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Title: Patients With Restless Legs Syndrome Helped by Extended Release Ropinirole: Presented at SLEEP

"Patients With Restless Legs Syndrome Helped by Extended Release Ropinirole: Presented at SLEEP"

By Micheal Casasnovas MINNEAPOLIS, MN -- June 18, 2007 -- Patients taking Ropinirole CR, a once-a-day extended release treatment for moderate-to-severe primary Restless Legs Syndrome, expressed significant satisfaction in symptom relief, doctors said at the 21st annual meeting of the Associated Professional Sleep Societies (SLEEP). "A total of 80% of patients receiving ropinirole CR reported being 'satisfied' or 'very satisfied' with their treatment," said Philip M. Becker, MD, president, Sleep Medicine Associates of Texas, Dallas, United States. Researchers designed a 12-week, randomised, double-blind, placebo-controlled study to observe the safety and efficacy of ropinirole CR. Patients were placed in two groups: ropinirole CR, -- 121 women, 68 men; and placebo, 132 women, 73 men. Both groups had similar baseline characteristics and patient demographics. All patients enrolled were between the ages of 18 and 79 years and diagnosed with Restless Legs Syndrome using the International Restless Legs Syndrome Study Group diagnostic criteria with a baseline score of equal to or greater than 15. It was also necessary for patients to have symptoms for at least 20 evenings and/or nights during the prior month and significant sleep impairment from those symptoms. This study shows that at week 12, a statistically significant greater improvement in mean IRLS total score was seen with ropinirole CR treatment, compared with placebo ([P <.001). The most commonly reported adverse events among patients receiving ropinirole CR versus placebo were nausea -- 28% for ropinirole versus 7% placebo; headache (20% vs. 18%), and somnolence (9% vs. 6%). Patients reporting adverse events leading to withdrawal were low; ropinirole CR (4%) and placebo (3%).

"Patient-assessed improvement with ropinirole CR was observed after the first night of treatment. Ropinirole CR-extended release- significantly improves restless legs syndrome symptoms in patients with moderate to severe primary restless legs syndrome," said Dr. Becker.

The study was funded by GlaxoSmithKline.

[Presentation title: Patient Satisfaction with Ropinirole CR, a Once-Daily Extended-Release Treatment for Moderate-to-Severe Primary Restless Legs Syndrome - Results from a 12-Week Pivotal Study. Abstract 0830]

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