加巴喷丁恩卡尼治疗不宁腿综合征的长期维持治疗：一项随机对照研究。
Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study.
机构信息
SleepMed, Columbia, SC 2920, USA.
出版信息
Mayo Clin Proc. 2010 Jun;85(6):512-21. doi: 10.4065/mcp.2009.0700.
OBJECTIVE
To assess maintenance of efficacy and tolerability of gabapentin enacarbil in patients with moderate to severe primary restless legs syndrome (RLS).
PATIENTS AND METHODS
This study (conducted April 18, 2006, to November 14, 2007) comprised a 24-week, single-blind (SB) treatment phase (gabapentin enacarbil, 1200 mg) followed by a 12-week randomized, double-blind (DB) phase. Responders from the SB phase (patients with improvements on the International Restless Legs Scale [IRLS] and investigator-rated Clinical Global Impression-Improvement scale at week 24 and stable while taking a gabapentin enacarbil dose of 1200 mg for at least 1 month before randomization) were randomized to gabapentin enacarbil, 1200 mg, or placebo once daily at 5 pm with food. The primary end point was the proportion of patients experiencing relapse (worse scores on the IRLS and investigator-rated Clinical Global Impression of Change scale on 2 consecutive visits at least 1 week apart or withdrawal because of lack of efficacy) during the DB phase.
RESULTS
A total of 221 of 327 patients completed the SB phase, 194 (96 in the gabapentin enacarbil group and 98 in the placebo group) were randomized to DB treatment, and 168 (84 in the gabapentin enacarbil group and 84 in the placebo group) completed the DB phase. A significantly smaller proportion of patients treated with gabapentin enacarbil (9/96 [9%]) experienced relapse compared with the placebo-treated patients (22/97 [23%]) (odds ratio, 0.353; 95% confidence interval, 0.2-0.8; P=.02). Somnolence and dizziness were the most common adverse events. One death occurred (unintentional choking during the SB phase) and was judged as being unrelated to the study drug. No clinically relevant changes were observed in laboratory values, in vital signs, or on electrocardiograms.
CONCLUSION
Gabapentin enacarbil, 1200 mg, maintained improvements in RLS symptoms compared with placebo and showed long-term tolerability in adults with moderate to severe primary RLS for up to 9 months of treatment.
目的
评估中重度原发性不安腿综合征（RLS）患者应用加巴喷丁恩卡尼的疗效维持和耐受性。
患者和方法
这项研究（2006 年 4 月 18 日至 2007 年 11 月 14 日进行）包括 24 周的单盲（SB）治疗阶段（加巴喷丁恩卡尼，1200mg），随后是 12 周的随机、双盲（DB）阶段。SB 阶段的应答者（IRLS 和研究者评定的临床总体印象-改善量表在第 24 周有改善，且在随机分组前至少 1 个月稳定服用加巴喷丁恩卡尼 1200mg 剂量）被随机分为加巴喷丁恩卡尼 1200mg 或安慰剂，每日一次，下午 5 时随餐服用。主要终点是 DB 阶段中出现复发（连续 2 次就诊时 IRLS 和研究者评定的临床总体印象变化量表评分恶化，或因疗效不佳而停药）的患者比例。
结果
共有 327 例患者中的 221 例完成了 SB 阶段，194 例（加巴喷丁恩卡尼组 96 例，安慰剂组 98 例）被随机分配至 DB 治疗，168 例（加巴喷丁恩卡尼组 84 例，安慰剂组 84 例）完成了 DB 阶段。与安慰剂组相比，加巴喷丁恩卡尼组（9/96[9%]）的患者发生复发的比例明显更小（22/97[23%]）（比值比，0.353；95%置信区间，0.2-0.8；P=0.02）。最常见的不良事件为嗜睡和头晕。1 例死亡（SB 阶段意外窒息），被判定与研究药物无关。实验室值、生命体征或心电图无临床相关变化。
结论
加巴喷丁恩卡尼，1200mg，与安慰剂相比维持了 RLS 症状的改善，并且在 9 个月的治疗中显示出对中重度原发性 RLS 成人的长期耐受性。
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