Tags

Type your tag names separated by a space and hit enter

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.
Curr Med Res Opin 2006; 22(10):1867-77CM

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.

RESEARCH DESIGN AND METHODS

Data was pooled from four, 12-week, pivotal studies: RESET PLM and TREAT RLS 1, 2 and US.

MAIN OUTCOME MEASURES

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+Show Affiliations

GlaxoSmithKline, Greenford, UK. luigi.2.giorgi@gsk.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17022844

Citation

Giorgi, Luigi, et al. "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." Current Medical Research and Opinion, vol. 22, no. 10, 2006, pp. 1867-77.
Giorgi L, Ritchie SY, Kirsch JM. 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. Curr Med Res Opin. 2006;22(10):1867-77.
Giorgi, L., Ritchie, S. Y., & Kirsch, J. M. (2006). 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. Current Medical Research and Opinion, 22(10), pp. 1867-77.
Giorgi L, Ritchie SY, Kirsch JM. 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. Curr Med Res Opin. 2006;22(10):1867-77. PubMed PMID: 17022844.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Giorgi,Luigi, AU - Ritchie,Sally Y, AU - Kirsch,Jeffrey M, PY - 2006/10/7/pubmed PY - 2006/10/25/medline PY - 2006/10/7/entrez SP - 1867 EP - 77 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 10 N2 - 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. RESEARCH DESIGN AND METHODS: Data was pooled from four, 12-week, pivotal studies: RESET PLM and TREAT RLS 1, 2 and US. MAIN OUTCOME MEASURES: 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. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17022844/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_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X132442 DB - PRIME DP - Unbound Medicine ER -