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Randomized, placebo-controlled trial of ferric carboxymaltose in restless legs syndrome patients with iron deficiency anemia

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Author(s)
Hyoeun BaeYong Won ChoKeun Tae KimRichard P. AllenChristopher J. Earley
Keimyung Author(s)
Cho, Yong WonKim, Keun Tae
Department
Dept. of Neurology (신경과학)
Journal Title
Sleep Med
Issued Date
2021
Volume
84
Keyword
Restless legs syndromeIron deficiency anemiaFerric carboxymaltoseClinical trial
Abstract
Objective:
Intravenous ferric carboxymaltose (FCM) has been shown to be efficacious in treating restless legs syndrome (RLS) symptoms in non-anemic patients. The aim of this study was to evaluate the effectiveness of FCM in treating RLS symptoms in patients who also had an iron deficiency anemia (IDA).

Methods:
This is a randomized, double-blinded, placebo-controlled study. Subjects with RLS and IDA were enrolled. Subjects received an infusion of either 1500 mg FCM or placebo in Phase I. The primary outcomes were a change-from-baseline at week six on the International Restless Legs Syndrome Study Group scale (IRLS). Phase II of the study involved long-term (52 weeks) follow-up, for those who responded to treatment in the prior phase, with the potential for further treatment if symptoms returned.

Results:
We enrolled 29 RLS patients with IDA (15 FCM and 14 placebo). At week six post-infusion, FCM compared to placebo group showed significant improvement from baseline in IRLS score (−13.47 ± 7.38 vs. 1.36 ± 3.59). Among secondary outcome variables, quality of sleep showed significant improvement from baseline in the FCM group. 61% of subjects remained off RLS medications at the Phase II, week-52 endpoint. There were no serious adverse events observed in the study.

Conclusion:
The study showed significant efficacy and safety of FCM 1500 mg treatment both in the short term (6 weeks) and long term (52 weeks) in RLS patients with IDA.
Keimyung Author(s)(Kor)
조용원
김근태
Publisher
School of Medicine (의과대학)
Citation
Hyoeun Bae et al. (2021). Randomized, placebo-controlled trial of ferric carboxymaltose in restless legs syndrome patients with iron deficiency anemia. Sleep Med, 84, 179–186. doi: 10.1016/j.sleep.2021.05.036
Type
Article
ISSN
1389-9457
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S1389945721003154
DOI
10.1016/j.sleep.2021.05.036
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43828
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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