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Title: Long-Term Ropinirole for Restless Legs Syndrome Tolerable: Presented at AGS

"Long-Term Ropinirole for Restless Legs Syndrome Tolerable: Presented at AGS"

By Crystal Phend CHICAGO, I.L. -- May 5, 2006 -- Long-term use of the dopamine agonist ropinirole appears to be generally well tolerated in patients with restless legs syndrome (RLS), according to a study presented here at American Geriatrics Society 2006 Annual Scientific Meeting (AGS). RLS is typically a chronic condition associated with an irresistible urge to move the legs. Individuals with the syndrome often have sleep disturbance and impaired quality of life. Previous studies have shown short-term efficacy and safety for ropinirole in individuals with condition. Ropinirole is approved by the FDA for treatment of moderate-to-severe primary RLS. Controlled studies previously evaluated the drug's safety for up to 36 weeks. To determine the drug's long-term tolerability, researchers therefore conducted a study of the safety of ropinirole in 2 studies of 52-week duration. The researchers enrolled patients from these earlier studies into 2 multicenter, 52-week, open-label studies. Together, the open-label studies included a total of 390 patients with primary RLS based on diagnostic criteria from the International Restless Legs Syndrome (IRLS) Study Group and at least 15 nights of RLS symptoms in the month prior to study entry. Participants received once-daily ropinirole titrated from 0.25 to 4.0 mg per day, which was to be taken 1 to 3 hours before bedtime. Dose adjustment was allowed during the course of the studies. Baseline IRLS score averaged 22.1 with a range of 0 to 40. The mean ropinirole dose was 1.9 mg per day, with about 12% of patients receiving the maximum of 4.0 mg per day. "Most adverse events were first reported during the up-titration phase and few resulted in patient withdrawal from the studies," said lead author Daniel O. Lee, MD, associate clinical professor of medicine, University Health System, East Carolina University, Greenville, North Carolina, in a presentation on May 4[^th.

Overall, 89% of patients reported at least 1 adverse event. The most frequent adverse events were nausea (37.2%), headache (18.5%), and joint pain (12.3%). Nasopharyngitis, back pain, dizziness, somnolence, and vomiting each occurred in about 10% of patients.

Most adverse events were mild or moderate in intensity. Ten percent of patients reported serious adverse events.

One treatment-related or possibly treatment-related serious adverse event was recorded, a case of benign intracranial hypertension that resolved without change in the dose of ropinirole.

Overall, 8.4% of patients withdrew from the 2 studies due to adverse events. Nausea accounted for 1.6%.

Average orthostatic and sitting blood pressure values were within a normal range at all time points. "There were few measurements that met prespecified criteria for potential concern," Dr. Lee said.

REFERENCES:
1. Allen et al. Sleep Med. 2003;4:101-119.
2. Hening et al. Sleep Med. 2004;5:237-246.
3. Milligan et al. Drugs Aging. 2002;19:741-751.

[Presentation title: Long-Term Tolerability of Ropinirole in Restless Legs Syndrome (RLS): Results From Two 52-Week Studies. Poster A101]

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