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Efficacy and tolerability of pramipexole for the treatment of primary restless leg syndrome: a meta-analysis of randomized placebo-controlled trials

Authors Zhang W, Wang Y, Cong SY, Nao JF, Feng J, Bi GR

Received 4 June 2013

Accepted for publication 1 July 2013

Published 30 July 2013 Volume 2013:9 Pages 1035—1043


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Wei Zhang, Ye Wang, Shu Yan Cong, Jian Fei Nao, Juan Feng, Guo Rong Bi

Neurology Department, Shengjing Hospital of China Medical University, Shenyang, People’s Republic of China

Abstract: Primary restless leg syndrome (RLS) is a common sensory-motor disorder that is characterized by an irresistible urge to move the limbs and unpleasant sensations in the legs, which affects 1.9%–4.6% adults. Pramipexole, a potent dopamine D2/3 agonist, is recommended as “effective” in the short-term and “possibly effective” in the long-term treatment of primary RLS in the European guidelines on management of RLS. In this meta-analysis, we summarized the efficacy and tolerability of pramipexole in treatment for primary RLS. Results of this meta-analysis showed a favorable effect of pramipexole versus placebo on RLS symptoms (mean change on International RLS Study Group Rating Scale [IRLS] score: mean difference [MD] = -5.96; 95% confidence interval [CI]: -7.79 to -4.41, P < 0.00001) and sleep quality (pooled standard mean difference [SMD] = -0.48, 95% CI: -0.61 to -0.35, P < 0.00001). Nausea (relative risk [RR] = 2.68, 95% CI: 1.82 to 3.95, P < 0.001) and fatigue (RR = 1.82, 95% CI: 1.14 to 2.93, P = 0.013) were the most common adverse events, but, by and large, pramipexole was well-tolerated in patients with primary RLS. Nevertheless, long-term studies and more evidence of head-to-head comparisons of pramipexole with other dopamine agonists, anticonvulsants, and levodopa are needed.

Keywords: restless legs syndrome, pramipexole, meta-analysis

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