The weight of evidence for ropinirole in restless legs syndrome.

Evidence-based guidelines consider dopaminergic therapy to be the mainstay of treatment for restless legs syndrome (RLS). l-dopa has been shown to reduce RLS symptoms, but subsequent augmentation of symptoms occurs in up to 73% of patients during continued treatment. The ergot-derived dopamine agonist pergolide has been shown to be effective in small, open or placebo-controlled studies, but there have been reports of pleuropulmonary or cardiac valvular disease with this ergoline agent. Amongst the non-ergoline dopamine agonists, pramipexole has been reported to reduce RLS symptoms, but robust trial data are limited. By contrast, the RLS clinical trial programme with ropinirole is the largest published to date. This programme includes 12-week randomized double-blind placebo-controlled studies and a 36-week maintenance-of-effect study. Data from the placebo-controlled studies show that ropinirole, 0.25-4.0 mg/day, produces rapid and significant reductions, compared with placebo, in the sensory and motor symptoms of RLS, and that these benefits are associated with significant improvements in sleep and quality of life. In addition, the maintenance study has shown that these benefits are maintained during longer-term treatment. Furthermore, ropinirole is generally well tolerated. Ropinirole thus represents a potential valuable approach to the management of RLS.

RCT Entities:   Population Interventions Outcomes