The study evaluated both the efficacy and adverse event profile of Requip in patients with both primary and secondary RLS. Requip is a second-generation dopamine agonist currently indicated in the U.S. for the treatment of the signs and symptoms of both early and advanced stages of Parkinson's disease.
"The results of this study are encouraging and indicate that there may be a role for Requip in the future treatment of restless legs syndrome," said William Ondo, M.D., study author and assistant professor of neurology at the Baylor College of Medicine. "Current medications for restless legs syndrome vary greatly and are often associated with significant side effects. We are pleased that this preliminary study shows that Requip was not only effective in relieving the symptoms of Restless legs syndrome in these patients, but was also associated with relatively mild adverse events."
Up to 12 million Americans suffer from restless legs syndrome, a movement disorder characterised by unusual sensations that occur typically deep within the legs, occasionally in the arms and infrequently in other body parts. These sensations result in an urge to move the extremities that can eventually become completely involuntary.
Since RLS is worse at night, it can lead to severe insomnia and excessive daytime sleepiness; sometimes causing patients to go days without sleep. RLS can also prevent patients from conducting certain daily activities such as sitting for extended periods of time or riding in a car.
Traditional drug therapies for RLS include older dopaminergic agents (such as levodopa/carbidopa, bromocriptine and pergolide), benzodiazepines, opioids and anticonvulsants. These medications have varying degrees of success in relieving symptoms and may be associated with significant side effects. Requip, a second-generation dopaminergic agent, although not indicated for RLS, was shown in this study to alleviate the symptoms of RLS and was associated with a mild side-effect profile.
In an open-label trial, patients with primary or secondary RLS were treated with 0.25mg doses of Requip on an individualized basis (for example, patients with night-time symptoms received only evening doses; patients with symptoms during the day received doses two-to-three times a day). Requip doses were titrated upwards until symptoms were resolved or adverse events became intolerable. Patients were permitted to reduce or discontinue other RLS medications if symptoms disappeared with Requip, but were not permitted to increase or add any other medications.
Drug effectiveness was assessed by having patients in the study complete a short questionnaire developed by the International Restless Legs Syndrome Study Group. Patients also gave an indication of drug effectiveness by subjectively rating Requip compared to other medications they had previously taken for RLS and provided a global impression of the overall effectiveness of Requip.
Thirteen of the 16 patients completed the trial and reported a more than 58 percent improvement in their RLS symptoms. Specifically, 10 patients reported marked improvement and three patients reported moderate improvement of their RLS symptoms.
Requip was generally well-tolerated. In the majority of patients, adverse events were generally mild and included sedation, nausea, fatigue, dyspepsia, shoulder pain, acne and hypomania. Three patients discontinued the therapy because of side effects. As recommended for patients with Parkinson's disease, all patients should be informed that syncope or symptomatic hypotension may occur more frequently during initial treatment or with an increase in dose. Hallucinations can occur at any time during the course of treatment with dopamine agonists such as Requip. Further clinical trials will need to be conducted to determine if these adverse events will occur in patients with RLS.<
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