Background: Pramipexole and ropinirole have become the first-line treatment for restless legs syndrome. The aim of this study was to perform the first direct comparison between these two molecules in restless legs syndrome.
Methods: A double-blind, placebo-controlled, double-night and prospective investigation was carried out in 45 consecutive naïve patients with idiopathic restless legs syndrome. Each patient underwent two consecutive full-night polysomnographies: the first baseline recording was performed without premedication and, before the second recording, first group received a single oral dose of 0.25 mg pramipexole, second group a single oral dose of 0.5 mg ropinirole, and the remaining patients received placebo.
Results And Discussion: Both dopamine agonists improved restless legs syndrome symptoms and markedly suppressed periodic leg movements during sleep compared to placebo, without significant differences between pramipexole and ropinirole. No significant side effects, except for mild morning nausea (2 patients treated with ropinirole, 3 with pramipexole, and 1 with placebo), were reported.
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