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Patient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome.
Clin Neuropharmacol. 2008 Sep-Oct; 31(5):281-6.CN

Abstract

OBJECTIVES

To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes.

METHODS

In this multicenter, double-blind, randomized, 12-week, flexible-dose study, patients with primary RLS, with symptom onset no earlier than 5 PM and a baseline International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score > or = 20 received ropinirole 0.5 to 6.0 mg/d twice daily in equally divided doses, or placebo. First dose was 1 hour before the usual onset of symptoms; second dose was 3 to 8 hours after the first. Primary end point: change from baseline in IRLS total score at week 12 last observation carried forward (LOCF). Key secondary end points: proportion of responders (rated "very much improved" or "much improved") on the Clinical Global Impression-Improvement and the Patient Global Improvement scales.

RESULTS

Improvements in IRLS total score were statistically significantly greater for ropinirole (n = 175), compared with placebo (n = 184) at all assessment points beginning at day 3 through to week 12 LOCF (P < 0.001). A statistically significantly greater proportion of patients were classified as responders on the Clinical Global Impression-Improvement scale at all assessment points from day 3 through week 12 LOCF (P < 0.001) and on the Patient Global Improvement scale at all assessment points from day 1 (P = 0.013) through day 7 LOCF (P < or = 0.05 for days 2-7 LOCF) and at week 12 LOCF (P < 0.001).

CONCLUSIONS

Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians.

Authors+Show Affiliations

Stanford Center of Excellence for Sleep Disorders, 401 Quarry Road, Suite 3301-A, Stanford, CA 94305-5730, USA. clete@stanford.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18836346

Citation

Kushida, Clete A., et al. "Patient- and Physician-rated Measures Demonstrate the Effectiveness of Ropinirole in the Treatment of Restless Legs Syndrome." Clinical Neuropharmacology, vol. 31, no. 5, 2008, pp. 281-6.
Kushida CA, Geyer J, Tolson JM, et al. Patient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome. Clin Neuropharmacol. 2008;31(5):281-6.
Kushida, C. A., Geyer, J., Tolson, J. M., & Asgharian, A. (2008). Patient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome. Clinical Neuropharmacology, 31(5), 281-6. https://doi.org/10.1097/WNF.0b013e31815a3eec
Kushida CA, et al. Patient- and Physician-rated Measures Demonstrate the Effectiveness of Ropinirole in the Treatment of Restless Legs Syndrome. Clin Neuropharmacol. 2008;31(5):281-6. PubMed PMID: 18836346.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Patient- and physician-rated measures demonstrate the effectiveness of ropinirole in the treatment of restless legs syndrome. AU - Kushida,Clete A, AU - Geyer,James, AU - Tolson,Jerry M, AU - Asgharian,Afsaneh, PY - 2008/10/7/pubmed PY - 2009/5/20/medline PY - 2008/10/7/entrez SP - 281 EP - 6 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 31 IS - 5 N2 - OBJECTIVES: To investigate the effect of twice-daily ropinirole in patients with early evening restless legs syndrome (RLS) symptoms, particularly focusing on the relationship of patient- and physician-rated assessment of treatment outcomes. METHODS: In this multicenter, double-blind, randomized, 12-week, flexible-dose study, patients with primary RLS, with symptom onset no earlier than 5 PM and a baseline International Restless Legs Syndrome Study Group Rating Scale (IRLS) total score > or = 20 received ropinirole 0.5 to 6.0 mg/d twice daily in equally divided doses, or placebo. First dose was 1 hour before the usual onset of symptoms; second dose was 3 to 8 hours after the first. Primary end point: change from baseline in IRLS total score at week 12 last observation carried forward (LOCF). Key secondary end points: proportion of responders (rated "very much improved" or "much improved") on the Clinical Global Impression-Improvement and the Patient Global Improvement scales. RESULTS: Improvements in IRLS total score were statistically significantly greater for ropinirole (n = 175), compared with placebo (n = 184) at all assessment points beginning at day 3 through to week 12 LOCF (P < 0.001). A statistically significantly greater proportion of patients were classified as responders on the Clinical Global Impression-Improvement scale at all assessment points from day 3 through week 12 LOCF (P < 0.001) and on the Patient Global Improvement scale at all assessment points from day 1 (P = 0.013) through day 7 LOCF (P < or = 0.05 for days 2-7 LOCF) and at week 12 LOCF (P < 0.001). CONCLUSIONS: Ropinirole is associated with consistent early and sustained improvements in the symptoms of RLS, as rated by patients and physicians. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/18836346/Patient__and_physician_rated_measures_demonstrate_the_effectiveness_of_ropinirole_in_the_treatment_of_restless_legs_syndrome_ L2 - http://dx.doi.org/10.1097/WNF.0b013e31815a3eec DB - PRIME DP - Unbound Medicine ER -