Garcia-Borreguero Diego, Winkelman John, Adams Alieu, Ellis Amanda, Morris Mark, Lamb Janice, Layton Gary, Versavel Mark
Department of Neurology, Fundación Jiménez Díaz, Sleep Disorders Unit, Universidad Autónoma de Madrid, Madrid, Spain.
Sleep Med. 2007 Mar;8(2):119-27. doi: 10.1016/j.sleep.2006.05.018. Epub 2007 Jan 18.
To compare the efficacy, safety and tolerability of sumanirole with placebo in patients with idiopathic restless legs syndrome (RLS).
In this double-blind, placebo-controlled, randomized, parallel-group, dose-response study, 270 patients with idiopathic RLS were enrolled and randomized to receive sumanirole 0.5, 1.0, 2.0, or 4.0mg, or placebo. The primary efficacy endpoint was mean change of the total score of the International Restless Legs Scale (IRLS-10), a 10-item scale, from baseline to end of maintenance. Secondary assessments included polysomnography (PSG) variables.
Treatment with sumanirole was well tolerated. Mean change in IRLS-10 showed no statistically significant change compared with placebo at any dose, although the mean change with the 4.0-mg dose was numerically greater than the other doses and placebo. PSG variables, specifically the periodic leg movements during sleep, showed statistically significant dose-related improvement in favor of sumanirole. Consistent with earlier multinational, multicenter studies in RLS, high placebo response rates were seen with IRLS-10 but not with PSG variables.
Given data published in Parkinson's disease, the dose range of sumanirole selected here may have been too low. Alternatively, dopamine D(2) selective agents could be intrinsically less effective than agonists with combined D(2)/D(3) activity. Sumanirole demonstrated an excellent safety profile.
比较苏曼尼罗与安慰剂治疗特发性不安腿综合征（RLS）患者的疗效、安全性和耐受性。
在这项双盲、安慰剂对照、随机、平行组、剂量反应研究中，270例特发性RLS患者入组并随机接受0.5、1.0、2.0或4.0mg苏曼尼罗或安慰剂治疗。主要疗效终点是国际不安腿量表（IRLS-10，一个10项量表）总分从基线到维持期末的平均变化。次要评估包括多导睡眠图（PSG）变量。
苏曼尼罗治疗耐受性良好。与安慰剂相比，任何剂量的IRLS-10平均变化均无统计学显著差异，尽管4.0mg剂量的平均变化在数值上大于其他剂量和安慰剂。PSG变量，特别是睡眠期间的周期性腿部运动，显示出有利于苏曼尼罗的统计学显著剂量相关改善。与早期关于RLS的多国、多中心研究一致，IRLS-10的安慰剂反应率较高，但PSG变量并非如此。
根据帕金森病发表的数据，此处选择的苏曼尼罗剂量范围可能过低。或者，多巴胺D(2)选择性药物本质上可能比具有D(2)/D(3)联合活性的激动剂效果更差。苏曼尼罗显示出良好的安全性。
