BACKGROUND:As with studies of other dopamine agonists, previously reported studies of ropinirole in restless legs syndrome (RLS) recruited patients with baseline International Restless Legs Scale (IRLS) total scores ≥ 15. The reported pooled analyses of clinical trials data suggest benefits of ropinirole in patients with IRLS total scores ≥ 24, but the effects of ropinirole have not been prospectively evaluated in this patient population. OBJECTIVE:The goal of this study was to evaluate the efficacy and tolerability of ropinirole in patients with RLS and baseline IRLS total scores ≥ 24. This study was conducted in part to fulfill a postlicensing commitment between the maker of ropinirole and the European Union's Committee for Medicinal Products for Human Use. METHODS:The protocol for this study comprised a randomized, double-blind, placebo-controlled, parallel-group, 26-week phase during which adults with baseline IRLS total scores ≥ 24 received a ropinirole dose from 0.25 to 4 mg (n = 197) or placebo (n = 207) followed by a 40-week, open-label phase during which all patients (n = 269) received ropinirole. The primary efficacy end point was the change from baseline in the IRLS total score at week 12. Tolerability measures included the incidence of adverse events, augmentation, and early morning rebound. Due to the possibility of a treatment-by-center group interaction (P = 0.04) in the IRLS analysis, further efficacy exploratory analyses were performed to assess the impact of the interaction on the overall assessment of efficacy. RESULTS:Demographic characteristics were comparable between groups (mean [SD] age: placebo, 56.1 [11.38] years; ropinirole, 56.5 [11.92] years; 63% female in both groups). All of the patients in the ropinirole group were white; 99% of the placebo group was white. Ropinirole was significantly better than placebo for change from baseline in the IRLS total score during both short- and long-term treatment, with mean treatment differences of -2.1 (P = 0.039) and -2.5 (P = 0.023) for weeks 12 and 26, respectively. A statistically significant treatment by center group interaction was observed (P = 0.040) for the change from baseline in IRLS total score, indicating variation of treatment effects among center groups; however, all center groups showed an improvement from baseline at both week 12 and week 26 for the ropinirole immediate-release group and the placebo group. The incidences of augmentation and early morning rebound were ≤ 4% for ropinirole. The adverse event profile of ropinirole was consistent with that reported in previous clinical trials. CONCLUSIONS:In this subset of patients with RLS and a baseline IRLS total score ≥ 24, ropinirole was effective and well tolerated compared with placebo. The incidence of augmentation and early morning rebound in this study was low.

译文

背景:与其他多巴胺受体激动剂的研究一样,先前报道的罗匹尼洛在国际躁动腿综合征基线总得分≥15的不安腿综合征(RLS)中的研究报道。临床试验数据的汇总分析表明罗匹尼罗的益处IRLS总评分≥24的患者中,尚未对该患者人群前瞻性评估罗匹尼罗的作用。
目的:本研究的目的是评估罗匹尼罗在RLS和基线IRLS总分≥24的患者中的疗效和耐受性。该研究的部分目的是为了履行罗匹尼罗制造商与欧盟委员会之间的后许可承诺。人用药品。
方法:这项研究的方案包括一个随机,双盲,安慰剂对照,平行组,为期26周的阶段,在该阶段中,基线IRLS总得分≥24的成年人接受0.25至4毫克的罗匹尼罗剂量(n = 197) )或安慰剂(n = 207),然后进行为期40周的开放标签治疗阶段,在此期间,所有患者(n = 269)均接受罗匹尼罗治疗。主要功效终点是在第12周时IRLS总评分相对于基线的变化。耐受性指标包括不良事件,增强和清晨反弹的发生率。由于在IRLS分析中可能存在按中心治疗的小组互动(P = 0.04),因此进行了进一步的功效探索性分析,以评估相互作用对整体功效评估的影响。
结果:各组的人口统计学特征相当(平均[SD]年龄:安慰剂,56.1 [11.38]岁;罗匹尼罗,56.5 [11.92]岁;两组中女性占63%)。罗匹尼罗组的所有患者均为白人。安慰剂组中99%是白色的。在短期和长期治疗期间,IRPINs总评分相对于基线的变化,罗匹尼罗明显优于安慰剂,第12周和第26周的平均治疗差异为-2.1(P = 0.039)和-2.5(P = 0.023)。 , 分别。通过中心组交互作用观察到统计学上显着的治疗(P = 0.040),IRLS总分相对于基线的变化,表明中心组之间的治疗效果存在差异。然而,罗匹尼罗速释组和安慰剂组的所有中心组在第12周和第26周均显示出相对于基线的改善。罗匹尼罗的增强和清晨反弹的发生率≤4%。罗匹尼罗的不良事件特征与先前临床试验中报道的一致。
结论:在RLS和基线IRLS总得分≥24的这一亚组患者中,罗匹尼罗与安慰剂相比有效且耐受性良好。在这项研究中增强和清晨反弹的发生率很低。

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