Garcia-Borreguero Diego, Grunstein Ronald, Sridhar Guruswamy, Dreykluft Tilman, Montagna Pasquale, Dom René, Lainey Eric, Moorat Anne, Roberts James
Sleep Research Institute, Alberto Alcocer 19, 28036 Madrid, Spain.
Sleep Med. 2007 Nov;8(7-8):742-52. doi: 10.1016/j.sleep.2006.09.009. Epub 2007 May 18.
To assess the long-term safety and efficacy of ropinirole in the treatment of patients with restless legs syndrome (RLS) over 52 weeks.
A 52-week, multicentre, open-label continuation study involving 310 patients, conducted in 11 countries. Eligible patients from four parent studies were invited to participate. At parent study entry, all patients had a score of > or =15 on the International Restless Legs Scale (IRLS). In this continuation study, all participants received ropinirole, 0.25-4.0 mg once daily, for 52 weeks. The primary study objective was to evaluate the safety of ropinirole. Efficacy was assessed by change in IRLS score, as well as by global improvements (clinical global impression [CGI] scale) and improvements in measures of sleep, work productivity, and quality of life.
Overall, 251 (81.0%) patients completed the study. The mean ropinirole dose at study end was 1.90 mg/day. A total of 282 patients (91.3%) reported > or = 1 adverse event. For the majority of patients, the reported adverse events were mild or moderate in intensity. The most common adverse event was nausea. Adverse events led to discontinuation in 8.7% of patients. At week 52, IRLS scores improved by an average of 12.0 points from baseline, and 82.8% of patients were 'much improved' or 'very much improved' on the CGI-improvement scale. Ropinirole treatment was also associated with improvements in measures of sleep and quality of life.
Ropinirole was well tolerated and therapeutic efficacy was maintained over 52 weeks in patients with RLS.
评估罗匹尼罗治疗不安腿综合征（RLS）患者52周的长期安全性和疗效。
一项在11个国家开展的为期52周的多中心、开放标签延续性研究，涉及310例患者。邀请来自四项母研究的符合条件的患者参与。在母研究入组时，所有患者的国际不安腿量表（IRLS）评分均≥15分。在这项延续性研究中，所有参与者接受罗匹尼罗，每日一次，剂量为0.25 - 4.0毫克，共52周。主要研究目的是评估罗匹尼罗的安全性。通过IRLS评分的变化、整体改善情况（临床整体印象[CGI]量表）以及睡眠、工作效率和生活质量指标的改善情况来评估疗效。
总体而言，251例（81.0%）患者完成了研究。研究结束时罗匹尼罗的平均剂量为1.90毫克/天。共有282例患者（91.3%）报告了≥1次不良事件。对于大多数患者，报告的不良事件强度为轻度或中度。最常见的不良事件是恶心。不良事件导致8.7%的患者停药。在第52周时，IRLS评分较基线平均改善了12.0分，82.8%的患者在CGI改善量表上“改善很多”或“改善非常多”。罗匹尼罗治疗还与睡眠和生活质量指标的改善相关。
罗匹尼罗耐受性良好，在RLS患者中52周内维持了治疗效果。
