By Maria Bishop
BOSTON, MA -- May 7, 2007 -- A novel 14-hour formulation of the dopamine agonist ropinirole controlled release (CR) significantly reduces symptoms in patients with moderate-to-severe primary restless legs syndrome (RLS), according to research presented here at the American Academy of Neurology (AAN) 59th Annual Meeting.
This reduction of RLS symptoms is accompanied by an improved overall health-related quality of life (QoL), according to the researchers.
Study presenter Ronald B. Ziman, MD, neurologist, Northridge Hospital Medical Center, Northridge, California, said that, for many patients with RLS, "symptoms begin in the late afternoon or early evening, and continue through the night." Therefore, a treatment with a long-lasting effect can have an important benefit.
In the 12-week, double-blind, placebo-controlled study Dr. Ziman and colleagues assigned 189 patients to 0.5 to 6.0 mg/day ropinirole CR and 195 patients to placebo. Treatment was titrated as needed and tolerated, and taken once daily (4 pm or later), 1 or 2 hours before the usual time of onset of RLS symptoms. Patients were aged 18 to 79 years.
The ropinirole group had a significantly greater mean improvement from baseline, defined as a reduction in score on the International Restless Legs Scale compared with the placebo group (adjusted mean treatment difference [AMTD]: -5.9, P <.001).
At week 12, ropinirole CR treatment was associated with a greater mean increase from baseline compared with placebo in the Overall Life Impact score of the Johns Hopkins RLS QoL questionnaire (AMTD: 9.1; P <.001).
At the last study visit, mean doses were 2.5 mg/day for the ropinirole CR group and 3.8 mg/day for the placebo group.
The total number of patients reporting adverse events leading to withdrawal during the treatment phase was 4% in the ropinirole CR group and 3% in the placebo group. The 3 most commonly reported adverse events in the treatment group were nausea, headache, and somnolence.
This study was supported by GlaxoSmithKline Research and Development.
The researchers concluded that treatment with ropinirole CR reduces the symptoms of RLS and improves quality of life in patients with moderate-to-severe primary RLS.
[Presentation title: Ropinirole CR -- An Extended-Release Formulation -- Improves Quality of Life in Patients With Moderate-to-Severe Primary Restless Legs Syndrome (RLS): Results From a 12-Week Pivotal Study. Abstract P06.006]
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