title: Efficacy and tolerability of ropinirole in patients with restless legs syndrome and a baseline IRLS total score > or = 24 points--data from the ropinirole clinical trial programme.
abstract: OBJECTIVE
  Results from one of the largest clinical trial programmes to date of a dopamine agonist in patients with primary restless legs syndrome (RLS) have demonstrated that ropinirole, 0.25-4.0 mg once daily 1-3 hours before bedtime, is associated with significant improvements in RLS symptoms, sleep parameters and quality-of-life measures, compared with placebo. Analyses were conducted in a subpopulation of patients with a baseline score on the International Restless Legs Scale (IRLS) of at least 24 points.
  
  
  METHODS
  Data was pooled from four, 12-week, pivotal studies: RESET PLM and TREAT RLS 1, 2 and US.
  
  
  METHODS
  Covariate analysis demonstrated that the magnitude of treatment difference between ropinirole and placebo for change in IRLS total score (a measure of RLS symptom severity) increased with increasing baseline IRLS total score. Mean treatment difference was > 3 points in patients with a baseline total score > or = 24. Among this population, ropinirole treatment was associated with significant reduction in RLS symptom severity compared with placebo, along with significant improvements in global symptoms and sleep measures. A treatment benefit was also observed for measures of quality of life. Ropinirole is well tolerated in this patient population.
  
  
  CONCLUSIONS
  Patients with primary RLS and baseline IRLS total score > or = 24 gain clinically meaningful benefits from ropinirole treatment. As with the overall population in the ropinirole clinical trial programme, ropinirole was associated with improvements in RLS symptoms, global symptoms, sleep and quality of life and was well tolerated in patients with a baseline IRLS total score > or = 24.
authors.affiliation: GlaxoSmithKline, Greenford, UK. luigi.2.giorgi@gsk.com
authors.forename: Luigi
authors.initials: L
authors.lastname: Giorgi
authors.forename: Sally Y
authors.initials: SY
authors.lastname: Ritchie
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Kirsch
mesh_terms: D000328:Adult; D000368:Aged; D018491:Dopamine Agonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012148:Restless Legs Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D007211:Indoles; C046649:ropinirole