Rotigotine in Hemodialysis-Associated Restless Legs Syndrome : A Randomized Controlled Trial

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Dauvilliers , Y , Benes , H , Partinen , M , Rauta , V , Rifkin , D , Dohin , E , Goldammer , N , Schollmayer , E , Schroeder , H & Winkelman , J W 2016 , ' Rotigotine in Hemodialysis-Associated Restless Legs Syndrome : A Randomized Controlled Trial ' , American Journal of Kidney Diseases , vol. 68 , no. 3 , pp. 434-443 .

Title: Rotigotine in Hemodialysis-Associated Restless Legs Syndrome : A Randomized Controlled Trial
Author: Dauvilliers, Yves; Benes, Heike; Partinen, Markku; Rauta, Virpi; Rifkin, Daniel; Dohin, Elisabeth; Goldammer, Nadine; Schollmayer, Erwin; Schroeder, Hanna; Winkelman, John W.
Contributor: University of Helsinki, Helsinki Sleep Clin, Vitalmed Res Ctr
University of Helsinki, Clinicum
Date: 2016-09
Language: eng
Number of pages: 10
Belongs to series: American Journal of Kidney Diseases
ISSN: 0272-6386
Abstract: Background: Restless legs syndrome (RLS) has been associated with insomnia, decreased quality of life, and increased morbidity and mortality in end-stage renal disease. This randomized controlled trial investigated effects of rotigotine in patients with RLS and end-stage renal disease. Study Design: Double-blind placebo-controlled study. Setting & Participants: Adults with moderate to severe RLS (International RLS Study Group Rating Scale [IRLS] >= 15) and Periodic Limb Movement Index (PLMI) >= 15 who were receiving thrice-weekly hemodialysis enrolled from sites in the United States and Europe. Intervention: Following randomization and titration ( Outcomes & Measurements: Primary efficacy outcome: reduction in PLMI, assessed by ratio of PLMI at end of maintenance to baseline. Secondary/other outcomes (P values exploratory) included mean changes from baseline in PLMI, IRLS, and Clinical Global Impression item 1 (CGI-1 [severity of illness]) score. Results: 30 patients were randomly assigned (rotigotine, 20; placebo, 10); 25 (15; 10) completed the study with evaluable data. Mean (SD) PLMI ratio (end of maintenance to baseline) was 0.7 +/- 0.4 for rotigotine and 1.3 +/- 0.7 for placebo (analysis of covariance treatment ratio, 0.44; 95% CI, 0.22 to 0.88; P = 0.02). Numerical improvements were observed with rotigotine versus placebo in IRLS and CGI-1 (least squares mean treatment differences of -6.08 [95% CI, -12.18 to 0.02; P = 0.05] and -0.81 [95% CI, -1.94 to 0.33; P = 0.2]). 10 of 15 rotigotine and 2 of 10 placebo patients were CGI-1 responders (>= 50% improvement). Hemodialysis did not affect unconjugated rotigotine concentrations. The most common adverse events (>= 2 patients) were nausea (rotigotine, 4 [20%]; placebo, 0); vomiting (3 [15%]; 0); diarrhea (1 [5%]; 2 [20%]); headache (2 [10%]; 0); dyspnea (2 [10%]; 0); and hypertension (2 [10%]; 0). Limitations: Small sample size and short duration. Conclusions: Rotigotine improved periodic limb movements and RLS symptoms in the short term among ESRD patients requiring hemodialysis in a small-scale study. No dose adjustments are necessary for hemodialysis patients. (C) 2016 by the National Kidney Foundation, Inc.
Subject: Chronic kidney disease (CKD)
dopamine agonist
restless legs syndrome (RLS)
periodic limb movements (PLM)
periodic limb movement index (PLMI)
end-stage renal disease (ESRD)
randomized controlled trial (RCT)
3121 General medicine, internal medicine and other clinical medicine

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