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By Joan Unger, RN, MS, ARNP-C
Two recently published randomized, double- blind, placebo-controlled, crossover studies reported that patients suffering restless legs syndrome (RLS) obtained objective and subjective relief from dopamine agonists.
The first study, by Canadian researchers, involved 10 patients who were evaluated for sensory and motor manifestations before and after two one-month periods of treatment. Subjects completed one week of home questionnaires followed by two nights of recordings in a sleep laboratory. Subjects received an initial dose of 0.375 mg/day of pramipexole which, if tolerated, was increased to 0.75 mg/day after the first week and to 1.5 mg/day after the second week.
Investigators reported that pramipexole reduced the periodic leg movements during sleep to normal values and also significantly reduced the values during wakefulness. Patient questionnaires reported that the drug reduced leg discomfort at bedtime and during the night. Study authors stated, "Pramipexole is the most potent therapeutic agent ever tested for RLS."1
German investigators conducted a similar study using the long-acting D1 and D2 dopamine agonist, pergolide. Thirty patients, free of psychoactive drugs for at least two weeks prior to the study, were monitored using sleep diaries, polysomnography, and clinical ratings for four weeks. Patients took pergolide 0.05 mg at bedtime and increased the dosage by 0.05 mg each day as needed to a maximum of 0.75 mg/day. All patients also received domperidone TID.
Researchers found that at a mean dose of 0.51 mg as a single daily dose two hours before sleep, subjects had fewer periodic leg movements per hour of time in bed (5.7 vs. 54.9, p < 0.0001) and total sleep time was significantly lengthened (373 vs. 261 minutes, p < 0.0001). Subject ratings of sleep quality, quality of life, and severity of RLS improved significantly without relevant adverse events. Study authors conclude that pergolide in combination with domperidone as a single low-to-medium bedtime dose was well-tolerated and effective in treating sensorimotor symptoms and sleep disturbance in patients with RLS.2
1. Montplaisir J, Nicolas A, Denesle R, et al. Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology 1999;23:938-943.
2. Wetter TC, Stiasny K, Winkelmann J, et al. A randomized controlled study of pergolide in patients with restless legs syndrome. Neurology 1999;23:944-950.