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AAN: Restless Leg Syndrome Eased with Transdermal Medication

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maxandevelyn added to health: RLS

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Restless leg syndrome symptom scores improved about 36% with the highest doses of a once-daily rotigotine (Neupro) patch compared with placebo (P<0.001), reported Wayne Hening, M.D., Ph.D., of the University of Medicine and... See more » Restless leg syndrome symptom scores improved about 36% with the highest doses of a once-daily rotigotine (Neupro) patch compared with placebo (P<0.001), reported Wayne Hening, M.D., Ph.D., of the University of Medicine and Dentistry of New Jersey in New Brunswick, N.J., and colleagues, here at the American Academy of Neurology meeting. Once-daily transdermal treatment with the dopamine agonist may have an advantage for patients because of the much longer drug half-life compared with oral medications, commented Flavia Consens, M.D., of the University of Michigan in Ann Arbor, who chaired the session in which the findings were presented. Currently, "patients who have symptoms early in the evening have to take several doses" of oral medications, she said. However, this advantage may be moot since the FDA announced rotigotine patches in use for early Parkinson's disease are being withdrawn from the market at the end of April. The drug was found to crystallize on the patches, reducing effectiveness by limiting absorption through the skin. (See: Rotigotine (Neupro) Patch for Parkinson's Withdrawn from Market) The multicenter trial included 505 patients who met diagnostic criteria for moderate to severe restless leg syndrome. They were randomized to six months of double-blind treatment with placebo or rotigotine at a dose of 0.5, 1, 2, or 3 mg per 24 hours. Rotigotine was given as a patch applied once a day in the morning and left on for 24 hours. The lowest 0.5 mg/day dose had been expected to be subtherapeutic. There was a dose response improvement in symptoms measured on the International Restless Legs Scale (IRLS) with a significantly greater benefit for the two highest dose groups compared with placebo (change -13.5 and -14.2 versus -9 points, P<0.001). This improvement was similar to those seen with other dopaminergic agents, Dr. Hening said. For the secondary endpoints, the percentage of patients whose IRLS score fell by at least 50% from baseline was better than placebo for all but the lowest dose group (52% for 1 mg, 60% for 2 mg, and 67% for 3 mg/day versus 37% for placebo; P<0.05, P<0.01, and P<0.001, respectively). Likewise, the percentage of patients whose symptoms remitted with an IRLS score of 10 or less was significantly greater than placebo for all three higher dose groups (50%, 54%, and 62% versus 32%; P<0.05, P<0.01, and P<0.001, respectively). Individual symptoms showed similar trends, except that there was no difference in daytime tiredness with similar scores across groups. "I'd like to understand that," Dr. Hening said. "Initially we had the idea that because sleep was so much improved there would be less somnolence." Somnolence was also one of the most common adverse events, but there was no dose response relationship in incidence and rates were similar for placebo and the highest dose group at about 13%. The rate was also not dramatically different than that seen with other treatments for restless leg syndrome, he said. There were a fair number of application site reactions with the patch, but Dr. Hening said these appeared to be related to the drug rather than the patch itself since these reactions were more common at higher doses. See less »

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AAN: Restless Leg Syndrome Eased with Transdermal Medication

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