title: Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany.
abstract: OBJECTIVE
  We aimed to assess effectiveness and tolerability of rotigotine in patients with moderate to severe idiopathic restless legs syndrome (RLS) under daily practice conditions in Germany.
  
  
  METHODS
  In this 3-month noninterventional study, effectiveness was assessed using RLS-6 (primary variables were symptom severity when falling asleep [item 2] and during the night [item 3]). Data were collected at baseline and at the end of treatment. Safety assessments included adverse events (AEs).
  
  
  RESULTS
  Six hundred and eighty-four patients were treated with rotigotine and 418 (61%) completed the study. The full analysis set (FAS) comprised 564 patients (106 de novo; 458 pretreated [454 had complete rotigotine dosing data]). Mean rotigotine dose of longest duration was 2.4±1.4 mg/24 h. Rotigotine improved all RLS-6 items (mean change from baseline [item 2], -2.4±3.6; [item 3], -2.7±3.4), with the most pronounced improvement observed in daytime symptoms while at rest (item 4, -2.9±3.2). AEs were typical of dopaminergic treatment and transdermal administration. De novo patients generally started rotigotine on 1 mg/24 h (85% [90/106]) and pretreated patients on 1 (50% [227/454]) or 2 mg/24 h (40% [183/454]). Most patients who were pretreated with levodopa (57%), pramipexole (84%), or ropinirole (78%) monotherapy discontinued these medications on initiation of rotigotine.
  
  
  CONCLUSIONS
  Rotigotine was effective and well-tolerated when used in routine clinical practice.
authors.affiliation: Somnomar, Institute for Medical Research and Sleep Medicine, Marburger Str. 9a, Marburg 35043, Germany. stiasny-kolster@somnomar.de
authors.forename: Karin
authors.initials: K
authors.lastname: Stiasny-Kolster
authors.forename: Daniela
authors.initials: D
authors.lastname: Berg
authors.forename: Werner E
authors.initials: WE
authors.lastname: Hofmann
authors.forename: Reinhard
authors.initials: R
authors.lastname: Berkels
authors.forename: Frank
authors.initials: F
authors.lastname: Grieger
authors.forename: Thomas
authors.initials: T
authors.lastname: Lauterbach
authors.forename: Erwin
authors.initials: E
authors.lastname: Schollmayer
authors.forename: Cornelius G
authors.initials: CG
authors.lastname: Bachmann
mesh_terms: D000368:Aged; D052160:Benzothiazoles / Q000008:administration & dosage / Q000009:adverse effects; D018491:Dopamine Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005858:Germany; D006801:Humans; D007980:Levodopa / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000077487:Pramipexole; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D012646:Self Administration; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D052160:Benzothiazoles; D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; D007980:Levodopa; D000077487:Pramipexole; C047508:rotigotine