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Efficacy of ferric carboxymaltose (FCM) 500mg dose for the treatment of Restless Legs Syndrome

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Author(s)
Yong Won ChRichard P. AllenChristopher J. Earley
Keimyung Author(s)
Cho, Yong Won
Department
Dept. of Neurology (신경과학)
Journal Title
Sleep Medicine
Issued Date
2018
Volume
42
Keyword
Restless Legs SyndromeTreatmentIV ferric carboxymaltose
Abstract
INTRODUCTION:

There have been four randomized, placebo-controlled, double-blinded studies of intravenous (IV) iron in Restless Legs Syndrome (RLS), all of which delivered a final total dose of 1000 mg of iron. The purpose of this study was to evaluate effects of a lesser total dose (500 mg of iron).

METHODS:

Subjects with idiopathic RLS were enrolled in a randomized, double-blinded, placebo-controlled study. Subjects received either 500 mg ferric carboxymaltose (FCM) or placebo as a single infusion (Phase I). Subjects who were previously on medication were off any RLS medications for at least two weeks prior to baseline assessment. The primary outcome variable was a change-from-baseline at week six on the International RLS Severity Scale (IRLSS) and a subject-completed Visual Analog Scale of Severity (VAS). Phase II of the study involved long-term (30 weeks) follow-up after completing the six week efficacy phase.

RESULTS:

At week six post infusion, FCM, compared to placebo recipients, showed no significantly greater change-from-baseline for both primary outcome measures (IRLSS scale, FCM 500 mg vs. placebo: -8.3 ± 7.5 vs. -4.8 ± 8.7, p = 0.100; VAS, FCM 500 mg vs. placebo: -23.4 ± 24.1 vs. -13.3 ± 23.1, p = 0.077). None of the secondary outcome variables showed a significant difference at week six. Seven (21.9%) of the 32 subjects treated with iron in Phase I remained free from further RLS medications at 30 weeks. No serious adverse effects were found in this study.

CONCLUSIONS:

This study did not show significant benefit from a single 500 mg FCM treatment for RLS symptoms. The two previous, well-controlled, trials of 1000 mg FCM showed significant treatment benefits which suggested that there may have been a clinically relevant total dose required to achieve a clinical response.
Keimyung Author(s)(Kor)
조용원
Publisher
School of Medicine (의과대학)
Citation
Yong Won Ch et al. (2018). Efficacy of ferric carboxymaltose (FCM) 500mg dose for the treatment of Restless Legs Syndrome. Sleep Medicine, 42, 7–12. doi: 10.1016/j.sleep.2017.11.1134
Type
Article
ISSN
1389-9457
Source
https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(17)31577-0
DOI
10.1016/j.sleep.2017.11.1134
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41231
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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