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Ropinirole Useful for Restless Legs Syndrome: Presented at AAN

By Jill Stein

MIAMI, FL -- April 12, 2005 -- The dopamine agonist ropinirole is usually effective and well tolerated when used as long-term treatment for restless legs syndrome (RLS), according to data presented here on April 12^th at the American Academy of Neurology 57^th Annual Meeting.

Diego Garcia-Borreguero, MD, director, Sleep Disorders Centre, Universidad Autonoma de Madrid, Madrid, Spain, presented the results of pooled data from 2 52-week, open-label, extension studies that enrolled patients with RLS.

All subjects initially had a diagnosis of idiopathic RLS according to the International Restless Legs Scale, a minimum of 15 nights of RLS symptoms in the prior month, and a score of at least 15 on the IRLSSG-derived scale of severity.

Overall, 391 patients were enrolled, and 311 completed 52 weeks of open-label ropinirole treatment, at an initial dose of 0.25 mg/day, followed by flexible dose titration to a maximum of 4.0 mg/day. The mean total daily dose of ropinirole was 1.66 mg/day.

Adverse events associated with ropinirole were reported by 89.0% of patients. The rates were 91.3% in 1 study and 80.2% in the other study.

The most common reported adverse event was nausea.

Most patients reported adverse events that were mild or moderate in intensity -- 72.3% were mild in severity, 68.5% were moderate, and 31.3% were severe.

The rates of dose reduction and study discontinuation due to adverse events were low, with 8.7% of patients dropping out of the study because of reported adverse events.

Dose augmentation due to worsening RLS was required in 3.8% of patients.

The efficacy assessments included 308 and 81 patients in each study, who received a mean dose of 1.6 and 1.7 mg/day of ropinirole, respectively, and comprised the intent-to-treat population.

Improvements in IRLS total scores were sustained for up to 52 weeks overall.

Overall, 81.0% and 70.7% of patients were "much improved" or "very much improved" on the Clinical Global Impressions-Improvement scale at week 52 observed case and week 52 last observation carried forward.

Improvements were observed in the 4 relevant domains in the Medical Outcomes Study Sleep Scale.

"Restless legs syndrome is a chronic disorder with patients usually needing long-term therapy, and our results show that ropinirole is highly valuable in patients with this condition," Dr. Garcia-Borreguero said.

Restless legs syndrome is a chronic condition associated with an urge to move the legs and usually accompanied by unpleasant sensations in the legs that have been described as crawling, pulling, and burning. The symptoms are usually worse in the evening or at night and are associated with sleep disturbances and impaired quality of life.

The study was sponsored by GlaxoSmithKline Research and Development.


[Presentation title: Ropinirole is Well-Tolerated and Effective for the Long-Term Treatment of Restless Legs Syndrome. Abstract P01.046]

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