Abstract：
BACKGROUND:Restless legs syndrome (RLS) often responds to agents that enhance dopamine neurotransmission. The present 12-week study aimed to evaluate the efficacy and adverse events of pramipexole (PPX) for the treatment of adult, Chinese people with primary RLS. METHODS:A total of 204 Chinese people with RLS were randomly assigned to receive either the placebo or PPX (flexibly titrated from 0.25 mg to 0.75 mg), 2 h to 3 h before bedtime for 12 weeks. The primary measuring outcomes were the International RLS Study Group Rating Scale (IRLS) and the Clinical Global Impressions-Improvement (CGI-I) scale. The secondary outcome was adverse events. RESULTS:One hundred and ninety participants completed the study. At 12 weeks, the adjusted mean (SE) change from baseline was greater for PPX (vs placebo) for the IRLS score (-13.2 ± 0.7 vs -9.4 ± 0.6; p <0.01), and (-12.1 ± 0.6 vs -8.3 ± 0.6; p <0.01) at the end of one month follow-up after treatment. The CGI-I rating of "very much improved" or "much improved" in the percentage of participants (61.8% vs 34.3%; p <0.01), and (51.0% vs 26.5%; p <0.01) after week 12, and one month follow-up of treatment, respectively. The proportion of adverse events was 60.8% in the PPX group and 45.1% in the placebo group. No deaths related to PPX treatment were recorded. CONCLUSIONS:In summary, the present study showed that PPX is efficacious and well tolerated in Chinese people with primary RLS.
journal_name
Sleep Medjournal_title
Sleep medicineauthors
Zhang J,Liu B,Zheng Y,Chu T,Yang Zdoi
10.1016/j.sleep.2014.09.015subject
Has Abstractpub_date
2015-01-01 00:00:00pages
181-5issue
1eissn
1389-9457issn
1878-5506pii
S1389-9457(14)00479-1journal_volume
16pub_type
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