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Effect of ropinirole on sleep outcomes in patients with restless legs syndrome: meta-analysis of pooled individual patient data from randomized controlled trials.
Pharmacotherapy. 2009 Mar; 29(3):255-62.P

Abstract

STUDY OBJECTIVE

To compare the effects of ropinirole with those of placebo on sleep, as evaluated by specific domains of the Medical Outcomes Study (MOS) sleep scale, as well as the Clinical Global Impression-Improvement (CGI-I) scale, in patients with restless legs syndrome (RLS).

DESIGN

Meta-analysis of six randomized, double-blind, placebo-controlled, parallel-group trials conducted in the United States and Europe.

PATIENTS

A total of 1679 patients aged 18-79 years with primary moderate-to-severe RLS who received ropinirole (835 patients) or placebo (844 patients).

MEASUREMENTS AND MAIN RESULTS

A systematic review of MEDLINE (January 1980-January 2007) and clinical trial registers was performed to identify placebo-controlled trials of ropinirole that used the 12-item MOS sleep scale to assess sleep in patients with RLS. Individual patient data from both published and nonpublished trials were pooled for meta-analysis. In the eligible studies, immediate-release ropinirole 0.25-6 mg or placebo had been given for at least 12 weeks. In addition, sleep scale summary scores for the domains of sleep quantity, adequacy, disturbance, and daytime somnolence had to have been assessed at baseline and at 12 weeks. Our meta-analysis found that at baseline study patients slept an average of 5.8 hours/night. At the end of 12 weeks, ropinirole-treated patients slept a mean of 2.5 hours/week more and had a 21% greater improvement from baseline in sleep adequacy scores compared with patients receiving placebo. Ropinirole-treated patients also had 14% less sleep disturbance and 8% less daytime somnolence than patients receiving placebo. Clinicians rated 63% of ropinirole-treated patients and 47% of patients receiving placebo as responders based on the CGI-I scale. Mixed effects analysis of covariance was used to estimate treatment effect adjusting for study center as a random effect, as well as the following fixed effects known to affect sleep: baseline sleep characteristics, age, sex, and chronic medical conditions. All differences were statistically significant (p<0.05), even after adjusting for multiple comparisons.

CONCLUSION

Pooled data from six similarly designed clinical trials provide evidence that ropinirole improves sleep quantity and adequacy, and lessens sleep disturbance and daytime somnolence in patients with primary RLS.

Authors+Show Affiliations

Division of Pharmaceutical Outcomes and Policy, Center for Pharmaceutical Outcomes and Policy, School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina 27599-7360, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Systematic Review

Language

eng

PubMed ID

19249945

Citation

Hansen, Richard A., et al. "Effect of Ropinirole On Sleep Outcomes in Patients With Restless Legs Syndrome: Meta-analysis of Pooled Individual Patient Data From Randomized Controlled Trials." Pharmacotherapy, vol. 29, no. 3, 2009, pp. 255-62.
Hansen RA, Song L, Moore CG, et al. Effect of ropinirole on sleep outcomes in patients with restless legs syndrome: meta-analysis of pooled individual patient data from randomized controlled trials. Pharmacotherapy. 2009;29(3):255-62.
Hansen, R. A., Song, L., Moore, C. G., Gilsenan, A. W., Kim, M. M., Calloway, M. O., & Murray, M. D. (2009). Effect of ropinirole on sleep outcomes in patients with restless legs syndrome: meta-analysis of pooled individual patient data from randomized controlled trials. Pharmacotherapy, 29(3), 255-62. https://doi.org/10.1592/phco.29.3.255
Hansen RA, et al. Effect of Ropinirole On Sleep Outcomes in Patients With Restless Legs Syndrome: Meta-analysis of Pooled Individual Patient Data From Randomized Controlled Trials. Pharmacotherapy. 2009;29(3):255-62. PubMed PMID: 19249945.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of ropinirole on sleep outcomes in patients with restless legs syndrome: meta-analysis of pooled individual patient data from randomized controlled trials. AU - Hansen,Richard A, AU - Song,Liping, AU - Moore,Charity G, AU - Gilsenan,Alicia W, AU - Kim,Mimi M, AU - Calloway,Michael O, AU - Murray,Michael D, PY - 2009/3/3/entrez PY - 2009/3/3/pubmed PY - 2009/4/21/medline SP - 255 EP - 62 JF - Pharmacotherapy JO - Pharmacotherapy VL - 29 IS - 3 N2 - STUDY OBJECTIVE: To compare the effects of ropinirole with those of placebo on sleep, as evaluated by specific domains of the Medical Outcomes Study (MOS) sleep scale, as well as the Clinical Global Impression-Improvement (CGI-I) scale, in patients with restless legs syndrome (RLS). DESIGN: Meta-analysis of six randomized, double-blind, placebo-controlled, parallel-group trials conducted in the United States and Europe. PATIENTS: A total of 1679 patients aged 18-79 years with primary moderate-to-severe RLS who received ropinirole (835 patients) or placebo (844 patients). MEASUREMENTS AND MAIN RESULTS: A systematic review of MEDLINE (January 1980-January 2007) and clinical trial registers was performed to identify placebo-controlled trials of ropinirole that used the 12-item MOS sleep scale to assess sleep in patients with RLS. Individual patient data from both published and nonpublished trials were pooled for meta-analysis. In the eligible studies, immediate-release ropinirole 0.25-6 mg or placebo had been given for at least 12 weeks. In addition, sleep scale summary scores for the domains of sleep quantity, adequacy, disturbance, and daytime somnolence had to have been assessed at baseline and at 12 weeks. Our meta-analysis found that at baseline study patients slept an average of 5.8 hours/night. At the end of 12 weeks, ropinirole-treated patients slept a mean of 2.5 hours/week more and had a 21% greater improvement from baseline in sleep adequacy scores compared with patients receiving placebo. Ropinirole-treated patients also had 14% less sleep disturbance and 8% less daytime somnolence than patients receiving placebo. Clinicians rated 63% of ropinirole-treated patients and 47% of patients receiving placebo as responders based on the CGI-I scale. Mixed effects analysis of covariance was used to estimate treatment effect adjusting for study center as a random effect, as well as the following fixed effects known to affect sleep: baseline sleep characteristics, age, sex, and chronic medical conditions. All differences were statistically significant (p<0.05), even after adjusting for multiple comparisons. CONCLUSION: Pooled data from six similarly designed clinical trials provide evidence that ropinirole improves sleep quantity and adequacy, and lessens sleep disturbance and daytime somnolence in patients with primary RLS. SN - 0277-0008 UR - https://www.unboundmedicine.com/medline/citation/19249945/Effect_of_ropinirole_on_sleep_outcomes_in_patients_with_restless_legs_syndrome:_meta_analysis_of_pooled_individual_patient_data_from_randomized_controlled_trials_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=19249945.ui DB - PRIME DP - Unbound Medicine ER -