviv, Israel.
UCB Pharma, Brussels, Belgium.
Parkinsonism Relat Disord. 2014 Dec;20(12):1345-51. doi: 10.1016/j.parkreldis.2014.09.016. Epub 2014 Sep 28.
In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.
Open-label rotigotine was titrated to optimal dose (≤16 mg/24 h). Concomitant levodopa was permitted. Dyskinesia data, recorded using the Unified Parkinson's Disease Rating Scale Part IV, were pooled from the two open-label studies.
Of 596 participants who received open-label rotigotine, 299 (50%) remained at trial closure; no patient discontinued due to dyskinesia. In the two studies, median exposure to rotigotine was 1910 days (∼5 years, 3 months), and 1564.5 days (∼4 years, 3 months). During up to 6 years of open-label rotigotine, 423/596 (71%) received levodopa. Dyskinesias were reported in 115/596 (19%) participants, 90/115 (78%) of who developed dyskinesia after levodopa was added; 25 reported dyskinesia in the absence of levodopa (includes patients who never received open-label levodopa, and those who reported dyskinesia before starting concomitant levodopa). Dyskinesia severity data were available for 107 of the 115 participants. In 56/107 (52%) participants, dyskinesia was considered 'not disabling' for all occurrences; the worst-case severity was 'mildly disabling' for 33/107 (31%), and 'moderately' or 'severely disabling' for 18/107 (17%; 3% of total participants).
During treatment with rotigotine in patients with PD for up to 6 years the incidence of dyskinesia was low, and the dyskinesia was generally 'not disabling' or 'mildly disabling'.
在两项为期6个月的双盲、安慰剂对照研究中，罗替戈汀透皮系统作为早期帕金森病（PD）的单一疗法耐受性良好且疗效显著。对这些研究的长期开放标签扩展研究（NCT00594165；NCT00599196）进行的这项事后分析评估了接受罗替戈汀治疗（无论是否联用左旋多巴）长达6年的参与者中异动症的发生率和严重程度。
开放标签的罗替戈汀滴定至最佳剂量（≤16 mg/24小时）。允许联用左旋多巴。使用统一帕金森病评定量表第四部分记录的异动症数据来自两项开放标签研究。
在596名接受开放标签罗替戈汀治疗的参与者中，299名（50%）在试验结束时仍在参与研究；没有患者因异动症而停药。在两项研究中，罗替戈汀的中位暴露时间分别为1910天（约5年3个月）和1564.5天（约4年3个月）。在长达6年的开放标签罗替戈汀治疗期间，423/596（71%）的参与者接受了左旋多巴治疗。115/596（19%）的参与者报告了异动症，其中90/115（78%）在加用左旋多巴后出现异动症；25名在未使用左旋多巴的情况下报告了异动症（包括从未接受开放标签左旋多巴治疗的患者，以及在开始联用左旋多巴之前报告异动症的患者）。115名参与者中的107名有异动症严重程度数据。在56/107（52%）的参与者中，所有发作的异动症均被认为“不致残”；最严重的严重程度为“轻度致残”的有33/107（31%），“中度”或“重度致残”的有18/107（17%；占总参与者的3%）。
在PD患者中使用罗替戈汀治疗长达6年期间，异动症的发生率较低，且异动症通常为“不致残”或“轻度致残”。
