title: Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson's disease: an open-label study.
abstract: OBJECTIVE
  Investigate safety, feasibility and efficacy of switching therapy in patients with advanced-stage Parkinson's disease (PD) inadequately controlled with pramipexole (≤ 3.5 mg/day) or ropinirole (≤ 14 mg/day) to rotigotine transdermal system (≤ 14 mg/24 h; dose adjustments ≤ 16 mg/24 h permitted).
  
  
  METHODS
  PD0009 (ClinicalTrials.gov: NCT01711866) was an open-label study in patients with advanced-stage PD receiving levodopa, and experiencing sleep disturbance or early-morning motor impairment. Pramipexole/ropinirole was switched to equivalent dose rotigotine overnight or in two stages. During the 4-week treatment period rotigotine dose adjustments were permitted (up to 16 mg/24 h). Primary variable: Clinical Global Impressions (CGI) item 4: side effects (assessing safety) at end of treatment.
  
  
  RESULTS
  79/87 (91%) patients completed the study; 2 (2%) withdrew due to adverse events (AEs). Most (84; 97%) had CGI item 4 score < 3 indicating switch did not interfere with functioning; three experienced drug-related AEs interfering with functioning (score = 3). 62% patients improved on Patient Global Impression of Change, assessing effectiveness. AEs occurring ≥ 5%: application site pruritus (10%), application site erythema (7%), dizziness (7%), dyskinesia (7%), erythema (6%), pruritus (6%). Unified Parkinson's Disease Rating Scale II and III, Parkinson's Disease Sleep Scale-2 and Pittsburgh Sleep Quality Index were unchanged. Numerical improvements in 'off' time, awakenings and nocturias were observed.
  
  
  CONCLUSIONS
  Switch from pramipexole or ropinirole to rotigotine (up to 14 mg/24 h) was feasible and possibly associated with some benefit.
authors.affiliation: University of Ulsan College of Medicine, Asan Medical Center, Department of Neurology , Seoul , Republic of Korea.
authors.forename: Sun Ju
authors.initials: SJ
authors.lastname: Chung
authors.forename: Jong-Min
authors.initials: JM
authors.lastname: Kim
authors.forename: Jae Woo
authors.initials: JW
authors.lastname: Kim
authors.forename: Beom Seok
authors.initials: BS
authors.lastname: Jeon
authors.forename: Pritibha
authors.initials: P
authors.lastname: Singh
authors.forename: Stephan
authors.initials: S
authors.lastname: Thierfelder
authors.forename: Junji
authors.initials: J
authors.lastname: Ikeda
authors.forename: Lars
authors.initials: L
authors.lastname: Bauer
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D052160:Benzothiazoles / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D000077487:Pramipexole; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D000978:Antiparkinson Agents; D052160:Benzothiazoles; D007211:Indoles; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C046649:ropinirole; D007980:Levodopa; D000077487:Pramipexole; C047508:rotigotine
keywords: Parkinson’s disease; pramipexole; ropinirole; rotigotine transdermal system; safety