ferric-carboxymaltose and Anemia--Iron-Deficiency

Iron deficiency (ID) is a common co-morbidity in patients with heart failure (HF). The present meta-analysis evaluates the effect of intravenous (IV) iron-carbohydrate complex supplementation in patients with HF with reduced ejection fraction (HFrEF) and ID/iron deficiency anaemia (IDA). Randomized controlled trials (RCTs) comparing IV iron-carbohydrate complexes with placebo/standard of care in patients with HFrEF with ID/IDA were identified using Embase (from 1957) and PubMed (from 1989) databases through 25 May 2021. Twelve RCTs including 2381 patients were included in this analysis. The majority (90.8%) of patients receiving IV iron-carbohydrate therapy were administered ferric carboxymaltose (FCM); 7.5% received iron sucrose and 1.6% received iron isomaltoside. IV iron-carbohydrate therapy significantly reduced hospitalization for worsening HF [0.53 (0.42-0.65); P < 0.0001] and first hospitalization for worsening HF or death [0.75 (0.59-0.95); P = 0.016], but did not significantly impact all-cause mortality, compared with control. IV iron-carbohydrate therapy significantly improved functional and exercise capacity compared with the control. There was no significant difference in outcome between IV iron-carbohydrate formulations when similar endpoints were measured. No significant difference in adverse events (AE) was observed between the treatment groups. IV iron-carbohydrate therapy resulted in improvements in a range of clinical outcomes and increased functional and exercise capacity, whereas AEs were not significantly different between IV iron-carbohydrate and placebo/standard of care arms. These findings align with the European Society of Cardiology's 2021 HF guidelines, which recommend the consideration of FCM in symptomatic patients with a left ventricular ejection fraction < 45% and ID.

Topics: Anemia, Iron-Deficiency; Hematinics; Humans; Iron; Iron Deficiencies; Maltose

Iron deficiency anemia (IDA) is common worldwide, and various iron replacement therapies are available. Ferumoxytol is an injectable, high-dose iron formulation (510 mg) that can be administered over a short period (15 min) without test administration. The drug was approved by the Food and Drug Administration in 2009 for the treatment of IDA in patients with chronic kidney disease (CKD), and in 2018, the indication was expanded to include patients without CKD.. This paper reviews studies testing the efficacy and safety of ferumoxytol in treating IDA compared with other iron formulations.. There is substantial evidence that ferumoxytol is effective for the treatment of IDA. The efficacy of ferumoxytol in improving anemia is comparable to that of iron sucrose and ferric carboxymaltose (FCM) and superior to that of oral iron or a placebo in replenishing iron stores. Treatment with ferumoxytol, although more expensive, is cost-effective for outpatients requiring parenteral administration because it requires fewer doses and shorter dosing times per dose. Ferumoxytol also causes less frequent hypophosphatemia than FCM. Currently, its use in children and pregnant women is under consideration, which may provide important information for the future applications of ferumoxytol in larger numbers of patients.

Topics: Anemia, Iron-Deficiency; Child; Female; Ferric Compounds; Ferrosoferric Oxide; Humans; Iron; Pregnancy; Renal Insufficiency, Chronic

It has been shown that ferric carboxymaltose (FCM) improves symptoms and quality of life in iron-deficient patients with heart failure (HF).. We aimed to systematically review studies conducted on the cost-effectiveness of FCM compared to placebo in iron-deficient patients with HF.. We searched PubMed, EMBASE, Scopus, and Web of Science to find the relevant studies. After removing duplicates, two authors independently evaluated the titles, abstracts, and full texts. We included studies that investigated the full economic evaluations of FCM in HF patients with iron deficiency (cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis) and used the CHEERS tool to evaluate the quality of the studies.. Seven studies were included which evaluated the economic analysis of treatments with FCM in iron-deficient patients with HF. The CHEERS scores for most of the studies (n = 6) were 0.77 or higher (very good quality). The lowest incremental cost-effectiveness ratio (ICER) per quality-adjusted life years (QALY) of FCM ($1801.96) was from Italy, and the highest ICER per QALY of FCM ($25,981.28) South Korea. Results of the studies showed that FCM, compared to placebo, was cost-effective in iron-deficient patients with HF.. FCM is a cost-effective treatment for iron-deficient patients with HF. Considering the fact that all the included studies in the present systematic review took place in high-income countries, we recommend further studies investigating the cost-effectiveness of FCM in low- and middle-income countries.

Topics: Anemia, Iron-Deficiency; Cost-Benefit Analysis; Heart Failure; Humans; Iron; Quality of Life

Intravenous iron is the preferred treatment for patients with iron deficiency anemia in a variety of clinical situations. Although uncommon, administration of modern IV iron formulations can result in hypersensitivity reactions (HSRs) and, rarely, anaphylactic or anaphylactoid reactions.. The objective of the present study was to systematically review the literature to identify and analyze data on the incidence of HSRs after administration of ferric derisomaltose (FDI) or ferric carboxymaltose (FCM).. A prospectively-registered systematic literature review was conducted to identify prospective randomized controlled trials comparing FDI and FCM with other intravenous iron formulations or oral iron. Searches were conducted in PubMed (including MEDLINE), EMBASE, and the Cochrane Library in November 2020. The relative incidence of serious or severe HSRs occurring on the day or day after dosing of intravenous iron, recorded under the standardized Medical Dictionary for Regulatory Activities query for anaphylactic reaction.. Data were obtained from seven randomized controlled trials of FCM (N = 2683) and ten of FDI (N = 3474) enrolling 10,467 patients in total. The number of patients experiencing any serious or severe HSR event was 29/2683 (1.08%) with FCM versus 5/3474 with FDI (0.14%). Bayesian inference of proportions showed the event rates to be significantly lower with FDI relative to FCM.. HSR events were uncommon with both intravenous iron formulations; however, the present study showed a significantly lower incidence of HSRs with FDI relative to FCM. Further large-scale, head-to-head trials of the iron formulations would be required to confirm this finding.

Topics: Administration, Intravenous; Anaphylaxis; Anemia, Iron-Deficiency; Bayes Theorem; Humans; Incidence; Iron; Prospective Studies

Iron deficiency (ID) complicates heart failure (HF) at different stages of the natural history of the disease; however, this frequent comorbidity is still not comprehensively understood and investigated in terms of pathophysiology. Intravenous iron therapy with ferric carboxymaltose (FCM) should be considered to improve the quality of life, exercise capacity, and symptoms in stable HF with ID, as well as to reduce HF hospitalizations in iron-deficient patients stabilized after an episode of acute HF. The therapy with intravenous iron, however, continues to generate important clinical questions for cardiologists.. In the current paper, we discuss the class effect concept for intravenous iron formulations beyond FCM, based on the experiences of nephrologists who administer different intravenous iron formulations in advanced chronic kidney disease complicated with ID and anemia. Furthermore, we discuss the neutral effects of oral iron therapy in patients with HF, because there are still some reasons to further explore this route of supplementation. The different definitions of ID applied in HF studies and new doubts regarding possible interactions of intravenous iron with sodium-glucose co-transporter type 2 inhibitors are also emphasized. The experiences of other medical specializations may provide new information on how to optimally replenish iron in patients with HF and ID.

Topics: Anemia, Iron-Deficiency; Heart Failure; Humans; Iron; Iron Deficiencies; Quality of Life

The objective of the FeminFER project was to assess the value of ferric carboxymaltose following a multicriteria decision analysis in obstetrics and gynaecology in Spain.. Ferric carboxymaltose (FCM) and ferrous sulphate were evaluated using the EVIDEM framework. Ten stakeholders participated to collect different perspectives. The framework was adapted considering evidence retrieved with a PICO-S search strategy and grey literature. Criteria/subcriteria were weighted by level of relevance and an evidence-based decision-making exercise was developed in each criterion; weights and scores were combined to obtain the value of intervention relative to each criterion/subcriterion, that were further combined into the Modulated Relative Benefit-Risk Balance (MRBRB).. The most important criterion favouring FCM was Compared Efficacy/Effectiveness (0.183 ± 0.07), followed by Patient Preferences (0.059 ± 0.10). Only Direct medical costs criterion favoured FS (-0.003 ± 0.03). MRBRB favoured FCM; 0.45 ± 0.19; in a scale from -1 to + 1.. In conclusion, considering the several criteria involved in the decision-making process, participants agreed with the use of FCM according to its MRBRB.

Topics: Anemia, Iron-Deficiency; Decision Support Techniques; Female; Ferric Compounds; Ferrous Compounds; Humans; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Risk Assessment; Spain; Stakeholder Participation

Intravenous (IV) iron is the preferred treatment for patients with iron deficiency anemia (IDA) who require rapid replenishment of iron stores or in whom oral iron is not tolerated or effective. Data from two large-scale randomized controlled trials (RCTs) have recently been published reporting the incidence of adjudicated cardiovascular events after ferric derisomaltose (FDI) and iron sucrose (IS). The objective was to calculate the relative incidence of cardiovascular events with FDI and IS, and to conduct an indirect comparison with ferric carboxymaltose (FCM) based on previously published studies of cardiovascular risk.. RCTs reporting the incidence of blindly adjudicated cardiovascular events in IDA patients treated with IV iron were identified by systematic literature review (SLR). Pairwise random effects meta-analyses of FDI versus IS, and FCM versus IS were conducted for the pre-specified adjudicated composite cardiovascular endpoint of: death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, congestive heart failure, arrhythmia, and protocol-defined hypertensive and hypotensive events. Analyses were also conducted for the composite endpoint excluding blood pressure events. Meta-analysis results were combined in an adjusted indirect comparison to provide an indirect estimate of cardiovascular risk with FDI versus FCM.. The SLR retrieved 694 unique articles, of which four were RCTs reporting the incidence of the composite cardiovascular endpoint; two studies comparing FCM (N = 1529) with IS (N = 1505), and two studies comparing FDI (N = 2008) with IS (N = 1000). The odds ratios of the composite CV endpoint were 0.59 (95% confidence interval: 0.39-0.90) for FDI versus IS, 1.12 (95% CI 0.90-1.40) for FCM versus IS, and the indirect OR for FDI versus FCM was 0.53 (95% CI 0.33-0.85).. Pooling data from four large-scale RCTs suggested that FDI was associated with significantly lower incidence of cardiovascular adverse events compared to both FCM and IS.

Topics: Anemia, Iron-Deficiency; Cardiovascular Diseases; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Heart Failure; Humans; Incidence; Iron; Maltose; Randomized Controlled Trials as Topic

Iron deficiency is the primary cause of anaemia worldwide and is particularly common among children and adolescents. Intravenous (IV) iron therapy is recommended for paediatric patients with certain comorbidities or if oral iron treatment has been unsuccessful. IV ferric carboxymaltose (FCM) has recently been approved by the US Food and Drug Administration for use in children aged > 1 year. This narrative review provides an overview of the available publications on the efficacy and safety of IV FCM in children and adolescents. A literature search using PubMed and Embase yielded 153 publications; 33 contained clinical data or reports on clinical experience relating to IV FCM in subjects < 18 years of age and were included in the review. No prospective, randomised controlled studies on the topic were found. Most publications were retrospective studies or case reports and included patients with various underlying conditions or patients with inflammatory bowel disease. Efficacy data were included in 27/33 publications and improvements in anaemia, and/or iron status parameters were reported in 26 of them. Safety data were included in 25/33 publications and were in line with the adverse events described in the prescribing information.. The available publications indicate that IV FCM, a nanomedicine with a unique and distinctive therapeutic profile, is an effective and generally well-tolerated treatment for iron deficiency or iron deficiency anaemia in children and adolescents. Despite the wealth of retrospective evidence, prospective, randomised controlled trials in the paediatric setting are still necessary.. • Iron deficiency and iron deficiency anaemia are usually managed using oral iron therapy, but intravenous iron therapy is recommended for certain paediatric patients. • Intravenous ferric carboxymaltose (FCM) has recently been approved in the US for use in children aged > 1 year.. • Despite evidence that FCM is effective and generally well tolerated in children and adolescents, so far, only retrospective studies, non-randomised uncontrolled prospective studies, or case reports have been published in full. • There is a strong need for prospective, randomised controlled trials on FCM in the paediatric setting.

Topics: Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Ferric Compounds; Humans; Iron; Iron Deficiencies; Maltose; Prospective Studies; Retrospective Studies; Treatment Outcome

To review the pharmacology, efficacy, and safety of ferric maltol (FM), an oral iron formulation, for iron deficiency anemia (IDA).. A MEDLINE/PubMed and EMBASE (January 1, 1985, to June 19, 2020) literature search was performed using the terms. English language literature evaluating FM pharmacology, pharmacokinetics, efficacy, or safety in the treatment of IDA were reviewed.. FM is a ferric, non-salt-based oral iron formulation demonstrating improved tolerance in patients with previous intolerance to other iron formulations. Phase 3 trials demonstrated significant improvements in anemia and serum iron parameters in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Common adverse effects were gastrointestinal intolerance.. FM is an effective and well-tolerated alternative to oral iron salts for patients with IBD or CKD and IDA. Emerging data suggest that FM is noninferior to intravenous (IV) ferric carboxymaltose in patients with IBD and IDA. Prior to selecting FM over IV iron products, consideration should be given to time to normalization of Hb, ease of administration, cost, and tolerability.. FM is a relatively safe, effective oral iron therapy that may be better tolerated than other oral iron formulations. FM may be an effective alternative to IV iron in patients with IBD.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Clinical Trials as Topic; Female; Ferric Compounds; Hematinics; Humans; Inflammatory Bowel Diseases; Male; Maltose; Pyrones; Renal Insufficiency, Chronic; Treatment Outcome

Hypophosphataemia is an increasingly recognized side-effect of ferric carboxymaltose (FCM) and possibly iron isomaltoside/ferric derisomaltose (IIM), which are used to treat iron deficiency. The aim of this study was to determine frequency, severity, duration and risk factors of incident hypophosphataemia after treatment with FCM and IIM.. A systematic literature search for articles indexed in EMBASE, PubMed and Web of Science in years 2005-2020 was carried out using the search terms 'ferric carboxymaltose' OR 'iron isomaltoside'. Prospective clinical trials reporting outcomes on hypophosphataemia rate, mean nadir serum phosphate and/or change in mean serum phosphate from baseline were selected. Hypophosphataemia rate and severity were compared for studies on IIM vs. FCM after stratification for chronic kidney disease. Meta-regression analysis was used to investigate risk factors for hypophosphataemia.. Across the 42 clinical trials included in the meta-analysis, FCM induced a significantly higher incidence of hypophosphataemia than IIM (47%, 95% CI 36-58% vs. 4%, 95% CI 2-5%), and significantly greater mean decreases in serum phosphate (0.40 vs. 0.06 mmol/L). Hypophosphataemia persisted at the end of the study periods (maximum 3 months) in up to 45% of patients treated with FCM. Meta-regression analysis identified low baseline serum ferritin and transferrin saturation, and normal kidney function as significant predictors of hypophosphataemia.. FCM is associated with a high risk of hypophosphataemia, which does not resolve for at least 3 months in a large proportion of affected patients. More severe iron deficiency and normal kidney function are risk factors for hypophosphataemia.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Fibroblast Growth Factor-23; Humans; Hypophosphatemia; Maltose; Prospective Studies

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Cardiovascular Diseases; Cause of Death; Ferric Compounds; Heart Failure; Hematinics; Hospitalization; Humans; Maltose; Mortality; Randomized Controlled Trials as Topic; Stroke Volume; Treatment Outcome

Inflammatory bowel disease affects approximately seven million people globally. Iron deficiency anaemia can occur as a common systemic manifestation, with a prevalence of up to 90%, which can significantly affect quality of life, both during periods of active disease or in remission. It is important that iron deficiency anaemia is treated effectively and not be assumed to be a normal finding of inflammatory bowel disease. The various routes of iron administration, doses and preparations present varying advantages and disadvantages, and a significant proportion of people experience adverse effects with current therapies. Currently, no consensus has been reached amongst physicians as to which treatment path is most beneficial.. The primary objective was to evaluate the efficacy and safety of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease.. We searched CENTRAL, MEDLINE, Embase, and two other databases on 21st November 2019. We also contacted experts in the field and searched references of trials for any additional trials.. Randomised controlled trials investigating the effectiveness and safety of iron administration interventions compared to other iron administration interventions or placebo in the treatment of iron deficiency anaemia in inflammatory bowel disease. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors.. Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology.. We included 11 studies (1670 randomised participants) that met the inclusion criteria. The studies compared intravenous iron sucrose vs oral iron sulphate (2 studies); oral iron sulphate vs oral iron hydroxide polymaltose complex (1 study); oral iron fumarate vs intravenous iron sucrose (1 study); intravenous ferric carboxymaltose vs intravenous iron sucrose (1 study); erythropoietin injection + intravenous iron sucrose vs intravenous iron sucrose + injection placebo (1 study); oral ferric maltol vs oral placebo (1 study); oral ferric maltol vs intravenous ferric carboxymaltose (1 study); intravenous ferric carboxymaltose vs oral iron sulphate (1 study); intravenous iron isomaltoside vs oral iron sulphate (1 study); erythropoietin injection vs oral placebo (1 study). All studies compared participants with CD and UC together, as well as considering a range of disease activity states. The primary outcome of number of responders, when defined, was stated to be an increase in haemoglobin of 20 g/L in all but two studies in which an increase in 10g/L was used. In one study comparing intravenous ferric carboxymaltose and intravenous iron sucrose, moderate-certainty evidence was found that intravenous ferric carboxymaltose was probably superior to intravenous iron sucrose, although there were responders in both groups (150/244 versus 118/239, RR 1.25, 95% CI 1.06 to 1.46, number needed to treat for an additional beneficial outcome (NNTB) = 9). In one study comparing oral ferric maltol to placebo, there was low-certainty evidence of superiority of the iron (36/64 versus 0/64, RR 73.00, 95% CI 4.58 to 1164.36). There were no other direct comparisons that found any difference in the primary outcomes, although certainty was low and very low for all outcomes, due to imprecision from sparse data and risk of bias varying between moderate and high risk. The reporting of secondary outcomes was inconsistent. The most common was the occurrence of serious adverse events or those requiring withdrawal of therapy. In no comparisons was there a difference seen between any of the intervention agents being studied, although the certainty was very low for all comparisons made, due to risk of bias and significant imprecision due to the low numbers of events. Time to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes were reported in any of the studies. An analysis of all intravenous iron preparations to all o. Intravenous ferric carboxymaltose probably leads to more people having resolution of IDA (iron deficiency anaemia) than intravenous iron sucrose. Oral ferric maltol may lead to more people having resolution of IDA than placebo. We are unable to draw conclusions on which of the other treatments is most effective in IDA with IBD (inflammatory bowel disease) due to low numbers of studies in each comparison area and clinical heterogeneity within the studies. Therefore, there are no other conclusions regarding the treatments that can be made and certainty of all findings are low or very low. Overall, intravenous iron delivery probably leads to greater response in patients compared with oral iron, with a NNTB (number needed to treat) of 11. Whilst no serious adverse events were specifically elicited with any of the treatments studied, the numbers of reported events were low and the certainty of these findings very low for all comparisons, so no conclusions can be drawn. There may be more withdrawals due to such events when oral is compared with intravenous iron delivery. Other outcomes were poorly reported and once again no conclusions can be made as to the impact of IDA on any of these outcomes. Given the widespread use of many of these treatments in practice and the only guideline that exists recommending the use of intravenous iron in favour of oral iron, research to investigate this key issue is clearly needed. Considering the current ongoing trials identified in this review, these are more focussed on the impact in specific patient groups (young people) or on other symptoms (such as fatigue). Therefore, there is a need for studies to be performed to fill this evidence gap.

Topics: Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Bias; Colitis, Ulcerative; Crohn Disease; Disaccharides; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Fumarates; Hematinics; Humans; Iron Compounds; Maltose; Middle Aged; Placebos; Pyrones; Randomized Controlled Trials as Topic; Young Adult

Treatment of iron deficiency (ID) in patients with heart failure (HF) has improved symptoms, quality of life, exercise capacity and has reduced hospitalizations in randomized controlled trials (RCTs) and meta-analyses. Intravenous ferric carboxymaltose (FCM) provided convincing results in this field, while oral iron supplementation failed. However, FCM and oral iron were compared to placebo, and a comparison between the two strategies is still lacking. We aimed to fill this gap of knowledge with an indirect comparison between them by means of a network meta-analysis of RCTs. Five studies measuring exercise capacity (i.e. 6-minute walking test) and quality of life (i.e. Kansas City Cardiomyopathy Questionnaire) were eligible to be included in our review. Given the limitations of a network meta-analysis, our findings support the better efficacy of FCM than oral iron as regards exercise capacity, with a trend towards an improvement in quality of life, suggesting that FCM seems to be strategy of choice to correct ID in HF patients.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Maltose; Network Meta-Analysis

Iron deficiency anemia (IDA) is common among obstetric and gynecologic patients. This systematic review aimed to assess the comparative efficacy and safety of commonly used intravenous (IV) iron formulations, ferric carboxymaltose (FCM), and iron sucrose (IS) in the treatment of IDA in obstetric and gynecologic patients.. We systematically searched PubMed, EMBASE, Cochrane CENTRAL, and Google Scholar for eligible randomized controlled trials (RCTs) comparing IV iron replacement using FCM and IS up to October 2019. The primary outcome was to compare the efficacy of FCM and IS, assessed by measuring serum hemoglobin (Hb) and ferritin levels before and after iron replacement. The secondary outcome was to compare the safety of FCM and IS, assessed by the incidence of adverse events during iron replacement. The meta-analysis was performed using RevMan 5.3.. We identified 9 RCTs with 910 patients (FCM group, n = 456; IS group, n = 454). Before iron replacement, FCM and IS group patients had similar baseline Hb (mean difference [MD], 0.04 g/dL; 95% confidence interval [CI], -0.07 to 015; I2 = 0%; P = 0.48) and ferritin levels (MD, -0.42 ng/mL; 95% CI, -1.61 to 0.78; I2 = 45%; P = 0.49). Following iron replacement, patients who received FCM had higher Hb (MD, 0.67; 95% CI, 0.25-1.08; I2 = 92%; P = 0.002) and ferritin levels (MD, 24.41; 95% CI, 12.06-36.76; I2 = 75%; P = 0.0001) than patients who received IS. FCM group showed a lower incidence of adverse events following iron replacement than IS group (risk ratio, 0.53; 95% CI, 0.35-0.80; I2 = 0%; P = 0.003). Serious adverse events were not reported in any group.. FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group for IDA treatment among obstetric and gynecologic patients. However, this meta-analysis was limited by the small number of RCTs and high heterogeneity.. The review was prospectively registered with the International Prospective Registry of Systematic Reviews (https://www.crd.york.ac.uk/prospero/, registration number CRD42019148905).

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Hematinics; Hemoglobins; Humans; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Randomized Controlled Trials as Topic; Treatment Outcome

Iron-deficiency anemia (IDA) is the most common form of anemia. It is treated through iron replacement therapy, with oral iron administration as the recommended first-line treatment. However, intravenous (IV) iron formulation is at timed used owing to adverse effects of oral iron administration such as gastrointestinal symptoms. Although saccharated ferric iron oxide had been the only available IV iron formulation in Japan for a long time, ferric carboxymaltose (FCM) has recently been approved. In this review, the characteristics, efficacy, and safety of FCM will be discussed mainly by introducing the results of three clinical trials for FCM conducted in Japan. More effective treatment for patients with IDA might be achieved through the introduction of FCM administration in clinical settings.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Iron; Japan; Maltose; Treatment Outcome

Numerous iron preparations are available for the treatment of iron deficiency anaemia in pregnancy. We aimed to provide a summary of the effectiveness and safety of iron preparations used in this setting.. We did a systematic review and network meta-analysis of randomised trials. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, trial registers, and grey literature for trials published in any language from Jan 1, 2011, to Feb 28, 2021. We included trials including pregnant women with iron deficiency anaemia and evaluating iron preparations, irrespective of administration route, with at least 60 mg of elemental iron, in comparison with another iron or non-iron preparation. Three authors independently selected studies, extracted data, and did a risk of bias assessment using the Cochrane tool (version 1.0). The primary outcome was the effectiveness of iron preparations, evaluated by changes in haemoglobin concentration at 4 weeks from baseline. The secondary outcomes were change in serum ferritin concentration at 4 weeks from baseline and treatment-related severe and non-severe adverse events. We did random-effects pairwise and network meta-analyses. Side-effects were reported descriptively for each trial. This study is registered with PROSPERO, CRD42018100822.. Among 3037 records screened, 128 full-text articles were further assessed for eligibility. Of the 53 eligible trials (reporting on 9145 women), 30 (15 interventions; 3243 women) contributed data to the network meta-analysis for haemoglobin and 15 (nine interventions; 1396 women) for serum ferritin. The risk of bias varied across the trials contributing to network meta-analysis, with 22 of 30 trials in the network meta-analysis for haemoglobin judged to have a high or medium global risk of bias. Compared with oral ferrous sulfate, intravenous iron sucrose improved both haemoglobin (mean difference 7·17 g/L, 95% CI 2·62-11·73; seven trials) and serum ferritin (mean difference 49·66 μg/L, 13·63-85·69; four trials), and intravenous ferric carboxymaltose improved haemoglobin (mean difference 8·52 g/L, 0·51-16·53; one trial). The evidence for other interventions compared with ferrous sulfate was insufficient. The most common side-effects with oral iron preparations were gastrointestinal effects (nausea, vomiting, and altered bowel movements). Side-effects were less common with parenteral iron preparations, although these included local pain, skin irratation, and, on rare occasions, allergic reactions.. Iron preparations for treatment of iron deficiency anaemia in pregnancy vary in effectiveness, with good evidence of benefit for intravenous iron sucrose and some evidence for intravenous ferric carboxymaltose. Clinicians and policy makers should consider the effectiveness of individual preparations before administration, to ensure effective treatment.. None.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Maltose; Nausea; Pregnancy

The mechanism of action of fibroblast growth factor-23 (FGF23) is becoming increasingly clearer as a result of studies that have defined its structure and pleiotropic effects. Furthermore, data are emerging on the effects exerted on this hormone by iron administration. Ten main iron formulations are recognized (with clear differences in composition and possible reactions of intolerance and anaphylaxis), which are indicated for iron deficiency anemia, including nephropathic subjects, as suggested by medical guidelines. With some types of iron formulation (especially iron carboxymaltose) a particular side effect has been observed: hypophosphatemia, mediated by FGF23. This review aims to draw attention to this correlation and the contradiction represented by the presence of both positive and negative modulation by FGF23, with the effects induced by its increase even after long-term treatment with iron formulation. However, more evidence is needed to understand the reasons for this differential stimulation.

Topics: Anemia, Iron-Deficiency; Drug-Related Side Effects and Adverse Reactions; Ferric Compounds; Fibroblast Growth Factor-23; Hematinics; Humans; Hypophosphatemia; Long Term Adverse Effects; Maltose

Fibroblast growth factor 23 (FGF23) was initially characterized as an important regulator of phosphate and calcium homeostasis. New research advances demonstrate that FGF23 is also linked to iron economy, inflammation and erythropoiesis. These advances have been fuelled, in part, by the serendipitous development of two distinct FGF23 assays that can substitute for invasive bone biopsies to infer the activity of the three main steps of FGF23 regulation in bone: transcription, post-translational modification and peptide cleavage. This 'liquid bone biopsy for FGF23 dynamics' enables large-scale longitudinal studies of FGF23 regulation that would otherwise be impossible in humans. The balance between FGF23 production, post-translational modification and cleavage is maintained or perturbed in different hereditary monogenic conditions and in acquired conditions that mimic these genetic disorders, including iron deficiency, inflammation, treatment with ferric carboxymaltose and chronic kidney disease. Looking ahead, a deeper understanding of the relationships between FGF23 regulation, iron homeostasis and erythropoiesis can be leveraged to devise novel therapeutic targets for treatment of anaemia and states of FGF23 excess, including chronic kidney disease.

Topics: Anemia, Iron-Deficiency; Bone and Bones; Calcium; Erythropoiesis; Familial Hypophosphatemic Rickets; Ferric Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Hypophosphatemia; Inflammation; Iron; Maltose; Phosphates; Protein Processing, Post-Translational; Renal Insufficiency, Chronic; RNA, Messenger; Transcription, Genetic

Intravenous iron supplementation is essential in hemodialysis (HD) patients to recover blood loss and to meet the requirements for erythropoiesis and, in patients receiving erythropoietin, to avert the development of iron deficiency. In a recent real-world study, Hofman et al. showed that a therapeutic shift from iron sucrose (IS) to ferric carboxymaltose (FCM) in HD patients improves iron parameters while reducing use of iron and erythropoietin. The objective of this economic analysis is to compare the weekly cost of treatment of FCM vs IS in hemodialysis patients in Italy. The consumption of drugs (iron and erythropoietin) was derived from Hofman’s data, while the value was calculated at Italian ex-factory prices. The analysis was carried on the total patient sample and in two subgroups: patients with iron deficiency and patients anemic at baseline. In addition, specific sensitivity analyses considered prices currently applied at the regional level, simulating the use of IS vs iron gluconate (FG) and epoetin beta vs epoetin alfa. In the base-case analysis, the switch to FCM generates savings of -€12.47 per patient/week (-21%) in all patients, and even greater savings in the subgroups with iron deficiency -€17.28 (-27%) and in anemic patients -€23.08 (-32%). Sensitivity analyses were always favorable to FCM and confirmed the robustness of the analysis. FCM may represent a cost-saving option for the NHS, and Italian real-world studies are needed to quantify the real consumption of resources in dialysis patients.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Humans; Iron Deficiencies; Iron Metabolism Disorders; Maltose; Renal Dialysis

Previous randomized controlled trials (RCTs) have shown beneficial effects of iron supplementation other than anemia improvement including treatment of restless leg syndrome and general fatigue, even in non-anemic subjects with iron deficiency. Recently, some RCTs in congestive heart failure (CHF) demonstrated that intravenous administration of ferric carboxymaltose improves patient symptoms and reduces incidence of hospitalization for worsening heart failure. Consequently, the European Society of Cardiology recommends that iron deficient patients with CHF are administered ferric carboxymaltose (evidence level A). Moreover, the PIVOTAL study for hemodialysis patients proved that proactive administration of iron sucrose decreases the dose of erythropoiesis-stimulating agents and frequency of transfusion compared with its sole administration in reaction to iron deficiency. Notably, this proactive treatment is superior to a low-dose regimen in preventing the primary composite endpoints of nonfatal myocardial infarction, stroke, hospitalization for CHF, and death. These clinical findings are supported by basic research on cardiomyocyte-specific transferrin receptor knock-out mice showing heart failure with impaired mitochondrial respiratory function. In this model, cardiac iron deficiency impairs the mitochondrial electron transport chain, thus leading to low adenosine triphosphate production, and it subsequently prevents mitophagy resulting in damaged mitochondrial accumulation in the heart.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Animals; Ferric Compounds; Ferric Oxide, Saccharated; Heart Failure; Humans; Iron; Maltose; Mice; Randomized Controlled Trials as Topic; Receptors, Transferrin

Iron deficiency is an extremely common comorbidity in patients with heart failure, affecting up to 50% of all ambulatory patients. It is associated with reduced exercise capacity and physical well-being and reduced quality of life. Cutoff values have been identified for diagnosing iron deficiency in heart failure with reduced ejection fraction as serum ferritin, <100 μg/l, or ferritin, 100 to 300 μg/l, with transferrin saturation of <20%. Oral iron products have been shown to have little efficacy in heart failure, where the preference is intravenous iron products. Most clinical studies have been performed using ferric carboxymaltose with good efficacy in terms of improvements in 6-min walk test distance, peak oxygen consumption, quality of life, and improvements in New York Heart Association functional class. Data from meta-analyses also suggest beneficial effects for hospitalization rates for heart failure and reduction in cardiovascular mortality rates. A prospective trial to investigate effects on morbidity and mortality is currently ongoing. This paper highlights current knowledge of the pathophysiology of iron deficiency in heart failure, its prevalence and clinical impact, and its possible treatment options.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Cardiovascular Diseases; Comorbidity; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Heart Failure; Hematinics; Hemoglobins; Hospitalization; Humans; Maltose; Oxygen Consumption; Prevalence; Quality of Life; Stroke Volume; Transferrin; Walk Test

The efficacy of oral iron in treating iron deficiency anemia (IDA) can be limited by poor gastrointestinal (GI) absorption and adverse GI symptoms; intravenous (IV) iron is a well-established alternative. The present study compared the efficacy of two IV iron formulations in patients with IDA: iron isomaltoside (IIM) and ferric carboxymaltose (FCM).. A systematic literature review (SLR) was conducted to identify randomized controlled trials (RCTs) of IIM and FCM in patients with IDA. An adjusted indirect treatment comparison (ITC) of IIM and FCM was then conducted to evaluate differences in change from baseline hemoglobin and the proportion of patients achieving a clinically-relevant response.. The SLR identified no completed RCTs of IIM versus FCM, 5 RCTs of IIM (4 versus oral iron and 1 versus iron sucrose), and 14 RCTs of FCM (11 versus oral iron and 3 versus iron sucrose). In an ITC via iron sucrose, IIM resulted in a significantly larger increase from baseline hemoglobin with a mean difference of +0.249 g/dL with IIM relative to FCM, but there was no significant difference in the proportion of patients with a clinically-relevant response.. IIM resulted in a larger increase from baseline hemoglobin than FCM in patients with IDA, but with no difference in the proportion of patients responding. Studies comparing IIM and FCM directly would be needed to confirm these findings.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Hematinics; Hemoglobins; Humans; Maltose

Heart failure with reduced ejection fraction (HFrEF) is a clinical reality with an incidence of >10% in the population over 65 years of age, expected to increase in the coming years. Alongside the well-known pharmacological options (e.g. angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, neprilysin inhibitors, beta-blockers, aldosterone antagonists), which have significantly improved the clinical and prognostic outcomes of HFrEF patients, we now have a new therapeutic target: iron deficiency, defined as a ferritin concentration <100 μg/l or between 100-300 μg/l in the presence of a transferrin saturation <20%. Iron plays a major role in the transport of oxygen as a component of hemoglobin, as an oxygen reservoir, and as a component of myoglobin, as well as in the formation of energy, as a constituent of respiratory chain enzymes. Iron deficiency can therefore lead to anemia, changes in cognitive performance, behavior, emotions, reduced exercise capacity and myocardial structural and functional changes. Several clinical studies have shown that intravenous iron carboxymaltose supplementation can improve anemia, NYHA class, quality of life and exercise capacity of HFrEF patients. There are no randomized studies of adequate sample size that positively correlate iron supplementation with the higher endpoints of mortality and morbidity both in chronic and acute heart failure. Several studies are ongoing to answer these questions in the next few years.

Topics: Aged; Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron Deficiencies; Maltose; Quality of Life; Stroke Volume

Iron deficiency (ID) is a common co-morbidity in patients with heart failure (HF) and has been suggested to be associated with poor prognosis. Recently completed double-blind randomised controlled trials (RCTs) studying HF patients with ID have shown improvements in functional capacity, symptoms and quality of life when treated with i.v. ferric carboxymaltose (FCM). This individual patient data meta-analysis investigates the effect of FCM vs. placebo on recurrent hospitalisations and mortality in HF patients with ID.. Individual patient data were extracted from four RCTs comparing FCM with placebo in patients with systolic HF and ID. The main outcome measures were recurrent cardiovascular (CV) hospitalisations and CV mortality. Other outcomes included cause-specific hospitalisations and death. The main analyses of recurrent events were backed up by time-to-first-event analyses. In total, 839 patients, of whom 504 were randomised to FCM, were included. Compared with those taking placebo, patients on FCM had lower rates of recurrent CV hospitalisations and CV mortality [rate ratio 0.59, 95% confidence interval (CI) 0.40-0.88; P = 0.009]. Treatment with FCM also reduced recurrent HF hospitalisations and CV mortality (rate ratio 0.53, 95% CI 0.33-0.86; P = 0.011) and recurrent CV hospitalisations and all-cause mortality (rate ratio 0.60, 95% CI 0.41-0.88; P = 0.009). Time-to-first-event analyses showed similar findings, with somewhat attenuated treatment effects. The administration of i.v. FCM was not associated with an increased risk for adverse events.. Treatment with i.v. FCM was associated with a reduction in recurrent CV hospitalisations in systolic HF patients with ID.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Global Health; Heart Failure; Hospitalization; Humans; Iron; Iron Deficiencies; Maltose; Survival Rate

Intravenous (IV) iron in pregnancy is useful where oral iron is not tolerated or a rapid replenishment of iron is required.. To review the literature on the efficacy and safety of different IV iron preparations in the management of antenatal iron-deficiency anaemia (IDA).. We searched MEDLINE, Embase and Scopus from inception to June 2016. Eligible studies were randomised controlled trials (RCTs) and observational studies, involving administration of IV iron (ferric carboxymaltose (FCM), iron polymaltose (IPM) or iron sucrose (IS)), regardless of comparator, to manage antenatal IDA. Two independent reviewers selected studies, extracted data and assessed quality.. A total of 47 studies were eligible (21 RCTs and 26 observational studies), investigating IS (n = 2635; 41 studies), FCM (n = 276; four studies) and IPM (n = 164; three studies). All IV preparations resulted in significant improvements in haematological parameters, with a median increase of 21.8 g/L at 3-4 weeks and 30.1 g/L by delivery, but there was no evidence of any associated improvements in clinical outcomes. A greater median increase in Hb was observed with a high (25 g/L; range: 20-39.6 g/L) compared with low dose (20 g/L; range: 6.2-50.3 g/L). The median prevalence of adverse drug reactions for IPM (2.2%; range: 0-4.5%) was lower than FCM (5.0%; range: 0-20%) and IS (6.7%; range: 0-19.5%).. While IV iron in pregnancy improves haematological parameters, there is an absence of evidence for improvements in important maternal or perinatal outcomes. No single preparation of IV iron appeared to be superior, with the current IV iron preparation of choice largely determined by cost and convenience around administration.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Quality of Life

Anemia and chronic heart failure are frequent comorbidities in geriatric patients. In approximately one third of older adults the cause of the anemia is an iron, vitamin B12 and/or folate deficiency and in another third a chronic inflammatory process is present. In the case of iron deficiency a differentiation must be made between the absolute and functional forms. Although in functional iron deficiency ferritin, as a parameter of iron metabolism, is within the normal range or can even be higher, an iron-deficient erythropoiesis is present. In cardiac insufficiency a chronic inflammatory process is assumed. According to the recent guidelines of the Deutsche Gesellschaft für Kardiologie (DGK, German Cardiac Society) and European Society of Cardiology (ESC) a routine contol of the iron status should be performed and, if necessary, initiation of adequate supplementation is recommended.

Topics: Aged; Anemia, Iron-Deficiency; Chronic Disease; Comorbidity; Cross-Sectional Studies; Female; Ferric Compounds; Heart Failure; Hemoglobinometry; Humans; Iron Compounds; Male; Maltose; Reference Values; Transferrin

Intravenous ferric carboxymaltose (Ferinject

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Chronic Disease; Female; Ferric Compounds; Heart Failure; Humans; Inflammatory Bowel Diseases; Kidney Diseases; Maltose; Neoplasms; Postpartum Period; Pregnancy; Treatment Outcome; Uterine Hemorrhage

: Due to aging of the patients with heart failure, comorbidities are an emerging problem and, among them, iron deficiency is an important therapeutic target, independently of concomitant hemoglobin level. Iron deficiency affects up to 50% of heart failure patients, and it has been largely established its association with poor quality of life, impaired exercise tolerance and higher mortality. Randomized controlled trials (RCTs) and meta-analyses have demonstrated that intravenous iron supplementation in heart failure patients with iron deficiency positively affects symptoms, quality of life, exercise tolerance (as measured by VO2 peak and 6MWT), with a global trend to reduction of hospitalization rates. Current European Society of Cardiology Guidelines for heart failure recommend a diagnostic work-up for iron deficiency in all heart failure patients and intravenous iron supplementation with ferric carboxymaltose for symptomatic patients with iron deficiency, defined by ferritin level less than 100 μg/l or by ferritin 100-300 μg/l with TSAT less than 20%. On-going studies will provide new evidence for a better treatment of this important comorbidity of heart failure patients.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Comorbidity; Ferric Compounds; Heart Failure; Humans; Maltose; Meta-Analysis as Topic; Quality of Life; Randomized Controlled Trials as Topic

Iron deficiency and iron deficiency anaemia remain prevalent in Australia. The groups at highest risk are pre-menopausal women, socially disadvantaged people and those of Indigenous background. Diagnosing iron deficiency using a full blood examination and iron studies can be difficult and can be further complicated by concomitant inflammation. Results of iron studies should always be interpreted as an overall picture rather than focusing on individual parameters. In difficult clinical scenarios, soluble transferrin receptor assays can be useful. Management of iron deficiency involves identification and treatment of the cause of iron deficiency, as well as effective iron replacement. Clinicians should always take a detailed history and perform a comprehensive physical examination of a patient with iron deficiency. Patients should be monitored even if a likely cause of iron deficiency is identified. Patients who fail to respond to iron replacement or maintain iron status should be referred for further investigation, including endoscopy to exclude internal bleeding. Both enteral and parenteral iron are effective at replacing iron. For most adult patients, we recommend trialling daily oral iron (30-100 mg of elemental iron) as the first-line therapy. Safety and efficacy of intravenous iron infusions have improved with the availability of a newer formulation, ferric carboxymaltose. Patients who fail to respond to oral iron replacement can be safely managed with intravenous iron. Blood transfusion for iron deficiency anaemia should be reserved for life-threatening situations and should always be followed by appropriate iron replacement.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Australia; Blood Transfusion; Bone Marrow; Child; Female; Ferric Compounds; Humans; Infusions, Intravenous; Iron; Iron Deficiencies; Maltose; Pregnancy

In non-dialysis-chronic kidney disease (CKD), iron deficiency is a frequent nutritional disorder due to either the greater tendency to occult gastrointestinal bleeding or to the chronic inflammatory state resulting in a reduced intestinal iron reabsorption through an increased synthesis of hepcidin. These phenomenon are responsible for a negative iron balance that compromises erythropoiesis and contributes to the pathogenesis of anemia in CKD. Several laboratory tests are now available to allow an adequate diagnosis of iron deficiency. Among the new parameters, the percentage of hypochromic red cells (% HYPO) and the reticulocyte hemoglobin content (CHr) are now considered as the most specific markers for diagnosing iron-deficiency erythropoiesis. Unfortunately, their implementation in clinical practice is limited by the scarce availability. In non-dialyzed CKD , subjects intolerant or non-responsive to oral iron therapy, can be effectively treated with novel intravenous iron preparations, such as iron carboxymaltose, that allow a complete and rapid correction of iron deficient anemia. Furthermore, this iron compound is associated with lower rate of adverse effects since the carbohydrate shell (carboxymaltose) is more stable than gluconate and saccarate thus reducing the release of free iron in the bloodstream. Of note, the possibility of administering this drug at high doses and reduced frequency decreases the risk of infusion reactions. Finally, a substantial economic saving mainly dependent on a reduction in indirect costs represents a further advantage in the use of iron carboxymaltose in this population.

Topics: Anemia, Iron-Deficiency; Biomarkers; Bone Marrow Examination; Erythropoiesis; Ferric Compounds; Ferritins; Gastrointestinal Hemorrhage; Hematinics; Hemoglobins; Hepcidins; Humans; Intestinal Absorption; Iron; Iron Deficiencies; Maltose; Multicenter Studies as Topic; Practice Guidelines as Topic; Renal Insufficiency, Chronic; Reticulocytes; Transferrin

Topics: Administration, Oral; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Iron; Male; Maltose; Randomized Controlled Trials as Topic

Iron deficiency is common in patients on chronic dialysis, and most require iron-replacement therapy. In addition to absolute iron deficiency, many patients have functional iron deficiency as shown by a suboptimal response to the use of erythropoietin-stimulating agents. Both absolute and functional iron-deficiency anemia have been shown to respond to intravenous (IV) iron replacement. Although parenteral iron is an efficacious method and superior to standard doses of oral iron in patients on hemodialysis, there are ongoing safety concerns about repeated exposure potentially enhancing infection risk and cardiovascular disease. Each IV iron product is composed of an iron core with a carbohydrate shell. The avidity of iron binding and the type of carbohydrate shell play roles in the safe maximal dose and the frequency and severity of acute infusion reactions. All IV iron products are taken up into the reticuloendothelial system where the shell is metabolized and the iron is stored within tissue ferritin or exported to circulating transferrin. IV iron can be given as large intermittent doses (loading therapy) or in smaller doses at frequent intervals (maintenance dosing regimen). Limited trial data and observational data suggest that a maintenance dosing regimen is more efficacious and possibly safer than loading therapy. There is no consensus regarding the preferred method of iron repletion in patients on peritoneal dialysis, although small studies comparing oral and parenteral iron regimens in these patients have shown the latter to be more efficacious. Use of IV iron in virtually all hemodialysis and many peritoneal dialysis patients remains the standard of care.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Hemoglobins; Humans; Iron Compounds; Iron-Dextran Complex; Kidney Failure, Chronic; Maltose; Renal Dialysis; Transferrin

In contrast to managing patients on hemodialysis in whom iron strategies are more focused on intravenous iron, nondialysis chronic kidney disease (CKD) patients may receive either oral or intravenous iron. There are advantages and disadvantages for both strategies. Oral iron is simple and cheap to administer and does not require hospital visits, but is poorly absorbed in advanced CKD and is associated with unpleasant gastrointestinal side effects. Intravenous iron, on the other hand, guarantees iron bioavailability and avoids problems of variable absorption of iron from the gastrointestinal tract, but requires specialist clinic services. Intravenous iron also is associated with hypersensitivity reactions, albeit very rarely. The efficacy of intravenous iron in improving hemoglobin, ferritin, and transferrin saturation is well established, and superior to oral iron, but the long-term safety of this route of administration has not been established and there are theoretical concerns that patients may be exposed to increased oxidative stress and exacerbation of infections. The final choice of iron management strategy will depend on individual physician preference, as well as the facilities that are available.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Glucaric Acid; Hematinics; Hemoglobins; Humans; Iron Compounds; Maltose; Renal Insufficiency, Chronic; Severity of Illness Index; Transferrin

Ferric carboxymaltose (Ferinject(®), Injectafer(®)) is an intravenous iron preparation approved in numerous countries for the treatment of iron deficiency. A single high dose of ferric carboxymaltose (up to 750 mg of iron in the US and 1,000 mg of iron in the EU) can be infused in a short time frame (15 min). Consequently, fewer doses of ferric carboxymaltose may be needed to replenish iron stores compared with some other intravenous iron preparations (e.g. iron sucrose). Ferric carboxymaltose improved self-reported patient global assessment, New York Heart Association functional class and exercise capacity in patients with chronic heart failure and iron deficiency in two randomized, placebo-controlled trials (FAIR-HF and CONFIRM-HF). In other randomized controlled trials, ferric carboxymaltose replenished iron stores and corrected anaemia in various populations with iron-deficiency anaemia, including patients with chronic kidney disease, inflammatory bowel disease or heavy uterine bleeding, postpartum iron-deficiency anaemia and perioperative anaemia. Intravenous ferric carboxymaltose was generally well tolerated, with a low risk of hypersensitivity reactions. It was generally better tolerated than oral ferrous sulfate, mainly reflecting a lower incidence of gastrointestinal adverse effects. The most common laboratory abnormality seen in ferric carboxymaltose recipients was transient, asymptomatic hypophosphataemia. The higher acquisition cost of ferric carboxymaltose appeared to be offset by lower costs for other items, with the potential for cost savings. In conclusion, ferric carboxymaltose is an important option for the treatment of iron deficiency.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Injections, Intravenous; Maltose

Iron deficiency is a major factor in the prevalence and severity of anemia in patients with chronic kidney disease (CKD). We review the pathophysiology impairing normal intestinal iron absorption in CKD and compare the characteristics of newer intravenous (i.v.) iron agents to the longstanding i.v. iron products in the market.. The newer iron products, ferumoxytol, ferric carboxymaltose, and iron isomaltoside, more avidly bind iron, minimizing the release of labile iron during infusions, thus permitting large dose infusions. These irons also have more complex carbohydrate shells than their predecessors, which may also diminish reactions. Newer agents can be routinely administered at higher single doses, in as little as 15 min, with an acceptable safety profile.. Newer i.v. iron products permit the rapid, and sometimes complete, repletion of iron-deficient patients with a single dose. However, further studies examining the long-term risks and benefits of i.v. iron repletion are needed.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Ferrosoferric Oxide; Hematinics; Homeostasis; Humans; Intestinal Absorption; Maltose; Renal Insufficiency, Chronic; Treatment Outcome

Anaemia and iron deficiency are frequent co-morbidities in patients with chronic heart failure. Both are bound to worsen an already reduced exercise capacity in these patients. Recent data have demonstrated that iron deficiency alone, i.e. without concomitant anaemia, reduces quality of life, exercise capacity and likely also survival. Two clinical entities should be differentiated in this context: absolute and functional iron deficiency, the first being an absolute deficiency of iron, the second representing a disturbed mobilisation capacity. The FAIR-HF study has shown that intravenous iron administration can improve quality of life and exercise capacity in affected patients. A correct diagnosis can easily be arrived at using parameters such as serum ferritin and transferrin saturation. Replenishing iron stores is most useful using the intravenous route, and administered doses need to be adjusted to individual needs.

Topics: Anemia, Iron-Deficiency; Comorbidity; Diagnosis, Differential; Drug Dosage Calculations; Exercise Tolerance; Ferric Compounds; Heart Failure; Hemoglobinometry; Humans; Infusions, Intravenous; Maltose; Quality of Life

Iron deficiency (ID) and anemia of chronic diseases (ACD) are the most common causes of anemia in inflammatory bowel disease (IBD), and frequently coexist. In these circumstances, detection of ID may be difficult as inflammation influences the parameters of iron metabolism. The prevalence of iron deficiency anemia (IDA) ranges between 36% and 76% in this population of patients. Anemia may impair physical condition, quality of life (QOL), and cognitive function, negatively affecting almost every aspect of daily life. Furthermore, it may be one of the causes of death in IBD. Consequently, iron replacement therapy should be initiated as soon as ID or IDA is detected, together with the treatment of underlying inflammation. Oral iron therapy is a simple and cheap treatment, but often is poorly tolerated and may worsen the intestinal damage. Moreover, in inflammatory states, duodenal iron absorption is blocked by a cytokine-mediated mechanism. Consequently, intravenous iron therapy is preferred in the presence of severe anemia, intolerance or lack of response to oral iron, and moderately to severely active disease. Recently, new intravenous iron compounds (iron carboxymaltose, iron isomaltoside 1000, ferumoxytol) have become available. Iron carboxymaltose has been shown to be safe and effective in IBD patients with IDA. Furthermore, it allows for rapid administration of high single doses, saving time and costs. If proven to be efficacious and well tolerated, it may become the standard therapy in the near future.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Clinical Trials as Topic; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Maltose; Quality of Life

With the challenge of optimizing iron delivery, new intravenous (iv) iron-carbohydrate complexes have been developed in the last few years. A good example of these new compounds is ferric carboxymaltose (FCM), which has recently been approved by the US Food and Drug Administration for the treatment of iron deficiency anemia in adult patients who are intolerant to oral iron or present an unsatisfactory response to oral iron, and in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). FCM is a robust and stable complex similar to ferritin, which minimizes the release of labile iron during administration, allowing higher doses to be administered in a single application and with a favorable cost-effective rate. Cumulative information from randomized, controlled, multicenter trials on a diverse range of indications, including patients with chronic heart failure, postpartum anemia/abnormal uterine bleeding, inflammatory bowel disease, NDD-CKD, and those undergoing hemodialysis, supports the efficacy of FCM for iron replacement in patients with iron deficiency and iron-deficiency anemia. Furthermore, as FCM is a dextran-free iron-carbohydrate complex (which has a very low risk for hypersensitivity reactions) with a small proportion of the reported adverse effects in a large number of subjects who received FCM, it may be considered a safe drug. Therefore, FCM appears as an interesting option to apply high doses of iron as a single infusion in a few minutes in order to obtain the quick replacement of iron stores. The present review on FCM summarizes diverse aspects such as pharmacology characteristics and analyzes trials on the efficacy/safety of FCM versus oral iron and different iv iron compounds in multiple clinical scenarios. Additionally, the information on cost effectiveness and data on change in quality of life are also discussed.

Topics: Anemia, Iron-Deficiency; Drug Delivery Systems; Ferric Compounds; Humans; Maltose

Anaemia is one of the most common diseases. Worldwide affects up to 25% of the population. Anaemia with iron deficiency (Fe) is the leading one. It is not surprising that iron deficiency mainly affects women. Generally, anaemia is one of the major problems in every department of internal medicine. There is no ambition to provide a comprehensive review of the diagnosis and treatment of anaemia. The aim is to point out the common (but sometimes neglected) facts from daily practice in internal department and on the other hand, to highlight the news in the treatment focusing on parenteral Fe.The importance of anaemia at the department of internal medicine. Mentioned above, anaemia is very frequent in internal medicine. Especially, it is anaemia of Fe deficiency and anaemia of chronic disease. Mostly elderly and polymorbid patients (often with one dominant, sometimes cryptogenic disease) suffer from anaemia. I am concern about the fact that anaemia is often seen only as a sign of other disease and usually is not the target of diagnostic and therapeutic efforts.Diagnosis and treatment. The internal department physician is responsible for patient care, but cooperates with haematologist in case of severe anaemia in diagnostic and therapeutic process. Basic examination contains analysis of Fe, ferritin, transferrin, circulating serum transferrin receptors or other parameters. Of course, the focus in iron deficiency anaemia is on its possible loss or in case of chronic disease anaemia on primary disease.Notes to Fe treatment. If the patient has iron deficiency the Fe treatment is often indicated (after finding the cause). Iron is administered orally in most cases. There are several situations when parenteral Fe is not only preferable, but also represents the only therapeutic option. Currently, the best evidence for the positive effects is observed in parenterally administered Fe ferric carboxymaltose, Ferinject.Parenteral administration of Fe in gastroenterology. Gastorenterology is a common field for the use of Fe administration. The losses in the GIT are frequent as well as malabsorption of Fe in several gastrointestinal diseases. A typical example may be inflammatory bowel disease, especially Crohn´s disease. Not only case reports demonstrate the positive effect of ferric carboxymaltose in Crohn´s disease.Parenteral administration of Fe in cardiology. Recently published work (multicentric randomized controlled double-blinde trial) CONFIRM HF have proved that adm

Topics: Anemia, Iron-Deficiency; Cardiology; Clinical Protocols; Female; Ferric Compounds; Gastroenterology; Heart Failure; Humans; Male; Maltose; Pilot Projects; Quality of Life; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome

Iron deficiency and anaemia occur in particular in women or as comorbid conditions to a varietyof chronic diseases. Besides oral preparations, parenteral iron therapies are also available for the treatment of iron deficiency or anaemia. In the light of the growing importance and increasing number of parenteral iron preparations, theirpharmacology and application as well as the chronology of their approvals and thecharacteristicsof the various preparations are presented herefor comparison.. Review.. To date, there are three different generations of parenteral iron preparations, which differ in terms of stability, safety and dosage. In particular, the active substances of the third generation, ferric carboxymaltose, iron isomaltoside and ferumoxytol are characterised by high complex stability and comparable safety, also allowing rapid application of high doses of iron.. High molecular weight iron dextran, as a representative of 1st generation iron preparations, should no longer be used if possible, as more recent i.v. iron preparations are available with considerably lower risk of serious anaphylactic reactions. Ferrous gluconate and iron sucrose, as representatives of the 2nd generation, are very efficient preparations, but they require frequent visits to the clinic or the doctor, as they may only be administered in low doses because of labile iron complexes. The three 3rd generation parenteral iron formulations have advantages in handling in everyday practice, since they offer comparably good safety profiles, high complex stability and thus the possibility of rapid application of high doses of iron up to the total cumulative dose. Furthermore, test doses are not required with these preparations, which also simplifies their use.

Topics: Anemia, Iron-Deficiency; Disaccharides; Dose-Response Relationship, Drug; Drug Substitution; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Humans; Infusions, Intravenous; Iron-Dextran Complex; Maltose; Structure-Activity Relationship; Treatment Outcome

Iron deficiency often occurs in patients with chronic kidney disease and can be effectively treated with parenteral supplementation of iron. In these patients, prompt application of iron therapy can help to reduce the dependence of erythropoietin-stimulating agents and effectively treat anemia. Correct evaluation of iron metabolism in CKD patients can be difficult. Duration of and response to therapy should always be considered while planning parenteral supplementation of iron. The main safety aspects of parenteral iron preparations relate to their possible anaphylactic potential and the potential induction of oxidative stress due to the release of free iron. However, parenteral iron supplementation is usually safe and without major side effects. Regarding current data, none of the iron preparations is showing definitive superiority. Although uncommon, iron preparations containing dextran can lead to severe side effects, therefore these preparations appear to have an inferior safety profile. Due to limited data, a comparison of third-generation iron preparations with previous preparations is not possible. Recently, for the first time, the third generation iron preparation ferumoxytol has been directly compared to iron sucrose. From this data and others, it remains unclear whether third generation iron preparations show safety-relevant superiority.

Topics: Administration, Oral; Anaphylaxis; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Humans; Infusions, Intravenous; Iron Compounds; Iron-Dextran Complex; Kidney Failure, Chronic; Maltose; Oxidative Stress; Renal Dialysis

Anemia and iron deficiency anemia are very common in inflammatory bowel disease (IBD). In most cases, anemia is a consequence of mixed pathogenesis; inflammation and iron deficiency being the most important factors. Iron status should be evaluated carefully, as ferritin is unreliable in the presence of inflammation. It is always necessary to control disease activity; however, supplementation is usually required to fully correct iron deficiencies. Oral iron, intravenous iron, erythropoietin, and blood transfusions can be used in different clinical scenarios. Oral iron may be used in mild cases if the disease has no clinical activity. Intravenous iron should be preferred where oral iron is poorly tolerated or where it has failed in moderate to severe anemia, and in combination with erythropoietin. Iron sucrose is very safe and effective, but not very convenient, as the total needed dose must be divided into several infusions. Ferric carboxymaltose is much more convenient, and has been shown to be more effective than iron sucrose in a large randomized trial. Iron isomaltose shows theoretical promise, but very limited data are available from IBD populations. Blood transfusion can be necessary, especially in acute life-threatening situations, but the trigger for indication should be in the low range. With the correct use of available resources, anemia and iron deficiency should be well controlled in practically all IBD patients.

Topics: Anemia, Iron-Deficiency; Animals; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Iron; Maltose

Iron deficiency anemia (IDA) frequently occurs in patients suffering from inflammatory bowel disease (IBD) and negatively impacts their quality of life. Nevertheless, the condition appears to be both under-diagnosed and undertreated. Regular biochemical screening of patients with IBD for anemia by the gastroenterology community has to be advocated. Oral iron is a low cost treatment however its effectiveness is limited by low bioavailability and poor tolerability. Intravenous (IV) iron rapidly replenishes iron stores and has demonstrated its safe use in a number of studies in various therapeutic areas. A broad spectrum of new IV iron formulations is now becoming available offering improved tolerability and patient convenience by rapidly restoring the depleted iron status of patients with IBD. The following article aims to review the magnitude of the problem of IDA in IBD, suggest screening standards and highlight existing and future therapies.

Topics: Algorithms; Anemia, Iron-Deficiency; Clinical Trials as Topic; Diagnosis, Differential; Disaccharides; Dose-Response Relationship, Drug; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Iron Deficiencies; Maltose; Prevalence; Thrombocytosis; Thromboembolism

Iron deficiency is an important clinical concern in chronic kidney disease (CKD), giving rise to iron-deficiency anemia and impaired cellular function. Oral supplementation, in particular with ferrous salts, is associated with a high rate of gastrointestinal side effects and is poorly absorbed, a problem that is avoided with intravenous iron. The most stable intravenous iron complexes (eg, iron dextran, ferric carboxymaltose, ferumoxytol, and iron isomaltoside 1000) can be given in higher single doses and more rapidly than less stable preparations (eg, sodium ferric gluconate). Iron complexes that contain dextran or dextran-derived ligands can cause dextran-induced anaphylactic reactions, which cannot occur with dextran-free preparations such as ferric carboxymaltose and iron sucrose. Test doses are advisable for conventional dextran-containing compounds. Iron supplementation is recommended for all CKD patients with anemia who receive erythropoiesis-stimulating agents, whether or not they require dialysis. Intravenous iron is the preferred route of administration in hemodialysis patients, with randomized trials showing a significantly greater increase in hemoglobin levels for intravenous versus oral iron and a low rate of treatment-related adverse events. In the nondialysis CKD population, the erythropoietic response is also significantly higher using intravenous versus oral iron, and tolerability is at least as good. Moreover, in some nondialysis patients intravenous iron supplementation can avoid, or at least delay, the need for erythropoiesis-stimulating agents. In conclusion, we now have the ability to achieve iron replenishment rapidly and conveniently in dialysis-dependent and nondialysis-dependent CKD patients without compromising safety.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Ferrosoferric Oxide; Hematinics; Humans; Iron-Dextran Complex; Maltose; Renal Dialysis; Renal Insufficiency, Chronic

Anemic patients may benefit from the various intravenous iron replacement options available. Ferric carboxymaltose (FCM) is a new iron formulation (150 kDa) that can be given at high doses (20 mg/kg, up to 1000 mg) over a short period (≤ 15 min), without test dosing.. This paper reviews studies dealing with the efficacy and safety of FCM for treating anemia in relatively large numbers of patients, in addition to analyzing the differences regarding clinical conditions, iron doses, follow-up, comparators, and hematologic response targets.. Overall, there is substantial evidence that FCM is effective in treating iron-deficiency anemia in many acute and chronic conditions, with a favorable benefit-risk profile. The efficacy of FCM for correcting anemia is similar to that of iron sucrose, and it is superior to oral iron or placebo in replenishing iron stores. Despite higher acquisition costs (as fewer administrations are needed), treatment with FCM (as well as with iron isomaltoside 1000 or ferumoxytol) seems to be cost-effective when compared to iron sucrose, and is more convenient for patients. There are, however, some aspects (such as hypophosphatemia) and important missing information (such as use in children and pregnant women) that need to be addressed for facilitating a widespread use of FCM.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Clinical Trials as Topic; Ferric Compounds; Follow-Up Studies; Humans; Maltose; Mouth Mucosa; Randomized Controlled Trials as Topic

High doses of intravenous iron have a role in the treatment of a number of clinical situations associated with iron deficiency, iron deficiency anemia, and blood loss. In the presence of functioning erythropoiesis, iron supplementation alone may be adequate to replenish iron stores and restore blood loss. Where hormone replacement with an erythropoiesis-stimulating agent is required, iron adequacy will optimize treatment. Intravenous iron offers a rapid means of iron repletion and is superior to oral iron in many circumstances, especially in the presence of anemia of chronic disease, where it appears to overcome the block to absorption of iron from the gastrointestinal tract and immobilization of stored iron. The clinical situations where high doses of iron are commonly required are reviewed. These include nondialysis-dependent chronic kidney disease, inflammatory bowel disease, obstetrics, menorrhagia, and anemia associated with cancer and its treatment. The literature indicates that high doses of iron are required, with levels of 1500 mg in nondialysis-dependent chronic kidney disease and up to 3600 mg in inflammatory bowel disease. New formulations of intravenous iron have recently been introduced that allow clinicians to administer high doses of iron in a single administration. Ferumoxytol is available in the US, has a maximum dose of 510 mg iron in a single administration, but is limited to use in chronic kidney disease. Ferric carboxymaltose can be rapidly administered in doses of 15 mg/kg body weight, up to a ceiling dose of 1000 mg. A test dose is not required, and it can be used more widely across a spectrum of iron deficiency and iron deficiency anemia indications. The latest introduction is iron isomaltoside 1000. Again, a test dose is not required, and it can be delivered rapidly as an infusion (in an hour), allowing even higher doses of iron to be administered in a single infusion, ie, 20 mg/kg body weight with no ceiling. This will allow clinicians to achieve high-dose repletion more frequently as a single administration. Treatment options for iron repletion have taken a major leap forward in the past two years, especially to meet the demand for high doses given as a single administration.

Topics: Anemia, Iron-Deficiency; Animals; Disaccharides; Dose-Response Relationship, Drug; Drug Administration Schedule; Ferric Compounds; Hemorrhage; Humans; Infusions, Intravenous; Iron; Iron Deficiencies; Maltose

Ferric carboxymaltose (Ferinject(R)), a novel iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell, allows for controlled delivery of iron to target tissues. Administered intravenously, it is effective in the treatment of iron-deficiency anaemia, delivering a replenishment dose of up to 1000 mg of iron during a minimum administration time of

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Hematinics; Humans; Maltose; Randomized Controlled Trials as Topic; Treatment Outcome

Cancer-related anemia is common and multifactorial in origin. Functional iron deficiency (FID) is now recognized as a cause of iron-restricted erythropoiesis and may be one of the major reasons for lack of response to treatment with Erythropoietic Stimulating Agents (ESAs). Numerous studies have shown that intravenous (IV), but not oral, iron therapy effectively provides sufficient iron for optimal erythropoiesis in anemic patients with chronic renal disease receiving ESA therapy. The use of IV iron has also been suggested in the cancer setting. Six recent studies have tested this assumption and are summarized in this review. Four formulations of IV iron are available in Europe, with different pharmacokinetics, iron bioavailability, and risk of acute adverse drug reactions.. Limited iron stores and FID are common causes of response failure during ESA treatment in cancer patients and should be diagnosed. There is now substantial scientific support for the use of IV iron supplementation to improve response and this has been acknowledged in international and national guidelines. Prospective long-term data on the safety of IV iron in this setting are still awaited. Recommendations concerning the optimal formulation, doses, and schedule of iron supplementation to ESA treatment in cancer-related anemia are provisional awaiting data from prospective, randomized trials.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Drug Administration Schedule; Erythropoiesis; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Iron Compounds; Iron-Dextran Complex; Iron, Dietary; Maltose; Neoplasms; Randomized Controlled Trials as Topic

To test the equivalence of two doses of intravenous iron (ferric carboxymaltose) in pregnancy.. Parallel, two-arm equivalence randomised controlled trial with an equivalence margin of 5%.. Single centre in Australia.. 278 pregnant women with iron deficiency.. Participants received either 500 mg (n = 152) or 1000 mg (n = 126) of intravenous ferric carboxymaltose in the second or third trimester.. The proportion of participants requiring additional intravenous iron (500 mg) to achieve and maintain ferritin >30 microg/L (diagnostic threshold for iron deficiency) at 4 weeks post-infusion, and at 6 weeks, and 3-, 6- and 12-months postpartum. Secondary endpoints included repeat infusion rate, iron status, birth and safety outcomes.. The two doses were not equivalent within a 5% margin at any time point. At 4 weeks post infusion, 26/73 (36%) participants required a repeat infusion in the 500-mg group compared with 5/67 (8%) in the 1000-mg group: difference in proportions, 0.283 (95% confidence interval [CI] 0.177-0.389). Overall, participants in the 500-mg arm received twice the repeat infusion rate (0.81 [SD = 0.824] versus 0.40 [SD = 0.69], rate ratio 2.05, 95% CI 1.45-2.91).. Administration of 1000 mg ferric carboxymaltose in pregnancy maintains iron stores and reduces the need for repeat infusions. A 500- mg dose requires ongoing monitoring to ensure adequate iron stores are reached and sustained.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Iron; Iron Deficiencies; Maltose; Pregnancy

Intravenous iron-a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD)-can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI).. This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured.. A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration.. Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.

Topics: Adult; Anemia, Iron-Deficiency; Humans; Hypophosphatemia; Iron; Phosphates

To determine whether intravenous (IV) or oral iron suppletion is superior in improving physical fitness in anemic children with inflammatory bowel disease (IBD).. We conducted a clinical trial at 11 centers. Children aged 8-18 with IBD and anemia (defined as hemoglobin [Hb] z-score < -2) were randomly assigned to a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate. Primary end point was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. Secondary outcome was a change in Hb z-score from baseline.. We randomized 64 patients (33 IV iron and 31 oral iron) and followed them for 6 months. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with -0.11 in the oral group (P = .01). At 3- and 6-month follow-ups, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3, and 6 months after initiation of iron therapy (overall P = .97).. In this trial involving anemic children with IBD, a single dose of IV ferric carboxymaltose was superior to oral ferrous fumarate with respect to quick improvement of physical fitness. At 3 and 6 months after initiation of therapy, no differences were discovered between oral and IV therapies. The increase of Hb over time was comparable in both treatment groups.. NTR4487 [Netherlands Trial Registry].

Topics: Administration, Oral; Anemia; Anemia, Iron-Deficiency; Child; Ferric Compounds; Hemoglobins; Humans; Inflammatory Bowel Diseases; Iron; Maltose; Treatment Outcome

A third of patients with colorectal cancer who are eligible for surgery in high-income countries have concomitant anaemia associated with adverse outcomes. We aimed to compare the efficacy of preoperative intravenous and oral iron supplementation in patients with colorectal cancer and iron deficiency anaemia.. In the FIT multicentre, open-label, randomised, controlled trial, adult patients (aged 18 years or older) with M0 stage colorectal cancer scheduled for elective curative resection and iron deficiency anaemia (defined as haemoglobin level of less than 7·5 mmol/L (12 g/dL) for women and less than 8 mmol/L (13 g/dL) for men, and a transferrin saturation of less than 20%) were randomly assigned to either 1-2 g of ferric carboxymaltose intravenously or three tablets of 200 mg of oral ferrous fumarate daily. The primary endpoint was the proportion of patients with normalised haemoglobin levels before surgery (≥12 g/dL for women and ≥13 g/dL for men). An intention-to-treat analysis was done for the primary analysis. Safety was analysed in all patients who received treatment. The trial was registered at ClincalTrials.gov, NCT02243735, and has completed recruitment.. Between Oct 31, 2014, and Feb 23, 2021, 202 patients were included and assigned to intravenous (n=96) or oral (n=106) iron treatment. Treatment began a median of 14 days (IQR 11-22) before surgery for intravenous iron and 19 days (IQR 13-27) for oral iron. Normalisation of haemoglobin at day of admission was reached in 14 (17%) of 84 patients treated intravenously and 15 (16%) of 97 patients treated orally (relative risk [RR] 1·08 [95% CI 0·55-2·10]; p=0·83), but the proportion of patients with normalised haemoglobin significantly increased for the intravenous treatment group at later timepoints (49 [60%] of 82 vs 18 [21%] of 88 at 30 days; RR 2·92 [95% CI 1·87-4·58]; p<0·0001). The most prevalent treatment-related adverse event was discoloured faeces (grade 1) after oral iron treatment (14 [13%] of 105), and no treatment-related serious adverse events or deaths were observed in either group. No differences in other safety outcomes were seen, and the most common serious adverse events were anastomotic leakage (11 [5%] of 202), aspiration pneumonia (5 [2%] of 202), and intra-abdominal abscess (5 [2%] 202).. Normalisation of haemoglobin before surgery was infrequent with both treatment regimens, but significantly improved at all other timepoints following intravenous iron treatment. Restoration of iron stores was feasible only with intravenous iron. In selected patients, surgery might be delayed to augment the effect of intravenous iron on haemoglobin normalisation.. Vifor Pharma.

Topics: Adult; Anemia, Iron-Deficiency; Colorectal Neoplasms; Dietary Supplements; Female; Hemoglobins; Humans; Iron; Male

Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women.. In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13-26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi. Women were eligible if they had capillary haemoglobin of less than 10·0 g/dL and negative malaria rapid diagnostic test. Participants were randomised by sealed envelope 1:1. Assessors for efficacy outcomes (laboratory parameters and birthweight) were masked to intervention; participants and study nurses were not masked. Participants were given ferric carboxymaltose up to 1000 mg (given once at enrolment in an outpatient primary care setting), or standard of care (60 mg elemental iron twice daily for 90 days), along with intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation. The primary neonatal outcome was birthweight. Analyses were performed in the intention-to-treat population for mothers and liveborn neonates, according to their randomisation group. Safety outcomes included incidence of adverse events during infusion and all adverse events from randomisation to 4 weeks' post partum. The trial is registered with ANZCTR, ACTRN12618001268235. The trial has completed follow-up.. Between Nov 12, 2018, and March 2, 2021, 21 258 women were screened, and 862 randomly assigned to ferric carboxymaltose (n=430) or standard of care (n=432). Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks' gestation compared with standard of care (179 [52%] of 341 in the ferric carboxymaltose group vs 189 [57%] of 333 in the standard of care group; prevalence ratio [PR] 0·92, 95% CI 0·81 to 1·06; p=0·27). Anaemia prevalence was numerically lower in mothers randomly assigned to ferric carboxymaltose compared with standard of care at all timepoints, although significance was only observed at 4 weeks' post-treatment (PR 0·91 [0·85 to 0·97]). Birthweight did not differ between groups (mean difference -3·1 g [-75·0 to 68·9, p=0·93). There were no infusion-related serious adverse events or differences in adverse events by any organ class (including malaria; ≥1 adverse event: ferric carboxymaltose 183 [43%] of 430 vs standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34).. In this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight.. Bill & Melinda Gates Foundation (INV-010612).

Topics: Anemia; Anemia, Iron-Deficiency; Birth Weight; Female; Humans; Infant, Newborn; Iron; Malaria; Malawi; Pregnancy; Pregnancy Trimester, Second; Pregnant Women

Reduced kidney function is common among patients with heart failure. In patients with heart failure and/or kidney disease, iron deficiency is an independent predictor of adverse outcomes. In the AFFIRM-AHF trial, patients with acute heart failure with iron deficiency treated with intravenous ferric carboxymaltose demonstrated reduced risk of heart failure hospitalization, with improved quality of life. We aimed to further characterize the impact of ferric carboxymaltose among patients with coexisting kidney impairment.. The double-blind, placebo-controlled AFFIRM-AHF trial randomized 1132 stabilized adults with acute heart failure (left ventricular ejection fraction <50%) and iron deficiency. Patients on dialysis were excluded. The primary end point was a composite of total heart failure hospitalizations and cardiovascular death during the 52-week follow-up period. Additional end points included cardiovascular hospitalizations, total heart failure hospitalizations, and days lost to heart failure hospitalizations or cardiovascular death. For this subgroup analysis, patients were stratified according to baseline eGFR.. Overall, 60% of patients had an eGFR <60 ml/min per 1.73 m 2 (the lower eGFR subgroup). These patients were significantly older, more likely to be female and to have ischemic heart failure, and had higher baseline serum phosphate levels and higher rates of anemia. For all end points, event rates were higher in the lower eGFR group. In the lower eGFR group, the annualized event rates for the primary composite outcome were 68.96 and 86.30 per 100 patient-years in the ferric carboxymaltose and placebo arms, respectively (rate ratio, 0.76; 95% confidence interval, 0.54 to 1.06). The treatment effect was similar in the higher eGFR subgroup (rate ratio, 0.65; 95% confidence interval, 0.42 to 1.02; Pinteraction = 0.60). A similar pattern was observed for all end points ( Pinteraction > 0.05).. In a cohort of patients with acute heart failure, left ventricular ejection fraction <50%, and iron deficiency, the safety and efficacy of ferric carboxymaltose were consistent across a range of eGFR values.. Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF), NCT02937454 .

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Heart Failure; Humans; Iron; Iron Deficiencies; Kidney; Male; Quality of Life; Renal Insufficiency; Stroke Volume; Ventricular Function, Left

Brain iron status is fundamental in RLS pathogenesis. The aim of this study was to determine the clinical efficacy and brain iron concentration improvement in RLS patients with IDA, using 1500 mg FCM.. This is a randomized, double-blinded, placebo-controlled study. RLS patients with IDA were grouped into either 1500 mg FCM or placebo. The primary outcomes were the change from baseline on the International Restless Legs Syndrome Study Group scale (IRLS) and brain iron measured by QSM and R2∗.. A total of 18 RLS patients with IDA were enrolled, 10 in the FCM group and 8 in the placebo. At the week 6 endpoint, the FCM group showed significant improvement in both IRLS (-13.60 ± 9.47 vs. -3.63 ± 5.40, p = 0.011) and VAS (-40.50 ± 28.81 vs. -0.63 ± 28.28, p = 0.004) from baseline. Change from baseline with R2∗ techniques showed a treatment effect for the thalamus and QSM technique for both the substantia nigra and pulvinar. A correlation was proved between the IRLS difference and the difference of QSM in thalamus (p = 0.028).. This study demonstrates that 1500 mg FCM effectively treats RLS symptoms in IDA patients over six weeks, with MRI measurements of improved brain iron content serving as a potential biomarker for RLS patients.

Topics: Anemia, Iron-Deficiency; Brain; Ferric Compounds; Humans; Iron; Restless Legs Syndrome; Treatment Outcome

Recent clinical guidelines suggest that treatment of postoperative anaemia in colorectal cancer surgery with intravenous iron reduces transfusion requirements and improves outcomes. The study aimed at comparing two intravenous iron regimens in anaemic patients after colorectal cancer surgery.. This was a single-centre, open-label, randomised, controlled trial in patients undergoing elective colorectal cancer surgery. Patients with moderate to severe anaemia (haemoglobin [Hb] <11 g/dL) after surgery were randomly assigned 1:1 to receive ferric carboxymaltose (FC; 1,000 mg, single dose) or iron sucrose (IS; 200 mg every 48 hours until covering the total iron deficit or discharge). Randomisation was stratified by Hb level: <10 g/dL (Group A) or ≥10-10.9 (Group B). The primary endpoint was the change in Hb concentration at postoperative day 30. Secondary endpoints included iron status parameters, transfusion requirements, complications, and length of hospital stay.. From September 2015 to May 2018, 104 patients were randomised (FC 50, IS 54). The median intravenous iron dose was 1,000 mg and 600 mg in the FC and IS groups, respectively. There were no between-group differences in mean change in Hb from postoperative day 1 to postoperative day 30 (FC: 2.5 g/dL, 95% CI: 2.1-2.9; IS: 2.4 g/dL, 95% CI: 2.0-2.8; p=0.52), in transfusion requirements or length of stay. The infection rate was lower in the FC group compared with the IS group (9.8% vs 37.2%, respectively).. The administration of approximately 500 mg of IS resulted in an increase in Hb at postoperative day 30 similar to that of 1,000 mg of FC, but it was associated with a higher infection rate. Future research will be needed to confirm the results, and to choose the best regime in terms of effectiveness and side effects to treat postoperative anaemia in colorectal cancer patients.

Topics: Administration, Intravenous; Anemia; Anemia, Iron-Deficiency; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Iron; Maltose

Iron deficiency affects exercise capacity because of the critical role iron plays in the optimal functioning of skeletal muscle metabolism. We hypothesized that intravenous iron may improve exercise tolerance, quality of life (QoL), and daily physical activity (DPA) in patients with chronic obstructive pulmonary disease (COPD).. This was a placebo-controlled, single-blind, parallel-group, randomized clinical trial. Iron deficiency was defined as a ferritin level<100ng/mL or a ferritin level between 100 and 299ng/mL with a transferrin saturation<20%, with or without mild anaemia. Patients were randomized at a 2:1 ratio to receive intravenous ferric carboxymaltose or placebo. The primary objective was to investigate whether intravenous iron replacement improved endurance time from baseline by at least 33%. The secondary objectives were to evaluate impact on QoL using the COPD Assessment Test (CAT) and on DPA by accelerometry.. We included 66 patients, 44 (66.7%) in the intervention group and 22 (33.3%) in the placebo group. Among patients receiving ferric carboxymaltose, 23 (52.3%) achieved the primary endpoint compared to 4 (18.2%) in the placebo group [p=0.009; relative risk 3.12, (95% CI, 1.19-8.12)]. CAT score decreased -3 (-6.0-1.3) points from baseline in the intervention group (p=0.007), in contrast to placebo group [-1 (-4.0-2.3) points, p=0.236] with no differences in DPA and adverse events in both groups.. Iron replacement improved exercise capacity and QoL in stable COPD patients with iron deficiency. The treatment was well tolerated.. EudraCT 2016-001238-89.

Topics: Anemia, Iron-Deficiency; Exercise Tolerance; Ferric Compounds; Ferritins; Humans; Iron; Iron Deficiencies; Maltose; Pulmonary Disease, Chronic Obstructive; Quality of Life; Single-Blind Method; Transferrins; Treatment Outcome

Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability.. In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center's standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations.. For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively.. Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Hemoglobins; Humans; Inflammatory Bowel Diseases; Male; Maltose; Pyrones; Treatment Outcome

Whether iron supplementation in patients on hemodialysis could be delivered by less frequent but higher single doses compared with the currently more common higher-frequency schedules of lower single iron doses is unknown.. In total, 108 patients completed the study. At 40 weeks, hemoglobin changed by -0.27 g/dl (95% confidence interval, -0.64 to 0.09) in the iron sucrose arm and by -0.74 g/dl (95% confidence interval, -1.1 to -0.39) in the ferric carboxymaltose arm compared with baseline. Noninferiority was not established in the per-protocol population as hemoglobin changes compared with baseline differed by -0.47 g/dl (95% confidence interval, -0.95 to 0.01) in the ferric carboxymaltose arm compared with the iron sucrose arm. Proportional changes from baseline to week 40 differed by -31% (98.3% confidence interval, -52 to -0.1) for ferritin, by 1% (98.3% confidence interval, -7 to 10) for transferrin, and by -27% (98.3% confidence interval, -39 to -13) for transferrin saturation in the ferric carboxymaltose arm compared with the iron sucrose arm. Erythropoiesis-stimulating agent dosing did not differ between groups. The overall number of adverse events was similar; however, more infections were observed in the iron sucrose arm.. An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet noninferiority for maintaining hemoglobin levels compared with iron sucrose administered more frequently.. Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients (COPEFER), NCT02198495.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Austria; Biomarkers; Drug Administration Schedule; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Transferrin; Treatment Outcome

Anaemia in pregnancy remains a critical global health problem, affecting 46% of pregnant women in Africa and 49% in Asia. Oral iron therapy requires extended adherence to achieve correction of anaemia and replenishment of iron stores. Ferric carboxymaltose (FCM) is a recently established intravenous iron formulation associated with substantial advantages in safety, speed of delivery and total dose deliverable in a single infusion. We aim to determine whether FCM given once during the second trimester of pregnancy compared with standard oral iron distributed through routine antenatal services is effective and safe for treatment of moderate to severe maternal anaemia in sub-Saharan Africa.. The randomized controlled trial of the effect of intravenous iron on anaemia in Malawian pregnant women (REVAMP) is a two-arm confirmatory individually randomised trial set in Blantyre and Zomba districts in Malawi. The trial will randomise 862 women in the second trimester of pregnancy with a capillary haemoglobin concentration below 100.0 g/L. The study comprises two arms: (a) intravenous FCM (20 mg/kg up to 1000 mg) given once at randomisation, and (b) standard of care oral iron (65 mg elemental iron two times per day) for 90 days (or the duration of pregnancy, whichever is shorter) provided according to local healthcare practices. Both arms receive sulfadoxine-pyrimethamine as intermittent preventive treatment in pregnancy. The primary outcome is the prevalence of anaemia (Hb <110.0 g/L) at 36 weeks' gestation. Secondary outcomes include birth weight, gestation duration and safety outcomes, including clinical malaria, serious perinatal events and postpartum haematologic and health-related outcomes in the mother and child.. Ethical approval was granted by the Research Ethics Committee (COMREC P.02/18/2357) in Malawi and the Human Research Ethics Committee (WEHI: 18/02), Melbourne, Australia. The protocol is registered with the Australian and New Zealand Clinical Trials Registry. The results will be shared with the local community that enabled the research, and also to the international fora.. ACTRN12618001268235; Pre-results.

Topics: Anemia; Anemia, Iron-Deficiency; Australia; Female; Ferric Compounds; Humans; Malawi; Maltose; Multicenter Studies as Topic; Pregnancy; Pregnant Women; Randomized Controlled Trials as Topic; Standard of Care

Iron deficiency anaemia is of major concern in low-income settings, especially for women of childbearing age. Oral iron substitution efficacy is limited by poor compliance and iron depletion severity. We aimed to assess the efficacy and safety of intravenous ferric carboxymaltose versus oral iron substitution following childbirth in women with iron deficiency anaemia in Tanzania.. This parallel-group, open-label, randomised controlled phase 3 trial was done at Bagamoyo District Hospital and Mwananyamala Hospital, Tanzania. Eligible participants were close to delivery and had iron deficiency anaemia defined as a haemoglobin concentration of less than 110 g/L and a ferritin concentration of less than 50 μg/L measured within 14 days before childbirth. Participants were randomly assigned 1:1 to receive intravenous ferric carboxymaltose or oral iron, stratified by haemoglobin concentration and site. Intravenous ferric carboxymaltose was administered at a dose determined by the haemoglobin concentration and bodyweight (bodyweight 35 kg to <70 kg and haemoglobin ≥100 g/L: 1000 mg in one dose; bodyweight 35 kg to <70 kg and haemoglobin <100 g/L, or bodyweight ≥70 kg and haemoglobin ≥100 g/L: 1500 mg in two doses at least 7 days apart; bodyweight ≥70 kg and haemoglobin <100 g/L: 2000 mg in two doses at least 7 days apart). Oral iron treatment consisted of three dried ferrous sulphate tablets of 200 mg containing 60 mg of elementary iron and 5 mg of folic acid every morning. Oral treatment was to be taken for 3 months after haemoglobin normalisation. The primary outcome was haemoglobin normalisation (>115 g/L) at 6 weeks. Follow-up visits were at 6 weeks, and 3, 6, and 12 months. Analyses were done in the modified intention-to-treat population of participants who had a 6-week haemoglobin concentration result, using logistic and linear regression models for binary and continuous outcomes, adjusted for baseline haemoglobin concentration and site. This trial is registered with ClinicalTrials.gov, NCT02541708.. Between Oct 8, 2015, and March 14, 2017, 533 individuals were screened and 230 were enrolled and randomly assigned to a study group (114 to intravenous iron, 116 to oral iron). At 6 weeks, 94 (82%) participants in the intravenous iron group and 92 (79%) in the oral iron group were assessed for the primary outcome. 75 (80%) participants in the intravenous iron group and 47 (51%) in the oral iron group had normalised haemoglobin (odds ratio 4·65, 95% CI 2·33-9·27). There were two mild to moderate infusion-related adverse events; and five serious adverse events (three in the intravenous iron group, two in the oral iron group), unrelated to the study medication.. Intravenous iron substitution with ferric carboxymaltose was safe and yielded a better haemoglobin response than oral iron. To our knowledge, this is the first study to provide evidence of the benefits and safety of intravenous iron substitution in a low-income setting.. Vifor Pharma, R Geigy-Stiftung, Freiwillige Akademische Gesellschaft, and Swiss Tropical and Public Health Institute.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferrous Compounds; Folic Acid; Hemoglobins; Humans; Iron; Maltose; Postnatal Care; Postpartum Period; Pregnancy; Tanzania; Treatment Outcome; Young Adult

Ferric carboxymaltose is increasingly utilised to treat iron deficiency and is usually diluted in saline and administered as an intravenous infusion over 15 min. Although this is highly convenient compared with older formulations, we hypothesised the drug could be administered, safely given as a rapid bolus injection.. To define the risk of serious adverse events following administration of an undiluted, rapid, high-dose ferric carboxymaltose injection. Secondary aims included all other adverse events, as well as longitudinal effects on haemoglobin, iron stores, phosphate and hepcidin.. In a single-arm, Phase II study in 121 patients with iron-deficiency anaemia, we administered up to 1000 mg of ferric carboxymaltose as a rapid undiluted bolus injection, and recorded adverse events and collected blood samples over the first hour, and again at 2 and 4 weeks post-treatment.. No patient experienced a serious adverse event. Flushing during the injection was common, as was a transient headache in the subsequent weeks. One patient experienced Grade 3 chest tightness, necessitating emergency department assessment but not admission or treatment. Treatment produced an average 12.3 g/L improvement in haemoglobin within 2 weeks, but commonly caused reductions in serum phosphate (although none of these was clinically symptomatic). Parenteral iron caused elevations in hepcidin sustained to 4 weeks post-injection. Patients stated they would be prepared to receive the treatment again.. Rapid injection of undiluted ferric carboxymaltose is well tolerated and could provide an approach to treat patients in the ambulatory setting.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Iron; Maltose

Anemia is a frequent complication of ulcerative colitis, and is frequently caused by iron deficiency. Oral iron supplementation displays high rates of gastrointestinal adverse effects. However, the formulation of sucrosomial iron (SI) has shown higher tolerability. We performed a prospective study to compare the effectiveness and tolerability of oral SI and intravenous ferric carboxy-maltose (FCM) in patients with ulcerative colitis in remission and mild-to-moderate anemia. Patients were randomized 1:1 to receive 60 mg/day for 8 weeks and then 30 mg/day for 4 weeks of oral SI or intravenous 1000 mg of FCM at baseline. Hemoglobin and serum levels of iron and ferritin were assessed after 4, 8, and 12 weeks from baseline. Hemoglobin and serum iron increased in both groups after 4 weeks of therapy, and remained stable during follow up, without significant treatment or treatment-by-time interactions (

Topics: Administration, Intravenous; Administration, Oral; Adult; Aged; Anemia, Iron-Deficiency; Colitis, Ulcerative; Comparative Effectiveness Research; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Hematinics; Hemoglobins; Humans; Iron; Male; Maltose; Middle Aged; Prospective Studies; Treatment Outcome

Patients with heart failure (HF) and iron deficiency experience poor health-related quality of life (HRQoL). We evaluated the impact of intravenous (IV) ferric carboxymaltose (FCM) vs. placebo on HRQoL for the AFFIRM-AHF population.. The baseline 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which was completed for 1058 (535 and 523) patients in the FCM and placebo groups, respectively, was administered prior to randomization and at Weeks 2, 4, 6, 12, 24, 36, and 52. The baseline KCCQ-12 overall summary score (OSS) mean ± standard error was 38.7 ± 0.9 (FCM group) and 37.1 ± 0.8 (placebo group); corresponding values for the clinical summary score (CSS) were 40.9 ± 0.9 and 40.1 ± 0.9. At Week 2, changes in OSS and CSS were similar for FCM and placebo. From Week 4 to Week 24, patients assigned to FCM had significantly greater improvements in OSS and CSS scores vs. placebo [adjusted mean difference (95% confidence interval, CI) at Week 4: 2.9 (0.5-5.3, P = 0.018) for OSS and 2.8 (0.3-5.3, P = 0.029) for CSS; adjusted mean difference (95% CI) at Week 24: 3.0 (0.3-5.6, P = 0.028) for OSS and 2.9 (0.2-5.6, P = 0.035) for CSS]. At Week 52, the treatment effect had attenuated but remained in favour of FCM.. In iron-deficient patients with HF and left ventricular ejection fraction <50% who had stabilized after an episode of acute HF, treatment with IV FCM, compared with placebo, results in clinically meaningful beneficial effects on HRQoL as early as 4 weeks after treatment initiation, lasting up to Week 24.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Maltose; Quality of Life; Stroke Volume; Treatment Outcome; Ventricular Function, Left

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).. 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.. 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.. 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.

Topics: Anemia, Iron-Deficiency; Double-Blind Method; Ferric Compounds; Humans; Maltose; Restless Legs Syndrome; Treatment Outcome

Atrial fibrillation (AF) is associated with significantly impaired quality-of-life. Iron deficiency (ID) is prevalent in patients with AF. Correction of ID in other patient populations with intravenous iron supplementation has been shown to be a safe, convenient and effective way of improving exercise tolerance, fatigue and quality-of-life. The IRON-AF (Effect of Iron Repletion in Atrial Fibrillation) study is designed to assess the effect of iron repletion with intravenous ferric carboxymaltose in patients with AF and ID.. The IRON-AF study is a double-blind, randomised controlled trial that will recruit at least 84 patients with AF and ID. Patients will be randomised to receive infusions of either ferric carboxymaltose or placebo, given in repletion and then maintenance doses. The study will have follow-up visits at weeks 4, 8 and 12. The primary endpoint is change in peak oxygen uptake from baseline to week 12, as measured by cardiopulmonary exercise testing (CPET) on a cycle ergometer. Secondary endpoints include changes in quality-of-life and AF disease burden scores, blood parameters, other CPET parameters, transthoracic echocardiogram parameters, 6-minute walk test distance, 7-day Holter/Event monitor burden of AF, health resource utilisation and mortality.. The study protocol has been approved by the Central Adelaide Local Health Network Human Research Ethics Committee, Australia. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.. Australian New Zealand Clinical Trials Registry (ACTRN12620000285954).

Topics: Anemia, Iron-Deficiency; Atrial Fibrillation; Australia; Double-Blind Method; Ferric Compounds; Humans; Iron; Maltose

Iron deficiency (ID) is one of the most commonly known nutritional deficiencies and is considered the primary cause of anemia (iron-deficiency anemia). Ferric carboxymaltose (FCM), an intravenous iron preparation, has been widely used for >10 years for iron-deficiency anemia treatment worldwide because of its many advantages.. This single-center, open-label, single dose escalation study in Chinese subjects was designed to assess the pharmacokinetic/pharmacodynamic parameters and safety of FCM in this population. The first 12 subjects received a 500-mg dose; after assessing safety data from the first 6 subjects in this cohort, another 12 subjects were assigned to the 1000-mg dose cohort.. After an infusion of FCM over 15 min, a rapid dose-dependent increase in total serum iron levels was observed with a median T. The pharmacokinetic/pharmacodynamic and safety profiles in Chinese subjects seemed comparable to those in white and Japanese populations. ChinaDrugTrials.org.cn identifier: CTR20160863.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Asian People; Female; Ferric Compounds; Ferritins; Humans; Iron; Male; Maltose

Intravenous iron enables rapid correction of iron-deficiency anemia, but certain formulations induce fibroblast growth factor 23-mediated hypophosphatemia.. To compare risks of hypophosphatemia and effects on biomarkers of mineral and bone homeostasis of intravenous iron isomaltoside (now known as ferric derisomaltose) vs ferric carboxymaltose.. Between October 2017 and June 2018, 245 patients aged 18 years and older with iron-deficiency anemia (hemoglobin level ≤11 g/dL; serum ferritin level ≤100 ng/mL) and intolerance or unresponsiveness to 1 month or more of oral iron were recruited from 30 outpatient clinic sites in the United States into 2 identically designed, open-label, randomized clinical trials. Patients with reduced kidney function were excluded. Serum phosphate and 12 additional biomarkers of mineral and bone homeostasis were measured on days 0, 1, 7, 8, 14, 21, and 35. The date of final follow-up was June 19, 2018, for trial A and May 29, 2018, for trial B.. Intravenous administration of iron isomaltoside, 1000 mg, on day 0 or ferric carboxymaltose, 750 mg, infused on days 0 and 7.. The primary end point was the incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) between baseline and day 35.. In trial A, 123 patients were randomized (mean [SD] age, 45.1 [11.0] years; 95.9% women), including 62 to iron isomaltoside and 61 to ferric carboxymaltose; 95.1% completed the trial. In trial B, 122 patients were randomized (mean [SD] age, 42.6 [12.2] years; 94.1% women), including 61 to iron isomaltoside and 61 to ferric carboxymaltose; 93.4% completed the trial. The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose (trial A: 7.9% vs 75.0% [adjusted rate difference, -67.0% {95% CI, -77.4% to -51.5%}], P < .001; trial B: 8.1% vs 73.7% [adjusted rate difference, -65.8% {95% CI, -76.6% to -49.8%}], P < .001). Beyond hypophosphatemia and increased parathyroid hormone, the most common adverse drug reactions (No./total No.) were nausea (iron isomaltoside: 1/125; ferric carboxymaltose: 8/117) and headache (iron isomaltoside: 4/125; ferric carboxymaltose: 5/117).. In 2 randomized trials of patients with iron-deficiency anemia who were intolerant of or unresponsive to oral iron, iron isomaltoside (now called ferric derisomaltose), compared with ferric carboxymaltose, resulted in lower incidence of hypophosphatemia over 35 days. However, further research is needed to determine the clinical importance of this difference.. ClinicalTrials.gov Identifiers: NCT03238911 and NCT03237065.

Topics: Adult; Anemia, Iron-Deficiency; Biomarkers; Disaccharides; Female; Ferric Compounds; Headache; Hematinics; Humans; Hypophosphatemia; Incidence; Male; Maltose; Middle Aged; Nausea; Phosphates

Topics: Administration, Intravenous; Aged; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Heart Failure; Hematinics; Humans; Iron; Magnetic Resonance Imaging; Male; Maltose; Middle Aged; Myocardium

Prospective, randomized, controlled, single-centre trial. (ClinicalTrials.gov: NCT01787526).. Tertiary care center in Graz, Austria.. 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).. Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation (10 g iron fumarate, 100 capsules, n = 90).. 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.. We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality (. 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.

Topics: Administration, Oral; Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Blood Donors; Dietary Supplements; Fatigue Syndrome, Chronic; Female; Ferric Compounds; Humans; Infusions, Intravenous; Iron, Dietary; Male; Maltose; Middle Aged; Quality of Life; Restless Legs Syndrome; Severity of Illness Index; Sleep Wake Disorders; Treatment Outcome; Young Adult

In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively.. In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias.. Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants.. While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI.. Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).

Topics: Adult; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Fibroblast Growth Factor-23; Humans; Hypophosphatemia; Iron; Male; Maltose; Prospective Studies

Intravenous ferric carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of ferric carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure.. AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100-299 μg/L with transferrin saturation <20%), and had a left ventricular ejection fraction of less than 50%. Before hospital discharge, participants were randomly assigned (1:1) to receive intravenous ferric carboxymaltose or placebo for up to 24 weeks, dosed according to the extent of iron deficiency. To maintain masking of patients and study personnel, treatments were administered in black syringes by personnel not involved in any study assessments. The primary outcome was a composite of total hospitalisations for heart failure and cardiovascular death up to 52 weeks after randomisation, analysed in all patients who received at least one dose of study treatment and had at least one post-randomisation data point. Secondary outcomes were the composite of total cardiovascular hospitalisations and cardiovascular death; cardiovascular death; total heart failure hospitalisations; time to first heart failure hospitalisation or cardiovascular death; and days lost due to heart failure hospitalisations or cardiovascular death, all evaluated up to 52 weeks after randomisation. Safety was assessed in all patients for whom study treatment was started. A pre-COVID-19 sensitivity analysis on the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT02937454, and has now been completed.. Between March 21, 2017, and July 30, 2019, 1525 patients were screened, of whom 1132 patients were randomly assigned to study groups. Study treatment was started in 1110 patients, and 1108 (558 in the carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value. 293 primary events (57·2 per 100 patient-years) occurred in the ferric carboxymaltose group and 372 (72·5 per 100 patient-years) occurred in the placebo group (rate ratio [RR] 0·79, 95% CI 0·62-1·01, p=0·059). 370 total cardiovascular hospitalisations and cardiovascular deaths occurred in the ferric carboxymaltose group and 451 occurred in the placebo group (RR 0·80, 95% CI 0·64-1·00, p=0·050). There was no difference in cardiovascular death between the two groups (77 [14%] of 558 in the ferric carboxymaltose group vs 78 [14%] in the placebo group; hazard ratio [HR] 0·96, 95% CI 0·70-1·32, p=0·81). 217 total heart failure hospitalisations occurred in the ferric carboxymaltose group and 294 occurred in the placebo group (RR 0·74; 95% CI 0·58-0·94, p=0·013). The composite of first heart failure hospitalisation or cardiovascular death occurred in 181 (32%) patients in the ferric carboxymaltose group and 209 (38%) in the placebo group (HR 0·80, 95% CI 0·66-0·98, p=0·030). Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to ferric carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47-0·97, p=0·035). Serious adverse events occurred in 250 (45%) of 559 patients in the ferric carboxymaltose group and 282 (51%) of 551 patients in the placebo group.. In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with ferric carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effect on the risk of cardiovascular death.. Vifor Pharma.

Topics: Administration, Intravenous; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Heart Failure; Hospitalization; Humans; Male; Maltose; Middle Aged; Patient Discharge; Treatment Outcome; Ventricular Function, Left

Frequent blood donation often leads to iron deficiency and even anemia but appropriate strategies for detection and prevention are currently not mandatory. At the Medical University of Graz, we conducted a single-center prospective clinical trial to compare oral and IV iron supplementation in iron deficient blood donors including Austrian regular whole blood and platelet apheresis donors. We aimed to determine the difference of transferrin saturation between the treatment groups 8-12 weeks iron administration besides other parameters of iron status and blood count.. 176 healthy male and female blood donors with iron deficiency (ferritin ≤30 ng/mL) were randomized to either a single dose of IV ferric carboxymaltose (1000 mg, n = 86) or oral iron (II)fumarate (100 tablets of 100 mg [10 per week], n = 90).. Between 2014 and 2016, 172 donors (137 women) completed the study; 4 in the oral group were lost to follow-up. At follow-up, median (IQR) transferrin saturation and ferritin were significantly higher in the intravenous group (27 [23-35]%, vs 21.0 [16-32]%; p < 0.001 and 105 [75-145] ng/mL vs 25 [17-34] ng/mL; p < 0.001, respectively) while median (IQR) hemoglobin levels were comparable (IV, 13.6 [13.0-14.4] g/dL vs oral, 13.6 [13.0-14.2] g/dL). The frequency of adverse effects was comparable (38% in both groups) and no serious adverse events occurred.. A single dose of 1000 mg of intravenous iron is highly effective to counteract iatrogenic iron deficiency in blood donors. Oral iron appears to be an acceptable alternative. The assessment of body iron stores should play a key role in maintaining blood donors' health. This trial was registered at www.clinicaltrials.gov as NCT01787526 on February 8, 2013 and at www.clinicaltrialsregister.eu (EudraCT identifier: 2013-000327-14) on September 24, 2013.

Topics: Administration, Intravenous; Administration, Oral; Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Blood Donors; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Follow-Up Studies; Humans; Male; Maltose; Middle Aged; Prospective Studies; Transferrin; Young Adult

Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF.. AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes.. The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.

Topics: Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Double-Blind Method; Female; Ferric Compounds; Follow-Up Studies; Heart Failure; Hospitalization; Humans; Injections, Intravenous; Inpatients; Male; Maltose; Middle Aged; Quality of Life; Retrospective Studies; Survival Rate; Switzerland; Treatment Outcome

The intravenous formulation for supplementing iron currently available in Japan requires frequent administration. In contrast, ferric carboxymaltose (FCM) can improve iron-deficiency anemia (IDA) with only a small number of administrations; however, its efficacy and safety have not been established in Japanese patients. In this randomized, open-label study, we verified the noninferiority of FCM to saccharated ferric oxide (SFO) in Japanese patients with IDA due to hypermenorrhea, with the mean change from baseline to the highest observed hemoglobin level as the primary endpoint. Two hundred and thirty-eight eligible subjects (119 in FCM group, 119 in SFO group) were administered the investigational medicinal product and included in the analysis. The adjusted mean change from baseline to the highest observed hemoglobin level (95% CI) was 3.90 g/dL (3.77, 4.04) in the FCM group and 4.05 g/dL (3.92, 4.19) in the SFO group, and the difference between the groups (95% CI) was - 0.15 g/dL (- 0.35, 0.04). The noninferiority of FCM was verified. Incidence of adverse events was < 60% in both groups, and no significant difference was observed between the treatment groups. These results indicate that FCM can be a new, well-tolerated, and rapid treatment option for Japanese patients with IDA.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Japan; Maltose; Menorrhagia; Middle Aged; Treatment Outcome; Young Adult

Iron-deficiency anemia (IDA) accounts for majority of anemia. Although iron replacement therapy is effective, in Japan, conventional iron formulations have disadvantages such as gastrointestinal side effects for oral formulations and issues of frequent administration for intravenous (IV) formulations. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron source overseas. In this multi-center, open-label, single-arm study, we investigated the safety and efficacy of FCM up to 12 weeks after the start of administration in patients with IDA caused by digestive diseases. Thirty-nine patients diagnosed with IDA based on hemoglobin and serum ferritin levels were included. Eligible subjects were administered FCM until the total calculated iron dose (1000 or 1500 mg) was achieved over intervals of at least 1 week. A single iron dose was 500 mg. In the full analysis set (n = 39), the incidence of adverse events and adverse drug reactions was 71.8 and 48.7%, respectively. All events were as expected from the safety profile of IV iron. The mean change from baseline (10.39 g/dL) to the highest observed hemoglobin level was 3.31 g/dL. These results indicate the safety and efficacy of FCM for treating IDA caused by digestive diseases in Japanese patients.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Ferric Compounds; Ferritins; Gastrointestinal Diseases; Hemoglobins; Japan; Maltose; Treatment Outcome

To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.. A randomized clinical trial was conducted from (January 2016-August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome.. Mean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group.. Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting. CLINICAL TRIAL REGISTRATION ( WWW.CTRI.NIC.IN ): CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Erythrocyte Count; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; India; Iron; Maltose; Pregnancy; Pregnancy Complications; Prenatal Care; Treatment Outcome; Young Adult

To compare ferric carboxymaltose (FCM) with iron sucrose (IS) for the effective and timely treatment of preoperative iron deficiency anemia (IDA) in women with menorrhagia.. This open-label, multicenter, two-arm study randomized patients to receive either a single dose of FCM or multiple doses of IS. The primary endpoint was the proportion of patients who achieved hemoglobin (Hb) levels ≥10 g/dL within 2 weeks after the first administration. Secondary endpoints included mean Hb levels, time to reach Hb ≥10 g/dL and quality of life (QoL).. In total, 101 patients (FCM n = 52; IS n = 49) were randomized to the study treatments. FCM was as effective as IS in achieving Hb ≥10 g/dL within 2 weeks after the first administration (78.8% vs 72.3%). The time to reach Hb ≥10 g/dL was significantly shorter in the FCM group than in the IS group (7.7 days vs 10.5 days). Mean Hb levels were higher in the FCM-treated patients than in the IS-treated patients with borderline significance. QoL scores did not differ between the two groups.. Ferric carboxymaltose is as effective as IS in correcting preoperative IDA among patients with menorrhagia. The added benefits of FCM over IS included significant rapid correction of IDA, replenishment of iron stores and reduced hospital visits.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; Maltose; Menorrhagia; Middle Aged; Outcome Assessment, Health Care; Young Adult

Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. This study assessed whether immediate preoperative treatment could result in reduced perioperative red blood cell (RBC) transfusions and improved outcome.. In this single-centre, randomised, double-blind, parallel-group controlled study, patients undergoing elective cardiac surgery with anaemia (n=253; haemoglobin concentration (Hb) <120 g/L in women and Hb <130 g/L in men) or isolated iron deficiency (n=252; ferritin <100 mcg/L, no anaemia) were enrolled. Participants were randomly assigned (1:1) with the use of a computer-generated range minimisation (allocation probability 0·8) to receive either placebo or combination treatment consisting of a slow infusion of 20 mg/kg ferric carboxymaltose, 40 000 U subcutaneous erythropoietin alpha, 1 mg subcutaneous vitamin B12, and 5 mg oral folic acid or placebo on the day before surgery. Primary outcome was the number of RBC transfusions during the first 7 days. This trial is registered with ClinicalTrials.gov, number NCT02031289.. Between Jan 9, 2014, and July 19, 2017, 1006 patients were enrolled; 505 with anaemia or isolated iron deficiency and 501 in the registry. The combination treatment significantly reduced RBC transfusions from a median of one unit in the placebo group (IQR 0-3) to zero units in the treatment group (0-2, during the first 7 days (odds ratio 0·70 [95% CI 0·50-0·98] for each threshold of number of RBC transfusions, p=0·036) and until postoperative day 90 (p=0·018). Despite fewer RBC units transfused, patients in the treatment group had a higher haemoglobin concentration, higher reticulocyte count, and a higher reticulocyte haemoglobin content during the first 7 days (p≤0·001). Combined allogeneic transfusions were less in the treatment group (0 [IQR 0-2]) versus the placebo group (1 [0-3]) during the first 7 days (p=0·038) and until postoperative day 90 (p=0·019). 73 (30%) serious adverse events were reported in the treatment group group versus 79 (33%) in the placebo group.. An ultra-short-term combination treatment with intravenous iron, subcutaneous erythropoietin alpha, vitamin B12, and oral folic acid reduced RBC and total allogeneic blood product transfusions in patients with preoperative anaemia or isolated iron deficiency undergoing elective cardiac surgery.. Vifor Pharma and Swiss Foundation for Anaesthesia Research.

Topics: Administration, Intravenous; Administration, Oral; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Cardiac Surgical Procedures; Double-Blind Method; Drug Therapy, Combination; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Folic Acid; Heart Diseases; Humans; Male; Maltose; Middle Aged; Preoperative Care; Prospective Studies; Time Factors; Vitamin B 12

Iron deficiency anemia (IDA) is a significant problem worldwide particularly in women. The aim of the study was to evaluate the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in comparison to iron sucrose (IS) in women with IDA.. Two hundred patients at Department of Obstetrics and Gynaecology, Sher-i-Kashmir Institute of Medical Sciences Medical College and Hospital, Jammu & Kashmir, India identified with IDA were enrolled for the study. Intravenous FCM and IS were both given as per the protocol. Change in the laboratory parameters such as hemoglobin (Hb), mean corpuscular value, and serum ferritin levels at two weeks and four weeks interval after the treatment was recorded.. A significant increase in the mean Hb was observed from 7.76 ± 0.709 to 13.25 ± 0.606 in patients treated with FCM and 7.64 ± 0.710 to 11.59 ± 0.733 g/dL (P < 0.001) in patients treated with IS after four weeks of therapy. The rise in mean corpuscular volume was from 66.82 ± 5.24 to 86.76 ± 3.765 and 68.05 ± 5.56 to 93.80 ± 3.80 and rise in serum ferritin levels were from 8.32 ± 1.787 to 38.94 ± 6.095 μg/L and 8.16 ± 1.540 to 27 ± 8.175 μg/L in patients treated with FCM and IS respectively after four weeks of therapy. No serious adverse effects were reported.. Parenteral therapy is effective in IDA, but FCM elevates hemoglobin level and restored iron stores faster than IS with minimum adverse drug reactions.. ISRCTN14484575 Dated: 15-12-2017 retrospectively registered. https://doi.org/10.1186/ISRCTN14484575.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Erythrocyte Indices; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Hematinics; Hemoglobins; Humans; Maltose; Pregnancy; Pregnancy Complications; Treatment Outcome; Young Adult

Iron deficiency is highly prevalent in Southeast Asians with heart failure (HF) and associated with worse outcomes. This trial aimed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF.. Fifty patients hospitalized for acute decompensated HF, regardless of ejection fraction, with iron deficiency (defined as serum ferritin <300 ng/mL if transferrin saturation is <20%) were randomized to receive either one dose of intravenous ferric carboxymaltose (FCM) 1000 mg or placebo (0.9% saline) following HF stabilization and before discharge in two Singapore tertiary centres. The primary endpoint was difference in 6-min walk test (6MWT) distance over 12 weeks, while secondary endpoints were quality of life assessed using validated Kansas City Cardiomyopathy Questionnaire (KCCQ) and Visual Analogue Scale (VAS). Improvement in 6MWT distance at Week 12 was observed in both FCM and placebo groups (from 252 ± 123 to 334 ± 128 m and from 243 ± 67 to 301 ± 83 m, respectively). Unadjusted analysis showed 6MWT distance for FCM exceeded that for placebo, but adjustment for baseline covariates and time attenuated this effect {adjusted mean difference between groups: 0.88 m [95% confidence interval (CI) -30.2 to 32.0, P = 0.956]}. KCCQ overall summary and VAS were similar in both groups [adjusted mean difference: KCCQ -1.48 (95% CI -8.27 to 5.31, P = 0.670) and VAS 0.26 (95% CI -0.33 to 0.86, P = 0.386)]. FCM was well tolerated with no serious treatment-related adverse events.. Intravenous FCM administered pre-discharge in Southeast Asians hospitalized with decompensated HF is clinically feasible. Changes in 6MWT distance should be measured beyond Week 12 to account for background therapy effects.

Topics: Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Double-Blind Method; Female; Ferric Compounds; Follow-Up Studies; Heart Failure; Humans; Injections, Intravenous; Iron; Male; Maltose; Middle Aged; Pilot Projects; Prevalence; Retrospective Studies; Singapore; Stroke Volume; Time Factors; Treatment Outcome

Iron deficiency is the commonest treatable cause of postpartum anaemia. Parenteral iron therapy results in faster and higher replenishment of iron stores and correction of haemoglobin levels with better compliance. Ferric Carboxy Maltose is an effective and a safe option which can be administered intravenously in single total correction dose without any serious adverse effects.The study was done to evaluate the efficacy and safety of Ferric Carboxy Maltose in the treatment of iron deficiency anaemia in post-natal patients.. It was an open, single arm study including 615 women with diagnosis of Iron deficiency anaemia and haemoglobin (Hb) levels between 4gm% and 11gm% from January 2013 to December 2016. Intravenous Ferric Carboxy Maltose(500-1500mg) was administered and the improvement in haemoglobin levels and iron stores were assessed after three weeks of total dose infusion.. Out of the 615 women, 595 women were included in the analysis. Most of the women were in the age group of 27-30 years. Most of the women had mild anaemia as per World Health Organisation guidelines. Mean hemoglobin levels significantly increased over a period of three weeks after Ferric Carboxy Maltose administration. Other parameters like total iron binding capacity, Ferritin and Iron also had a significant improvement after Ferric Carboxy Maltose administration. No serious adverse events were observed after Ferric Carboxy Maltose.. Intravenous Ferric Carboxy Maltose was an effective and a safe treatment option for iron deficiency anaemia and has an advantage of single administration of high doses without serious adverse effects.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Female; Ferric Compounds; Hematinics; Hemoglobins; Humans; Maltose; Nepal; Postpartum Period; Young Adult

Few trials have examined rates of hypersensitivity reactions (HSRs) with intravenous iron formulations used to treat iron deficiency anemia (IDA). This randomized, multicenter, double-blind clinical trial compared the safety, and efficacy of ferumoxytol versus ferric carboxymaltose (FCM), focusing on rates of HSRs and hypotension as the primary end point. Patients with IDA of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol (n = 997) or FCM (n = 1000) intravenously over ≥15 minutes on days 1 and 8 or 9 for total respective doses of 1.02 g and 1.50 g. Composite incidences of moderate-to-severe HSRs, including anaphylaxis, or moderate-to-severe hypotension from baseline to week 5 (primary safety end point) were 0.6% and 0.7% in the ferumoxytol and FCM groups, respectively, with ferumoxytol noninferior to FCM. No anaphylaxis was reported in either group. The secondary safety end point of incidences of moderate-to-severe HSRs, including anaphylaxis, serious cardiovascular events, and death from baseline to week 5 were 1.3% and 2.0% in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Least-squares mean changes in hemoglobin at week 5 were 1.4 g/dL and 1.6 g/dL in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Incidence of hypophosphatemia was 0.4% for ferumoxytol and 38.7% for FCM.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Drug Hypersensitivity; Female; Ferric Compounds; Ferrosoferric Oxide; Humans; Hypophosphatemia; Male; Maltose; Middle Aged; Treatment Outcome

Treatment with intravenous ferric carboxymaltose (FCM) has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure and iron deficiency. However, the underlying mechanisms for these beneficial effects remain undetermined. The aim of this study is to quantify cardiac magnetic resonance changes in myocardial iron content after administration of intravenous FCM in patients with heart failure and iron deficiency and contrast them with parameters of heart failure severity. This is a multicenter, double-blind, randomized study. Fifty patients with stable symptomatic heart failure, left ventricular ejection fraction <50%, and iron deficiency will be randomly assigned 1:1 to receive intravenous FCM or placebo. Intramyocardial iron will be evaluated by T2* and T1 mapping cardiac magnetic resonance sequences before and at 7 and 30 days after FCM. After 30 days, patients assigned to placebo will receive intravenous FCM in case of persistent iron deficiency. The main endpoint will be changes from baseline in myocardial iron content at 7 and 30 days. Secondary endpoints will include the correlation of these changes with left ventricular ejection fraction, functional capacity, quality of life, and cardiac biomarkers. The results of this study will add important knowledge about the effects of intravenous FCM on myocardial tissue and cardiac function. We hypothesize that short-term (7 and 30 days) myocardial iron content changes after intravenous FCM, evaluated by cardiac magnetic resonance, will correlate with simultaneous changes in parameters of heart failure severity. The study is registered at http://www.clinicaltrials.gov (NCT03398681).

Topics: Aged; Anemia, Iron-Deficiency; Clinical Protocols; Double-Blind Method; Female; Ferric Compounds; Heart Failure; Hematinics; Humans; Infusions, Intravenous; Magnetic Resonance Imaging, Cine; Male; Maltose; Myocardium; Quality of Life; Recovery of Function; Research Design; Severity of Illness Index; Spain; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left

Topics: Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Ferric Compounds; Heart Failure; Humans; Hypophosphatemia; Infusions, Intravenous; Maltose; Pilot Projects; Prospective Studies; Stroke Volume

An analytic-decision model was built to estimate the cost-effectiveness of using ferric carboxymaltose for pre-operative haemoglobin optimisation in patients with iron deficiency anaemia undergoing primary knee arthroplasty.. We simulated 20,000 patients who were randomly assigned to the haemoglobin optimisation arm or the non-optimisation control arm in a strict 1:1 ratio. The main outcomes were cost per patient transfusion avoided and red blood cell units spared. The analyses were performed from the hospital perspective with length of stay as the time horizon.. In the reference case scenario, pre-operative haemoglobin optimisation led to fewer patients being exposed to allogeneic red blood cell transfusion (2,212 vs 6,595 out of 10,000 patients) and a relevant decrease in the number of red blood cell units transfused (4.342 vs 13.336). The costs of avoiding one patient transfusion and sparing one red blood cell unit were € 831 and € 405, respectively. Increased costs in the optimisation arm were mostly associated with the outpatient day hospital visit (54%) and ferric carboxymaltose treatment (40%).. In primary knee arthroplasty, pre-operative haemoglobin optimisation with intravenous ferric carboxymaltose is less expensive than other reported patient blood management modalities and must be considered in patients with iron deficiency anaemia.

Topics: Anemia, Iron-Deficiency; Arthroplasty, Replacement, Knee; Costs and Cost Analysis; Decision Making; Erythrocyte Transfusion; Female; Ferric Compounds; Humans; Male; Maltose; Preoperative Care

To compare the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) versus oral iron and other IV iron therapies in patients with iron-deficiency anemia (IDA) resulting from gastrointestinal (GI) disorders.. A pooled analysis of four prospective, randomized, active-controlled trials in patients with IDA was performed. Efficacy measures included change from baseline in hemoglobin (Hb), ferritin, and transferrin saturation (TSAT) and correlations of baseline Hb, ferritin, and TSAT to change in Hb. The incidence and type of adverse events were evaluated.. A total of 191 patients were evaluated. The mean change in Hb from baseline to the maximum value was 0.8 g/dL with oral iron (P = 0.001 vs. FCM), 2.2 g/dL with FCM, 2.0 g/dL with any IV iron (P = 0.391 vs. FCM), and 1.9 g/dL with iron sucrose (P = 0.329 vs. FCM). Patients treated with FCM and iron sucrose had larger increases in Hb. This effect may have been attributed to a lower baseline Hb level. Drug-related adverse events occurred in 11.9, 12, 26.2, and 25% and serious adverse events (SAEs) occurred in 6.9, 4, 9.8, and 12.5% of patients in the FCM, oral iron, other IV iron therapies, and iron sucrose groups, respectively. No SAEs were considered treatment related in the FCM group, compared with two treatment-related SAEs in two patients (6.3%) in the iron sucrose group.. FCM is an effective therapy in patients with IDA who have GI disorders and has a safety profile comparable to that of other IV iron agents.

Topics: Administration, Intravenous; Administration, Oral; Adult; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Gastrointestinal Diseases; Hemoglobins; Humans; Iron; Male; Maltose; Middle Aged; Prospective Studies

Iron deficiency anaemia (IDA) is the most common nutritional deficiency affecting pregnant women worldwide. This study aims to compare the efficacy and safety of a newly available intravenous (IV) iron preparation, ferric carboxymaltose (FCM), against IV iron polymaltose (IPM), and standard oral iron (ferrous sulphate) for the treatment of IDA in pregnancy. This is an open-labelled prospective randomised controlled trial (RCT) with intention-to-treat analysis conducted at a primary health care facility with a single tertiary referral centre in Launceston. Tasmania, Australia. A 3-arm randomised controlled trial was conducted comparing a single IV infusion of 1000mg of FCM (n = 83 patients) over 15 minutes against a single IV infusion of 1000mg of IPM (n = 82) over 2 hours against 325mg daily oral ferrous sulphate (n = 81) until delivery, for the treatment of IDA in pregnancy. A total of 246 consecutive pregnant women were recruited between September 2013 and July 2014. The median age was 28 years, with a median and mean gestation of 27 weeks. The median serum ferritin was 9µg/L, with a mean of 13µg/L. The mean haemoglobin (Hb) was 114g/L. The primary outcome was the change in ferritin and Hb levels at 4 weeks after intervention. Secondary outcomes included ferritin and Hb improvements at predelivery, safety, tolerability, quality of life (QoL), cost utility, and fetal outcomes. The mean Hb level differences between the baseline intervention time point and 4 weeks thereafter were significantly higher in the FCM versus the oral group by 4.35g/L (95% CI: 1.64-7.05; P = 0.0006) and in the IPM vs the oral group by 4.08g/L (95% CI: 1.57-6.60; P = 0.0005), but not different between the FCM and IPM groups (0.26g/L; 95% CI: -2.59 to 3.11; P = 0.9740). The mean ferritin level differences were significantly higher at 4 weeks in the FCM vs oral iron group by 166µg/L (95% CI: 138-194; P < 0.0001) and in the IPM vs oral iron group by 145µg/L (95% CI: 109-1180, P < 0.0001), but not between the 2 IV groups (21.5µg/L; 95% CI: -23.9 to 66.9; P = 0.4989). Administration of IV FCM during pregnancy was safe and better tolerated than IV IPM or oral iron. Compliance to oral iron was the lowest amongst treatment groups with one-third of the patients missing doses of daily iron tablets. Significant improvement in overall QoL scores was observed in both IV iron supplement groups by achieving normal ferritin following effective and prompt repletion of iron stores, compared to the o

Topics: Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferrous Compounds; Humans; Infusions, Intravenous; Maltose; Middle Aged; Pregnancy; Prospective Studies; Young Adult

Hypophosphatemia can complicate intravenous iron therapy, but no head-to-head trials compared the effects of newer intravenous iron formulations on risks and mediators of hypophosphatemia.. In a randomized, double-blinded, controlled trial of adults with iron deficiency anemia from February 2016 to January 2017, we compared rates of hypophosphatemia in response to a single FDA-approved course of ferric carboxymaltose (n = 1,000) or ferumoxytol (n = 997). To investigate pathophysiological mediators of intravenous iron-induced hypophosphatemia, we nested within the parent trial a physiological substudy (ferric carboxymaltose, n = 98; ferumoxytol, n = 87) in which we measured fibroblast growth factor 23 (FGF23), calcitriol, and parathyroid hormone (PTH) at baseline and 1, 2, and 5 weeks later.. The incidence of hypophosphatemia was significantly higher in the ferric carboxymaltose versus the ferumoxytol group (<2.0 mg/dl, 50.8% vs. 0.9%; <1.3 mg/dl, 10.0% vs. 0.0%; P < 0.001), and hypophosphatemia persisted through the end of the 5-week study period in 29.1% of ferric carboxymaltose-treated patients versus none of the ferumoxytol-treated patients (P < 0.001). Ferric carboxymaltose, but not ferumoxytol, increased circulating concentrations of biologically active FGF23 (mean within-patient percentage change from baseline to week 2 peak: +302.8 ± 326.2% vs. +10.1 ± 61.0%; P < 0.001), which was significantly associated with contemporaneous hypophosphatemia, renal phosphate wasting, and decreased serum calcitriol and calcium, and increased PTH concentrations.. Ferric carboxymaltose rapidly increases biologically active FGF23 in patients with iron deficiency anemia. Paralleling hereditary and other acquired syndromes of hypophosphatemic rickets/osteomalacia, ferric carboxymaltose-induced FGF23 elevation triggers a pathophysiological cascade of renal phosphate wasting, calcitriol deficiency, and secondary hyperparathyroidism that frequently culminates in hypophosphatemia.. ClinicalTrials.gov, NCT02694978FUNDING. AMAG Pharmaceuticals, Inc.Role of the funding source: This study was supported by AMAG Pharmaceuticals, Inc. The academic investigators designed the clinical trial, performed the analyses, and authored the manuscript with input from the coauthors from AMAG Pharmaceuticals, Inc.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Calcitriol; Calcium; Female; Ferric Compounds; Ferrosoferric Oxide; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Homeostasis; Humans; Hyperparathyroidism; Hypophosphatemia; Iron; Male; Maltose; Middle Aged; Phosphates; Risk Factors

The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration.. FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 µg/L) or lower (100-200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period.. The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups.. These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.

Topics: Administration, Intravenous; Administration, Oral; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Glomerular Filtration Rate; Humans; Iron; Male; Maltose; Prospective Studies; Renal Insufficiency, Chronic; Time Factors

To compare the efficacy and safety of intravenous ferric carboxymaltose (FCM) with first-line oral ferrous sulfate (FS) in pregnant women with iron deficiency anemia (IDA).. Pregnant women (n=252; gestational weeks 16-33) with IDA were randomized 1:1 to FCM (1000-1500 mg iron) or FS (200 mg iron/day) for 12 weeks. The primary objective was to compare efficacy; secondary objectives included safety and quality of life.. Hemoglobin (Hb) levels improved at comparable rates across both treatments; however, significantly more women achieved anemia correction with FCM vs. FS [Hb ≥11.0 g/dL; 84% vs. 70%; odds ratio (OR): 2.06, 95% confidence interval (CI): 1.07, 3.97; P=0.031] and within a shorter time frame (median 3.4 vs. 4.3 weeks). FCM treatment significantly improved vitality (P=0.025) and social functioning (P=0.049) prior to delivery. Treatment-related adverse events were experienced by 14 (FCM; 11%) and 19 (FS; 15%) women, with markedly higher rates of gastrointestinal disorders reported with FS (16 women) than with FCM (3 women). Newborn characteristics were similar across treatments.. During late-stage pregnancy, FCM may be a more appropriate option than first-line oral iron for rapid and effective anemia correction, with additional benefits for vitality and social functioning.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferrous Compounds; Humans; Infant, Newborn; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Quality of Life; Treatment Outcome

Treatment of preoperative anaemia is recommended as part of patient blood management, aiming to minimize perioperative allogeneic red blood cell transfusion. No clear evidence exists outlining which treatment modality should be used in patients with colorectal cancer. The study aimed to compare the efficacy of preoperative intravenous and oral iron in reducing blood transfusion use in anaemic patients undergoing elective colorectal cancer surgery.. Anaemic patients with non-metastatic colorectal adenocarcinoma were recruited at least 2 weeks before surgery and randomized to receive oral (ferrous sulphate) or intravenous (ferric carboxymaltose) iron. Perioperative changes in haemoglobin, ferritin, transferrin saturation and blood transfusion use were recorded until postoperative outpatient review.. Some 116 patients were included in the study. There was no difference in blood transfusion use from recruitment to trial completion in terms of either volume of blood administered (P = 0·841) or number of patients transfused (P = 0·470). Despite this, increases in haemoglobin after treatment were higher with intravenous iron (median 1·55 (i.q.r. 0·93-2·58) versus 0·50 (-0·13 to 1·33) g/dl; P < 0·001), which was associated with fewer anaemic patients at the time of surgery (75 versus 90 per cent; P = 0·048). Haemoglobin levels were thus higher at surgery after treatment with intravenous than with oral iron (mean 11·9 (95 per cent c.i. 11·5 to 12·3) versus 11·0 (10·6 to 11·4) g/dl respectively; P = 0·002), as were ferritin (P < 0·001) and transferrin saturation (P < 0·001) levels.. Intravenous iron did not reduce the blood transfusion requirement but was more effective than oral iron at treating preoperative anaemia and iron deficiency in patients undergoing colorectal cancer surgery.

Topics: Adenocarcinoma; Administration, Oral; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Colorectal Neoplasms; Elective Surgical Procedures; Erythrocyte Transfusion; Female; Ferric Compounds; Ferrous Compounds; Follow-Up Studies; Hematinics; Humans; Injections, Intravenous; Male; Maltose; Middle Aged; Postoperative Complications; Preoperative Care; Prospective Studies; Treatment Outcome

To determine if preoperative intravenous (IV) iron improves outcomes in abdominal surgery patients.. Preoperative iron deficiency anemia (IDA) occurs frequently; however if left untreated, increases the risk of blood transfusion allogeneic blood transfusion (ABT). Limited evidence supports IDA treatment with preoperative IV iron. This randomized controlled trial aimed to determine whether perioperative IV iron reduced the need for ABT.. Between August 2011 and November 2014, 72 patients with IDA were assigned to receive either IV iron or usual care. The primary endpoint was incidence of ABT. Secondary endpoints were various hemoglobin (Hb) levels, change in Hb between time points, length of stay, iron status, morbidity, mortality, and quality of life 4 weeks postsurgery.. A 60% reduction in ABT was observed in the IV iron group compared with the usual care group (31.25% vs 12.5%). Hb values, although similar at randomization, improved by 0.8 g/dL with IV iron compared with 0.1 g/dL with usual care (P = 0.01) by the day of admission. The IV iron group had higher Hb 4 weeks after discharge compared with the usual care group (1.9 vs 0.9 g/dL, P = 0.01), and a shorter length of stay (7.0 vs 9.7 d, P = 0.026). There was no difference in discharge Hb levels, morbidity, mortality, or quality of life.. Administration of perioperative IV iron reduces the need for blood transfusion, and is associated with a shorter hospital stay, enhanced restoration of iron stores, and a higher mean Hb concentration 4 weeks after surgery.

Topics: Abdominal Cavity; Aged; Anemia, Iron-Deficiency; Blood Loss, Surgical; Blood Transfusion; Body Mass Index; Digestive System Surgical Procedures; Female; Ferric Compounds; Follow-Up Studies; Humans; Injections, Intravenous; Length of Stay; Male; Maltose; Middle Aged; Perioperative Care; Postoperative Care; Quality of Life; Treatment Outcome

To evaluate the efficacy and safety of intravenous ferric carboxymaltose (FCM) in comparison with intravenous iron sucrose (ISC) in the treatment of anemia due to abnormal uterine bleeding (AUB).. A randomized controlled trial was conducted between April 2013 and May 2014 in patients older than 18 years of age presenting at a hospital in New Delhi, India, with anemia due to AUB. Patients were randomized in a 1:1 ratio to receive treatment with intravenous FCM or ISC. The primary outcome, increase in hemoglobin above baseline, was monitored over a 12-week period. Patients completing the full treatment and follow-up protocol were included in the analyses. Participants and investigators were not masked to treatment allocations.. Overall, 30 patients were assigned to each group. Increases in mean hemoglobin levels from baseline were significantly higher in the FCM group at 6 weeks (P=0.005). At 12 weeks, there was no significant difference in hemoglobin increase from baseline between the two groups (P=0.11). Adverse events were similar between both treatment groups.. Treatment with FCM resulted in a rapid increase in hemoglobin levels in patients with anemia due to AUB, with similar increases in hemoglobin over a 12-week period. Clinical Trial Registration (www.ctri.nic.in):CTRI/2015/09/006224.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Hematinics; Hemoglobins; Humans; India; Maltose; Middle Aged; Prospective Studies; Treatment Outcome; Uterine Hemorrhage

Hepcidin is the key regulator of iron homeostasis but data are limited regarding its temporal response to iron therapy, and response to intravenous versus oral iron. In the 56-week, open-label, multicenter, prospective, randomized FIND-CKD study, 626 anemic patients with non-dialysis dependent chronic kidney disease (ND-CKD) and iron deficiency not receiving an erythropoiesis stimulating agent were randomized (1:1:2) to intravenous ferric carboxymaltose (FCM), targeting higher (400-600μg/L) or lower (100-200μg/L) ferritin, or to oral iron. Serum hepcidin levels were measured centrally in a subset of 61 patients. Mean (SD) baseline hepcidin level was 4.0(3.5), 7.3(6.4) and 6.5(5.6) ng/mL in the high ferritin FCM (n = 17), low ferritin FCM (n = 16) and oral iron group (n = 28). The mean (SD) endpoint value (i.e. the last post-baseline value) was 26.0(9.1),15.7(7.7) and 16.3(11.0) ng/mL, respectively. The increase in hepcidin from baseline was significantly smaller with low ferritin FCM or oral iron vs high ferritin FCM at all time points up to week 52. Significant correlations were found between absolute hepcidin and ferritin values (r = 0.65, p<0.001) and between final post-baseline increases in both parameters (r = 0.70, p<0.001). The increase in hepcidin levels over the 12-month study generally mirrored the cumulative iron dose in each group. Hepcidin and transferrin saturation (TSAT) absolute values showed no correlation, although there was an association between final post-baseline increases (r = 0.42, p<0.001). Absolute values (r = 0.36, p = 0.004) and final post-baseline increases of hepcidin and hemoglobin (p = 0.30, p = 0.030) correlated weakly. Baseline hepcidin levels were not predictive of a hematopoietic response to iron therapy. In conclusion, hepcidin levels rose in response to either intravenous or oral iron therapy, but the speed and extent of the rise was greatest with intravenous iron targeting a higher ferritin level. However neither the baseline level nor the change in hepcidin was able to predict response to therapy in this cohort.

Topics: Administration, Intravenous; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Hepcidins; Humans; Iron; Male; Maltose; Middle Aged; Prospective Studies; Renal Insufficiency, Chronic; Time Factors

Despite increasing efforts in perioperative management, postoperative iron deficiency anaemia persists, and few data are available about the management of this condition. In this study, we aimed to determine whether giving postoperative intravenous iron (in the form of ferric carboxymaltose) improved iron stores, haemoglobin concentrations, and outcomes following surgery.. We did a prospective, open-label, randomised, controlled study of patients at two centres (a general hospital and a private health-care centre) in Tasmania, Australia, undergoing elective surgery with functional iron deficiency anaemia (haemoglobin 70-120 g/L and ferritin ≤100 μg/L or iron saturation ≤20%), measured at day 1 postoperatively. Consecutive routine elective surgical patients who were having major orthopaedic surgery, abdominal, and genitourinary surgery, and other surgeries were recruited. Via computer-generated randomisation, patients were randomly assigned (1:1) to either a single dose of intravenous 1000 mg ferric carboxymaltose (intervention group) or standard care, consisting of observation (control group). The primary endpoints were changes in haemoglobin concentrations and iron stores at 4 weeks postoperatively, and the number of transfused units of blood required postoperatively until discharge. Analyses were done on an intention-to-treat basis. This trial is registered with the Australian New Zealand Clinical Trials Registry and the WHO International Clinical Trials Registry platform (number ACTRN12614001261606).. Between Dec 17, 2014, and May 7, 2015, we recruited 201 eligible patients, assigning 103 to intravenous ferric carboxymaltose and 98 to standard care only. Baseline mean haemoglobin was 105·5 g/L (SD 13·8) in the standard care group versus 106·2 g/L (11·9) in the ferric carboxymaltose group, improving at 4 weeks to 121·5 g/L (SD 14·5) in the standard group and 130·1 g/L (11·3) in the ferric carboxymaltose group (mean difference of 7·84 g/L, 95% CI 3·79-11·9; p<0·0001 in favour of the ferric carboxymaltose group). Significant improvements in serum iron (5·36 μmol/L, 95% CI 3·62-7·09; p<0·0001), iron saturation (11·40%, 95% CI 8·33-14·50; p<0·0001), and serum ferritin concentrations (468 μg/L, 95% CI 355-582; p<0·0001) were also noted in the ferric carboxymaltose group at 4 weeks compared with standard care, although no differences were noted in transferrin concentrations (0·06 g/L, 95% CI -0·97 to 1·09; p=0·62). Fewer transfused blood units were given in the ferric carboxymaltose group (to one of 103 patients [<1%]) than in the standard care group (to five of 98 patients [5%]; incidence rate ratio 0·10; 95% CI 0·01-0·85; p=0·035). No adverse events were observed with ferric carboxymaltose treatment.. Postoperative intravenous ferric carboxymaltose is a feasible and pragmatic management approach in surgical patients with functional iron deficiency anaemia. Our study suggests that patient blood management guidelines should be updated, incorporating the use of postoperative intravenous iron infusion to optimise patient outcomes. Further trials to assess our approach are warranted.. Launceston General Hospital, Launceston, TAS, Australia, in affiliation with the University of Tasmania, TAS, Australia.

Topics: Administration, Intravenous; Aged; Anemia, Iron-Deficiency; Elective Surgical Procedures; Female; Ferric Compounds; Follow-Up Studies; Hemoglobins; Humans; Male; Maltose; Middle Aged; Postoperative Complications; Prognosis; Standard of Care

Topics: Adult; Aged; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Ferritins; Hemoglobinometry; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Postoperative Complications; Prospective Studies

Anaemia and iron deficiency are constituents of the cardio-renal syndrome in chronic heart failure (CHF). We investigated the effects of i.v. iron in iron-deficient CHF patients on renal function, and the efficacy and safety of this therapy in patients with renal dysfunction.. The FAIR-HF trial randomized 459 CHF patients with iron deficiency (ferritin <100 µg/L, or between 100 and 299 µg/L if transferrin saturation was <20%): 304 to i.v. ferric carboxymaltose (FCM) and 155 to placebo, and followed-up for 24 weeks. Renal function was assessed at baseline and at weeks 4, 12, and 24, using the estimated glomerular filtration rate (eGFR, mL/min/1.73 m(2) ), calculated from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. At baseline, renal function was similar between groups (62.4 ± 20.6 vs. 62.9 ± 23.4 mL/min/1.73 m(2) , FCM vs. placebo). Compared with placebo, treatment with FCM was associated with an increase in eGFR [treatment effect: week 4, 2.11 ± 1.21 (P = 0.082); week 12, 2.41 ± 1.33 (P = 0.070); and week 24, 2.98 ± 1.44 mL/min/1.73 m(2) (P = 0.039)]. This effect was seen in all pre-specified subgroups (P > 0.20 for interactions). No interaction between the favourable effects of FCM and baseline renal function was seen for the primary endpoints [improvement in Patient Global Assessment (P = 0.43) and NYHA class (P = 0.37) at 24 weeks]. Safety and adverse event profiles were similar in patients with baseline eGFR <60 and ≥60 mL/min/1.73 m(2) .. Treatment of iron deficiency in CHF patients with i.v. FCM was associated with an improvement in renal function. FCM therapy was effective and safe in CHF patients with renal dysfunction.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Glomerular Filtration Rate; Heart Failure; Humans; Infusions, Intravenous; Kidney; Male; Maltose; Middle Aged; Renal Insufficiency

At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer.. In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland.. This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity.. ClincalTrials.gov: NCT02243735 .

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Clinical Protocols; Colorectal Neoplasms; Dietary Supplements; Female; Ferric Compounds; Ferrous Compounds; Fumarates; Hematinics; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Preoperative Care; Treatment Outcome; Young Adult

Many patients receiving oral iron for iron deficiency anemia (IDA) cannot tolerate or fail to respond to therapy, and existing intravenous (IV) iron formulations often require repeated administrations. Ferric carboxymaltose (FCM), a nondextran IV formulation, permits larger single doses.. We evaluated FCM versus oral iron in IDA patients. After 14 days of oral iron, 507 participants responding inadequately to oral iron (hemoglobin [Hb] increase <1 g/dL; Cohort 1) were assigned to Group A (two doses of FCM, 750 mg, 1 week apart) or Group B (oral iron, 325 mg, 3 × day for 14 additional days). Also, 504 subjects not appropriate for oral iron (Cohort 2) were assigned to Group C (FCM as above) or Group D (standard-of-care IV iron). The primary efficacy endpoint was change to highest observed Hb from baseline to Day 35. The composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, heart failure, arrhythmias, and hyper- or hypotensive events.. Mean (± standard deviation [SD]) Hb increase was significantly greater in Group A-FCM than Group B-oral iron: 1.57 (±1.19) g/dL versus 0.80 (±0.80) g/dL (p = 0.001). Post hoc comparison of Group C-FCM and Group D-IV standard of care also demonstrated significant mean (±SD) increase in Hb from baseline to highest value by Day 35 in Group C versus Group D: 2.90 (±1.64) g/dL versus 2.16 (±1.25) g/dL (p = 0.001). Safety endpoints occurred in 17 of 499 (3.4%) participants receiving FCM versus 16 of 498 (3.2%) in comparator groups.. Two 750-mg FCM infusions are safe and superior to oral iron in increasing Hb levels in IDA patients with inadequate oral iron response.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Heart Diseases; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Iron; Male; Maltose; Middle Aged; Risk Factors; Stroke; Treatment Outcome

Iron-deficiency anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) frequently requires parenteral iron replacement, but existing therapies often require multiple administrations. We evaluated the efficacy and cardiovascular safety of ferric carboxymaltose (FCM), a non-dextran parenteral iron permitting large single-dose infusions, versus iron sucrose in patients with iron-deficiency anemia and NDD-CKD.. A total of 2584 participants were randomized to two doses of FCM 750 mg in one week, or iron sucrose 200 mg administered in up to five infusions in 14 days. The primary efficacy endpoint was the mean change to highest hemoglobin from baseline to Day 56. The primary composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, congestive heart failure, arrhythmias and hyper- and hypotensive events.. The mean hemoglobin increase was 1.13 g/dL in the FCM group and 0.92 g/dL in the iron sucrose group (95% CI, 0.13-0.28). Similar results were observed across all subgroups, except Stage 2 CKD. More subjects in the FCM group achieved a hemoglobin increase of ≥ 1.0 g/dL between baseline and Day 56 (48.6 versus 41.0%; 95% CI, 3.6-11.6%). There was no significant difference between FCM and iron sucrose recipients with respect to the primary composite safety endpoint, including the major adverse cardiac events of death, myocardial infarction, or stroke. A significant difference in the number of protocol-defined, predominantly transient hypertensive episodes was observed in the FCM group.. Two 750-mg infusions of FCM are a safe and effective alternative to multiple lower dose iron sucrose infusions in NDD-CKD patients with iron-deficiency anemia.

Topics: Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glomerular Filtration Rate; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Iron; Male; Maltose; Middle Aged; Renal Dialysis; Renal Insufficiency, Chronic; Treatment Outcome

Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD).. FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values <10 g/dL without an increase of ≥ 0.5 g/dL).. The background, rationale and study design of the trial are presented here. The study has been completed and results are expected in late 2013.. FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.

Topics: Administration, Oral; Adult; Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Follow-Up Studies; Glomerular Filtration Rate; Hemoglobins; Humans; Injections, Intravenous; Iron; Male; Maltose; Middle Aged; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Treatment Outcome

The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown.. Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400-600 µg/L) or lower (100-200 µg/L) ferritin or oral iron therapy. The primary end point was time to initiation of other anaemia management (ESA, other iron therapy or blood transfusion) or haemoglobin (Hb) trigger of two consecutive values <10 g/dL during Weeks 8-52.. The primary end point occurred in 36 patients (23.5%), 49 patients (32.2%) and 98 patients (31.8%) in the high-ferritin FCM, low-ferritin FCM and oral iron groups, respectively [hazard ratio (HR): 0.65; 95% confidence interval (CI): 0.44-0.95; P = 0.026 for high-ferritin FCM versus oral iron]. The increase in Hb was greater with high-ferritin FCM versus oral iron (P = 0.014) and a greater proportion of patients achieved an Hb increase ≥1 g/dL with high-ferritin FCM versus oral iron (HR: 2.04; 95% CI: 1.52-2.72; P < 0.001). Rates of adverse events and serious adverse events were similar in all groups.. Compared with oral iron, IV FCM targeting a ferritin of 400-600 µg/L quickly reached and maintained Hb level, and delayed and/or reduced the need for other anaemia management including ESAs. Within the limitations of this trial, no renal toxicity was observed, with no difference in cardiovascular or infectious events.. NCT00994318.

Topics: Administration, Oral; Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferritins; Follow-Up Studies; Hemoglobins; Humans; Injections, Intravenous; Iron; Male; Maltose; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Treatment Outcome

This randomized trial evaluated ferric carboxymaltose without erythropoiesis-stimulating agents (ESA) for correction of anemia in cancer patients with functional iron deficiency. Patients on treatment for indolent lymphoid malignancies, who had anemia [hemoglobin (Hb) 8.5-10.5 g/dL] and functional iron deficiency [transferrin saturation (TSAT) ≤ 20%, ferritin >30 ng/mL (women) or >40 ng/mL (men)], were randomized to ferric carboxymaltose (1,000 mg iron) or control. Primary end point was the mean change in Hb from baseline to weeks 4, 6 and 8 without transfusions or ESA. Difficulties with patient recruitment led to premature termination of the study. Seventeen patients (8 ferric carboxymaltose and 9 control) were included in the analysis. In the ferric carboxymaltose arm, mean Hb increase was significantly higher versus control at week 8 (p = 0.021). All ferric carboxymaltose-treated patients achieved an Hb increase >1 g/dL (control 6/9; p = 0.087), and mean TSAT was >20% from week 2 onwards. No treatment-related adverse events were reported. In conclusion, ferric carboxymaltose without ESA effectively increased Hb and iron status in this small patient population.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Anemia, Iron-Deficiency; Antineoplastic Agents; Female; Ferric Compounds; Hemoglobins; Humans; Injections, Intravenous; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Male; Maltose; Middle Aged; Multiple Myeloma; Treatment Outcome

Fibroblast growth factor 23 (FGF23) is an osteocyte-derived hormone that regulates phosphate and vitamin D homeostasis. Through unknown mechanisms, certain intravenous iron preparations induce acute, reversible increases in circulating FGF23 levels that lower serum phosphate in association with inappropriately low levels of calcitriol, similar to genetic diseases of primary FGF23 excess. In contrast, studies in wild-type mice suggest that iron deficiency stimulates fgf23 transcription but does not result in hypophosphatemia because FGF23 is cleaved within osteocytes by an unknown catabolic system. We tested the association of iron deficiency anemia with C-terminal FGF23 (cFGF23) and intact FGF23 (iFGF23) levels in 55 women with a history of heavy uterine bleeding, and assessed the longitudinal biochemical response over 35 days to equivalent doses of randomly-assigned, intravenous elemental iron in the form of ferric carboxymaltose (FCM) or iron dextran. Iron deficiency was associated with markedly elevated cFGF23 (807.8 ± 123.9 relative units [RU]/mL) but normal iFGF23 (28.5 ± 1.1 pg/mL) levels at baseline. Within 24 hours of iron administration, cFGF23 levels fell by approximately 80% in both groups. In contrast, iFGF23 transiently increased in the FCM group alone, and was followed by a transient, asymptomatic reduction in serum phosphate <2.0 mg/dL in 10 women in the FCM group compared to none in the iron dextran group. Reduced serum phosphate was accompanied by increased urinary fractional excretion of phosphate, decreased calcitriol levels, and increased parathyroid hormone levels. These findings suggest that iron deficiency increases cFGF23 levels, and that certain iron preparations temporarily increase iFGF23 levels. We propose that intravenous iron lowers cFGF23 in humans by reducing fgf23 transcription as it does in mice, whereas carbohydrate moieties in certain iron preparations may simultaneously inhibit FGF23 degradation in osteocytes leading to transient increases in iFGF23 and reduced serum phosphate.

Topics: Adult; Anemia, Iron-Deficiency; Animals; Calcium; Demography; Erythropoiesis; Female; Ferric Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Homeostasis; Humans; Iron; Iron-Dextran Complex; Maltose; Mice; Models, Biological; Parathyroid Hormone; Phosphates; Vitamin D

Red cell distribution width (RDW), a measure of variability in red blood cell size, is a novel prognostic marker in chronic heart failure (CHF). Iron deficiency contributes to elevated RDW. In the FAIR-HF trial, i.v. ferric carboxymaltose (FCM) improved the 6 min walk test (6MWT) distance in iron-deficient CHF patients. We studied the effect of FCM on RDW and the relationship between RDW and 6MWT distance.. In FAIR-HF, iron-deficient CHF patients were randomized to FCM or placebo in a 2:1 ratio. From the total cohort (n = 459), we included 415 patients in whom RDW values and 6MWT distance were available for baseline and at least one follow-up visit (after 4, 12, and 24 weeks). Baseline RDW was higher in anaemic (haemoglobin <12 g/dL) compared with non-anaemic patients [15.2% (14.0-16.8) vs. 14.2% (13.4-15.4), P < 0.0001, median (interquartile range)]. In multivariate analysis, RDW was significantly associated with transferrin saturation (P < 0.001) and C-reactive protein levels (P = 0.002). Treatment with FCM led to a biphasic response; RDW increased within 4 weeks (+0.54% absolute change from baseline, P = 0.01) but fell to values below the placebo group after 24 weeks (-1.0 %, P = 0.03). The 6MWT distance and RDW were inversely related at baseline (r = -0.30, P < 0.0001). In all patients, the increase in 6MWT distance after 24 weeks was significantly correlated with a decrease in RDW (r= -0.25, P < 0.0001), even after adjustment for changes in haemoglobin.. Iron deficiency in CHF is associated with high RDW, even after adjustment for the presence of anaemia. Treatment with i.v. FCM in iron-deficient CHF patients decreases RDW.

Topics: Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Double-Blind Method; Erythrocyte Indices; Female; Ferric Compounds; Follow-Up Studies; Heart Failure; Hemoglobins; Humans; Injections, Intravenous; Male; Maltose; Prospective Studies; Treatment Outcome

Secondary thrombocytosis is a common clinical feature. In patients with cancer, it is a risk factor for venous thromboembolic events. In inflammatory bowel disease (IBD), thrombocytosis is so far considered a marker of active disease and may contribute to the increased thromboembolic risk in this population. Observed effects of iron therapy on normalization of platelet counts led us to hypothesize that iron itself may regulate megakaryopoiesis. Here, we want to test the effect of iron replacement on platelet count and activity in IBD-associated thrombocytosis.. We performed a randomized, single-blinded placebo-controlled trial testing the effect of ferric carboxymaltose (FCM) in patients with IBD with secondary thrombocytosis (platelets > 450 G/L). Changes in platelet counts, hemoglobin, iron parameters, disease activity, megakaryopoietic growth factors, erythropoietin, and platelet activity were assessed. Patients received placebo or up to 1500 mg iron as FCM. Endpoints were evaluated at week 6.. A total of 26 patients were included in the study, 15 patients were available for the per protocol analysis. A drop in platelets >25% (primary endpoint) was observed in 4 of 8 (50%, iron group) and 1 of 7 patients (14%, placebo group, P = 0.143). Mean platelet counts dropped on FCM but not on placebo (536 G/L to 411 G/L versus 580 G/L to 559 G/L; P = 0.002). Disease activity and megakaryopoietic growth factors remained unchanged and hemoglobin and iron parameters increased on FCM. The normalization of platelet counts was associated with a decrease in platelet aggregation and P-selectin expression.. FCM lowers platelet counts and platelet activation in patients with IBD-associated secondary thrombocytosis.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Erythropoietin; Female; Ferric Compounds; Hepcidins; Humans; Inflammatory Bowel Diseases; Intercellular Signaling Peptides and Proteins; Male; Maltose; Middle Aged; P-Selectin; Platelet Activation; Platelet Aggregation; Platelet Count; Prognosis; Prospective Studies; Thrombocytosis; Young Adult

Therapy with i.v. iron in patients with chronic heart failure (CHF) and iron deficiency (ID) improves symptoms, functional capacity, and quality of life. We sought to investigate whether these beneficial outcomes are independent of anaemia.. FAIR-HF randomized 459 patients with CHF [NYHA class II or III, LVEF ≤40% (NYHA II) or ≤45% (NYHA III)] and ID to i.v. iron as ferric carboxymaltose (FCM) or placebo in a 2:1 ratio. We analysed the efficacy and safety according to the presence or absence of anaemia (haemoglobin ≤120 g/L) at baseline. Of 459 patients, 232 had anaemia at baseline (51%). The effect of FCM on the primary endpoints of self-reported Patient Global Assessment (PGA) and NYHA class at week 24 was similar in patients with and without anaemia [odds ratio (OR) for improvement, 2.48 vs. 2.60, P = 0.97 for PGA and 1.90 vs. 3.39, P = 0.51 for NYHA). Results were also similar for the secondary endpoints, including PGA and NYHA at weeks 4 and 12, 6 min walk test distance, Kansas City Cardiomyopathy Questionnaire overall score, and European Quality of Life-5 Dimensions Visual Analogue Scale at most time points. Regarding safety, no differences were noticed in the rates of death or first hospitalization between FCM and placebo both in anaemic and in non-anaemic patients.. Treatment of ID with FCM in patients with CHF is equally efficacious and shows a similar favourable safety profile irrespective of anaemia. Iron status should be assessed in symptomatic CHF patients both with and without anaemia and treatment of ID should be considered.

Topics: Administration, Intravenous; Aged; Anemia, Iron-Deficiency; Case-Control Studies; Chronic Disease; Deficiency Diseases; Female; Ferric Compounds; Heart Failure; Hematinics; Humans; Iron Deficiencies; Male; Maltose; Middle Aged; Quality of Life; Treatment Outcome

Heart failure (HF) is a burden to patients and health care systems. The objectives of HF treatment are to improve health related quality of life (HRQoL) and reduce mortality and morbidity. We aimed to evaluate determinants of health-related quality of life (HRQoL) in patients with iron deficiency and HF treated with intravenous (i.v.) iron substitution or placebo.. A randomised, double-blind, placebo-controlled trial (n = 459) in iron-deficient chronic heart failure (CHF) patients with or without anaemia studied clinical and HRQoL benefits of i.v. iron substitution using ferric carboxymaltose (FCM) over a 24-week trial period. Multivariate analysis was carried out with various clinical variables as independent variables and HRQoL measures as dependent variables.. Mean change from baseline of European Quality of Life - 5 Dimensions (EQ-5D) (value set-based) utilities (on a 0 to 100 scale) at week 24 was 8.91 (i.v. iron) and 0.68 (placebo; p < 0.01). In a multivariate analysis excluding baseline HRQoL, a higher exercise tolerance and i.v. iron substitution positively influenced HRQoL, whereas impaired renal function and a history of stroke had a negative effect. The level of HRQoL was also influenced by country of residence. When baseline HRQoL was factored in, the multivariate model remained stable.. In this study, i.v. iron substitution, exercise tolerance, stroke, country of residence and renal function influenced measures of HRQoL in patients with heart failure and iron deficiency.

Topics: Aged; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Heart Failure; Humans; Internationality; Male; Maltose; Middle Aged; Quality of Life; Retrospective Studies; Treatment Outcome

Patients with chronic heart failure (CHF) show impaired health-related quality of life (HRQoL), an important target for therapeutic intervention. Impaired iron homeostasis may be one mechanism underlying the poor physical condition of CHF patients. This detailed subanalysis of the previously published FAIR-HF study evaluated baseline HRQoL in iron-deficient patients with CHF and the effect of intravenous ferric carboxymaltose (FCM) on HRQoL.. FAIR-HF randomized 459 patients with reduced left ventricular ejection fraction and iron deficiency, with or without anaemia, to FCM or placebo (2:1). Health-related quality of life was assessed at baseline and after 4, 12, and 24 weeks of therapy using the generic EQ-5D questionnaire and disease-specific Kansas City cardiomyopathy questionnaire (KCCQ). Baseline mean visual analogue scale (VAS) score was 54.3 ± 16.4 and KCCQ overall summary score was 52.4 ± 18.8. Ferric carboxymaltose significantly improved VAS and KCCQ (mean differences from baseline in KCCQ overall, clinical and total symptom scores, P< 0.001 vs. placebo) at all time points. At week 24, significant improvement vs. placebo was observed in four of the five EQ-5D dimensions: mobility (P= 0.004), self-care (P< 0.001), pain/discomfort (P= 0.006), anxiety/depression (P= 0.012), and usual activity (P= 0.035). Ferric carboxymaltose improved all KCCQ domain mean scores from Week 4 onward (P≤ 0.05), except for self-efficacy and social limitation. Effects were present in both anaemic and non-anaemic patients.. HRQoL is impaired in iron-deficient patients with CHF. Intravenous FCM significantly improved HRQoL after 4 weeks, and throughout the remaining study period. The positive effects of FCM were independent of anaemia status.

Topics: Aged; Anemia, Iron-Deficiency; Chronic Disease; Double-Blind Method; Ferric Compounds; Heart Failure; Hematinics; Homeostasis; Humans; Injections, Intravenous; Iron Deficiencies; Maltose; Quality of Life; Treatment Outcome; Ventricular Dysfunction, Left

Iron-deficiency anemia is the most common systemic complication of inflammatory bowel diseases (IBD). Iron-deficiency anemia recurs frequently and rapidly after iron-replacement therapy in patients with IBD. We performed a randomized, placebo-controlled trial to determine if administration of ferric carboxymaltose (FCM) prevents anemia in patients with IBD and low levels of serum ferritin.. We performed a single-blind, multicenter study of nonanemic patients who had completed the FERGIcor study. Serum levels of ferritin were assessed every second month, and patients were given FCM (total iron dose, 1181 ± 662 mg; n = 105) or placebo (n = 99) when levels decreased to less than 100 μg/L. The primary end point was time to recurrence of anemia within 8 months. Secondary end points included changes of quality of life, disease activity, results from laboratory tests, and adverse events.. Anemia recurred in 26.7% of subjects given FCM and in 39.4% given placebo. The time to anemia recurrence was longer in the FCM group (hazard ratio, 0.62; 95% confidence interval, 0.38-1.00; P = .049). Markers of body levels of iron increased or remained at normal levels in subjects given FCM (ferritin increased by 30.3 μg/L, transferrin saturation increased by 0.6%) but decreased in the group given placebo (ferritin decreased by 36.1 μg/L, transferrin saturation decreased by 4.0%). Changes in quality of life and disease activity were comparable between groups. Adverse events were reported in 59.0% of the FCM group and 50.5% of the placebo group, and serious adverse events were reported in 6.7% and 8.1%, respectively.. FCM prevents recurrence of anemia in patients with IBD, compared with placebo. Nevertheless, the high rate of anemia recurrence warrants optimization of the frequency and requirements for FCM treatment.

Topics: Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Dietary Supplements; Female; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Male; Maltose; Middle Aged; Placebos; Secondary Prevention; Single-Blind Method; Treatment Outcome; Young Adult

Currently available intravenous (IV) iron agents vary in indication, dosing regimens and safety profiles. Ferric carboxymaltose (FCM) is a stable, non-dextran-containing iron formulation developed for rapid IV administration in high doses with controlled delivery of iron into target tissues. The objective of the present study was to evaluate the safety of FCM compared with standard medical care (SMC) in dialysis (HD) and non-dialysis-dependent (NDD) chronic kidney disease (CKD) patients.. Adults 18-85 years of age with CKD were enrolled. NDD-CKD (n = 204) patients received an undiluted IV dose of FCM (15 mg/kg to a maximum of 1000 mg IV) and HD-CKD (n = 50) patients received an undiluted IV push of 200 mg ~30-60 min into the dialysis session. Subjects randomized to the SMC group (n = 259) received treatment determined by the investigator that could include oral iron, IV iron or no iron.. Single doses of FCM of 200 mg in HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated. Incidences of treatment-emergent adverse events were similar between the groups: 30.3% (77 of 254) in the FCM group and 32.8% (85 of 259) in the SMC group. Incidences of serious adverse events were higher in the SMC group overall and in patients receiving iron sucrose or sodium ferric gluconate. There were no clinically significant differences in laboratory or clinical chemistry values or vital signs between the groups. There were no statistically significant differences between the FCM and SMC groups in indices of hemoglobin (Hb) improvement, including proportions of patients achieving a ≥ 1 g/dL increase in Hb and proportions of patients achieving Hb level of >12 g/dL.. FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Follow-Up Studies; Humans; Injections, Intravenous; Iron; Male; Maltose; Middle Aged; Prognosis; Renal Dialysis; Renal Insufficiency, Chronic; Young Adult

Levels of hepcidin, a major regulator of iron homeostasis, may identify patients with iron deficiency anemia (IDA) who will not respond to oral iron therapy. In this study, IDA patients underwent a 14-day trial (run-in) course of ferrous sulfate therapy. Nonresponders (Hgb increase <1 g/dL with 67% compliance rate) were randomized to IV ferric carboxymaltose (FCM; two injections of 750 mg) or further oral iron for 14 days. Screening hepcidin levels were 38.4 versus 11.3 ng/mL, P = 0.0002 in nonresponders versus responders to a trial of oral iron. Hepcidin of > 20 ng/mL, showed sensitivity of 41.3%, specificity of 84.4%, and positive predictive value of 81.6% for predicting nonresponsiveness to oral iron. PPVs for ferritin> 30 ng/mL or transferrin saturation (TSAT)>15% were 59.2 and 55%, respectively. Negative predictive values for hepcidin, ferritin, and TSAT were 46.3, 22.7, and 19.7, respectively. FCM versus oral iron showed Hgb increases of ≥ 1 gm/dL in 65.3% versus 20.8% (P < 0.0001) and Hgb increases of 1.7 ± 1.3 versus 0.6 ± 0.9 g/dL (P = 0.0025), respectively. We conclude that hepcidin predicts nonresponsiveness to oral iron in patients with IDA and is superior to TSAT or ferritin for this purpose. Nonresponse to oral iron therapy does not rule out IDA, since two-thirds of patients subsequently responded to intravenous iron.

Topics: Adult; Anemia, Iron-Deficiency; Antimicrobial Cationic Peptides; Biomarkers; Dietary Supplements; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Hemoglobins; Hepcidins; Humans; Injections, Intravenous; Iron, Dietary; Male; Maltose; Predictive Value of Tests; Sensitivity and Specificity; Transferrin

There is evidence of iron deficiency (ID) in patients treated with lipoprotein apheresis. Aim of this study was to assess ID in apheresis patients and to study its management comparing safety and efficacy of two approved intravenous (i.v.) iron formulations.. Inclusion criteria were defined as a) serum ferritin < 300 μg/l and transferrin saturation < 20%, b) ferritin < 100 μg/l. Both iron deficient alone and ID anemic (IDA) patients were included. Other causes for anemia were ruled out by thorough history-taking and examination/blood tests. Patients were treated with six different lipoprotein apheresis methods: DALI, Liposorber D, TheraSorb LDL, HELP, MONET and Lipidfiltration. 50 patients were randomized to either ferric carboxymaltose (FCM, 500-1000 mg as single shot infusion over 20 min) or ferric gluconate (FG, 62.5 mg once weekly).. 50 of 67 patients of our Lipoprotein Apheresis Center showed iron deficiency. Both i.v. iron formulations studied were equally safe (no serious adverse events (SAEs), 6 patients/group showed adverse events (AEs)) and both effective (clinically and with respect to laboratory data) in lipoprotein apheresis patients, however FCM led to a more rapid and steeper rise of iron parameters.. ID and IDA are common findings in lipoprotein apheresis patients. The pathogenesis remains yet poorly understood and is probably multifactorial. Differential diagnosis of ID/IDA is as essential as differential therapy. Handled with care, older i.v. iron preparations like FG appear to be safe and effective in lipoprotein apheresis patients. However, novel formulations like FCM can be administered rapidly at higher doses due to high complex stability, allowing faster filling of iron stores. Newer laboratory parameters (Reticulocyte-He, low/medium/high fluorescence reticulocytes (LFR/MFR/HFR)) assessing iron status may be helpful in early detection of ID and in monitoring iron replacement therapy.

Topics: Aged; Anemia, Iron-Deficiency; Biomarkers; Blood Component Removal; Chemistry, Pharmaceutical; Drug Administration Schedule; Dyslipidemias; Female; Ferric Compounds; Ferritins; Germany; Hematinics; Humans; Infusions, Intravenous; Lipoproteins; Male; Maltose; Middle Aged; Time Factors; Transferrin; Treatment Outcome

Iron deficiency is a common cause of anaemia and hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. Current intravenous iron agents cannot be administered in a single high dose because of adverse effects. Ferric carboxymaltose, a non-dextran parenteral iron preparation, can be rapidly administered in high doses.. This open-label trial randomized 255 subjects with glomerular filtration rates ≤ 45 mL/min/1.73 m(2), haemoglobin ≤ 11 g/dL, transferrin saturation ≤ 25%, ferritin ≤ 300 ng/mL, and stable ESA dose to either intravenous ferric carboxymaltose 1000 mg over 15 min (with up to two additional doses of 500 mg at 2-week intervals) or oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days.. In the modified intent-to-treat population, the proportion of subjects achieving a haemoglobin increase ≥ 1 g/dL at any time was 60.4% with ferric carboxymaltose and 34.7% with oral iron (P < 0.001). At Day 42, mean increase in haemoglobin was 0.95 ± 1.12 vs 0.50 ± 1.23 g/dL (P = 0.005), mean increase in ferritin was 432 ± 189 ng/mL vs 18 ± 45 ng/mL (P < 0.001) and mean increase in transferrin saturation was 13.6 ± 11.9% vs 6.1 ± 8.1% (P < 0.001). Treatment-related adverse events were significantly fewer with ferric carboxymaltose than with oral iron (2.7% and 26.2%, respectively; P < 0.0001).. We conclude that 1000 mg ferric carboxymaltose can be rapidly administered, is more effective and is better tolerated than oral iron for treatment of iron deficiency in ND-CKD patients.

Topics: Administration, Oral; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Glomerular Filtration Rate; Humans; Injections, Intravenous; Iron; Kidney Failure, Chronic; Male; Maltose; Prognosis

Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA.. This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7-12 g/dL [female] or 7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥ 2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12.. The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group.. The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Comorbidity; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Maltose; Middle Aged; Outcome Assessment, Health Care; Treatment Outcome; Young Adult

There is limited safety information about ferric carboxymaltose (FCM), a new intravenous iron preparation. This randomized, crossover study compared the safety and tolerability of double-blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia. Subjects (559) with iron deficiency anemia received a dose of either FCM (15 mg/kg, maximum 1000 mg) over 15 minutes or placebo on day 0. On day 7, subjects received the other agent. Safety evaluations were performed on days 7 and 14. The primary endpoint was the incidence of treatment-emergent adverse events during each 7-day study period. During the first 24 hours and during the 7-day treatment period, at least one treatment-emergent adverse event was experienced by 15.0% and 29.3% of subjects after FCM and 11.4% and 19.7% after placebo, respectively. Most were classified as Grade 1 or 2. Six subjects had Grade 3 treatment-emergent adverse events after FCM and 9 subjects after placebo. One subject had a Grade 4, and 1 subject had a Grade 5 treatment-emergent adverse event, but neither was considered study drug-related. During the first 24 hours of the treatment period, drug-related adverse events were reported in 9.3% of subjects receiving FCM and 4.8% receiving placebo. Of drug-related Grade 3 events, 4 subjects received FCM and 5 subjects received placebo. Administration of FCM (15 mg/kg, maximum of 1000 mg) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia.

Topics: Adult; Anemia, Iron-Deficiency; Cross-Over Studies; Double-Blind Method; Female; Ferric Compounds; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Maltose; Middle Aged; Treatment Outcome

Patients with chronic kidney disease (CKD) often present with iron depletion and iron deficiency anaemia (IDA) because of frequent blood (and iron) loss. Therapy consists of repletion of iron stores and intravenous (i.v.) iron has become the standard care in this setting. However, older i.v. iron preparations have their limitations. This study primarily investigated the safety, and also the efficacy, of ferric carboxymaltose (FCM), a next-generation i.v. iron formulation, given as a bolus-push injection in patients with CKD undergoing maintenance haemodialysis (HD).. Patients (aged 18-65 years) with IDA undergoing HD received 100-200 mg of iron as FCM via an i.v. bolus-push injection into the HD venous line, two to three times weekly for or=1.0 g/dl increase in haemoglobin (Hb) from baseline at any time during the study. Enrolled patients (safety population) receiving >or=1 dose of study medication were included in the efficacy analyses [intent-to-treat (ITT) population].. Of 163 patients enrolled, 150 (92%) completed the study. The mean +/- SD total cumulative dose of iron as FCM administered was 2133.3 +/- 57.7 mg. In total, 193 AEs were reported in 89 out of 163 (54.6%) patients. Almost three-quarters of patients (73.6%) received erythropoiesis-stimulating agents (ESAs), but the dose remained stable during the study. Serious AEs occurred in 12 out of 163 (7.4%) patients and two patients died; none of these was considered by the investigator to be related to the study medication. Only five out of 163 (3.1%) patients discontinued study medication due to an AE. Overall, 100 out of 162 (61.7%; ITT population) patients were treatment responders, and mean Hb levels increased from 9.1 +/- 1.30 g/dl at baseline to 10.3 +/- 1.63 g/dl at follow-up.. FCM is well-tolerated and effective in the correction of Hb levels and iron stores in patients with IDA undergoing HD. As changes in anaemia treatment other than i.v. FCM (e.g. increased ESA doses) were not permitted during the study, the clinically relevant increase in Hb in the majority of patients can be solely attributed to efficient iron utilization. The incidence of AEs was as expected for this population.

Topics: Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferritins; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Kidney Diseases; Male; Maltose; Middle Aged; Renal Dialysis; Treatment Outcome; Young Adult

Topics: Anemia, Iron-Deficiency; Biomarkers; Double-Blind Method; Female; Ferric Compounds; Heart Failure; Hemoglobins; Humans; Iron; Male; Maltose; Treatment Outcome

Patients with iron deficiency anaemia (IDA) in the setting of non-dialysis-dependent chronic kidney disease (NDD-CKD) may benefit from treatment with intravenous (IV) iron. Ferric carboxymaltose (FCM) is a novel IV iron formulation designed to permit larger infusions compared to currently available IV standards such as Venofer(R) (iron sucrose).. The primary objective of REPAIR-IDA is to estimate the cardiovascular safety and efficacy of FCM (two doses at 15 mg/kg to a maximum of 750 mg per dose) compared to Venofer(R) (1000 mg administered as five infusions of 200 mg) in subjects who have IDA and NDD-CKD. REPAIR-IDA is a multi-centre, randomized, active-controlled, open-label study. Eligible patients must have haemoglobin (Hgb) < or = 11.5 g/dL and CKD defined as (1) GFR < 60 mL/min/1.73 m(2) on two occasions or (2) GFR < 90 mL/min/1.73 m(2) and either evidence of renal injury by urinalysis or elevated Framingham cardiovascular risk score. Two thousand and five hundred patients will be randomized to FCM or Venofer(R) in a 1:1 ratio. The primary efficacy endpoint is mean change in Hgb from baseline to the highest observed Hgb between baseline and Day 56. The primary safety endpoint is the proportion of subjects experiencing at least one of the following events: death due to any cause, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalization, congestive heart failure requiring hospitalization or medical intervention, arrhythmias, hypertension or hypotension during the 120 days following randomization.. REPAIR-IDA will assess the efficacy and safety of two 750-mg infusions of FCM compared to an FDA-approved IV iron regimen in patients with NDD-CKD at increased risk for cardiovascular disease.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Biomarkers; Cardiovascular Diseases; Chronic Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Glucaric Acid; Hemoglobins; Humans; Kidney Diseases; Male; Maltose; Middle Aged; Risk Factors; Sucrose; Treatment Outcome

Iron-deficiency anaemia (IDA) represents a major burden to public health worldwide. The therapeutic aim for patients with IDA is to return iron stores and haemoglobin (Hb) levels to within the normal range using supplemental iron therapy and erythropoiesis-stimulating agents. Oral and previous intravenous (i.v.) iron formulations have a number of disadvantages, including immunogenic reactions, oxidative stress, low dosages, long administration times and the requirement for a test dose. Ferric carboxymaltose (FCM, Ferinject) is a novel, next-generation i.v. iron formulation with the potential to overcome these limitations. In this single-centre, randomized, double-blind, placebo-controlled study, the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of single, escalating doses of FCM were investigated. Four ascending doses were investigated in a total of 24 patients with mild IDA (defined as serum ferritin < 20 microg/l and transferrin saturation [TfS] < 16%): 100 mg iron as FCM given as an i.v. bolus injection, and 500, 800 and 1000 mg iron as FCM given as an i.v. infusion over 15 min. At each dose level six patients received FCM and two received placebo. The decision to escalate to the next dose was based on evaluation of safety and tolerability data from the previous dose. The maximum duration of the study was 5 weeks from screening to final assessment. Assessments were made of PK iron-status parameters up to 168 h post-dose. Safety assessments included incidence of adverse events (AEs), clinical laboratory parameters and vital signs. PK and PD parameters were analysed using descriptive statistics. All analyses were performed on the safety population, which included all patients who received > or = 1 dose of study medication. Seventy-seven patients were screened and, of these, 32 male and female patients with pre-study Hb between 9.2 and 11.9 g/dl and serum ferritin < 20 microg/l were included in the study. Two patients had TfS > 16% (19.2% and 17.2%); both patients were considered by the investigator to be eligible for inclusion. Compared with placebo, a rapid, dose-dependent increase in total serum iron was observed across all dose groups. Mean (standard deviation) maximum total serum iron levels ranged between 36.9 (4.4) and 317.9 (42.3) microg/ml in the 100 and 1000 mg groups. Concentration-time curves of total serum iron continuously declined for up to 24 and 72 h post-dose in the 100 and 500-1000 mg groups, respectively. Non-co

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Blood Pressure; Body Temperature; Dose-Response Relationship, Drug; Double-Blind Method; Electrocardiography; Female; Ferric Compounds; Heart Rate; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged

This multiple-dose Phase I/II study provided pharmacodynamics and pharmacokinetics data on the therapeutic benefit of ferric carboxymaltose (FCM, Ferinject) and evaluated the safety and tolerability of this intravenous (i.v.) iron preparation. Two doses of iron as FCM were given as i.v. infusion over 15 min, 500 mg iron given once weekly for up to 4 weeks (Cohort 1) or 1000 mg iron weekly for 2 weeks (Cohort 2), in patients with a total requirement > or = 1000 mg iron (total cumulative maximum dose < or = 2000 mg iron). Adults with moderate to severe, stable iron-deficiency anaemia (IDA) (haemoglobin [Hb] < or = 11.0 g/dl, serum ferritin < 100 microg/l, transferrin saturation [TSAT] < 16%) due to a gastrointestinal (GI) disorder were included. Pharmacodynamics variables: proportion of patients achieving values within the reference range for Hb (men: 14.0-18.0 g/dl, women: 12.0-16.0 g/dl), serum ferritin (20-500 microg/l), TSAT (16-45%) and proportion of patients with an increase in Hb of at least 2.0 g/dl. Pharmacokinetics variables: total serum iron levels at time of maximum serum iron concentration during the fast elimination phase and at trough time-points. Safety assessments: the incidence of adverse events (AEs) and changes in vital signs, physical examinations, and clinical laboratory parameters. In Cohorts 1 and 2, 14/20 (70%) versus 19/26 (73%) of patients completed the study. Individual calculated iron deficits were 1000-2100 mg. The mean cumulative dose of FCM in Cohorts 1 and 2 was 1800 mg and 1563 mg iron, respectively. At baseline, patients in both cohorts had similar Hb levels (mean 8.7 g/dl in both cohorts). More than 97% of patients demonstrated a clinically meaningful increase in Hb levels (> or = 1.0 g/dl) during the study. By the week 4 follow-up visit, an increase of at least 2.0 g/dl was achieved by 15/20 (75%) and by 19/26 (73.1%) patients in Cohorts 1 and 2, respectively, and the mean increase in Hb was 3.2 g/dl in Cohort 1 and 3.3 g/dl in Cohort 2. By day 28, 3/6 (50%) patients in Cohort 1 had achieved normal Hb levels, and by the 4-week post-treatment followup visit 7/19 patients (37%) in Cohort 1 and 12/25 (48%) in Cohort 2 had reached Hb levels within the reference range. Serum ferritin levels increased rapidly at the start of treatment and remained in the reference range throughout the study; increases were greater in Cohort 2. Mean baseline TSAT values were similar in both cohorts (24.2% in Cohort 1, 20.7% in Cohort 2), and we

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Ferric Compounds; Ferritins; Gastrointestinal Diseases; Hemoglobins; Humans; Male; Maltose; Middle Aged; Patient Selection; Transferrin

The objective was to evaluate efficacy and safety of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding.. In a randomized, controlled trial, 477 women with anemia, iron deficiency, and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose (or= 12 g/dL) of anemia (73% vs. 50%, p < 0.001). Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue (p < 0.05). There were no serious adverse drug events.. In patients with iron deficiency anemia due to heavy uterine bleeding, rapid IV administration of large doses of a new iron agent, ferric carboxymaltose, is more effective than oral iron therapy in correcting anemia, replenishing iron stores, and improving quality of life.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Calcium; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Maltose; Middle Aged; Phosphates; Potassium; Quality of Life; Treatment Outcome; Uterine Hemorrhage

Iron deficiency (ID) and anaemia are common in patients with chronic heart failure (CHF). The presence of anaemia is associated with increased morbidity and mortality in CHF, and ID is a major reason for the development of anaemia. Preliminary studies using intravenous (i.v.) iron supplementation alone in patients with CHF and ID have shown improvements in symptom status. FAIR-HF (Clinical Trials.gov NCT00520780) was designed to determine the effect of i.v. iron repletion therapy using ferric carboxymaltose on self-reported patient global assessment (PGA) and New York Heart Association (NYHA) in patients with CHF and ID.. This is a multi-centre, randomized, double-blind, placebo-controlled study recruiting ambulatory patients with symptomatic CHF with LVEF < or = 40% (NYHA II) or < or =45% (NYHA III), ID [ferritin <100 ng/mL or ferritin 100-300 ng/mL when transferrin saturation (TSAT) < 20%], and haemoglobin 9.5-13.5 g/dL. Patients were randomized in a 2:1 ratio to receive ferric carboxymaltose (Ferinject((R))) 200 mg iron i.v. or saline i.v. weekly until iron repletion (correction phase), then monthly until Week 24 (maintenance phase). Primary endpoints are (i) self-reported PGA at Week 24 and (ii) NYHA class at Week 24, adjusted for baseline NYHA class.. This study will provide evidence on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anaemia.

Topics: Algorithms; Anemia, Iron-Deficiency; Chronic Disease; Clinical Protocols; Double-Blind Method; Female; Ferric Compounds; Heart Failure; Humans; Injections, Intravenous; Male; Maltose; Patient Care; Reference Values; Research Design; Treatment Outcome

Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (ferric carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia.. We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (ferric carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life.. Among the patients receiving ferric carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to ferric carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups.. Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780).

Topics: Aged; Anemia, Iron-Deficiency; Chronic Disease; Female; Ferric Compounds; Ferritins; Follow-Up Studies; Heart Failure; Hematinics; Humans; Iron Deficiencies; Male; Maltose; Quality of Life; Stroke Volume; Ventricular Dysfunction, Left

The objective of the study was to evaluate the efficacy, safety, and tolerability of intravenous ferric carboxymaltose, compared with oral ferrous sulfate in women with postpartum anemia.. In a multicenter, randomized, controlled study, 291 women less than 10 days after delivery with hemoglobin 10 g/dL or less were randomized to receive ferric carboxymaltose (n = 143) 1000 mg or less intravenously over 15 minutes or less, repeated weekly to a calculated replacement dose (maximum 2500 mg) or ferrous sulfate (n = 148) 325 mg orally thrice daily for 6 weeks.. Ferric carboxymaltose-treated subjects were significantly more likely to: (1) achieve a hemoglobin greater than 12 g/dL in a shorter time period with a sustained hemoglobin greater than 12 g/dL at day 42, (2) achieve hemoglobin rise 3 g/dL or greater more quickly, and (3) attain higher serum transferrin saturation and ferritin levels. Drug-related adverse events occurred less frequently with ferric carboxymaltose.. Intravenous ferric carboxymaltose was safe and well tolerated with an efficacy superior to oral ferrous sulfate in the treatment of postpartum iron deficiency anemia.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferrous Compounds; Hematinics; Humans; Injections; Maltose; Puerperal Disorders; Treatment Outcome

To compare the safety and efficacy of iron carboxymaltose with ferrous sulfate to treat iron deficiency anemia in the post partum.. Patients were randomized (2:1 ratio) to receive iron carboxymaltose (up to 3 weekly doses of 1000 mg maximum, applied in 15 min; n=227) or ferrous sulfate (100 mg twice daily, 12 weeks; n=117). Changes in hemoglobin and iron stores up to week 12 were analyzed.. Iron carboxymaltose was as effective as oral iron sulfate in changing hemoglobin, despite the much shorter treatment period (2 weeks vs 12 weeks). Ferritin levels were significantly higher. Except for injection site burning, iron carboxymaltose was better tolerated than ferrous sulfate, mainly concerning gastrointestinal side effects. There were no safety concerns identified in breast-fed infants.. Parenteral iron carboxymaltose is a safe and effective treatment option for postpartum anemia, with advantages of a shorter treatment period, better compliance, rapid normalization of iron storages, and lower incidence of gastrointestinal side effects.

Topics: Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Infusions, Intravenous; Iron; Iron Deficiencies; Maltose; Postpartum Period; Time Factors; Treatment Outcome

Anemia is a common complication of inflammatory bowel diseases (IBD) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation, ferric carboxymaltose (FeCarb), in comparison with oral ferrous sulfate (FeSulf) in reducing iron deficiency anemia (IDA) in IBD.. Two hundred patients were randomized in a 2:1 ratio (137 FeCarb:63 FeSulf) to receive FeCarb (maximum 1,000 mg iron per infusion) at 1-wk intervals until the patients' calculated total iron deficit was reached or FeSulf (100 mg b.i.d.) for 12 wk. The primary end point was change in hemoglobin (Hb) from baseline to week 12.. The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group, demonstrating noninferiority (P= 0.6967). Response (defined as Hb increase of >2.0 g/dL) was higher for FeCarb at week 2 (P= 0.0051) and week 4 (P= 0.0346). Median ferritin increased from 5.0 to 323.5 mug/L at week 2, followed by a continuous decrease in the FeCarb group (43.5 mug/L at week 12). In the FeSulf group, a moderate increase from 6.5 to 28.5 mug/L at week 12 was observed. Treatment-related adverse events (AEs) occurred in 28.5% of the FeCarb and 22.2% of the FeSulf groups, with discontinuation of study medication due to AEs in 1.5% and 7.9%, respectively.. FeCarb is effective and safe in IBD-associated anemia. It is noninferior to FeSulf in terms of Hb change over 12 wk, and provides a fast Hb increase and a sufficient refill of iron stores.

Topics: Administration, Oral; Adult; Aged; Anemia, Iron-Deficiency; Cohort Studies; Colitis, Ulcerative; Crohn Disease; Female; Ferric Compounds; Ferritins; Ferrous Compounds; Germany; Hemoglobinometry; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged

Methemoglobinemia is a life-threatening disorder, with levels above 1 percent considered abnormal and typically resulting from drug or toxic substance exposure.. In this study, we describe a case of a 43-year-old woman with a long-standing complaint of fatigue. Iron deficiency anemia was diagnosed based on the blood test findings of hemoglobin of 101 g/L, mean red blood cell volume of 75 fL, ferritin of 2.81 ug/L, transferrin saturation of 4.3 percent, and C-reactive protein of 0.6 mg/L. As a preferred treatment option, 1000 mg ferric carboxymaltose on two distinct days was preferred. After administering the first dose of the medication, we noticed incidentally that methemoglobin levels increased to 2.3%. When venous blood gas was repeated before and after administration of the second dose of the drug, methemoglobin levels were found to be 0.8% and 1.8%, respectively. There was no change in vital signs in both two dosages, and she only suffered a temporary sore throat. Her anemia improved with intravenous iron therapy, and she is currently being followed in our clinic.. No case or research reporting an increase in methemoglobin levels following oral and/or intravenous treatment to patients with iron deficiency anemia has been found in the literature. Therefore, this is the first contribution to the existing literature.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Maltose; Methemoglobin; Methemoglobinemia

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Maltose

Iron deficiency anemia in children is a public health problem. Although oral iron treatment is the first choice, common side effects and compliance problems can cause the treatment to be interrupted. This study retrospectively evaluated children treated with intravenous (IV) iron sucrose or ferric carboxymaltose (FCM) and compared the treatment processes and efficacy. The demographic characteristics and treatment details of the 44 children with iron deficiency anemia were retrospectively evaluated. Iron sucrose was administered to 25 patients and FCM was administered to 19 patients. The IV iron infusion was applied to 64% of the patients because of unresponsiveness to oral treatment, 25% of the patients because of compliance problems, and 11% of the patients because of severe anemia. IV iron therapy increased hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin, red-cell distribution width, and serum ferritin levels and decreased platelet count. The mean number of infusions per patient in the FCM group was lower, and the total treatment time was shorter. In conclusion, IV iron sucrose or FCM can be used in children with nonadherence to oral therapy and severe anemia in addition to specific indications.

Topics: Administration, Intravenous; Anemia; Anemia, Iron-Deficiency; Child; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Infusions, Intravenous; Iron; Retrospective Studies

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Fibroblast Growth Factor-23; Heart Failure; Humans; Kidney; Maltose

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Humans; Maltose

Ferric carboxymaltose (FCM) is increasingly used in the management of cancer-related anemia, yet it may cause hypophosphatemia. This retrospective study describes the incidence, evolution and risk factors of hypophosphatemia in a cohort of patients with solid tumors receiving FCM.. Serum phosphorus concentration was assessed longitudinally using a random intercepts model. The probability of developing hypophosphatemia, as graded by CTCAE version 4.0, was investigated using a multi-state model. Transition hazards were modeled non-parametrically and semi-parametrically by a Cox model. Causal marginal risk differences between baseline interventions on serum phosphorus and/or FCM dose were obtained via G-computation.. In 174 ambulatory patients with solid tumors receiving FCM at two university hospitals between October 2020 and September 2021, the risk of developing moderate-to-severe hypophosphatemia was 36.0% (95% confidence interval (CI) 28.2-43.9%) and peaked within 16 days after first FCM administration. The average duration of moderate-to-severe hypophosphatemia was 12.4 days. After adjustment for confounders, lower baseline serum phosphorus (adjusted hazard ratio (aHR) 0.88 per 0.1 mmol/L increase, 95% CI 0.79-0.98) and higher FCM dose (first dose: aHR 1.12 per 1 mg/kg increase, 95% CI 1.01-1.25; second dose: aHR 1.06 per 1 mg/kg increase, 95% CI 1.00-1.13) significantly increased the hazard of moderate-to-severe hypophosphatemia.. Approximately one out of three ambulatory patients with solid tumors may develop moderate-to-severe hypophosphatemia after FCM administration. Baseline serum phosphorus and FCM dose may be modifiable risk factors that should be considered for intervention in order to mitigate the risk of hypophosphatemia.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Hypophosphatemia; Incidence; Neoplasms; Phosphorus; Retrospective Studies; Risk Factors

To assess the efficacy of intravenous ferric carboxymaltose (IV FCM) for the treatment of iron deficiency anemia (IDA) diagnosed de novo in the third trimester of pregnancy.. Case-control study conducted in pregnant women with IDA newly diagnosed in the third trimester of pregnancy. Women treated with a single IV FCM injection were included as cases and those who received daily 210 g of oral ferrous sulphate (FS) as controls. Controls were matched to cases in a 2:1 ratio by basal hemoglobin (Hb) concentration (±0.5 g/dl).. A total of 35 cases and 70 controls were included in the study. The mean Hb concentration level significantly increased after iron treatment in both cases (from 9.3 ± 0.8 to 11.1 ± 0.8 g/dl, p < 0.0001) and controls (from 9.6 ± 0.9 to 10.9 ± 1 g/dl, p < 0.0001). The rate of women who exceeded the recommended threshold of 11 g/dl after treatment did not significantly differ between cases (63% (95%CI, 45%-79%)) and controls (56% (95%CI, 44%-68%)) (p = 0.48). Comparison of maternal and neonatal outcomes and adverse effects did not show any significant difference between groups.. Our results suggest that IV FCM and oral FS can be considered equally effective in the treatment of IDA newly detected in the third trimester of pregnancy.

Topics: Anemia, Iron-Deficiency; Case-Control Studies; Female; Ferric Compounds; Hemoglobins; Humans; Infant, Newborn; Pregnancy; Pregnancy Trimester, Third

Iron deficiency (ID) is comorbid in up to 50% patients with heart failure (HF) and exacerbates disease burden. Ferric carboxymaltose (FCM) reduced HF hospitalizations and improved quality of life when used to treat ID at discharge in patients hospitalized for acute HF with left ventricular ejection fraction <50% in the AFFIRM-AHF trial. We quantified the effect of FCM on burden of disease and the wider pharmacoeconomic implications in France, Germany, Poland, Spain and Sweden.. The per country eligible population was calculated, aligning with the 2021 European Society of Cardiology (ESC) HF guidelines and the AFFIRM-AHF trial. Changes in burden of disease with FCM versus standard of care (SoC) were represented by disability-adjusted life years (DALYs), hospitalization episodes and bed days, using AFFIRM-AHF data. A Markov model was adapted to each country to estimate cost-effectiveness and combined with epidemiology data to calculate the impact on healthcare budgets. Between 335 (Sweden) and 13 237 (Germany) DALYs were predicted to be avoided with FCM use annually. Fewer hospitalizations and shorter lengths of stay associated with FCM compared to SoC were projected to result in substantial annual savings in bed days, from 5215 in Sweden to 205 630 in Germany. In all countries, FCM was predicted to be dominant (cost saving with gains in quality-adjusted life years), resulting in net savings to healthcare budgets within 1 year.. This comprehensive evaluation of FCM therapy highlights the potential benefits that could be realized through implementation of the ESC HF guideline recommendations regarding ID treatment.

Topics: Anemia, Iron-Deficiency; Cost-Benefit Analysis; Ferric Compounds; Heart Failure; Hospitalization; Humans; Iron Deficiencies; Maltose; Patient Discharge; Quality of Life; Stroke Volume; Ventricular Function, Left

Iron deficiency (ID) with or without anemia is frequently observed in patients with heart failure (HF). Uncorrected ID is associated with higher hospitalization and mortality in patients with acute HF (AHF) and chronic HF (CHF). Hence, in addition to chronic renal insufficiency, anemia, and diabetes, ID appears as a novel comorbidity and a treatment target of CHF. Intravenous (IV) ferric carboxymaltose (FCM) reduces the hospitalization risk due to HF worsening and improves functional capacity and quality of life (QOL) in HF patients. The current consensus document provides criteria, an expert opinion on the diagnosis of ID in HF, patient profiles for IV FCM, and correct administration and monitoring of such patients.

Topics: Anemia, Iron-Deficiency; Heart Failure; Humans; Iron; Iron Deficiencies; Quality of Life

Coadministration of ferric carboxymaltose and denosumab may cause hypocalcaemia and hypophosphataemia; however, this interaction is not well-described in the literature and has typically been described in patients with chronic kidney disease (CKD). We present a case of this interaction in a patient without preexisting CKD. We suggest the use of alternative iron preparations and an interval of at least 4 weeks between administrations.

Topics: Anemia, Iron-Deficiency; Denosumab; Humans; Hypocalcemia; Hypophosphatemia; Renal Insufficiency, Chronic

Iron deficiency anemia is the most common and preventable cause of anemia. Oral and parenteral iron preparations can be used for treatment. There are some concerns about the effect on oxidative stress of parenteral preparations. In this study, we aimed to investigate the effect of ferric carboxymaltose and iron sucrose on short- and long-term oxidant-antioxidant status. The study was designed as a prospective, single-center, observational study. Patients diagnosed with iron deficiency anemia and receiving intravenous iron therapy were included. Patients were divided into 3 groups as those receiving 1000 mg iron sucrose, 1000 mg ferric carboxymaltose, and 1500 mg ferric carboxymaltose. Blood samples were collected for blood tests before treatment, at the 1st hour of the first infusion, and at the 1st month of follow-up. The total oxidant and total antioxidant status were analyzed to evaluate oxidative stress and antioxidant status. Fifty-eight patients are included. Nineteen patients received iron sucrose 1000 mg (G1), 21 patients received ferric carboxymaltose 1000 mg (G2), and 18 patients received ferric carboxymaltose 1500 mg (G3). First hour total antioxidant status was higher in the iron sucrose group than in the ferric carboxymaltose group [G1 and G2 (p = 0.027), G1 and G3 (p = 0.004)]. At the 1st hour, total oxidant status was higher in iron sucrose group than in ferric carboxymaltose group [G1 and G2 (p = 0.016), G1 and G3 (p = 0.011)]. There was no difference in total oxidant and antioxidant stress between the three treatment groups at the 1st month evaluation [p: 0.19 and p: 0.12]. Total oxidant and antioxidant status in iron sucrose and ferric carboxymaltose formulations were found to be higher in the iron sucrose group in the acute period at the 1st hour after infusion. There was no significant difference between antioxidant and oxidant total status in all three treatment groups at the 1st month of long-term control. The fact that total oxidant status was lower in the ferric carboxymaltose group containing high-dose treatment compared to iron sucrose according to the 1st hour change showed that high-dose iron did not significantly affect oxidant stress in the short term. In addition, long-term oxidant stress evaluation at the 1st month did not show any difference between iron preparations. In conclusion, it has been shown that high-dose intravenous iron therapy, which is easier to use in clinical practice, has no effect on the oxidant-antioxida

Topics: Anemia, Iron-Deficiency; Antioxidants; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Iron; Oxidants; Prospective Studies

Ferric carboxymaltose (FCM) administration helps reduce transfusion requirements in the perioperative situation, which improves patient outcomes and reduces healthcare costs. However, there is increasing evidence of hypophosphataemia after FCM use. We aim to determine the incidence of hypophosphataemia after FCM administration and elucidate potential biochemical factors associated with the development of subsequent hypophosphataemia. A retrospective review of anonymised data of all FCM administrations in a single institution was conducted from August 2018 to August 2021. Each unique FCM dose administered was examined to assess its effect on Hb and serum phosphate levels within the subsequent 28 days from each FCM administration. Phosphate levels were repeatedly measured within the 28-day interval and the lowest phosphate level within that period was determined. Patients' serum phosphate levels within 28 days of FCM administration were compared against normal serum phosphate levels within 2 weeks before FCM administration. The odds ratios of various pre-FCM serum markers were calculated to elucidate potential biochemical predictors of post-FCM hypophosphataemia. In 3 years, a total of 1296 doses of FCM were administered to 1069 patients. The mean improvement in Hb was 2.45 g/dL (SD = 1.94) within 28 days of FCM administration, with the mean time taken to peak Hb levels being 6.3 days (SD = 8.63), which is earlier than expected, but was observed in this study and hence reported. The incidence of hypophosphataemia <0.8 mmol/L was 22.7% (n = 186), and <0.4 mmol/L was 1.6% (n = 9). This figure is lower than the numbers reported in previously published meta-analyses given that routine checks of serum phosphate levels were not conducted initially and hence could possibly be higher. The odds of developing hypophosphataemia (<0.8 mmol/L) were 27.7 (CI: 17.3-44.2, p < 0.0001) if baseline serum phosphate was less than 1 mmol/L. The odds of developing hypophosphataemia (<0.8 mmol/L) were 1.3 (CI: 1.08-1.59, p < 0.01) if the change in Hb levels observed after FCM administration were more than 4 g/dL. Hypophosphataemia after FCM administration is significant and FCM should be used by clinicians with caution.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Hypophosphatemia; Incidence; Phosphates; Singapore

Among cardio-surgical patients, the prevalence of iron deficiency conditions reaches 70 %, and anemia is detected in less than 50% cases. Meanwhile, both anemia and latent iron deficiency are risk factors for adverse outcomes in cardio-surgical patients. These conditions are associated with a high frequency and greater volume of blood transfusions as well as with a longer stay in the hospital. Timely diagnosis and correction of iron deficiency, regardless of the presence of anemia, are mandatory at the stage of preoperative preparation. The use of oral iron medicines is limited by their low efficacy in this category of patients and a high risk of adverse events. Intravenous iron medicines have a high potential for correcting iron deficiency, and their efficacy and safety have been previously demonstrated. Administration of ferric carboxymaltose has proved beneficial in studies on iron deficiency correction in cardiological and cardio-surgical patients. In these patients, ferric carboxymaltose improved the dynamics of ferritin and hemoglobin, reduced the risk of blood transfusion, and decreased the duration of stay in the hospital. Preoperative intravenous administration of ferric carboxymaltose to cardio-surgical patients can improve clinical outcomes and the cost effectiveness of cardiac surgery.

Topics: Administration, Intravenous; Anemia; Anemia, Iron-Deficiency; Cardiac Surgical Procedures; Hemoglobins; Humans; Iron; Iron Deficiencies

Hypophosphataemia is a common side-effect in patients with iron deficiency anaemia treated with ferric carboxymaltose, which is not a class effect of all intravenous (IV) iron formulations. The report by Chu et al. shows that moderate and severe hypophosphataemia is common and can even require IV supplementation of phosphate with unknown long-term consequences. Commentary on: Chu et al. Incidence and predictors of hypophosphataemia after ferric carboxymaltose use-a 3-year experience from a single institution in Singapore. Br J Haematol 2023;202:1199-1204.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Hypophosphatemia; Iron; Maltose

Intravenous (IV) administration of iron is considered a safe and efficacious treatment for iron deficiency anemia (IDA), recommended in patients requiring rapid replenishment of iron, or intolerant or unresponsive to oral administration of iron. Recent randomized controlled trials (RCTs) have shown high incidence of hypophosphatemia after administration of two IV iron preparations: saccharated ferric oxide (SFO) and ferric carboxymaltose (FCM). The present study aimed to conduct matching-adjusted indirect comparison (MAIC) of hypophosphatemia incidence with these iron formulations and ferric derisomaltose (FDI) based on data from head-to-head RCTs conducted in Japan.. A MAIC of hypophosphatemia incidence was conducted on the basis of data from two head-to-head RCTs. The relative odds of hypophosphatemia with FDI versus SFO were obtained from patient-level data from a recent RCT and adjusted for cumulative iron dose, while parametric models of serum phosphate levels from a separate RCT were used to estimate the relative odds of hypophosphatemia with FCM with SFO. An anchored MAIC was then conducted comparing FDI with FCM.. The adjusted odds of experiencing hypophosphatemia were significantly lower with FDI than SFO [odds ratio (OR) of 0.02; 95% confidence interval (CI) 0.01-0.05]. The parametric models of serum phosphate from the RCT comparing FCM with SFO provided an estimated OR of 1.17 for the incidence of hypophosphatemia with FCM versus SFO. Combining the two estimates in the MAIC showed that the odds of experiencing hypophosphatemia would be 52.5 (95% CI 27.7-99.4) times higher with FCM than FDI in patients with IDA associated with heavy menstrual bleeding in Japan.. Direct comparison of patient-level data and a MAIC from two RCTs in Japanese patients with heavy menstrual bleeding indicated that hypophosphatemia is less frequent in patients treated with FDI than those with FCM or SFO. Results are in agreement with RCTs comparing FDI and FCM in patients with various etiologies conducted in the USA and Europe.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; East Asian People; Female; Ferric Oxide, Saccharated; Humans; Hypophosphatemia; Incidence; Iron; Menorrhagia; Phosphates; Randomized Controlled Trials as Topic

Corpus Atrophic Gastritis (CAG) is characterised by iron malabsorption leading to iron deficiency anaemia (IDA), which rarely responds to oral therapy. Ferric carboxymaltose (FCM), shown to be a safe and effective intravenous iron therapy in other diseases, has not been investigated yet in CAG. Thus, we aimed to assess the safety and efficacy of FCM in CAG-related IDA. A retrospective study on 91 patients identified CAG as the only cause of IDA treated with FCM. Twenty-three were excluded for incomplete follow-up. Sixty-eight were evaluated for safety and efficacy, while three were evaluated for safety only due to infusion interruption for side effects. Haemoglobin and iron storage were evaluated pre-infusion (T0), at 4 weeks (T4) and 12 weeks (T12) after infusion. An eventual IDA relapse was analysed. Two cases reported mild side effects. Haemoglobin significantly increased at T4, and T12, reaching +3.1 g/dL. Ferritin increased at T4, decreasing at T12, while transferrin saturation increased progressively until reaching a plateau. IDA relapsed in 55.4% of patients at a mean of 24.6 months. The only factor associated with relapse was female gender [OR (95% CI): 6.6 (1.5-28.6)]. FCM proved to be safe and effective in treating CAG-related IDA, ensuring quick and long-lasting recovery.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Gastritis, Atrophic; Hemoglobins; Humans; Iron; Recurrence; Retrospective Studies

The efficacy of treatments for fibromyalgia is limited and many factors have been identified to trigger the current complaints. Iron deficiency anemia is one of these factors. We aimed to re-evaluate the quality of life of fibromyalgia patients with the Fibromyalgia Impact Questionnaire after ferric carboxymaltose treatment.. This study was conducted on 90 female patients older than 18 years of age with ferritin <60 mcg/dL who presented to the Internal Medicine outpatient clinic in a large tertiary care hospital in Eskişehir, Turkey, with FM symptoms. Patients were selected from women who had previously received oral iron therapy for at least 3 months and whose ferritin could not be increased to >60 mcg/dL. Patients who met the 2010 criteria of the American College of Rheumatology for fibromyalgia were included in the study. Patient characteristics and laboratory parameters were recorded. The Fibromyalgia Impact Questionnaire (FIQ1, FIQ2) was applied and compared before and after IV iron treatment.. The mean age of the patients was 40±12 years (18-83). There was a significant change in the total score (FIQ1 mean: 54, FIQ2 mean: 21) and all parameters of the FIQ questionnaire after ferric carboxymaltose treatment (p=0.000).. Ferric carboxymaltose treatment reduces pain levels and improves the quality of life in women with fibromyalgia.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferritins; Fibromyalgia; Humans; Iron; Middle Aged; Pain; Quality of Life; Young Adult

Anemia remains an essential concern affecting the quality of life and the survival of cancer patients. Although there are different approaches to treating anemia in cancer patients, the number of studies reporting the efficacy of iron replacement in cancer patients is limited. In this study, the efficacy and safety of iron carboxymaltose, a parenteral iron treatment option, in the treatment of anemia, were examined retrospectively. A total of 1102 adult patients who received IV ferric carboxymaltose treatment at Hacettepe Oncology Hospital between 2014 and 2020 were included. The mean hemoglobin change observed at the end of the 12th week was 1.8 g/dL, and the rate of patients with an increase in hemoglobin of 1 g/dL or more was 72.1%. It was observed that the treatment demonstrated effectiveness in patients receiving active cancer treatment in all tumor types. The treatment was generally safe, and no grade 3-5 side effects were observed in the patients included in the study. According to one of the most extensive series published in the literature, iron carboxymaltose is an efficient and safe alternative for cancer patients with iron-deficiency anemia.

Topics: Adult; Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Hemoglobins; Humans; Iron; Neoplasms; Quality of Life; Retrospective Studies

Background In Australia, iron deficiency anaemia can be managed by ferric carboxymaltose, and iron polymaltose given via either a traditional slow or new rapid infusion protocol. These differ in their manufacturing, administration, and monitoring requirements, with unknown associated costs. Aim To compare the direct costs of iron infusions used in Australia; and explore potential savings associated with increased uptake of the least-expensive option at a local hospital. Method A time-motion method was used to determine the labour and consumables associated with each infusion protocol. Secondly, a frequency analysis identified the most common iron infusion doses prescribed at the study site. The total direct costs per protocol were compared at these doses and then the potential savings from switching to the lowest-costing of these protocols where possible were explored. Results The most common doses were 0.5 g, 1 g, 1.5 g and 2 g. At these dose points, ferric carboxymaltose infusions are the least expensive, but only if national health subsidies are applied. In cases where they do not apply, iron polymaltose prepared from ampoules and infused using the rapid protocol ('Iron Polymaltose Ampoules Rapid') is the least expensive. Switching all applicable ferric carboxymaltose infusions and iron polymaltose infusions administered using the slow infusion protocol to Iron Polymaltose Ampoules Rapid is projected to yield up to $12,000 worth of savings annually. Conclusions Increased use of the Iron Polymaltose Ampoules Rapid protocol when government-subsidised options are not available is projected to have cost-saving outcomes. Investigation of implementation strategies to increase the use of this protocol are warranted.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Humans; Infusions, Intravenous; Maltose

Hypophosphatemia, osteomalacia, and fractures are complications of certain intravenous iron formulations.. This study investigated risk factors for incident, severe, and persistent hypophosphatemia, and associated alterations in bone and mineral biomarkers following intravenous iron treatment.. We analyzed data from the PHOSPHARE-IDA randomized clinical trials, comprising 245 patients aged 18 years or older with iron deficiency anemia at 30 outpatient clinics in the United States who received intravenous ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). Outcome measures included serum phosphate, intact fibroblast growth factor-23 (iFGF23), 1,25-dihydroxyvitamin D (1,25(OH)2D), ionized calcium, parathyroid hormone (PTH), and alkaline phosphatase.. FCM was the only consistent risk factor for incident hypophosphatemia (< 2.0 mg/dL; odds ratio vs FDI: 38.37; 95% CI: 16.62, 88.56; P < 0.001). Only FCM-treated patients developed severe hypophosphatemia (< 1.0 mg/dL; 11.3%; 13/115) or persistent hypophosphatemia (< 2.0 mg/dL at study end; 40.0%; 46/115). More severe hypophosphatemia associated with significantly greater increases in iFGF23, PTH, and alkaline phosphatase, and more severe decreases in 1,25(OH)2D and ionized calcium (all P < 0.05). Patients with persistent vs resolved hypophosphatemia demonstrated significantly greater changes in iFGF23, PTH, 1,25(OH)2D, and N-terminal procollagen-1 peptide levels (all P < 0.01), but alkaline phosphatase increased similarly in both groups.. Treatment with FCM was the only consistent risk factor for hypophosphatemia. Patients who developed severe or persistent hypophosphatemia after FCM treatment manifested more severe derangements in bone and mineral metabolism. Changes in bone biomarkers continued beyond resolution of hypophosphatemia, suggesting ongoing effects on bone that may help explain the association of FCM with osteomalacia and fractures.

Topics: Alkaline Phosphatase; Anemia, Iron-Deficiency; Biomarkers; Calcium; Disaccharides; Familial Hypophosphatemic Rickets; Female; Ferric Compounds; Humans; Hypophosphatemia; Iron; Male; Maltose; Minerals; Osteomalacia; Parathyroid Hormone; Risk Factors

We evaluated an on-demand ferric carboxymaltose (FCM) infusion strategy in inflammatory bowel disease (IBD) patients with iron deficiency anemia (IDA).. The primary outcome was the response rate to single or multiple FCM infusions after 12 months. Secondary outcomes were the response rate to a single FCM infusion after 3 months and the FCM safety profile.. We retrospectively included 185 IBD patients who received at least one FCM infusion of 500 mg, between 2015 and 2018. FCM was administered to patients with Hb ≤10 g/dL and hypoferritinemia and repeated according to the physician's assessment. Complete response (CR) was defined as Hb ≥12 g/dL (≥13 g/dL for men) or Hb increase ≥2 g/dL. Partial response (PR) was defined as an Hb increase between 1 and 2 g/dL. A univariate analysis was performed at 3 and 12 months.. After 12 months, the response rate was 75.1% (CR, 48.6%; PR, 26.4%; mean number of FCM infusions, 1.7 ± 1.1). In total 169/185 patients received a single FCM infusion during the first 3 months and 79.2% achieved response (CR, 56.8%; PR, 22.4%). At univariate analysis, no variable was associated with response. No adverse events were reported.. An on-demand strategy was effective and well-tolerated in treating IDA in IBD patients.

Topics: Anemia, Iron-Deficiency; Chronic Disease; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Male; Maltose; Retrospective Studies; Treatment Outcome

Timely and effective iron supplementation may help reduce the incidence of postoperative anemia and its associated problems. In this study, we aim to assess the efficacy of intravenous ferric carboxy maltose (FCM) on improving hemoglobin(Hb) level posttotal knee arthroplasty (TKA).. We retrospectively reviewed 263 patients who had undergone unilateral TKA with 157 patients in the study group (year 2019) and 106 in the control group (year 2016). Patients in the study group received FCM (500 mg IV) on postoperative day 1, whereas patients in the control group did not receive FCM or any other iron supplementation postoperatively. Hb levels were recorded preoperatively (Pr-Hb), postoperatively on day 3 (Day3-Hb) and postoperatively at 5(+1) weeks (Week5-Hb). Statistical analysis was performed using student's paired and unpaired t-tests.. Pr-Hb and Day3-Hb levels were comparable in the control and study group, while Week5-Hb levels were significantly higher (P < .001) in the study group. The drop in Hb at Day3 from preoperative values was comparable between the two groups (P = 1.0). The rise in Hb from Day3 to 5 weeks was significantly higher in the study group as compared to the control group (P < .001). The difference between Pr-Hb and Week5-Hb was significantly lower (P < .001) in the study group compared to the control group. However, Week5-Hb in both groups remained lower than Pr-Hb (P < .001) in all patients.. Intravenous FCM (500 mg) was found to be a safe method of iron supplementation to improve hemoglobin levels rapidly and consistently, post-TKA. We need to further study the additive effect of higher dose FCM (1000 mg) on hemoglobin recovery.

Topics: Anemia, Iron-Deficiency; Arthroplasty, Replacement, Knee; Ferric Compounds; Hemoglobins; Humans; Iron; Maltose; Retrospective Studies

Improving functional capacity is a key goal in heart failure (HF). This pooled analysis of FAIR-HF and CONFIRM-HF assessed the likelihood of improvement or deterioration in 6-min walk test (6MWT) among iron-deficient patients with chronic HF with reduced ejection fraction (HFrEF) receiving ferric carboxymaltose (FCM).. Data for 760 patients (FCM: n = 454; placebo: n = 306) were analysed. The proportions of patients receiving FCM or placebo who had ≥20, ≥30, and ≥40 m improvements or ≥10 m deterioration in 6MWT at 12 and 24 weeks were assessed. Patients receiving FCM experienced a mean (standard deviation) 31.1 (62.3) m improvement in 6MWT versus 0.1 (77.1) m improvement for placebo at week 12 (difference in mean changes 26.8 [16.6-37.0]). At week 12, the odds [95% confidence interval] of 6MWT improvements of ≥20 m (odds ratio 2.16 [1.57-2.96]; p < 0.0001), ≥30 m (2.00 [1.44-2.78]; p < 0.0001), and ≥40 m (2.29 [1.60-3.27]; p < 0.0001) were greater with FCM versus placebo, while the odds of a deterioration ≥10 m were reduced with FCM versus placebo (0.55 [0.38-0.80]; p = 0.0019). Among patients who experienced 6MWT improvements of ≥20, ≥30, or ≥40 m with FCM at week 12, more than 80% sustained this improvement at week 24.. Ferric carboxymaltose resulted in a significantly higher likelihood of improvement and a reduced likelihood of deterioration in 6MWT versus placebo among iron-deficient patients with HF. Of the patients experiencing clinically significant improvements at week 12, the majority sustained this improvement at week 24. These results are supportive of FCM to improve exercise capacity in HF.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Iron Deficiencies; Maltose; Stroke Volume; Treatment Outcome; Ventricular Dysfunction, Left; Walk Test

Iron supplementation is required for pediatric patients with intestinal failure (IF). There is a paucity of literature on optimal iron formulation and outcomes in this patient population that requires ongoing supplementation. The aim of this study was to assess outcomes in pediatric patients with IF receiving iron sucrose (IS) vs ferric carboxymaltose (FCM) iron infusions.. This was a single-center observational cohort study of pediatric patients with IF requiring ongoing intravenous iron supplementation. Patients were transitioned from IS to FCM as iron therapy. Longitudinal linear mixed-effects models and generalized estimating equations were used to compare outcomes, including hematologic, iron, and growth parameters for 12-month treatment duration on each iron formulation. Adverse effects were descriptively summarized.. Twenty-three patients were included. Sixteen received IS and later switched to FCM, five received IS only, and two received FCM only. Most patients' etiology of IF was short bowel syndrome (FCM: 81%, IS: 83%). No differences were seen over time for iron, hematologic, and growth metrics between IS and FCM. The median number of infusions over 12 months for those taking IS was 15 (interquartile range [IQR] = 13-26) and 2 for FCM (IQR = 1-2). Asymptomatic hypophosphatemia was noted in both groups. Similar central line-associated bloodstream infection rates were noted.. IS and FCM infusions both maintained hematologic and iron parameters with no significant difference noted between the two types of iron, though the number of FCM infusions was significantly less. No significant adverse effects were noted.

Topics: Anemia, Iron-Deficiency; Child; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Infusions, Intravenous; Intestinal Failure; Iron; Maltose

Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in premenopausal women. Clinical studies have shown that iron carboxymaltose (ICM) is an appropriate, effective, and well-tolerated treatment option for clinical situations associated with iron deficiency (ID).. This study took 78 out of 400 consecutive patients diagnosed with IDA due to HMB and intolerant or insufficient response of oral iron. All patients were administered the total calculated dose of ICM separately, based on the body weight and current hemoglobin (Hb) level. All the anemia parameters of the patients were compared before and after treatment.. All anemia parameters, including median Hb, ferritin, and transferrin saturation, significantly increased four weeks after treatment. Pre- and post-treatment mean Hb levels were 8.9 (± 1.7) g/dL and 12.3 (± 1.2) g/dL, respectively. The mean ferritin level of the patients before treatment was 3.93 (± 2.7) ng/mL. After treatment, the mean ferritin level was 244 (± 185) ng/mL. The mean transferrin saturation levels before and after treatment were 5.7% (± 5.0) and 43.1% (± 20.9), respectively. Although no serious side effects were observed in all patients, headache was detected in 2 patients (2.6%), urticaria in 3 patients (3.8%), and flushing in 2 patients (2.6%).. ICM is an effective and safe treatment option for patients with IDA due to HMB, in which oral iron therapy is insufficient or intolerant. In fact, without waiting for the failure or intolerance of oral iron therapy, moving ICM to the frontline could be cost-effective and more convenient to patients with HMB and health care providers.

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Iron; Maltose; Menorrhagia; Transferrins

Chronic non-specific multiple ulcers of the small intestine is a disease condition postulated in Japan. It is an uncommon gastrointestinal disease that causes chronic anemia and hypoalbuminemia by causing numerous ulcers without any histopathologically identifiable features. In recent years, it has been revealed that the mutations of SLCO2A1, which codes the prostaglandin transporter protein, are the cause of this disease;it is called the new name "chronic enteropathy associated with SLCO2A1 gene." The ileum, except the terminal ileum, is the most common place making it difficult to identify major lesions. Other than conservative treatments, such as nutrition therapy and iron supplements, no effective treatment has been identified so far. We present a case of chronic non-specific multiple ulcers of the small intestine diagnosed by capsule endoscopy and effectively treated by ferric carboxymaltose. A 48-year-old female had chronic iron deficiency anemia since around the age of 15. Because of severe anemia, the patient had upper and lower endoscopy at the age of 47 to find the source of the bleeding, but it was not detected. Except for the terminal ileum, the capsule endoscopy revealed ring-like ulcers, tape-like ulcers, and oblique ulcer scars in the ileum. Genetic analysis showed a homozygous mutation in intron 7, c.940+1G>A, indicating a definitive diagnosis of non-specific multiple ulcers of the small intestine. Anemia and anemia-related symptoms such as general malaise persisted despite continuous oral administration of iron drugs. Three intravenous injections of ferric carboxymaltose increased hemoglobin and enhanced the symptoms.

Topics: Anemia; Anemia, Iron-Deficiency; Capsule Endoscopy; Female; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Iron; Maltose; Middle Aged; Organic Anion Transporters; Ulcer

In AFFIRM-AHF, intravenous ferric carboxymaltose (FCM) reduced heart failure (HF) hospitalisations and improved quality of life versus placebo in iron-deficient patients stabilised after an acute HF episode. This analysis explored the effects of FCM versus placebo in patients with ischaemic and non-ischaemic HF aetiology.. We included 1082 patients from AFFIRM-AHF: 590 with ischaemic HF (defined as investigator-reported ischaemic HF aetiology and/or prior acute myocardial infarction and/or prior coronary revascularisation) and 492 with non-ischaemic HF. The prevalences of male sex, comorbidities, and history of HF were higher in the ischaemic versus non-ischaemic HF subgroup. Annualised event rates for the primary composite outcome of total HF hospitalisations and cardiovascular death with FCM versus placebo were 65.3 versus 100.6 per 100 patient-years in the ischaemic HF subgroup (rate ratio [RR] 0.65, 95% confidence interval [CI] 0.47-0.89, p = 0.007) and 58.3 versus 52.5 in the non-ischaemic HF subgroup (RR 1.11, 95% CI 0.75-1.66, p = 0.60) (p. Heart failure hospitalisations and cardiovascular deaths occurred at a higher rate in patients with ishaemic versus those with non-ischaemic HF and were reduced by FCM versus placebo only in ischaemic patients. Further studies are needed to assess the role of aetiology in FCM efficacy.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron Deficiencies; Male; Maltose; Quality of Life

Ferric carboxymaltose (FCM) can be used in Patient Blood Management (PBM) to promote the optimization of preoperative haemoglobin (Hb), which aims to minimise the use of allogeneic blood components and improve clinical outcomes, with better cost-effectiveness. This was an observational study conducted in a retrospective and multicentre cohort with adults from elective orthopaedic, cardiac and colorectal surgeries, treated according to local standards of PBM with allogeneic blood product transfusions (ABTs) on demand and with FCM to correct iron deficiency with or without anaemia. In this work, only the first pillar of the PBM model issue by Directorate-General for Health (DGS) was evaluated, which involves optimising Hb in the preoperative period with iron treatment if it's necessary/indicated. Before the implementation of PBM in Portugal, most patients did not undergo preoperative laboratory evaluation with blood count and iron kinetics. Therefore, the existence of Iron Deficiency Anaemia (IDA) or Iron Deficiency (ID) without anaemia was not early detected, and there was no possibility of treating these patients with iron in order to optimise their Hb and/or iron stores. Those patients ended up being treated with ABTs on demand. A total of 405 patients from seven hospitals were included; 108 (26.7%) underwent FCM preoperatively and 197 (48.6%) were transfused with ABTs on demand. In the FCM preoperative cohort, there was an increase in patients with normal preoperative Hb, from 14.4 to 45.7%, before and after FCM, respectively, a decrease from 31.7 to 9.6% in moderate anaemia and no cases of severe anaemia after FCM administration, while 7.7% of patients were severely anaemic before FCM treatment. There were significant differences (p < 0.001) before and after correction of preoperative anaemia and/or iron deficiency with FCM in Hb, serum ferritin and transferrin saturation rate (TS). In the ABT group, there were significant differences between pre- and postoperative Hb levels (p < 0.001). Hb values tended to decrease, with 44.1% of patients moving from mild anaemia before transfusion to moderate anaemia in the postoperative period. Concerning the length of hospital stay, the group administered with ABTs had a longer hospital stay (p < 0.001). Regarding the clinical outcomes of nosocomial infection and mortality, there was no evidence that the rate of infection or mortality differed in each group (p = 0.075 and p = 0.243, respectively). However, there we

Topics: Adult; Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Hemoglobins; Hospitals; Humans; Iron; Maltose; Portugal; Retrospective Studies; State Medicine

Topics: Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Iron Deficiencies; Maltose

Pulmonary arterial hypertension (PAH) is a progressive disease with limited survival. Iron deficiency (ID) correlates with disease severity and mortality. While oral iron supplementation was shown to be insufficient in such patients, the potential impact of parenteral iron on clinical measures warrants further investigation.. We retrospectively analysed the long-term effects of intravenous ferric carboxymaltose (FCM) on iron status and clinical measures in patients with PAH and ID [ferritin < 100 μg/L or ferritin 100-300 μg/L and transferrin saturation (TSAT) < 20%] who were on stable targeted PAH therapy, compared with matched controls without ID. Patients with ID received a single infusion of FCM (500 to 1000 mg). Clinical measures monitored included exercise capacity, World Health Organization (WHO) functional class, ESC/ERS risk status, and hospitalizations. The observation period was up to 18 months.. One hundred and seventeen patients (mean age 60.9 ± 16.1 years; 64.1% females) with confirmed PAH and on stable targeted therapy for ≥3 months were included (58 with and 59 patients without ID who did not receive FCM). In patients with ID, iron supplementation with FCM resulted in an immediate and sustained improvement of iron status for up to 18 months (serum iron, ferritin, TSAT, all P < 0.01). Fourteen patients in the FCM group received a second FCM infusion after 9.6 ± 4.8 months due to recurrent ID. At 6 and 18 months after FCM infusion, 6 min walk distance improved from 377.5 ± 15.9 at baseline to 412.5 ± 15.1 and 400.8 ± 14.5 m, respectively (both P < 0.05). WHO functional class (P < 0.05) and ESC/ERS risk status also improved, and there was a reduction of hospitalizations for worsening PAH in the 12 months post vs. prior to iron repletion (P = 0.029). No significant changes were observed in the control group. FCM was well tolerated in all patients, with no severe adverse events.. In addition to targeted therapy, correction of ID by parenteral iron supplementation with FCM appears feasible and safe, has sustained effects on iron status, and may improve the clinical status and hospitalization rates in patients with PAH. Larger controlled studies are required to confirm this finding.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Iron Deficiencies; Male; Maltose; Middle Aged; Pulmonary Arterial Hypertension; Retrospective Studies

Jankowska EA, Kirwan BA, Kosiborod M, et al.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Maltose; Quality of Life

Recent work has identified clinical and polysomnographic features of a newly defined pediatric sleep disorder, restless sleep disorder (RSD). One of these features is low serum ferritin. In this retrospective, pilot study, we assess the response to iron supplementation. Children were given oral ferrous sulfate (FS) or intravenous ferric carboxymaltose (IV FCM).. Children 5-18 years old with a diagnosis of RSD were evaluated clinically. Serum ferritin, iron profile, and video-polysomnography were obtained at baseline. Oral or IV iron supplementation was offered as part of routine care. Oral FS was one 325 mg tablet daily or 3 mg/kg/day liquid for 3 months. IV FCM was 15 mg/kg, up to 750 mg as a single infusion. Adverse effects were assessed. Ferritin and iron profile were checked after 2-3 months. Eight weeks after FCM, the phosphorus level was checked. Clinical Global Impression (CGI) scale was obtained pre- and posttreatment.. A total of 15 children received oral FS and 15 IV FCM. Baseline RSD severity, age, gender, or pretreatment lab values did not differ significantly between groups. CGI-improvement median score was "minimally improved" after oral FS and "much improved" after IV FCM (effect size 1.008, p < 0.023). All iron parameters were found to be significantly higher after intravenous iron treatment than oral iron, especially ferritin (effect size 3.743, p < 0.00003). Adverse effects: constipation, three with FS; noncompliance, one with FS; syncope, one with FCM infusion; and hypophosphatemia, zero post-FCM.. In this retrospective, clinical case series, RSD responded to iron supplementation with improvement in both clinical and laboratory parameters. The response was greater with IV FCM than oral FS.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Ferric Compounds; Ferrous Compounds; Humans; Maltose; Pilot Projects; Retrospective Studies; Sleep Wake Disorders

Inherited platelet function defects are characterized by sub-acute and chronic mucocutaneous bleedings leading to iron deficiency anemia (IDA). Oral supplementation is the mainstay of treatment of IDA; however, it can be insufficient to compensate the losses and is often associated with gastrointestinal (GI) side effects. Intravenous (IV) iron is indicated for severe anemia or to overcome GI intolerance. Previous IV iron formulations were limited by the risk of free iron toxicity and immunogenicity, while currently available compounds (ferumoxytol, iron isomaltoside and ferric carboxymaltose (FCM)) allow the administration of high doses with low immunogenicity. There are neither any randomized studies nor case reports evaluating the efficacy of FCM in patients with inherited platelet disorders. We herein present three cases of patients with IDA related to Glanzmann thrombasthenia and Bernard-Soulier syndrome, who have been successfully treated with FCM with increase in hemoglobin levels, reduced hospital visits and improvement in quality of life.

Topics: Administration, Intravenous; Adult; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Maltose; Thrombasthenia

Although more practical for use, the impact of ferric carboxymaltose (FCM) on the hospital budget is considerable, and intravenous iron sucrose complex (ISC) represents a cost-saving alternative for the management of iron deficiency anemia in patients during hospitalization. The Drug Committee decided to reserve FCM for day hospitalizations and contraindications to ISC, especially allergy. ISC was available for prescription for all other situations.. The impact of a multifaceted intervention promoting a switch from FCM to ISC was evaluated using an interrupted time series model with segmented regression analysis. The standardized rate of the dispensing of FCM, ISC, and oral iron by the hospital pharmacy, as well as the rate of the dispensing of packed red blood cells and the number of biological iron status measurements, was analyzed before and after the intervention.. There was an immediate decrease in FCM consumption following the intervention, with a reduction of 88% (RR: 0.12 [CI. Our intervention to lower the impact of intravenous iron therapy on the hospital budget was effective.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Cost Savings; Cost-Benefit Analysis; Decision Support Systems, Clinical; Drug Prescriptions; Ferric Compounds; Ferric Oxide, Saccharated; France; Health Plan Implementation; Hematinics; Hospital Costs; Hospitalization; Humans; Infusions, Intravenous; Interrupted Time Series Analysis; Iron; Maltose; Pharmacy Service, Hospital; Program Evaluation; Treatment Outcome

Topics: Administration, Intravenous; Adolescent; Anemia; Anemia, Iron-Deficiency; Child; Ferric Compounds; Humans; Iron; Maltose; Risk Assessment

The aim of the study was to assess the efficacy, safety and side-effect profile of ferric carboxymaltose (FCM) for correcting IDA in children and adolescents in paediatric gastroenterology, hepatology, and nutrition.. This was a retrospective study of all gastroenterology patients <18 years who had FCM (October 2015 to October 2017). Haematological and biochemical parameters were recorded pre-infusion, at 4 weeks, 3 months, 6 months, and 1 year post-infusion. Recognised side-effects were documented.. Sixty-six children received FCM during this period. Data was analysed on 61 children, 5 excluded because of inadequate data. The median age at administration was 14 years (IQR 7). Thirty-two (52%) were boys. Twenty-six (42%) were <14 years old. Seven (11.5%) were <5 years old. Seventeen (28%) were switched from oral iron supplements to FCM. The median dose of FCM delivered was 19 mg/kg. The median haemoglobin increased from 108 to 126 g/L at 1 month post-infusion (P value <0.00001). The mean cell volume also improved from 80 to 84 fL at 1 month post-infusion (P value = 0.0007). Forty-eight (94%) children corrected their anaemia after receiving FCM. Two patients (3%) reported side-effects with skin bruising and staining.. FCM appears to be effective in correcting IDA in children across a wide range of gastroenterology indications and all ages. It is effective and generally well tolerated including in very young patients. Potential side-effects can be avoided by careful monitoring during infusions.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Ferric Compounds; Gastroenterology; Humans; Infusions, Intravenous; Male; Maltose; Retrospective Studies

Topics: Anemia, Iron-Deficiency; Double-Blind Method; Ferric Compounds; Heart Failure; Humans; Iron; Maltose; Patient Discharge

Topics: Adolescent; Age Factors; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Humans; Hypophosphatemia; Infant; Infusions, Intravenous; Male; Maltose; Phosphorus; Retrospective Studies; Young Adult

Although intravenous ferric carboxymaltose (FCM) is effective in treating iron deficiency anemia (IDA) in paediatric inflammatory bowel disease (pIBD), no data are available on its post-infusion related risks.. We assessed the efficacy of FCM and the rate of post-infusion hypophosphatemia in a large cohort of children with IBD and IDA.. All children with IBD with IDA treated with FCM over 5-year period were reviewed. Disease activity, biohumoral assessment and treatments were evaluated at baseline, 4-6 and 12 weeks after each infusion.. 128 patients [median age at first infusion: 13 years] were identified, 81 (63.3%) were <14 years, 10 (7.8%) <6 years. Eighty-three children (64.8%) received one infusion, whilst 45 (35.2%) repeated infusions. A significant increase in Hb (p<0.001), iron (p<0.001) and ferritin (p<0.001) was observed 4-6 and 12 weeks post-infusion. Hb gain was unrelated to disease severity. Low baseline iron was the main predicting factor for repeated infusions (p<0.05). Three patients reported infusion reactions, none <6 years. Twenty-five children had low post-infusion serum phosphate (11 were <14 years, 3 <6 years). Two children developed severe hypophosphatemia.. FCM administration is effective for IDA management in pIBD, including children <6 years. Due to the high prevalence of post-infusion hypophosphatemia, serum phosphate monitoring should be mandatory.

Topics: Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Hypophosphatemia; Inflammatory Bowel Diseases; Iron; Male; Maltose; Phosphates; Prevalence; Risk Factors; Severity of Illness Index; Treatment Outcome

Ponikowski P, Kirwan BA, Anker SD, et al. Lancet. 2020;396:1895-904. 33197395.

Topics: Anemia, Iron-Deficiency; Double-Blind Method; Ferric Compounds; Heart Failure; Hospitalization; Humans; Maltose; Patient Discharge

Iron deficiency anaemia is a public health problem. In case oral iron treatment is ineffective, poorly tolerated or contraindicated, the intravenous route becomes the first choice. The aim of the study was to evaluate the shift between ferrous gluconate (FG) and ferric carboxymaltose (FCM) usage at our hospitals over the years. We also performed a cost comparison between pre and post-FCM availability periods, taking into account the acquisition costs of both intravenous iron and red blood cell units (PRBC).. The amount and costs of FG and FCM released by hospital Pharmacy Services from 2010 to 2019 were analysed, along with the number of transfused PRBC units in the same timeframe.. Overall, the proportion of FCM usage rose from 8.6 % in 2014 to 71.9 % in 2019, as percentage of total intravenous iron released. After exclusion of haemodialysis, where FG is still widely used, the FCM use in the last four years raised from 12.9% to 92.5%. Despite the higher FCM cost, the mean yearly expenditure for intravenous iron plus PRBC units did not differ between pre- and post-FCM eras (2010-2013, € 2,396,876 € versus 2014-2019, € 2,307,875 - p = 0.234), as a result of a net decrease of PRBC usage, namely from 15,083 to 12,654 (-16.1 %), respectively.. Intravenous iron has a major role in treating iron deficiency anaemia in several settings. Third generation compounds are paving the way to more updated and safer treatments.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Costs and Cost Analysis; Drug Prescriptions; Female; Ferric Compounds; Ferrous Compounds; Humans; Male; Maltose

Iron deficiency (ID) has a prevalence of ≈40% to 50% among patients in heart failure (HF) with reduced ejection fraction and is associated with worse prognosis. Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited.. The objective of the HEART-FID trial (Ferric Carboxymaltose in Heart Failure With Iron Deficiency) is to assess efficacy and safety of ferric carboxymaltose compared with placebo as treatment for symptomatic HF with reduced ejection fraction with ID. HEART-FID is a multicenter, randomized, double-blind, placebo-controlled trial enrolling ≈3014 patients at ≈300 international centers. Eligible patients are aged ≥18 years in stable chronic HF with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, ID (ferritin <100 ng/mL or ferritin 100-300 ng/mL with a transferrin saturation <20%), and documented HF hospitalization or elevated N-terminal pro-brain natriuretic peptide. Consented patients are assigned to ferric carboxymaltose or placebo at baseline, with repeated visits/assessments every 6 months for additional study drug based on hemoglobin and iron indices for the trial duration. The primary end point is a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.. The HEART-FID trial will inform clinical practice by clarifying the role of long-term treatment with intravenous ferric carboxymaltose, added to usual care, in ambulatory patients with symptomatic HF with reduced ejection fraction with ID. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037931.

Topics: Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Heart Failure; Humans; Male; Maltose; Middle Aged; Stroke Volume; Treatment Outcome; Ventricular Dysfunction, Left

Oral iron promotes intestinal tumourigenesis in animal models. In humans, expression of iron transport proteins are altered in colorectal cancer. This study examined whether the route of iron therapy alters iron transport and tumour growth. Colorectal adenocarcinoma patients with pre-operative iron deficiency anaemia received oral ferrous sulphate (n = 15), or intravenous ferric carboxymaltose (n = 15). Paired (normal and tumour tissues) samples were compared for expression of iron loading, iron transporters, proliferation, apoptosis and Wnt signalling using immunohistochemistry and RT-PCR. Iron loading was increased in tumour and distributed to the stroma in intravenous treatment and to the epithelium in oral treatment. Protein and mRNA expression of proliferation and iron transporters were increased in tumours compared to normal tissues but there were no significant differences between the treatment groups. However, intravenous iron treatment reduced ferritin mRNA levels in tumours and replenished body iron stores. Iron distribution to non-epithelial cells in intravenous iron suggests that iron is less bioavailable to tumour cells. Therefore, intravenous iron may be a better option in the treatment of colorectal cancer patients with iron deficiency anaemia due to its efficiency in replenishing iron levels while its effect on proliferation and iron metabolism is similar to that of oral iron treatment.

Topics: Administration, Intravenous; Administration, Oral; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Cell Proliferation; Colorectal Neoplasms; Female; Ferric Compounds; Ferrous Compounds; Humans; Iron; Male; Maltose; Middle Aged

There is limited clinical evidence of ferric carboxymaltose injection (FCM) usage in Indian pregnant women. We assessed the efficacy and safety of FCM in Indian pregnant women with moderate-to-severe anemia.. Single-center, retrospective, observational data collection was conducted at a tertiary care research institute. Data of pregnant women with anemia who received FCM in their second and third trimester was retrieved and analyzed for hematological parameters at baseline and at 4 ± 2 weeks. Neonatal outcomes were also assessed. Adverse events and other safety parameters were noted.. Data of 271 patients was retrieved and analyzed for safety and data for 168 patients analyzed for efficacy. A significant increase in hemoglobin was noted with FCM in 4 weeks (1.25 g/dL; p < 0.001). Patients with severe anemia reported an increase in hemoglobin of 4.23 g/dL (p = 0.01). Patients receiving FCM in the second trimester noted a significant increase in hemoglobin of 1.74 g/dL (p < 0.001). A significant increase in hemoglobin was noted as early as 20 days (p < 0.001) and also in patients receiving FCM after 34 weeks (p = 0.002). No adverse fetal or neonatal outcomes were observed. Adverse events noted in 4% of patients with itching and rash being most common. Continuous monitoring of blood pressure, heart rate, and oxygen saturation for 40 min during and after FCM administration reported no deterioration or negative safety signal.. FCM corrects anemia in all subsets of Indian pregnant women and supports evidence of efficacy and safety. Continuous monitoring of vital parameters during FCM infusions supports its excellent safety.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Infant, Newborn; Maltose; Pregnancy; Retrospective Studies; Treatment Outcome

Iron deficiency anaemia (IDA) is a major health issues and common type of nutritional deficiency worldwide. For IDA treatment, intravenous (IV) iron is a useful therapy.. To determine the efficacy and cost-effectiveness (CE) of intravenous (IV) Ferric Carboxymaltose (FCM) versus IV Iron Sucrose (IS) in treating IDA.. Electronic medical record i.e. Cerner® system.. Adults patients with iron deficiency anaemia.. A 12-month period (01/01/2018-31/12/2018).. Hamad Medical Corporation (HMC, a public hospital).. IV Ferric Carboxymaltose versus IV Iron Sucrose.. With regard to responses to treatment i.e., efficacy of treatment with FCM & IS in IDA patients, hemoglobin (Hgb), ferritin, and transferrin saturation (TSAT) levels were the primary outcomes. Additionally, the researchers also collected levels of iron, platelet, white blood cell (WBC), red blood cell (RBC), mean corpuscular hemoglobin (MCH), and mean corpuscular volume (MCV). The costs i.e. resources consumed (obtained from NCCCR-HMC) and the CE of FCM versus IS were the secondary outcomes.. There was a significant improvement in Hgb, RBC and MCH levels in the IS group than the FCM group. The overall cost of IS therapy was significantly higher than FCM. The medication cost for FCM was approximately 6.5 times higher than IS, nonetheless, it is cheaper in terms of bed cost and nursing cost. The cost effectiveness (CE) ratio illustrated that FCM and IS were significantly different in terms of Hgb, ferritin and MCH levels. Further, Incremental Cost Effectiveness Ratio (ICER) indicated that further justifications and decisions need to be made for FCM when using Hgb, iron, TSAT, MCH and MCV levels as surrogate outcomes.. Not applicable.. The study did not consider the clinical or humanistic outcome.. The higher cost of FCM versus IS can be offset by savings in healthcare personnel time and bed space. ICER indicated that further justifications and decisions need to be made for FCM when using Hgb, iron, TSAT, MCH and MCV levels as surrogate outcomes.

Topics: Administration, Intravenous; Adult; Aged; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Health Expenditures; Humans; Male; Maltose; Middle Aged; Treatment Outcome; Young Adult

The AABB Choosing Wisely Campaign recommends "don't transfuse for iron deficiency without hemodynamic instability". However, the management of iron deficiency anemia (IDA) in the emergency department (ED) is heterogeneous and patients are often over-transfused. Intravenous iron is effective in correcting anemia and new formulations, including ferric carboxymaltose (FCM), allow the administration of high doses with low immunogenicity. The aim of this retrospective study was to analyze the management of hemodynamically stable patients aged 18-55 years with severe IDA (hemoglobin < 8 g/dL), who presented to the ED from January 2014 to July 2018. Patients who received FCM (FCM1) and those who did not receive FCM (FCM0) were compared. Efficacy and safety of FCM at follow-up were evaluated. Seventy-one subjects fulfilled the inclusion criteria (FCM0 n = 48; FCM1 n = 23). The mean Hb at admission was 6.6 g/dL. 40% in the FCM0 and 13% in FCM1 were transfused (p = 0.02). 21% of FCM0 patients were admitted to the ward, while all FCM1 were discharged (p = 0.02). Within 2 weeks, the Hb increase was 2.8 ± 1 g/dL in the FCM1 group. Sixteen FCM1 patients were evaluated at 52 ± 28 days (median 42, range 27-122): the average Hb increase was 5.3 ± 1.4 g/dL. In summary, we showed that FCM administration in the ED in hemodynamically stable patients was associated with fewer transfusions and hospital admissions compared to the FCM0 group; moreover, it succeeded in safely, effectively and rapidly increasing Hb levels after discharge from the ED. Further studies are needed to develop recommendations for IDA in the ED and to identify transfusion thresholds for non-hospitalized patients.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Emergency Service, Hospital; Female; Ferric Compounds; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Retrospective Studies

Topics: Adult; Anemia, Iron-Deficiency; Antibodies, Monoclonal, Humanized; Ferric Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Hypophosphatemia; Male; Maltose; Osteomalacia; Treatment Outcome

Topics: Anemia, Iron-Deficiency; Child; Ferric Compounds; Humans; Hypophosphatemia; Maltose

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Emergency Medicine; Emergency Service, Hospital; Ferric Compounds; Humans; Maltose

Intravenous (IV) iron is typically the preferred treatment for patients with iron deficiency anemia (IDA) who cannot tolerate or absorb oral iron, or who require fast replenishment of iron stores pre-operatively. Several IV iron formulations are available with different dosing characteristics affecting infusion speed and maximum dose. The aim was to develop a resource impact model to calculate the cost of establishing an IV iron clinic and model resource impact of different IV irons to inform clinicians and service providers implementing innovative pre-operative IV iron services in Ireland.. A resource impact tool was developed to model resource utilization and IDA treatment costs. Two fast-administration, high-dose formulations of IV iron are available in Ireland: iron isomaltoside 1000/ferric derisomaltose (IIM) and ferric carboxymaltose (FCM). The tool modeled clinic throughput based on their different dosing characteristics in a specific IDA population, capturing fixed overheads, variable costs, clinic income from private and publicly-funded patients, and savings associated with IV iron.. Based on a 70:30 split between public and private patients in a new pre-operative service with capacity for 12 infusion slots weekly, IIM would facilitate correction of iron deficits in 474 patients annually, resulting in a net annual clinic balance of €42,736 on income of €159,887 and net costs of €117,151. FCM would facilitate treatment of 353 patients, resulting in a net annual clinic balance of €36,327 on income of €116,050 and costs of €79,722, a difference of €6408 and 121 patients treated in favor of using IIM over FCM.. Based on this provider-perspective analysis, IIM would maximize clinic throughput relative to other IV iron formulations, allowing clinicians in Ireland to optimize their current service provision and expenditure, and model the impact of introducing IV iron clinics for pre-operative patients with IDA.

Topics: Administration, Intravenous; Ambulatory Care Facilities; Anemia, Iron-Deficiency; Costs and Cost Analysis; Disaccharides; Ferric Compounds; Health Resources; Humans; Ireland; Maltose; Models, Economic; Preoperative Care

Iron deficiency (ID) is recognized as an important comorbidity in patients undergoing cardiac surgery; however, it still remains under-diagnosed and under-treated in clinical practice. This study aims at comparing efficacy and the effects on exercise capacity of intravenous ferric carboxymaltose (FCM) versus ferric gluconate (FG) in patients with ID anemia (IDA) resulting from cardiac surgery. We retrospectively analyzed data from our records of in-hospital patients with IDA after cardiac surgery undergoing cardiac rehabilitation. Group I was treated with FG, group II with FCM. Efficacy measures included changes (baseline vs discharge) in hemoglobin (Hb) and in distance traveled at six-minutes walking test (6MWT). Data from 74 in-patients (mean age 67.5±10.4 years, 43% women) were analyzed. At discharge, patients treated with FCM showed higher levels of Hb (11.1±1.2g/dl vs 10.2±1.1 g/dl; p=0.001), greater distance traveled at 6MWT (279.2±108.8 meters vs 236.3±72.7 meters; p=0.048), and lower in-hospital rehabilitation length of stay (20.3±7 vs 25.3±11.7 days; p=0.043) as compared to FG group. At multivariate analysis, the most powerful predictors of Hb increase >1 g/dl at discharge were transferrin levels (p=0.019) and treatment with FCM (p<0.001). FCM replacement therapy and iron serum levels were the most powerful predictors of 6MWT distance improvement (>100 meters) at discharge (p=0.13 and p=0.003, respectively). In patients with IDA following cardiac surgery, intravenous FCM is effective in restoring Hb levels and in improving exercise capacity after cardiac surgery.

Topics: Aged; Anemia, Iron-Deficiency; Cardiac Surgical Procedures; Exercise Tolerance; Female; Ferric Compounds; Hematinics; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Retrospective Studies; Treatment Outcome

Iron and erythropoietin deficiencies are determinants of anemia in chronic kidney disease. In hemodialysis (HD) patients, intravenous (IV) iron is associated with a greater hemoglobin (Hb) production and better erythropoietin response but may be associated to hypersensitivity reaction. After the 2013 European Medicines Agency report regarding early detection/management of iron allergic reactions, IV iron administration dramatically reduced in Italian Hemodialysis-Limited-Assistance-Centre (HD-CAL) where a physician is present only once a week. Objective of the study was providing an effective and secure IV iron administration protocol for HD-CAL patients. IV ferric carboxymaltose (FCM) administration was more effective and better tolerated than sodium ferric gluconate for iron deficiency correction and resolution of anemia in 24 patients undergoing HD in our HD-CAL. Six months of FCM IV treatment once a week increased ferritin and Hb compared to sodium ferric gluconate once a week leading to decreased erythropoietin consumption from 24 000 to 15 000 U/patient/week with an erythropoietin annual expense reduction. No blood transfusions, gastrointestinal intolerance or other adverse effects were reported. The FCM IV administration protocol for our HD-CAL patients was safe and no adverse events were reported, resulting in significantly increased ferritin, transferrin saturation, and Hb levels, reduction of erythropoietin requirements, and consequently reduction of erythropoietin expenses.

Topics: Administration, Intravenous; Ambulatory Care Facilities; Anemia, Iron-Deficiency; Clinical Protocols; Costs and Cost Analysis; Erythropoietin; Female; Ferric Compounds; Ferritins; Hematinics; Humans; Iron; Italy; Male; Maltose; Renal Dialysis; Renal Insufficiency, Chronic; Treatment Outcome

Iron deficiency is the main cause of anemia in both sexes, with women being more commonly affected. Iron therapy is currently considered an effective and safe remedy to replenish the iron storages. Iron can be administrated both orally and intravenously. In particular, intravenous (IV) iron therapy is widely used when oral iron preparations are either not tolerated or ineffective. Indeed, IV iron improves iron stores more rapidly. Two main immunological responses have been described for iron hypersensitivity reactions (HSRs): IgE-mediated allergy and complement activation-related pseudo-allergy. Here, we report 3 cases of adult patients with iron allergy, who were successfully treated with two different desensitization procedures, respectively. Analysis of these cases demonstrates that, in the presence of HSRs to iron products, desensitization is an effective and safe procedure that prevents treatment discontinuation and hence allows therapeutic target achievement.

Topics: Adult; Anemia, Iron-Deficiency; Chlorpheniramine; Dexamethasone; Female; Ferric Compounds; Hematinics; Humans; Hypersensitivity; Iron; Maltose; Middle Aged; Skin Tests

Iron deficiency is a common finding in patients with previous bariatric surgery, and parenteral supplementation is frequently required. Ferric carboxymaltose (FCM) is among the preferred compounds used but may be associated with new-onset hypophosphatemia. This study was undertaken to study the prevalence of hypophosphatemia following FCM in patients with previous bariatric surgery, a population that may be at particular risk due to highly prevalent secondary hyperparathyroidism.. Patients with previous bariatric surgery and iron depletion scheduled for FCM infusion were prospectively studied before and one week after FCM application. The primary endpoint was new-onset hypophosphatemia. Patients were followed until plasma phosphate had normalized without replacement.. Patients with previous bariatric surgery receiving FCM are at considerable risk of developing significant hypophosphatemia secondary to increased renal phosphate wasting through a mechanism involving FGF23. Monitoring plasma phosphate should be considered following FCM in patients with previous bariatric surgery.. ISRCTN registry, ISRCTN12291677, https://www.isrctn.com.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Bariatric Surgery; Female; Ferric Compounds; Fibroblast Growth Factor-23; Humans; Hypophosphatemia; Maltose; Middle Aged; Obesity, Morbid; Prospective Studies; Young Adult

Topics: Administration, Oral; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Hypophosphatemia; Infusions, Intravenous; Maltose; Middle Aged; Phosphates; Severity of Illness Index; Vitamin D Deficiency

Intravenous iron replacement is recommended for iron-deficient patients with inflammatory bowel disease (IBD), but may be associated with hypophosphataemia, predisposing to osteomalacia and fractures. This study aimed to evaluate the incidence and risk factors for hypophosphataemia following intravenous ferric carboxymaltose (FCM) in patients with IBD.. This prospective observational study of patients with and without IBD evaluated serum phosphate for 28 days following intravenous FCM, and assessed associations with symptoms, markers of inflammation and vitamin D status.. Twenty-four patients with IBD (11 with Crohn's disease [CD], 13 with ulcerative colitis [UC], mean age 45 years [range 19-90], 7 female), and 20 patients without IBD (mean age 56 [22-88] y, 11 female), were included. Overall, serum phosphate declined by a mean of 36% at Day 7, with a mean fall of 42% (SD 19%) at some time point over 28 days (p <  0.001). Twenty-four of 44 (55%) patients developed moderate to severe hypophosphataemia (serum phosphate < 0.6 mmol/L). No differences between patients with and without IBD were seen, but patients with CD had greater decline in phosphate than those with UC. There was no association between hypophosphataemia and symptomatic adverse events, faecal calprotectin, C-reactive protein, albumin, platelet count, 25(OH) vitamin D, or 1,25(di-OH) vitamin D. Serum phosphate < 1.05 mmol/L on Day 2 predicted susceptibility to moderate-severe hypophosphataemia (OR 7.0).. Hypophosphataemia following FCM is common, unrelated to symptomatic adverse events, baseline intestinal or systemic inflammation, or vitamin D status.

Topics: Administration, Intravenous; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Colitis, Ulcerative; Crohn Disease; Female; Ferric Compounds; Humans; Hypophosphatemia; Incidence; Male; Maltose; Middle Aged; Nutritional Status; Phosphates; Prospective Studies; Risk Factors; Treatment Outcome; Vitamin D; Young Adult

The presence of iron deficiency (ID) in patients with acute heart failure (AHF) is high. There are few studies on the characteristics of these patients and the safety of ferric carboxymaltose administration (FCM).. Study the differences among patients with AHF based on the presence and type of ID as well as the safety of FCM administration in these patients.. The AHF-ID study is a multicentre, analytical, prospective follow-up cohort including patients admitted to six Spanish hospitals for AHF. ID was defined as serum ferritin <100 μg/L (group A) or ferritin 100-299 μg/L with a TSAT <20% (group B). In cases receiving FCM the appearance of adverse events was analysed. Adjusted Cox regression was used to determine the association with 30-days reattendance for AHF after discharge.. A total of 221 patients were recruited; 191 (86.4%) presented ID, 121 (63.4%) group A and 70 (36.6%) group B. There were scarce differences between the groups analysed. No differences were found in 30-days reattendance for AHF. FCM was administered to 158 (71.5%) patients, with 8 (5.1%) presenting adverse events, the most frequent being digestive alterations. Treatment was not discontinued in any case.. There are scarce differences between the presence and the type of ID in patients with AHF. The administration of FCM in patients with ID and AHF is safe.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Heart Failure; Humans; Male; Maltose; Middle Aged; Prospective Studies; Treatment Outcome

Asymptomatic severe iron deficiency anemia is a common finding in subjects admitted to the outpatient anemia clinic. Although the condition can be easily be reversed with intravenous iron (IVI) therapy and several guidelines have suggested a restrictive threshold for using transfusion in hemodynamically stable patients, transfusion is often the rule in clinical practice. This study describes clinical practice results of IVI therapy without transfusion.. In this multicenter retrospective observational study, data of severely anemic outpatients treated only with high-dose IVI with ferric carboxymaltose were collected. Inclusion criteria were hemoglobin (Hb) level of less than 7.0 g/dL and ferritin level of less than 30 ng/mL or mean corpuscular volume of less than 75 fL.. Overall, 303 patients referred to the anemia clinic mainly from primary health care centers (46.2%) or the emergency department (28.7%) met the inclusion criteria. Median (interquartile range [IQR]) age was 47 (37-62) years and 84.5% were female. The median (IQR) Hb concentration at first visit was 6.5 (6.1-6.8) g/dL, 64 patients (21.1%) presented with a Hb level of less than 6.0 g/dL at diagnosis, and 11 of them (3.6%) had extreme anemia (Hb ≤ 5 g/dL). Gynecologic and gastroenteric bleeding were the main cause. After a mean IV administration of 1500 mg of iron, the Hb increased by a median of 5.7 g/dL. Thirteen patients experienced only mild side effects.. In chronic very severe sideropenic anemias, third-generation IVI is effective and safe for quick correction and avoidance of red blood cell transfusion. These results suggest that more specific guidelines for this clinical setting are warranted.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Iron; Male; Maltose; Middle Aged; Outpatients; Retrospective Studies; Severity of Illness Index

The objective of this single-center observational study was to determine the clinical and hematologic responses to intravenous ferric carboxymaltose (FCM) in a cohort of pediatric patients with poor response to oral iron therapy. The occurrence of adverse events was systematically recorded for up to 96 hours after infusion.. A retrospective cohort of 144 consecutive patients aged 18 months to < 18 years with iron deficiency anemia (IDA) or iron deficiency (ID) without anemia was investigated. All patients had failed oral iron therapy. The assessments before and after FCM treatment followed a predefined protocol.. One hundred of 117 (85 %) of patients with complete data achieved the target ferritin level ≥ 30 µg/L after a single FCM dose. Of 77 patients with IDA and complete data, 38 (49%) showed a complete hematological response within 6-12 weeks; a complete or partial response was achieved by 83%. Clinical symptoms improved in 85% of all patients. In 92% of patients (n = 133 /144), FCM infusion was uneventful. During the 96-hour follow-up, five patients reported potentially related symptoms. No serious adverse events occurred.. The study confirms the safety and efficacy of FCM in children (aged 18 months and older) and adolescents unresponsive to oral therapy, in real-world experience. Single-dose FCM treatment was followed by clinical improvement with advantages of safety, compliance, and lower cost compared with previous generation parenteral iron preparations that had to be administered in fractionated sessions.

Topics: Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Follow-Up Studies; Humans; Infant; Iron Metabolism Disorders; Male; Maltose; Prognosis; Retrospective Studies

Two weekly infusions of ferric carboxymaltose (FCM) are commonly prescribed for treatment of iron-deficiency anemia. However, administration of FCM increases intact levels of fibroblast growth factor 23 (FGF23), which causes hypophosphatemia due to renal phosphate wasting, calcitriol deficiency and secondary hyperparathyroidism. The adverse effects of FCM on mineral metabolism and bone health emerged from case reports and secondary analyses of trials. Data on these safety signals with FCM in clinical practice are limited because markers of mineral and bone metabolism are not routinely checked.. To obtain real-world experience with effects of FCM on mineral and bone metabolism, we conducted a prospective observational study of 16 women who were managed at a single-center hematology clinic for iron-deficiency anemia. From October 2016 to February 2018, all participants received two weekly infusions of FCM at a hematology infusion clinic. We hypothesized that FCM would decrease phosphate, increase intact FGF23 (iFGF23), and decrease c-terminal FGF23 (cFGF23). Secondary outcomes were changes in hemoglobin, iron indices, urine fractional excretion of phosphate (FePi), parathyroid hormone (PTH), calcitriol, calcium, osteocalcin, and bone-specific alkaline phosphatase (BAP). FCM was administered at weeks zero and one, and we measured laboratory values at weeks zero, one, two, and five of the study. We used linear mixed models to analyze the significance of the changes in laboratory values over time.. After two FCM infusions, nearly all (14 of 16) participants developed hypophosphatemia. iFGF23 increased, cFGF23 decreased, and phosphate decreased significantly from week zero to week two (iFGF23 increased by +134.0% [40.6, 305.8], p < 0.001; cFGF23 decreased by -516.3% [-1332.7, -142.7], p = 0.002; phosphate decreased by -49.8 ± 15.4%, p < 0.001). There was also a significant increase in FePi, PTH, and BAP and a significant decrease in calcitriol and calcium from week zero to week two. There was no significant change in osteocalcin during this time period. iFGF23, but not PTH, was independently associated with decreased phosphate. iFGF23 was also significantly associated with decrease in calcitriol from week zero to week two. Elevation in BAP suggests disordered bone mineralization in response to FCM therapy.. In this prospective observational study of women with iron deficiency anemia, two FCM infusions significantly altered markers of bone mineralization and mineral metabolism. The results suggest that FCM should be used cautiously in the treatment of iron-deficiency anemia.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Fibroblast Growth Factor-23; Humans; Maltose; Minerals

Topics: Aged; Anaphylaxis; Anemia, Iron-Deficiency; Fatal Outcome; Ferric Compounds; Humans; Male; Maltose

Anemia is a frequent disorder worldwide. Iron deficiency anemia (IDA) is the most common form of anemia. Although oral iron is the first choice for treatment, the efficacy of oral iron preparations may be limited. Ferric carboxymaltose (FCM) is a novel parenteral iron preparation which can rapidly replenish iron stores. The aim of the present study is to investigate the impact of FCM dose on hemoglobin (Hb) and ferritin levels and the frequency of hypersensitivity reactions.. This study was conducted with 765 IDA patients between September 1, 2016 and September 1, 2018. He-moglobin (Hb), serum ferritin, transferrin saturation values were examined at the time of diagnosis, Hb and ferritin values at first month.. Post-treatment Hb and ferritin levels significantly increased. The mean Hb level alteration was 2.43 ± 1.2 g/dL, the median ferritin level alteration was 157.3 ng/mL. The mean Hb level was lower and the mean change in Hb level was higher in higher doses. Allergic reactions were more frequent in higher doses.. Ferric carboxymaltose is a novel treatment option with a low risk of hypersensitivity reactions and well tolerated even in high doses.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferritins; Hemoglobins; Humans; Maltose

Significant benefit of intravenous ferric carboxymaltose (FCM) treatment for restless legs syndrome (RLS) has been well-established. However, no clinical indicators predicting treatment response of RLS have been established. This study aimed to determine factors predicting outcome of clinical FCM treatment of RLS patients.. Data were retrospectively reviewed from all patients who received FCM treatment for RLS from April 2016 to April 2019. These data included: detailed history, international RLS scale score (IRLS), questionnaires, comorbidity, and previous RLS medication use. Morning fasting serum iron, ferritin, and total iron-binding capacity were measured before and at four weeks after treatment. RLS patients with possible secondary RLS were identified by reviewing the medical histories. This included patients with iron deficiency anemia, lumbosacral radiculopathy, and gastrectomy. Primary RLS included those with no indication of secondary medical factors contributing to RLS. Treatment response was assessed using the IRLS and clinical ratings at four weeks after FCM administration. Patients with a greater than 40% decrease in IRLS were classified as responders.. The study comprised 164 patients with IRLS and clinical ratings obtained before and at four weeks after intravenous (IV) iron. Treatment responses differed considerably between diagnostic groups of RLS. Percentage responding was: 64.7% (66 of 102) for patients with primary RLS, 90.9% (10 of 11) with gastrectomy, 91.3% (21 of 23) with iron deficiency anemia and 39.3% (11 of 28) with lumbosacral radiculopathy. When responders were compared to non-responders in primary RLS patients, responders had significantly lower serum iron (80.5 ± 26.7 vs. 95.8 ± 30.5 μg/dL, p = 0.022) and percentage transferrin saturation (%TSAT) (25.4 ± 9.6 vs. 30.5 ± 10.5%, p = 0.026) in females, but not males. Logistic regression controlling for major subject variables showed that %TSAT significantly predicted response. (odds ratio [OR]: 0.955, confidence interval: 0.913-0.998, p = 0.040).. Intravenous FCM in moderate to severe RLS patients is beneficial as a first-line or add-on treatment, particularly for patients with compromised peripheral iron state. Overall, lower %TSAT predicted better chance of responding to the IV iron treatment especially for females.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Maltose; Restless Legs Syndrome; Retrospective Studies; Treatment Outcome

The treatment of iron deficiency (ID) with ferric carboxymaltose (FCM) improves the functional class and quality of life of chronic heart failure (CHF) patients with reduced left ventricular ejection fraction (LVEF), and reduces the rate of hospitalization due to worsening CHF. This study aims to evaluate the budget impact for the Spanish National Health System (SNHS) of treating ID in reduced LVEF CHF with FCM compared to non-iron treatment.. We simulated a hypothetical cohort of 1000 CHF patients with ID and reduced LVEF based on the Spanish population characteristics. A decision-analytic model was also built using the data from the largest FCM clinical trial (CONFIRM-HF) that lasted for a year. We considered the use of healthcare resources from a national prospective study. A deterministic sensitivity analysis was carried out varying the corresponding baseline data by ±25%.. The cost of treating the simulated population with FCM was €2,570,914, while that of the non-iron treatment was €3,105,711, which corresponds to a cost saving of €534,797 per 1,000 patients in one year. Cost savings were mainly due to a decrease in the number of hospitalizations. All sensitivity analysis showed cost savings for the SNHS.. FCM results in an annual cost saving of €534.80 per patient, and would thus be expected to reduce the economic burden of CHF in Spain.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Maltose; Prospective Studies; Quality of Life; Spain; Stroke Volume; Ventricular Function, Left

Topics: Administration, Intravenous; Adult; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Hematinics; Humans; Male; Maltose; Middle Aged

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Budgets; Chronic Disease; Cost-Benefit Analysis; Ferric Compounds; Heart Failure; Humans; Italy; Maltose; Markov Chains; Models, Econometric

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Ferric Compounds; Humans; Male; Maltose

Intravenous iron supplementation is widely used to treat iron deficiency and iron deficiency anemia when oral iron administration is ineffective or poorly tolerated. Hypersensitivity reactions (HSRs) during infusions are rare, but can be life-threatening. This study aimed to compare the risk for HSRs with the intravenous administration of iron isomaltoside-1000 and ferric carboxymaltose for the treatment of iron deficiency and iron deficiency anemia.. This was a single-centre cohort study. Nurses and physicians were instructed to fill out an HSR registration form with every administration of intravenous iron. HSRs were distinguished into serious and non-serious HSRs using the Ring and Messmer classification.. HSRs occurred in 18/836 (2.1%) ferric carboxymaltose and 43/496 (8.7%) iron isomaltoside-1000 administrations. The crude risk for HSRs was 75% lower after ferric carboxymaltose treatment (RR = 0.248, 95% CI: 0.145-0.426, P < 0.0001). The risk for grade II HSRs was 88% lower after ferric carboxymaltoside (RR = 0.123, 95% CI: 0.051-0.294). The likelihood of HSRs was 3.4 times higher after the administration of iron isomaltoside-1000 (95% CI: 1.910-6.093, P < 0.0001). Regardless of the type of intravenous iron, patients with comorbidities have a factor 3.6 higher risk (95% CI: 1.899-6.739, P < 0.0001).. Ferric carboxymaltose is associated with a 75% lower risk for HSRs compared with iron isomaltoside-1000 in our population. The presence of a comorbidity raises the likelihood of an HSR by a factor of three regardless of the type of intravenous iron infusion. Further research is needed to clarify the underlying mechanism in various patient groups.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Comorbidity; Disaccharides; Drug Hypersensitivity; Female; Ferric Compounds; Hematinics; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Netherlands; Prospective Studies; Risk Factors

Iron deficiency is present in ~50% of heart failure (HF) patients. Large multicenter trials have shown that treatment of iron deficiency with i.v. iron benefits HF patients, but the underlying mechanisms are not known. To investigate the actions of iron deficiency on the heart, mice were fed an iron-depleted diet, and some received i.v. ferric carboxymaltose (FCM), an iron supplementation used clinically. Iron-deficient animals became anemic and had reduced ventricular ejection fraction measured by magnetic resonance imaging. Ca2+ signaling, a pathway linked to the contractile deficit in failing hearts, was also significantly affected. Ventricular myocytes isolated from iron-deficient animals produced smaller Ca2+ transients from an elevated diastolic baseline but had unchanged sarcoplasmic reticulum (SR) Ca2+ load, trigger L-type Ca2+ current, or cytoplasmic Ca2+ buffering. Reduced fractional release from the SR was due to downregulated RyR2 channels, detected at protein and message levels. The constancy of diastolic SR Ca2+ load is explained by reduced RyR2 permeability in combination with right-shifted SERCA activity due to dephosphorylation of its regulator phospholamban. Supplementing iron levels with FCM restored normal Ca2+ signaling and ejection fraction. Thus, 2 Ca2+-handling proteins previously implicated in HF become functionally impaired in iron-deficiency anemia, but their activity is rescued by i.v. iron supplementation.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Animals; Calcium; Calcium-Binding Proteins; Cells, Cultured; Disease Models, Animal; Down-Regulation; Ferric Compounds; Heart Failure; Humans; Iron; Magnetic Resonance Imaging; Male; Maltose; Mice; Myocardial Contraction; Myocardium; Myocytes, Cardiac; Primary Cell Culture; Ryanodine Receptor Calcium Release Channel; Sarcoplasmic Reticulum; Sarcoplasmic Reticulum Calcium-Transporting ATPases; Stroke Volume

The FIND-CKD study has validated the use of ferric carboxymaltose (FCM) injection with a target of ferritin level between 400 and 600ng/mL to treat iron deficiency anemia in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. In order to assess this strategy in clinical practice, we constituted a cohort of patients within our nephrology department.. Patients had CKD stages 3 to 5, hemoglobin level (Hb)<13g/dL (men) or<12g/dL (women), and ferritin level (F)<100ng/mL or transferrin saturation (TSAT)<20%. They were not treated by erythropoiesis-stimulating agent (ESA) for at least one month, and oral iron had been poorly tolerated or ineffective. FCM first dose was adjusted according to patient weight. A new infusion was possible, at least one month after the first, with a half-dose if TSAT<20% but F≥200ng/mL; no perfusion was performed if F≥400ng/mL.. In all, 53 patients were included with a mean Hb of 11.4g/dL and a mean TSAT of 16%. Over one year of follow-up, only 12 patients (22.6%) needed another treatment for anemia (blood transfusion or ESA). No patient showed a significant decrease in Hb. In all, 62% of patients received only one infusion of FCM.. The administration of FCM IV with ferritin levels in the recommended target has proven effective in correcting anemia of ND-CKD patients while limiting the use of another therapeutic strategy.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Cohort Studies; Female; Ferric Compounds; Follow-Up Studies; Hematinics; Hospitals, General; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Renal Insufficiency, Chronic

Iron is administered intravenously (IV) to many dialysis patients at regular intervals and iron stores are evaluated through periodic measurements of ferritin and transferrin saturation (TSAT). In patients without kidney diseases, large single doses of IV iron lead to a transient rise in serum ferritin that does not reflect iron stores. It is not known whether and to what extent smaller IV iron doses used to maintain adequate stores in hemodialysis patients lead to transient spurious elevations of ferritin and TSAT.. Ferritin and TSAT were serially determined over four weeks after the administration of ferric carboxymaltose (FCM) in hemodialysis patients on a stable maintenance FCM dosing regimen of 100 mg or 200 mg every four weeks.. Ferritin values increased by 113 ± 72.2 μg/l (P < 0.001) from baseline to the peak value and remained significantly elevated until two weeks after the administration of 100 mg FCM (n = 19). After the administration of 200 mg FCM (n = 12), ferritin values increased by 188.5 ± 67.56 μg/l (P < 0.001) and remained significantly elevated by the end of week three. TSAT values increased by 12.0 ± 9.7% (P < 0.001) and 23.1 ± 20.4% (P = 0.002) in patients receiving 100 or 200 mg FCM, respectively, and returned to baseline within four days.. IV administration of FCM at doses of 100 or 200 mg in hemodialysis patients leads to dose-dependent transient ferritin elevations of extended duration. Temporal coordination of blood sampling for iron status evaluation with the maintenance IV iron dosing schedule is advisable.. ISRCTN12825165 (retrospectively registered 01/02/2019).

Topics: Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Monitoring; Female; Ferric Compounds; Ferritins; Hematinics; Humans; Infusions, Intravenous; Iron; Male; Maltose; Middle Aged; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Transferrin

Topics: Anemia, Iron-Deficiency; Extravasation of Diagnostic and Therapeutic Materials; Female; Ferric Compounds; Humans; Infusions, Intravenous; Maltose; Middle Aged; Pigmentation Disorders

Topics: Anemia, Iron-Deficiency; Cost-Benefit Analysis; Denmark; Disaccharides; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Maltose

Topics: Anemia, Iron-Deficiency; Cost-Benefit Analysis; Denmark; Disaccharides; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Maltose

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Renal Insufficiency, Chronic

This report describes the case of a 36-year-old woman, gravida 3, para 2, at 11 weeks' gestation, who received a ferric carboxymaltose infusion for iron deficiency anaemia after medical management of a miscarriage. The following morning, light brown skin staining was noted at the infusion site, and the staining was present 2 months later at follow-up. Skin staining following intravenous iron infusion is a rare but important side effect. The skin staining is potentially permanent but may fade in time. Such an adverse effect may have cosmetic consequences for the patient.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Infusions, Intravenous; Maltose; Pregnancy; Pregnancy Trimester, First; Skin Pigmentation

Iron deficiency and iron deficiency anaemia are common complications in inflammatory bowel disease (IBD). In patients with moderate-to-severe anaemia, oral iron intolerance or ineffectiveness of oral iron, ferric carboxymaltose and iron isomaltoside are widely used. Hypophosphatemia is a side effect of both preparations.. To investigate the occurrence of hypophosphatemia in IBD patients with iron deficiency/iron deficiency anaemia treated with high-dose intravenous iron.. A prospective observational study of adult IBD patients with iron deficiency/iron deficiency anaemia was conducted at two study sites where patients received 1000 mg of ferric carboxymaltose or iron isomaltoside. At baseline, weeks 2 and 6, blood and faecal samples were collected. The primary endpoint was to determine the incidence of moderate-to-severe hypophosphatemia. Secondary endpoints included the total incidence of hypophosphatemia, possible risk factors for hypophosphatemia, and response to single-dose intravenous iron.. One hundred and thirty patients were included. In the per-protocol set, 52 patients received ferric carboxymaltose and 54 patients received iron isomaltoside. Ferric carboxymaltose treatment had a significantly higher incidence of moderate-to-severe hypophosphatemia compared with iron isomaltoside at week 2 (56.9% vs 5.7%, P < 0.001) and a higher incidence at week 6 (13.7% vs 1.9%, P = 0.054).The overall incidence of hypophosphatemia was significantly higher with ferric carboxymaltose compared with iron isomaltoside treatment at weeks 2 (72.5% vs 11.3%, P < 0.001) and 6 (21.6% vs 3.7%, P = 0.013).. In IBD patients with iron deficiency/iron deficiency anaemia, ferric carboxymaltose was associated with higher incidence, severity and persistence of hypophosphatemia compared with iron isomaltoside. The presence of moderate-to-severe hypophosphatemia beyond 6 weeks is a clinical concern that requires further investigation.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Disaccharides; Female; Ferric Compounds; Humans; Hypophosphatemia; Incidence; Inflammatory Bowel Diseases; Male; Maltose; Middle Aged; Norway; Prospective Studies; Quality of Life; Risk Factors

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Maltose

Iron deficiency anaemia frequently complicates inflammatory bowel disease (IBD) in children and adults. Oral iron may exacerbate gastrointestinal symptoms and absorption may be insufficient in intestinal inflammation. Even where oral iron is successful, repletion of iron stores can be unacceptably slow. Intravenous iron compounds were in the past associated with serious adverse reactions and historically were considered a last resort in children. New generation preparations have a safer profile in adults, although reluctance to use them in children may persist, where safety data are lacking. We investigate the safety and efficacy of ferric carboxymaltose and iron sucrose in children.. We retrospectively identified all children with IBD who received parenteral iron over a 38-month period in a single regional referral centre. Safety, tolerability and adverse events were established by case note review. Efficacy was assessed by change in haematinic indices pre- and post-treatment.. Forty-one children (18 male; median age 14 years, range 3-17) received a total of 104 iron infusions. Of these, 44% (18) had Crohn's disease; 56% (23) ulcerative colitis. Thirty-five received ferric carboxymaltose, seven iron sucrose and one both. Three children developed mild rash post infusion which resolved quickly with chlorphenamine. Mean increase in haemoglobin was 2.5 g dl. New generation parenteral iron preparations are safe, well tolerated and efficacious in children with iron deficiency anaemia and IBD.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Colitis, Ulcerative; Crohn Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Infusions, Intravenous; Male; Maltose; Retrospective Studies; Transferrin

Ferric carboxymaltose (FCM) is a novel iron formulation increasingly prescribed due to its effectiveness and fast infusion time. FCM administration can cause an asymptomatic hypophosphataemia secondary to fibroblast growth factor 23 (FGF23) dysregulation. In patients with chronic iron needs, however, a severe, long-lasting hypophosphataemia can lead to osteomalacia with associated bone pain. Lack of awareness of this complication results in delayed time to diagnosis and significant morbidity. We report a case of a patient with Crohn's disease and chronic iron-deficiency anaemia receiving multiple doses of FCM who developed severe hypophosphataemic osteomalacia with urinary phosphate loss and increased FGF23. FGF23 excess and osteomalacia resolved only months after FCM discontinuation and aggressive phosphate repletion. Potential mechanisms of FGF23 dysregulation are discussed, with the aim of raising awareness of this significant side effect for prescribers of chronic intravenous iron supplementation, and to help guide future studies to determine the safety of FCM in all patient populations.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Crohn Disease; Diagnosis, Differential; Ferric Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Hypophosphatemia; Male; Maltose; Middle Aged; Osteomalacia; Phosphates; Treatment Outcome

Iron-deficiency anemia (IDA) is the most common form of anemia. Iron replacement therapy is an effective treatment, but oral and previously available intravenous (IV) formulations in Japan have disadvantages such as side effects, immunogenic reactions, low dose per tablet/vial, and the need for continuous administration. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron preparation outside of Japan. In this single-center, open-label, single-dose escalation study, we investigated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of FCM in Japanese subjects. Twenty-four Japanese IDA patients, diagnosed by hemoglobin, serum ferritin, and transferrin saturation, were assigned in equal groups to the 100, 500, 800, and 1000 mg iron dose arms. All subjects completed the study without important protocol deviations. Mean total serum iron concentrations showed a rapid, dose-dependent increase after FCM injection, reaching a maximum within 1 h. Mean reticulocyte counts significantly increased in all arms, suggesting improved hematopoietic function. Fourteen of 24 subjects experienced adverse events, but these were neither serious nor led to drug interruption. The PK/PD and safety profiles were similar in Japanese and European subjects. Ferric carboxymaltose is safe for administration in Japanese patients with IDA.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Asian People; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Ferric Compounds; Hematopoiesis; Humans; Infusions, Intravenous; Iron; Male; Maltose; Middle Aged; Reticulocyte Count; Safety; Young Adult

The main objective of our study was to determinate the effectiveness of intravenous iron treatment with ferric carboxymaltose in inflammatory bowel disease (IBD) patients. Our other objectives were to study parameters that would predict a good response to the treatment and to chart out possible side-effects of the treatment.. In our retrospective chart review study we collected clinical data and laboratory results related to IBD from medical records of 87 IBD patients who were treated with ferric carboxymaltose in Helsinki University Hospital between 2014 and 2016.. The mean increase in hemoglobin levels of the patients was 24.6 g/l (+ 24%) after one month, 27.6 g/l (+ 27%) after three months and 26.0 g/l (+ 27%) after six months. Nine out of 87 treated patients (10.3%) reported side-effects during the iron infusion. A linear regression model assessing the change in hemoglobin levels after six months demonstrated close correlation with transferrin receptor count (p = .004) and ferritin (p = .016) with an adjusted R square of 0.463.. Ferric carboxymaltose was found to be an effective and well tolerated treatment for iron deficiency anemia in patients with IBD. The results of our study further strengthen the current knowledge of the effectiveness and safety of the treatment.

Topics: Administration, Intravenous; Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Exanthema; Female; Ferric Compounds; Ferritins; Finland; Humans; Inflammatory Bowel Diseases; Iron; Linear Models; Male; Maltose; Middle Aged; Nausea; Receptors, Transferrin; Retrospective Studies; Treatment Outcome; Young Adult

To examine the adverse drug reactions (ADRs) and the efficacy of intravenous iron polymaltose and ferric carboxymaltose (FCM) among gynecology/obstetric patients with anemia.. The present retrospective observational study examined data from anemic obstetrics and gynecology patients who received either iron polymaltose or FCM between January 1, 2011, and April 30, 2015, at The Royal Women's Hospital, Victoria, Australia. Patient demographic data, dosage, ADR documentation, and hemoglobin levels were collected from medical records and compared.. The study included 221 patients; 111 and 110 received iron polymaltose and FCM, respectively. ADRs were documented for 18 (16.2%) patients in the iron polymaltose group and 2 (1.8%) in the FCM group (P<0.001), with no incidences of anaphylaxis. Both formulations achieved increased hemoglobin levels within 12 weeks (P<0.001 for both). Mean hemoglobin level increases were similar in both groups among non-pregnant patients (P=0.186), but were greater in the iron polymaltose cohort among pregnant patients (P=0.005). FCM dose compliance was suboptimal, with 8 of 57 (14%) patients who required second visits for doses greater than 1000 mg returning for the infusion.. FCM was associated with a lower incidence of ADRs than iron polymaltose. Patients receiving FCM infusions were less likely to receive their total required iron dose. Further randomized prospective studies are required to compare clinical efficacy of iron polymaltose versus FCM.

Topics: Administration, Intravenous; Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Australia; Cohort Studies; Female; Ferric Compounds; Humans; Maltose; Middle Aged; Pregnancy; Retrospective Studies; Treatment Outcome; Young Adult

Background Intravenous (IV) iron preparations bypass the difficulties (malabsorption and side effects) associated with oral iron for the treatment of iron deficiency anaemia (IDA). Ferric carboxymaltose (FCM) can be administered as a single infusion over short periods of time but is more expensive than iron sucrose (IS) when the patients are hospitalized. Objectives To evaluate the appropriateness of FCM prescriptions and to establish the economic impact of this management (including disease coding) compared to the use of IV IS. Setting This study was conducted for inpatients in all departments (orthopaedic department, gastroenterology department and two units of the internal medicine department) where FCM was widely prescribed. Method We retrospectively identified 224 patients, diagnosed with IDA using laboratory parameters and/or disease coding, who received FCM between January and December 2014. Main outcome measure The primary outcome was the rate of appropriateness of FCM prescriptions and the financial impact compared to IV IS. Results 89 Patients were included. The total additional cost for an inappropriate prescription of IV FCM (68% of cases) was of 6053 €. The total incremental cost of unsuitable disease coding was estimated at 31,688 €. Indications for IV FCM were categorized: intestinal bleeding (31%), malabsorption (17%), intolerance (9%) and refractory to oral iron (7%). The majority of patients (62%) received 1000 mg of FCM per week. The average length of hospital stay was of 10 days. Conclusion The prescription of IV iron was appropriate in most cases but did not necessarily require FCM. The use of IV IS, in many cases, could present a cost-saving option for inpatients with IDA. The lack of an IDA coding generated incremental costs.

Topics: Administration, Intravenous; Aged; Anemia, Iron-Deficiency; Drug Costs; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Inpatients; Length of Stay; Male; Maltose; Middle Aged; Retrospective Studies

To evaluate the efficacy and safety of intravenous ferric carboxymaltose administration to pregnant women with varying severities of iron deficiency anemia and iron deficiency without anemia.. In this prospective observational study of local obstetric practice, we analyzed data from 863 pregnant women with iron deficiency according to anemia status and severity. All women were treated with intravenous ferric carboxymaltose in pregnancy. Treatment efficacy was assessed by repeat hemoglobin measurements at 3 and 6 week post-infusion and ferritin levels, where available. Safety was assessed by analysis of adverse events, fetal heart rate monitoring, and newborn health outcome data.. Ferric carboxymaltose significantly increased hemoglobin in women with mild, moderate, and severe iron deficiency anemia and women with iron deficiency alone at 3 and 6 week post-infusion (p < 0.01 for all). No hemoconcentration occurred in iron-deficient women without anemia. No serious adverse events were recorded, with minor temporary side effects (including local skin irritation, nausea, and headache) occurring in 96 (11%) women. No adverse fetal or neonatal outcomes were observed.. Ferric carboxymaltose infusion corrects iron deficiency or various degrees of iron deficiency anemia efficaciously and safely pregnant women, and does not cause hemoconcentration.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Infant, Newborn; Infusions, Intravenous; Iron Deficiencies; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Pregnant Women; Prenatal Care; Prospective Studies; Treatment Outcome

Anemia is often associated with a lower quality of life and less tolerance to treatments in cancer patients.. The aims of this retrospective study were to assess the biological (hemoglobin, Hb) and clinical (ECOG index) impact of ferric carboxymaltose (FCM) and to identify predictive factors of response in cancer patients with iron deficiency.. We included 133 patients with solid tumors who received at least one dose of FCM in 2015.. At baseline, most patients had metastatic cancer (70%), were undergoing chemotherapy (82%), suffered from anemia (90%), and 72% had an ECOG 0-1 index. Mean Hb level was statistically higher at M1 (108.3 g/L ± 13.9), M2 (110.3 g/L ± 16.1), and M3 (111.7 g/L ± 12.6) than M0 (99.2 g/L ± 13.9). Mean ECOG score increased significantly at M1 (1.31 ± 0.80) and M2 (1.31 ± 0.87) compared to M0 (1.13 ± 0.80). Variations of ECOG index between M0 and M1 were independent of levels of Hb and ferritin at inclusion and pretreatment use of transfusion and ESAs. Increase of Hb level was higher in patients with Hb < 100 g/L, ferritinemia < 800 ng/ml, or transfused before inclusion. In multivariate analysis, an ECOG index of 0 was the only predictive factor of an increase of ECOG index and Hb level < 100 g/L and ferritinemia < 800 ng/ml were predictive of an increase in Hb.. Even though there was no improvement in ECOG index, this study did identify an increase of Hb for patients receiving FCM, indicating its potential benefit in iron-deficient cancer patients.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Blood Transfusion; Female; Ferric Compounds; Ferritins; Follow-Up Studies; Health Status Indicators; Hemoglobins; Humans; Male; Maltose; Middle Aged; Neoplasms; Quality of Life; Retrospective Studies; Young Adult

Iron deficiency is a frequent complication of chronic kidney disease (CKD) that is associated with a decrease in the quality of life of patients and an increase in the risk of other clinical complications. Iron therapy represents one of the fundamentals of patients with CKD. Sucrosomial. The main objective of this study was to assess the economic impact of the oral iron Fisiogen Ferro Forte. A 4-year budget impact model was developed for the period 2017-2020 for CKD patients with iron deficiency who were candidates for intravenous iron due to a lack of response to oral iron, from the perspective of the Spanish healthcare system. Three subgroups of CKD patients were included in the analysis: predialysis, peritoneal dialysis, and post-transplant. The intravenous iron formulations Ferinject. The average annual budget savings due to an increase in Fisiogen Ferro Forte. The increase in the use of Fisiogen Ferro Forte

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Budgets; Cost Savings; Ferric Compounds; Health Care Costs; Hospitalization; Humans; Iron; Kidney Transplantation; Maltose; Models, Economic; Peritoneal Dialysis; Renal Insufficiency, Chronic; Spain

Iron deficiency and iron deficiency anaemia are common complications in inflammatory bowel disease [IBD] patients. Anaemia in IBD is attributable to chronic blood loss and/or impaired iron intake and absorption. International guidelines recommend intravenous iron supplementation in IBD patients, since oral supplements are frequently poorly tolerated and can exacerbate inflammation. Intravenous ferric carboxymaltose [FCM; Ferinject® 50 mg ferric iron[III]/mL suspension] was approved in Europe in 2007 for correction of iron deficiency, and can be administered in single 15-min infusions of up to 1000 mg.. A prospective non-interventional post-marketing study was performed in 101 centres in Germany to assess the efficacy, tolerability, and convenience of Ferinject® in clinical practice in a large cohort of IBD patients. Primary endpoints were haemoglobin [Hb] normalisation or increase ≥2 g/dL [responders], and normalisation of serum ferritin [s-ferritin] and transferrin saturation. Adverse events [AEs], clinical signs/symptoms, and disease activity indices were also analysed.. In all, 224 subjects (127 Crohn's disease [CD]; 97 ulcerative colitis [UC]) were treated. Mean total iron dose was 1139 mg [range: 100 mg-4800 mg], with 76.7% of doses between 500 mg and 2000 mg; 63.3% of patients responded, and no adverse drug reactions or drug-attributed serious adverse events [SAEs] or deaths occurred. Mean increases of Hb [10.0 to 12.3 g/dL], ferritin [52 μg/L to 103 μg/L], transferrin saturation [TSAT, 15% to 25%], and s-iron [6.1 to 12.4 μmol/L] were significant [p = 0.0001]. Clinical scores and quality of life improved due to the amelioration of anaemia symptoms.. Ferinject®-therapy was proven to be effective and safe in a large cohort of patients with IBD-associated anaemia in routine practice. Rapid, high-dose application is convenient for physicians and reduces patients' time lost from work.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Colitis, Ulcerative; Crohn Disease; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Male; Maltose; Middle Aged; Prospective Studies; Quality of Life; Severity of Illness Index; Transferrin; Young Adult

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferrosoferric Oxide; Humans; Maltose

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferrosoferric Oxide; Humans; Maltose

Topics: Administration, Intravenous; Aged; Anemia, Iron-Deficiency; Ferric Compounds; Hemoglobins; Humans; Iron; Male; Maltose

We performed a post-hoc subgroup analysis in Korean women who participated in the Phase III FER-ASAP (FERric carboxymaltose-Assessment of SAfety and efficacy in Pregnancy) study to compare the efficacy and safety of ferric carboxymaltose (FCM) with oral ferrous sulfate (FS).. Pregnant Korean women (gestational weeks 16-33) with iron-deficiency anemia (IDA) were randomized 1:1 to FCM (n = 46; 1000-1500 mg iron) or FS (n = 44; 200 mg iron/day) group for 12 weeks. The primary objective was to compare the mean hemoglobin (Hb) increase at week 3; secondary objectives included change in iron parameters, quality of life (QoL), and safety.. Baseline characteristics of the Korean subgroup were consistent with those of non-Korean FER-ASAP population except for lower body-mass index and higher maternal age. Hb level increases were comparable between the two treatment groups in Korean women at week 3 (FCM 1.23 ± 0.89 g/dL vs FS 1.14 ± 1.72 g/dL). Iron parameters improved over time as secondary endpoints were significantly in favor of FCM. In terms of QoL, FCM treatment significantly improved the mental and physical components as well as vitality prior to delivery. Both treatments were well tolerated.. FCM provided significantly greater improvements in iron parameters and QoL compared to FS in the Korean subgroup. FCM may be a preferable alternative to currently available treatments for IDA during pregnancy.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferrous Compounds; Hemoglobins; Humans; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Republic of Korea; Young Adult

Although the efficacy of iron sucrose (IS) and ferric carboxymaltose (FCM) in treating anemia in hemodialysis (HD) patients has been studied individually, a comparison of these two intravenous iron formulations has not yet been performed in HD patients.. We performed a retrospective audit on records of 221 stable HD patients from different HD centers in the Netherlands, who were switched from IS to FCM on a 1:1 ratio. To assess the effect of the switch on iron status parameters, data from 3 time points before and 3 time points after the switch were analyzed using linear mixed effects models. Subanalyses were done in 2 subgroups of patients anemic or iron deficient at baseline.. Hemoglobin increased in all groups (anemic [1.4 g/dL, P < 0.001] iron deficient [0.6 g/dL, P < 0.001]), while the weekly iron dose was significantly lower when patients received FCM compared to IS (48 vs 55 mg/week, P = 0.04). Furthermore, serum ferritin and transferrin saturation increased in all groups (anemic [64 μg/L, 5.0%, P < 0.001] iron deficient [76 μg/L, 3.6%, P < 0.001]). Finally, the darbepoetin α dose decreased significantly in all groups (anemic [- 16 μg/wk., P = 0.01] iron deficient [- 11 μg/wk., P < 0.001]).. In this real-life study in HD patients, a switch from IS to FCM resulted in an improvement of iron status parameters despite a lower weekly dose of FCM. Furthermore, the ESA dose was reduced during FCM, while hemoglobin levels increased.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Drug Substitution; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Humans; Iron; Longitudinal Studies; Male; Maltose; Middle Aged; Netherlands; Renal Dialysis; Retrospective Studies

Iron deficiency (ID) and iron deficiency anemia (IDA) in pregnancy are global health issues, affecting around 30% of women in high-resourced countries, and increasing to over 50% of women in low-resourced countries.. Froessler et al. study published in Archives of Gynecology and Obstetrics (2018) 298: 75. https://doi.org/10.1007/s00404-018-4782-9 , raised many queries and we would like to know the answers of those queries from the authors if possible.. Diagnosis of IDA should be based on hemoglobin concentration (gm/dl), serum ferritin (ug/l), mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH), and the efficacy of the treatment of IDA evaluated by comparing pre-treatment values of hemoglobin, serum ferritin, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) by the post-treatment values. Parenteral iron dose for correction of IDA calculated according to the formula; total iron needed in mg = 2.4 × pre-pregnancy weight in kg × (target hemoglobin concentration - actual hemoglobin concentration) gm/dl + 500 mg.. The efficacy of the treatment of IDA evaluated by comparing pre-treatment values of hemoglobin, serum ferritin, MCV, and MCH by the post-treatment values. Parenteral iron dose for correction of IDA calculated according to the formula; total iron needed in mg = 2.4 + pre-pregnancy weight in kg + (target hemoglobin concentration - actual hemoglobin concentration) gm/dl + 500 mg.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Hemoglobins; Humans; Iron; Maltose; Pregnancy

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Maltose; Pregnancy

The incidence of inflammatory bowel disease (IBD) in Denmark is among the highest in the world, with Crohn's disease and ulcerative colitis occurring at rates of 9.1 and 18.6 per 100,000 person-years respectively in 2010-2013. Anemia is the most prevalent extraintestinal complication of IBD, most commonly caused by iron deficiency. In treating IBD-associated iron deficiency anemia (IDA), intravenous iron is more effective and better tolerated and shows a faster response than oral iron. The present study evaluated resource use and costs associated with using iron isomaltoside (Monofer; IIM) versus ferric carboxymaltose (Ferinject; FCM) in patients with IDA and IBD in Denmark.. A budget impact model was developed to evaluate the cost of IIM compared with FCM from a Danish healthcare payer perspective. Iron deficits were modeled using dosing tables and a joint distribution of bodyweight [mean 75.4 kg, standard deviation (SD) 17.4 kg] and hemoglobin (mean 10.8 g/dL, SD 1.4 g/dl) based on observational data from patients with IBD. Retreatment frequency was modeled using a pooled retrospective analysis of randomized trial data, and costs were modeled using diagnosis-related groups with an outpatient infusion cost of DKK 2855.. Using IIM required 1.2 infusions (per treatment) to correct the mean iron deficit compared with 1.6 with FCM. Treating 2.54 patients with IIM would therefore avoid one infusion compared with FCM. Patients using IIM required multiple infusions in 25.0% of cases compared with 64.3% with FCM. Over 5 years, total estimated costs were DKK 21,406 per patient with IIM compared with DKK 28,137 with FCM, corresponding to savings of DKK 6731 with IIM.. Using IIM in place of FCM markedly reduced the number of iron infusions required in patients with IBD and IDA in Denmark. The reduction in infusions was accompanied by reductions in cost compared with FCM.. Pharmacosmos A/S.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Denmark; Disaccharides; Female; Ferric Compounds; Hemoglobins; Humans; Inflammatory Bowel Diseases; Maltose; Middle Aged; Retrospective Studies

Guidelines of the European Society of Cardiology (ESC) recommend that ferritin and transferrin saturation should be tested in chronic heart failure (HF) and state that iron treatment with ferric carboxymaltose should be considered in HF patients with iron deficiency to alleviate symptoms and improve exercise tolerance and quality of life. This study evaluates the cost effectiveness of the implementation of this recommendation in four Nordic countries (Denmark, Finland, Norway, and Sweden).. We performed a cost-utility analysis comparing ferric carboxymaltose treatment with placebo over a one-year time period in each country. Data on healthcare resource use and health outcomes were taken from the CONFIRM-HF study and combined with country-specific unit costs. Differences in per-patient costs and quality-adjusted life years (QALYs) were calculated.. QALYs were higher (increase of 0.050 QALYs per patient) in the iron-treated group compared with placebo. Per-patient costs were lower in all countries (with reductions ranging from €36 to €484). Fewer hospitalizations were one key driver of these results. Another important driver was how well the new routines for iron treatment can be integrated into the current healthcare management of HF. A sensitivity analysis confirmed the results to be robust.. Iron deficiency therapy in HF with ferric carboxymaltose compared with placebo is estimated to both improve health-related quality of life and save healthcare costs in all Nordic countries. A well-organized healthcare management of HF patients can enable the implementation of ESC-recommended treatment of iron deficiency without need for additional resources.

Topics: Aged; Anemia, Iron-Deficiency; Clinical Trials, Phase III as Topic; Cost Savings; Cost-Benefit Analysis; Drug Costs; Female; Ferric Compounds; Guideline Adherence; Heart Failure; Hematinics; Humans; Male; Maltose; Models, Economic; Practice Guidelines as Topic; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Registries; Scandinavian and Nordic Countries; Time Factors; Treatment Outcome

Iron deficiency is a prevalent and clinically relevant comorbidity in up to 50% of patients with chronic heart failure (CHF). Iron deficiency in CHF patients is associated with impaired quality of life, reduced exercise capacity and increased mortality, irrespective of the presence of anaemia. It is diagnosed by determining circulating ferritin levels and transferrin saturation. Three randomised trials (CONFIRM-HF, FAIR-HF, and EFFECT-HF) of intravenous ferric carboxymaltose in the treatment of iron deficiency in CHF patients with reduced left ventricular ejection fraction demonstrated improvement of symptoms, functional capacity and quality of life. These beneficial effects were independent of the presence of anaemia. In addition, CONFIRM-HF and subsequent meta-analyses indicated that treatment of iron deficiency may reduce the rate of hospitalisations for worsening CHF. Oral iron is available at lower cost than intravenous iron, but its use did not translate into beneficial effects in CHF patients with iron deficiency. Large randomised trials designed to assess long-term clinical outcomes of iron treatment in CHF patients are pending. Current guidelines advise establishing evidence-based pharmacological and device therapy to improve symptoms and prognosis in patients with CHF. In addition, screening for iron deficiency is recommended. Intravenous ferric carboxymaltose should be considered for treating iron deficiency in ambulatory symptomatic patients with reduced left ventricular ejection fraction in order to alleviate heart failure symptoms, and to improve exercise capacity and quality of life.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Chronic Disease; Comorbidity; Ferric Compounds; Heart Failure; Hospitalization; Humans; Iron Deficiencies; Maltose; Prognosis; Randomized Controlled Trials as Topic

Iron deficiency anaemia (IDA) is the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD). The Health Technology Assessment approach was applied to evaluate the sustainability of intravenous (IV) iron formulations in the Italian hospital setting, with particular focus on ferric carboxymaltose. Data on the epidemiology of IBD and associated IDA, in addition to the efficacy and safety of IV iron formulations currently used in Italy, were retrieved from scientific literature. A hospital-based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed. IDA prevalence in IBD patients varies markedly from 9 to 73%. IV iron preparations were proven to have good efficacy and safety profiles, and ferric carboxymaltose provided a fast correction of haemoglobin and serum ferritin levels in iron-deficient patients. Despite a higher price, ferric carboxymaltose would confer a beneficial effect to the hospital, in terms of reduced cost related to individual patient management and additionally to the patient by reducing the number of infusions and admissions to healthcare facilities. Ethically, the evaluation is appropriate due to its efficacy and compliance. This assessment supports the introduction of ferric carboxymaltose in the Italian outpatient setting.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Ferric Compounds; Hemoglobins; Hospitals; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Iron; Italy; Maltose; Technology Assessment, Biomedical; Treatment Outcome

In the paediatric population, ferric carboxymaltose (FCM) is only licenced for use in children older than 14 years, and the data in younger children remains scarce. We retrospectively reviewed data of all paediatric patients less than 14 years old who had received FCM infusion from August 2011 to June 2015 at the John Radcliffe Hospital (Oxford University Hospitals), UK. The patient demographics, significant medical history, FCM dose, and blood investigations (pre-FCM and post-FCM) were reviewed. Of the 51 children, 41 had inflammatory bowel disease. There were 24 girls and 27 boys, aged 1 to 13 years, mean (SD) weight 28.4 (13.6) kg. Fifteen patients received at least one more course of FCM up to 35 months later. The time interval between pre-FCM and post-FCM investigations was 1 to 8 months. An improved, median (range) rise in blood indices following one FCM infusion was haemoglobin 2.7 (- 2.4 to 7) g/dL, serum iron 6.6 (- 0.6 to 21.1) μmol/L, and transferrin saturation 14 (- 14 to 38)%. No adverse outcomes were documented.. FCM was effective in increasing the key blood indices with no adverse outcomes in children less than 14 years of age, with a range of different conditions, majority with gastrointestinal disorders such as IBD. What is Known: • Ferric carboxymaltose (FCM) given via the intravenous (IV) route has been used widely in adults for the treatment of iron deficiency anaemia. • Sparse data exists on FCM use in paediatric population, including young children What is New: • FCM infusion should be considered as a means of iron administration in the paediatric population less than 14 years of age • No adverse outcomes were recorded following FCM in a young paediatric population (less than 14 years of age); the majority of whom had gastrointestinal disorders.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Hematinics; Humans; Infant; Infusions, Intravenous; Male; Maltose; Retrospective Studies; Tertiary Care Centers; Treatment Outcome; United Kingdom

Iron deficiency occurs frequently in pregnancy and can be diagnosed by serum ferritin-level measurement (threshold value < 30 μg/L). Screening for iron-deficiency anemia is recommended in every pregnant women, and should be done by serum ferritin-level screening in the first trimester and regular hemoglobin checks at least once per trimester. In the case of iron deficiency with or without anaemia in pregnancy, oral iron therapy should be given as first-line treatment. In the case of severe iron-deficiency anemia, intolerance of oral iron, lack of response to oral iron, or in the case of a clinical need for rapid and efficient treatment of anaemia (e.g., advanced pregnancy), intravenous iron therapy should be administered. In the postpartum period, oral iron therapy should be administered for mild iron-deficiency anemia (haemorrhagic anemia), and intravenous iron therapy for moderately severe-to-severe anemia (Hb < 95 g/L). If there is an indication for intravenous iron therapy in pregnancy or postpartum, iron-containing drugs which have been studied in well-controlled clinical trials in pregnancy and postpartum such as ferric carboxymaltose must be preferred for safety reasons. While anaphylactic reactions are extremely are with non-dextrane products, close surveillance during administration is recommended for all intravenous iron products.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Humans; Iron; Maltose; Postpartum Period; Practice Guidelines as Topic; Pregnancy; Pregnancy Complications, Hematologic; Pregnancy Outcome; Severity of Illness Index; Treatment Outcome

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Humans; Maltose

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Humans; Maltose

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Heart Failure; Humans; Iron; Maltose

Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anaemia is associated with significant maternal, foetal and infant morbidity. Current options for treatment include oral iron, which can be ineffective and poorly tolerated, and red blood cell transfusions, which carry an inherent risk and should be avoided. Ferric carboxymaltose is a modern treatment option. The study was designed to assess the safety and efficacy of intravenous ferric carboxymaltose for correction of iron deficiency anaemia in pregnant women.. A prospective study was conducted at Institute of Kidney Disease and Research Centre, Ahmedabad from January 2014 to December 2016. Antenatal women (108) with iron deficiency anaemia were the study subjects. Socio-demographic profile was recorded and anaemia was assessed based on recent haemoglobin reports. Iron deficiency was diagnosed on basis of serum ferritin value. Intravenous ferric carboxymaltose as per total correction dose (maximum 1500mg) was administered to all women; the improvement in haemoglobin levels were assessed after 3 weeks of total dose infusion.. Most of the women(n= 45, 41.7%), were in the age group of 27-30 years. Most of the women (n = 64, 59.3%) had moderate anaemia as per WHO guidelines. Mean haemoglobin levels significantly increased over a period of 3 weeks after Ferric carboxymaltose administrationand no serious life threatening adverse events were observed.. Intravenous ferric carboxymaltose was safe and effective in pregnent women with iron deficiency anaemia.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Maltose; Nepal; Pregnancy; Pregnancy Complications, Hematologic; Prospective Studies; Socioeconomic Factors; Young Adult

Iron deficiency is the leading cause of anemia in patients with inflammatory bowel disease (IBD). Intravenous iron is the first-line treatment for clinically active IBD or previous oral iron intolerance. The aim of the present study was to develop a comparative model of iron deficiency and delivery for iron isomaltoside (IIM), ferric carboxymaltose (FCM), low molecular weight iron dextran (LMWID), and iron sucrose (IS) in the treatment of iron deficiency anemia associated with IBD. Areas covered: A model was developed to evaluate iron delivery characteristics, resource use and costs associated with IIM, FCM, LMWID and IS. Iron deficiency was modeled using dosing tables and retreatments were modeled based on a pooled retrospective analysis. The analyses were conducted over 5 years in patients with IBD with mean bodyweight of 75.4 kg and hemoglobin levels of 10.77 g/dL based on observational data. Expert opinion: The modeling analysis showed that using IIM required 1.2 infusions (per treatment) to correct the mean iron deficit, compared with 1.6, 1.2, and 7.1 with FCM, LMWID and IS, respectively. Costs were estimated to be 2,518 pounds sterling (GBP) per patient with IIM or LMWID, relative to GBP 3,309 with FCM or GBP 14,382 with IS.

Topics: Anemia, Iron-Deficiency; Budgets; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Iron-Dextran Complex; Maltose; Retrospective Studies; United Kingdom

Increasing evidence in adults demonstrates efficacy and safety of IV iron in inflammatory Bowel disease (IBD) associated iron deficiency anemia; however, evidence in pediatric patients is yet scarce and no previous study has included a long follow-up. This study aimed to evaluate safety and efficacy of IV iron (primary end point), and the need of re-treatment (secondary end point), in this setting.. Prospective recruitment (40 months); PCDAI determined before and after treatment; anemia defined according to WHO criteria; IV iron treatment included iron sucrose and ferric carboxymaltose. Primary and secondary endpoints included hemoglobin, serum ferritin, transferrin saturation at baseline and 4-6 weeks after treatment; and the need of re-treatment during the median follow-up period (18 months), respectively.. Nineteen patients (median age: 15.5 years) with remissive/mild disease were included. At recruitment, the median hemoglobin was 10.5 g/dl, (median s-ferritin: 20.1 ug/l, median transferrin saturation; 6%) and 4-6 weeks after treatment was 12.7 g/dl. Median hemoglobin according to age groups before vs. after treatment: <12 years:11 vs. 12.0 g/dl; females ≥12 years:9.9 vs. 12.6 g/dl; and males ≥12 years:11.1 vs. 13.3 g/dl. Patients with remissive vs. mild disease had median Hb of 10.5 g/dl vs. 10.6 g/dl, and median s-ferritin: 6.8 ug/dl vs. 43.3 ug/dl, respectively). Nine patients were treated with iron sucrose (median dose 672.6 mg/dl) and 10 patients with ferric carboxymaltose (median dose 811.5 mg/dl). No major adverse reactions occurred. Six patients needed re-treatment after a median 15.5 months period.. Our prospective study, concerning pediatric IBD anemia patients with remission/mild disease and a significant follow-up, emphasizes efficacy and safety of IV-iron and the importance of long-term follow-up of iron status.. In pediatric IBD iron anemia, the evidence supporting the efficacy and safety of IV-iron is scare. This prospective study aims to evaluate the safety and efficacy (short and long term) of IV-iron in these patients. Nineteen pediatric CD patients were evaluated before and after IV iron treatment (40-month period).The median Hb before and after IV iron was 10.5 and 12.7 g/dl, respectively. No major adverse reactions were documented. Six patients needed re-treatment (median period of 15.5 months). This study further demonstrates the efficacy and safety of IV iron. It reinforces the importance of long-term follow-up of the iron status in pediatric CD patients.

Topics: Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Crohn Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Glucaric Acid; Hemoglobins; Humans; Male; Maltose; Portugal; Prospective Studies; Transferrin

To assess the benefits and risks of intravenous (IV) ferric carboxymaltose (FCM) in children with iron deficiency anemia (IDA).. In a retrospective cohort study of patients seen at our center, we identified all FCM infusions in children with IDA over a 12-month period through a query of pharmacy records. Clinical data, including hematologic response and adverse effects, were extracted from the electronic medical record.. A total of 116 IV FCM infusions were administered to 72 patients with IDA refractory to oral iron treatment (median age, 13.7 years; range, 9 months to 18 years). Median preinfusion and postinfusion hemoglobin values were 9.1 g/dL and 12.3 g/dL, respectively (at 4-12 weeks after the initial infusion; n = 53). Sixty-five patients (84%) experienced no adverse effects. Minor transient complications were encountered during or immediately after 7 infusions.. FCM administered as a short IV infusion without a test dose proved to be safe and highly effective in a small yet diverse population of infants, children, and adolescents with IDA refractory to oral iron therapy.

Topics: Administration, Oral; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Cohort Studies; Female; Ferric Compounds; Humans; Infant; Infusions, Intravenous; Iron; Male; Maltose; Retrospective Studies; Treatment Outcome

Intravenous (IV) iron preparations are widely used in the treatment of anemia in patients undergoing hemodialysis (HD). All IV iron preparations carry a risk of causing hypersensitivity reactions. However, the pathophysiological mechanism is poorly understood. We hypothesize that a relevant number of these reactions are mediated by complement activation, resulting in a pseudo-anaphylactic clinical picture known as complement activation-related pseudo allergy (CARPA).. First, the in-vitro complement-activating capacity was determined for 5 commonly used IV iron preparations using functional complement assays for the 3 pathways. Additionally, the preparations were tested in an ex-vivo model using the whole blood of healthy volunteers and HD patients. Lastly, in-vivo complement activation was tested for one preparation in HD patients.. In the in-vitro assays, iron dextran, and ferric carboxymaltose caused complement activation, which was only possible under alternative pathway conditions. Iron sucrose may interact with complement proteins, but did not activate complement in-vitro. In the ex-vivo assay, iron dextran significantly induced complement activation in the blood of healthy volunteers and HD patients. Furthermore, in the ex-vivo assay, ferric carboxymaltose and iron sucrose only caused significant complement activation in the blood of HD patients. No in-vitro or ex-vivo complement activation was found for ferumoxytol and iron isomaltoside. IV iron therapy with ferric carboxymaltose in HD patients did not lead to significant in-vivo complement activation.. This study provides evidence that iron dextran and ferric carboxymaltose have complement-activating capacities in-vitro, and hypersensitivity reactions to these drugs could be CARPA-mediated.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Complement Activation; Complement C1q; Complement C3d; Complement Membrane Attack Complex; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Humans; In Vitro Techniques; Iron Compounds; Iron-Dextran Complex; Kidney Failure, Chronic; Maltose; Mannose-Binding Lectin; Properdin; Renal Dialysis

A fast-track anaemia clinic (FTAC) for the management of moderate-to-severe iron-deficiency anaemia (IDA) was established in our Emergency Department in 2010. In this FTAC, the replacement of packed red cell transfusion by ferric carboxymaltose administration was proven to be safe and effective. The aim of this study was a cost-analysis of IDA management in the FTAC, comparing this management with the previous standard care pathway consisting of packed red cell transfusion, if needed, and referral to outpatient specialised care.. A cost study was performed for patients with IDA who were at risk of requiring transfusion (haemoglobin <9 g/dL) but did not require hospitalisation. Total IDA treatment costs in the FTAC were compared to those theoretically incurred if these patients had been managed using the standard care pathway. In addition, a sensitivity analysis considering variations of up to ±30% in ferric carboxymaltose and packed red cell acquisition costs was performed (49 possible scenarios).. Between 2012 and 2015, 238 IDA patients were treated in the FTAC. The average treatment cost was € 594±337/patient in the FTAC group and € 672±301/patient in the standard care pathway group, with a saving of € 78±28/patient (95% CI, 22-133; p<0.001). The sensitivity analysis showed that IDA treatment costs in the FTAC (€ 480-722/patient), compared with those of the standard care pathway (€ 550-794/patient), resulted in significant cost-savings for all studied scenarios (€ 51-104/patient; p<0.005).. The administration of ferric carboxymaltose for IDA management in a FTAC may be cost-saving compared with the standard care pathway.

Topics: Administration, Intravenous; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Costs and Cost Analysis; Emergency Service, Hospital; Female; Ferric Compounds; Humans; Iron; Male; Maltose; Middle Aged

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Ferric Compounds; Humans; Iron; Maltose

Iron deficiency is now recognized as an independent predictor of poor outcome in patients with chronic heart failure and reduced left ventricular ejection fraction. In randomized controlled trials, treatment with ferric carboxymaltose results in improvement in functional capacity, symptoms and quality of life, and might reduce hospitalizations. Thus, the recent European Society of Cardiology guidelines on heart failure recommend treating these patients with intravenous ferric carboxymaltose, whether or not anemic.. Récemment, la carence martiale a été reconnue comme un marqueur indépendant de mauvais pronostic dans l’insuffisance cardiaque à fraction d’éjection du ventricule gauche (FEVG) diminuée. Des études randomisées contrôlées ont démontré que l’administration de fer intraveineux améliore la capacité fonctionnelle, les symptômes et la qualité de vie de ces patients, et pourrait diminuer la fréquence des hospitalisations. Ainsi, les nouvelles recommandations de la Société européenne de cardiologie de 2016 mentionnent de traiter la carence martiale chez ces patients par l’administration intraveineuse de fer, qu’ils soient anémiques ou non.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Chronic Disease; Ferric Compounds; Heart Failure; Hospitalization; Humans; Iron Deficiencies; Maltose; Practice Guidelines as Topic; Quality of Life; Randomized Controlled Trials as Topic

This study collected data on the use of ferric carboxymaltose (FCM) in a cancer patient population in France to evaluate the feasibility and the conditions of use of FCM in routine clinical practice beyond the limiting criteria of clinical trials.. This observational, prospective study of patients with a solid tumour or a haematological malignancy who have received treatment with FCM after 01 July 2011 evaluated data about the circumstances of iron administration, concomitant medication and laboratory tests in the period from 3 months prior to the first FCM administration (baseline) until 3 months post-baseline.. Data from 367 FCM-treated patients were analysed. FCM was mainly given as a single dose at baseline (69.2%) and without additional erythropoiesis-stimulating agent (ESA, 64.3%). The median total iron dose was 1000 mg per patient. Median haemoglobin (Hb) levels of FCM-treated patients improved from 10.3 g/dL (interquartile range 9.5, 11.1 g/dL) at baseline to 11.8 g/dL (11.1, 13.0 g/dL) until the end of the 3-month observational period. Patients treated with FCM alone or additional ESA achieved similar median Hb increase (1.3 [0.4, 2.1] g/dL and 1.4 [0.4, 2.5] g/dL, respectively). Patients with baseline Hb up to 11.0 g/dL and serum ferritin up to 500 ng/mL and beyond achieved stable median Hb levels ≥11.0 g/dL without signs of iron overload. No severe or serious adverse reaction and no hypersensitivity reactions were reported.. The results of this observational study confirm the effectiveness and tolerability of FCM when given in clinical routine practice alone or in combination with an ESA.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Antineoplastic Agents; Female; Ferric Compounds; France; Hematinics; Hematologic Neoplasms; Hemoglobins; Humans; Iron; Male; Maltose; Middle Aged; Prospective Studies; Young Adult

Topics: Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Follow-Up Studies; Heart Failure; Humans; Infusions, Intravenous; Male; Maltose; Middle Aged; Prognosis; Treatment Outcome; Ventricular Dysfunction, Left

Ferric Carboxymaltose (FCM), Iron Sucrose (IS) and Oral Iron (OI) are alternative treatments for preoperative anaemia.. To compare the cost implications, using a cost-minimization analysis, of three alternatives: FCM vs. IS vs. OI for treating iron-deficient anaemia before surgery in patients with colon cancer.. Data from 282 patients with colorectal cancer and anaemia were obtained from a previous study. One hundred and eleven received FCS, 16 IS and 155 OI. Costs of intravenous iron drugs were obtained from the Spanish Regulatory Agency. Direct and indirect costs were obtained from the analytical accounting unit of the Hospital. In the base case mean costs per patient were calculated. Sensitivity analysis and probabilistic Monte Carlo simulation were performed.. Total costs per patient were 1827® in the FCM group, 2312® in the IS group and 2101® in the OI group. Cost savings per patient for FCM treatment were 485® compared to IS and 274® compared to OI. A Monte Carlo simulation favoured the use of FCM in 84.7% and 84.4% of simulations when compared to IS and OI, respectively.. FCM infusion before surgery reduced costs in patients with colon cancer and iron-deficiency anaemia when compared with OI and IS.

Topics: Administration, Intravenous; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Cohort Studies; Colonic Neoplasms; Costs and Cost Analysis; Female; Ferric Compounds; Humans; Iron; Male; Maltose; Middle Aged; Monte Carlo Method; Preoperative Care; Retrospective Studies; Sucrose

Worldwide, iron deficiency anemia is the most common nutritional disorder. Treatment with oral iron supplementation may not be well tolerated due to gastrointestinal side effects. Therapy with Intravenous (IV) iron supplementation is more effective and better tolerated, especially in patients with underlying Inflammatory Bowel Disease (IBD) or malignancy. However, Hypersensitivity Reactions (HSR) and anaphylaxis to IV iron have been described.. We evaluated the literature and developed an eleven step desensitization protocol for ferric carboxymaltose to be administered in high risk patients.. We present the first case series demonstrating the safety of ferric carboxymaltose desensitization in patients with a history of anaphylaxis to IV iron and iron deficiency anemia.. While there are many IV iron formulations available, ferric carboxymaltose can replenish iron stores with fewer doses. Ferric carboxymaltose is contraindicated in patients with prior hypersensitivity reactions to iron formulations. This novel eleven step desensitization protocol was well tolerated without any adverse reactions and allowed the patients to receive iron supplementation when limited therapeutic options existed.

Topics: Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Ferric Compounds; Humans; Infusions, Intravenous; Maltose; Middle Aged; Treatment Outcome

Anaemia and iron deficiency are very common in inflammatory bowel disease. Clinical trials have shown intravenous iron to be effective and well tolerated. However, published experience in clinical practice with specific evaluation of the effect on quality of life is limited.. We carried out a prospective, multicentre, observational study on the effects of ferric carboxymaltose in the treatment of iron deficiency anaemia in inflammatory bowel disease. Anaemia and iron deficiency were defined according to World Health Organization criteria. Efficacy and safety were evaluated at infusion, at 2 weeks and at 12 weeks. Quality of life was evaluated according to the SIBDQ-9 index. Complete response was defined as anaemia correction or more tan 2 g/dL increase in haemoglobin.. A total of 88 courses of ferric carboxymaltose in 72 patients were evaluated. Complete response was observed in 46% of patients at week 2, and 81.2% at week 12. Quality of life improved significatively at week 2 in both complete responders and partial responders (p<0.0005); complete responders showed siginficantly better response (p=0.016). No predictive factor was identified. Only one transient adverse effect was observed; however, this was severe.. Ferric carboxymaltose showed comparable efficacy to that demonstrated in clinical trials. After only two weeks of treatment, there was a significant improvement in quality of life, with a greater effect observed in those patients with a complete haematologic response. Intravenous iron can very quickly improve quality of life in inflammatory bowel disease.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Male; Maltose; Middle Aged; Prospective Studies; Quality of Life; Young Adult

Treatment of iron deficiency with intravenous (i.v.) iron is a first-line strategy to improve anaemia of chronic kidney disease. Previous in vitro experiments demonstrated that different i.v. iron preparations inhibit differentiation of haematopoietic stem cells to monocytes, but their effect on monocyte differentiation to macrophages and mature dendritic cells (mDCs) has not been assessed. We investigated substance-specific effects of iron sucrose (IS), sodium ferric gluconate (SFG), ferric carboxymaltose (FCM) and iron isomaltoside 1000 (IIM) on monocytic differentiation to M1/M2 macrophages and mDCs.. Via flow cytometry and microRNA (miRNA) expression analysis, we morphologically and functionally characterized monocyte differentiation to M1/M2 macrophages and mDCs after monocyte stimulation with IS, SFG, FCM and IIM (0.133, 0.266 and 0.533 mg/mL, respectively). To assess potential clinical implications, we compared monocytic phagocytosis capacity in dialysis patients who received either 500 mg IS or IIM.. Phenotypically, IS and SFG dysregulated the expression of macrophage (e.g. CD40, CD163) and mDC (e.g. CD1c, CD141) surface markers. Functionally, IS and SFG impaired macrophage phagocytosis capacity. Phenotypic and functional alterations were less pronounced with FCM, and virtually absent with IIM. In miRNA expression analysis of mDCs, IS dysregulated miRNAs such as miR-146b-5p and miR-155-5p, which are linked to Toll-like receptor and mitogen-activated protein kinase signalling pathways. In vivo, IS reduced monocytic phagocytosis capacity within 1 h after infusion, while IIM did not.. This study demonstrates that less stable i.v. iron preparations specifically affect monocyte differentiation towards macrophages and mDCs.

Topics: Anemia, Iron-Deficiency; Case-Control Studies; Cell Differentiation; Dendritic Cells; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Iron Compounds; Macrophages; Maltose; MicroRNAs; Monocytes; Phagocytosis

Topics: Anemia, Iron-Deficiency; Ferric Compounds; General Practice; Humans; Infusions, Intravenous; Maltose; Prospective Studies; Quality of Life

Topics: Administration, Oral; Anemia, Iron-Deficiency; Cholecalciferol; Ferric Compounds; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Injections, Intramuscular; Maltose; Vitamin D Deficiency

No reliable biomarker exists to predict responsiveness to intravenous (IV) iron (Fe) in iron deficient patients with CKD. We aimed to investigate the clinical value of bioactive Hepcidin-25 and soluble Transferrin Receptor (sTfR) levels in predialysis patients.. In this prospective study 78 stable stage III-IV CKD predialysis patients with (responders) (40 patients) and without (non-responders) (38 patients) adequate erythropoiesis after IV administration of ferric-carboxymaltose (FCM). Patients were divided in two groups according to their response to IV administration of ferric-carboxymaltose (FCM). Along with measurements of common hematologic and blood chemistry parameters, determinations of sTfR and bioactive Hepcidin-25 were performed.. Hepcidin-25 levels were lower in the responders (p=0.025), while sTfR and sTfR/Hepcidin-25 ratio were higher (p<0.01 and p=0.002 respectively). Diagnostic efficacy indicated cut off point of 1.49 for Hepcidin-25 had sensitivity 84% and specificity 48%, while cut off point of 1.21 for sTfR/Hepcidin-25 ratio had sensitivity 82% and specificity 52% to predict correctly response to iron supplementation therapy. Furthermore, log sTfR/Hepcidin-25 correlated negatively with hs-CRP (p=0.005) and IL-6 (p<0.04) in non-responders, while such correlations were not found in responders (p>0.05).. These results suggest that lower Hepcidin-25, as well as higher sTfR and sTfR/Hepcidin-25 ratio were significant predictors of favorable hemoglobin response within a month after IV administration of FCM in patients with CKD. Further experiments and clinical studies in other groups of patients are needed to better elucidate the role of Hepcidin-25 and sTfR/Hepcidin-25 ratio as predictors of response to intravenous iron administration.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Dialysis; Drug Monitoring; Erythropoiesis; Female; Ferric Compounds; Hepcidins; Humans; Male; Maltose; Middle Aged; Prognosis; Prospective Studies; Receptors, Transferrin; Renal Insufficiency, Chronic; Sensitivity and Specificity

The aim of this study was to evaluate the effectiveness of ferric carboxymaltose (FCM) in patients with iron deficiency anemia (IDA) secondary to gastrointestinal chronic blood loss (CBL), who received chronic transfusion support.. We retrospectively evaluated 38 patients with IDA (hemoglobin [Hb] < 10 g/dL and ferritin < 12 ng/mL or transferrin saturation [TSAT] < 16%) refractory or intolerant to oral iron therapy that necessitated transfusion support in the previous 12 months. They were treated with FCM (500-2500 mg). The primary endpoint was to evaluate the reduction of transfusion requirements (red blood cell [RBC] units) after FCM treatment.. The median age of the cohort was 78 years, with a male:female ratio of 22:16. Before FCM treatment a median of 6 RBC units had been transfused. At the treatment (T0) the median value of Hb was 8.7 g/dL, the TSAT 6%, and ferritin 12 ng/mL. The median FCM dose was 1000 mg. At 5 weeks from T0 the median Hb level was 11 g/dL, with a median increase of 2.4 g/dL. With a median follow-up of 326 days, the median transfusion requirement was 0 RBC units, significantly lower than before T0 (p < 0.001). Overall 17 patients still necessitated transfusion support. Twenty-three patients needed retreatment with FCM for recurrence of IDA: 10 of them obtained a response again. The percentage of transfusion-independent patients at median follow-up was equal to 52%.. In patients with IDA secondary to CBL, FCM significantly reduces the need of transfusions and achieves transfusion independence in half of the cases.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Blood Transfusion; Female; Ferric Compounds; Gastrointestinal Hemorrhage; Humans; Male; Maltose; Middle Aged; Retrospective Studies

Iron deficiency (ID) has been identified as an important co-morbidity in patients with heart failure (HF). Intravenous iron therapy reduced symptoms and rehospitalizations of iron-deficient patients with HF in randomized trials. The present multicenter study investigated the "real-world" management of iron status in patients with HF. Consecutive patients with HF and ejection fraction ≤40% were recruited and analyzed from December 2010 to October 2015 by 11 centers in Germany and Switzerland. Of 1,484 patients with HF, iron status was determined in only 923 patients (62.2%), despite participation of the centers in a registry focusing on ID and despite guideline recommendation to determine iron status. In patients with determined iron status, a prevalence of 54.7% (505 patients) for ID was observed. Iron therapy was performed in only 8.5% of the iron-deficient patients with HF; 2.6% were treated with intravenous iron therapy. The patients with iron therapy were characterized by a high rate of symptomatic HF and anemia. In conclusion, despite strong evidence of beneficial effects of iron therapy on symptoms and rehospitalizations, diagnostic and therapeutic efforts on ID in HF are low in the actual clinical practice, and the awareness to diagnose and treat ID in HF should be strongly enforced.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; C-Reactive Protein; Cohort Studies; Disease Management; Female; Ferric Compounds; Germany; Heart Failure; Humans; Iron; Logistic Models; Male; Maltose; Middle Aged; Multivariate Analysis; Natriuretic Peptide, Brain; Odds Ratio; Peptide Fragments; Prevalence; Registries; Switzerland; Trace Elements; Treatment Outcome

Ferric carboxymaltose (FCM) and iron isomaltoside 1000 (IIM) are increasingly used because they allow correction of severe iron deficiency in a single infusion. A transient decrease in serum phosphate concentrations is a frequent side effect of FCM.. To characterize this adverse event and search for its predictors in a gastroenterology clinic patient cohort.. Electronic medical records of patients attending the University Hospital of Innsbruck were searched for the keywords ferric carboxymaltose or iron isomaltoside. Eighty-one patients with documented administration of FCM or IIM with plasma phosphate concentrations before and after treatment were included.. The prevalence of hypophosphatemia (<0.8 mmol/L) increased from 11% to 32.1% after treatment with i.v. iron. The hypophosphatemia risk was greater after FCM (45.5%) compared with IIM (4%). Severe hypophosphatemia (<0.6 mmol/L) occurred exclusively after FCM (32.7%). The odds for hypophosphatemia after i.v. iron treatment were independently determined by baseline phosphate and the choice of i.v. iron preparation (FCM vs. IIM-OR = 20.8; 95% CI, 2.6-166; p = 0.004). The median time with hypophosphatemia was 41 days, but prolonged hypophosphatemia of ≥ 2 months was documented in 13 of 17 patients in whom follow-up was available. A significant increase in the phosphaturic hormone intact FGF-23 in hypophosphatemic patients shows that this adverse event is caused by FCM-induced hormone dysregulation.. Treatment with FCM is associated with a high risk of developing severe and prolonged hypophosphatemia and should therefore be monitored. Hypophosphatemia risk appears to be substantially lower with IIM.

Topics: Administration, Intravenous; Adult; Aged; Anemia, Iron-Deficiency; Biomarkers; Disaccharides; Female; Ferric Compounds; Fibroblast Growth Factor-23; Humans; Hypophosphatemia; Male; Maltose; Middle Aged; Phosphates; Prevalence; Retrospective Studies; Risk

Topics: Anemia; Anemia, Iron-Deficiency; Dietary Supplements; Ferric Compounds; Humans; Iron; Maltose; Prospective Studies

Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD). In clinical practice, many patients receive initial treatment with iron tablets although intravenous (i.v.) iron supplementation is often preferable.. This study investigated whether systemic inflammation at initiation of treatment (assessed by C-reactive protein [CRP] and interleukin-6 [IL-6] measurements) predicts response to iron therapy.. Data from a previously published phase III trial were retrospectively analyzed after stratification of patients according to baseline CRP (> 4 vs. ≤ 4 mg/L) and IL-6 (> 6 vs. ≤ 6 pg/mL) levels. The study population consisted of patients with Crohn's disease or ulcerative colitis and IDA (Hb ≤ 110 g/L and TSAT < 20 % or serum ferritin < 100 ng/mL), randomized to either oral (ferrous sulfate) or i.v. iron (ferric carboxymaltose).. A total of 196 patients were evaluated (oral iron: n = 60; i.v. iron: n = 136). Baseline CRP and IL-6 levels were independent of patients' initial Hb levels and iron status (serum ferritin and TSAT; all p > 0.05). Among iron tablet-treated patients, Hb increase was significantly smaller in the high- versus low-CRP subgroup (1.1 vs. 2.0, 2.3 vs. 3.1, and 3.0 vs. 4.0 g/dL at weeks 2, 4, and 8, respectively; all p < 0.05). Differences were less pronounced with stratification according to baseline IL-6. Response to i.v. iron was mainly independent of inflammation.. Patients with high baseline CRP achieved a lower Hb response with oral iron therapy. Our results suggest that CRP may be useful to identify IBD patients who can benefit from first-line treatment with i.v. iron to improve their IDA.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Biomarkers; C-Reactive Protein; Clinical Trials, Phase III as Topic; Colitis, Ulcerative; Crohn Disease; Ferric Compounds; Ferrous Compounds; Hematinics; Hemoglobins; Humans; Inflammation Mediators; Interleukin-6; Maltose; Randomized Controlled Trials as Topic; Retrospective Studies; Time Factors; Treatment Outcome

To determine the frequency, severity, time of onset and factors associated with the development of hypophosphatemia (HF) in patients with iron deficiency anemia treated with intravenous ferric carboxymatose (ivFCM).. Retrospective cohort study in patients iron deficiency anemia who received ivFCM and had an a prior and subsequent determination of serum phosphate. We carried out a comparative analysis between baseline and post-ivFCM levels of serum phosphate. In order to identify variables independently associated with HF a logistic regression analysis was also performed.. One hundred twenty-five patients were included. HF frequency was 58%. The median time to onset of HF was 18 days. Age, baseline ferritin levels and baseline phosphate levels were independently associated with the development of HF. The risk of HF in patients with baseline phosphate levels ≤ 3.1mg/dl was 67% higher than patients with ≥ 3.7 mg/dl.. ivFCM-associated HF is a frequent, early and, sometimes, prolonged effect in patients with iron deficiency anemia. Serum phosphate levels should be monitored after ivFCM administration, especially in older patients and in those with lower baseline phosphate or ferritin levels.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Hematinics; Humans; Hypophosphatemia; Infusions, Intravenous; Logistic Models; Male; Maltose; Middle Aged; Retrospective Studies; Treatment Outcome

Treatment with ferric carboxymaltose improves symptoms, functional capacity, and quality of life in patients with chronic heart failure and iron deficiency. The aim of this study was to assess the cost-effectiveness of ferric carboxymaltose treatment vs no treatment in these patients.. We used an economic model based on the Spanish National Health System, with a time horizon of 24 weeks. Patient characteristics and ferric carboxymaltose effectiveness (quality-adjusted life years) were taken from the Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure trial. Health care resource use and unit costs were taken either from Spanish sources, or from the above mentioned trial.. In the base case analysis, patients treated with and without ferric carboxymaltose treatment acquired 0.335 and 0.298 quality-adjusted life years, respectively, representing a gain of 0.037 quality-adjusted life years for each treated patient. The cost per patient was €824.17 and €597.59, respectively, resulting in an additional cost of €226.58 for each treated patient. The cost of gaining 1 quality adjusted life year with ferric carboxymaltose was €6123.78. Sensitivity analyses confirmed the robustness of the model. The probability of ferric carboxymaltose being cost-effective (< €30 000 per quality-adjusted life year) and dominant (more effective and lower cost than no treatment) was 93.0% and 6.6%, respectively.. Treatment with ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, is cost-effective in Spain.

Topics: Aged; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Drug Costs; Female; Ferric Compounds; Follow-Up Studies; Heart Failure; Humans; Incidence; Male; Maltose; Spain

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anemia, Iron-Deficiency; Anorexia Nervosa; Escherichia coli Infections; Female; Ferric Compounds; Humans; Maltose; Peritonitis; Zinc

Iron deficiency (ID) and iron deficiency anemia (IDA) are common findings in patients undergoing lipoprotein apheresis (LA). Different intravenous (iv) formulations are used to treat ID in LA patients, however guidelines and data on ID/IDA management in LA patients are lacking. We therefore performed a prospective observational multi-center cohort study of ID/IDA in LA patients, comparing two approved i.v. iron formulations, ferric gluconate (FG) and ferric carboxymaltose (FCM).. Inclusion criteria were a) serum ferritin <100 μg/L or b) serum ferritin <300 μg/L and transferrin saturation <20%. Patients received either FG (62.5 mg weekly) or FCM (500 mg once in ID or up to 1000 mg if IDA was present) i.v. until iron deficiency was resolved. Efficacy and safety were determined by repeated laboratory and clinical assessment. Iron parameters pre and post apheresis were measured to better understand the pathogenesis of ID/IDA in LA patients.. 80% of LA patients treated at the three participating centers presented with ID/IDA; 129 patients were included in the study. Serum ferritin and transferrin levels were reduced following apheresis (by 18% (p < 0.0001) and by 13% (p < 0.0001) respectively). Both FG and FCM were effective and well tolerated in the treatment of ID/IDA in LA patients. FCM led to a quicker repletion of iron stores (p < 0.05), while improvement of ID/IDA symptoms was not different. Number and severity of adverse events did not differ between FG and FCM, no severe adverse events occurred.. Our results suggest that FG and FCM are equally safe, well-tolerated and effective in treating ID/IDA in LA patients. These data form the basis for follow-up randomized controlled trials to establish clinical guidelines.

Topics: Aged; Anemia, Iron-Deficiency; Biomarkers; Blood Component Removal; Drug Administration Schedule; Female; Ferric Compounds; Ferritins; Germany; Hematinics; Humans; Hyperlipoproteinemias; Infusions, Intravenous; Iron; Lipoproteins, LDL; Male; Maltose; Middle Aged; Prospective Studies; Time Factors; Transferrin; Treatment Outcome

To obtain preliminary safety and efficacy data on intravenous (IV) administration of infliximab (IFX) and ferric carboxymaltose (FCM) to inflammatory bowel disease (IBD) patients in a single treatment session.. A two-phase non-interventional, observational, prospective pilot study was performed to evaluate safety and efficacy of FCM given immediately after IFX. IBD patients were recruited consecutively in the outpatient clinic in two groups. Control group patients (n = 12) received FCM on a separate day from IFX. Subsequently, single-session group patients (n = 33) received FCM after IFX on the same day. All patients received 5mg/kg IFX and 1000mg FCM for iron-restricted anemia (IRA) or 500mg FCM for iron deficiency without anemia. Safety assessment was performed by recording adverse events (AEs) during and immediately after infusion, 30 minutes afterwards, and via follow-up at 7 days and 8 weeks. For efficacy assessment, hematological parameters were assessed prior to FCM infusion (pre-FCM) and after 8 weeks. Economic impact of FCM given immediately after IFX was assessed.. All 45 patients (35 Crohn´s disease, 10 ulcerative colitis) received IFX 5mg/kg. 21 patients received 500mg FCM and 24 received 1000mg. FCM administration immediately after IFX corrected iron deficiency or IRA as shown by increases in hematological parameters. No AEs were reported during the safety evaluation at the end of FCM or IFX administration, 30 minutes, 7 days and 8 weeks afterwards, in either control or single-session groups. Total cost per patient for single-session administration was 354.63€; for patients receiving IFX and FCM on separate days, it was 531.94€, giving a 177.31€ per-patient cost saving.. Single-session administration of FCM after IFX was safe and effective in IBD patients and can offer a good cost-benefit ratio and improve treatment adherence. To our knowledge, this study is the first to evaluate FCM and IFX administration in a single treatment session.

Topics: Adult; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Drug Administration Schedule; Ferric Compounds; Gastrointestinal Agents; Humans; Inflammatory Bowel Diseases; Infliximab; Infusions, Intravenous; Male; Maltose; Middle Aged; Patient Compliance; Pilot Projects; Prospective Studies; Treatment Outcome

The objective of this study was to test the efficacy and safety of intravenous ferric carboxymaltose (FCM) in pregnant women with restless legs syndrome (RLS) and iron deficiency or anemia. The open-label pilot study (exploratory) was performed at the University Hospital of Zürich and the Neurocenter of Southern Switzerland (Lugano).. Nineteen women in the third trimester of pregnancy with moderate-to-severe RLS and serum ferritin levels <35 µg/l or hemoglobin (Hb) < 11.0 g/dl were included in the study. RLS was graded according to the International Restless Legs Syndrome (IRLS) Study Group rating scale. All participants had a score of ≥20 or had RLS ≥3 times/week. Based on the Hb levels, 500 or 700 mg of FCM was administered over 20 min. The primary end point was a ≥ 50% reduction in the mean IRLS score one week after FCM infusion. The secondary end points included periodic limb movements (PLMs; assessed using nocturnal foot actigraphy), sleep quality (assessed using the Pittsburgh Sleep Quality Index), and safety.. The IRLS score decreased from 23 ± 7 (baseline) to 13 ± 7 (P <0.01), whereas the PLM index decreased from 35 ± 26 (baseline) to 25 ± 20 (P <0.001). Significant improvement in sleep quality was also reported (P <0.029), and treatment was well tolerated. Three serious adverse events were reported, but they were considered unrelated to treatment.. These data provide promising evidence on the safety and efficacy of FCM for moderate-to-severe RLS in pregnant women with iron deficiency or anemia. Therefore, a future placebo-controlled study is warranted.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Ferritins; Humans; Maltose; Pilot Projects; Pregnancy; Pregnancy Complications; Prospective Studies; Restless Legs Syndrome; Switzerland; Time Factors; Treatment Outcome

Anemia is the most common hematological alteration in patients with Crohn's disease, and is frequently related to intestinal inflammatory activity. Its cause is multifactorial and mostly associated with absolute iron deficiency (iron deficiency anemia) and/or functional iron deficiency (inflammation anemia or anemia of chronic disease). It may also be identified through other causes, such as folic acid or vitamin B12 deficiency and secondary to adverse effects from medications (salicylic derivatives and immunosuppressive drugs). In the present study, patients with active Crohn's disease and anemia were evaluated and treated with intravenous ferric carboxymaltose. We discuss the therapeutic schemes (doses), safety, results and improvement of quality of life.. In the present prospective study, 10 consecutive patients with Crohn's disease, with moderate to severe activity, with anemia (Hb: 6.7 to 10 g/dL), who were attended between March 2014 and March 2015, were evaluated. Six (60%) were men and four were women, all with moderate or severe anemia (hemoglobin <10 g/dL). They were treated with a maximum of three intravenous infusions of 1000 mg of ferric carboxymaltose, of at least 15 minutes in duration. It was also sought to correlate the inflammatory Crohn's disease activity degree (measured using the Crohn's Disease Activity Index, CDAI) and C-reactive protein level with the severity of anemia. The primary outcome was an increase in Hb of ≥2 g/dL and the secondary outcome was the normalization of anemia (Hb ≥12 g/dL for women and ≥13 g/dL for men) and the improvement in quality of life seen 12 weeks after the last application of carboxymaltose.. Among the 10 patients studied, parenteral iron supplementation was administered in three cases during hospitalization and the others received this on an outpatient basis. The total iron dose ranged from 1,000 to 2,000 mg, with an average of 1,650 mg. Crohn's disease activity measured using CDAI and C-reactive protein correlated with the intensity of anemia. An increase of 2 g/dL occurred in eight (80%) patients after 12 weeks and normalization of anemia was found in seven (70%) patients. Improvements in quality-of-life scores were found for all (100%) patients after 12 weeks. Carboxymaltose was well tolerated. Three patients presented adverse reactions (two with nausea and one with headache) of mild intensity.. Anemia is a frequent complication for Crohn's disease patients. Intravenous iron therapy has been recommended for Crohn's disease patients, because for these patients, oral iron absorption is very limited. This is because of the inflammatory state and "blocking" of iron entry into enterocytes through hepcidin action on ferroportin, along with the elevated rates of gastrointestinal adverse events that compromise adherence to treatment and possibly aggravate the intestinal inflammatory state. The degree of Crohn's disease activity, as measured using CDAI and C-reactive protein, correlates with the severity of anemia. Carboxymaltose is a safe drug, which can be administrated in high doses (up to 1,000 mg per application per week) and corrects anemia and iron stocks over a short period of time, with consequent improvement in quality of life.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Crohn Disease; Female; Ferric Compounds; Humans; Male; Maltose; Middle Aged; Prospective Studies; Quality of Life; Severity of Illness Index; Treatment Outcome; Young Adult

Iron deficiency is common in pregnancy, postpartum, inflammatory bowel disease, chronic kidney disease, chronic heart failure, heavy uterine bleeding, cancer and following surgery. We estimate the budget impact (BI) on the Swiss mandatory health insurance associated with substituting iron sucrose (standard) with ferric carboxymaltose (new treatment) using real-life data.. Resource use was based on recent primary data (Polyquest Prescriber Analysis, Anemia Patient Record Study in Switzerland). Personnel costs were estimated using the Swiss Tarmed fee-for-service reimbursement system. Drug costs and costs of materials used were based on official tariffs (Spezialitätenliste, MiGeL). Actual IMS sales data of both products were used to verify the BI model (1 CHF ≈ 1 USD, Jan 2013).. Ferric carboxymaltose was associated with cost savings of 30-44 % per patient per treatment cycle compared to iron sucrose. Costs per 200/500/1,000 mg total dosage treatment cycle were CHF 101/210/420 for ferric carboxymaltose and CHF 144/375/721 for iron sucrose. This results in cost savings of CHF 22-31 million across all indications in 2009. Savings were driven by personnel cost reductions (application time and number of applications). Sensitivity analyses confirmed these cost savings, even for the higher application costs of ferric carboxymaltose, with minimum savings of CHF 17 million per year.. Treating iron deficiency involves substantial costs to the Swiss MHI which may be reduced by substituting iron sucrose with ferric carboxymaltose. The use of real-life data raises methodological questions about the fundamental compatibility of this data with the conceptual framework of BI analysis.

Topics: Anemia, Iron-Deficiency; Budgets; Cost Savings; Drug Substitution; Female; Ferric Compounds; Ferric Oxide, Saccharated; Financing, Personal; Glucaric Acid; Humans; Maltose; National Health Programs; Switzerland

Topics: Aged; Anemia, Iron-Deficiency; Causality; Diabetes Mellitus, Type 2; Ferric Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Hepatitis C, Chronic; Humans; Hypocalcemia; Hypophosphatemia; Infusions, Intravenous; Male; Maltose

Malnutrition may result in a phosphate-deficient state owing to a chronically insufficient phosphate intake. Concomitant iron deficiency is common and often supplemented by the intravenous route. It is not widely recognized that some parenteral iron formulations can induce hypophosphatemia. Herein we report a case of a severe and symptomatic hypophosphatemia (0.18 mM, normal range 0.8-1.4 mM) associated with an inappropriately reduced tubular reabsorption of phosphate (33%, norm >95%) in a malnourished patient with anorexia/bulimia who received 2 × 500 mg iron carboxymaltose (FCM) intravenously. Despite intravenous and oral phosphate supplements, it required 2 months to achieve a normal serum phosphate level. Our case demonstrates that in a chronically malnourished and phosphate-deficient state intravenous FCM could potentially be dangerous. If this form of iron application cannot be avoided, phosphate supplementation before and after iron infusion as well as close monitoring of phosphate levels are needed.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Anorexia; Bulimia; Dietary Supplements; Female; Ferric Compounds; Humans; Hypophosphatemia; Injections, Intravenous; Malnutrition; Maltose; Parenteral Nutrition; Phosphates; Weight Loss; Young Adult

Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anaemia (IDA) is associated with significant maternal, fetal and infant morbidity. Current options for treatment are limited: these include oral iron supplementation, which can be ineffective and poorly tolerated, and red blood cell transfusions, which carry an inherent risk and should be avoided. Ferric carboxymaltose is a new treatment option that may be better tolerated.The study was designed to assess the safety and efficacy of iron deficiency anaemia (IDA) correction with intravenous ferric carboxymaltose in pregnant women with mild, moderate and severe anaemia in the second and third trimester.. Prospective observational study; 65 anaemic pregnant women received ferric carboxymaltose up to 15 mg/kg between 24 and 40 weeks of pregnancy (median 35 weeks gestational age, SD 3.6). Treatment effectiveness was assessed by repeat haemoglobin (Hb) measurements and patient report of well-being in the postpartum period. Safety was assessed by analysis of adverse drug reactions and fetal heart rate monitoring during the infusion.. Intravenous ferric carboxymaltose infusion significantly increased Hb values (p < 0.01) above baseline levels in all women. Increased Hb values were observed at 3 and 6 weeks post infusion and up to 8 weeks post-infusion. Ferritin values increased significantly after the infusion. Only 4 women had repeat ferritin values post-partum which remained above baseline levels. Fetal heart rate monitoring did not indicate a drug related negative impact on the fetus. Of the 29 (44.6%) women interviewed, 19 (65.5%) women reported an improvement in their well-being and 9 (31%) felt no different after the infusion. None of the women felt worse. No serious adverse effects were found and minor side effects occurred in 13 (20%) patients.. Our prospective data is consistent with existing observational reports of the safe and effective use of ferric carboxymaltose in the treatment of iron deficiency anaemia in pregnancy.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Follow-Up Studies; Gestational Age; Hemoglobins; Humans; Infant, Newborn; Infusions, Intravenous; Iron; Maltose; Pregnancy; Pregnancy Complications, Hematologic; Pregnancy Outcome; Prospective Studies; Treatment Outcome

Nearly half of all non-dialysis chronic kidney disease (CKD) patients respond to iron therapy. Factors affecting anemia response to iron therapy are not well characterized. Oxidative stress (OS) is a recognized factor for anemia in CKD and promotes erythropoiesis stimulating agent (ESA) resistance; however, the influence in predicting response to intravenous (IV) iron has not been evaluated.. Patients (n = 47) with non-dialysis CKD stages 3 - 5 (mean eGFR: 26 ± 10.4 mL/min/1.73 m2) and iron-deficiency anemia (hemoglobin < 11 g/dL, transferrin saturation (TSAT) index < 20%, and/or ferritin < 100 ng/mL) received a single injection of 1,000 mg of ferric carboxymaltose (FCM) and were observed for 12 weeks. Based on erythropoietic response (defined as ≥ 1 g/dL increase in hemoglobin level), patients were classified as responders or non-responders. Baseline conventional markers of iron status (TSAT and ferritin), inflammatory markers (C-reactive protein and IL-6), OS markers (oxidized LDL, protein carbonyl groups, erythrocyte superoxide dismutase, and glutathione peroxidase (GPx)), and catalase activity were measured.. FCM resulted in a significant increase in hemoglobin, TSAT, and ferritin (10 ± 0.7 vs. 11.4 ± 1.3 g/dL, p < 0.0001; 14.6 ± 6.4% vs. 28.9 ± 10%, p < 0.0001; 67.8 ± 61.7 vs. 502.5 ± 263.3 ng/dL, p < 0.0001, respectively). Responders and non-responders were 34 (72%) and 13 (28%), respectively. Age, baseline hemoglobin, estimated glomerular filtration rate, parathyroid hormone, and use of ESA or angiotensin-modulating agents were similar in both groups. Responders showed a tendency towards lower TSAT than non-responders (13.6 ± 6.5% vs. 17.2 ± 5.6%, p = 0.06) but similar ferritin levels. Inflammatory markers were similar in both groups. eGPx activity was lower in non-responders compared to responders (103.1 ± 50.9 vs. 144.9 ± 63.1 U/g Hb, p = 0.01, respectively), although the other proteins, lipid oxidation markers, and enzymatic antioxidants did not differ between the two groups. In the multivariate adjusted model, odds (95% CI) for achieving erythropoietic response to FCM were 10.53 (1.25 - 88.16) in the third tertile of eGPX activity and 3.20 (0.56 - 18.0) in the second tertile compared to those in the lowest tertiles (p = 0.02).. Decreased eGPx activity has adverse influences on response to FCM, suggesting that impaired erythrocyte antioxidant defense may be involved in the response to iron therapy in CKD patients.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Biomarkers; Drug Administration Schedule; Erythrocytes; Erythropoiesis; Female; Ferric Compounds; Glutathione Peroxidase; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Male; Maltose; Middle Aged; Multivariate Analysis; Odds Ratio; Oxidative Stress; Predictive Value of Tests; Renal Insufficiency, Chronic; Time Factors; Treatment Outcome

Topics: Adult; Anemia, Iron-Deficiency; Chronic Disease; Diagnosis, Differential; Erythrocyte Indices; Female; Ferric Compounds; Ferritins; Hemoglobinometry; Humans; Infusions, Intravenous; Iron Deficiencies; Maltose; Menorrhagia; Transferrin

Pulmonary arterial hypertension (PAH) is a progressive condition harboring a poor prognosis. Iron deficiency in PAH correlates with disease severity and mortality. While replacement therapy may be beneficial, dietary iron absorption is impaired in PAH patients by hepcidin, a key regulatory protein of iron homoeostasis. We therefore assessed the therapeutic potential and safety of intravenous iron supplementation in patients with PAH and iron deficiency.. 20 patients with PAH and iron deficiency, who were on stable targeted PAH therapy, received a single infusion of ≤1000 mg ferric carboxymaltose. All patients were assessed at baseline and two months after iron treatment. Exercise capacity was evaluated based on the 6-minute-walking distance (6MWD), and quality of life (QoL) was assessed by the SF-36 questionnaire (100 point scale). The effects were compared to 20 matched patients with stable PAH without iron deficiency who did not receive ferric carboxymaltose.. In iron deficient patients, iron supplementation led to a marked improvement of iron status (serum iron 5.7±0.4 to 11.1±1.1 μmol/L, ferritin 29.3±6.3 to 145.2±25.4 μg/L, transferrin saturation 7.5±0.7 to 19.3±2.3%, all p≤0.001). Iron-deficient patients receiving ferric carboxymaltose showed a significant increase of the 6MWD from 346.5±28.3 to 374.0±25.5 m (p=0.007), whereas no significant changes were found in the control group not receiving iron supplementation (6MWD 389.9±25.3 to 379.6±26.2 m; n.s.), resulting in a net increase in the 6MWD of 37.8m (p=0.003). This was associated with an improvement in QoL (SF-36 score from 44.3±3.7 to 50.6±3.6; p=0.01). Only minimal side-effects were reported.. These data indicate that parenteral iron supplementation with ferric carboxymaltose significantly improves exercise capacity and QoL and is well tolerated in patients with PAH and iron deficiency, and when administered in addition to targeted PAH therapies. Our results provide proof of concept for further studies evaluating the potential of iron as an adjunct in PAH treatment on a larger scale.

Topics: Aged; Anemia, Iron-Deficiency; Exercise Test; Female; Ferric Compounds; Humans; Hypertension, Pulmonary; Infusions, Intravenous; Male; Maltose; Middle Aged; Pilot Projects; Prospective Studies; Quality of Life

The treatment of iron deficiency anemia in children with inflammatory bowel disease is a particular challenge and often insufficient. Absorption of orally given iron may be impaired by intestinal inflammation and treatment with oral iron may aggravate intestinal inflammation. This retrospective study is the first to describe the use of intravenous ferric carboxymaltose (FCM) in the pediatric setting.. All subjects who had received at least one dose of FCM intravenously in the observation period were included in this analysis with data collected for up to 3 months post last FCM dose.. In total, 72 children between 0 and 18 years with underlying gastrointestinal disorders had been treated for concomitant iron deficiency anemia. The majority of patients had Crohn's disease (40.3%) or ulcerative colitis (30.5%). The total number of FCM administrations was 147, the mean number per patient was 2.0 and the mean cumulative dose 821 mg iron (median single dose: 500 mg; max. 1000 mg). Post administration of FCM, correction of iron deficiency anemia was observed with improved mean hemoglobin levels from 9.5 g/dL at baseline to 11.9 g/dL within 5-12 weeks. Decreases in white cell count, platelets and C-reactive protein were observed post FCM, potentially suggesting reduced inflammation with iron repletion. Three subjects reported mild adverse drug reactions related to FCM; two of these were considered to be potentially related to long duration of administration and to high volume of saline solution for dilution. As such, the method of administration was amended to have a maximum infusion time of 60 minutes and dilution with less than or equal to 100 mL saline solution.. Overall FCM was well tolerated in this pediatric population and appeared to be effective in correcting iron deficiency anemia. We cannot exclude that the correction of iron deficiency anaemia is in some part due to the treatment of the underlying disease and not related to the iron supplementation only.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Gastrointestinal Diseases; Humans; Infant; Infant, Newborn; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Maltose; Retrospective Studies; Treatment Outcome

Anemia in the elderly is a common clinical finding. Prevalence in hospitalized geriatric patients approximates up to 40% presenting as iron deficiency anemia associated with absolute iron deficiency, anemia of chronic disease associated with functional iron deficiency or unexplained anemia. In patients with functional iron deficiency oral iron substitution is ineffective due to elevated hepcidin levels, such as in renal anemia. In these patients intravenous iron substitution represents a cornerstone. However, data among geriatric patients are limited. We conducted three non-interventional studies collecting data with respect to efficacy and tolerance of ferric carboxymaltose (ferinject) in three patient groups (cancer, chronic kidney disease [CKD], chronic inflammatory bowel disease [CIBD]) with anemia and functional iron deficiency. The present sub-analysis describes the results among the geriatric patients (age > 70 years) observed in all three observational studies.. 264 patients were analyzed (mean age of 76.9 years [70-90 years; SD +/- 5.2 years]). Patients received an average amount of 1200 mg ferric carboxymaltose (746-1575 mg).. Hemoglobin levels (p < 0.001), serum ferritin (p < 0.001) and transferrin saturation (p < 0.05) rose significantly in CKD patients; in CIBD patients hemoglobin and transferrin saturation rose significantly (p < 0.05) while the rise of ferritin failed to be significant. In oncologic patients the rise of hemoglobin and ferritin levels was of high statistic significance (p < 0.001) and transferrin saturation also rose significantly (p = 0.02) Fatigue, mental capacities as well as dyspnea improved among CKD-and CIBD-groups. No severe adverse reactions occurred.. Administration of ferric carboxymaltose in geriatric patients is well tolerated and offers an effective treatment option for the treatment of functional iron deficiency.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Chronic Disease; Dose-Response Relationship, Drug; Female; Ferric Compounds; Follow-Up Studies; Germany; Hemoglobinometry; Humans; Infusions, Intravenous; Male; Maltose; Transferrin

Topics: Anemia, Iron-Deficiency; Bone Marrow Examination; Diagnosis, Differential; Early Diagnosis; Ferric Compounds; Ferritins; Hemoglobinometry; Humans; Maltose; Predictive Value of Tests

Iron deficiency anemia (IDA) is a common finding in patients after bariatric surgery. The cause is multifactorial including reduced oral iron intake and malabsorption. While many patients can be managed with oral supplements, parenteral iron may be needed to restore and maintain iron stores.. Subjects who had previous bariatric surgery and had participated in phase 3 industry-sponsored clinical trials designed to assess the safety and/or efficacy of intravenous (IV) ferric carboxymaltose (FCM) were retrospectively selected from the databases of each of these studies. Demographic data, efficacy measures [hemoglobin, ferritin, and transferrin saturation (TSAT)], and adverse events were compared between FCM and other agents utilized as comparators in the trials.. Two hundred eighty-one subjects from the intention to treat (ITT) population were included (mean age 49 years, BMI 33 kg/m(2), including 253 females). FCM had similar or improved efficacy (p < 0.05) in terms of increasing hemoglobin, ferritin, and TSAT values when compared to other iron products used as standard of care for IDA. The incidence of adverse events in the FCM patients (n = 123) versus patients receiving any IV iron (n = 126) was 61 and 56.3 %, respectively. The adverse events were similar in both groups with the exception of a transient decrease in serum phosphate which was observed more frequently in the FCM group.. These data in post-bariatric surgery IDA patients suggest that FCM is a safe and effective alternative to existing iron products permitting higher and thus less frequent individual doses.

Topics: Adult; Anemia, Iron-Deficiency; Bariatric Surgery; Biomarkers; Dietary Supplements; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferritins; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Iron, Dietary; Malabsorption Syndromes; Male; Maltose; Middle Aged; Obesity, Morbid; Parenteral Nutrition; Postoperative Complications; Randomized Controlled Trials as Topic; Retrospective Studies; Transferrin; Treatment Outcome; United States

Treatment with parenteral iron causes oxidative stress, inflammation and endothelial dysfunction. Ferric carboxymaltose (FCM) is a new preparation of non-dextran iron which, due to its pharmacokinetics and stability, may induce less toxicity than other iron molecules. The aim of this study was to analyse the effect of FCM on inflammation and adhesion molecules in chronic kidney disease (CKD).. Forty-seven patients with predialysis CKD and iron-deficiency anaemia received a single dose of FCM (15 mg/kg, maximum dose 1 gram). At baseline and after 60 minutes (acute effect) and after 3 weeks and 3 months (sub-acute effect), we determined inflammatory markers: C-reactive protein (CRP), interleukin-6 (IL-6) and endothelial dysfunction: intercellular adhesion molecule (ICAM) and vascular adhesion molecule (VCAM).. Treatment with FCM was associated with a significant increase in haemoglobin levels: 10 (0.7) vs. 11.4 (1.3)g/dl, p<.0001. CRP, IL-6, ICAM and VCAM levels did not correlate with baseline haemoglobin or ferritin levels and there was no relationship between changes in these markers and those of haemoglobin after administration of FCM. No significant, acute or sub-acute changes occurred in any of the inflammatory or endothelial markers studied. Statin therapy was associated with lower VCAM concentrations.. Treatment with high doses of FCM in patients with predialysis CKD has no proinflammatory effect and does not alter levels of adhesion molecules ICAM and VCAM in this population.

Topics: Aged; Anemia, Iron-Deficiency; Cell Adhesion Molecules; Female; Ferric Compounds; Humans; Inflammation; Kidney Failure, Chronic; Male; Maltose; Prospective Studies

Implantable central venous access port (portacath) is used to provide long-term venous access and to deliver chemotherapy in cancer patients. Intravenous iron complexes are frequently prescribed in this setting, and some physicians use a portacath for their administration. The aim of this survey was to assess the frequency of this practice and the reasons supporting it.. This declarative survey was conducted in France; 497 oncologists/hematologists were contacted to answer a survey on their practices regarding the administration of intravenous iron via a portacath.. A total of 141 recipients (29.5 %) completed the questionnaire. The intravenous iron complexes most frequently used were iron sucrose and ferric carboxymaltose, and 55.2 % of the responders reported using a portacath to administer intravenous iron complexes. The main reasons mentioned for this practice were ease of administration (27.9 %) and preservation of venous capital (27.6 %). The main reasons reported for not using a portacath to administer intravenous iron were a history of thrombosis (45.1 %) or potential drug interactions (17.7 %). Efficacy and safety were expected to be similar to those observed with peripheral administration. A 47.6 % of physicians declared that they usually did not observe adverse reactions after use of a portacath for iron administration. Intravenous iron administration was always planned after chemotherapy for 46.6 % of the responders and before chemotherapy for 38.2 %, whereas 15.3 % did not have any preference for either option.. Intravenous iron complexes (mainly iron sucrose and ferric carboxymaltose) are commonly administered through a portacath in cancer patients in France. The choice for this route of administration is supported by clinical considerations, but further studies are needed to confirm the efficacy and safety of this practice.

Topics: Anemia, Iron-Deficiency; Central Venous Catheters; Ferric Compounds; Ferric Oxide, Saccharated; France; Glucaric Acid; Humans; Infusions, Intravenous; Maltose; Neoplasms; Practice Patterns, Physicians'; Surveys and Questionnaires

Topics: Anemia, Iron-Deficiency; Erythrocyte Indices; Female; Ferric Compounds; Heart Failure; Hemoglobins; Humans; Male; Maltose

Iron anaemia and iron-deficient erythropoiesis are treated with oral iron supplements. For chronic haemodialysis or in the case of therapy failure or intolerance to oral iron therapy, intravenous supplements are administered. The costs of iron supplements borne by statutory health care insurance had strongly increased during the observation period from 2006 to 2010. Based on the invoice data of a large health insurance company with a market share of around 18 %, prescription data of iron preparations and laboratory tests were analysed and extrapolated to the Swiss population. During the 5-year observation period, costs of intravenous iron substitution increased by 16.5 m EUR (340.3 %) and the number of individuals treated by 243.5 %. A sharp rise was observed in women of menstruating age, which was mainly due to prescriptions issued by primary care physicians. More than 8 % of intravenous iron substitutions were administered without prior laboratory analysis,and must therefore be regarded as off-label use. A cost-benefit analysis is needed to demonstrate the additional value of intravenous over oral iron supplementation, and intravenous iron supplementation should be administered only to patients with proven iron deficiency.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Anemia, Iron-Deficiency; Child; Child, Preschool; Cost Savings; Cross-Sectional Studies; Drug Costs; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobinometry; Humans; Infant; Infusions, Intravenous; Iron Compounds; Male; Maltose; Middle Aged; National Health Programs; Off-Label Use; Retrospective Studies; Switzerland; Young Adult

Topics: Anemia, Iron-Deficiency; Drug Approval; Ferric Compounds; Humans; Infusions, Intravenous; Maltose

Topics: Adult; Anemia, Iron-Deficiency; Drug Approval; Ferric Compounds; Humans; Infusions, Intravenous; Maltose; United States; United States Food and Drug Administration

Historically, the Renal Unit at King's College Hospital used intravenous (IV) iron sucrose (IS) to treat iron deficiency anaemia in patients with chronic kidney disease who were not on dialysis (CKD-ND). As part of a service initiative to improve patient experience, new products were considered as alternatives. This study investigated the potential impact on patient experience and service costs by switching from IS to ferric carboxymaltose (FCM).. A decision analytical model was used to calculate the impact of switching from IS to FCM for a cohort of CKD-ND patients. Service provision data were collected for 365 patients who received 600 mg IS within a 12 month period, creating the IS data set. The service provision data, along with a clinically relevant FCM administration protocol (stipulating total doses of 500 mg FCM), were used to calculate a corresponding theoretical data set for FCM for the same cohort of patients.. The FCM protocol saved each patient two hospital visits and 2.66 hours of time (equating to approximately a saving of £36.21 in loss of earnings) and £19 in travel costs. Direct attributable costs for iron administration (which included drug, disposables, nursing staff, and hospital-provided patient transport costs) were £58,646 for IS vs £46,473 for FCM. Direct overhead costs (which included nursing preparation time, administration staff, clinic space, and consultant time costs) were £40,172 for the IS service vs £15,174 for the FCM service.. Based on clinical experience with the products, this analysis assumes that 500 mg FCM is therapeutically equivalent to 600 mg IS. Consultant time costs are assumed to be the same between the two treatment groups. IV iron administration protocols and data are specific to King's College Hospital. The design is retrospective and changes to the management of the clinic, including service delivery optimization, may also affect real costs.. FCM was associated with fewer hospital visits and reduced transport costs for CKD-ND patients receiving IV iron and has the potential to save 19-37% in service costs. Owing to increased administration efficiency, FCM can improve the overall patient experience while reducing the total cost of the King's College Hospital IV iron service for CKD-ND patients, compared with treatment with IS.

Topics: Administration, Intravenous; Ambulatory Care Facilities; Anemia, Iron-Deficiency; Clinical Protocols; Costs and Cost Analysis; Decision Support Techniques; Efficiency, Organizational; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hospitalization; Humans; Maltose; Patient Preference; Renal Insufficiency, Chronic; Transportation; United Kingdom

Intravenous (i.v.) iron can improve anaemia of chronic disease and response to erythropoiesis-stimulating agents (ESAs), but data on its use in practice and without ESAs are limited. This study evaluated effectiveness and tolerability of ferric carboxymaltose (FCM) in routine treatment of anaemic cancer patients.. Of 639 patients enrolled in 68 haematology/oncology practices in Germany, 619 received FCM at the oncologist's discretion, 420 had eligible baseline haemoglobin (Hb) measurements, and 364 at least one follow-up Hb measurement. Data of transfused patients were censored from analysis before transfusion.. The median total iron dose was 1000 mg per patient (interquartile range 600-1500 mg). The median Hb increase was comparable in patients receiving FCM alone (1.4 g/dl [0.2-2.3 g/dl; N = 233]) or FCM + ESA (1.6 g/dl [0.7-2.4 g/dl; N = 46]). Patients with baseline Hb up to 11.0 g/dl and serum ferritin up to 500 ng/ml benefited from FCM treatment (stable Hb ≥ 11.0 g/dl). Also patients with ferritin >500 ng/ml but low transferrin saturation benefited from FCM treatment. FCM was well tolerated, 2.3% of patients reported putative drug-related adverse events.. The substantial Hb increase and stabilisation at 11-12 g/dl in FCM-treated patients suggest a role for i.v. iron alone in anaemia correction in cancer patients.

Topics: Aged; Anemia, Iron-Deficiency; Antineoplastic Agents; Female; Ferric Compounds; Ferritins; Hematinics; Hemoglobins; Humans; Male; Maltose; Middle Aged; Neoplasms; Treatment Outcome

We analyzed iron deficiency and the therapeutic response following intravenous ferric carboxymaltose in a large single-center inflammatory bowel disease (IBD) cohort.. 250 IBD patients were retrospectively analyzed for iron deficiency and iron deficiency anemia. A subgroup was analyzed regarding efficacy and side effects of iron supplementation with ferric carboxymaltose.. In the cohort (n = 250), 54.4% of the patients had serum iron levels ≤60 μg/dl, 81.2% had ferritin ≤100 ng/ml, and 25.6% had hemoglobin (Hb) of ≤12 g/dl (females) or ≤13 g/dl (males). In the treatment subcohort (n = 80), 83.1% of the patients had iron ≤60 μg/dl, 90.4% had ferritin ≤100 ng/ml, and 66.7% had Hb ≤12/13 g/dl before ferric carboxymaltose treatment. After a median dose of 500 mg ferric carboxymaltose, 74.7% of the patients reached iron >60 μg/dl, 61.6% had ferritin >100 ng/ml, and 90.7% reached Hb >12/13 g/dl at follow-up (p < 0.0001 for all parameters vs. pretreatment values). The most frequent adverse event was a transient increase of liver enzymes with male gender as risk factor (p = 0.008, OR 8.62, 95% CI 1.74-41.66).. Iron deficiency and anemia are frequent in IBD patients. Treatment with ferric carboxymaltose is efficious, safe and well tolerated in iron-deficient IBD patients.

Topics: Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Cohort Studies; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Iron; Male; Maltose; Middle Aged; Treatment Outcome; Young Adult

Iron restriction has been proposed as a cause of erythropoietic suppression in malarial anemia; however, the role of iron in malaria remains controversial, because it may increase parasitemia. To investigate the role of iron-restricted erythropoiesis, A/J mice were infected with Plasmodium chabaudi AS, treated with intravenous ferric carboxymaltose at different times, and compared with untreated controls. Iron treatment significantly increased weight and hemoglobin nadirs and provided enhanced reticulocytosis and faster recovery, compared with controls. Our findings challenge the restrictive use of iron therapy in malaria and show the need for trials of intravenous ferric carboxymaltose as an adjunctive treatment for severe malarial anemia.

Topics: Anemia, Iron-Deficiency; Animals; Disease Models, Animal; Erythropoiesis; Ferric Compounds; Growth Substances; Malaria; Male; Maltose; Mice; Mice, Inbred A; Plasmodium chabaudi; Treatment Outcome

Topics: Anemia, Iron-Deficiency; Cystic Fibrosis; Ferric Compounds; Humans; Hypersensitivity; Infusions, Intravenous; Iron; Lung Diseases; Maltose; Retrospective Studies

The purpose of this study is to compare the safety and efficacy of intravenous (IV) high-dose iron carboxymaltose (ICM) with iron sucrose (IS) for the treatment of postpartum anemia.. We performed a retrospective cohort study with 210 anemic inpatient women in the postpartum period who received IV high-dose ICM (15 mg/kg; maximum, 1000 mg) or IS (2×200 mg), respectively. Safety and tolerability of both groups were compared on the basis of reported systemic and local adverse events. The cohorts were matched for baseline characteristics and their initial hemoglobin (Hb) values. The secondary endpoint included drug efficacy assessment by measurement of Hb level increase up to 8 days after treatment.. Rapid administration of high ICM doses was as well tolerated as IS with overall adverse events of 5% (ICM) vs. 6% (IS). The most common complaint was burning and pain at the injection site. ICM was as effective as IS in changing Hb levels from the baseline. There was no difference in the mean daily Hb increase between the groups. Women with severe anemia showed the most effective responsiveness.. IV ICM is as safe as IS in the management of postpartum (IDA) iron deficiency anemia despite five times of higher dosage. Both drugs are effective and offer a rapid normalization of Hb after delivery. The single application of ICM shows advantages of lower incidence of side effects at the injection site, a shorter treatment period, and better patient compliance.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Blood Transfusion; Cohort Studies; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Maltose; Puerperal Disorders; Retrospective Studies; Treatment Outcome

Intravenous iron is widely used to treat iron deficiency in day-care units. Ferric carboxymaltose (FCM) allows administration of larger iron doses than iron sucrose (IS) in each infusion (1000 mg vs. 200 mg). As FCM reduces the number of infusions required but is more expensive, we performed a cost-minimization analysis to compare the cost impact of the two drugs.. The number of infusions and the iron dose of 111 consecutive patients who received intravenous iron at a gastrointestinal diseases day-care unit from 8/2007 to 7/2008 were retrospectively obtained. Costs of intravenous iron drugs were obtained from the Spanish regulatory agencies. The accounting department of the Hospital determined hospital direct and indirect costs for outpatient iron infusion. Non-hospital direct costs were calculated on the basis of patient interviews. In the pharmacoeconomic model, base case mean costs per patient were calculated for administering 1000 mg of iron per infusion using FCM or 200 mg using IS. Sensitivity analysis and Monte Carlo simulation were performed.. Under baseline assumptions, the estimated cost of iron infusion per patient and year was €304 for IS and €274 for FCM, a difference of €30 in favour of FCM. Adding non-hospital direct costs to the model increased the difference to €67 (€354 for IS vs. €287 for FCM). A Monte Carlo simulation taking into account non-hospital direct costs favoured the use of FCM in 97% of simulations.. In this pharmacoeconomic analysis, FCM infusion reduced the costs of iron infusion at a gastrointestinal day-care unit.

Topics: Ambulatory Care; Anemia, Iron-Deficiency; Costs and Cost Analysis; Ferric Compounds; Humans; Infusions, Intravenous; Maltose; Monte Carlo Method; Retrospective Studies; Sucrose

Topics: Anemia, Iron-Deficiency; Chronic Disease; Ferric Compounds; Heart Failure; Hematinics; Humans; Infusions, Intravenous; Iron-Dextran Complex; Maltose

Topics: Anemia, Iron-Deficiency; Cost-Benefit Analysis; Dose-Response Relationship, Drug; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Maltose; Quality of Life; Treatment Outcome

Topics: Administration, Oral; Anemia, Iron-Deficiency; Erythropoietin; Ferric Compounds; Humans; Injections, Intramuscular; Injections, Intravenous; Iron; Iron Overload; Maltose; Recombinant Proteins; Renal Dialysis

Ferric carboxymaltose (FCM, Ferinject) was effective and well tolerated in the treatment of iron-deficiency anemia (IDA) in nine, Phase III, randomized, controlled, multicenter trials in a diverse range of indications, including patients with inflammatory bowel disease (IBD), post-partum anemia (PPA) or abnormal uterine bleeding (AUB), chronic heart failure (CHF), non-dialysis-dependent chronic kidney disease (CKD) and those undergoing hemodialysis (HD). In most trials, patients received either FCM doses of < or = 1000 mg, administered intravenously (i.v.) over < or = 15 min. or oral ferrous sulfate (FeSulf) 325 mg (65 mg iron), three times daily (t.i.d.), or 304 mg (100 mg iron), twice daily (b.i.d.). In one trial, patients on HD received 200 mg i.v. of either FCM or iron sucrose (ISC), two-to-three times weekly. In a pilot study in patients with CHF and CKD, patients received 200 mg of FCM by push injection compared with 200 mg of ISC slow injection. FCM was usually administered until the patient's calculated total iron replacement dose was achieved. Treatment with FCM improved indices of anemia (hemoglobin [Hb], ferritin and transferrin saturation [TSAT] values). In patients on HD with IDA secondary to CKD, FCM demonstrated comparable efficacy to ISC in achieving an increase in Hb. In patients with IBD or PPA, improvements in Hb levels were more rapid with FCM than with FeSulf. Patients with PPA receiving FCM compared with those receiving oral iron achieved an Hb rise > or = 2.0 g/dl earlier (7 days compared with 14 days; p < 0.001), were more likely to achieve an Hb rise > or = 3.0 g/dl at any time beginning at day 14 (86.3% compared with 60.4%; p < 0.001), and achieve an Hb > 12.0 g/dl at the end of the study (Day 42; 90.5% compared with 68.6%, p < 0.01). Serum ferritin increased in the i.v. FCM treatment group, but not in the oral iron group. Differences between groups were significant at each study interval. TSAT increased significantly at every interval in both groups; however, FCM-treated patients showed higher TSAT at each interval after the first week. FCM improved patient quality of life to an equivalent extent to oral FeSulf in patients with IBD or PPA, and to a greater extent than oral FeSulf in women with AUB. FCM also improved quality of life as well as functional symptoms and exercise capacity in patients with CHF. Safety data from more than 3000 patients showed that FCM was well tolerated. No safety concerns have been identified in breas

Topics: Anemia; Anemia, Iron-Deficiency; Breast Feeding; Female; Ferric Compounds; Ferritins; Heart Failure; Humans; Infant; Inflammatory Bowel Diseases; Maltose; Pilot Projects; Puerperal Disorders; Randomized Controlled Trials as Topic; Renal Insufficiency; Safety; Transferrin

Anemia is common in IBD patients and intravenous iron treatment is preferred. The drug cost of intravenous iron carboxymaltose is approximately twice the cost of intravenous iron sucrose. The aim was to evaluate the health care costs of intravenous iron sucrose (Venofer®, Vifor) and intravenous iron carboxymaltose (Ferinject®, Vifor) treatment to IBD patients in an outpatient setting.. Based on data from 111 IBD patients treated with intravenous iron in an outpatient setting health care costs were evaluated by means of Budget Impact Analysis, Cost Effective Analysis and Cost Benefit Analysis.. The Cost Effective Analysis showed that iron carboxymaltose was more cost-effective than iron sucrose, due to fewer outpatient setting visits. Even a sensitivity analysis using a reduced patient income (50%) in the Cost Effective Analysis showed iron carboxymaltose to be the most cost effective treatment. The Budget Impact Analysis from a hospital perspective showed that iron carboxymaltose was more expensive than iron sucrose regardless of the dose given. In contrast the Cost Benefit Analysis showed that the average patients' 'willingness to pay' for a total of iron dose of 1400 mg was €233 in order to reduce the number of infusions from 7 to 2 by using iron carboxymaltose rather than iron sucrose.. Both the Cost Effective Analysis and the Cost Benefit Analysis showed clearly that iron carboxymaltose is a more cost effective way of giving intravenous iron than iron sucrose in IBD patients. Only the Budget Impact Analysis showed that intravenous iron sucrose was the cheapest choice if only direct cost was included in the analysis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Drug Costs; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Health Care Costs; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Maltose; Middle Aged; Young Adult

Iron deficiency is common in patients with chronic kidney disease and in kidney transplant recipients.. We analyzed the safety and tolerability of the new intravenous iron preparation ferric carboxymaltose (FCM) in these two patient groups. Adverse events after administration of the drug were assessed by using a questionnaire. Vital signs and laboratory data were collected before and after the application of FCM. A total of 46 FCM doses were applied to 44 patients (17 with chronic kidney disease and 27 kidney transplant recipients) either as single injection of 100 or 200 mg (n = 42) or as short infusion with up to 500 mg (n = 4).. Mild and transient adverse events (metallic taste, headache, dizziness) occurred in six patients. The estimated glomerular filtration rate remained unchanged by the FCM administration.. We conclude that safety and tolerability of FCM were excellent. Compared with other intravenous iron preparations the considerably shorter administration time of FCM allows to save time and to reduce costs.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Kidney Transplantation; Male; Maltose; Prospective Studies; Statistics, Nonparametric; Surveys and Questionnaires; Treatment Outcome

Topics: Anemia, Iron-Deficiency; Chronic Disease; Ferric Compounds; Heart Failure; Hematinics; Humans; Iron Deficiencies; Maltose; Stroke Volume