title: The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis.
abstract: OBJECTIVE
  Transdermal delivery of rotigotine maintains stable plasma concentrations for 24 hours. Three phase 3 studies of rotigotine as add-on to levodopa in advanced Parkinson's disease showed a significant reduction in "off" time from baseline to end of maintenance (EoM). However, detailed analyses over the range of a day have not yet been performed. The objective was to examine the time course of the efficacy profile of rotigotine throughout the day.
  
  
  METHODS
  Post hoc analysis of diary data from 3 double-blind, placebo-controlled studies of rotigotine in patients with advanced Parkinson's disease inadequately controlled with levodopa, with average "off" time of ≥2.5 h/d (CLEOPATRA-PD [NCT00244387], 16-week maintenance; PREFER, 24-week maintenance; SP921 [NCT00522379], 12-week maintenance). Patients marked 30-minute intervals as "off," "on without troublesome dyskinesia," "on with troublesome dyskinesia," or "sleep." Diaries completed on the 3 days before EoM were analyzed. A 2-sample t test was performed for comparison of rotigotine + levodopa versus placebo + levodopa for mean percentage of time per status during four 6-hour periods: 12:00AM (midnight) to 6:00AM, 6:00AM to 12:00PM (noon), noon to 6:00PM, and 6:00PM to midnight.
  
  
  RESULTS
  Data were available for 967 patients (placebo + levodopa, 260; rotigotine + levodopa, 707). During the 24-hour period at EoM, an advantage in mean percentage time spent "off" and "on without troublesome dyskinesia" was observed with rotigotine + levodopa versus placebo + levodopa during the three 6-hour periods from 6:00AM to midnight (P < 0.05; exploratory analysis).
  
  
  CONCLUSIONS
  These exploratory analyses of patients with motor fluctuations suggest that the efficacy of rotigotine transdermal patch, as captured by diary data, in reducing "off" time and increasing "on time without troublesome dyskinesia" may cover the full waking day.
authors.affiliation: *Department of Neurology, Henry Ford Hospital; and †Department of Neurology, Wayne State University School of Medicine, Detroit, MI; ‡Medical University of Innsbruck, Innsbruck, Austria; §Gardner-McMaster Parkinson Center, University of Toledo, Toledo, OH; ∥UCB Pharma, Raleigh, NC; and ¶UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Peter A
authors.initials: PA
authors.lastname: LeWitt
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
authors.forename: Lawrence W
authors.initials: LW
authors.lastname: Elmer
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Asgharnejad
authors.forename: Babak
authors.initials: B
authors.lastname: Boroojerdi
authors.forename: Frank
authors.initials: F
authors.lastname: Grieger
authors.forename: Lars
authors.initials: L
authors.lastname: Bauer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology*; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*; D014851:Wakefulness / Q000187:drug effects*
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; D007980:Levodopa; C047508:rotigotine