ROPINIROLE MAY BE SAFE AND EFFECTIVE FOR RESTLESS LEGS SYNDROME

Ropinirole is safe and effective for the treatment of restless legs syndrome (RLS), according to the results of a randomized, multinational trial published in Movement Disorders.

In this 12-week, double-blind, parallel-group study, 267 outpatients with moderate-to-severe RLS were randomized to receive ropinirole, 0.25 to 4.0 mg/day, or placebo, one to three hours before bedtime. Primary outcome was the change in International Restless Legs Scale (IRLS) score at Week 12, and secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression Improvement (CGI-I) scale at Week 12, and changes in IRLS and CGI-I scale scores at Week 1. The Medical Outcomes Study (MOS) sleep scale and RLS Quality of Life (QoL) questionnaire were also administered.

Compared with placebo, improvements were significantly greater for ropinirole for change in IRLS score at Week 12. The ropinirole group also fared better than the placebo group in all key secondary endpoints, sleep, and QoL parameters. Improvements appeared as early as Week 1 and continued through Week 12, suggesting rapid and sustained relief of symptoms.

Although ropinirole treatment was associated with adverse events typical for dopamine agonists, it was generally well-tolerated, and withdrawal rates because of adverse events were comparable to those in the placebo group. Disease augmentation was not directly assessed, but it was not reported. Study limitations include the subjective nature of the disease, unknown sensitivity of the IRLS to linear treatment, and withdrawal from other treatments during the baseline assessment period.

"Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well-tolerated," the authors write, while acknowledging the need for further studies. "These data, therefore, support the first-line use of ropinirole for patients with RLS."