title: Impact of 6-month earlier versus postponed initiation of rotigotine on long-term outcome: post hoc analysis of patients with early Parkinson's disease with mild symptom severity.
abstract: OBJECTIVE
  Investigate impact of 6-month earlier versus postponed initiation of rotigotine in patients with early Parkinson's disease (PD) with mild symptom severity.
  
  
  BACKGROUND
  Long-term benefit of rotigotine in early-PD has been demonstrated: SP702 (NCT00594165) and SP716 (NCT00599196) were long-term, open-label extensions of double-blind, placebo-controlled studies of 6-month maintenance; rotigotine was well tolerated for up to 6 years, and demonstrated efficacy (Unified Parkinson's Disease Rating Scale [UPDRS] II + III below baseline) for ∼ 2 years (SP702) and ∼ 4 years (SP716).
  
  
  METHODS
  Post hoc analysis of patients at Hoehn and Yahr 1-2; groups defined by treatment received in 6-month double-blind studies: 'Rotigotine-Rotigotine' received rotigotine (n = 221), 'Placebo-Rotigotine' received placebo (n = 125).
  
  
  RESULTS
  At the start of open-label rotigotine maintenance, UPDRS II + III mean ± SD change from double-blind baseline was: -8.5 ± 10.6 'Rotigotine-Rotigotine', -7.7 ± 9.0 'Placebo-Rotigotine.' After this initial improvement scores gradually increased: It took ∼ 45 months for mean scores to cross baseline in 'Rotigotine-Rotigotine', and ∼ 21 months in 'Placebo-Rotigotine.' At the time mean UPDRS II + III had crossed baseline in 'Placebo-Rotigotine' (open-label week 84; ∼ 21 months), treatment difference (LS-mean) to 'Rotigotine-Rotigotine' change from baseline was -3.89 (95% CI -6.94, -0.84); p = 0.013.
  
  
  CONCLUSIONS
  In this post hoc analysis, 6-month earlier initiation of rotigotine resulted in slower return to baseline mean UPDRS II + III; initiation of rotigotine in patients with minimal/no functional disability or impairment may lead to an extended benefit.
authors.affiliation: University Hospital Cologne, Department of Neurology , Cologne , Germany +49 221 478 7494 ; +49 221 478 87512 ; Lars.timmermann@uk-koeln.de.
authors.forename: Lars
authors.initials: L
authors.lastname: Timmermann
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Asgharnejad
authors.forename: Babak
authors.initials: B
authors.lastname: Boroojerdi
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Dohin
authors.forename: Franz
authors.initials: F
authors.lastname: Woltering
authors.forename: Lawrence W
authors.initials: LW
authors.lastname: Elmer
mesh_terms: D000203:Activities of Daily Living; D000279:Administration, Cutaneous; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011446:Prospective Studies; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
keywords: Unified Parkinson’s Disease Rating Scale; activities of daily living; early Parkinson’s disease; long-term efficacy; motor control; rotigotine transdermal patch