加巴喷丁恩卡必利治疗成人中重度原发性不安腿综合征相关疼痛的效果：三项随机对照试验的汇总分析。
The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials.
机构信息
Movement Disorders Program, Department of Neurology, University of California Irvine, 100 Irvine Hall, Irvine, CA, 92697, USA.
Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA.
出版信息
CNS Drugs. 2016 May;30(5):443-54. doi: 10.1007/s40263-016-0333-8.
BACKGROUND
Adults with moderate-to-severe primary restless legs syndrome (RLS) often experience painful dysesthesias, which may lead to impaired quality of life.
OBJECTIVES
The aim of this study was to assess the effects of gabapentin enacarbil (GEn) on pain associated with moderate-to-severe primary RLS in adults.
METHODS
Data were pooled from three double-blind, randomized, placebo-controlled, 12-week trials (NCT00298623, NCT00365352, NCT01332305) for adults receiving GEn or placebo once daily. Change in average daily RLS pain score and a combined International Restless Legs Scale (IRLS)-pain response were examined.
RESULTS
The modified intention-to-treat population included 671 adults (placebo, n = 244; GEn 600 mg, n = 161; GEn 1200 mg, n = 266). Both GEn doses significantly improved average daily RLS pain score at week 12 (p < 0.001 for GEn 600 mg vs. placebo and GEn 1200 mg vs. placebo). The combined IRLS-pain response subanalysis included 366 patients with a baseline IRLS total score ≥15 and pain score ≥4 (placebo, n = 133; GEn 600 mg, n = 86; GEn 1200 mg, n = 147). Most patients were both IRLS and pain responders (placebo, 40 %; GEn 600 mg, 70 %; GEn 1200 mg, 67 %). Spearman rank correlations between IRLS total and pain score (change from baseline to week 12) were moderate or strong. The most frequent treatment-emergent adverse events were somnolence (placebo, 5 %; GEn 600 mg, 20 %; GEn 1200 mg, 23 %) and dizziness (placebo, 4 %; GEn 600 mg, 13 %; GEn 1200 mg, 22 %).
CONCLUSIONS
This post hoc pooled analysis suggests that GEn (600 and 1200 mg) once daily significantly improved pain associated with moderate-to-severe primary RLS in adults; however, the analysis was not powered to detect statistical differences between the two GEn doses. Numerically, more GEn-treated patients had a combined IRLS-pain response than placebo-treated patients.
背景
患有中度至重度原发性不宁腿综合征（RLS）的成年人常经历疼痛性感觉异常，这可能导致生活质量受损。
目的
本研究旨在评估加巴喷丁恩卡比（GEn）对成人中度至重度原发性 RLS 相关疼痛的影响。
方法
对三项双盲、随机、安慰剂对照、为期 12 周的试验（NCT00298623、NCT00365352、NCT01332305）的数据进行了汇总，这些试验纳入了接受 GEn 或安慰剂每日一次治疗的成年人。评估平均每日 RLS 疼痛评分的变化和联合国际不宁腿综合征量表（IRLS）-疼痛反应。
结果
意向治疗人群包括 671 名成年人（安慰剂组 n=244；GEn 600mg 组 n=161；GEn 1200mg 组 n=266）。GEn 两种剂量均能显著改善第 12 周的平均每日 RLS 疼痛评分（与安慰剂相比，GEn 600mg 组和 GEn 1200mg 组 p<0.001）。联合 IRLS-疼痛反应亚分析纳入了基线 IRLS 总分≥15 分且疼痛评分≥4 分的 366 名患者（安慰剂组 n=133；GEn 600mg 组 n=86；GEn 1200mg 组 n=147）。大多数患者既是 IRLS 也是疼痛反应者（安慰剂组 40%；GEn 600mg 组 70%；GEn 1200mg 组 67%）。IRLS 总分与疼痛评分（从基线到第 12 周的变化）之间的 Spearman 等级相关系数为中度或高度相关。最常见的治疗相关不良事件为嗜睡（安慰剂组 5%；GEn 600mg 组 20%；GEn 1200mg 组 23%）和头晕（安慰剂组 4%；GEn 600mg 组 13%；GEn 1200mg 组 22%）。
结论
这项事后汇总分析表明，GEn（600 和 1200mg）每日一次治疗可显著改善成年人中度至重度原发性 RLS 的疼痛；然而，该分析未检测到两种 GEn 剂量之间的统计学差异。与安慰剂组相比，接受 GEn 治疗的患者中有更多的患者出现联合 IRLS-疼痛反应。
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