title: Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.
abstract: OBJECTIVE
  In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.
  
  
  METHODS
  Open-label rotigotine was titrated to optimal dose (≤16 mg/24 h). Concomitant levodopa was permitted. Dyskinesia data, recorded using the Unified Parkinson's Disease Rating Scale Part IV, were pooled from the two open-label studies.
  
  
  RESULTS
  Of 596 participants who received open-label rotigotine, 299 (50%) remained at trial closure; no patient discontinued due to dyskinesia. In the two studies, median exposure to rotigotine was 1910 days (∼5 years, 3 months), and 1564.5 days (∼4 years, 3 months). During up to 6 years of open-label rotigotine, 423/596 (71%) received levodopa. Dyskinesias were reported in 115/596 (19%) participants, 90/115 (78%) of who developed dyskinesia after levodopa was added; 25 reported dyskinesia in the absence of levodopa (includes patients who never received open-label levodopa, and those who reported dyskinesia before starting concomitant levodopa). Dyskinesia severity data were available for 107 of the 115 participants. In 56/107 (52%) participants, dyskinesia was considered 'not disabling' for all occurrences; the worst-case severity was 'mildly disabling' for 33/107 (31%), and 'moderately' or 'severely disabling' for 18/107 (17%; 3% of total participants).
  
  
  CONCLUSIONS
  During treatment with rotigotine in patients with PD for up to 6 years the incidence of dyskinesia was low, and the dyskinesia was generally 'not disabling' or 'mildly disabling'.
authors.affiliation: Department of Neurology, Tel-Aviv University, Tel-Aviv, Israel; Sago School of Neuroscience, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: nirg@tlvmc.gov.il.
authors.forename: Nir
authors.initials: N
authors.lastname: Giladi
authors.affiliation: UCB Pharma, Brussels, Belgium.
authors.forename: Liesbet
authors.initials: L
authors.lastname: Ghys
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Erwin
authors.initials: E
authors.lastname: Surmann
authors.affiliation: UCB Biosciences Inc., Raleigh, NC, USA.
authors.forename: Babak
authors.initials: B
authors.lastname: Boroojerdi
authors.affiliation: Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Department of Neurology, Houston, TX, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Jankovic
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000008:administration & dosage*; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D020820:Dyskinesias / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007980:Levodopa / Q000627:therapeutic use; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D012737:Sex Factors; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*
chemical_list: D000978:Antiparkinson Agents; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; D007980:Levodopa; C047508:rotigotine
keywords: Dyskinesia; Levodopa; Parkinson's disease; Rotigotine