title: Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease.
abstract: OBJECTIVE
  To evaluate the efficacy of ropinirole 24-hour prolonged release (ropinirole 24-hour) as an adjunct to levodopa in patients with Parkinson disease (PD) and motor fluctuations.
  
  
  METHODS
  In a double-blind, placebo-controlled, 24-week study, 393 subjects with PD were randomized to ropinirole 24-hour (n = 202) or placebo (n = 191). The primary outcome measure was reduction in hours of daily "off" time.
  
  
  RESULTS
  At week 24, the mean dose of ropinirole 24-hour was 18.8 mg/day with a mean reduction in daily levodopa of 278 mg. There was a mean reduction in daily "off" time of 2.1 hours in the ropinirole 24-hour group and 0.3 hours with placebo. Secondary outcome measures including change in hours and percent of daily "on" time and "on" time without troublesome dyskinesia, Unified PD Rating Scale motor and activities of daily living subscales, Beck Depression Inventory-II, PDQ-39 subscales of mobility, activities of daily living, emotional well-being, stigma and communication, and PD Sleep Scale were significantly improved at week 24 with ropinirole 24-hour. The most common adverse events (AE) with ropinirole 24-hour were dyskinesia, nausea, dizziness, somnolence, hallucinations, and orthostatic hypotension and AEs led to study withdrawal in 5% of both the active and placebo groups.
  
  
  CONCLUSIONS
  Ropinirole 24-hour was effective and well tolerated as adjunct therapy in patients with Parkinson disease (PD) not optimally controlled with levodopa. Ropinirole 24-hour demonstrated an improvement in both motor and non-motor PD symptoms, while permitting a reduction in adjunctive levodopa dose.
authors.affiliation: University of Kansas Medical Center, Kansas City, KS 66160, USA. rpahwa@kumc.edu
authors.forename: R
authors.initials: R
authors.lastname: Pahwa
authors.forename: M A
authors.initials: MA
authors.lastname: Stacy
authors.forename: S A
authors.initials: SA
authors.lastname: Factor
authors.forename: K E
authors.initials: KE
authors.lastname: Lyons
authors.forename: F
authors.initials: F
authors.lastname: Stocchi
authors.forename: B P
authors.initials: BP
authors.lastname: Hersh
authors.forename: L W
authors.initials: LW
authors.lastname: Elmer
authors.forename: D D
authors.initials: DD
authors.lastname: Truong
authors.forename: N L
authors.initials: NL
authors.lastname: Earl
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010300:Parkinson Disease / Q000188:drug therapy*; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D000978:Antiparkinson Agents; D007211:Indoles; C046649:ropinirole