USA: A recent study in the journal Sleep Medicine has suggested IV ferric carboxymaltose (IV FCM) to be an alternative treatment option to oral iron supplementation in children with restless legs syndrome (RLS) or periodic limb movement disorder (PLMD).
According to the study, IV iron supplementation improved both clinical severity and laboratory parameters and was well tolerated in children with RLS and PLMD. Following a single dose of ferric carboxymaltose, ferritin level improved significantly.
Iron supplementation is the first-line treatment for children with RLS or PLMD. However, there is a lack of evidence on the effectiveness of intravenous preparations. Considering this, Lourdes M.DelRosso, University of Washington School of Medicine, Seattle Children's Hospital, WA, USA, and colleagues aimed to evaluate the effectiveness and tolerability of intravenous ferric carboxymaltose (IV FCM) on clinical symptoms and iron indices in children with RLS or PLMD.
For this purpose, they designed a single-center retrospective data analysis. The analysis included children with a diagnosis of RLS or PLMD, who underwent a single infusion of IV FCM. 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.
Thirty-nine children received IV FCM, 29 with RLS, and 10 with PLMD.
The study revealed the following findings:
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, 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.
"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," concluded the authors.
Reference:
Lourdes M. DelRosso, Raffaele Ferri, Maida L. Chen, Vidhi Kapoor, Richard P. Allen, Maria Paola Mogavero, Daniel L. Picchietti, Clinical efficacy and safety of intravenous ferric carboxymaltose treatment of pediatric restless legs syndrome and periodic limb movement disorder, Sleep Medicine, Volume 87, 2021, Pages 114-118, ISSN 1389-9457, https://doi.org/10.1016/j.sleep.2021.08.030.