Controlled withdrawal of pramipexole after 6 months of open‐label treatment in patients with restless legs syndrome
Controlled withdrawal of pramipexole after 6 months of open‐label treatment in patients with restless legs syndrome
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不宁腿综合征患者开放标签治疗 6 个月后控制普拉克索停药
DOI：
10.1002/mds.20983
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发表时间：
2006
影响因子：
8.6
通讯作者：
J. Reess
中科院分区：
文献类型：
--
作者：
C. Trenkwalder;K. Stiasny‐Kolster;A. Kupsch;W. Oertel;J. Koester;J. Reess
虽然多巴胺激动剂正在成为不宁腿综合征（RLS）的一线治疗，但很少有报告描述治疗时间超过12周。在此，150例在6个月导入期（平均剂量，0.50 mg）内对普拉克索有应答的RLS患者被随机分配接受安慰剂或继续接受普拉克索，个体优化剂量为0.125 - 0.75 mg/天，持续3个月。转换至安慰剂组的患者达到主要终点（临床总体不适-总体改善量表和国际RLS研究组评定量表的预定义恶化）的频率显著高于继续接受普拉克索的患者（85.5% vs. 20.5%; P < 0.0001）。他们也更快地达到主要终点，Kaplan-Meier生存估计值为0.85，5天与42天，7天与> 84天，估计值为0.5。在总共9个月的时间里，临床医生和患者对症状、睡眠和生活质量的评级未发现普拉克索的获益或耐受性下降。绝大多数不良事件（AE）为轻度或中度，属于预期类型。隆乳被视为AE，但在该应答者人群中未发生。© 2006运动障碍协会
Although dopamine agonists are becoming first‐line therapy for restless legs syndrome (RLS), few reports describe treatment periods exceeding 12 weeks. Here, 150 RLS patients who had responded to pramipexole during a 6‐month run‐in period (mean dose, 0.50 mg) were randomly assigned to receive placebo or continue receiving pramipexole at an individually optimized dose of 0.125 to 0.75 mg/day for a further 3 months. Patients switched to placebo reached the primary endpoint (a predefined worsening on both the Clinical Global Impressions‐Global Improvement scale and the International RLS Study Group Rating Scale) significantly more often than patients who continued to receive pramipexole (85.5% vs. 20.5%; P < 0.0001). They also reached the primary endpoint faster, in 5 versus 42 days to a Kaplan–Meier survival estimate of 0.85 and 7 versus > 84 days to an estimate of 0.5. Over the total 9 months, clinician and patient ratings of symptoms, sleep, and quality of life identified no decline in pramipexole's benefit or tolerability. The great majority of adverse events (AEs) were mild or moderate, and of expected types. Augmentation was considered an AE, but in this population of responders it did not occur. © 2006 Movement Disorder Society
影响因子：
4.5
作者：
Abetz, L;Vallow, SM;Earley, CJ
通讯作者：
Earley, CJ