Clinical efficacy and safety of intravenous ferric carboxymaltose treatment of pediatric restless legs syndrome and periodic limb movement disorder.

Abstract

BACKGROUND:

Iron supplementation is the most commonly considered treatment option for children with restless legs syndrome (RLS) or periodic limb movement disorder (PLMD); however, there is a scarcity of evidence on the effectiveness of intravenous preparations. In this study, we evaluated the effectiveness and tolerability of intravenous ferric carboxymaltose (IV FCM) on clinical symptoms and iron indices in children with RLS or PLMD.

METHODS:

This was a single-center retrospective data analysis. Children with a diagnosis of RLS or PLMD, who underwent a single infusion of IV FCM, were included. Clinical Global Impression (CGI) Scale scores, serum ferritin, and serum iron profile at baseline and after eight weeks post infusion were obtained. Adverse effects were assessed.

RESULTS:

Thirty-nine children received IV FCM, 29 with RLS and 10 with PLMD. Pre-infusion CGI-Severity revealed moderate illness, with post-infusion CGI-Improvement between "very much improved" and "much improved". Ferritin increased from 14.6 μg/L±7.01 to 112.4 μg/L±65.86 (p < 0.00001), together with improvements in iron, total iron binding capacity, and transferrin levels from baseline to post-treatment. When compared to children with RLS, those with PLMD had a similar improvement in clinical symptoms and laboratory parameters. Seven subjects (14.3%) experienced one or two adverse events; all were mild.

CONCLUSIONS:

Children with RLS and PLMD responded to IV iron supplementation with improvement in both clinical severity and laboratory parameters. Treatment was well tolerated. Although larger, randomized-controlled trials are needed, IV FCM appears to be a promising alternative to oral iron supplementation for the treatment of pediatric RLS or PLMD.

• Authors: Lourdes M DelRosso, Raffaele Ferri, Maida L Chen, Vidhi Kapoor, Richard P Allen, Maria Paola Mogavero, Daniel L Picchietti
• Journal: Sleep medicine (Sleep Med) Vol. 87 Pg. 114-118 (11 2021) ISSN: 1878-5506 [Electronic] Netherlands
• PMID: 34562823 (Publication Type: Journal Article)
• Copyright: Copyright © 2021 Elsevier B.V. All rights reserved.

Chemical References

• Ferric Compounds
• ferric carboxymaltose
• Maltose

Topics

• Child
• Ferric Compounds (adverse effects)
• Humans
• Maltose (analogs & derivatives)
• Nocturnal Myoclonus Syndrome
• Restless Legs Syndrome (drug therapy)
• Retrospective Studies
• Treatment Outcome