Departments of Clinical Pharmacology and Neurosciences, University Hospital, University of Toulouse, Toulouse, France.
Fundam Clin Pharmacol. 2013 Feb;27(1):81-95. doi: 10.1111/j.1472-8206.2012.01028.x. Epub 2012 Feb 9.
Rotigotine, a non-ergot dopamine agonist, has been developed as a novel transdermal formulation. The rotigotine transdermal patch has received EMEA marketing authorization for the treatment of adult patients with early or advanced Parkinson's disease (PD) or with moderate to severe restless legs syndrome (RLS). FDA originally granted a marketing authorization for early PD, which was later suspended, and is now studying the authorization for RLS. The aim of this review is to review the pharmacokinetics, pharmacodynamics as well as the clinical efficacy and tolerability of the rotigotine transdermal patch in PD. Source material was identified using a PubMed search for the term 'rotigotine' and PD. Articles published up to January 2011 or abstract submitted to most relevant international neurology congresses were reviewed. The rotigotine transdermal patch is efficacious for the treatment of PD. Tolerability profile appears to be well within the range of that observed with other non-ergot dopamine agonists in PD. Application-site reactions were the most frequent adverse event, and they were considered mild to moderate in the majority of cases. The rotigotine transdermal patch offers a safe and efficacious alternative for the treatment of PD. Further studies should focus on the possibility that continuous dopamine stimulation by means of the transdermal patch has any influence on levodopa-related motor complications.
罗替戈汀是一种非麦角类多巴胺激动剂,已被开发为一种新型透皮制剂。罗替戈汀透皮贴剂已获得欧洲药品管理局和美国食品药品监督管理局批准,用于治疗成人早期或晚期帕金森病(PD)或中重度不宁腿综合征(RLS)。美国食品药品监督管理局最初批准用于早期 PD 的营销授权,后来被暂停,目前正在研究 RLS 的授权。本综述的目的是回顾罗替戈汀透皮贴剂在 PD 中的药代动力学、药效学以及临床疗效和耐受性。使用 PubMed 搜索术语“罗替戈汀”和“PD”来确定原始资料。综述了截至 2011 年 1 月发表的文章或向相关国际神经病学大会提交的摘要。罗替戈汀透皮贴剂对 PD 的治疗有效。耐受性特征似乎与 PD 中其他非麦角类多巴胺激动剂观察到的一致。贴剂部位反应是最常见的不良事件,大多数情况下为轻度至中度。罗替戈汀透皮贴剂为 PD 的治疗提供了一种安全有效的替代方案。进一步的研究应集中于透皮贴剂持续多巴胺刺激是否对与左旋多巴相关的运动并发症有任何影响。