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Annals of Family Medicine 6:253-262 (2008)
© 2008 Annals of Family Medicine, Inc.
doi: 10.1370/afm.845
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Effect of Nonergot Dopamine Agonists on Symptoms of Restless Legs Syndrome

William L. Baker, PharmD1,2, C. Michael White, PharmD1,2 and Craig I. Coleman, PharmD1,2

1 University of Connecticut School of Pharmacy, Storrs
2 Department of Drug Information, Hartford Hospital, Hartford, Connecticut

CORRESPONDING AUTHOR: Craig I. Coleman, PharmD, Pharmacoeconomics and Outcomes Studies Group, Hartford Hospital, 80 Seymour St, Hartford, CT 06102-5037, ccolema{at}harthosp.org

PURPOSE We performed a meta-analysis of randomized placebo-controlled trials of nonergot dopamine agonists (NEDAs) for the treatment of restless legs syndrome.

METHODS A systematic literature search was conducted through July 2007. The primary outcome measures assessed were the percentage of responders to medication as determined by the Clinical Global Impression-Improvement (CGI-I) scale and the adjusted mean change in the International Restless Legs Syndrome Study Group Scale (IRLS) score from baseline compared with placebo. Meta-regression analysis was performed to evaluate the impact of study duration on the primary outcomes. Safety endpoints were also evaluated.

RESULTS A total of 14 trials (n = 3,197 subjects) were included in the meta-analysis. NEDA use resulted in greater response as measured by the CGI-I scale (relative risk [RR] 1.36; 95% CI, 1.24 to 1.49; P <.001), and greater reductions in IRLS scores (weighted mean difference [WMD] –4.93; 95% CI, –6.42 to –3.43; P <.001) from baseline vs placebo. Meta-regression analysis showed an inverse relationship between study duration and reduction in IRLS score. NEDAs were associated with a significant risk of adverse events (including nausea, dizziness, somnolence, and fatigue.)

CONCLUSIONS Use of NEDAs in patients with moderate-to-severe restless legs syndrome results in significant reductions in symptom severity, but a significant portion of patients will discontinue their use as a result of adverse events.

Key Words: Restless legs syndrome • dopamine agonists • nonergot • meta-analysis




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Ann. Fam. Med, May 1, 2008; 6(3): 194 - 195.
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