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

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&rsquo;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%&ndash;4.6% adults. Pramipexole, a potent dopamine D2/3 agonist, is recommended as &ldquo;effective&rdquo; in the short-term and &ldquo;possibly effective&rdquo; 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-analysi