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Clinical efficacy of ferric carboxymaltose treatment in patients with restless legs syndrome

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Author(s)
Yong Won ChoRichard P. AllenChristopher J. Earley
Keimyung Author(s)
Cho, Yong Won
Department
Dept. of Neurology (신경과학)
Journal Title
Sleep Medicine
Issued Date
2016
Volume
25
Keyword
Restless legs syndromeIV ferric carboxymaltoseTreatment
Abstract
Objective : There have been three randomized, placebo-controlled, double-blind studies of intravenous iron in restless legs syndrome (RLS), with differing outcomes. The one positive study used ferric carboxymaltose (FCM) at a total dose of 1000 mg. The purpose of this study was to replicate and extend the findings from the prior FCM study.
Methods : Non-anemic, idiopathic RLS patients were enrolled in a randomized, double-blinded, placebo-controlled study and received either 1000 mg FCM or placebo as a single infusion (phase I). Subjects were off any RLS medications for at least two weeks prior to baseline assessment. The primary outcome variable was change from baseline at week 6 on the International Restless Legs Syndrome Severity (IRLSS) scale and a subject-completed, visual analog scale (VAS) of severity. Phase II of the study involved long-term (30 weeks) follow-up after completion of the six-week efficacy phase.
Results : At week 6 postinfusion, FCM compared to placebo recipients showed significantly greater change from baseline for both primary outcome measures (IRLSS scale, −11.9 ± 8.04 vs −7.88 ± 5.89, p = 0.03; VAS, −40.6 ± 22.7 vs −21.3 ± 20.0, p = 0.001). None of the secondary outcome variables showed a significant difference at week 6. After six weeks of treatment, the FCM group had 19 (59.4%) responders, of which 12 had IRLSS scores <10 (“remitters”). Twelve (37.5%) of the 32 subjects treated with iron in phase I remained free of further RLS medications at 30 weeks. There were no serious adverse events observed in this study.
Conclusion : Two studies now support the value of FCM treatment both in the short term (six weeks) and long term (30 weeks) for improving RLS symptoms.
Keimyung Author(s)(Kor)
조용원
Publisher
School of Medicine
Citation
Yong Won Cho et al. (2016). Clinical efficacy of ferric carboxymaltose treatment in patients with restless legs syndrome. Sleep Medicine, 25, 16–23. doi: 10.1016/j.sleep.2016.06.021
Type
Article
ISSN
1389-9457
Source
https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(16)30112-5
DOI
10.1016/j.sleep.2016.06.021
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/32846
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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