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| |  APSS: Dopamine Agonists Safe, Effective for Long-term Treatment of Restless Legs Syndrome By W. A. Thomasson, PhD Special to DG News
CHICAGO, IL -- June 8, 2001 -- Several different dopamine agonists are effective for treatment of restless legs syndrome and presentations made yesterday at the annual meeting of the Associated Professional Sleep Societies demonstrated that two, pramipexole and pergolide, can be safely used for a year or more. Michael Silber, MD, and his colleagues at Mayo Clinic in Rochester, Minnesota, presented data on 75 patients treated with pramipexole and who were followed for up to 29 months (mean 13.1 months). Significantly, all but three of these patients had failed previous therapy, usually with levodopa or pergolide. Treatment began with a single, low daily dose and was increased until a therapeutic effect was achieved. The average final dose in the 61 patients with adequate follow-up data was 0.66 mg. Only 28 percent required a dose greater than 0.75 mg and there was no evidence that final dose increased with duration of use. Twenty-three percent eventually required daytime as well as evening doses. The drug proved effective in 67 percent of the patients and partially effective in 26 percent. Of the 61 patients adequately followed, 11 discontinued treatment - all but one for reasons involving adverse events. Only one however, discontinued after more than six months of treatment. Eleven patients developed augmentation - more intense symptoms during the daytime. Most, but not all, had experienced augmentation with levodopa or pergolide. As Dr. Silber noted, this frequency of augmentation is about the same as with pergolide but considerably less than is seen with levodopa. In all instances augmentation could be treated by adding doses earlier in the day, which is not generally true with levodopa. Twenty-four of the 61 patients experienced an adverse event, most commonly: insomnia (13 percent), nausea or dyspepsia (11 percent), and postural dizziness (10 percent). Dr. Silber said that this frequency of adverse events is somewhat lower than was seen in his previous study of pergolide. He also noted that sleepiness was rather uncommon. This session also saw reports on an even larger - 100 patients - trial of pergolide in which patients were followed for one year. Efficacy data were reported by Claudia Trenkwalder, MD, of the Max Plank Institute for Psychiatry in Munich, Germany and safety data by H.P. Hundemer, MD, of Lilly Deutchland in Bad Homburg, Germany, both joined by colleagues from a variety of institutions in Europe and Australia. A new technique of centralized, standardized reading of polysomnographic data made this multicenter trial possible. Patients were initially randomized to either pergolide or placebo, but those who reported no effect after six weeks were thereafter treated open-label with pergolide. Nevertheless, a small number of patients continued on placebo until the end of the study. There was no statistically significant difference in the number of adverse events between these patients and those treated with pergolide. The study likewise confirmed previous reports of pergolide’s efficacy in restless legs syndrome. In addition, data supporting the safety and efficacy of cabergoline was presented by Marco Zucconi, MD, and his colleagues at San Raffaele Hospital in Milan, Italy. This, however, was a smaller, shorter study, with 12 patients followed for three months.
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