title: Rotigotine and specific non-motor symptoms of Parkinson's disease: post hoc analysis of RECOVER.
abstract: BACKGROUND
  Non-motor symptoms of Parkinson's disease (PD) represent major causes of morbidity. RECOVER, a randomized controlled trial of rotigotine transdermal system, was the first prospective controlled trial to use the Non-Motor Symptoms Scale (NMSS) as an exploratory outcome for assessment of treatment effects on non-motor symptoms in PD. Rotigotine improved NMSS total score compared with placebo, and the "Sleep/fatigue" and "Mood/apathy" domains. This post hoc analysis further characterizes the effects of rotigotine on sleep/fatigue and mood/apathy.
  
  
  METHODS
  Patients with PD and unsatisfactory early-morning motor impairment were randomized to transdermal patches of rotigotine (2-16 mg/24 h) or placebo. Treatment was titrated to optimal dose over 1-8 weeks, maintained for 4 weeks. The NMSS was assessed at baseline and end of treatment. Post hoc analyses are presented for individual items of the "Sleep/fatigue" and "Mood/apathy" domains. The interpretation of p-values is considered exploratory in nature.
  
  
  RESULTS
  Of 287 patients randomized, NMSS data were available for 267 patients (178 rotigotine, 89 placebo). Within the "Sleep/fatigue" domain there was a significant difference, in favor of rotigotine, in change from baseline score in 1 of 5 items: "fatigue (tiredness) or lack of energy" (ANCOVA, p < 0.0001). Within the "Mood/apathy" domain, there were significant differences in favor of rotigotine in 4 of 7 items: "lost interest in surroundings" (p < 0.0001), "lost interest in doing things" (p < 0.0001), "seems sad or depressed" (p < 0.01), and "difficulty experiencing pleasure" (p < 0.05).
  
  
  CONCLUSIONS
  Rotigotine transdermal system may improve non-motor symptoms such as fatigue, symptoms of depression, anhedonia, and apathy in patients with PD; further prospective controlled studies are required to confirm this post hoc analysis.
authors.affiliation: National Parkinson Foundation Centre of Excellence, King's College Hospital, and MRC Centre for Neurodegeneration Research, King's College, London, UK. ray.chaudhuri@nhs.net
authors.forename: K
authors.initials: K
authors.lastname: Ray Chaudhuri
authors.forename: Pablo
authors.initials: P
authors.lastname: Martinez-Martin
authors.forename: Angelo
authors.initials: A
authors.lastname: Antonini
authors.forename: Richard G
authors.initials: RG
authors.lastname: Brown
authors.forename: Joseph H
authors.initials: JH
authors.lastname: Friedman
authors.forename: Marco
authors.initials: M
authors.lastname: Onofrj
authors.forename: Erwin
authors.initials: E
authors.lastname: Surmann
authors.forename: Liesbet
authors.initials: L
authors.lastname: Ghys
authors.forename: Claudia
authors.initials: C
authors.lastname: Trenkwalder
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D057565:Apathy / Q000187:drug effects; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy* / Q000209:etiology; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*; D011569:Psychiatric Status Rating Scales; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine