Augmentation in the treatment of restless legs syndrome with transdermal rotigotine
| Autor: | Diego Garcia-Borreguero, Erwin Schollmayer, Luigi Ferini-Strambi, Heike Benes, Ralf Kohnen, Andreas Fichtner |
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| Rok vydání: | 2012 |
| Předmět: |
Tetrahydronaphthalenes
Thiophenes Administration Cutaneous Placebo Severity of Illness Index Dopamine agonist Time pattern Risk Factors Restless Legs Syndrome Severity of illness medicine Humans Restless legs syndrome Retrospective Studies Transdermal Dose-Response Relationship Drug business.industry Rotigotine Retrospective cohort study General Medicine medicine.disease United States Europe Anesthesia Dopamine Agonists Controlled Clinical Trials as Topic business medicine.drug |
| Zdroj: | Sleep Medicine. 13:589-597 |
| ISSN: | 1389-9457 |
| DOI: | 10.1016/j.sleep.2011.09.016 |
| Popis: | Objective To assess the risk of augmentation under treatment with the transdermally delivered dopamine agonist rotigotine for restless legs syndrome (RLS). Methods Experts in RLS augmentation retrospectively reviewed data from two double-blind, placebo-controlled 6-month trials (745 rotigotine and 214 placebo subjects, NCT00136045 and NCT00135993) and from two open-label 1-year trials (620 rotigotine subjects, NCT00498108 and NCT00263068). All study visits were systematically evaluated applying the Max Planck Institute (MPI) criteria for the diagnosis of both augmentation and clinically relevant augmentation. Results MPI criteria for augmentation were met on at least one visit by 8.2% of all subjects in the double-blind trials with 12 subjects meeting the criteria for clinically relevant augmentation: 11 under rotigotine (1.5%) and one under placebo treatment. In the open-label trials, 9.7% of all subjects met the MPI criteria for augmentation and 2.9% met the criteria for clinically relevant augmentation. None of the patients treated with rotigotine for up to 1.5 years (double-blind plus open-label trial) discontinued prematurely owing to augmentation. Neither could dose-dependency or a time pattern for clinically relevant augmentation episodes be detected. Conclusions Our analyses suggest that the risk for clinically relevant augmentation for the duration of up to 18 months of rotigotine treatment is low. |
| Databáze: | OpenAIRE |
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