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A method to switch from oral dopamine agonists to rotigotine in patients with restless legs syndrome and mild augmentation
Institution:1. Departments of Psychiatry and Neurology, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Square, Boston, MA 02114, USA;2. Department of Medicine, Brigham and Women''s Hospital, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA;3. Massachusetts General Hospital, 1 Bowdoin Square, Boston, MA 02114, USA;4. Marian University, 3200 Cold Spring Rd, Indianapolis, IN, USA;1. Channing Division of Network Medicine, Department of Medicine, Brigham and Women''s Hospital, and Harvard Medical School, USA;2. California Pacific Medical Center Research Institute, USA;3. Department of Health Studies, Center for Behavioral Neuroscience, American University, USA;4. Division of Epidemiology, Department of Family Medicine and Public Health, University of California San Diego, USA;5. Department of Psychiatry, University of California San Diego, USA;6. Department of Medicine, University of California San Diego, USA;7. Department of Psychiatry, University of California San Francisco, USA;8. Department of Neurology, University of California San Francisco, USA;9. Department of Epidemiology, University of California San Francisco, USA;10. Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, USA;11. Department of Medicine, University of Minnesota, USA;12. Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, USA;13. Department of Epidemiology and Biostatistics, University of California San Francisco, USA;14. Departments of Medicine, Brigham and Women''s Hospital and Beth Israel Deaconess Medical Center, and Harvard Medical School, USA;15. Oregon Clinical and Translational Research Institute and School of Medicine, Oregon Health and Science University, USA;p. Department of Epidemiology, H.T. Chan Harvard School of Public Health, USA;q. Department of Epidemiology, Center for Public Health, Medical University of Vienna, Austria;1. Department of Psychology, Umeå University, Sweden;2. Stress Research Institute, Stockholm University, Sweden;1. Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum, University of Bologna, Bologna, Italy;2. IRCCS Istituto delle Scienze Neurologiche di Bologna, ASL di Bologna, Bologna, Italy;3. Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genova, Italy;4. Sleep Research Centre, Department of Neurology I.C., Oasi Institute for Research on Mental Retardation and Brain Aging (IRCCS), Troina, Italy
Abstract:BackgroundWe examined the short- and long-term efficacy and tolerability of a cross-titration algorithm from oral dopamine agonists to the rotigotine transdermal patch in patients dissatisfied with their restless legs syndrome (RLS) treatment, predominantly with mild augmentation.MethodsPatients with RLS (n = 20) were recruited at a single site. The cross-titration consisted of decreasing oral dopaminergic agents (ropinirole by 1 mg or pramipexole by 0.25 mg) and increasing rotigotine by 1 mg every two days. Efficacy and adverse events (AEs) were assessed at one, three, six and 12 months after the switch.ResultsPatients had moderate–severe RLS symptoms at the baseline (mean international restless legs syndrome (IRLS) score 19.4 ± 5.5); 85% had augmentation and 45% reported afternoon RLS symptoms. The baseline mean pramipexole equivalent dose was 0.6 ± 0.3 mg. At Week 5, 85% (17/20) had successfully switched from their oral dopamine agonist to rotigotine (mean dose 2.5 ± 0.6 mg; change in IRLS score: ?6.7 ± 8.4, p = 0.002); 14 patients were CGI-I responders (much or very much improved). Three patients withdrew due to lack of efficacy. Twelve months after cross-titration, 10 patients continued on rotigotine, of whom four required either higher doses of rotigotine or supplemental RLS medication compared with their optimal Week 5 dose; five patients withdrew due to AEs and two due to lack of efficacy.ConclusionA cross-titration to rotigotine was efficacious after five weeks in 70% of patients dissatisfied with RLS treatment, most of whom had mild augmentation. At one year following the medication switch, 50% had discontinued rotigotine due to lack of continued efficacy or side effects.
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