OBJECTIVE: To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome. METHODS: A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of > or =15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25-4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed. RESULTS:112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache. CONCLUSIONS: Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated.
RCT Entities:
OBJECTIVE: To assess the efficacy, safety, and tolerability of ropinirole in the treatment of patients with restless legs syndrome. METHODS: A 12 week, prospective, double blind, randomised comparison involving 284 patients from 10 European countries. All participants had a score of > or =15 on the international restless legs scale (IRLS). Patients were randomised (1:1) to receive either ropinirole 0.25-4.0 mg once daily or placebo. The primary efficacy end point was mean change from baseline to week 12 in total IRLS score. Global improvements (clinical global impression (CGI) scale) and improvements in sleep, health related quality of life (QoL; using generic and disease specific measures), work, and other activities were also assessed. RESULTS: 112/146 patients (76.7%) taking ropinirole and 109/138 (79.0%) taking placebo completed the study. Improvement in IRLS at week 12 with ropinirole (mean (SD) dose, 1.90 (1.13) mg/day) was greater than with placebo (mean (SE): -11.04 (0.719) v -8.03 (0.738) points; adjusted difference = -3.01 (95% confidence interval (CI), -5.03 to -0.99); p = 0.0036). More patients in the ropinirole group (53.4%) showed improvement on the CGI scale at week 12 than in the placebo group (40.9%; adjusted odds ratio = 1.7 (1.02 to 2.69); p = 0.0416). Significant differences on both IRLS and CGI scales favouring ropinirole were apparent by week 1. Ropinirole was also associated with significantly greater improvements in sleep and QoL end points. The most common adverse events were nausea and headache. CONCLUSIONS:Ropinirole improves restless legs syndrome compared with placebo, with benefits apparent by week 1. It is generally well tolerated.
Authors: M Saletu; P Anderer; B Saletu; C Hauer; M Mandl; S Oberndorfer; A Zoghlami; G Saletu-Zyhlarz Journal: Neuropsychobiology Date: 2000 Impact factor: 2.328
Authors: K Stiasny; T C Wetter; J Winkelmann; U Brandenburg; T Penzel; M Rubin; H P Hundemer; W H Oertel; C Trenkwalder Journal: Neurology Date: 2001-05-22 Impact factor: 9.910
Authors: B Saletu; G Gruber; M Saletu; N Brandstätter; C Hauer; W Prause; K Ritter; G Saletu-Zyhlarz Journal: Neuropsychobiology Date: 2000 Impact factor: 2.328
Authors: C Trenkwalder; K Stiasny; T Pollmächer; T Wetter; J Schwarz; R Kohnen; J Kazenwadel; H P Krüger; S Ramm; M Künzel Journal: Sleep Date: 1995-10 Impact factor: 5.849
Authors: Clete A Kushida; Arthur S Walters; Philip Becker; Stephen G Thein; A Thomas Perkins; Thomas Roth; Daniel Canafax; Ronald W Barrett Journal: Sleep Date: 2009-02 Impact factor: 5.849
Authors: Crystal S Denlinger; Jennifer A Ligibel; Madhuri Are; K Scott Baker; Wendy Demark-Wahnefried; Debra L Friedman; Mindy Goldman; Lee Jones; Allison King; Grace H Ku; Elizabeth Kvale; Terry S Langbaum; Kristin Leonardi-Warren; Mary S McCabe; Michelle Melisko; Jose G Montoya; Kathi Mooney; Mary Ann Morgan; Javid J Moslehi; Tracey O'Connor; Linda Overholser; Electra D Paskett; Muhammad Raza; Karen L Syrjala; Susan G Urba; Mark T Wakabayashi; Phyllis Zee; Nicole McMillian; Deborah Freedman-Cass Journal: J Natl Compr Canc Netw Date: 2014-05 Impact factor: 11.908