1001 Intravenous Ferric Carboxymaltose For Restless Legs Syndrome In Children And Adolescents

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A380-A380
Author(s):  
L M DelRosso ◽  
R Ferri ◽  
R P Allen ◽  
M L Chen ◽  
S Kotagal ◽  
...  
Keyword(s):  
Side Effects ◽  
Children And Adolescents ◽  
Serum Ferritin ◽  
Restless Legs Syndrome ◽  
Iron Supplementation ◽  
Oral Iron ◽  
Ferric Carboxymaltose ◽  
Chi Square ◽  
Restless Legs ◽  
Post Infusion

Abstract Introduction Substantial scientific evidence implicates brain iron deficiency in the pathophysiology of restless legs syndrome (RLS). Current clinical guidelines recommend oral and intravenous iron (IV) in the treatment of both adult and pediatric RLS but studies using ferric carboxymaltose (FCM) are lacking in children and adolescents. Methods Retrospective case series of children and adolescents with RLS treated with IV FCM who had serum ferritin levels <50 μg/L. Patients were offered a single dose of IV FCM, 15 mg/kg if weighting <50 kg or 750 mg if weighting >50 kg. Iron profile, serum ferritin, and severity assessment by the International Restless Legs Study Group severity scale (IRLS) were collected pre- and post-infusion. Clinical Global Impression Scale (CGI) was used instead of the IRLS for children. Phosphorus level and adverse effects were assessed post-infusion in all patients. Age and sex-matched children with RLS treated with oral iron supplementation (mean dosage 1.5±0.62 mg/kg/day) were included as a comparison group. Results Twenty-eight subjects (15 females, mean age 11.5 years, SD 4.23) and 24 controls were included. Baseline ferritin levels were not significantly different from those of controls but increased significantly from 13.9±7.02 to 112.9±12.00 μg/L after 8 weeks from infusion (p<0.000001), when they were also significantly higher than control values (34.2±21.64 μg/mL, p<0.000001). Transferrin saturation increased from 22.8±9.77% to 31.7±6.81% (p<0.0001), total iron binding capacity decreased from 366.7±51.32 to 302.0±37.83 μg/dL (p<0.0000035). RLS was reported to be resolved or improved in all children treated with IV iron (vs. 62.5% of controls) while none of them reported no change (vs. 37.5% of controls; Chi-square test 9.84, p<0.002). IRLS Score decreased in adolescents from 30.7±22.68 to 3.2±4.21 (p<0.000008) while CGI-I was “very much improved” in six children and “much improved” in four. Side effects were reported in 17.8% of patients treated IV and 20.8% controls (Chi-square 0.0169, p=0.897). FCM side effects included lightheadedness and gastrointestinal discomfort. Post IV phosphorus levels were normal in all participants. Conclusion This open-label, observational and retrospective study indicates that FCM IV infusion is an effective treatment for pediatric RLS with higher efficacy than oral iron supplementation. Support  

584 Response to Intravenous Ferric Carboxymaltose in the Treatment of Childhood Restless Legs Syndrome/Periodic Limb Movement Disorder

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A230-A230
Author(s):  
Wendy Edlund ◽  
Suresh Kotagal
Keyword(s):  
Side Effects ◽  
Movement Disorder ◽  
Serum Ferritin ◽  
Restless Legs Syndrome ◽  
Ferric Carboxymaltose ◽  
Periodic Limb Movement ◽  
Periodic Limb Movement Disorder ◽  
Restless Legs ◽  
Before And After

Abstract Introduction Pediatric Restless Legs Syndrome (RLS)/Periodic Limb Movement Disorder (PLMD) are treatable disorders affecting quality of life. The first line therapy is oral iron, which may have gastrointestinal side effects or suboptimal absorption. Consequently, parenteral iron preparations are needed, but have been insufficiently studied in children. This study evaluates the response to intravenous ferric carboxymaltose (FCM) in pediatric RLS/PLMD. Methods We performed a retrospective chart review of children who received FCM between May 2018 and January 2019 for treating RLS/PLMD. Serum ferritin before and after the infusion were compared. Where possible, the Clinical Global Impressions of Improvement (CGI-I) was evaluated. Side effects documented in the charts were extracted. The median administered dose of FCM was 10.1 mg/kg (range 9.6–20.8) over 0.6 to2 hours. Results There were 27 patients, with mean age of 10.0 +/-4.2 years. 52% were female. 24 had RLS and 3 had PLMD. 20/27 (69.7%) had prior oral iron therapy; 4/20 (26.0%) experienced side effects. Adverse events from FCM infusion included procedure-related anxiety in 4/27, nausea in 1/27, infusion site pain in 2/27, and tachycardia in 1/27. One patient developed subcutaneous extravasation of iron with brownish skin discoloration and a resulting adjustment disorder. Three patients had phosphorus checked following infusion; all were normal. Serum ferritin was available both before and after the infusion for 17 patients. Mean serum ferritin prior to infusion was 27.2 +/-15.7 µg/L (range 6–58) and after the infusion it was 109.8 +/-49.34 µg/L (range 27–192). Mean ferritin increase was 82.6 +/-41.5 µg/L (range 14–160; p=0.0001). Post-infusion ferritin was over 50 µg/L for all but 2 of the subjects, with follow up ranging from 31–266 days (mean 120 days). A larger increase was seen at higher doses (p=0.01). Ferritin increase was not impacted by age, gender, symptom severity, PLMI or prior ferritin level. CGI-I was applied to 15 patients with sufficient follow-up documentation and showed improvement in 86%, with 79% much or very much improved. Conclusion The administration of FCM in children with RLS/PLMD is associated with a satisfactory rise in serum ferritin and modest symptomatic improvement. Support (if any):

scholarly journals The Effect of Parenteral or Oral Iron Supplementation on Fatigue, Sleep, Quality of Life and Restless Legs Syndrome in Iron-Deficient Blood Donors: A Secondary Analysis of the IronWoMan RCT

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1313
Author(s):  
Susanne Macher ◽  
Cornelia Herster ◽  
Magdalena Holter ◽  
Martina Moritz ◽  
Eva Maria Matzhold ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Restless Legs Syndrome ◽  
Iron Supplementation ◽  
Blood Donors ◽  
Secondary Analysis ◽  
Chronic Fatigue ◽  
Oral Iron ◽  
Restless Legs ◽  
Fatigue Syndrome ◽  
Iron Deficient

Background: Besides anemia, iron deficiency may cause more subtle symptoms, including the restless legs syndrome (RLS), the chronic fatigue syndrome (CFS) or sleeping disorders. Objective: The aim of this pre-planned secondary analysis of the IronWoMan randomized controlled trial (RCT) was to compare the frequency and severity of symptoms associated with iron deficiency before and after (intravenous or oral) iron supplementation in iron deficient blood donors. Methods/Design: Prospective, randomized, controlled, single-centre trial. (ClinicalTrials.gov: NCT01787526). Setting: Tertiary care center in Graz, Austria. Participants: 176 (138 female and 38 male) whole-blood and platelet apheresis donors aged ≥ 18 and ≤ 65 years with iron deficiency (ferritin ≤ 30ng/mL at the time of blood donation). Interventions: Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation (10 g iron fumarate, 100 capsules, n = 90). Measurements: Clinical symptoms were evaluated by a survey before iron therapy (visit 0, V0) and after 8–12 weeks (visit 1, V1), including questions about symptoms of restless legs syndrome (RLS), chronic fatigue syndrome (CFS), sleeping disorders, quality of life and symptoms like headaches, dyspnoea, dizziness, palpitations, pica and trophic changes in fingernails or hair. Results: We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality (p < 0.001). Furthermore, a significant decrease in headaches, dyspnoea, dizziness and palpitations was reported (p < 0.05). There was no difference between the type of iron supplementation (intravenous versus oral) and clinical outcome data. Conclusion: Iron supplementation in iron-deficient blood donors may be an effective strategy to improve symptoms related to iron deficiency and the wellbeing of blood donors.

Comparison of the efficacies of oral iron and pramipexole for the treatment of restless legs syndrome patients with low serum ferritin

2013 ◽  
Vol 21 (2) ◽  
pp. 260-266 ◽  
Author(s):  
C. S. Lee ◽  
S. D. Lee ◽  
S.-H. Kang ◽  
H. Y. Park ◽  
I.-Y. Yoon
Keyword(s):  
Serum Ferritin ◽  
Restless Legs Syndrome ◽  
Oral Iron ◽  
Restless Legs ◽  
Low Serum

scholarly journals Oral Iron Supplementation—Gastrointestinal Side Effects and the Impact on the Gut Microbiota

2021 ◽  
Vol 12 (2) ◽  
pp. 491-502
Author(s):  
Sarah R. Bloor ◽  
Rudolph Schutte ◽  
Anthony R. Hobson
Keyword(s):  
Side Effects ◽  
Gut Microbiota ◽  
Iron Supplementation ◽  
Methanogenic Archaea ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Intestinal Lumen ◽  
Gastrointestinal Side Effects ◽  
Potential Link ◽  
The Impact

Iron deficiency anaemia (IDA) is a worldwide healthcare problem affecting approximately 25% of the global population. The most common IDA treatment is oral iron supplementation, which has been associated with gastrointestinal (GI) side effects such as constipation and bloating. These can result in treatment non-adherence and the persistence of IDA. Intravenous iron does not cause GI side effects, which may be due to the lack of exposure to the intestinal lumen. Luminal iron can cause changes to the gut microbiota, aiding the promotion of pathogenic species and decreasing beneficial protective species. Iron is vital for methanogenic archaea, which rely on iron for growth and metabolism. Increased intestinal methane has been associated with slowing of intestinal transit, constipation, and bloating. Here we explore the literature to understand a potential link between iron and methanogenesis as a novel way to understand the mechanism of oral iron supplementation induced GI side effects.

scholarly journals Restless Legs Syndrome and Poor Sleep Quality in Obese Children and Adolescents

2018 ◽  
Vol 10 (2) ◽  
pp. 131-138 ◽  
Author(s):  
Rıza Taner Baran ◽  
Müge Atar ◽  
Özgür Pirgon ◽  
Serkan Filiz ◽  
Meral Filiz
Keyword(s):  
Sleep Quality ◽  
Children And Adolescents ◽  
Restless Legs Syndrome ◽  
Poor Sleep ◽  
Obese Children ◽  
Poor Sleep Quality ◽  
Restless Legs

scholarly journals The Safety and Efficacy of Pregabalin Add-on Therapy in Restless Legs Syndrome Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Hyoeun Bae ◽  
Yong Won Cho ◽  
Keun Tae Kim ◽  
Richard P. Allen ◽  
Christopher J. Earley
Keyword(s):  
Side Effects ◽  
Restless Legs Syndrome ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Restless Legs ◽  
Persistent Symptoms ◽  
Before And After ◽  
Severity Index Score ◽  
Irls Score ◽  
Symptomatic Control

Pregabalin is increasingly being used as a first-line treatment for symptomatic control of restless legs syndrome (RLS). This study aimed to evaluate the efficacy and safety of pregabalin as add-on therapy in RLS patients already taking dopamine agonists (DA) but still in need of further management. Patients with idiopathic RLS were enrolled, and all had already been prescribed DA for at least 3 months but still had either persistent symptoms, side effects, or comorbid insomnia. An initial dose of 75 mg pregabalin was begun, adjusted as needed, and maintained at a stable dose for 4 weeks, followed by observation for a total of 8 weeks. RLS symptoms and insomnia scores were evaluated before and after add-on pregabalin treatment. Patients were monitored for side effects that could be attributed to pregabalin. A total of 32 RLS patients were enrolled, and 20 subjects remained until the endpoint. After the pregabalin add-on, the mean IRLS score showed significant improvement compared to the baseline (p &lt; 0.001). The insomnia severity index score also improved (p = 0.036), and no serious adverse effects were observed. Our preliminary data suggests the potential for pregabalin as an add-on therapy to DA with regards to both efficacy and safety in patients who have inadequate RLS improvement.

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