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.
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.
Authors: Wolfgang H Oertel; Karin Stiasny-Kolster; Bettina Bergtholdt; Yngve Hallström; Jaan Albo; Lena Leissner; Thomas Schindler; Juergen Koester; Juergen Reess Journal: Mov Disord Date: 2007-01-15 Impact factor: 10.338
Authors: Diego Garcia-Borreguero; John Winkelman; Alieu Adams; Amanda Ellis; Mark Morris; Janice Lamb; Gary Layton; Mark Versavel Journal: Sleep Med Date: 2007-01-18 Impact factor: 3.492
Authors: Michael H Silber; Bruce L Ehrenberg; Richard P Allen; Mark J Buchfuhrer; Christopher J Earley; Wayne A Hening; David B Rye Journal: Mayo Clin Proc Date: 2004-07 Impact factor: 7.616
Authors: Judit Horvath; Robin D Fross; Galit Kleiner-Fisman; René Lerch; Hans Stalder; Suzanne Liaudat; William J Raskoff; Keith D Flachsbart; Harry Rakowski; Jean-Claude Pache; Pierre R Burkhard; Anthony E Lang Journal: Mov Disord Date: 2004-06 Impact factor: 10.338