ferric-oxide--saccharated and Restless-Legs-Syndrome

Restless legs syndrome (RLS) is a common neurological disorder of unclear pathophysiology that appears to involve an iron deficiency in the brain. Some studies, but not others, suggest that intravenous injection of iron can reduce RLS severity.. The databases Web of Science, PubMed, Embase, Chinese National Knowledge Infrastructure, Wanfang, and SinoMed were searched for randomized controlled trials, cohort studies and case-control studies of intravenous iron therapy to treat RLS. Eligible studies were meta-analyzed using Stata 12.0.. This analysis indicated that IV iron was more efficacious than placebo in treating RLS (OR: 4.71,95%CI 4.21-5.21,p < 0.0001). According to sub-group analysis, either IV ferric carboxymaltose (FCM) or iron sucrose was more efficacious than placebo in treating RLS. Adverse events did not differ significantly between patients receiving intravenous iron or placebo (OR 1.68, 95%CI 0.92-3.07, p = 0.093). The present study also indicated after accepting IV iron treatment the IRLS score in RLS patients decreased (OR = 6.75,95%CI 4.02-9.49, p < 0.0001). The subgroup analysis showed that IV iron dextran, iron sucrose, and FCM could alleviate the IRLS score.. The available evidence suggests that intravenous iron is effective and tolerable for patients with RLS regardless of peripheral iron status.

Topics: Ferric Compounds; Ferric Oxide, Saccharated; Humans; Injections, Intravenous; Iron-Dextran Complex; Maltose; Observational Studies as Topic; Randomized Controlled Trials as Topic; Restless Legs Syndrome

BACKGROUND Restless legs syndrome (RLS) is a common disorder in hemodialysis (HD) patients that causes sleep disturbances and diminished quality of life. Because iron deficiency has been implicated in the pathogenesis of RLS, we sought to investigate the effects of intravenous (IV) iron sucrose on symptoms of RLS in HD patients. MATERIAL AND METHODS The study was a randomized, placebo-controlled study of 1000 mg iron sucrose versus normal saline as placebo. Patients were evaluated at baseline and 2 weeks after the last injection. The severity of RLS was assessed using the International RLS Study Group rating scale (IRLS). Blood samples were taken to measure iron parameters reflecting the iron status, including serum ferritin (SF) concentration, percentage transferrin saturation (TSAT%) and hemoglobin (Hb), and other biochemical parameters as safety assessments, including creatinine (Cr), urea, intact parathyroid hormone (iPTH), and the index of urea clearance (Kt/V). Adverse events were monitored in all subjects during the period of infusion. RESULTS After 2 weeks, IRLS scores decreased more in the IV-iron group (-7.38±2.03) than in the placebo group (-0.81±2.61) (P=0.000). Serum ferritin, TSAT, and hemoglobin increased more in the IV-iron group (227.63±77.64 µg/L; 26.06±7.77%; 13.98±3.62g/L, respectively) than in the placebo group (SF, p=0.000; TSAT, p=0.000; Hb, p=0.000, respectively). There were no significant differences between IV-iron and placebo groups in Cr, urea, iPTH, and Kt/V. No adverse effects were observed in the study. CONCLUSIONS IV iron sucrose is a safe and effective treatment for reducing RLS symptoms in HD patients over the short-term.

Topics: Administration, Intravenous; Aged; Double-Blind Method; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Iron; Male; Middle Aged; Quality of Life; Renal Dialysis; Restless Legs Syndrome

Iron depletion is common in regular blood donors. The objective of the study was to investigate the frequency and severity of iron depletion in regular blood donors and whether IV iron is more effective than oral to avoid iron depletion and symptoms thereof, especially restless legs syndrome (RLS).. One hundred and twenty blood donors with at least five previous whole blood donations were randomized to receive either IV iron sucrose (Venofer(®), RenaPharma/Vifor, Uppsala, Sweden), 200 mg, or to 20×100 mg of oral iron sulphate (Duroferon(®), GlaxoSmithKline, Stockholm, Sweden), after each blood donation during 1 year. Iron status and RLS incidence and severity were investigated.. Iron status was generally poor among regular blood donors, especially in women, with a high incidence of iron depletion (>20%) and RLS (18%). The IV iron group increased storage iron to a greater extent than the oral iron group after 12 months (P=0·0043). Female donors were more responsive to IV iron sucrose compared to oral iron sulphate, particularly female donors below 50 years of age. RLS severity scores were significantly lower in the IV iron group. The two treatments were safe.. Iron status is poor in regular blood donors, restless legs syndrome is common, and the routine iron supplementation is insufficient. IV iron sucrose substitutes iron loss in blood donors more efficiently compared with oral iron sulphate, especially in women. Iron substitution to blood donors should be individualized and based on P-ferritin monitoring.

Topics: Adult; Age Factors; Blood Donors; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Incidence; Iron; Iron Deficiencies; Male; Middle Aged; Restless Legs Syndrome; Sex Factors

Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S-ferritin < or =45 microg/L) recruited from a cohort of 231 patients were randomly assigned in a 12-months double-blind, multi-centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan-Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long-term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS.

Topics: Adult; Double-Blind Method; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Male; Middle Aged; Restless Legs Syndrome; Surveys and Questionnaires; Time Factors

The aim of this study was to ascertain whether high-dose intravenous (IV) iron sucrose could improve symptoms and change brain iron concentrations in idiopathic RLS.. The study was a randomized, parallel-group double-blind study of 1000mg iron sucrose given IV versus placebo. Primary measures of the clinical status were global rating scale (GRS) and periodic leg movements of sleep (PLMS). Primary measures of brain iron status were CSF ferritin and MRI-determined iron in the substantia nigra.. At the time of the interim analysis there were 7 placebo and 11 iron-treated subjects. At 2-weeks post-treatment, iron treatment resulted in a small but significant increase in CSF ferritin and a decrease in RLS severity (GRS) but did not change PLMS or MRI iron index. None of the secondary outcomes changed with treatment. There was no single case of clear treatment benefit in any of the patients. This interim analysis revealed an effect size that was too small to allow for adequate power to find significant differences with the planed 36-subject enrollment for either the primary objective outcome of PLMS or any of the secondary outcomes. The study was stopped at this planned break-point given the lack of both adequate power and any indication for clinically significant benefit.. High-dose IV iron failed to demonstrate the robust changes reported in three prior open-label studies. Differences in iron formulation, dosing regiment, and peripheral iron status may explain some of the discrepancies between this and previous IV iron treatment studies.

Topics: Aged; Dose-Response Relationship, Drug; Double-Blind Method; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Iron; Male; Middle Aged; Restless Legs Syndrome; Substantia Nigra; Treatment Failure

An alternative treatment approach is needed for children who cannot tolerate oral iron preparations or when there is a need for rapid replenishment of iron stores. We report on the safety, adverse effects, and efficacy of intravenous iron sucrose in a retrospective sample of children with restless legs syndrome (RLS) or periodic limb movement disorder (PLMD).. Sixteen children with RLS/PLMD who received intravenous iron sucrose at our institution between 2005 and 2011 were identified. The diagnosis of RLS/PLMD was established after formal sleep consultation and nocturnal polysomnography (PSG). Serum ferritin was assayed in all 16 subjects prior to iron sucrose infusion and in 14 subjects after infusion. The medical records were reviewed for treatment-related details.. The mean age of subjects was 6.6 years (range, 2-16 y; 5/16 girls). The mean periodic limb movement index (PLMI) was 18.2±12.8. Fifteen of the 16 subjects (93.7%) had systemic or neurologic comorbidities. Fourteen of 16 (87.5%) subjects had received prior oral iron supplementation for sleep-related concerns, with the majority of the subjects either having gastrointestinal (GI) side effects or insufficient benefits. Intravenous iron sucrose therefore was provided to these 16 subjects through our outpatient pediatric infusion therapy center. The average dose of intravenous iron sucrose of 3.6 mg/kg was infused over 2 h. The baseline mean serum ferritin was 16.4±6.6 ng/mL. After infusion with intravenous iron sucrose, the mean serum ferritin rose to 45.7±22.4 ng/mL (n=14; [95% confidence interval, 17.2-41.3]; P<.0001). Parental assessment of response to iron sucrose therapy was conducted on follow-up clinic visits or via telephone calls. There was improved sleep in 62.5% (n=10) of subjects and no improvement in 12.5% (n=2) of subjects. No follow-up information was available for 25% (n=4) of subjects. Minor adverse events occurred in 25% (n=4) of subjects--two subjects experienced difficulty with peripheral intravenous catheter placement, while two had transient GI symptoms, such as anorexia, nausea, and vomiting. None of the subjects had anaphylaxis.. Intravenous iron sucrose appears to be a relatively effective therapy for patients with childhood-onset RLS/PLMD and iron deficiency who do not tolerate or respond to oral iron supplements. Side effects were transient. The most common adverse events were difficulty with intravenous line placement and GI disturbance. There is a need for systematic prospective studies on the safety and efficacy of intravenous iron sucrose in RLS/PLMD in children.

Topics: Administration, Intravenous; Administration, Oral; Adolescent; Age of Onset; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Humans; Male; Nocturnal Myoclonus Syndrome; Polysomnography; Restless Legs Syndrome; Retrospective Studies

We report on two pregnant women who either had de novo restless legs syndrome (RLS) or had marked enhancement of preexisting RLS symptoms during pregnancy. Both patients had ferritin values <50 μg/L at baseline. The patients had relevant sleep disorders and daytime symptoms caused by RLS. The women were treated in an open paradigm with intravenous iron sucrose. A few weeks after therapy, both patients experienced a significant reduction or even remission of RLS symptoms. Their quality of life and sleep substantially improved and no treatment-related adverse effects were observed. According to our initial experience, intravenous iron sucrose administration appears to be an effective therapy in RLS patients with low ferritin values during pregnancy.

Topics: Administration, Intravenous; Adult; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Humans; Pregnancy; Pregnancy Complications; Restless Legs Syndrome; Treatment Outcome

Initially, the patient in this case received CPAP for sleep apnea and pramipexole for RLS. Her symptoms failed to resolve, which led to consultation with a sleep specialist who recommended diagnostic studies that identified an underlying iron/ferritin deficiency. After receiving IV iron therapy, the patient's RLS symptoms resolved. Only about one-quarter of patients with RLS symptoms receive an appropriate diagnosis, and thus, many are treated less than optimally. Agents used to treat RLS have been heavily advertised, and patients may request a prescription from their health care provider. This case reaffirms the importance of the medical history and diagnostic studies when evaluating a patient with symptoms of RLS. Screening first for iron/ferritin deficiency may prevent subjecting patients to the potential side effects of unnecessary medications.

Topics: Continuous Positive Airway Pressure; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Middle Aged; Restless Legs Syndrome; Sleep Apnea, Obstructive