Efficacy and safety of pramipexole in idiopathic restless legs syndrome: A polysomnographic dose-finding study - The PRELUDE study
Efficacy and safety of pramipexole in idiopathic restless legs syndrome: A polysomnographic dose-finding study - The PRELUDE study
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DOI：
10.1016/j.sleep.2006.03.011
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发表时间：
2006-08-01
期刊：
影响因子：
4.8
通讯作者：
Reess, Juergen
中科院分区：
文献类型：
--
作者：
Partinen, Markku;Hirvonen, Kari;Reess, Juergen
背景和目的：评价普拉克索(0.125-0.75 mg/d)对不宁腿综合征患者和临床医生评分的影响。患者和方法：将中到重度不宁腿综合征患者随机分为安慰剂和固定剂量的普拉克索，进行为期3周的双盲、安慰剂对照剂量发现研究。结果：与安慰剂相比，普拉克索各剂量组的卧床时间周期性肢体运动指数均显著降低(调整后的对数变换均值差为0.125 mg，-1.54；0.25 mg，-1.93；0.5 mg，-1.89；和0.75 mg，-1.52；P<；0.0001)。在所有剂量下，国际RLS研究小组评价量表(IRLS)的分数也显著降低，调整后的平均降幅最大的是0.50毫克组(-17.01)。除了最低剂量的普拉克索，应答者的百分比(=IRLS评分降低50%)显著高于安慰剂组(61.9-77.3，vs33.3%)。在服用普拉克索组中，50.0-77.3%的患者认为他们的病情“非常好”或“非常好”，而安慰剂组的这一比例为38.1%(0.5毫克剂量时P=0.0139)。临床总体印象(CGI)评分在普拉克索组为61.9-86.4%，而安慰剂组为42.9%(0.25、0.50和0.75毫克组P<；0.05)。结论：普拉克索治疗RLS的客观和主观方面均有效、安全。(C)2006爱思唯尔B.V.保留所有权利。
Background and purpose: To evaluate the effects of pramipexole (0.125-0.75 mg/d) on poly somnographic (PSG) measures and patient and clinician ratings of restless legs syndrome (RLS).Patients and methods: Patients (n=109) with moderate to severe RLS were randomized to placebo or fixed doses of pramipexole during a 3-week, double-blind, placebo-controlled, dose-finding study.Results: In each pramipexole dose group, the periodic limb movements during time in bed index (PLMI) decreased significantly, compared with placebo (adjusted mean difference in log-transformed data: 0.125 mg, -1.54; 0.25 mg, -1.93; 0.50 mg, -1.89; and 0.75 mg, -1.52; P < 0.0001). At all doses, International RLS Study Group Rating Scale (IRLS) scores were also significantly reduced, with the greatest adjusted mean reduction in the 0.50 mg group (-17.01). At all but the lowest pramipexole dose, the percentage of responders (>= 50% reduction of IRLS score) was substantially higher than for placebo (61.9-77.3, vs 33.3%). In the pramipexole groups, 50.0-77.3% of patients rated their condition as 'much better' or 'very much better', compared with 38.1% of patients in the placebo group (P=0.0139 for the 0.50 mg dose). Clinical global impressions (CGI) scale ratings of 'much improved' or 'very much improved' were given to 61.9-86.4% of patients in the pramipexole groups, compared with 42.9% in the placebo group (P < 0.05 for the 0.25, 0.50, and 0.75 mg groups). Pramipexole was well tolerated and did not produce somnolence at any dose.Conclusion: Pramipexole is effective and safe in the treatment of both objective and subjective facets of RLS. (c) 2006 Elsevier B.V. All rights reserved.