Abstract
To compare efficacy and safety of the dopamine agonist pramipexole (PPX) versus reference treatment with dual release levodopa/benserazide (L/B) in de novo patients with restless legs syndrome (RLS). A total of 39 men and women between 25 and 85 years old, fulfilling all clinical criteria for diagnosis of idiopathic RLS, previously untreated, participated. The study was performed as a randomised, double-blind, double-dummy crossover trial with two treatment periods of four weeks and took place in six Swiss certified sleep-centres. Interventions were PPX 0.25-0.75 mg and dual-release L/B 125-375 mg. The primary outcome measure was the frequency of periodic limb movements while in bed (PLM index, PLMI). Secondary endpoints included the changes in patient ratings on the International RLS Study Group Rating Scale (IRLS). Both pramipexole and dual-release L/B were effective in reducing PLM and RLS symptoms. Mean PLMI reduction was -11.5 for PPX and -7.7 for L/B (baseline 21.1 and 21.5), and the mean IRLS score reduction was -7.2 and -4.0 (baseline 20.8 and 21.1). In patients with an IRLS score >20 (38%), a significantly (p = 0.047) higher PLMI reduction for PPX (-8.5), as compared to L/B (-4.3), was found. A higher incidence of "augmentations" and "involuntary movements" for L/B, and "nausea or vomiting" and "hypotension with dizziness" for PPX treatment were noted as adverse effects. This study showed comparable effects of PPX versus dual-release L/B for short-term treatment of de novo patients with mild to moderate RLS.
Highlights
Restless legs syndrome (RLS) is the most common movement disorder and one of the most common sleep-related disorders with a frequency in the general population between 2 to 10% [1]
The primary outcome measure was the frequency of periodic limb movements while in bed (PLM index, PLMI)
Secondary endpoints included the changes in patient ratings on the International restless legs syndrome (RLS) Study Group Rating Scale (IRLS)
Summary
Restless legs syndrome (RLS) is the most common movement disorder and one of the most common sleep-related disorders with a frequency in the general population between 2 to 10% [1]. Levodopa administered near bedtime was of clear therapeutic value in treating RLS and PLMS in a series of controlled trials [7, 8]. Previous clinical trials have demonstrated that PPX is useful in short- and long-term treatment of RLS [9,10,11,12]. Only two studies comparing the clinical efficacy of levodopa and dopamine agonist therapy in RLS have been reported far [13, 14]. In a double-blind, cross-over randomised 16-day trial including 11 patients with idiopathic RLS, pergolide (0.125 mg/ d) was found to be superior to standard levodopa (250 mg/ d) in reduction of both PLMI (as assessed by polysomnography) and RLS symptoms (as assessed by a simple scale: complete, nearly complete and no relief) [13]. In a second double-blind, randomised, active-controlled, parallelgroup, multi-centre 30-week long-term study with 361 pa-
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