ferric-oxide--saccharated and Anemia--Iron-Deficiency

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

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

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

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

Iron deficiency and iron-deficiency anemia are associated with increased morbidity and mortality in a wide range of conditions. In many patient populations, this can be treated effectively with oral iron supplementation; but in patients who are unable to take or who do not respond to oral iron therapy, intravenous iron administration is recommended. Furthermore, in certain conditions, such as end-stage kidney disease, chronic heart failure, and inflammatory bowel disease, intravenous iron administration has become first-line treatment. One of the first available intravenous iron preparations is iron sucrose (Venofer

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Humans; Kidney Failure, Chronic

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

Topics: Anemia, Iron-Deficiency; Ferric Oxide, Saccharated; Hematinics; Humans; Randomized Controlled Trials as Topic; Renal Dialysis

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

Iron Deficiency (ID) is increasingly recognized as a prevalent comorbid condition in Heart Failure (HF). Despite this, the pathophysiological mechanisms for progressive ID in either chronic or acute HF are still poorly understood. Beyond the traditional factors for iron deficit in the general population, we ought to review the specificities of such paucity in the HF patient, particularly focusing on the interplay between heightened inflammation, overactivity of the sympathetic nervous system and the so-called cardio-renal-anaemia-ID syndrome. Currently, ID constitutes not only an independent prognostic marker but also a novel safe therapeutic target. Particularly, in selected stable HF patients with reduced left ventricular ejection fraction, intravenous (IV) iron improves symptomatic burden and reduces hospitalizations due to worsening HF. On this topic, the main trials of IV iron with either iron sucrose (Toblli et al., FERRIC-HF and IRON-HF) or ferric carboxymaltose (FAIR-HF, CONFIRM-HF and EFFECT-HF) will be summarized and discussed. Finally, we debate the gaps in knowledge of ID in special populations, namely the unreliability of routine plasmatic surrogate markers to assess iron status in acute and advanced HF, the challenging patient with both HF and Chronic Kidney Disease, as well as efficacy and safety concerns in these settings and the potential role of iron correction in cardiac resynchronization therapy candidates.

Topics: Acute Disease; Anemia, Iron-Deficiency; Chronic Disease; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Hematinics; Hospitalization; Humans; Quality of Life; Renal Insufficiency, Chronic

Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Iron; Nanoparticles; Therapeutic Equivalency; Treatment Outcome

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

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Birth Weight; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infant, Newborn; Iron; Pregnancy; Pregnancy Complications, Hematologic; Randomized Controlled Trials as Topic; Treatment Outcome

Intravenous iron sucrose and oral iron therapy are the main therapies for iron deficiency anaemia (IDA), but there is still a debate regarding their efficacy and especially as to which one is the best choice during pregnancy.. A meta-analysis of randomised controlled trials comparing patients treated with intravenous iron sucrose (intravenous group) with those treated with oral iron (oral group) for IDA during pregnancy was performed. The primary outcomes of interest were mean maternal haemoglobin and serum ferritin levels at the end of treatment. Secondary outcomes were treatment-related adverse events and foetal birth weight.. Six randomised controlled trials, involving a total of 576 women, were included in the present review. Significant increases in haemoglobin [mean difference (MD), 0.85; 95% confidence interval (CI), 0.31-1.39; p = 0.002] and ferritin levels (MD, 63.32; 95% CI, 39.46-87.18; p < 0.00001) were observed in the intravenous group. Compared with the oral group, there were fewer adverse events in the intravenous group (risk ratio, 0.50; 95% CI, 0.34-0.73; p = 0.0003). There was no significant difference in birth weight between the two groups.. For pregnant women who could not tolerate the side effects of oral treatment or required a rapid replacement of iron stores, intravenous iron sucrose was associated with fewer adverse events and was more effective than regular oral iron therapy.

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Iron Compounds; Pregnancy; Pregnancy Complications, Hematologic

Fibroblast growth factor 23 (FGF23) is an essential hormone for phosphate metabolism. It has been shown that intravenous administration of some iron formulations including saccharated ferric oxide induces hypophosphatemic osteomalacia with high FGF23 levels. On the other hand, iron deficiency promotes FGF23 and induces hypophosphatemia in patients with autosomal dominant hypophosphatemic rickets (ADHR). While iron and phosphate metabolism is connected, the detailed mechanism of this connection remains to be clarified.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Glucaric Acid; Humans; Hypophosphatemia; Injections, Intravenous; Iron; Osteomalacia; Phosphates; Renal Insufficiency, Chronic; Rickets, Hypophosphatemic

Rates of postpartum hemorrhage have been increasing in Canada over the last 10 years, with postpartum iron deficiency anemia as the most common consequence. Postpartum anemia is treated with oral iron supplementation and/or blood transfusion. Recent studies have evaluated the use of parenteral iron as a better tolerated treatment modality. Compared with oral iron supplements, parenteral iron is associated with a more rapid rise in serum ferritin and hemoglobin and improved maternal fatigue scores in the postpartum period. It may also decrease rates of blood transfusion. Parenteral iron may be considered in select clinical situations for the treatment of postpartum anemia.. Les taux d’hémorragie postpartum ont connu une hausse au Canada depuis les 10 dernières années, la manifestation d’une anémie ferriprive postpartum en étant la conséquence la plus courante. L’anémie postpartum est prise en charge au moyen d’une supplémentation orale en fer et/ou d’une transfusion sanguine. De récentes études ayant évalué l’utilisation de fer parentéral ont indiqué qu’il s’agissait d’une modalité de traitement mieux tolérée. Par comparaison avec les suppléments oraux de fer, le fer parentéral est associé à une hausse plus rapide des taux sériques de ferritine et d’hémoglobine, en plus de mener à une amélioration des scores de fatigue maternelle au cours de la période postpartum. Le fer parentéral pourrait également mener à une diminution des taux de transfusion sanguine. Son utilisation pourrait être envisagée dans certaines situations cliniques particulières, aux fins de la prise en charge de l’anémie postpartum.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Parenteral; Iron-Dextran Complex; Puerperal Disorders

Iron is a key element in the transport and utilization of oxygen and a variety of metabolic pathways. Iron deficiency is a major cause of anemia and can be associated with fatigue, impaired physical function and reduced quality of life. Administration of oral or intravenous (i.v.) iron is the recommended treatment for iron-deficiency anemia (IDA) in different therapeutic areas.. This article provides an overview of studies that evaluated i.v. iron sucrose for anemia and iron status management, either alone or in combination with erythropoiesis-stimulating agents, across various diseases and conditions.. Iron sucrose is an established, effective and well-tolerated treatment of IDA in patients with acute or chronic conditions such as chronic kidney disease, inflammatory bowel disease, pregnancy (second and third trimester), postpartum period, heavy menstrual bleeding and cancer who need rapid iron supply and in whom oral iron preparations are ineffective or not tolerated. Available data on patient blood management warrant further studies on preoperative iron treatment. First experience with iron sucrose follow-on products raises questions about their therapeutic equivalence without comparative clinical data in newly diagnosed patients or patients on existing chronic treatment.

Topics: Anemia, Iron-Deficiency; Drug Therapy, Combination; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Iron Deficiencies

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

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

To review clinical trials conducted in hemodialysis patients of the 4 intravenous iron products available in the US in an attempt to discern strengths and inferiorities between products and evaluate current safety data that can be used to assist the clinician in selecting the most appropriate agent.. Literature was accessed through PubMed (January 2000-October 2010). In some cases, reference citations from selected review articles were evaluated as well.. Clinical trials published in the English language were selected using the search terms iron dextran, iron sucrose, sodium ferric gluconate, and ferumoxytol. Studies were further pared down to include only those enrolling hemodialysis patients.. There are currently 4 intravenous iron formulations in the US used to treat iron-deficiency anemia in hemodialysis patients. Ferumoxytol has not yet been directly compared to the other 3 agents. Eight studies have been conducted in hemodialysis patients directly comparing iron dextran, iron sucrose, and/or sodium ferric gluconate. These studies were further categorized for evaluation based on iron products compared. Four studies directly compared iron dextran to iron sucrose, 1 study compared iron dextran to sodium ferric gluconate, 1 study compared iron sucrose to sodium ferric gluconate, and 2 studies compared all 3 agents. Of the 3 agents, iron dextran appears to have the least favorable safety profile, while iron sucrose appears most favorable.. The newest intravenous iron product, ferumoxytol, has not been directly compared to the other 3 agents. Large well-controlled studies of these products specifically in the hemodialysis population would further help clinicians determine appropriate therapy. Iron sucrose appears to offer the most favorable safety profile when compared to iron dextran and sodium ferric gluconate in treating hemodialysis patients. Oxidative stress and hypersensitivity reactions are common problems encountered when administering intravenous iron.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Clinical Trials as Topic; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Ferrous Compounds; Glucaric Acid; Humans; Iron-Dextran Complex; Renal Dialysis; Renal Insufficiency, Chronic

Iron deficiency anemia (IDA) still remains universally problematic worldwide. The primary focus of this review is to critique articles published over the past 18 months that describe strategies for the diagnosis and management of this prevalent condition.. The medical community continues to lack consensus when identifying the optimal approach for the diagnosis and management of IDA. Current diagnostic recommendations revolve around the validity and practicality of current biomarkers such as soluble transferrin-receptor concentrations and others, and cause-based diagnostics that potentially include endoscopy. Management of IDA is based on supplementation combined with effective etiological treatment. Advances in oral and parenteral low-molecular-weight iron preparations has expanded and improved treatment modalities for IDA. Since the introduction of low versus high-molecular-weight intravenous iron administration, there have been fewer serious adverse events associated with parenteral iron preparations.. Best practice guidelines for diagnosing and managing IDA should include the design of an algorithm that is inclusive of multiple biomarkers and cause-based diagnostics, which will provide direction in managing IDA, and distinguish between IDA from the anemia of chronic disease.

Topics: Anemia, Iron-Deficiency; Antimicrobial Cationic Peptides; Biomarkers; Endoscopy, Digestive System; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hepcidins; Humans; Infusions, Parenteral; Iron; Iron Chelating Agents

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

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Erythropoiesis; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous

In the review paper an issue of the administration of iron containing drugs in the treatment of anemia in non-dialyzed patients with chronic kidney disease (CKD) is presented. Iron deficiency in patients with CKD (serum ferritin concentration below 100 ng/ml, transferrin saturation below 20%) occurs in 20-70% of cases. Prevalence of iron deficiency depends on stage of CKD and patients' gender. Among causes of iron deficiency the following reasons are mentioned: blood loss through gastrointestinal tract (17-18% of patients in pre-dialysis stage show positive results of tests on occult blood), diminished absorption (uremic gastroenteropathy, administration of drugs decreasing iron absorption), decreased delivery of food (anorexia, low protein diet), infections and inflammatory state. In the course of infections and inflammatory states body iron storage may be normal, but its utilization for erythropoesis is deteriorated (functional iron deficiency). Results of randomized controlled studies indicate greater efficiency of intravenous therapy in comparison with oral route of iron administration. In practice, the main route of administration of iron-containing drugs to non-dialyzed patients with CKD remains, however, the oral one (iron sulfate, iron fumarate, hem iron) as more convenient and seldom leading to serious side effects. Intravenous iron therapy (iron dextrose, iron polymaltose, sodium-iron gluconate, iron sucrose) is required for cases with absolute deficiency of this microelement, disturbed intestinal absorption, poor tolerance of oral iron medication or its ineffectiveness from other reasons. Administration of erythropoiesis stimulating agents in predialysis period may require intravenous iron therapy because of enhanced consumption of its stores for erythropoiesis. Attention should be paid to possible nephrotoxic effects of administration of iron containing drugs (transient proteinuria, damage of renal tubules, decrease in glomerular filtration rate).

Topics: Administration, Oral; Anemia, Iron-Deficiency; Diet, Protein-Restricted; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Iron; Iron Metabolism Disorders; Iron, Dietary; Kidney Failure, Chronic; Risk Factors; Sex Distribution; Treatment Outcome

Intravenous iron is widely used to maintain adequate iron stores and prevent iron deficiency anemia in patients with chronic kidney disease, yet concerns remain about its long-term safety with respect to oxidative stress, kidney injury, and accelerated atherosclerosis, which are the subjects of this review. Three parenteral iron formulations are available for use in the United States: Iron dextran, iron gluconate, and iron sucrose. Iron dextran, especially the high molecular form, has been linked with anaphylactoid and anaphylactic reactions, and its use has been declining. A portion of intravenous iron preparations is redox-active, labile iron available for direct donation to transferrin. In vitro tests show that commonly available intravenous iron formulations have differing capacities to saturate transferrin directly: Iron gluconate > iron sucrose > iron dextran. Intravenous iron treatment produces oxidative stress, as demonstrated by increases in plasma levels of lipid peroxidation products (malondialdehyde), at a point that is much earlier than the time to peak concentration of catalytically active iron, suggesting a direct effect of iron sucrose on oxidative stress. Furthermore, iron sucrose infusion produces endothelial dysfunction that seems to peak earlier than the serum level of free iron. Intravenous iron sucrose infusion also has been shown to produce acute renal injury and inflammation as demonstrated by increased urinary albumin, enzyme (N-acetyl-beta-glucosaminidase), and cytokine (chemokine monocyte chemoattractant protein-1) excretions. Although the long-term dangers of intravenous iron are unproved, these data call for examination of effects of intravenous iron on the potential for long-term harm in patients with chronic kidney disease.

Topics: Acute Kidney Injury; Anemia, Iron-Deficiency; Animals; Atherosclerosis; Endothelium, Vascular; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Inflammation; Infusions, Intravenous; Iron-Dextran Complex; Oxidative Stress; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Transferrin

Ferric iron (Fe)-carbohydrate complexes are widely used for treating Fe deficiency in patients who are unable to meet their Fe requirements with oral supplements. Intravenous Fe generally is well tolerated and effective in correcting Fe-deficient states. However, the complexing of Fe to carbohydrate polymers does not block its potent pro-oxidant effects; systemic free radical generation and, possibly, tissue damage may result. The purpose of this review is to (1) underscore the capacity of currently used parenteral Fe formulations to induce oxidative stress, (2) compare the severity of these oxidant reactions with those that result from unshielded Fe salts and with each other, and (3) speculate as to the potential of these agents to induce acute renal cell injury and augment systemic inflammatory responses. The experimental data that are reviewed should not be extrapolated to the clinical setting or be used for clinical decision making. Rather, it is hoped that the information provided herein may have utility for clinical hypothesis generation and, hence, future clinical studies. By so doing, a better understanding of Fe's potential protean effects on patients with renal disease may result.

Topics: Acute Kidney Injury; Adenosine Triphosphate; Anemia, Iron-Deficiency; Animals; Endothelial Cells; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Inflammation; Infusions, Intravenous; Iron Compounds; Iron-Dextran Complex; Kidney Cortex; Kidney Tubules, Proximal; Lipid Peroxidation; Mitochondria; Oxidative Stress; Renal Dialysis; Renal Insufficiency, Chronic; Tumor Necrosis Factor-alpha

Parenteral iron therapy is occasionally necessary for patients intolerant or unresponsive to oral iron therapy, for receiving recombinant erythropoietin therapy, or for use in treating functional iron deficiency. There are now three parenteral iron products available: iron dextran, ferric gluconate, and iron sucrose. We summarize the advantages and disadvantages of each product, including risk of anaphylaxis and hypersensitivity, dosage regimens, and costs. The increased availability of multiple parenteral iron preparations should decrease the need to use red cell transfusions in patients with iron-deficiency anemia.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Injections, Intravenous; Iron-Dextran Complex

The effectiveness of iron sucrose was recently evaluated in several small groups of hemodialysis patients in five regional dialysis units. Iron sucrose did not maintain hemoglobin levels above 11 g/dl and transferrin saturation above 25%. In addition, close to 50% of the patients experienced serum ferritin levels greater than 1100 ng/ml, suggesting iron overload. Consequently, iron therapy was withheld in these patients. Eventually, several patients experienced a decrease in ferritin levels to below 800 ng/ml and were administered iron therapy with sodium ferric gluconate instead of iron sucrose. These patients achieved hemoglobin levels greater than 11 g/dl, and serum ferritin levels remained within the target range after several months of treatment.

Topics: Anemia, Iron-Deficiency; Clinical Protocols; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Infusions, Intravenous; Renal Dialysis; Transferrin; Treatment Outcome

Absolute or functional iron deficiency is a common problem in chronic disease which may lead to iron-deficient erythropoesis. Moreover, lack of available iron is the most common reason for unresponsiveness to epoetin in patients on chronic dialysis. Measurements of serum ferritin, transferrin saturation and percentage of hypochromic red blood cells allow the assessment of iron status. Lack of iron resorption and dose-dependent side-effects limit oral supplementation in a number of patients. Several iron preparations are available for intravenous substitution, especially the newly registered iron-saccharose offers safe and reliable iron supplementation and reduces the risk of anaphylaxis and iron toxicity. This review discusses new guidelines concerning diagnosis of iron status, indication for therapy and application of intravenous iron preparation.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Child; Erythrocyte Count; Erythropoiesis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Infusions, Intravenous; Injections, Intravenous; Iron Deficiencies; Male; Renal Dialysis; Sucrose; Time Factors; Transferrin

Fe is an essential component of haem in myoglobin and accounts for 70 % of haemoglobin. The balance of Fe, unlike that of other metals such as Na or Ca, is regulated solely by gastrointestinal absorption, which itself depends on the bioavailability of Fe in food, i.e. the chemical Fe species. Factors that maintain Fe homeostasis by modulating Fe transfer through the intestinal mucosa are found at the luminal, mucosal and systemic levels. Fe deficiency and its consequence, Fe-deficiency anaemia, form the commonest nutritional pathology in pregnant women. The current gold standard to detect Fe deficiency remains the serum ferritin value. Previously there was general consensus against parenteral Fe administration, i.e. parenteral Fe was only recommended for special conditions such as unresponsiveness to oral Fe, intolerance to oral Fe, severe anaemia, lack of time for therapy etc. However, especially in hospital settings, clinicians regularly face these conditions but are still worried about reactions that were described using Fe preparations such as Fe-dextrans. A widely used and safe alternative is the Fe-sucrose complex, which has become of major interest to prevent functional Fe deficiency after use of recombinant erythropoietin Numerous reports show the effectiveness and safety of the Fe-sucrose complex. Good tolerance to this Fe formulation is partly due to the low allergenic effect of the sucrose complex, partly due to slow release of elementary Fe from the complex. Accumulation of Fe-sucrose in parenchyma of organs is low compared with Fe-dextrans or Fe-gluconate, while incorporation into the bone marrow for erythropoiesis is considerably faster. Oral Fe is only started if haemoglobin levels are below 110 g/l. If levels fall below 100 g/l or are below 100 g/l at time of diagnosis, parenteral Fe-sucrose is used primarily. In cases of severe anaemia (haemoglobin <90 g/l) or non-response to parenteral Fe after 2 weeks, recombinant erythropoietin is considered in combination. By using parenteral Fe-sucrose in cases of severe Fe deficiency, anaemia during pregnancy is treated efficiently and safely according to our results and rate of blood transfusion could be reduced considerably to below 1 % of patients per year.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Parenteral; Pregnancy; Pregnancy Complications, Hematologic

Intravenous iron is required by most dialysis patients receiving erythropoietin (EPO) to maintain an adequate hematocrit. In the United States, there are currently two parenteral iron preparations, iron dextran and iron gluconate, approved for such use, and a third product, iron sucrose, is under development. This article reviews each of these products. Each of the iron products increases the efficacy of EPO use in anemia management. There is considerable experience in the United States and elsewhere with the use of iron dextran. Although it is clinically effective, iron dextran is also associated with significant morbidity from both dose-dependent and -independent side effects. The slow release of iron from this complex necessitates a delay in monitoring iron indices after the administration of large doses of iron dextran. Recommended doses of iron sucrose appear very safe with little risk of anaphylactic reactions. Adverse effects are uncommon and not life threatening. If approved for use in the United States, iron sucrose may be a safe and effective alternative to iron dextran. Iron dissociates from iron gluconate quite rapidly and may increase the production of ionized free iron. Iron gluconate may be a safe alternative to iron dextran for patients with severe reactions, including anaphylaxis. The risk of allergic reactions to iron gluconate is very low. The exact place in therapy for the newer iron complexes remains unclear. Currently available data suggest that iron sucrose and iron gluconate may have diminished adverse effect profiles when compared with iron dextran. Additional clinical experience will establish the role for these new iron products.

Topics: Anemia, Iron-Deficiency; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Iron-Dextran Complex; Kidney Failure, Chronic; Peritoneal Dialysis; Recombinant Proteins; Renal Dialysis

Saccharaed ferric oxide (SFO)-induced osteomalacia develops when excessive SFO infusions are administrated to patients with anemia for prolonged periods for a few years. The small particles and almost neutral saccharide of SFO filter through the glomerular tufts into the renal tubules, resulting in impairment of proximal renal tubular function, particularly renal reabsorption of phosphate and 1alpha-hydroxylase activity, resulting in decreased serum levels of phosphorus and active vitamin D, both of which lead to development of hypophosphatemic osteomalacia. Furthermore, SFO, at concentrations attainable in serum, exacerbates the osteomalacia by inhibiting bone formation directly. In contrast to itai-itai disease, another iatrogenic osteomalacia due to cadmium nephropathy [44], the proximal renal tubular function impairment induced by SFO is reversible simply by discontinuing the nephrotoxin, which is followed by improvement of all the clinical manifestations, except bone deformities. So far, SFO-induced osteomalacia, that is, SFO-induced osteopathy due to nephropathy, has been reported only in Japan, probably due to the lax surveillance system of the health insurance scheme. All physicians who prescribe SFO should be aware of its severe adverse effects. We hope that such iatrogenic osteomalacia caused by abusive infusion of SFO will never again be reported in our country.

Topics: Aged; Anemia, Iron-Deficiency; Anemia, Refractory; Animals; Calcitriol; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Hypophosphatemia; Iatrogenic Disease; Kidney Diseases; Male; Middle Aged; Osteomalacia; Phosphates

Absolute and functional iron deficiency is the most common cause of epoetin (recombinant human erythropoietin) hyporesponsiveness in renal failure patients. Diagnostic procedures for determining iron deficiency include measurement of serum iron levels, serum ferritin levels, saturation of transferrin and percentage of hypochromic red blood cells. Patients with iron deficiency should receive supplemental iron, either orally or intravenously. Adequate intravenous iron supplementation allows reduction of epoetin dosage by approximately 40%. Intravenous iron supplementation is recommended for all patients undergoing haemodialysis and for pre-dialysis and peritoneal dialysis patients with severe iron deficiency. During the maintenance phase (period of epoetin therapy after correction of iron deficiency), the use of low-dose intravenous iron supplementation (10 to 20 mg per haemodialysis treatment or 100 mg every second week) avoids iron overtreatment and minimises potential adverse effects. Depending on the degree of pre-existing iron deficiency, markedly higher iron doses are necessary during the correction phase (period of epoetin therapy after correction of iron deficiency) [e.g. intravenous iron 40 to 100 mg per haemodialysis session up to a total dose of 1000 mg]. The iron status should be monitored monthly during the correction phase and every 3 months during the maintenance phase to avoid overtreatment with intravenous iron.

Topics: Anemia, Iron-Deficiency; Citric Acid; Drug Combinations; Drug Monitoring; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Humans; Infusions, Intravenous; Injections, Intravenous; Iron Compounds; Iron Overload; Iron-Dextran Complex; Kidney Failure, Chronic; Sorbitol

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

A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Hypophosphatemia; Iron; Iron Deficiencies; Menorrhagia; Phosphorus

Topics: Administration, Oral; Anemia, Iron-Deficiency; Dietary Supplements; Double-Blind Method; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Humans; Iron

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

Anemia is one of the main complications of chronic kidney disease especially kidney failure, which includes treatment with erythropoiesis-stimulating agents and iron supplementation, including intravenous and oral iron. However, intravenous iron may pose limitations, such as potential infusion reactions. Oral iron is mainly composed of divalent iron, which can excessively stimulate the gastrointestinal tract. Iron polysaccharide complex capsules are a novel oral iron trivalent supplement with higher iron content and lower gastrointestinal irritation. However, since high-quality evidence-based medicinal support is lacking, it is necessary to conduct clinical studies to further evaluate the effectiveness and safety of oral iron polysaccharide complex in chronic kidney disease patients.. This randomized controlled trial uses an open-label, parallel group design, where the efficacy and safety of maintenance hemodialysis (MHD) participants is evaluated. The experimental group is assigned erythropoietins and iron polysaccharide complex (two capsules each time, bid), and the control group is assigned erythropoietin and sucrose iron (100mg, 2w) injection. Participants (aged 18-75 years) undergoing maintenance hemodialysis were considered for screening. Inclusion criteria included hemoglobin (Hb) ≥110g/L and < 130g/L, transferrin saturation (TSAT) > 20% and < 50%, and serum ferritin (SF) > 200μg/L and < 500μg/L. Exclusion criteria included acute or chronic bleeding, serum albumin < 35g/L, hypersensitive C-reactive protein (HsCRP) > 10 mg/L, and severe secondary hyperparathyroidism (iPTH ≥ 800 pg/mL). Full inclusion and exclusion criteria are described in the "Methods" section. The primary endpoint is TSAT of the participants at week 12. Secondary endpoints include Hb, SF, hematocrit (Hct), HsCRP, pharmacoeconomic evaluation, drug costs, quality of life, and indicators of oxidative stress. The treatment will last for 24 weeks with a follow-up visit at baseline (within 7 days prior to initial treatment) and weeks 4, 8, 12, 16, 20, and 24 after initial treatment. This clinical research includes 9 hemodialysis centers in mainland China and plans to enroll 186 participants.. It is expected that it will provide strong evidence to reveal the clinical efficacy and safety of oral iron in the treatment of chronic CKD-related anemia in MHD patients through this clinical trial.. Chinese Clinical Trial Registry ChiCTR2000031166 . Registered on March 23, 2020.

Topics: Anemia, Iron-Deficiency; Capsules; Ferric Oxide, Saccharated; Humans; Iron; Multicenter Studies as Topic; Polysaccharides; Quality of Life; Randomized Controlled Trials as Topic; Renal Dialysis

The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia.. In this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000 mg IIM or iron sucrose (IS) administered as 200 mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs).. A total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5 mL/min/1.73 m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: -0.19; 0.77; P > 0.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P = 0.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4 weeks (P ≤ 0.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met.. Compared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.

Topics: Administration, Intravenous; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Disaccharides; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Male; Middle Aged; Prospective Studies; Renal Insufficiency, Chronic; Time Factors

Topics: Anemia, Iron-Deficiency; Female; Ferric Oxide, Saccharated; Humans; Male

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

Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation approved in the US for the treatment of iron deficiency anemia in adults who are intolerant of/have had an unsatisfactory response to oral iron, or who have non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a randomized, open-label, multicenter clinical trial evaluating the safety and efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe hypersensitivity reactions was low and did not differ between treatment groups. Cardiovascular adverse events (AEs) were reported for 9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE was longer following administration of FDI compared with IS (hazard ratio: 0.59 [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with or without HF (p=0.908 for interaction). Patients achieved a faster hematological response (assessed by changes in hemoglobin and ferritin concentrations, and increase in transferrin saturation) with FDI versus IS. In conclusion, in patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was associated with fewer cardiovascular AEs and a faster hematological response, compared to multiple doses of IS. These effects were similar for patients with and without HF.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Case-Control Studies; Disaccharides; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Heart Failure; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Male; Middle Aged; Proportional Hazards Models; Renal Insufficiency, Chronic; Severity of Illness Index; Transferrin; Treatment Outcome

Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoiesis-stimulating agents (ESA) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials.. This was a retrospective observational study in 2 centres designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer® and monitored for at least 12 months for each iron preparation.. A total of 190 patients were included and had a mean age of 65.8 years (SD ± 15.5). Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the number of reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after conversion, including adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P < 0.01). The weekly iron dose was similar after adjustment (P = 0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM.. This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients. Iron isomaltoside is non-inferior to iron sucrose in maintaining Hb in patients on regular haemodialysis/haemodiafiltration with no difference in the number of reported adverse events.

Topics: Aged; Anemia, Iron-Deficiency; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; Middle Aged; Renal Dialysis; Renal Insufficiency, Chronic; Retrospective Studies

Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.. We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626.. Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.. The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia.. WHO, India.

Topics: Administration, Intravenous; Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Female; Ferric Oxide, Saccharated; Humans; India; Iron; Pregnancy; Severity of Illness Index; Treatment Outcome; Young Adult

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

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

Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA).. The Ferumoxytol for Anemia of CKD Trial (FACT), a randomized, multicenter, open-label, phase 4 study, compared the long-term safety and efficacy of ferumoxytol with iron sucrose for the treatment of IDA in patients with CKD undergoing hemodialysis. Patients with IDA and CKD undergoing hemodialysis were randomized 2:1 to ferumoxytol 1.02 g (2 × 510 mg) or iron sucrose 1.0 g (10 × 100 mg) for a 5-week treatment period (TP). Over 11 months, patients underwent additional 5-week TPs whenever IDA (hemoglobin < 11.5 g/dL and transferrin saturation < 30%) was detected. The primary efficacy endpoint was mean change in hemoglobin from baseline to week 5 for each TP. Adverse events were recorded during the study.. Overall, 293 patients received ferumoxytol (n = 196) or iron sucrose (n = 97). Ferumoxytol was noninferior to iron sucrose regarding hemoglobin change from baseline to week 5. The mean change in hemoglobin in the ferumoxytol and iron sucrose groups was 0.5 and 0.4 g/dL, respectively, in TP 1 (least-squares mean difference, 0.13; 95% confidence interval, -0.11 to 0.36) and 0.6 and 0.3 g/dL, respectively, in TP 2 (0.30; 0.06 - 0.55). Treatment-related and serious adverse events were similar in both groups; no new safety signals emerged.. Long-term administration of ferumoxytol has noninferior efficacy and a similar safety profile to iron sucrose when used to treat IDA in patients with CKD undergoing hemodialysis.
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Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Renal Dialysis; Renal Insufficiency, Chronic; Young Adult

To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery.. A prospective, single-blinded, randomized controlled study.. National Center for Cardiovascular Diseases and a university hospital.. The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery.. The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group.. The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20 g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p = 0.023, p = 0.037, and p = 0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24 hours, postoperative hospital stay >10 days, poor wound healing, and perivalvular leakage between the 2 groups.. Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.

Topics: Administration, Intravenous; Adult; Aged; Anemia, Iron-Deficiency; Biomarkers; Female; Ferric Oxide, Saccharated; Follow-Up Studies; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Single-Blind Method; 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

Intravenous (IV) iron is frequently used to treat iron deficiency/anemia in patients who are unable to tolerate oral iron or the oral iron is not sufficient toreplete iron requirements. However, safety concerns regarding the potential increase in oxidative stress and other adverse effects persist and it remains unclear whether all iron preparations are equivalent. Indeed, the comparative risk of adverse events with IV iron preparations has not been extensively assessed. We hypothesize that IV iron leads to changes in oxidative stress, endothelial function, and potential renal damage depending on the iron formulation (related to the generation of "free" or catalytic labile iron) and this may result in more tubular and glomerular injury manifested as increased proteinuria and raised neutrophil gelatinase-associated lipocalin (NGAL) levels in patients with chronic kidney disease (CKD).. IRON-CKD is a prospective, open-label, explorative, randomized, single-center study designed to compare the safety and efficacy of three parenteral iron preparations: low-molecular-weight iron dextran-Cosmofer, iron sucrose-Venofer, and iron isomaltoside-Monofer. The study includes 40 adults who have established CKD stages 3-5 and serum ferritin (SF) of less than 200 μg/L or transferrin saturation (TS) of less than 20% (or both); they were randomly assigned in a 1:1:1:1 ratio to 200 mg iron dextran, 200 mg iron sucrose, 200 mg iron isomaltoside, or 1000 mg iron isomaltoside. After randomization, participants undergo baseline assessments and then an iron infusion. Each participant is followed up at 2 h, day 1, week 1, and months 1 and 3. At each follow-up visit, patients undergo clinical review, measurement of pulse wave velocity (PWV), blood tests for renal function, and collection of serum/plasma samples for oxidative stress and inflammatory markers. The primary outcomes are measures of oxidative stress, inflammatory markers, and markers of acute renal injury in comparison with baseline measures of each iron preparation and between each of the iron preparations. Secondary objectives include effects on hematinic profiles and hemoglobin concentrations, changes in arterial stiffness, incidence of significant side effects, and change in patients' quality of life.. Between October 2015 and April 2018, 521 individuals were identified as potential participants; 216\ were contacted, 56 expressed an interest, 49 attended a screening visit, and 40 were confirmed to meet the eligibility criteria and were randomly assigned. The mean age was 58.8 (standard error of the mean 2.2) years, and 23 (58%) were male. All patients were white and English-speaking. The mean SF was 68.8 μg/L, TS was 21.4%, and haemoglobin was 122.6 g/L at randomization for the whole group. The mean estimated glomerular filtration rate was 28.2 mL/min/1.73 m2 the urinary protein/ creatinine ratio was 154.2 mg/mmol, and CRP was 7.5 mg/L.. IRON-CKD will provide important information on the short-term effects of three preparations of IV iron in CKD patients with biochemical functional or absolute iron deficiency on measures of oxidative stress, inflammation, endothelial function, and renal injury.. European Clinical Trials Database (EudraCT) number 2010-020452-64 .

Topics: Acute Kidney Injury; Anemia, Iron-Deficiency; Biomarkers; Disaccharides; England; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; Inflammation Mediators; Infusions, Intravenous; Iron-Dextran Complex; Kidney; Lipocalin-2; Male; Middle Aged; Oxidative Stress; Prospective Studies; Proteinuria; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Time Factors; Treatment Outcome

Iron deficiency anemia (IDA) is prevalent, and intravenous iron, especially if given in a single dose, may result in better adherence compared with oral iron. The present trial (FERWON-IDA) is part of the FERWON program with iron isomaltoside 1000/ferric derisomaltose (IIM), evaluating safety and efficacy of high dose IIM in IDA patients of mixed etiologies. This was a randomized, open-label, comparative, multi-center trial conducted in the USA. The IDA patients were randomized 2:1 to a single dose of 1000 mg IIM, or iron sucrose (IS) administered as 200 mg intravenous injections, up to five times. The co-primary endpoints were adjudicated serious or severe hypersensitivity reactions, and change in hemoglobin from baseline to week eight. A total of 1512 patients were enrolled. The frequency of patients with serious or severe hypersensitivity reactions was 0.3% (95% confidence interval: 0.06;0.88) vs 0.4% (0.05;1.45) in the IIM and IS group, respectively. The co-primary safety objective was met, and no risk difference was observed between groups. The co-primary efficacy endpoint of non-inferiority in hemoglobin change was met, and IIM led to a significantly more rapid hematological response in the first two weeks. The frequency of cardiovascular events was 0.8% and 1.2% in the IIM and IS group, respectively (P = .570). The frequency of hypophosphatemia was low in both groups. Iron isomaltoside administered as 1000 mg resulted in a more rapid and more pronounced hematological response, compared with IS, which required multiple visits. The safety profile was similar with a low frequency of hypersensitivity reactions and cardiovascular events.

Topics: Adult; Anemia, Iron-Deficiency; Disaccharides; Female; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Male; Middle Aged; Prospective Studies

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

Topics: Adult; Anemia, Iron-Deficiency; Disaccharides; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Menorrhagia; Pregnancy; Quality of Life; Treatment Outcome; Young Adult

Iron administration affects serum levels of intact (I-) fibroblast growth factor-23 (FGF23) and its cleavage product C-terminal (C-) FGF23 in iron-deficient patients on maintenance hemodialysis (MHD). The objective of this study was to compare the effect of oral or intravenous iron administration on serum levels of I-FGF23 and C-FGF23 in iron-deficient patients on MHD.. A prospective randomized study.. Participants on MHD with severe iron deficiency (n = 61).. Participants were randomized to receive oral iron (50 mg of sodium ferrous citrate daily; oral group, n = 29) or intravenous iron (40 mg of saccharated ferric oxide weekly; IV group, n = 32).. Changes in I-FGF23 and C-FGF23 after 10 weeks of treatment.. Iron supplementation significantly increased hemoglobin, mean corpuscular volume, ferritin, and transferrin saturation rate, and decreased erythropoiesis-stimulating agent dose and erythropoiesis-stimulating agent resistance index value. Serum phosphate, calcium, and intact parathyroid hormone levels did not change significantly during the study. I-FGF23 levels increased significantly in the IV group and did not change in the oral group, whereas C-FGF23 levels were significantly reduced in both groups. Serum interleukin-6 and tumor necrosis factor-α levels were increased in both groups. Multiple regression analysis indicated the relationship between iron or erythropoiesis and FGF23 metabolism.. Iron administration to patients on MHD with severe iron deficiency decreased C-FGF23 levels, whereas intravenous iron increased I-FGF23 levels though oral iron did not. If the target of chronic kidney disease-mineral and bone disorder therapy is reducing I-FGF23 levels, we suggest the use of oral iron.

Topics: Administration, Intravenous; Administration, Oral; Aged; Anemia, Iron-Deficiency; Citric Acid; Dietary Supplements; Female; Ferric Oxide, Saccharated; Ferrous Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Male; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Treatment Outcome

Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown.. PIVOTAL (Proactive IV irOn Therapy in hemodiALysis patients) is a multicenter, open-label, blinded endpoint, randomized controlled (PROBE) trial. Incident HD adults with a serum ferritin < 400 µg/L and transferrin saturation (TSAT) levels < 30% receiving erythropoiesis-stimulating agents (ESA) were eligible. Enrolled patients were randomized to a proactive, high-dose IV iron arm (iron sucrose 400 mg/month unless ferritin > 700 µg/L and/or TSAT ≥40%) or a reactive, low-dose IV iron arm (iron sucrose administered if ferritin <200 µg/L or TSAT < 20%). We hypothesized that proactive, high-dose IV iron would be noninferior to reactive, low-dose IV iron for the primary outcome of first occurrence of nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for heart failure or death from any cause. If noninferiority is confirmed with a noninferiority limit of 1.25 for the hazard ratio of the proactive strategy relative to the reactive strategy, a test for superiority will be carried out. Secondary outcomes include infection-related endpoints, ESA dose requirements, and quality-of-life measures. As an event-driven trial, the study will continue until at least 631 primary outcome events have accrued, but the expected duration of follow-up is 2-4 years.. Of the 2,589 patients screened across 50 UK sites, 2,141 (83%) were randomized. At baseline, 65.3% were male, the median age was 65 years, and 79% were white. According to eligibility criteria, all patients were on ESA at screening. Prior stroke and MI were present in 8 and 9% of the cohort, respectively, and 44% of patients had diabetes at baseline. Baseline data for the randomized cohort were generally concordant with recent data from the UK Renal Registry.. PIVOTAL will provide important information about the optimum dosing of IV iron in HD patients representative of usual clinical practice.. EudraCT number: 2013-002267-25.

Topics: Administration, Intravenous; Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Female; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Hematinics; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Renal Dialysis; Thrombosis; Treatment Outcome

Iron deficiency anemia (IDA) is a common manifestation of chronic kidney disease (CKD), affecting most patients on hemodialysis and imposing a substantial clinical burden. Treatment with iron supplementation increases hemoglobin levels and can reduce the severity of anemia in patients with CKD. While correcting anemia in these patients is an important therapeutic goal, there is a lack of long-term trials directly comparing intravenous iron therapies in patients with CKD receiving hemodialysis.. The Ferumoxytol for Anemia of CKD Trial (FACT) is a 13-month, open-label, randomized, multicenter, international, prospective study with 2 substudies. Entry criteria for the main study include adults with IDA (defined as hemoglobin <11.5 g/dL [<115.0 g/L] and a transferrin saturation <30%), serum ferritin <800 ng/mL (<1798 pmol/L), and receiving hemodialysis for ≥3 months. Patients are randomized to receive ferumoxytol (1.02 g over 2 doses) or iron sucrose (1.0 g over 10 doses) during the initial 5-week treatment period. Those with persistent/recurrent IDA over the 11-month observation period will receive additional 5-week treatment periods, as appropriate. The primary efficacy endpoint of the main study is the mean change in hemoglobin from Baseline to Week 5 for each treatment period. The secondary efficacy endpoints include the mean change in transferrin saturation from Baseline to Week 5 and the proportion of patients with a hemoglobin increase of ≥1.0 g/dL at any time from Baseline to Week 5. Safety will be assessed through an examination of the adverse event profile over the course of the study. An "oxidative stress" substudy in approximately 100 patients will assess the effects of treatment on biomarkers of oxidative stress/inflammation during the initial 5-week treatment period, and a magnetic resonance imaging substudy in approximately 70 patients will assess the potential for iron deposition in target tissues over 24 months.. FACT fulfills the need for a long-term comparative trial in patients with IDA and CKD receiving hemodialysis. The efficacy and safety results will provide useful information for guiding therapy in this population. Two hundred ninety-six patients have been enrolled, and completion of the main study is expected soon.. ClinicalTrials.gov identifier: NCT01227616 (registered October 22, 2010); EudraCT number: 2010-022133-28.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Heart; Hematinics; Humans; Kidney Failure, Chronic; Liver; Magnetic Resonance Imaging; Pancreas; Renal Dialysis

The objective of this study was to compare the efficacy, safety and tolerability of intravenous iron sucrose with that of oral ferrous fumarate in iron deficiency anemia during 14 to 34 weeks of pregnancy.. A randomized controlled trial was performed involving 112 patients attending the antenatal clinic at Shri B.M.Patil Medical college Hospital, Bijapur from October 2011 to August 2012,with hemoglobin levels between 70-110 g/L and serum ferritin of < 15 ng/ml. In the intravenous group,200 mg of iron sucrose was administered in 100 ml 0.9% sodium chloride per day. Participants in the oral group were given 200 mg of ferrous fumarate per day. The primary outcome measures for the trial, haemoglobin and serum ferritin levels were measured after 4 weeks. Statistical significance was assessed using Student's t-test.. The change in haemoglobin in women receiving intravenous iron was higher than with oral ferrous fumarate 22 ± 11.5 g/L vs 12 ± 9 g/L (p < 0.0001).Similarly the change of serum ferritin was significantly higher in women receiving intravenous iron compared to oral iron. 55% participants in the intravenous group had an improvement in haemoglobin more than 20 g/L compared to only 11% of the oral therapy group.48% of patients in I.V group showed increase in ferritin level between 51 to 100 ng/ml in comparison to only 3.5% in oral group. Intravenous iron sucrose is an effective in correction of anemia in pregnancy or iron store depletion.. Intravenous iron sucrose is more effective than 200 mg a day ferrous fumarate in increasing maternal iron stores.. The trial registration number is CTRI/2016/12/007552 registered in Clinical Trial Registry India on 8/12/2016. It is a retrospectively registered trial.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Glucaric Acid; Hematinics; Hemoglobins; Humans; Pregnancy; Pregnancy Complications; Prospective Studies; Treatment Outcome

Iron deficiency is a common complication in patients with IBD and oral iron therapy is suggested to exacerbate IBD symptoms. We performed an open-labelled clinical trial to compare the effects of per oral (PO) versus intravenous (IV) iron replacement therapy (IRT).. The study population included patients with Crohn's disease (CD; N=31), UC (N=22) and control subjects with iron deficiency (non-inflamed, NI=19). After randomisation, participants received iron sulfate (PO) or iron sucrose (IV) over 3 months. Clinical parameters, faecal bacterial communities and metabolomes were assessed before and after intervention.. Both PO and IV treatments ameliorated iron deficiency, but higher ferritin levels were observed with IV. Changes in disease activity were independent of iron treatment types. Faecal samples in IBD were characterised by marked interindividual differences, lower phylotype richness and proportions of Clostridiales. Metabolite analysis also showed separation of both UC and CD from control anaemic participants. Major shifts in bacterial diversity occurred in approximately half of all participants after IRT, but patients with CD were most susceptible. Despite individual-specific changes in phylotypes due to IRT, PO treatment was associated with decreased abundances of operational taxonomic units assigned to the species. Shifts in gut bacterial diversity and composition associated with iron treatment are pronounced in IBD participants. Despite similar clinical outcome, oral administration differentially affects bacterial phylotypes and faecal metabolites compared with IV therapy.. clinicaltrial.gov (NCT01067547).

Topics: Administration, Intravenous; Administration, Oral; Anemia, Iron-Deficiency; Colitis, Ulcerative; Crohn Disease; Feces; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Gastrointestinal Microbiome; Glucaric Acid; Hematinics; Humans; Iron Deficiencies; Metabolome; Quality of Life; RNA, Ribosomal, 16S

Iron deficiency anemia (IDA) is common in many chronic diseases, and intravenous (IV) iron offers a rapid and efficient iron correction. This trial compared the efficacy and safety of iron isomaltoside (also known as ferric derisomaltose) and iron sucrose in patients with IDA who were intolerant of, or unresponsive to, oral iron. The trial was an open‐label, comparative, multi‐center trial. Five hundred and eleven patients with IDA from different causes were randomized 2:1 to iron isomaltoside or iron sucrose and followed for 5 weeks. The cumulative dose of iron isomaltoside was based on body weight and hemoglobin (Hb), administered as either a 1000 mg infusion over more than 15 minutes or 500 mg injection over 2 minutes. The cumulative dose of iron sucrose was calculated according to Ganzoni and administered as repeated 200 mg infusions over 30 minutes. The mean cumulative dose of iron isomaltoside was 1640.2 (standard deviation (SD): 357.6) mg and of iron sucrose 1127.9 (SD: 343.3) mg. The primary endpoint was the proportion of patients with a Hb increase ≥2 g/dL from baseline at any time between weeks 1‐5. Both non‐inferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside. For all biochemical efficacy parameters, faster and/or greater improvements were found with iron isomaltoside. Both treatments were well tolerated; 0.6% experienced a serious adverse drug reaction. Iron isomaltoside was more effective than iron sucrose in achieving a rapid improvement in Hb. Furthermore, iron isomaltoside has an advantage over iron sucrose in allowing higher cumulative dosing in fewer administrations. Both treatments were well tolerated in a broad population with IDA.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Disaccharides; Drug Dosage Calculations; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Middle Aged; Time Factors; Treatment Outcome; Young Adult

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

Intravenous (IV) iron supplementation is widely used in hemodialysis (HD) patients to treat their periodic losses. However, the ideal dose and frequency is unknown. The goal of the study is to see if a 20 mg dose of iron IV at the end of each session of HD as iron maintenance is better than the iron prior therapy. We analyze the erythropoiesis activity (EA) and functional iron (FI) after four weeks of treatment.. In 36 patients, we measure reticulocyte count and content of hemoglobin reticulocyte (CHr) as EA and FI markers, respectively, before and after the treatment. Before the study, 23 patients received another different therapy with IV iron as maintenance therapy.. Reticulocyte count: 49.7 ± 23.8 × 10(3) before and 47.2 ± 17.2 × 10(3) after the treatment (p= 0.51). The CHr: 34.8 ± 3.7 pg and 34.4 ± 3.5 pg, respectively, (p= 0.35), showing an excellent correlation with the other FI markers (serum iron r = 0.6; p = 0.001; saturation transferrin r = 0.49; p = 0.004); that is not shown with the serum ferritin (r = 0.23; p = 0.192) or the hepcidin levels (r = 0.22; p = 0.251). There was not a correlation between the C-Reactive Protein, reticulocyte count, and CHr. The 13 patients who did not receive the iron prior to the study showed high FI levels, but not an increased of the serum ferritin or the serum hepcidin levels.. The administration of a small quantity of iron at the end of every HD session keeps the EA and the FI levels and allows reducing the iron overload administered and/or decreasing the iron stores markers in some patients.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Biomarkers; C-Reactive Protein; Erythropoiesis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Hepcidins; Humans; Kidney Failure, Chronic; Maintenance Chemotherapy; Male; Renal Dialysis; Reticulocyte Count; Reticulocytes; Transferrin

Treatment of iron deficiency helps to improve cardiac and renal function in patients with chronic heart failure. However, the mechanism by which this occurs is currently unclear.. We undertook a double-blind, randomised, placebo-controlled study of intravenous iron sucrose treatment (200mg/mL weekly for five weeks) in patients with chronic heart failure, chronic kidney disease and iron-deficiency anaemia receiving optimal treatment for chronic heart failure (N=60). Markers of disease severity, iron status, anaemia and inflammation were measured during a six-month follow-up period, and evaluation of echocardiographic parameters was performed at baseline and six months after treatment.. At six months after treatment initiation, intravenous iron was associated with reduced severity of the symptoms of chronic heart failure and improved renal function (both p<0.001 versus control). Also, ferritin and transferrin saturation levels were increased, as were haemoglobin levels, whereas inflammatory markers were reduced (all p<0.001 versus control). Left ventricular systolic and diastolic diameters were increased and improved left ventricular function correlated with iron status in patients receiving intravenous iron but not patients in the control group.. Intravenous iron treatment was associated with improved myocardial functional parameters and cardiac dimensions in patients with anaemia and chronic kidney disease.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Hematinics; Humans; Iron; Iron Deficiencies; Male; Pilot Projects; Renal Insufficiency, Chronic; Ventricular Function, Left

Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients.. This was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B). Subjects in Group A were equally divided into A1 (500 mg single bolus injection) and A2 (500 mg split dose). Group B were also treated with 500 mg split dose. The primary end point was the proportion of subjects with haemoglobin (Hb) in the target range 9.5-12.5 g/dL at 6 weeks. Secondary outcome measures included haematology parameters and safety parameters.. A total of 351 subjects were enrolled. Both treatments showed similar efficacy with >82% of subjects with Hb in the target range (non-inferiority, P = 0.01). Similar results were found when comparing subgroups A1 and A2 with Group B. No statistical significant change in Hb concentration was found between any of the groups. There was a significant increase in ferritin from baseline to Weeks 1, 2 and 4 in Group A compared with Group B (Weeks 1 and 2: P < 0.001; Week 4: P = 0.002). There was a significant higher increase in reticulocyte count in Group A compared with Group B at Week 1 (P < 0.001). The frequency, type and severity of adverse events were similar.. Iron isomaltoside 1000 and iron sucrose have comparative efficacy in maintaining Hb concentrations in haemodialysis subjects and both preparations were well tolerated with a similar short-term safety profile.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Disaccharides; Early Intervention, Educational; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Maintenance Chemotherapy; Male; Middle Aged; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Treatment Outcome; Young Adult

Although iron is commonly used to correct iron deficiency anemia (IDA) in chronic kidney disease (CKD), its effect on kidney function is unclear. To assess this, we randomly assigned patients with stage 3 and 4 CKD and IDA to either open-label oral ferrous sulfate (69 patients to 325 mg three times daily for 8 weeks) or intravenous iron sucrose (67 patients to 200 mg every 2 weeks, total 1 g). The primary outcome was the between-group difference in slope of measured glomerular filtration rate (mGFR) change over two years. The trial was terminated early on the recommendation of an independent data and safety monitoring board based on little chance of finding differences in mGFR slopes, but a higher risk of serious adverse events in the intravenous iron treatment group. mGFR declined similarly over two years in both treatment groups (oral -3.6 ml/min per 1.73 m(2), intravenous -4.0 ml/min per 1.73 m(2), between-group difference -0.35 ml/min per 1.73 m(2); 95% confidence interval -2.9 to 2.3). There were 36 serious cardiovascular events among 19 participants assigned to the oral iron treatment group and 55 events among 17 participants of the intravenous iron group (adjusted incidence rate ratio 2.51 (1.56-4.04)). Infections resulting in hospitalizations had a significant adjusted incidence rate ratio of 2.12 (1.24-3.64). Thus, among non-dialyzed patients with CKD and IDA, intravenous iron therapy is associated with an increased risk of serious adverse events, including those from cardiovascular causes and infectious diseases.

Topics: Administration, Intravenous; Administration, Oral; Aged; Anemia, Iron-Deficiency; Biomarkers; Disease Progression; Early Termination of Clinical Trials; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glomerular Filtration Rate; Glucaric Acid; Hematinics; Hemoglobins; Humans; Indiana; Kidney; Male; Middle Aged; Quality of Life; Renal Insufficiency, Chronic; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; 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

Intravenous (IV) ferric iron (Fe)-carbohydrate complexes are used for treating Fe deficiency in children with iron-refractory iron-deficiency anemia (IRIDA). An optimal treatment has yet to be determined. There are relatively little publications on the responsiveness to IV iron therapy in children with IRIDA.. This study analyzed responses to IV iron sucrose therapy given to 11 children, ranging in age from 2 to 13 years (mean 4.8 years), with iron-deficiency anemia who were unresponsive to oral iron therapy.. The hemoglobin and ferritin values (mean) of the 11 children with IRIDA were 7.7 g/dL and 4.8 ng/mL at diagnosis. Both hemoglobin and ferritin levels increased to 9.5 g/dL, and 24 ng/mL, respectively, at 6 weeks after the first therapy. Although the level of hemoglobin was steady at 6 months after the first, and 6 weeks after the second therapy, the ferritin levels continued to increase up to 30 ng/mL and 47 ng/mL at 6 months after the first and 6 weeks after the second therapy, respectively.. We recommend that IRIDA should be considered in patients presenting with iron-deficiency anemia of unknown cause that is unresponsive to oral iron therapy. Our results suggest that IV iron therapy should be administered only once in cases of IRIDA. Continued administration of IV iron would be of no benefit to increase hemoglobin levels. On the contrary, ferritin levels may continue to increase resulting in untoward effects of hyperferritinemia.

Topics: Administration, Oral; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Drug Resistance; Erythrocyte Indices; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Humans; Infusions, Intravenous; Iron; Male; Sucrose; Treatment Outcome

The aim of the study was to evaluate the effectiveness of intravenous iron versus placebo added to standard oral iron therapy in the treatment of severe postpartum anaemia.. A randomised, double-blind, parallel-group, placebo-controlled clinical trial was performed in a single centre.. Hospital Clinic of Barcelona, Barcelona, Spain.. A cohort of 72 women with severe postpartum anaemia (6.0-8.0 g/dl) treated with oral ferrous sulphate (two tablets of 525 mg).. Women were randomised to receive either intravenous ferrous sucrose (200 mg/24 hours for two consecutive days) or intravenous placebo, in addition to standard iron therapy. Clinical and laboratory data were obtained at 1, 2, and 6 weeks.. Haemoglobin and haematocrit at 1, 2, and 6 weeks. Other haematological and clinical parameters, psychological status, and adverse side effects were also evaluated.. Haemoglobin and haematocrit values were comparable in women receiving intravenous iron or placebo in addition to oral iron therapy at any of the time points. At 6 weeks, haemoglobin level (mean ± SD) was 12.2 ± 1.0 versus 12.2 ± 0.9 g/dl, with a mean difference of -0.03 (95% CI -0.6 to 0.6), in the placebo and in the intravenous iron groups, respectively. No differences were found between clinical symptoms of anaemia, psychological status, and adverse side effects between groups.. Intravenous iron added to oral iron therapy did not show significant benefits over placebo, neither in haemoglobin rise nor in symptoms or adverse side effects.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Dietary Supplements; Double-Blind Method; Drug Therapy, Combination; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hematocrit; Hemoglobins; Humans; Infusions, Intravenous; Iron, Dietary; Puerperal Disorders; Severity of Illness Index; Spain; Treatment Outcome

Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia.. In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1.02 g ferumoxytol (2 × 510-mg injections) or 1.0 g iron sucrose administered as either a slow injection or infusion (10 doses for dialysis patients and 5 doses for nondialysis patients). Inclusion criteria included hemoglobin<11.0 g/dl, transferrin saturation<30%, and eGFR<60 ml/min per 1.73 m(2) or a diagnosis of underlying CKD (e.g., nephropathy or nephritis). The primary end point was change in hemoglobin from baseline to week 5.. In total, 162 patients were randomized. Demographics were balanced between the treatment groups. Adverse event profiles of the two regimens were fairly similar: overall adverse events, 48% ferumoxytol versus 65% iron sucrose; related adverse events, 10% ferumoxytol versus 16% iron sucrose; and adverse events leading to study discontinuation, 1% ferumoxytol versus 5% iron sucrose. Rates of serious adverse events and related serious adverse events were similar between the ferumoxytol and iron sucrose groups: serious adverse events, 9% versus 7%, respectively and related serious adverse events, 1% versus 1%, respectively. Overall, increases in hemoglobin were similar between treatment groups. Based on an ANOVA model adjusted for baseline hemoglobin level and dialysis status, the least squares mean change from baseline to week 5 was 0.8 ± 0.1 g/dl in the ferumoxytol-treated group and 0.7 ± 0.1 g/dl in the iron sucrose group. The difference in the mean change from baseline between the two treatment groups was 0.1 g/dl (95% confidence interval, -0.2 to 0.4).. In this randomized, controlled trial, ferumoxytol and iron sucrose showed comparable efficacy and adverse events rates.

Topics: Aged; Anemia, Iron-Deficiency; Biomarkers; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Injections, Intravenous; Least-Squares Analysis; Male; Middle Aged; Renal Dialysis; Renal Insufficiency, Chronic; Time Factors; Treatment Outcome

Iron deficiency anemia (IDA) is the most common form of anemia worldwide. Although oral iron is used as first-line treatment, many patients are unresponsive to or cannot take oral iron. This Phase III, open-label, non-inferiority study compared the efficacy and safety of ferumoxytol, a rapid, injectable intravenous (IV) iron product with low immunological reactivity and minimal detectable free iron, with IV iron sucrose in adults with IDA of any cause. Patients (N = 605) were randomized 2:1 to receive ferumoxytol (n = 406, two doses of 510 mg 5 ± 3 days apart) or iron sucrose (n = 199, five doses of 200 mg on five nonconsecutive days over 14 days) and followed for 5 weeks. Ferumoxytol demonstrated noninferiority to iron sucrose at the primary endpoint, the proportion of patients achieving a hemoglobin increase of ≥2 g dL(-1) at any time from Baseline to Week 5 (ferumoxytol, 84.0% [n = 406] vs. iron sucrose, 81.4% [n = 199]), with a noninferiority margin of 15%. Ferumoxytol was superior to iron sucrose (2.7 g dL(-1) vs. 2.4 g dL(-1) ) in the mean change in hemoglobin from Baseline to Week 5 (the alternative preplanned primary endpoint) with P = 0.0124. Transferrin saturation, quality-of-life measures, and safety outcomes were similar between the two treatment groups. Overall, ferumoxytol demonstrated comparable safety and efficacy to iron sucrose, suggesting that ferumoxytol may be a useful treatment option for patients with IDA in whom oral iron was unsatisfactory or could not be used.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Humans; Injections, Intravenous; Male; Middle Aged

Anemia in heart failure patients and has been associated with increased morbi-mortality. Previous studies have treated anemia in heart failure patients with either erythropoietin alone or combination of erythropoietin and intravenous (i.v.) iron. However, the effect of i.v. or oral (p.o.) iron supplementation alone in heart failure patients with anemia was virtually unknown.. To compare, in a double-blind design, the effects of i.v. iron versus p.o. iron in anemic heart failure patients.. IRON-HF study was a multicenter, investigator initiated, randomized, double-blind, placebo controlled trial that enrolled anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels. Interventions were Iron Sucrose i.v. 200 mg, once a week, for 5 weeks, ferrous sulfate 200 mg p.o. TID, for 8 weeks, or placebo. Primary endpoint was variation of peak oxygen consumption (peak VO2) assessed by ergospirometry over 3 month follow-up.. Eighteen patients had full follow-up data. There was an increment of 3.5 ml/kg/min in peak VO2 in the i.v. iron group. There was no increment in peak VO2 in the p.o. iron group. Patients' ferritin and TSat increased significantly in both treated groups. Hemoglobin increased similarly in all groups.. I.v. iron seems to be superior in improving functional capacity of heart failure patients. However, correction of anemia seems to be at least similar between p.o. iron and i.v. iron supplementation.

Topics: Aged; Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Heart Failure; Humans; Infusions, Intravenous; Male; Middle Aged; Prospective Studies; Treatment Outcome

Iron deficiency is a leading cause of anemia in pregnancy. The present study aimed to compare the efficacy of oral and intravenous iron therapy in improving iron deficiency anemia in pregnancy and restoring iron stores, compare the obstetric outcome in the two groups and evaluate the safety of intravenous iron sucrose.. This was a prospective study, where 100 anemic antenatal women with hemoglobin 7-9 g/dL, mean corpuscular volume <85 fL and serum ferritin <15 ng/mL, were randomized into two groups. In group A (n=50), the women received 200 mg tablets of ferrous sulphate, each containing 60 mg elemental iron, three times a day for 4 weeks. In group B (n=50), iron sucrose was given in divided doses of 200 mg each on alternate days by slow intravenous infusion. Primary outcome measure was treatment efficacy, assessed by measurement of hemoglobin, red blood cell indices and reticulocytes on days 7, 14, 21, and 30 and at delivery, and of ferritin on day 30 and at delivery. Any side-effects of treatment and the neonatal outcome were studied as secondary outcome measures.. There was a statistically significant difference in increase of hemoglobin levels (3.1g/dL in group A vs 5.1 g/dL in group B; P=0.002) and ferritin levels between the two groups on day 30 (P=0.005). The adverse effects from iron treatment were mild but more prominent in group A. Neonatal outcome was comparable in the two groups.. Intravenous administration of iron sucrose is a safe treatment for correction of anemia in pregnancy, without serious side-effects.

Topics: Adult; Anemia, Iron-Deficiency; Dietary Supplements; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; India; Infusions, Intravenous; Iron, Dietary; Pregnancy; Pregnancy Complications; Young Adult

To compare oral iron to intravenous iron administration to women in late pregnancy and/or after labor to correct iron deficiency.. 271 anemic women (148 pregnant women and 123 women post lower segment caesarean section) with hemoglobin (Hb) levels below 110 g/L were enrolled over a two-year period and randomized to receive either two tablets FGF (ferrous sulfate with folic acid) or 400 mg of intravenous iron sucrose plus folic acid 600 µg. Treatment effectiveness was assessed by measuring Hb and ferritin postpartum on day 1, day 14 and day 42. Transfusions of red blood cells and adverse drug reactions were recorded.. Data of 214 women were available for analysis. Both forms of iron replacement therapy led to increased hemoglobin and ferritin levels over the testing period. Ferritin was significantly higher in the i.v. iron treatment group compared to the oral iron treatment group (p = 0.004) two weeks after delivery, while Hb values did not differ between the groups. No serious adverse drug reactions were observed. Red blood cell transfusion rate was low (1.9%), with equal rates observed in both treatment groups.. Intravenous and oral irons were both effective in correcting peripartum anemia, although intravenous iron restored stores faster than oral iron.

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia, Iron-Deficiency; Blood Loss, Surgical; Cesarean Section; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Postpartum Period; Pregnancy; Pregnancy Complications, Hematologic; Pregnancy Trimester, Third; Young Adult

Iron deficiency is a common cause of anemia in young persons with chronic kidney disease (CKD). Iron repletion with intravenous (IV) iron formulations has been studied in children; maintenance IV iron regimens have not been reported extensively.. A multicenter randomized trial of IV iron sucrose.. 145 children, adolescents, and young adults with CKD receiving erythropoiesis-stimulating agent (ESA) therapy were stratified by dialysis category (hemodialysis, peritoneal dialysis, or non-dialysis dependent) and weight (<50 and ≥50 kg).. Patients were randomly assigned to 1 of 3 dosing arms: 0.5, 1.0, or 2.0 mg/kg (maximum single dose, 100 mg), stratified into hemodialysis versus nonhemodialysis (peritoneal dialysis or non-dialysis-dependent CKD) groups. Patients treated with hemodialysis received study medication once every other week for 6 doses. Patients in the nonhemodialysis group received study medication once every 4 weeks for 3 doses.. We assessed adverse event rates between dosing groups. The main clinical end point was a composite of hemoglobin level ≥10.5-14.0 g/dL, inclusive; transferrin saturation ≥20%-50%, inclusive; and stable ESA dosing (±25% of baseline dose).. Between-group difference for composite clinical end point rate attainment was -3.9% (95% CI, -21.4% to 13.7%) for the 1.0-mg/kg group versus 0.5-mg/kg group, +3.9% (95% CI, -15.1% to 23.0%) for the 2-mg/kg group versus 0.5-mg/kg group, and +7.8% (95% CI, -10.9% to 26.5%) for the 2-mg/kg group versus 1-mg/kg group. No differences were noted between regimens in reported adverse effects, which were all minor.. Absence of a control group receiving no IV iron. Short duration of intervention and observation. A small proportion of patients having achieved the primary clinical outcome.. IV iron sucrose at a dose of 0.5 mg/kg at the intervals prescribed is noninferior to higher doses in maintaining hemoglobin levels >10.5 g/dL in children, adolescents, and young adults receiving ESA therapy.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Male; Peritoneal Dialysis; Prospective Studies; Renal Insufficiency, Chronic; Young Adult

The effects of iron deficiency anemia (IDA) and its treatment on plasma total antioxidant capacity (TAOC) were investigated.. Sixty patients with IDA and 20 healthy controls were divided into four subgroups: an oral (per os: PO) group (n = 20); an intramuscular (IM) group (n = 20); an intravenous (IV) group (n = 20); and the control group (n = 20). Blood samples were obtained from all patients before treatment, and at 24 h, 7 days, 6 and 13 weeks after initiation of IDA therapy.. TAOC in the IDA group was low when compared with the control group (P < 0.001). Although TAOC at 24 h in the PO group was not different from the control group, the TAOC in the IM and IV groups was relatively lower (P < 0.001). The TAOC in the PO group at 7 days, and at 6 and 13 weeks was closest to the control group level. The mean TAOC in the IV group at 13 weeks was clearly lower relative to the PO and IM groups.. Oxidative stress was minimally induced with oral therapy, while IM and IV therapies induced higher levels of oxidative stress, in increasing order of intensity.

Topics: Administration, Oral; Adolescent; Anemia, Iron-Deficiency; Antioxidants; Child; Child, Preschool; Developing Countries; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Glycine; Hemoglobinometry; Humans; Infant; Infusions, Intravenous; Injections, Intramuscular; Male; Oxidative Stress; Sucrose; Turkey

Anaemia is a frequent complication after cardiopulmonary bypass surgery. Iron therapy has been variably employed by medical centres over the years. In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia, and its impact on blood transfusion requirements, in patients undergoing cardiopulmonary bypass surgery.. A double-blind, randomized, placebo-controlled clinical trial with three parallel groups of patients. Group I (n = 54): intravenous iron(III)-hydroxide sucrose complex, three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge. Group II (n = 53): oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge, and intravenous placebo while hospitalized. Group III (n = 52): oral and intravenous placebo pre- and postoperatively, following the same protocol. Data were collected preoperatively, at theatre, at intensive care unit admission, before hospital discharge and 1 month later.. (1) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups; (2) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period; (3) the intravenous iron group showed higher serum ferritin levels at hospital discharge (1321 ± 495 ng/ml; P < 0.001) and 1 month later (610 ± 387; P < 0.001) compared with the other groups and (4) we did not observe statistical differences in blood transfusion requirements between the three groups.. The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements. [Current Controlled Trials number: NCT01078818 (oral and intravenous iron in patients postoperative cardiovascular surgery under EC)].

Topics: Administration, Oral; Aged; Analysis of Variance; Anemia, Iron-Deficiency; Blood Transfusion; Cardiac Surgical Procedures; Cardiopulmonary Bypass; Chi-Square Distribution; Double-Blind Method; Elective Surgical Procedures; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Male; Middle Aged; Spain; Sucrose; Tablets; Time Factors; Treatment Failure

Among patients with chronic kidney disease (CKD), differences in proteinuria are seen between intravenous iron preparations after a single dose exposure. This study examined differences in proteinuria between two intravenous iron preparations after multiple doses.. Patients with iron-deficiency anemia and CKD, stratified by angiotensin converting enzyme inhibitor (ACEI)/angiotensin receptor-blocker (ARB) use, were randomized to iron sucrose or ferric gluconate. Each patient at 12 centers received 100 mg of study drug weekly for 5 weeks. Urine protein/urine creatinine ratio was measured before each dose and frequently thereafter for 3 hours.. Postbaseline data were available from 33 patients receiving iron sucrose and 29 patients receiving ferric gluconate. Although neither preparation of intravenous iron increased the predose level of proteinuria, the proteinuric response to intravenous iron was dependent on the type of iron and ACEI/ARB use. Without ACEIs/ARBs, ferric gluconate tended to cause less proteinuria with repeated iron administration; iron sucrose did not mitigate or aggravate proteinuria. Among patients receiving ACEIs/ARBs, in contrast to ferric gluconate, which produced only mild transient proteinuria, iron sucrose produced a consistent and persistent proteinuric response that was on average 78% greater.. Although multiple doses of either intravenous iron did not increase basal levels of proteinuria, postdose proteinuria was greater with iron sucrose than with ferric gluconate. These data suggest that nephrotoxicity of iron may depend on type of intravenous iron and on ACEI/ARB use. The long-term effects on kidney function need to be further evaluated.

Topics: Adult; Aged; Albuminuria; Anemia, Iron-Deficiency; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Chronic Disease; Creatinine; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Kidney Diseases; Male; Middle Aged; Proteinuria

Postpartum anemia is a common problem in obstetrics. Depending on the severity of anemia, it can cause a wide range of symptoms. Obstetrical management should be focused on avoiding blood transfusion in young and otherwise healthy women. The aim of this study was to examine the effectiveness of recombinant human erythropoietin (rhEPO) combined with iron sucrose compared to iron sucrose alone in patients with severe postpartum anemia.. A prospective randomized study was conducted in women with severe postpartum anemia (Hb < 8.5 g/dL). The first group received 200 mg iron sucrose intravenously daily on days 1-4. The second group received 200 mg iron sucrose plus 10.000E rhEPO in the same regimen. Twenty women were enrolled in each group. The follow-up period was two weeks.. Baseline Hb was 7.1 g/dL and 7.5 g/dL, respectively, depending on the subgroup. Hemoglobin values increased close to normal values within two weeks in both groups treated with iron sucrose alone or in combination with rhEPO (10.5 g/dL, 10.7 g/dL, respectively).. In general, iron sucrose alone is a sufficient anemia therapy agent. A subgroup of patients (i.e. with a more pronounced inflammatory response after cesarean section) may benefit from additional rhEPO therapy. Despite being severely anemic, none of our patients required transfusion. Iron sucrose as well as rhEPO was very well tolerated. The benefit of the therapy lies in the avoidance of allogenic blood transfusions with their potential side effects. In cases of severe anemia after operative delivery, additional rhEPO therapy can result in a faster Hb increase and, therefore, faster recovery.

Topics: Anemia; Anemia, Iron-Deficiency; C-Reactive Protein; Drug Administration Schedule; Drug Therapy, Combination; Erythrocyte Indices; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Interleukin-6; Pregnancy; Pregnancy Complications; Prospective Studies; Recombinant Proteins; Treatment Outcome

Intravenous (i.v.) iron sucrose similar (ISS) preparations are available but clinical comparisons with the originator iron sucrose (IS) are lacking.. The impact of switching from IS to ISS on anaemia and iron parameters was assessed in a sequential observational study comparing two periods of 27 weeks each in 75 stable haemodialysis (HD) patients receiving i.v. iron weekly and an i.v. erythropoiesis-stimulating agent (ESA) once every 2 weeks. Patients received IS in the first period (P1) and ISS in the second period (P2).. Mean haemoglobin value was 11.78 ± 0.99 g/dL during P1 and 11.48 ± 0.98 g/dL during P2 (P = 0.01). Mean serum ferritin was similar for both treatment periods (P1, 534 ± 328 μg/L; P2, 495 ± 280 μg/L, P = 0.25) but mean TSAT during P1 (49.3 ± 10.9%) was significantly higher than during P2 (24.5 ± 9.4%, P <0.0001). The mean dose of i.v. iron per patient per week was 45.58 ± 32.55 mg in P1 and 61.36 ± 30.98 mg in P2 (+34.6%), while the mean ESA dose was 0.58 ± 0.52 and 0.66 ± 0.64 μg/kg/week, respectively (+13.8%). Total mean anaemia drug costs increased in P2 by 11.9% compared to P1.. The switch from the originator IS to an ISS preparation led to destabilization of a well-controlled population of HD patients and incurred an increase in total anaemia drug costs. Prospective comparative clinical studies are required to prove that ISS are as efficacious and safe as the originator i.v. IS.

Topics: Anemia, Iron-Deficiency; Cohort Studies; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Male; Middle Aged; Prognosis; Renal Dialysis

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

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

To determine the contribution of injectable iron administered to hemodialysis (HD) patients in causing oxidative stress and the beneficial effect of N-acetylcysteine (NAC) in reducing it, we studied in a prospective, double blinded, randomized controlled, cross over trial 14 adult HD patients who were randomized into two groups; one group received NAC in a dose of 600 mgs twice daily for 10 days prior to intravenous iron therapy and the other group received placebo. Both the groups were subjected to intravenous iron therapy, 100 mg of iron sucrose in 100 mL of normal saline given over a period of one hour. Blood samples for the markers of oxidative stress were taken before and after iron therapy. After the allowance of a week of wash out period for the effect of N-acetylcysteine we crossed over the patients to the opposite regimen. We measured the lipid peroxidation marker, malondiaaldehyde (MDA), to evaluate the oxidative stress and total anti-oxidant capacity (TAC) for the antioxidant level in addition to the highly sensitive C-reactive protein (HsCRP). Non-invasive assessment of endothelial dysfunction was measured by digital plethysmography before and after intravenous iron therapy. There was an increase of MDA (21.97 + 3.65% vs 7.06 + 3.65%) and highly sensitive C-reactive protein (HsCRP) (11.19 + 24.63% vs 13.19 + 7.7%) after iron administration both in the placebo and the NAC groups. NAC reduced the baseline acute systemic generation of oxidative stress when compared to placebo, which was statistically significant with MDA (12.76 + 4.4% vs 9.37 + 4.40%: P = 0.032) but not with HsCRP though there was a declining trend (2.85 + 22.75 % vs 8.93 + 5.19%: P = 0.112). Pre-treatment with NAC reduced the endothelial dysfunction when compared to placebo, but it was not statistically significant, except for reflection index (RI). We conclude that in our HD patients NAC reduced the oxidative stress before and after the administration of intravenous iron therapy in addition to the endothelial dysfunction induced by this treatment.

Topics: Acetylcysteine; Adult; Anemia, Iron-Deficiency; Antioxidants; Biomarkers; C-Reactive Protein; Cross-Over Studies; Double-Blind Method; Endothelium, Vascular; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; India; Infusions, Intravenous; Lipid Peroxidation; Male; Malondialdehyde; Middle Aged; Oxidative Stress; Placebo Effect; Plethysmography; Prospective Studies; Renal Dialysis; Time Factors; Treatment Outcome

To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women.. 260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were randomised between the 21st and 24th week into either the intravenous iron group or the oral iron group. Of 130 women in the intravenous iron group, 75 women received two doses of 200mg iron sucrose and 55 three doses of 200mg iron sucrose. The first dose was administered between the 21st and 24th gestational weeks, the second between the 28th and 32nd and the third between the 35th and 37th. The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily, beginning on the day of study enrolment and stopping on the day of delivery.. There was a non-significant trend to a higher frequency of responders (haemoglobin> or =11 g/dl) in the intravenous iron group (75 vs. 80%). There was a significant difference of repleted iron stores before delivery (ferritin>50 microg/l) in the group with three intravenous iron doses in comparison to the oral iron group (49 vs. 14%; p<0.001). No differences were observed in regard to maternal and perinatal outcomes.. There was no clinically significant difference in the haematological, maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women.

Topics: Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Iron; Middle Aged; Pregnancy; Pregnancy Complications, Hematologic; Trace Elements; Young Adult

Anemia is a common complication of inflammatory bowel disease (IBD) and iron deficiency (ID) is its predominant cause. Therefore, oral and intravenous iron replacements are widely used. This study was performed to evaluate the frequency and timing of anemia and ID recurrence after a successful treatment cycle.. Medical records of patients who had received iron sucrose with or without erythropoietin (EPO) in one of three prospective clinical trials that had been conducted at our center (Ann Intern Med 1997, Digestion 1999, and Am J Gastroenterol 2001) were analyzed for a 5-year follow-up period. The risk for recurrence of anemia (hemoglobin (Hb)<12/13 g per 100 ml) and ID (ferritin <30 microg/l) was evaluated by Kaplan-Meier analysis using the log-rank test.. Eighty-eight patients were available for analysis. Patients had received a mean iron dose of 2,500 mg (range 600-3,600 mg); 33 (37.1%) patients had also received EPO. Anemia recurred in a median of 10 months (95% confidence interval (CI) 8-12) and ID recurred within 19 months (95% CI 11-28). The iron dose had no influence on recurrence of ID or anemia. ID (but not anemia) recurred faster in patients with a post-treatment ferritin level <100 microg/l (median 4 months, 95% CI 1-7) than in patients with ferritin level between 100 and 400 microg/l (median 11 months, 95% CI 6-16) and >400 microg/l (median 49 months, 95% CI 32-66; P<0.001).. IBD-associated ID and anemia recur surprisingly fast, indicating that maintenance treatment may be needed in a portion of the patient population. Recurrence of ID (but not anemia) can be delayed by aiming for high post-treatment ferritin levels.

Topics: Adult; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Glucaric Acid; Hemoglobins; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Iron; Male; Prognosis; Prospective Studies; Recurrence; Treatment Outcome

Patients have to discontinue the use of oral iron therapy due to the development of side effects and lack of long-term adherence to medication for iron deficiency anemia. This study aimed to evaluate the therapeutic effectiveness, safety, and cost of intravenous iron sucrose therapy. The computerized database and medical records of 453 patients diagnosed with iron deficiency anemia who received intravenous iron sucrose therapy for iron deficiency anemia between 2004 and 2008 were reviewed. The improvement of hematologic parameters and cost of therapy were evaluated 4 weeks after therapy. 453 patients (443 females, 10 males; age: 44.2 +/- 12.3 years) received iron sucrose therapy. Mean hemoglobin, hematocrit, and mean corpuscular volume values were 8.2 +/- 1.4 g/dL, 26.9 +/- 3.8%, and 66.1 +/- 7.8 fL, respectively, before therapy and 11.5 +/- 1.0 g/dL, 35.8 +/- 2.5%, 76.5 +/- 6.1 fL, respectively, after therapy (P < 0.001). A mean ferritin level of 3.4 +/- 2.4 ng/mL before therapy increased to 65.9 +/- 40.6 ng/mL after therapy (P < 0.001). All patients responded to intravenous iron therapy (transferrin saturation values of the patients were >50%). The mean cost of therapy was 143.07 +/- 29.13 US dollars. The therapy was well tolerated. Although the cost of intravenous iron sucrose therapy may seem high, a lack of adherence to therapy and side effects including gastrointestinal irritation during oral iron therapy were not experienced during intravenous therapy.

Topics: Adult; Anemia, Iron-Deficiency; Costs and Cost Analysis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hematocrit; Hemoglobins; Humans; Male; Middle Aged

To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose.. One hundred and ninety-four patients on maintenance dialysis with the hemoglobin (Hb) level of 60 - 100 g/L and hematocrit (Hct) of 18% - 30% were randomly divided into 2 sex, age, duration of dialysis, weekly erythropoietin dosage, and hematological parameters-matched groups: intravenous iron sucrose group (n = 102) and oral medication group (n = 92). The intravenous iron sucrose group were sub-divided into 2 subgroups: (1) hemodialysis (HD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks, and (2) peritoneal dialysis (PD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks. The oral medication group received ferrous succinate 200 mg tid for 12 weeks. The levels of serum ferritin (SF), transferrin saturation (TSAT), Hb, and Hct were examined before treatment and 4, 8, and 12 weeks after treatment.. (1) Compared with baseline levels, the levels of Hb, Hct, SF, and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group, and 4 weeks after treatment in the oral medication group (all P < 0.05). (2) The Hb, Hct, SF, and TSAT levels 4, 6, 8, and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group (all P < 0.05). (3) The Hb, Hct, SF, and TSAT levels 12 weeks after treatment 6, 8, and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group (all P > 0.05). (4) The response rate of the intravenous iron sucrose group was 95.09%, significantly higher than that of the oral medication group (55.44%, P < 0.05). (5) The mean EPO doses 6, 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group (all P < 0.05). (6) The Hb, Hct, SF, and TSAT levels maintained stable during the period 6, 8, and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency. (7) The Hb, Hct, SF, and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup. (8) No adverse event was found in the intravenous iron sucrose group, and adverse gastrointestinal effects occurred in 12 patients of the oral medication group. (9) After 12 weeks, the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate.. Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated. Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO. However, the total cost of intravenous iron treatment is relatively high.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Humans; Injections, Intravenous; Male; Middle Aged; Prospective Studies; Renal Dialysis

The transfusion rate following colorectal cancer resection is between 10 and 30 per cent. Receipt of allogeneic blood is not without risk or cost. A preoperative adjunct that reduced the need for transfusion would mitigate these risks. This study was designed to determine whether iron sucrose reduces the likelihood of postoperative blood transfusion in patients undergoing elective colorectal cancer resection.. In this randomized prospective blinded placebo-controlled trial of patients undergoing resectional surgery with a preoperative diagnosis of colorectal cancer, 600 mg iron sucrose or placebo was given intravenously in two divided doses, at least 24 h apart, 14 days before surgery. The primary outcome measures were serum haemoglobin concentration, recorded at recruitment, immediately before surgery and at discharge, and perioperative blood transfusions.. No difference was demonstrated between treatment groups (iron sucrose, 34 patients; placebo, 26) for any of the primary outcome measures, for either the whole study population or a subgroup of anaemic patients.. This pilot study provided no support for the use of intravenous iron sucrose as a preoperative adjunct to increase preoperative haemoglobin levels and thereby reduce the likelihood of allogeneic blood transfusion for patients undergoing resectional surgery for colorectal cancer.. 2005-003608-13UK (Medicines and Healthcare products Regulatory Agency).

Topics: Adult; Aged; Anemia, Iron-Deficiency; Blood Transfusion; Colorectal Neoplasms; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Iron; Male; Middle Aged; Pilot Projects; Postoperative Complications; Prospective Studies; Transferrin; Treatment Outcome; Young Adult

The relative safety of parenteral iron preparations is a controversial issue in the management of anemia in chronic kidney disease (CKD), as direct head-to-head comparative trials are lacking. In this study, patients of CKD were randomized to receive intravenous low molecular weight iron dextran (ID), sodium ferrigluconate complex (SFGC), and iron sucrose (IS) at doses and infusion rates recommended by the product manufacturer. One time test dose was used only for ID and SFGC. A total of 2,980 injections (n = 339) of i.v. iron was given, and 49 patients (14.45% per patient) and a total of 56 adverse events (1.88% per infusion) were noted. Odds ratios (OR) of serious adverse drug events (ADE; i.e., death, anaphylaxis, or suspected immuno-allergic events) per patient was not significant between ID vs. SFGC (3.566) and SFGC vs. IS (2.129), whereas that between ID vs. IS (7.594) was highly significant (p = 0.034). OR of serious ADE exposure was significantly higher in ID vs. SFGC (OR = 5.670, p = 0.0147) and ID vs. IS (OR = 7.799, p < 0.001). No significant difference was seen between the three groups in terms of non-serious ADEs. Drug discontinuation occurred significantly more often with ID. One patient who developed anaphylactoid reaction with SFGC and ID tolerated iron sucrose well.

Topics: Adult; Age Factors; Analysis of Variance; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Humans; Infusions, Intravenous; Iron-Dextran Complex; Kidney Failure, Chronic; Logistic Models; Male; Middle Aged; Predictive Value of Tests; Probability; Renal Dialysis; Risk Assessment; Severity of Illness Index; Sex Factors; Treatment Outcome

Anaemia is a common in chronic kidney disease. Although erythropoietin and iron supplementation are established treatments, knowledge on the use of IV iron alone in patients not on dialysis or erythropoietin is incomplete. The responses of 82 patients referred to the renal anaemia service with haemoglobin of 11.5 g/dl or less were assessed 1 week after completing four once weekly doses of 200 mg of venofer. No patients were on dialysis or erythropoietin. The haemoglobin rise 1 week after treatment was 0.53 g/dl. Ferritin levels improved from 110.8 to 410.2 ng/l and transferrin saturation from 17.7 to 27.3%. Ferritin levels remained below our target range (200-500 ng/l) in 7.7% while 25.6% had levels above this. Ferritin levels remained less than 800 ng/l in nearly all patients. Intravenous iron is cost effective and should be considered for use in patients with renal anaemia. Patients with CKD stage 5 appeared to respond less well.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Cost-Benefit Analysis; Drug Administration Schedule; Drug Monitoring; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glomerular Filtration Rate; Glucaric Acid; Hemoglobins; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Severity of Illness Index; Sucrose; Transferrin; Treatment Outcome

Anemia is a common finding in heart failure (HF) patients and has been associated with increased morbidity and mortality. It is generally denominated as anemia of chronic disease (ACD), but the association with true ferropenic anemia is common. Many studies have investigated the effects of treating anemia in HF patients with either erythropoietin alone or combination of erythropoietin and intravenous iron. However, the effect of iron supplementation alone in HF patients with ACD, ferropenic anemia, or both is unknown.. IRON-HF study is a multicenter, investigator initiated, randomized, double-blind, placebo controlled trial that will enroll anemic HF patients with relatively preserved renal function, low transferrin saturation, low iron levels, and low to moderately elevated ferritin levels. Interventions are iron sucrose intravenously 200 mg once per week for 5 weeks, ferrous sulfate 200 mg by mouth 3 times per day for 8 weeks, or placebo. The primary objective is to assess the impact of iron supplementation (intravenously or by mouth) compared with placebo in HF patients with anemia from deficient iron availability. The primary end point is variation of peak oxygen consumption assessed by ergospirometry over 3-month follow-up. Secondary end points include functional class, brain natriuretic peptide levels, quality of life scores, left ventricular ejection fraction, adverse events, HF hospitalization, and death.. The results of IRON-HF should help to clarify the potential clinical impact of mild to moderate anemia correction in HF patients.

Topics: Adult; Anemia, Iron-Deficiency; Double-Blind Method; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Hematinics; Humans; Prospective Studies; Research Design

To assess the effectivity and safeness of intravenous treatment of pospartal anemia with trivalent ferrum preparation.. Prospective randomized study.. Department of Obstetric and Gynecology 2nd Medical Faculty Charles University and Teaching Hospital Motol, Prague, and Department of Obstetric and Gynecology 1st Medical Faculty and Teaching Hospital Bulovka, Prague.. 500 mg of sacharose ferric oxide (Venofer) was intravenously administered in two days regimen to 50 women with clinical and lab signs of postpartal anemia. The effect of administered drug was determined by comparsion of values of red blood count recovered before the treatment, 2nd or 3rd day post administration and two weeks later. The serum values of soluble transferrin receptors and ferritin were observed as markers of iron cell saturation and body iron reserves, too. Integral part of the study was the monitoring of adverse events during the treatment.. Venofer came in sight as effective drug in the treatment of pospartal anemia and could become as the alternative to blood transfusion in mid-severe cases. It should be emphasized that we have not encountered any serious adverse event with intravenous trivalent saccharose ferric oxide treatment.

Topics: Anemia, Iron-Deficiency; Blood Cell Count; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Infusions, Intravenous; Pregnancy; Puerperal Disorders; Sucrose

Topics: Adult; Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Kidney Failure, Chronic; Male; Middle Aged; Treatment Outcome

Fast intravenous (i.v.) iron administration during hemodialysis (HD) is associated with the augmentation of oxidative stress and the increase in inflammatory biomarkers, which are also induced by the hemodialysis procedure itself. The aim of this study was to investigate if slow i.v. iron administration would aggravate the status of oxidative stress and inflammatory biomarkers during a hemodialysis session.. Twenty dialysis patients 30-92 years of age that were iron replete and had values for hemoglobin, transferrin saturation and serum ferritin among recommended goals were evaluated in three separate hemodialysis sessions. In the first session patients did not receive any iron treatment, whereas during the second and the third session patients received slow (60 min) i.v. infusions of 100 mg of iron sucrose and 100 mg of iron dextran, respectively. Blood samples were drawn before the hemodialysis session, 15 min after the end of iron administration and at the end of the hemodialysis session in all occasions, for the measurement of markers of oxidant stress (oxidized LDL and ischemia-modified albumin) and inflammation (high-sensitivity C-reactive protein, interleukin-6 and tumor necrosis factor-alpha).. Oxidized LDL was not significantly altered during hemodialysis and this pattern was similar between the three occasions studied. In contrast, ischemia-modified albumin was significantly increased and this effect was also not different between the net hemodialysis and the occasions of iron administration. High-sensitivity CRP, IL-6 and TNF-alpha were all significantly elevated during hemodialysis and again both types of iron administration did not produce significant changes in this pattern.. We did not find an increase in the markers of oxidation/inflammation studied, after slow i.v. iron administration during hemodialysis session.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Biomarkers; C-Reactive Protein; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Inflammation Mediators; Infusions, Intravenous; Interleukin-6; Iron-Dextran Complex; Kidney Failure, Chronic; Lipoproteins, LDL; Male; Middle Aged; Oxidative Stress; Renal Dialysis; Serum Albumin; Tumor Necrosis Factor-alpha

Our objective was to evaluate in a double-blind, randomized, placebo-controlled study possible modifications in NT-pro-brain natriuretic peptide (NT-proBNP) and C-reactive protein (CRP) levels together with clinical and functional parameters, in a group of anemic patients with chronic heart failure (CHF) and chronic renal failure (CRF) receiving intravenous iron therapy, without recombinant human erythropoietin (rhEPO), versus placebo.. Chronic heart failure and CRF associated with absolute or relative iron deficiency anemia is a common problem. This situation is linked with a variable inflammatory status. Both NT-proBNP and CRP are recognized markers for left ventricular dysfunction and inflammatory status, respectively. In this double-blind, randomized, placebo-controlled study, modifications in NT-proBNP and CRP level and clinical and functional parameters, in anemic patients with CHF and CRF receiving intravenous iron therapy, without rhEPO, versus placebo were evaluated.. Forty patients with hemoglobin (Hb) <12.5 g/dl, transferrin saturation <20%, ferritin <100 ng/ml, creatinine clearance (CrCl) <90 ml/min, and left ventricular ejection fraction (LVEF) < or =35% were randomized into 2 groups (n = 20 for each). For 5 weeks, group A received isotonic saline solution and group B received iron sucrose complex, 200 mg weekly. Minnesota Living with Heart Failure Questionnaire (MLHFQ) and 6-min walk (6MW) test were performed. NT-pro brain natriuretic peptide and CRP were evaluated throughout the study. No patients received erythroprotein any time.. After 6 months follow-up, group B showed better hematology values and CrCl (p < 0.01) and lower NT-proBNP (117.5 +/- 87.4 pg/ml vs. 450.9 +/- 248.8 pg/ml, p < 0.01) and CRP (2.3 +/- 0.8 mg/l vs. 6.5 +/- 3.7 mg/l, p < 0.01). There was a correlation initially (p < 0.01) between Hb and NT-proBNP (group A: r = -0.94 and group B: r = -0.81) and after 6 months only in group A: r = -0.80. Similar correlations were observed with Hb and CRP. Left ventricular ejection fraction percentage (35.7 +/- 4.7 vs. 28.8 +/- 2.4), MLHFQ score, and 6MW test were all improved in group B (p < 0.01). Additionally, group B had fewer hospitalizations: 0 of 20 versus group A, 5 of 20 (p < 0.01; relative risk = 2.33).. Intravenous iron therapy without rhEPO substantially reduced NT-proBNP and inflammatory status in anemic patients with CHF and moderate CRF. This situation was associated with an improvement in LVEF, NYHA functional class, exercise capacity, renal function, and better quality of life.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Biomarkers; C-Reactive Protein; Double-Blind Method; Exercise Tolerance; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Heart Failure; Hematinics; Hospitalization; Humans; Infusions, Intravenous; Male; Middle Aged; Natriuretic Peptide, Brain; Peptide Fragments; Pilot Projects; Prospective Studies; Quality of Life; Renal Insufficiency, Chronic; Treatment Outcome

Intravenous iron is commonly used in conjunction with erythropoietic agents to treat anemia in patients with chronic kidney disease. Iron has been proposed to promote oxidative stress and endothelial dysfunction in vascular tissues. We studied the acute effects of intravenous iron sucrose on homocysteine-induced endothelial dysfunction in the brachial artery of normal human subjects. In all, 40 healthy subjects received intravenous iron sucrose 100 mg or placebo over 30 min immediately before ingestion of 100 mg/kg of oral methionine in a double-blind, randomized study. Flow- and nitroglycerin-mediated dilation in the brachial artery, serum markers of iron stores, and homocysteine and nitrotyrosine levels were measured before and after study drug administration. Intravenous iron significantly increased transferrin saturation and non-transferrin-bound iron (NTBI) when compared with placebo. Flow-mediated dilation significantly decreased from baseline 1 h after administration of iron sucrose when compared with placebo (from 6.66+/-0.47 to 1.93+/-0.35% after iron sucrose vs from 6.00+/-0.40 to 5.61+/-0.46% after placebo, P<0.001), but did not differ between groups at 4 h (1.10+/-0.39 vs 1.33+/-0.51%). Nitroglycerin-mediated vasodilation, and homocysteine and 3-nitrotyrosine levels did not differ after administration of iron sucrose and placebo. Intravenous administration of iron sucrose in the setting of transient hyperhomocysteinemia induced by methionine ingestion significantly increased transferrin saturation and plasma levels of NTBI and significantly attenuated flow-mediated dilation in the brachial artery when compared with placebo. This potential mechanistic link between intravenous iron and endothelial dysfunction warrants further study of cardiovascular effects of intravenous iron in anemic chronic kidney disease populations.

Topics: Adult; Anemia, Iron-Deficiency; Brachial Artery; Cardiovascular Diseases; Chelating Agents; Double-Blind Method; Endothelium, Vascular; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Homocysteine; Humans; Iron; Male; Methionine; Nitroglycerin; Oxidative Stress; Razoxane; Regional Blood Flow; Risk Factors; Transferrin; Tyrosine; Vasodilation

Postpartum iron deficiency anaemia (IDA) is common in women. Most women are treated with either oral iron supplementation or blood transfusion. Hence, the aim of our study was to compare the effect of treatment with either oral ferrous sulphate or intravenous ferrous sucrose on postpartum IDA.. A single centre, prospective randomised controlled trial.. Women's Centre, John Radcliffe Hospital, Oxford, UK.. Forty-four women with haemoglobin (Hb) of <9 g/dl and ferritin of <15 microgram/l at 24-48 hours postdelivery.. Women were randomised to receive either oral ferrous sulphate 200 mg twice daily for 6 weeks (group O) or intravenous ferrous sucrose 200 mg (Venofer; Vifor International Ltd, St Gallen, Switzerland), two doses given on days 2 and 4 following recruitment (group I).. were analysed by the Students t-test, chi-square test and analysis of variance.. Hb, haematocrit, red cell indices, ferritin and serum iron levels were measured on days 0, 5, 14 and 40. Results By day 5, the Hb level in women treated with intravenous iron had risen from 7.3 +/- 0.9 to 9.9 +/- 0.7 g/dl, while there was no change in those treated with oral iron. Women treated with intravenous iron had significantly higher Hb levels on days 5 and 14 (P < 0.01) than those treated with oral iron; although by day 40, there was no significant difference between the two groups. Throughout the study, ferritin levels rose rapidly in those treated with intravenous iron and remained significantly higher than in those treated with oral iron (P < 0.01).. Intravenous iron sucrose increases the Hb level more rapidly than oral ferrous sulphate in women with postpartum IDA. It also appears to replenish iron stores more rapidly. However, this study was not large enough to address the safety of this strategy.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Prospective Studies; Puerperal Disorders

Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents (ESA), randomized, controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis (PD) patients. In a multicenter trial, patients who had anemia, PD-dependent chronic kidney disease, stable ESA therapy, and a broad range of iron status (ferritin < or = 500 ng/ml, transferrin saturation < or = 25%) were randomly assigned to receive either 1 g of iron sucrose intravenously in three divided doses (300 mg over 1.5 h on days 1 and 15, 400 mg over 2.5 h on day 29) or no supplemental iron. No serious adverse drug events occurred after intravenous iron administration. The primary end point, peak hemoglobin increase, was higher (1.3 +/- 1.1 versus 0.7 +/- 1.1, mean +/- SD; P = 0.0028), and anemia intervention (transfusion, increase in ESA dose, or intravenous iron therapy not called for in protocol) occurred later (P = 0.0137) and less often in intravenous iron-treated patients compared with untreated control subjects (one of 66 [1.3%] versus five of 30 [16.7%]). Among patients who did not require intervention, iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects. Baseline iron status did not predict responsiveness to intravenous iron therapy. Intravenous iron sucrose is an effective adjunct to ESA therapy in anemic patients with PD-dependent chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of iron deficiency at baseline is not required to demonstrate intravenous iron efficacy.

Topics: Anemia, Iron-Deficiency; Darbepoetin alfa; Epoetin Alfa; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Male; Middle Aged; Peritoneal Dialysis; Recombinant Proteins

Anemia in hemodialysis patients is a complex syndrome. The impetus of this study was to assess the safety and efficacy of iron saccharate complex (ISC) and sodium ferric gluconate complex (SFGC) in treating anemia in hemodialysis patients.. Forty-eight adult anemic patients of both genders (33 males and 15 females) who had an adequate level of both hemodialysis and nutrition status and received neither EPO nor parenteral iron therapy during the preceding 6 months were randomized to 2 groups. The first group comprised 22 patients who were treated with parenteral ISC, 100 mg twice weekly for 2 months and once weekly thereafter. The second group included 26 patients who received SFGC, 62.5 mg twice weekly for 2 months and once weekly thereafter. The patients were followed up for 6 months.. This head-to-head study showed that iron stores were adequately repleted by the use of both drugs. Repletion of iron stores was associated with a significant rise in both hemoglobin and hematocrit in both groups at the end of the follow-up period in comparison to their initial values at the start of the study (p < 0.001). Both parenteral iron therapy preparations were tolerated without a statistical difference between both groups.. This head-to-head study confirmed that both parenteral iron preparations are effective for adequate repletion of iron stores and constituted a step forward in the management of anemic hemodialysis patients without noticeable adverse effects related to the administration of both iron preparations.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gluconates; Humans; Kidney Failure, Chronic; Male; Parenteral Nutrition; Renal Dialysis

Anemia is a frequent complication in patients with inflammatory bowel disease (IBD). The optimal route for iron supplementation to replenish iron stores has not been determined so far. We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia (IDA) in patients with IBD.. A randomized, prospective, open-label, multicenter study was performed in 46 patients with anemia and transferrin saturation

Topics: Abdominal Pain; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Glucaric Acid; Hematinics; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Male; Middle Aged; Nausea; Prospective Studies; Transferrin; Treatment Outcome

The provision of adequate iron to support erythropoiesis in iron deficient patients is a time-consuming process which may present compliance problems for patients in the outpatient setting. The aim of the present study was to evaluate the safety and tolerability of intravenous high-dose iron sucrose therapy specifically in patients with iron deficiency anemia (IDA) due to gastrointestinal blood loss.. A single dose of iron sucrose of 7 mg iron/kg body weight (not exceeding 500 mg) was infused over 3.5 hours in 31 consecutive patients with IDA due to gastrointestinal blood loss. Safety and tolerability of the therapy was assessed by the occurrence of adverse events under therapy and up to one week after completion of the study. Further examinations comprised vital parameters, ECG, and clinical chemistry including iron indices.. A total of 14 adverse events were observed in 10 patients, of which two adverse events in two patients were considered as being definitely related to drug administration. None of the patients had to be withdrawn from therapy. Significant changes in vital parameters and ECG during therapy and follow-up were not observed and clinical chemistry remained unchanged.. A single intravenous high-dose iron sucrose therapy in patients with IDA due to gastrointestinal blood loss appears to be safe and therefore is a therapeutic option which may save time and improve patient compliance.

Topics: Adult; Aged; Aged, 80 and over; Anaphylaxis; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Tolerance; Edema; Female; Ferric Compounds; Ferric Oxide, Saccharated; Gastrointestinal Hemorrhage; Glucaric Acid; Humans; Infusions, Intravenous; Male; Middle Aged; Nausea; Thrombophlebitis; Treatment Outcome; Urticaria

Almost all hemodialysis (HD) patients require intravenous iron therapy to correct their anemia and maintain their iron stores. Sodium ferric gluconate complex (SFGC) is approved by the Food and Drug Administration (FDA) for treatment of iron deficiency anemia in HD patients at individual doses up to 125 mg over 10 minutes (12.5 mg/min) and has been shown to have a superior safety profile compared with iron-dextran. Higher individual doses of SFGC would permit more rapid repletion of iron stores and greater flexibility in maintenance iron therapy as well as simplify treatment of peritoneal dialysis patients and chronic kidney disease patients.. The authors reviewed the safety and tolerability of higher-dose SFGC infusions (> or =250 mg) in 144 HD patients who were previously tolerant to a single 125-mg dose of SFGC. These 144 patients received a total of 590 doses of > or =250 mg of SFGC; 571 doses were 250 mg SFGC, and most of these were infused over 1 hour, an infusion rate of 4.17 mg/min. The other 19 doses were 312.5 mg (n = 1), 375 mg (n = 14), and 500 mg (n = 4). Infusion rates varied from 1.22 mg/min to 25.0 mg/min.. Only one patient was considered intolerant to higher-dosing SFGC after having pruritus after a second 250-mg dose of SFGC. Three patients had nonserious events that did not preclude further dosing of SFGC.. Administration of 250 mg SFGC over 1 hour is safe and well tolerated. Individual doses of 375 mg and 500 mg SFGC also were well tolerated, but further research and experience are needed to confirm the safety and tolerance of these doses.

Topics: Anemia, Iron-Deficiency; Drug Administration Schedule; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Peritoneal Dialysis; Population Surveillance; Treatment Outcome

The aim of this study was to compare intravenous iron sucrose versus oral iron sulfate in anemia at 6 months of pregnancy.. A random, prospective, open study with individual benefit was performed involving 50 patients with hemoglobin levels between 8 and 10 g/dL and a ferritin value of <50 microg/L. In the intravenous group (IV group), the iron dose was calculated from the following formula: Weight before pregnancy (kg) x (120 g/L - Actual hemoglobin [g/L]) x 0.24 + 500 mg. The oral group (PO group) received 240 mg of iron sulfate per day for 4 weeks. Treatment efficacy was assessed by measurement of hemoglobin and reticulocytes on days 8, 15, 21, and 30 and at delivery and of ferritin on day 30 and at delivery. The baby's birth weight and iron stores were noted. Results were expressed as median +/- interquartile range. Mann-Whitney and Wilcoxon tests were used for the analysis, with P <.05 considered significant.. An increase in hemoglobin was observed, rising from 9.6 +/- 0.79 g/dL to 11.11 +/- 1.3 g/dL on day 30 in the IV group and from 9.7 +/- 0.5 g/dL to 11 +/- 1.25 g/dL on day 30 in the PO group (not significant). On day 30 (P <.0001) and at delivery (P =.01) ferritin was higher in the IV group. A mean higher birth weight of 250 g was noted in the IV group (not significant).. Iron sucrose appears to be a treatment without serious side effects indicated in correction of pregnancy anemia or iron stores depletion.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Birth Weight; Delivery, Obstetric; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Infant, Newborn; Injections, Intravenous; Iron; Pregnancy; Pregnancy Trimester, Second; Prospective Studies; Sulfates

Iron sucrose has been used to provide intravenous (IV) iron therapy to patients outside the United States for more than 50 years. In a multicenter North American clinical trial, we determined the efficacy and safety of iron sucrose therapy in patients with dialysis-associated anemia, evidence of iron deficiency, and below-target hemoglobin (Hgb) levels despite epoetin therapy. Evidence of iron deficiency included a transferrin saturation (Tsat) less than 20% and ferritin level less than 300 ng/mL, and below-target Hgb levels included values less than 11.0 g/dL. We administered iron sucrose in 10 doses, each administered undiluted as 100 mg IV push over 5 minutes, without a prior test dose. We assessed efficacy by determining the subsequent change in Hgb, Tsat, and ferritin values. We assessed safety by recording blood pressure and adverse events after iron sucrose injection and comparing results with those for the same patients during an observation control period. Results showed a significant increase in Hgb level that was first evident after three doses of iron sucrose and persisted at least 5 weeks after the 10th dose. Tsat and ferritin levels also increased significantly and remained elevated. In 77 enrolled patients, including those with previous iron dextran sensitivity, other drug allergies, or concurrent angiotensin-converting enzyme inhibitor use, we saw no serious adverse drug reactions and no change in intradialytic blood pressure associated with iron sucrose administration. We conclude that iron sucrose injection administered as 1,000 mg in 10 divided doses by IV push without a prior test dose is safe and effective for the treatment of iron deficiency in patients with dialysis-associated anemia.

Topics: Aged; Anemia, Iron-Deficiency; Epoetin Alfa; Erythrocyte Indices; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Iron; Kidney Failure, Chronic; Middle Aged; Prospective Studies; Recombinant Proteins; Renal Dialysis

This study was undertaken to determine the efficacy and safety of intravenously administered iron sucrose with versus without adjuvant recombinant human erythropoietin in the treatment of gestational iron-deficiency anemia resistant to therapy with orally administered iron alone.. Forty patients with gestational iron-deficiency anemia were randomly assigned to receive intravenously iron sucrose plus recombinant human erythropoietin or iron sucrose alone twice weekly. Target hemoglobin value was 11.0 g/dL. Efficacy measures were reticulocyte count, increase in hematocrit, and time to target hemoglobin level (treatment duration in weeks and need for continued therapy after 4 weeks).. Both regimens were effective, but with adjuvant recombinant human erythropoietin the reticulocyte counts were higher from day 4 (P<.01), increases in hematocrit were greater from day 11 (P <.01), and the median duration of therapy was shorter (18 vs 25 days), with more patients reaching the target hemoglobin level by 4 weeks of treatment (n = 19 vs. n = 15). The groups did not differ with respect to maternal-fetal safety parameters.. Adjuvant recombinant human erythropoietin safely enhanced the efficacy of iron sucrose in the treatment of gestational iron-deficiency anemia resistant to orally administered iron alone.

Topics: Anemia, Iron-Deficiency; Erythrocyte Count; Erythrocyte Indices; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Fetal Growth Retardation; Glucaric Acid; Hematocrit; Humans; Placental Insufficiency; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Recombinant Proteins; Reticulocyte Count; Transferrin; Treatment Outcome; Ultrasonography

Inflammatory bowel disease (IBD)-associated anemia responds to i.v. iron therapy. However, because of concurrent chronic inflammation, some patients do not respond adequately. Erythropoietin therapy has been shown to be effective in the latter cohort. Our goal was to find parameters that can predict the effectiveness of iron sucrose in IBD-associated anemia.. One hundred three patients with severe IBD-associated anemia (Hb < or = 10.5 g/dl) were treated prospectively for 4 wk with iron sucrose (total iron dose = 1.2 g) in an open label, multicenter trial. Treatment response was defined as an increase in Hb of > or =2.0 g/dl. A logistic regression analysis was performed with treatment response as the dependent variable and the following independent variables: serum erythropoietin, mean corpuscular Hb, transferrin, ferritin, soluble transferrin receptor (sTfR), C-reactive protein, interleukin 6 (IL-6), and disease activity.. Sixty-seven of 103 patients (65%) responded to iron sucrose. From the variables under investigation, erythropoietin, sTfR, transferrin, and IL-6 were significantly associated with treatment response. The R2 values showed that erythropoietin (8.0%), sTfR (11.4%), and transferrin (10.4%), but not IL-6 (1.3%), contribute a relevant amount of information to the model. An estimated 80% probability of treatment response was found at erythropoietin levels of >166 U/L, sTfR levels of >75 nmol/L, or transferrin levels of >3.83 g/L.. Serum erythropoietin, sTfR, and transferrin concentrations have the potential to predict the response to iron sucrose therapy in IBD-associated anemia. These parameters may help to identify individuals who benefit the most from additional erythropoietin treatment.

Topics: Anemia, Iron-Deficiency; Enzyme-Linked Immunosorbent Assay; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Inflammatory Bowel Diseases; Interleukin-6; Logistic Models; Male; Prospective Studies; Receptors, Transferrin; ROC Curve; Sensitivity and Specificity; Transferrin; Treatment Outcome

Sensitivity to iron dextran is a potent obstacle to maintaining optimum iron status in patients with dialysis-associated anemia. As part of the North American clinical trials for iron sucrose injection, we examined the effect of intravenous (IV) iron sucrose in 23 hemodialysis patients with documented sensitivity to iron dextran, ongoing epoetin alfa therapy, and below-target-range hemoglobin (Hgb) levels (<11.0 g/dL). We assigned patients to treatment groups according to whether reactions they had experienced to iron dextran were judged to be mild (n = 16; group A) or severe (n = 7; group B). We prospectively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment. We administered iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients. We did not administer a test dose. Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose (184 doses by IV push, 39 doses by IV infusion). Intradialytic blood pressure changes after IV iron sucrose injection did not differ from those recorded during dialysis sessions without treatment. An increase in values for Hgb, hematocrit, transferrin saturation, and ferritin, coupled with no significant change in epoetin dose and a decrease in total iron-binding capacity, confirmed the efficacy of iron sucrose injection in managing anemia. We conclude that iron sucrose injection is safe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion.

Topics: Anemia, Iron-Deficiency; Blood Pressure; Drug Hypersensitivity; Epoetin Alfa; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Injections, Intravenous; Iron-Dextran Complex; Middle Aged; Prospective Studies; Recombinant Proteins; Renal Dialysis

Intravenous iron and erythropoietin have been shown to be effective in Crohn's disease-associated anemia. The aim of this study was to test the sequential treatment of anemia in ulcerative colitis with intravenous iron in the first phase and erythropoietin in the second.. Twenty patients with ulcerative colitis-associated anemia (hemoglobin < or = 10.5 g/dl) entered this open-label trial. In the first phase all patients received intravenous iron saccharate for 8 weeks. A response was defined as an increase in hemoglobin > or = 2.0 g/dl; a final hemoglobin >10.5 g/dl was regarded as full response, < or = 10.5 g/dl as partial response. A hemoglobin increase < 2.0 g/dl was regarded as nonresponse. In the second phase (n = 4) erythropoietin was initiated in patients without response. Patients with partial response were continued on iron saccharate for another 8 weeks.. During the first phase the hemoglobin increased from 8.3 to 11.9 g/dl (mean hemoglobin difference 3.6+/-2.3 g/dl, p < 0.001). Fifteen patients (75%) showed a full response (mean hemoglobin difference 4.5+/-1.5 g/dl), 1 (5%) a partial response (hemoglobin difference 2.1 g/dl) and 4 no response (mean hemoglobin difference 0.4+/-1.8 g/dl) with a need for blood transfusions in a single patient. In the second study phase erythropoietin was highly effective in previous nonresponders (mean hemoglobin difference 3.3+/-1.9 g/dl). The single patient with partial response had a minor hemoglobin increase (hemoglobin difference 1.0 g/dl).. Most patients with ulcerative colitis-associated anemia improve on intravenous iron alone. Erythropoietin is effective in those who do not respond.

Topics: Adult; Anemia, Iron-Deficiency; C-Reactive Protein; Colitis, Ulcerative; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Glucocorticoids; Hemoglobins; Humans; Immunosuppressive Agents; Injections, Intravenous; Male; Recombinant Proteins; Reticulocyte Count; Treatment Outcome

The aim of this prospective study was to test a new protocol for iron supplementation in haemodialysis patients, as well as to assess the utility of different iron metabolism markers in common use and their 'target' values for the correction of iron deficiency.. Thirty-three of 56 chronic haemodialysis patients were selected for long-term (6 months) i.v. iron therapy at 20 mg three times per week post-dialysis based on the presence of at least one of the following iron metabolism markers: percentage of transferrin saturation (%TSAT) <20%; percentage of hypochromic erythrocytes (%HypoE) > 10% and serum ferritin (SF) <400 microg/l. Reasons for patient exclusion were active inflammatory or infectious diseases, haematological diseases, psychosis, probable iron overload (SF > or =400 microg/l) and/or acute need of blood transfusion mostly due to haemorrhage and change in renal replacement treatment.. More than half (51.8%) of the patients of our dialysis centre proved to have some degree of iron deficiency in spite of their regular oral iron supplementation. At the start of the study the mean haemoglobin was 10.8 g/dl and increased after the 6 months of iron treatment to 12.8 g/dl (P<0.0001). The use of erythropoietin decreased from 118 units/kg/week to 84 units/kg/week. The criterion for iron supplementation with the best sensitivity/specificity relationship (100/87.9%) was ferritin <400 microg/l. Patients with ferritin < 100 [microg/l and those with ferritin between 100 microg/l and 400 microg/l had the same increase in haemoglobin but other parameters of iron metabolism were different between the two groups.. Routine supplementation of iron in haemodialysis patients should be performed intravenously. Target ferritin values should be considered individually and the best mean haemoglobin values were achieved at 6 months with a mean ferritin of 456 microg/l (variation from to 919 microg/l). The percentage of transferrin saturation, percentage of hypochromic erythrocytes and ferritin <100 microg/l, were not considered useful parameters to monitor routine iron supplementation in haemodialysis patients. No significant adverse reactions to iron therapy were observed.

Topics: Anemia, Iron-Deficiency; Biomarkers; Drug Administration Routes; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Glucaric Acid; Hemoglobins; Humans; Iron; Iron Deficiencies; Kidney Failure, Chronic; Male; Middle Aged; Nutritional Support; Practice Guidelines as Topic; Prospective Studies; Recombinant Proteins; Renal Dialysis; Sucrose; Transferrin

To evaluate the safety and efficacy of intravenous iron sucrose complex (ISC) as compared with oral ferrous sulfate in the treatment of iron deficiency anemia during pregnancy.. prospective, open, controlled study in which pregnant women with iron deficiency anemia were sequentially selected from the antenatal clinic and assigned either to ISC (study group) or to ferrous sulfate (control group).. Each study patient was given the total calculated amount of ICS (Hb deficit (g/l) x body weight (kg) x 0.3) in divided doses (200 mg (elemental iron) in 100 ml normal saline intravenously over 1 h daily) followed by 10 mg/kg to replenish iron stores. Each patient of the control group was given ferrous sulfate 300 mg (60 mg elemental iron) orally three times a day. All patients were monitored for adverse effects, clinical and laboratory response.. There were 52 patients and 59 controls. ISC group achieved a significantly higher Hb level (128.5 +/- 6.6 g/l vs. 111.4 +/- 12.4 g/l in the control group P < or = 0.001) in a shorter period (6.9 +/- 1.8 weeks vs. 14.9 +/- 3.1 weeks in the control group, P < or = 0.001). ISC complex group showed no major side effects while 4 (6%) of the control group could not tolerate ferrous sulfate, 18 (30%) complained of disturbing gastrointestinal symptoms and 18 (30%) had poor compliance.. We conclude that ISC is safe and effective in the treatment of iron deficiency anemia during pregnancy.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Erythrocyte Indices; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Pregnancy; Pregnancy Complications, Hematologic; Prospective Studies; Reference Values; Sucrose; Time Factors

Anemia is extremely common among patients admitted to pediatric intensive care. Alternative treatments to transfusions such as intravenous iron must be considered. There are no published data for a prospective intravenous (IV) iron study focused in the critically ill children. The objective is to examine the safety and efficacy of intravenous iron sucrose infusion to manage anemia in pediatric critical care. A secondary objective is to examine the effect of different dose regimens of iron sucrose (3, 5, and 7 mg/kg dose).. Prospective investigation of intravenous iron sucrose utilization at a tertiary pediatric intensive care unit between October 2017 and November 2022.. In all 115 patients received a total of 616 infusions of IV iron. Transferrin saturation index (TSI) was the most common altered iron deficiency biomarker (91.8%). After IV iron treatment, hemoglobin showed a significant increase within a 30-day follow-up (9.2 vs. 11.6 g/dL, p < .001). There was also a significant improvement in TSI and serum iron (p < .001). Iron deficit replacement was higher in the 7 mg/kg dose group (94%) compared to 85.9% in the 5 mg/kg regimen and 77.5% in the lower dose group (p = .008), requiring less doses and a shorter time. Very few mild adverse reactions were reported (1.3% of infusions), with no differences between groups. The most frequent adverse effect was gastrointestinal in three cases. There were no anaphylaxis-like or other serious/life-threatening adverse effects.. This is the first study to evaluate intravenous iron therapy in pediatric critical care, providing preliminary evidence of safety and efficacy of IV iron sucrose. The 7 mg/kg dose regimen showed higher iron deficit replacement in a shorter time, which could be beneficial in critically ill children.

Topics: Anemia; Anemia, Iron-Deficiency; Child; Critical Illness; Drug-Related Side Effects and Adverse Reactions; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Infusions, Intravenous; Iron; Prospective Studies

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

Iron-deficiency anemia (IDA) is highly prevalent in children with intestinal failure (IF) and oral iron supplementation is often ineffective in this patient population. Even though various intravenous (IV) iron formulations are available, there is a dearth of data on the use of newer parenteral iron products such as IV iron sucrose, especially in infants and young children (<2 years of age) with IF. To determine safety and efficacy, we performed a retrospective chart review on infants and children younger than 2 years with IF who received IV iron sucrose for IDA between October 2019 and August 2021. The review revealed that 10 events of IV iron sucrose replacement were administered to five children aged 4-22 months with IF and IDA. We observed a mean increase in hemoglobin of 1.9 ± 0.6 g/dl, and peak hemoglobin levels were seen at 4.3 ± 0.8 weeks after the IV iron sucrose dose. The infusions were well tolerated, and no short-term adverse reactions or laboratory abnormalities were observed. Based on these observations, the use of IV iron sucrose appears to be safe and effective in infants and young children with IF and could be considered in the management of IDA in this patient population.

Topics: Anemia, Iron-Deficiency; Child; Child, Preschool; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Infant; Infusions, Intravenous; Intestinal Failure; Iron; Retrospective Studies

Topics: Anemia, Iron-Deficiency; Blood Pressure; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Renal Dialysis

Iron infusions have become increasingly common in the treatment of iron-deficiency anemia during pregnancy. Although iron infusions are generally well tolerated, adverse reactions have been reported.. A pregnant patient was diagnosed with rhabdomyolysis after receiving a second dose of intravenous (IV) iron sucrose at 32 6/7 weeks of gestation. On admission to the hospital, creatine kinase was 2,437 units/L, sodium was 132 mEq/L, and potassium was 2.1 mEq/L. Intravenous fluids and electrolyte repletion were administered, with improvement of symptoms within 48 hours. Creatinine kinase normalized 1 week after hospital discharge.. Rhabdomyolysis can be associated with IV iron infusion during pregnancy.

Topics: Anemia, Iron-Deficiency; Female; Ferric Oxide, Saccharated; Humans; Infusions, Intravenous; Iron; Pregnancy; Rhabdomyolysis

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

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

The study evaluated the safety and effectiveness of the generic intravenous (IV) iron treatment (Feriv®), in a Spanish cohort with absolute iron deficiency (ID) (serum ferritin <50 ng/ml, with or without anaemia) (n = 122; 91% women; median age of 44 years [IQR: 33.7-54]). Iron-related biomarkers were measured before treatment (baseline), 2 weeks after beginning the protocol (intermediate control, IC) and between 7 and 10 days after treatment completion (final time-point). Primary efficacy endpoints were ferritin levels ≥ 50 ng/ml, anaemia restoration or an increase in haemoglobin (Hb) of at least one point in patients without baseline anaemia. After treatment, iron-related biomarkers improved, including ferritin, Hb, sideremia, transferrin, transferrin saturation index, soluble transferrin receptor (sTfR), and hepcidin. Baseline ferritin concentration (13.5 ng/ml [IQR: 8-24.2]) increased at the IC and continued rising at the final time-point, reaching a median ferritin of 222 ng/ml and 97.3% of patients ≥ 50 ng/ml. At the final time-point, anaemia prevalence decreased from 26.2% to 5%, while the 34.1% without baseline anaemia showed an increase in Hb of at least one point. Headache was the only drug-adverse event recorded in 2.3% of patients. At a late time-point (27.5 median weeks after ending therapy [IQR: 22-40]), evaluated in a subgroup of 66 patients, 18% had ferritin levels < 50 ng/ml. Multivariate analysis showed that low baseline ferritin and high sTfR/hepcidin ratio tended to be independently associated with ID recurrence. Feriv® is a safe, effective first-line treatment for absolute ID, with improvement of serum ferritin and Hb. ID recurrence was associated with the baseline degree of iron stores depletion, indicated by serum ferritin, and sTfR/hepcidin ratio.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Biomarkers; Dietary Supplements; Female; Ferric Oxide, Saccharated; Ferritins; Hemoglobins; Hepcidins; Humans; Iron; Iron Deficiencies; Male; Middle Aged; Receptors, Transferrin; Transferrin

In randomized trials, antepartum intravenous iron sucrose is effective at improving predelivery hemoglobin in iron deficiency anemia. Yet, there is a gap between this knowledge and its implementation into care.. We aimed to determine if the implementation of a standardized protocol for the management of antepartum anemia outside of a clinical trial improves intravenous iron sucrose utilization and clinical outcomes.. We performed a prospective cohort study evaluating the incorporation of an anemia protocol into routine clinical care for women with antepartum hemoglobin <11.0 g/dL. Our protocol, developed with multidisciplinary stakeholders, included (1) serial third trimester hemoglobin assessment, (2) oral iron supplementation for antepartum hemoglobin 9.5-11 g/dL, and (3) antepartum intravenous iron sucrose use (300 mg weekly for 3 weeks) for hemoglobin <9.5 g/dL. We compared 6-months preimplementation (January 2018 to June 2018) to 6-months postimplementation (January 2019 to June 2019). The outcomes evaluated were antepartum intravenous iron sucrose utilization, the number of intravenous iron sucrose dosages, predelivery hemoglobin, and blood transfusion.. A total of 1423 women were included (pre=778; post=645) without significant baseline differences. The antepartum hemoglobin nadir was no different between the groups (pre: 10.2; interquartile range [9.6-10.6] vs post: 10.2; interquartile range [9.6-10.6]; P=.77). The implementation of a standardized protocol for the management of antepartum anemia was associated with 80% increased odds of receiving intravenous iron sucrose than the preimplementation group (pre: 4.8% vs post: 8.2%, P=.008; odds ratio, 1.79; 95% confidence interval, [1.16-2.77]). The implementation of a standardized protocol for the management of antepartum iron deficiency anemia was also associated with higher hemoglobin at admission for delivery (pre: 10.9; interquartile range [10.1-11.6] vs post: 11.0; interquartile range [10.3-11.7], P=.048). There were no significant differences between the groups in blood product transfusion (pre: 7.1% vs post: 5.1%, P=.13).. Implementation of a standardized antepartum anemia protocol is associated with increased intravenous iron sucrose utilization and improvement in predelivery hemoglobin.

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; Iron Deficiencies; Male; Prospective Studies; Puerperal Disorders; Treatment Outcome

Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery.. Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia.. The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed.. In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.

Topics: Adult; Anemia, Iron-Deficiency; Bariatric Surgery; Disaccharides; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Hypophosphatemia; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Treatment Outcome

To evaluate IV iron sucrose safety and impact on hematologic and iron indices in healthy cats.. 5 healthy research cats.. Cats were administered iron sucrose (0.5 mg/kg, IV) over 30 minutes. Monitoring for acute reactions (temperature, heart rate, respiratory rate, and blood pressure) was performed every 5 minutes during injection and every 15 minutes for an additional hour. Baseline, 24-hour, and 1-, 2-, and 3-week postinjection measurements of CBC with reticulocyte indices, iron panel (ferritin, total iron-binding capacity, and iron), calculated transferrin saturation (TSAT), and serum amyloid A (SAA) concentration were performed.. No cat experienced an acute drug reaction. SAA concentration was increased at 24 hours versus baseline. TSAT and ferritin decreased over time, with 3 cats developing concurrent functional iron deficiency (FID) and anemia. Hct (Spearman correlation [rs] = 0.805), hemoglobin (rs = 0.770), and reticulocyte hemoglobin content (rs = 0.581) correlated with TSAT.. IV iron sucrose was well tolerated in healthy cats but was associated with transient increase in the systemic inflammatory marker SAA. Efficacy evaluation of dose based on iron deficit is needed in sick cats. Despite cumulative blood draw volume below recommended limits, anemia and FID were observed, which has important implications for experimental designs and serial hematologic monitoring. Further evaluation of inflammatory response to IV iron sucrose administration is warranted.

Topics: Anemia; Anemia, Iron-Deficiency; Animals; Cat Diseases; Cats; Ferric Oxide, Saccharated; Ferritins; Hemoglobins; Iron; Iron Deficiencies; Phlebotomy

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

We sought to determine risk factors for iv iron infusion-related reactions (IRR), and identify strategies for iron repletion after IRR.. We conducted a retrospective chart review of patients treated in the classical hematology clinic at Yale Cancer Center (n = 330 consecutive patients) from 2016 to 2021, who received iv ferumoxytol (60.3%), iron sucrose (14.8%), or iron dextran (10.9%).. The iv iron IRR was noted in 58 (17.6%) patients, 62.1% of whom had previously tolerated iv iron. The severity of IRR was mild in 22, moderate in 23, and severe in 11 patients. Most (72.4%) patients who experienced IRR tolerated a subsequent iv iron infusion. On multivariable analysis, a history of non-medication allergies was associated with greater odds of IRR (odds ratio [OR] 2.12, 95% confidence interval (CI): 1.16-3.87, p = .01). No patients with type AB blood, and few with type A blood (n = 6), had IRR; compared to type A or AB together, patients with type B (OR 5.00, 95% CI: 1.56-16.06, p = .007) or type O (OR 3.71, 95% CI: 1.44-9.55, p = .007) blood had greater odds of IRR.. This study highlights a possible association of blood type with iv iron IRR; prospective studies with larger patient numbers are warranted to explore this association.

Topics: Anemia, Iron-Deficiency; Dextrans; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Humans; Iron; Prospective Studies; Retrospective Studies

Dave CV, Brittenham GM, Carson JL, et al.

Topics: Aged; Anaphylaxis; Anemia, Iron-Deficiency; Dextrans; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Humans; Iron; Iron-Dextran Complex; Retrospective Studies

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

Studies have demonstrated that antepartum intravenous iron sucrose infusion (IVFe) is safe and improves predelivery hemoglobin (Hb). Yet, there is little data guiding timing of administration or number of doses required to be impactful. We sought to determine if timing of antepartum IVFe and number of doses provided impacts efficacy.. We performed a retrospective cohort study of women who obtained prenatal care and delivered at our institution 10/1/2015-10/30/2017. Women with a third-trimester hemoglobin (Hb) < 9.5 g/dL were included. Women with hemoglobinopathies and those who received an antepartum blood transfusion were excluded. Women receiving ≥1 antepartum 300 mg IVFe dose were considered in the IVFe group.. Five-hundred-twenty-three (6.1%) of 8563 delivering women were included. Sixty-five (12.4%) of included women received IVFe. By timing of IVFe, the earlier IVFe was received before delivery, the greater the median Hb increase (No IVFe: Δ0.8g/dL, IVFe 0-1 weeks predelivery: Δ0.05 g/dL, 1-2 weeks: Δ0.9 g/dL, 2-4 weeks: Δ1.5 g/dL, 4-6 weeks: Δ1.8 g/dL, 6-8 weeks: Δ1.8 g/dL, 8-12 weeks: Δ2.75 g/dL,. Antepartum IVFe effectively increases Hb from the third trimester to delivery admission when administered 2-12 weeks predelivery. There is increasing benefit the further out the IVFe is administered and with an increasing number of doses. Initiatives to combat antepartum anemia should focus on early detection and treatment to best optimize outcomes.

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Pregnancy; Retrospective Studies

Intravenous (IV) iron sucrose can be used for iron deficiency anemia (IDA), but little information exists on total dose infusion (TDI) of this drug. At a tertiary hospital, an iron sucrose TDI protocol was implemented with staff pharmacists aiding physicians in appropriate dosing.. We sought to define the safety and efficacy of this protocol in adults ≥18 years old with IDA.. We conducted a retrospective chart review of patients who received iron sucrose TDI. Inclusion criteria included patients ≥18 years old who were hospitalized and received iron sucrose in doses ≥300 mg. We reviewed the medical record for adverse reactions to any TDI of iron sucrose as well as pre-TDI and post-TDI hemoglobin (Hgb) levels to assess efficacy.. A total of 238 patients received iron sucrose TDI for IDA during the study period. One hundred ninety-three (81%) patients were female, and the mean age in our cohort was 60.6 years. Mean pre-TDI Hgb was 8.76 g/dL. The mean total dose of iron sucrose in the total cohort was 680 mg (range: 300-2500 mg). Adverse effects attributable to iron sucrose were reported in 15 patients, with nausea being the most common effect (7/238, 2.9%). When matching patients' preadmission and postadmission records, a Hgb increase of 2.1 g/L was found (. A pharmacist-assisted iron sucrose TDI protocol for patients with IDA successfully increased serum Hgb and was well tolerated. Anaphylaxis was not reported.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Hospitals; Humans; Inpatients; Male; Middle Aged; Pharmacists; Retrospective Studies

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

Anemia is one of the most common disorders in the world. Serum iron is an essential element for the synthesis of hemoglobin and contribution of the oxygen-carrying ability of red blood cells (RBCs). Iron sucrose injection may effectively correct iron deficiency, increase iron storage, and then improve anemia. The aim of the present study was to evaluate the therapeutic effect of iron sucrose injection in anemia patients with reduced serum iron concentration.. Overall, 95 anemia patients with digestive and/or liver diseases were included. They were divided according to the infusion of iron sucrose injection during hospitalization. The paired sample t test was used for comparison between last and baseline hemoglobin concentration. The independent sample t test was used for comparison of a dynamic change of hemoglobin concentration between patients who received and did not receive infusion of iron sucrose injection.. Iron sucrose injection was infused in 74 (77.90%) patients. Mean hemoglobin concentration after infusion of iron sucrose injection was significantly increased (91.61 vs. 94.98 g/L, P=0.011). Δ Hemoglobin concentration was significantly different between patients who received and did not receive infusion of iron sucrose injection (P=0.007). Mean hemoglobin concentration after infusion of iron sucrose injection remained significantly increased in subgroup analyses of patients with cirrhosis (88.30 vs. 91.98 g/L, P=0.035) and gastrointestinal bleeding (85.70 vs. 92.63 g/L, P<0.01).. Iron sucrose injection can significantly increase the hemoglobin concentration in anemia patients with serum iron concentration below the lower limit of the normal range.

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hospitalization; Humans; Iron; Liver Diseases

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

To evaluate trends in diagnosis and management of iron deficiency anemia using a large national children's hospital database in pediatric patients admitted with inflammatory bowel disease (IBD).. In this retrospective multicenter cohort study, we used the Pediatric Health Information System de-identified administrative database. Patients age <21 years with ≥2 admissions with International Classification of Disease, Ninth Revision and Tenth Revision codes for Crohn's disease or ulcerative colitis from 2012 to 2018 were included. We extracted data regarding diagnoses of anemia and/or iron deficiency, and receipt of oral iron, intravenous (IV) iron, and/or blood transfusion. Data were analyzed descriptively.. We identified 8007 unique patients meeting study criteria for a total of 28 260 admissions. The median age at admission was 15.4 years. A diagnosis of anemia was documented in 29.8% of admissions and iron studies were performed in 12.6%. IV iron was given in 6.3% of admissions and blood transfusions in 7.4%. The prevalence of the diagnosis of anemia among IBD admissions increased from 24.6% in 2012 to 32.4% in 2018 (P < .0001). There was a steady increase in the proportion of IBD admissions that used IV iron, from 3.5% in 2012 to 10.4% in 2018 (P < .0001), and the proportion of admissions with red cell transfusions decreased over time from 9.4% to 4.4% (P < .0001).. Iron deficiency anemia is prevalent among pediatric patients with IBD admitted to US children's hospitals. From 2012 to 2018, there was an increase in the use of inpatient IV iron for the treatment of iron deficiency anemia and a decrease in transfusions.

Topics: Adolescent; Anemia, Iron-Deficiency; Blood Transfusion; Child; Child, Preschool; Cohort Studies; Colitis, Ulcerative; Crohn Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hospitalization; Humans; Infant; Iron-Dextran Complex; Male; Prevalence; Retrospective Studies; Young Adult

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; California; Female; Ferric Oxide, Saccharated; Hematinics; Humans; Incidence; Medical Records; Phlebitis; Pregnancy; Prenatal Care; Puerperal Disorders; Retrospective Studies

Anemia is common but under-diagnosed and often inadequately treated in KTX recipients. ID is the major cause of early-onset anemia. We introduced routine use of parenteral (IV) iron in patients (2-18 years) who had KTX between January 2011 and December 2015. We explored the clinical benefits of this practice by comparing the iron-treated subjects [TX] with historical controls who had KTX between 2005 and 2010. The prevalence of anemia at 6 months (early-onset) for the cohort (both the study group and controls) was 55% and for anemia at 12 months (late-onset) was 60%. Although cause-effect relationship may not be proven in a retrospective study design, there was a significant greater frequency of ID and anemia at 3 (P < .02) and 6 months (P < .04), and a reduced allograft function (eGFR < 60 mL/min/1.73 m

Topics: Adolescent; Allografts; Anemia, Iron-Deficiency; Child; Dose-Response Relationship, Drug; Female; Ferric Oxide, Saccharated; Follow-Up Studies; Hematinics; Humans; Infusions, Parenteral; Kidney Transplantation; Male; Postoperative Complications; Prevalence; Retrospective Studies; Time Factors; Transplant Recipients; United States

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

Iron deficiency anemia (IDA) is a global public health issue that affect more than 2 billion individuals worldwide. However evidence for optimal management of IDA is lacking.. To assess the diagnostic criteria and therapeutic modalities for pediatric IDA employed by physicians in a major public healthcare facility in Riyadh, a validated questionnaire including demographic data and patient case-scenarios related to diagnosis and treatment of IDA was employed. Robust regression analysis was used to identify factors associated with overall score of participants.. Of the 166 physicians surveyed 147(88.6%) were included in the study. Wide variability was observed in IDA diagnosis and therapy practises. For nutritional IDA, only 15.6% recommended no other laboratory tests in addition to CBC. The majority preferred treatment with ferrous sulfate (77.6%) divided into two doses (57.1%), but the total daily elemental iron doses varied widely from 2 to 6 mg/kg. For intravenous iron, 42.9% recommended iron dextran, 32.7% iron sucrose, and 13.4% would continue oral iron. Of all assessed factors, median score was significantly highest in pediatric hematologists compared with pediatricians, family medicine specialists and GPs; p = 0.007, and those work in tertiary care compared with those in primary care; p = 0.043. However, in multivariate robust regression analysis, overall score was only significantly associated with professional qualification [pediatric hematologist β = 13.71,95%CI 2.48-24.95, p = 0.017; pediatrician β = 1.77,95%C (- 6.05-9.59, p = 0.66; family medicine β = 2.66,95%CI-4.30-9.58, p = 0.45 compared with general practitioner].. Wide variations exist among physicians in diagnosis and treatment of pediatric IDA. Intervention programs and national guidelines are urgently needed.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Blood Cell Count; Blood Transfusion; Chi-Square Distribution; Clinical Laboratory Techniques; Cross-Sectional Studies; Disease Management; Female; Ferric Oxide, Saccharated; Ferrous Compounds; Health Care Surveys; Hematinics; Hemoglobin A; Humans; Infant; Injections, Intravenous; Iron; Iron-Dextran Complex; Male; Physicians; Regression Analysis; Saudi Arabia; Statistics, Nonparametric

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

Iron deficiency anemia (IDA) is a common complication of pediatric inflammatory bowel disease (IBD), yet the effectiveness of oral iron supplementation is limited. Intravenous iron sucrose is an effective and safe alternative treatment for IDA in adults with IBD, but its role in the treatment of IDA in pediatric IBD is unclear. The primary aim of this study was to evaluate the use of iron sucrose in pediatric IBD subjects with IDA and determine the clinical response as measured by improvement in hemoglobin concentration. The secondary aim was to describe adverse events associated with iron sucrose use in this cohort.. A retrospective chart review was performed of all pediatric patients with IBD receiving iron sucrose infusions for IDA at a single tertiary care center between 2011 and 2015.. Seventy-two subjects (53 with Crohn disease, 11 with ulcerative colitis, and 8 with IBD-unclassified) received a total of 273 iron sucrose infusions. Forty-three subjects qualified for the efficacy analysis. There was a significant increase in hemoglobin over the treatment course, with mean (±SD) hemoglobin increasing from 9.6 ± 1.2 g/dL at baseline to 12.1 ± 1.3 g/dL after iron sucrose treatment (P < 0.001). Eighteen adverse events were reported in 13 subjects (18.1% of subjects and 6.6% of infusions). No anaphylaxis reactions occurred and none of the adverse events were, however, life-threatening or required hospitalization.. Intravenous iron sucrose is a safe and potentially efficacious treatment choice for IDA in pediatric IBD.

Topics: Administration, Intravenous; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Oxide, Saccharated; Hemoglobins; Humans; Inflammatory Bowel Diseases; Iron; Male; Philadelphia; Retrospective Studies; Treatment Outcome; Young Adult

Chronic intravenous iron administration is often required after bariatric surgery. Oral sucrosomial iron has a particular form of absorption and may represent an alternative treatment.. To assess the effect of switching to oral sucrosomial iron in patients receiving intravenous iron supplementation after bariatric surgery.. A case-control study was conducted on 40 women of childbearing age, of whom 20 were switched to oral sucrosomial iron, while 20 patients continued on intravenous iron sucrose every three months.. No significant differences were seen in Hb, ferritin, and TSI levels before and after three months of treatment with sucrosomial iron.. Oral sucrosomial iron could be an alternative in patients who require parenteral treatment with iron after bariatric surgery.

Topics: Administration, Oral; Adult; Anemia, Iron-Deficiency; Case-Control Studies; Comorbidity; Drug Substitution; Female; Ferric Oxide, Saccharated; Ferritins; Gastric Bypass; Hemoglobins; Humans; Infusions, Intravenous; Intestinal Absorption; Iron Deficiencies; Iron, Dietary; Malabsorption Syndromes; Middle Aged; Young Adult

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

Iron sucrose (IS), a nanocolloidal solution used in the treatment of iron deficiency anemia, is currently under investigation for the elucidation of its critical quality attributes. Assessment of IS's size and size distribution has been recently attempted using dynamic light scattering (DLS). However, due to heterogeneous interpretation of DLS data, variable results were retrieved. The aim of this work was to establish a simple and reproducible DLS protocol to unequivocally define the size and size distribution of IS by using size distribution approximation in Number. Underlining the limitations of the commonly used DLS approximations, we identified the drug as being composed of a population of monodisperse nanoparticles of about 7 nm in diameter. The method here described might therefore be useful for the evaluation of quality, safety and efficacy of IS and its follow-on versions.

Topics: Anemia, Iron-Deficiency; Dynamic Light Scattering; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Light; Nanoparticles; Particle Size; Scattering, Radiation

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

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 anemia (IDA) is the most common nutritional deficiency in children. Most children with IDA are treated with oral iron preparations. However, intravenous (IV) iron is an alternative for children with severe IDA who have difficulty in adhering to or absorbing oral iron. We sought to describe the safety and effectiveness of IV iron sucrose for treatment of IDA in children. Pharmacy records of children who received IV iron sucrose at a children's hospital between 2004 and 2014 were reviewed. Laboratory markers of anemia and iron studies were obtained and preinfusion and postinfusion values were compared. Records were also reviewed for adverse reactions. A total of 142 patients received IV iron sucrose over 10 years. The mean age was 11 years, 9 months. One patient of 142 developed cough and wheezing during the infusion. No other adverse events were found. IV iron sucrose resulted in a statistically significant and clinically meaningful increase in hemoglobin, mean corpuscular volume, serum iron, ferritin, and % iron saturation, with a corresponding decrease in total iron binding capacity. The use of IV iron sucrose in pediatric patients with IDA is safe and leads to a moderate increase in hemoglobin and substantial improvement in iron studies.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Erythrocyte Indices; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Infant; Iron; Male; Young Adult

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Child; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Humans; Renal Insufficiency, Chronic

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

Topics: Anemia, Iron-Deficiency; Emergency Medical Services; Female; Ferric Oxide, Saccharated; Fibrin Fibrinogen Degradation Products; Gastrointestinal Hemorrhage; Humans; Middle Aged

Iron sucrose (IS) is a complex nanocolloidal intravenous suspension used in the treatment of iron-deficiency anemia. Follow-on IS products (iron sucrose similars (ISSs)) have obtained marketing authorization by the generic pathway, implying that identical copies of IS may be manufactured. However, recent prospective and retrospective clinical studies showed discrepancies in clinical outcomes, which might be related to differences in physicochemical properties. The aim of this work is to measure and compare the physicochemical properties of IS and three ISSs available in the market using innovative analytical procedures. The comprehensive elucidation of size, size distribution, morphology, and stability of these complex drugs revealed very significant differences between the products. This study serves to provide the basis to define critical quality attributes that may be linked to differences in clinical outcome and thus may contribute to an adequate regulatory approach for IS and its follow-on products.

Topics: Anemia, Iron-Deficiency; Biosimilar Pharmaceuticals; Chemical Phenomena; Chemistry, Pharmaceutical; Drug Approval; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Particle Size; Technology, Pharmaceutical; Therapeutic Equivalency

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

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

Intravenous iron sucrose is not recommended by its manufacturers for use in children despite extensive safety and efficacy data in adults.. We reviewed the experience of our department between January, 2011 and February, 2014 with the use of intravenous iron sucrose in children ≤14 years of age who failed in oral iron therapy for iron deficiency anemia (IDA).. Twelve children (6 females) aged 1.2-14 years (median age 8.9 years) received at least one dose of intravenous iron sucrose. Ten patients had IDA inadequately treated or non-responsive to oral iron therapy. One patient received therapy for blood transfusion avoidance and one for presumed iron refractory iron deficiency anemia (IRIDA). Iron sucrose infusions were given on alternate days up to three times per week. The number of infusions per patient ranged from 2 to 6 (median, 3), the individual doses from 100 mg to 200 mg (median, 200 mg), and the total doses from 200 mg to 1200 mg (median, 400 mg). Iron sucrose was effective in raising the hemoglobin concentration to normal in all patients with IDA, i.e., from 7.6±2.38 g/dL to 12.4±0.64 g/dL, within 31-42 days after the first infusion. The single patient with IRIDA demonstrated a 1.8 g/dL rise. Injection site disorders in three cases and transient taste perversion in one case were the only side effects.. Intravenous iron sucrose appears to be safe and very effective in children with IDA who do not respond or cannot tolerate oral iron therapy.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infant; Male; Retrospective Studies

Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.. Retrospective cohort study using the clinical database of a large dialysis provider (2004-2005) merged with administrative data from the US Renal Data System.. 66,207 patients with Medicare coverage who received center-based hemodialysis.. Iron formulation use assessed during repeated 1-month exposure periods (n=278,357).. All-cause mortality, infection-related hospitalizations and mortality, and cardiovascular-related hospitalizations and mortality occurring during a 3-month follow-up period.. For all outcomes, we estimated 90-day risk differences between the formulations using propensity score weighting of Kaplan-Meier functions, which controlled for a wide range of demographic, clinical, and laboratory variables. Risk differences were also estimated within various clinically important subgroups.. Ferric gluconate was administered in 11.4%; iron sucrose, in 48.9%; and no iron in 39.7% of the periods. Risks for most study outcomes did not differ between ferric gluconate and iron sucrose; however, among patients with a hemodialysis catheter, use of ferric gluconate was associated with a slightly decreased risk for both infection-related death (risk difference, -0.3%; 95% CI, -0.5% to 0.0%) and infection-related hospitalization (risk difference, -1.5%; 95% CI, -2.3% to -0.6%). Bolus dosing was associated with an increase in infection-related events among both ferric gluconate and iron sucrose users.. Residual confounding and outcome measurement error.. Overall, the 2 iron formulations studied exhibited similar safety profiles; however, ferric gluconate was associated with a slightly decreased risk for infection-related outcomes compared to iron sucrose among patients with a hemodialysis catheter. These associations should be explored further using other data or study designs.

Topics: Anemia, Iron-Deficiency; Cohort Studies; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Male; Middle Aged; Renal Dialysis; Retrospective Studies; Time Factors

Iron deficiency is one of the most prominent mineral deficiencies around the world, which especially affects large population of women and children. Development of new technologies to combat iron deficiency is on high demand. Therefore, we developed alginate microcapsule with encapsulated iron that had better oral iron bioavailability. Microcapsules containing iron with varying ratios of sodium alginate ferric(III)-saccharide were prepared using emulsification method. In vitro studies with Caco-2 cells suggested that newly synthesized microemulsions had better iron bioavailability as compared to commercially available iron dextran formulations. Ferrozine in vitro assay showed that alginate-encapsulated ferric galactose microemulsion (AFGM) had highest iron bioavailability in comparison to other four ferric saccharate microemulsions, namely AFGlM, AFMM, AFSM, and AFFM synthesized in our laboratory. Mice studies also suggested that AFGM showed higher iron absorption as indicated by increased serum iron, hemoglobin, and other hematopoietic measures with almost no toxicity at tested doses. Development of iron-loaded microemulsions leads to higher bioavailability of iron and can provide alternative strategies to treat iron deficiency.

Topics: Alginates; Anemia, Iron-Deficiency; Animals; Biological Availability; Caco-2 Cells; Cells, Cultured; Emulsions; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Glucuronic Acid; Hexuronic Acids; Humans; Male; Mice

The optimal route for iron administration in anemic patients with inflammatory bowel disease (IBD) has not been determined. The aim of this study was to compare the efficacies of parenteral and oral iron therapy in IBD patients in Korea.. A retrospective multicenter study was performed. Patients who had been administered parenteral iron were matched to the controls with oral iron at a 1:1 ratio according to age, sex, and type of IBD.. Patients that received parenteral iron exhibited increases in hemoglobin levels of ≥20% from the baseline at lower doses and in shorter durations (p=0.034 and p=0.046, respectively). In the multivariate analysis, parenteral iron therapy appeared to be more efficient than oral iron therapy, but this difference was not statistically significant (hazard ratio [HR], 1.552; 95% confidence interval [CI], 0.844 to 2.851; p=0.157). Patients with ulcerative colitis responded better to iron therapy than those with Crohn's disease (HR, 3.415; 95% CI, 1.808 to 6.450; p<0.001). Patients with an initial hemoglobin level of 10 g/dL or higher responded poorly to iron therapy (HR, 0.345; 95% CI, 0.177 to 0.671; p=0.002).. Parenteral iron therapy appears to be more efficient than oral iron therapy. Physicians should focus on the iron deficiency of IBD patients and consider parenteral iron supplements in appropriate patient groups.

Topics: Administration, Oral; Adolescent; Adult; Anemia, Iron-Deficiency; Dietary Supplements; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Infusions, Parenteral; Male; Republic of Korea; Retrospective Studies; Treatment Outcome; Young Adult

Iron deficiency is common in heart failure (HF), and intravenous (IV) iron therapy has been associated with improved clinical status in ambulatory patients with HF. There are limited data to support the safety and efficacy of IV iron administration in patients with acute HF. This was a retrospective cohort study of patients admitted to the University of Michigan Health System for HF with low iron studies during admission. Patients were grouped based on the receipt of IV iron therapy. Study outcomes included change in hemoglobin, 30-day readmission, and adverse events. Forty-four patients who received IV iron and 128 control patients were identified. The mean dose of IV iron received was 1,057 (±336) mg. IV iron resulted in a significantly greater increase in hemoglobin over time (p = 0.0001). The mean change in hemoglobin in the iron and control groups was 0.74 g/dl and 0.01 g/dl at day 7 and 2.61 g/dl and 0.23 g/dl at day 28, respectively. Thirty-day readmission rates were 30% and 22% for patients in the iron and control groups, respectively (p = 0.2787). In conclusion, total dose infusion IV iron is well tolerated and associated with significant improvement in hemoglobin in acute HF.

Topics: Acute Disease; Aged; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Heart Failure; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Iron-Dextran Complex; Male; Middle Aged; Retrospective Studies; Time Factors; Treatment Outcome

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

Iron deficiency anemia (IDA) is common in children with inflammatory bowel disease (IBD) affecting their cognitive development and school performance. Oral iron supplementation has serious limitations including poor adherence and iron malabsorption related to chronic inflammation. Our objective was to evaluate the feasibility of periodic intravenous (IV) iron treatments for correction of IDA in children with IBD.. This prospective study was conducted in 24 children with IBD treated with infliximab (IFX). Participants received 3 mg/kg (maximum 200 mg) IV iron sucrose (IS) after IFX treatments if they were iron deficient according to criteria: ferritin <30 ng/mL or transferrin saturation (TSAT) <20% with normal C-reactive protein (CRP), or ferritin <100 ng/mL and TSAT <20% with elevated CRP. They continued to receive IV IS with each IFX treatment until 2 consecutive laboratories showed no evidence of iron deficiency. Hematology and iron indices obtained during the study were compared with historic controls from the same patients.. Mean ferritin, TSAT, and hemoglobin (Hb) (±SE) rose from 21.9 (±3.2) to 48.8 (±6.3) ng/mL (P = 0.0004), 13.2 (±1.8) to 23.6 (±2.6)%, (P = 0.0009) and 11.4 (±0.3) to 12.7 (±0.3) g/dL, (P = 0.006) respectively. The proportion of patients with normal mean ferritin, TSAT, and Hb rose from 33% to 75% (P = 0.002), 21% to 63% (P = 0.006), and 25% to 79% (P = 0.0002), respectively. There were no adverse reactions.. Periodic IV IS is safe and effective for routine management of IDA in children with IBD.

Topics: Adolescent; Anemia, Iron-Deficiency; C-Reactive Protein; Child; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Gastrointestinal Agents; Glucaric Acid; Hemoglobins; Humans; Inflammatory Bowel Diseases; Infliximab; Injections, Intravenous; Iron; Male; Prospective Studies

Severe iron deficiency requires intravenous iron supplementation to replenish iron stores. Intravenous iron sucrose has been used for decades for the treatment of anemia. New generic iron sucrose products are now marketed for the use in several countries and there is an ongoing discussion about the safety and efficacy of iron sucrose similars.. In this study, we compared the iron sucrose originator Venofer® and the generic iron sucrose AZAD (ISA) regarding bioavailability, toxicity and stability in human THP-1 cells and HepG2 cells.. The bioavailability of Venofer® and ISA was investigated in both cell types by a ferrozin-based assay. The release of incorporated iron was assayed by atomic absorption spectroscopy. Ferritin content was measured by enzyme-linked immunosorbent assay (ELISA). HepG2 cells were used to investigate the intracellular labile iron pool (LIP), which was measured by the fluorescent calcein assay. The amount of redox-active iron within the iron formulations was assayed using fluorescent dichlorofluorescein.. We found no significant differences in all parameters between Venofer® and ISA in regard of bioavailability, toxicity and stability in vitro.. ISA shows identical physico-chemical features and identical bioavailability in vitro. This study is a profound basis for future clinical tests with generic iron sucrose compounds.

Topics: Anemia, Iron-Deficiency; Biological Availability; Cell Culture Techniques; Dose-Response Relationship, Drug; Drug Liberation; Drug Stability; Drugs, Generic; Enzyme-Linked Immunosorbent Assay; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hep G2 Cells; Humans; Injections, Intravenous; Macrophages; Spectrophotometry, Atomic; Sucrose

Topics: Aged; Anemia, Iron-Deficiency; Extravasation of Diagnostic and Therapeutic Materials; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Lasers, Solid-State; Male; Skin Diseases; Sucrose

Intravenous polynuclear iron formulations are vital components in the treatment of iron deficiency anemia associated with chronic kidney disease as well as other diseases associated with gastro-intestinal and cardio-vascular system. Intravenous iron preparations consist of iron-carbohydrate nanoparticles with iron-oxyhydroxide as a core covered by carbohydrate shell. These preparations should be very well characterized in terms of their physicochemical properties and pharmacological profile in order to establish safety and efficacy. The present research work was aimed to physicochemically characterize a new generic iron-sucrose preparation (IS-Claris) and establish its equivalency with the reference product (Venofer®). Various analytical techniques including gel permeation chromatography (GPC), mass spectroscopy (MALDI-TOF), absorption spectroscopy, X-ray diffraction analysis (XRD), nuclear magnetic resonance spectroscopy (proton and (13)C NMR), Fourier transform infrared spectroscopy (FTIR) and thermal gravimetric analysis (TGA) were employed. It was observed that the specifications of IS-Claris obtained through these analyses reflect those of Venofer® and hence the two formulations were considered comparable.

Topics: Anemia, Iron-Deficiency; Chromatography, Gel; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Magnetic Resonance Spectroscopy; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Spectroscopy, Fourier Transform Infrared; Sucrose

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: Anemia, Iron-Deficiency; Angioedema; Desensitization, Immunologic; Drug Hypersensitivity; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Humans; Middle Aged; Sucrose; Urticaria

This case study examines the impact of low serum ferritin (sFe) on physiological assessment measures and performance in a young female 1500-m runner undertaking approximately 95-130 km/wk training. The study spans 4 race seasons and an Olympic Games. During this period, 25 venous blood samples were analyzed for sFe and hemoglobin (Hb); running economy, VO(2max), and lactate threshold were measured on 6 occasions separated by 8-10 mo. Training was carefully monitored including 65 monitored treadmill training runs (targeting an intensity associated with the onset of blood lactate accumulation) using blood lactate and heart rate. Performances at competitive track events were recorded. All data were compared longitudinally. Mean sFe was 24.5 ± 7.6 μg/L (range 10-47), appearing to be in gradual decline with the exception of 2 data points (37 and 47 μg/L) after parenteral iron injections before championships, when the lowest values tended to occur, coinciding with peak training volumes. Each season, 1500-m performance improved, from 4:12.8 in year 1 to 4:03.5 in year 4. VO(2max) (69.8 ± 2.0 mL · kg(-1) · min(-1)) and running economy (%VO(2max) at a fixed speed of 16 km/h; max 87.8%, min 80.3%) were stable across time and lactate threshold improved (from 14 to 15.5 km/h). Evidence of anemia (Hb <12 g/dL) was absent. These unique data demonstrate that in 1 endurance athlete, performance can continue to improve despite an apparent iron deficiency. Raising training volume may have caused increased iron utilization; however, the effect of this on performance is unknown. Iron injections were effective in raising sFe in the short term but did not appear to affect the long-term pattern.

Topics: Adolescent; Anemia, Iron-Deficiency; Athletes; Athletic Performance; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Lactic Acid; Oxygen Consumption; Running; Sucrose; Young Adult

CASE 1: An 80-year-old man presented at our hospital with pain in both knees.He had received continuous intravenous administration of saccharated ferric oxide (SFO) over a period of five years following a diagnosis of iron-deficiency anemia.Blood tests revealed hypophosphatemia (1.4 mg/dl) and high circulating levels of fibroblast growth factor 23 (FGF23) at 248.8 mg/dl.These findings led to the diagnosis of FGF23-related osteomalacia due to SFO administration.Accordingly, the treatment plan was first to discontinue SFO, which led to a decrease in pain and normalization of phosphorus and FGF23 after 1 month.CASE 2: A 63-year-old woman presented at our hospital with leg pain.She had undergone total gastrectomy for gastric cancer at 36 years of age.Blood tests revealed hypocalcemia (8.3 mg/dl) and hypophosphatemia (2.2 mg/dl), and 25(OH)D at no more than 5 pg/ml.Bone X-rays showed significantly diminished bone shadowing.These findings led to a diagnosis of vitamin D-deficient osteomalacia due to impaired absorption following total gastrectomy.For therapy, she was treated with 1 μg/day oral alfacalcidol.Two months after initiating treatment, the pain improved.. When a patient is diagnosed with unexplained pain, it is important to pay attention to the possibility of an iatrogenic etiology.

Topics: Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Gastrectomy; Glucaric Acid; Humans; Hypophosphatasia; Iatrogenic Disease; Male; Middle Aged; Osteomalacia; Postoperative Complications; Vitamin D Deficiency

Topics: Adult; Anemia, Iron-Deficiency; Epoetin Alfa; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Fluid Therapy; Glucaric Acid; Hematinics; Humans; Jehovah's Witnesses; Male; Oxygen Inhalation Therapy; Recombinant Proteins; Severity of Illness Index; Vitamin B 12; Vitamin B Complex

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

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: Administration, Intravenous; Anemia, Iron-Deficiency; Clinical Trials as Topic; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Humans

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

Severe iron deficiency resulting in anemia is a common problem during pregnancy and in menstruating women. Several choices for IV iron replacement therapies exist and increased pressures on budgets may require cheaper 'iron sucrose similar' (ISS) to be used. In our practice, an iron sucrose similar (Ferex; ISS(FRX)) was introduced to reduce costs in the treatment of pregnant women or those planned for surgery. Post several months of use we observed increased rates of adverse events from patients and hence performed this analysis to confirm these findings.. Data on adverse events was retrospectively collected from 658 patients treated between September 2004 and December 2011. Patients were analyzed in three cohorts, iron sucrose originator (IS(ORIG)), ISS(FRX) diluted in 100 mL saline and ISS(FRX) diluted in 200 mL saline.. The mean age was 38.5 years and included patients having normal delivery, Cesarean section, myomectomy, hysterectomy, cystectomy and adnexectomy. There were 169 patients in the IS(ORG) group and 210 and 279 in the ISS(FRX)-100 and ISS(FRX)-200 groups respectively. Adverse drug reactions were more frequent in the ISS(FRX) groups vs. IS(ORIG) (11.0 vs. 14.3 vs. 1.8%; p < 0.02). Events were mild-to-moderate in nature and were predominately injection site reactions and phlebitis.. may be impacted by imbalance in baseline characteristics and cumulative iron dose received, however events were mostly acute and all patients received 200 mg iron as single administration.. This is the first large analysis suggesting increased adverse events due to an ISS. For our practice, the use of ISS(FRX) was discontinued owing to safety concerns outweighing the theoretical cost benefit. This study raises the question on the appropriate approval process for complex drugs and if these can be substituted without appropriate clinical testing, both for efficacy and most importantly safety, in routine clinical practice.

Topics: Administration, Intravenous; Adult; Anemia, Iron-Deficiency; Confidence Intervals; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Medical Audit; Middle Aged; Obstetric Surgical Procedures; Postpartum Period; Pregnancy; Pregnancy Complications, Hematologic; Republic of Korea; Retrospective Studies

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Hypophosphatemia; Low Back Pain; Magnetic Resonance Imaging; Middle Aged; Osteomalacia; Pelvic Pain; Remission Induction; Treatment Outcome

Intravenous iron sucrose has been used to treat iron deficiency and iron deficiency anaemia associated with different chronic diseases for several decades. Despite the complex structure of iron sucrose, copies called iron sucrose similars (ISSs) have been approved according to the generic approach and therefore, therapeutic equivalence is taken for granted. In February 2011, three patients who previously tolerated well the prescribed iron sucrose originator experienced urticaria, oedema and headache within 1 hour after infusion of an ISS that had been substituted for the originator at the pharmacy level. One patient collapsed due to severe hypovolaemic dysregulation and required hospitalisation. Due to emerging evidence that ISSs differ from the iron sucrose originator in safety and efficacy profiles, it seems prudent for physicians as well as patients who require intravenous (i.v.) iron to have available data on therapeutic equivalence of new ISS preparations versus the originator. This may be especially important in patients who are chronically ill and need iron supplementation on a regular, long-term basis.

Topics: Adult; Anemia, Iron-Deficiency; Drugs, Generic; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Iron, Dietary; Middle Aged; Therapeutic Equivalency; Young Adult

Iron sucrose originator (IS(ORIG)) has been used to treat iron deficiency and iron deficiency anemia for decades. Iron sucrose similars (ISSs) have recently entered the market. In this non-clinical study of non-anemic rats, five doses (40 mg iron/kg body weight) of six ISSs marketed in Asian countries, IS(ORIG) or saline solution (control) were administered intravenously over four weeks to compare their toxicologic effects. Vasodilatory effects, impaired renal function and hepatic damage were only observed in the ISS groups. Significantly elevated serum iron and transferrin saturation levels were observed in the ISS groups suggesting a higher release of iron resulting in higher amounts of non-transferrin bound (free) iron compared to IS(ORIG). This might explain the elevated oxidative stress and increased levels of inflammatory markers and antioxidant enzymes in the liver, heart and kidneys of ISS-treated animals. Physico-chemical analyses showed that the molecular structure of most of the ISSs differed greatly from that of the IS(ORIG). These differences may be responsible for the organ damage and oxidative stress observed in the ISS groups. Significant differences were also found between different lots of a single ISS product. In contrast, polarographic analyses of three different IS(ORIG) lots were identical, indicating that the molecular structure and thus the manufacturing process for IS(ORIG) is highly consistent. Data from this study suggest that ISSs and IS(ORIG) differ significantly. Therefore, before widespread use of these products it would be prudent to evaluate additional non-clinical and/or clinical data proving the safety, therapeutic equivalence and interchangeability of ISSs with IS(ORIG).

Topics: Anemia, Iron-Deficiency; Animals; Disease Models, Animal; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Inflammation; Male; Oxidative Stress; Rats; Rats, Sprague-Dawley

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

Oral iron replacement is the standard therapy in iron-deficiency anemia (IDA). However, 59% of patients have gastrointestinal toxicity. With impaired iron uptake from the gastrointestinal tract (in anemia of chronic disease (ACD) or after bariatric surgery), suboptimal responsiveness to exogenous erythropoietin (in chronic renal failure), in patients with cancer receiving chemotherapy, or when oral iron is poorly tolerated, IV iron therapy is the preferred mode of repletion. Although effective in increasing hemoglobin, the relative safety of the available IV iron preparations is not well documented. We examined the comparative safety of IV iron formulations used at hospitals associated with our institution. Among 619 unique patients who received IV iron over a 2-year period, we found 32 adverse events (AEs), ranging from urticaria to chest pain. There were no serious AEs or anaphylactic-type reactions. In a multivariate model, there was no difference in AE rates between low-molecular-weight iron dextran (LMWD) and ferric gluconate; however, iron sucrose had significantly higher odds ratio of AEs (OR = 5.7; 95% CI = 1.6–21.3). Our data suggest that AE rates with IV iron are acceptable. More widespread use of LMWD, in particular, which can be given safely as a total dose infusion (TDI), should be considered.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Iron-Dextran Complex; Male; Middle Aged; Multivariate Analysis; Retrospective Studies

A 44-year-old woman with iron deficiency anemia was on a continuous course of intravenous saccharated ferric oxide (SFO). She came to our hospital because of right hip joint pain. She was found to have hypophosphatemia caused by impaired phosphorus resorption and her fibroblast growth factor 23 (FGF-23) levels were elevated. Therefore, she was diagnosed with FGF-23-related osteomalacia due to SFO administration. Discontinuation of the SFO treatment rapidly improved the impaired phosphorus resorption and also normalized the blood levels of phosphorus and FGF-23. During the treatment with SFO, it is important to regularly measure the blood levels of phosphorus in order to prevent the occurrence of osteomalacia.

Topics: Absorptiometry, Photon; Adult; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Glucaric Acid; Hematinics; Humans; Osteomalacia; Phosphorus; Time Factors; Treatment Outcome; Withholding Treatment

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Cardiac Surgical Procedures; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Male; Sucrose

A regimen of a single high dose iron administration was initially adopted for patients commencing haemodialysis (HD) treatment. Iron stores are established and iron metabolism and erythropoiesis stabilise allowing haematinic parameters to be more confidently assessed for use in anaemia management decisions. High doses of IV iron delay the need for subsequent iron supplementation. A high-dose, low-frequency iron infusion regimen for all HD patients was adopted. The outcomes of administering this dosage regimen are reported as observational retrospective analysis using patient record data in 2009. Patients received three [median; semi-interquartile range (SIQR) 0.5] high-dose iron infusions during the year. The median infusion dose was 1100 mg iron (SIQR 0.0) and the median amount of iron received during the year by each patient was 3200 mg (SIQR 750). The median haemoglobin (Hb) level prior to infusion was 108 g/l and post infusion 114 g/l; ZHb = 2.656, p = 0.008). Ferritin levels increased from a median of 376 μg/l preinfusion to 690 μg/l postinfusion; Zferritin =-4.796, p < 0.001. The median time between infusions was 125 days (approximately four months). The 51 patients (76%) who received three or less infusions within the study period received 2537 mg (mean) of iron. These findings indicate that both Hb and ferritin levels can be adequately managed using a high-dose, low-frequency regimen of IV iron in patients undergoing HD.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Middle Aged; Renal Dialysis; Young Adult

Topics: Anemia, Iron-Deficiency; Child; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Iron-Dextran Complex; Molecular Weight

For decades, parenteral iron has been used in patients with iron deficiency unresponsive to oral iron therapy and in hemodialysis-dependent patients receiving erythropoietin. Newer intravenous (IV) iron formulations such as iron sucrose have replaced high-molecular weight iron (HMW) dextran in dialysis patients; however, the use of parenteral iron in children without renal disease has not been well defined.. Pharmacy records were reviewed on children (≤ 18 years of age) who received IV iron sucrose at Children's Medical Center Dallas between January 1, 2004 and June 30, 2009. Patients who received iron sucrose for chronic renal disease were excluded from analysis.. Thirty-eight children received iron sucrose for non-renal indications, 13 with iron deficiency refractory to oral iron therapy, 13 with iron malabsorption or dependence on parenteral nutrition, 7 for chronic gastrointestinal blood loss, and 5 for miscellaneous indications. Among these 38 children, who received a total of 510 doses of IV iron sucrose, there were only six adverse reactions. Patients in all categories had a good response to the iron sucrose, with a median hemoglobin rise of 1.9-3.1 g/dl depending on the indication.. Parenteral iron is a safe and effective means to treat iron deficiency in children who cannot receive or do not respond to oral iron due to intolerance, poor adherence, or iron malabsorption.

Topics: Administration, Oral; Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infant; Infusions, Intravenous; Male

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

Patients with iron-deficiency anemia benefit from intravenous iron therapies. Development of these pharmaceutical agents requires pharmacokinetic studies monitoring levels of both the administered agent and transferrin-bound iron (TBI). Successful pharmacokinetic methods must discriminate iron species.. Routine colorimetric procedures were used to reliably measure total iron and TBI following iron-sucrose administration. Iron was liberated from iron-sucrose allowing the determination of all circulating iron. Solid-phase sample processing allowed the measurement of TBI. Circulating iron-sucrose could then be calculated as the difference between total iron and TBI.. A reproducible and robust spectrophotometric method was developed and validated for measuring total iron and TBI in human serum following iron-sucrose therapy.

Topics: Anemia, Iron-Deficiency; Colorimetry; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron; Reproducibility of Results; Spectrophotometry; Transferrin

To determine the efficacy and safety of subcutaneously administered recombinant human erythropoietin in combination with intravenous iron sucrose for the management of iron deficiency anaemia in gynaecological patients in Jinnah Postgraduate Medical Centre Karachi.. It was an interventional quasi experimental study carried out in the Department of Obstetrics /Gynaecology, at JPMC from 1st Nov 2007 to May 2008. All patients with indications for major Gynaecological surgery with iron deficiency anaemia having a mean haemoglobin level of 7 gm/dl were selected and the target haemoglobin was 11 gm/dl. Patients who were symptomatic, had chronic bleeding, renal failure or had signs of anaemia other than iron deficiency were excluded from the study. All investigations were done on day one before the start of therapy, and then treatment was initiated with recombinant human erythropoietin in a dose of 5000 IU subcutaneously and injection Iron Sucrose 200 mg in 100cc NaCI intravenously on 3 alternate days. The parameters checked in succession on day 4 and day 10 included increase in haemoglobin level, haematocrit, reticulocyte count, and time required to reach the target haemoglobin.. Twenty three patients fulfilled the inclusion criteria and were selected for the study. At the end of 10 days of starting therapy increase in haemoglobin was on an average of 2.8 gm/dl, increase in mean corpuscular volume was 4fl, Serum Iron increased by 99.86 ug%, total iron binding capacity decreased by 30.86%, transferrin saturation increased by 15.5% .There were no serious reactions to Erythropoietin or Iron sucrose. It is concluded that recombinant erythropoietin along with iron sucrose safely increased the haemoglobin level in 10 days to the target level thus rendering the patients fit for surgery and, none of the selected patients needed blood transfusion.

Topics: Academic Medical Centers; Adult; Anemia, Iron-Deficiency; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gynecologic Surgical Procedures; Hematinics; Humans; Pakistan; Preoperative Care; Recombinant Proteins; Reticulocyte Count; Time Factors; Treatment Outcome

Anemia is iron responsive in 30 to 50% of nondialysis patients with chronic kidney disease (CKD), but the utility of bone marrow iron stores and peripheral iron indices to predict the erythropoietic response is not settled. We investigated the accuracy of peripheral and central iron indices to predict the response to intravenous iron in nondialysis patients with CKD and anemia.. A diagnostic study was conducted on 100 nondialysis patients who had CKD and anemia and were erythropoiesis-stimulating agent and iron naive. Bone marrow iron stores were evaluated by aspiration. Hemoglobin, transferrin saturation index (TSAT), and ferritin were measured at baseline and 1 month after 1000 mg of intravenous iron sucrose. Posttest predictive values for the erythropoietic response (> or =1-g/dl increase in hemoglobin) of peripheral and central iron indices were calculated.. The erythropoietic response was noted in a higher proportion in bone marrow iron-deplete than in iron-replete patients (63 versus 30%). Peripheral iron indices had a moderate accuracy in predicting response. The positive (PPV) and negative predictive values (NPV) were 76 and 72% for a TSAT of 15% and 74 and 70% for a ferritin of 75 ng/ml, respectively. In the final logistic regression model, including TSAT and ferritin, the chances of a positive response increased by 7% for each 1% decrease in TSAT.. Because an erythropoietic response is seen in half of patients and even one third of those with iron-replete stores responded whereas peripheral indices had only a moderate utility in predicting response, the therapeutic trial to intravenous iron seems to be a useful tool in the management of anemia in nondialysis patients with CKD.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Biomarkers; Blood Chemical Analysis; Bone Marrow; Bone Marrow Examination; Chi-Square Distribution; Chronic Disease; Erythropoiesis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Iron; Kidney Diseases; Logistic Models; Male; Middle Aged; Predictive Value of Tests; Time Factors; Transferrin; Treatment Outcome; Young Adult

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Postoperative Complications; Preoperative Care; Randomized Controlled Trials as Topic

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Postoperative Complications; Randomized Controlled Trials as Topic

New Medicare rules that set forth a revised reimbursement scheme for dialysis services will introduce significant changes for providers. The new rules will abandon the current system of separate reimbursement for drugs associated with the hemodialysis services, including erythropoiesis-stimulating agents (ESAs) and intravenous (i.v.) iron. These rules will "bundle" these agents and related laboratory tests into a single, case-mix adjusted composite rate. These bundling rules will be gradually phased-in, beginning in 2011. One of the primary effects of the new reimbursement policy will be to discourage over-utilization of ESAs that comprise nearly one-quarter of hemodialysis-related Medicare expenditures. As a result, hemodialysis providers will be challenged to make hemodialysis services more cost-effective, while ensuring that Medicare clinical performance measures are met and patient care is not compromised. i.v. iron has an integral role in making anemia care more cost-effective in the hemodialysis setting by improving measures of iron-deficiency anemia, maintaining necessary iron balance, and reducing the utilization of ESAs. This review discusses the potential benefits of i.v. iron in the management of hemodialysis patients with iron-deficiency anemia. It also focuses on the available i.v. iron options, particularly the established efficacy and safety profile of i.v. iron dextran compared with other i.v. iron formulations as well as cost considerations.

Topics: Anemia, Iron-Deficiency; Chemistry, Pharmaceutical; Dextrans; Drug Costs; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Iron Compounds; Iron-Dextran Complex; Medicare; Reimbursement Mechanisms; Renal Dialysis; Risk Adjustment; Safety; Sucrose; Treatment Outcome; United States

A 43-year-old African-American female with anemia secondary to uterine leiomyomas and menorrhagia presented with induration and stiffness of the right arm and hand four weeks after receiving intravenous iron infusions at multiple infusion sites along the right proximal forearm. Multiple intravenous sites between her right antecubital fossa and wrist had to be used because developing pain necessitated the site changes. The iron infusions were performed because the patient had refused blood transfusions and her symptoms failed to resolve on oral iron supplementation. The skin induration persisted and progressed for several months at which time a skin biopsy was performed. The skin histology was consistent with eosinophilic fasciitis and her complete blood count was notable for a peripheral eosinophilia. Because of the location of the fibrosis and the time proximity in relation to her infusions, a relationship between the iron infusions and eosinophilic fasciitis was made. Cutaneous fibrosis has been linked to immunologic dysfunction, autoantibody production, tissue hypoxia, and vascular damage, which may have been contributing factors in this patient. Eosinophilic fasciitis has been linked to certain drugs and chemicals, notably L-tryptophan ingestion and the statin family of drugs.

Topics: Adult; Anemia, Iron-Deficiency; Eosinophilia; Fasciitis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron-Dextran Complex; Renal Dialysis

Detection of iron deficiency in patients with end-stage renal disease (ESRD) remains challenging due to the lack of reliable markers. The immature reticulocyte fractions (IRF) RET-Y and RBC-Y may serve as useful novel markers. We investigated the ability of IRF to detect functional iron deficiency in ESRD patients in comparison to Serum ferritin (SF) and Transferrin saturation (TSAT) and the influence of intravenous iron therapy on these markers.. Cross sectional (n=40) and prospective (n=20) studies of hemodialysis patients were performed; 20 patients received intravenous iron (200 mg) monthly and were followed up for 5 months. Iron deficiency was defined as SF < or =200 microg/L and/or TSAT < or =20%. A RBC-Y < or =171 and/or RET-Y < or =168.7 were criteria for iron deficiency. Correlations between traditional and novel markers were examined. Results are given as mean+/-SEM. Paired t-test was used to test for significance.. 27 male and 13 female patients, mean age of 56.7+/-3.02 years were enrolled in the cross-sectional study. TSAT correlated with RBC-Y and RET-Y, r=0.47 and 0.61, respectively. Correlations for SF with RBC-Y and RET-Y were r=0.23 and 0.22, respectively. In the prospective component (11 males and 9 females of mean age 60+/-3.4 years), RET-Y and RBC -Y remained stable during iron therapy. The coefficients of variation were RBC-Y 2.54%, RET-Y 4.23%, TSAT 28.74% and SF 35.34%.. RBC-Y and RET-Y correlated with TSAT and SF allowing detection of functional iron deficiency. These measures were less susceptible to fluctuations than traditional markers.

Topics: Anemia, Iron-Deficiency; Biomarkers; Cross-Sectional Studies; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Renal Dialysis; Reticulocytes; Time Factors; Transferrin; Treatment Outcome

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemoglobins; Humans; Preoperative Care

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

Use of parenteral iron for anemia management in dialysis patients has greatly increased. Exceeding hemoglobin target levels is not without risk, and whether parenteral iron administration contributes to exceeding targets has not been tested. The authors aimed to determine prevalence of parenteral iron administration and its contribution to exceeding hemoglobin target levels.. The authors performed a retrospective observational study of 149,292 hemodialysis patients using Centers for Medicaid & Medicare Services data. All patients were point prevalent on January 1, 2004; survived through June 30, 2004; had Medicare as primary payer; were treated with erythropoiesis stimulating agents (ESAs); and had valid hemoglobin values in April, May, and June, 2004.. Of the cohort, 58% received parenteral iron; use was more likely among men, whites, younger patients, and patients with end-stage renal disease as a result of diabetes. Age > 75 yr, African American and other races, baseline hemoglobin > 12 g/dl, higher ESA dose, and iron use in months 1 to 4 of the study period were independently associated with the risk of exceeding hemoglobin levels of 12, 13, and 14 g/dl. Receiving iron in month 4 of the study period showed the highest probability of exceeding targets (odds ratios 1.49, 1.43, 1.50 for hemoglobin levels 12, 13, 14 g/dl, respectively).. Parenteral iron use is prevalent, and although adequate iron stores are central to ESA response, iron use may contribute to exceeding recommended hemoglobin levels. Only data from a prospective trial can confirm this association.

Topics: Aged; Anemia, Iron-Deficiency; Centers for Medicare and Medicaid Services, U.S.; Drug Therapy, Combination; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Iron-Dextran Complex; Kidney Failure, Chronic; Male; Middle Aged; Odds Ratio; Practice Guidelines as Topic; Renal Dialysis; Retrospective Studies; Risk Assessment; Time Factors; Treatment Outcome; United States

This study aimed to assess the safety and efficacy of iron sucrose in hemodialysis (HD) patients with documented hypersensitivity reactions to iron dextran. Of 205 HD patients who received low molecular weight iron dextran, 15 (7.3%) patients developed documented hypersensitivity reactions. The patients were treated with iron sucrose (100 mg administered as an intravenous push over 5-10 minutes once a week) for 8 weeks. Complete blood count, serum iron, serum ferritin, and parathyroid hormone were measured at the beginning and at the end of the study (except parathyroid hormone). All patients received subcutaneous erythropoietin at a constant dose of 5000 IU twice weekly unless a change was required. All the patients completed the study period and none of them developed hypersensitivity reactions to iron sucrose. The mean hematocrit increased from 23.8% to 32.27% (p < 0.0001), the mean serum ferritin from 185 ng/mL to 599 ng/mL (p < 0.0001), and the mean serum iron from 29.3 ng/dL to 76.8 ng/dL (p = 0.01). We conclude that iron sucrose is safe and effective in HD patients with documented hypersensitivity reactions to low molecular weight iron dextran.

Topics: Adult; Aged; Anemia, Iron-Deficiency; Dialysis Solutions; Drug Hypersensitivity; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Hematinics; Humans; Iron-Dextran Complex; Male; Middle Aged; Renal Dialysis; Treatment Outcome; Young Adult

There is a high incidence of perioperative anemia among surgical patients (20%-70%). Preoperative anemia has been linked to an increased postoperative morbidity and mortality, as well as a decreased quality of life of surgical patients. In addition, a low preoperative hemoglobin constitutes an important predictive factor of allogeneic blood transfusion in major surgery. We evaluated the efficacy of intravenous iron sucrose (IVIS) administration for correction of anemia in these patient populations.. Data from 84 patients with anemia who were scheduled for major elective surgery (30 colon cancer resections, 33 abdominal hysterectomies, 21 lower limb arthroplasties) and who received preoperative IVIS during 3-5 weeks were propectively collected.. Administration of IVIS -mean dose (standard deviation): 1000 (440)mg- caused a significant increase of hemoglobin levels -2.0 (1.6)g/dl (p<0.001)- and anemia was resolved in 58% of patients. No life-threatening adverse effect was witnessed.. Because of the low incidence of side effects and the rapid increase of hemoglobin levels, IVIS emerges as a safe, effective drug for treating preoperative anemia in these patient populations.

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Male; Middle Aged; Preoperative Care; Prospective Studies

Low-molecular-weight iron dextran (CosmoFer) is the only form of parenteral iron that can be administered as a total dose infusion (TDI) in the United Kingdom (UK). This study aimed to evaluate the safety and efficacy of TDI CosmoFer in comparison to intravenous iron sucrose infusion (Venofer) in patients with chronic kidney disease (CKD).. A retrospective study of outpatients with CKD undergoing intravenous TDI CosmoFer or Venofer infusion was conducted at Salford Royal Hospital and Sunderland Royal Hospital. A total of 979 doses of CosmoFer and 504 doses of Venofer were administered. There were three minor adverse events in patients receiving CosmoFer compared with one minor event in a Venofer treated patient. There were no anaphylactoid-type reactions in either group. Serum haemoglobin, ferritin and transferrin saturation (TSAT) improved significantly 4-6 months postinfusion in both treatment groups.. TDI CosmoFer is an efficacious method of replenishing iron stores in CKD patients in an outpatient setting. Furthermore, TDI CosmoFer is safe and not associated with an increase in adverse events compared to Venofer.

Topics: Anemia, Iron-Deficiency; Drug-Related Side Effects and Adverse Reactions; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Iron-Dextran Complex; Male; Middle Aged; Renal Insufficiency, Chronic; Retrospective Studies; Sucrose

Iron deficiency is the most common single cause of anemia worldwide. Treatment consists of improved nutrition along with oral, intramuscular or intravenous iron administration.. To describe the efficacy and adverse effects of intravenous iron sucrose therapy in a group of children with iron deficiency anemia who did not respond to oral iron therapy.. We conducted a prospective investigation of 45 children, aged 11 months to 16 years, whose oral iron therapy had failed. The children attended the Pediatric Day Care Unit where they received intravenous iron sucrose infusion.. Forty-four of the 45 patients were non-compliant. Nine had Helicobacter pylori gastritis and 16 patients suffered from intestinal malabsorption from different causes. Before treatment, the blood mean hemoglobin concentration was 7.43 g/dl (range 5-10.1 g/dl). Fourteen days after treatment it increased to 9.27 g/dl (SD 1.23) and 6 months later to 12.40 g/dl (SD 1.28). One patient demonstrated a severe side effect with temporary and reversible reduced blood pressure during treatment.. These preliminary data suggest that administration of intravenous iron in pediatric patients is well tolerated and has a good clinical result, with minimal adverse reactions.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infant; Infusions, Intravenous; Male; Prospective Studies; Treatment Outcome

Topics: Administration, Oral; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Infusions, Parenteral; Iron; Patient Compliance

The safety and efficacy of a total-dose iron sucrose infusion protocol used in a large, tertiary care teaching hospital were studied.. Nondialysis-dependent patients ages 18 years or older who received > or =250 mg of iron sucrose as a single i.v. infusion between January 2005 and January 2007 were eligible for study inclusion. The protocol for total-dose iron sucrose infusion was the same for all patients. The total dose of iron sucrose for each patient was calculated using an equation that included the desired hemoglobin (Hb) value, observed Hb level, ideal body weight, and sex. The calculated dose was divided into portions, rounded to the nearest 250 mg, and administered over four hours every other day. Outcomes measured included Hb, transferrin saturation, and serum ferritin values.. A total of 26 patients met the inclusion criteria. The mean +/- S.D. Hb concentration before total-dose iron sucrose infusion was 9.37 +/- 0.9 g/dL, and the mean +/- S.D. corpuscular volume was 75 +/- 7.1 mum(3). The mean +/- S.D. postinfusion Hb concentration for 19 patients for whom follow-up Hb levels were available was 11.4 +/- 1.2 g/dL, significantly higher than the 9.45 +/- 0.8 g/dL measured before the first infusion (p = 0.03). No significant adverse effects were reported in 47 of 49 infusions, with 2 patients experiencing mild nausea.. A treatment protocol consisting of alternate-day total-dose iron sucrose infusions was well tolerated and appeared to be effective in improving Hb concentrations in patients with iron deficiency anemia and without chronic kidney disease.

Topics: Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Infusions, Intravenous; Male

Topics: Aged; Anemia, Iron-Deficiency; Arm; Extravasation of Diagnostic and Therapeutic Materials; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Hyperpigmentation

To study the transfer of parenteral iron sucrose into maternal milk in the postpartum period.. Ten healthy lactating mothers with functional iron deficiency 2-3 days after delivery received 100 mg intravenous iron sucrose and were observed together with a control group (n=5) without iron treatment during four days. Milk samples were taken before the treatment and every day afterwards.. Mean milk iron levels at baseline were 0.43 and 0.46 mg/kg in the treatment and control group and decreased until the end of observation in both groups by 0.11 mg/kg. No significant difference between the groups was found on any study day as well as in the mean change from baseline over all four days.. We could not show transfer of iron-sucrose into maternal milk for the given dosage. Since parenteral iron sucrose is widely used in obstetrics, the results provide information about safety of parenteral iron sucrose in the lactation period. The findings are also in agreement with other reports on active biological mammary gland regulation of milk iron concentration.

Topics: Adult; Anemia, Iron-Deficiency; Breast Feeding; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Iron; Iron Deficiencies; Milk, Human; Postpartum Period; Puerperal Disorders

A 67-year-old woman with iron deficiency anemia required parenteral iron therapy and was treated with intravenous ferric gluconate. She tolerated the first dose, but after the second dose, she developed a tingling feeling all over her body, along with swelling in her hands and feet, and a rash with hives over most of her body. It was thought that she had likely experienced a hypersensitivity reaction to ferric gluconate. The decision was made to continue therapy; however, two modifications were made. The patient was given dexamethasone, diphenhydramine, and ibuprofen 1 hour before administering the third dose, and the infusion time was prolonged by 1 hour. Approximately 45 minutes after the infusion was completed, the patient developed hives on her arms and legs. At the patient's next clinic visit, it was decided that continuation of parenteral iron repletion was necessary, and the decision was made to attempt a challenge with iron sucrose. The patient was given dexamethasone 8 mg to be taken the night before and the morning of treatment. She successfully completed the iron repletion therapy with iron sucrose. Three parenteral iron products are available in the United States: iron dextran, sodium ferric gluconate complex, and iron sucrose. Iron dextran, the oldest of these products, carries the highest risk for hypersensitivity reactions. Available data suggest that either iron sucrose or ferric gluconate can be safely administered to patients with known hypersensitivity to iron dextran. Our patient's experience implies that it may be possible to safely administer iron sucrose to a patient with hypersensitivity to ferric gluconate. This finding has clinical implications and warrants confirmation in a larger population.

Topics: Aged; Anemia, Iron-Deficiency; Drug Hypersensitivity; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hispanic or Latino; Humans; Infusions, Intravenous; Injections, Intravenous; Self Administration; Treatment Outcome

Iron deficiency is a frequent complication in chronically ill patients and in pregnant women. Iron status can now be characterised precisely and relatively easily by determining serum ferritin, transferritin saturation and if necessary hypochromic erythrocytes and the haemoglobin content of erythrocytes (CHr). Oral iron replacement is usually restricted by limited absorption and low tolerability. Intravenous iron therapy is possible in such cases and can be combined with rHuEPO (e.g. EPREX/ epoetin alfa) in severe cases. Iron saccharate (VENOFER) is commercially available in Switzerland and this permits high dose iron replacement without any danger of anaphylaxis or acute iron toxicity.

Topics: Anemia, Iron-Deficiency; Biomarkers; Drug Therapy, Combination; Epoetin Alfa; Erythrocyte Count; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hematocrit; Hemoglobins; Humans; Injections, Intravenous; Pregnancy; Pregnancy Complications, Hematologic; Recombinant Proteins; Sucrose; Switzerland; Transferrin

This study was undertaken to assess the safety and tolerability of the use of intravenous (IV) iron sucrose in the therapy of iron-deficiency anemia in elderly, hemodialysis dependent (HDD), chronic kidney disease (CKD) patients.. This was a multicenter, open-label study in a large consecutive sample of 665 HDD-CKD patients (in 11 locations). Patients received IV iron sucrose therapy in treatment and maintenance dosing cycles over 10-week periods. There were 10 doses of 100 mg of iron sucrose in each drug cycle, and participants could receive multiple cycles of either or both regimens. Variables evaluated in the intent-to-treat population included adverse events (AEs), hemoglobin, and iron indices.. Of the 665 patients, 391 patients were under the age of 65 (younger adults) and 274 were 65 years of age or older (elder adults). Iron needs and erythropoietin dosing were similar in both the elder and younger adult patients. The incidence, severity, and nature of AEs and overall mortality were similar in both age groups. There were no drug-related deaths or drug-related serious AEs in either group. There were no hypersensitivity reactions or allergic reactions in either patient population, even among those with a prior history of intolerance to other parenteral-iron products. Comparison of the two age groups also revealed no differences in the efficacy of iron treatment as reflected by hemoglobin, transferring saturation, and ferritin response.. There is no apparent difference in the safety and efficacy of iron sucrose between elder and younger adults in the treatment of iron-deficiency anemia in HDD patients with CKD.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Geriatrics; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis

Topics: Anemia, Iron-Deficiency; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Hematinics; Humans; Infusions, Intravenous; Natriuretic Peptide, Brain; Peptide Fragments; Treatment Outcome

In vitro evidence suggests that different intravenous iron (i.v. Fe) preparations may be associated with different infection rates. This observational study was to determine if different bacteremia rates are associated with different types or amounts of i.v. Fe preparations.. This retrospective, single-center study was carried out from April 2001 November 2002, a period in which a global switch from ferric gluconate (FG) to iron sucrose (IS) occurred. During Period I (April 2001 - January 2002) FG was the only i.v. Fe administered in our hemodialysis unit. During Period II (February 2002 - November 2002) IS was the only i.v. Fe administered in our unit. Group A (n = 63) received hemodialysis during both Period I and Period II. Group B (n = 41) received hemodialysis either during Period I or Period II.. More bacteremic episodes occurred while IS than while FG was being administered. The adjusted bacteremia incidence rate ratios (IRRs) associated with use of IS vs. FG were 2.92 (95% CI, 1.01 - 8.5) and 2.84 (95% CI 1.32 - 6.09) in Groups A and B, respectively. The adjusted bacteremia IRRs associated with receiving > 2,000 mg of i.v. Fe were 2.42 (95% CI 1.03 - 5.6) and 1.54 (95% CI 0.43 - 5.69) in Groups A and B, respectively. Use of catheters as hemodialysis access increased bacteremia risk in both groups.. Use of iron sucrose is associated with higher bacteremia rates than ferric gluconate. The potential association between the cumulative amount of i.v. Fe administered and bacteremia risk is unclear. Randomized clinical trials are needed to verify our findings.

Topics: Aged; Anemia, Iron-Deficiency; Bacteremia; Chi-Square Distribution; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Poisson Distribution; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Statistics, Nonparametric

Topics: Anemia, Iron-Deficiency; Celiac Disease; Diagnosis, Differential; Ferric Compounds; Ferric Oxide, Saccharated; Folic Acid Deficiency; Glucaric Acid; Humans; Injections, Intravenous; Iron; Sucrose

The financial advantage of the oral treatments of iron is minimised by their low bioavailibility (10 to 20%) and the fact that instructions for oral treatments are often badly followed by the patient (eg: tablets taken too far away from meals inducing frequent digestive problems). In France, since Maltofer (hydroxic ferric polymaltose) has been discontinued, Venofer (complex hydroxide ferric saccharose) is the only alternative intraveinous treatment with a cost which is now ten times higher than it was before. In foreign countries, other specialised products for intraveinous treatments (notably with a base of dextran iron with low molecular weight) have shown similar efficiency and are as safe to use as the complex hydroxide ferric saccharose. The hypothesis of a better control of the oxydative stress in giving a prophylactic treatment of 20 to 50 mg of hydroxide ferric saccharose at each treatment (because of the presence of free plasmatic iron) must be validated and the conditioning by unit may have to be adjusted.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; France; Glucaric Acid; Humans; Iron; Iron Deficiencies

The preferable route of iron delivery for most iron-deficient patients is oral. Parenteral iron therapy is used in patients who cannot tolerate oral iron or in cases in which oral iron is not sufficiently effective. The most frequent indications for parenteral iron therapy are unbearable gastrointestinal side effects induced by oral iron itself, worsening of inflammatory bowel disease symptoms, insufficient intestinal absorption, renal failure-caused anemia that is treated with erythropoietin, and unresolved ongoing bleeding, which would cause the acceptable oral doses of iron therapy to be exceeded. The serious adverse effects of iron dextran that was used in the past could explain the reluctance of medical personnel to prescribe this effective treatment. Patients with iron deficiency anemia were treated with intravenous iron in a primary care clinic. The iron gluconate was given in a dosage of 62.5 mg diluted in 150 mL of normal saline and was infused intravenously over 30 min, while iron sucrose was given in a dosage of 100 mg diluted in the same volume of normal saline and given at the same rate. In total, 724 infusions were administered to 57 patients. Iron sucrose was used in 628 infusions, and iron gluconate was used in the remaining 96. The frequency of the infusion treatments depended on the underlying disease and ranged from three times a week to once a month. Adverse effects were seldom observed and were minor in patients receiving iron gluconate, and were not registered at all in patients treated with iron sucrose. Two cases of flushing with paresthesias occurred. Slowing the infusion rate successfully eliminated these side effects. One case of hypotension was treated successfully with 500 cc of normal saline infusion. One case of dropout occurred, due to the patient's refusal to cooperate. No anaphylactic reactions were observed. Iron gluconate and iron sucrose are effective and safe for use in primary care clinics. The risk of adverse effects is low.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Injections, Intravenous; Renal Insufficiency; Sucrose

The maximum tolerated single dose of intravenous iron infusion and iron pharmacokinetics are not known in children and not clear in adults. The case reported here is of a child given a large dose of intravenous iron sucrose (16 mg/kg) over 3 hours, who subsequently developed features of systemic iron toxicity. A TDM consultant discusses the case in the context of toxicokinetic analysis. Because the maximum tolerated dose and pharmacokinetics of intravenous iron preparations are not known, their use in both adults and children should still be undertaken with caution.

Topics: Anemia, Iron-Deficiency; Chemical and Drug Induced Liver Injury; Child, Preschool; Deferoxamine; Ferric Compounds; Ferric Oxide, Saccharated; Gastrointestinal Diseases; Glucaric Acid; Humans; Infusions, Intravenous; Liver Diseases; Male; Siderophores; Treatment Outcome

Many patients require parenteral iron therapy for optimal correction of anemia, including cancer patients who require erythropoietic drugs. Available parenteral iron therapy options include iron dextran, iron gluconate, and iron sucrose. The purpose of this study is to summarize our institution's experience with parenteral iron therapy over a 5-year period, with a focus on comparative safety profiles. All patients receiving parenteral iron therapy over this period were included in the analysis. Chi-squared test and Fisher's exact test were used to compare the adverse event rates of each product. A total of 121 patients received 444 infusions of parenteral iron over this period. Iron dextran was the most commonly used product (85 patients) and iron sucrose was the least used (2 patients). Iron gluconate was used by 34 patients. Overall adverse event rates per patient with iron dextran and iron gluconate were 16.5% and 5.8%, respectively (P = .024). Premedication with diphenhydramine and acetaminophen before infusions of iron dextran reduced adverse event rates per infusion from 12.3% to 4.4% (P = .054). Test doses of iron dextran were used 88% of the time for initial infusions of iron dextran. All adverse events for all parenteral iron products were mild or moderate. There were no serious adverse events and no anaphylaxis was observed. Our results suggest that, if test doses and premedications are used, iron dextran is an acceptable product to treat iron deficiency.

Topics: Acetaminophen; Anemia, Iron-Deficiency; Diphenhydramine; Female; Ferric Compounds; Ferric Oxide, Saccharated; Gastrointestinal Hemorrhage; Glucaric Acid; Humans; Infusions, Parenteral; Iron Metabolism Disorders; Iron-Dextran Complex; Kidney Diseases; Male; Menorrhagia; Neoplasms; Premedication; Retrospective Studies; Telangiectasia, Hereditary Hemorrhagic; United States; von Willebrand Diseases

Topics: Administration, Oral; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Parenteral; Pregnancy; Pregnancy Complications, Hematologic

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; History, 20th Century; Humans; Infusions, Intravenous; Pregnancy; Pregnancy Complications, Hematologic

Topics: Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Postpartum Period; Pregnancy; Prevalence

This report summarizes the data gathered in four prospective studies of intravenous iron sucrose therapy administered to iron-deficient hemodialysis patients with a history of intolerance to other parenteral iron preparations.. A total of 130 iron dextran- and/or sodium ferric gluconate-sensitive patients received intravenous iron sucrose therapy to correct iron deficiency, and/or maintain body iron stores. A history of intolerance to iron dextran alone was reported in 109 patients, to ferric sodium gluconate alone in 6 patients, and to both iron dextran and ferric sodium gluconate in 15 patients. Therapy with iron sucrose consisted of 100- or 200-mg doses administered undiluted intravenously over 2-5 min, or diluted in normal saline and infused over 15-30 min. Test doses of iron sucrose were not administered. The median cumulative dose was 1,000 mg, with a range of 100-5,000 mg.. There were no serious adverse events related to iron sucrose therapy in the 130 patients intolerant to other iron preparations. There were 14 nonserious drug-related adverse events in 8 patients attributed to iron sucrose, none of which resulted in discontinuation of therapy. These events were classified as either of severe (diarrhea), moderate (hypotension, nausea, vomiting), or mild severity (constipation, dry mouth, skin irritation).. Iron sucrose therapy is safe and well tolerated in hemodialysis patients intolerant to iron dextran and/or sodium ferric gluconate.

Topics: Anemia, Iron-Deficiency; Diarrhea; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Hypotension; Infusions, Intravenous; Male; Nausea; Prospective Studies; Renal Dialysis; Vomiting

The effect of intravenous ascorbic acid was compared with that of intravenous iron in the treatment of functional iron deficiency, as defined as serum ferritin levels over 300 ng/ml and serum iron levels below 50 microg/dl, in patients on chronic hemodialysis. Thirteen patients on chronic hemodialysis with functional iron deficiency received intravenous injections of ascorbic acid, 100 mg, three times a week, after hemodialysis. The therapy was continued until serum ferritin decreased to below 300 ng/ml (3 months at the maximum). The iron and control group were composed of patients who had serum iron levels below 50 microg/dl within 3 months after serum ferritin rose to over 300 ng/ml. Seven patients with the iron group received more than a total of 10 intravenous injections of saccharated ferric oxide (40 mg/dose) after hemodialysis, and seven patients with the control group received no iron preparation during the 3 months. In the ascorbic acid group, while hemoglobin did not change from 10.9 +/- 0.5 g/dl (mean +/- SE) during the three-month period, serum iron increased significantly from 37 +/- 4 microg/dl to 49 +/- 4 microg/dl after one month (p<0.01), and remained elevated until the end of the three-month period. Serum ferritin decreased significantly from 607 +/- 118 ng/ml to 354 +/- 30 ng/ml after 3 months (p<0.01). In the iron group, hemoglobin and serum iron increased significantly from the respective pre-treatment levels during the 2-month period, and serum ferritin rose significantly after 3 months. In the control group, hemoglobin, serum iron and ferritin levels decreased significantly from the respective pre-treatment levels during the 3 months. The recombinant erythropoietin dose remained stable for three months in the ascorbic acid, iron, and control groups, respectively. These results suggest that in hemodialysis patients with a functional iron deficiency, treatment with intravenous ascorbic acid can prevent iron overload due to treatment with intravenous iron, and provide a useful adjuvant means of maintaining hemoglobin and serum iron levels.

Topics: Aged; Anemia, Iron-Deficiency; Ascorbic Acid; Biomarkers; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Iron; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Retrospective Studies; Treatment Outcome

To study the effect of intravenous administration of the iron-containing medicine Venofer to pregnant women and young mothers with anaemic syndrome.. A 2-year prospective study was conducted to 50 pregnant women and young mothers, which were treated for iron deficiency anemia in First Obstetrical Clinic of University Hospital - Pleven. There were 27 pregnant women (gestational age 24-39 g. w.) and 23 young mothers. A treatment with Venofer was conducted following 5 ampules regimen of administration--1st day 3 amps and 2d day--2 amps. Venofer is a stabile iron-sucrose complex designed for intravenous application. It is a structural analogue of feritine. Control studies of haemoglobin (Hb) and erythrocytes (Er) were made on 6-7 day after the therapy.. The pregnant women had average starting Hb-data of 90.74 g/l and after the therapy--106.19 g/l. The increase was of 15.74 g/l. Young mothers had Hb-data before the therapy 88.04 g/l and after the therapy 104.5 g/l. The mean increase of Hb was of 16.46 g/l. Undesired side reactions were observed only in one pregnant woman and that necessitated the stop of therapy. Intravenous administration of iron contributed to the good, normal course of pregnancy and fetal growth, and the effect to young mothers consisted of quick and certain recovery of their general state without accomplishing haemotransfusion.. Therapy with iron-containing medicine gives a good opportunity to avoid the risk of haemotransfusional infections, incopatible haemotransfusions and immunocompromizing effect of allogene haemotransfusion. It is also economically more beneficial.

Topics: Anemia, Iron-Deficiency; Blood Transfusion; Drug Administration Schedule; Erythrocyte Count; Female; Ferric Compounds; Ferric Oxide, Saccharated; Gestational Age; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Prospective Studies; Sucrose

Optimal response to recombinant human erythropoietin (rHuEpo) in haemodialysis (HD) patients requires provision of sufficient available iron. However, a balance between iron requirements and supplements remains a challenge in clinical practice. Reticulocyte parameters, i.e. reticulocyte haemoglobin content (CHr) and reticulocytes in a high-fluorescence intensity region (HFR), have been shown to be accurate predictors of iron-deficient erythropoiesis as compared with traditional markers. Therefore, the aim of this study was to appraise the diagnostic power of these two parameters in the early prediction of response to intravenous iron (IVFE) medications in HD patients receiving rHuEpo.. Sixty-five HD patients with a serum ferritin level of <500 microg/l and on rHuEpo therapy for >6 months were enrolled for IVFE supplementation (100 mg iron saccharate three times a week for 4 weeks, then 100 mg every 2 weeks for 5 months). Haemoglobin, haematocrit, serum ferritin, transferrin saturation, reticulocyte count, percentage of hypochromic red cells, CHr and HFR were measured before and following iron supplementation. Response was defined as a rise in haematocrit of >3% and/or a reduction in rHuEpo dose of >30% over the baseline values at the end of the study.. Forty-two patients had a dramatic response to IVFE therapy with a 13.5% increase in mean haematocrit and a 38% reduction in rHuEpo dose at the end of the study (P<0.001). This paralleled a statistically significant rise in CHr and HFR (P<0.001). Univariate analyses showed that ferritin (P<0.010) and CHr (P<0.001) at baseline, changes in CHr (DeltaCHr(2W), P<0.001) and HFR (DeltaHFR(2W), P<0.010) at 2 weeks, as well as changes in CHr (DeltaCHr(4W), P<0.001) and HFR (DeltaHFR(4W), P<0.001) at 4 weeks, strongly correlated with response to IVFE supplementation. Stepwise discriminant analysis disclosed that DeltaCHr(4W) in conjunction with DeltaHFR(4W) exhibited an r(2) value of 0.531 (P<0.001) to predict response to IVFE therapy. Analyses by receiver operating characteristic curves and logistic regression further revealed that DeltaCHr(4W) at a cut-off value of >1.2 pg and DeltaHFR(4W) of >500/microl were more specific to the status of iron-deficient erythropoiesis following IVFE medications. Combined use of the two cut-off values allowed for the highest accuracy in the early prediction of the response to IVFE therapy, with a sensitivity of 96% and a specificity of 100%.. Our study shows that changes in CHr and HFR at either 2 or 4 weeks are superior to the conventional erythrocyte and iron metabolism indices and may serve as reliable parameters to detect iron-deficient erythropoiesis in HD patients undergoing rHuEpo therapy. During aggressive IVFE treatment, early identification of non-responsiveness and subsequent discontinuation of treatment can avoid the inadvertent iron-related toxicity due to over-treatment.

Topics: Anemia, Iron-Deficiency; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Fluorescence; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Male; Middle Aged; Predictive Value of Tests; Prognosis; Prospective Studies; Recombinant Proteins; Renal Dialysis; Reticulocyte Count; Reticulocytes

To study iron metabolism in patients on programmed hemodialysis (PH) in oral and intravenous administration of iron drugs; to compare clinical and financial results of using such drugs.. A two-stage trial studied iron metabolism in 158 PH patients on replacement therapy with erythropoetin. They received correction of iron deficiency with oral drugs (stage I) and venofer (stage II).. The study of iron metabolism has found its deficiency in 2/3 patients receiving oral iron: absolute (48%) and relative (20%). Administration of venofer led to a 2-fold increase in the number of patients with normal iron metabolism. The target Hb and Ht were achieved in 2.5 times more patients than before venofer treatment. The dose of erythpoetin in such cases was reduced by 40%. Side effects were not observed. The week cost of venofer treatment per patient was lower by 22.5$ than the cost of treatment with oral iron drugs.. Venofer correction of iron deficiency in PH patients is more effective both clinically and financially than use of oral iron preparations.

Topics: Administration, Oral; Adolescent; Adult; Aged; Anemia, Iron-Deficiency; Drug Costs; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Kidney Diseases; Male; Middle Aged; Renal Dialysis; Sucrose; Treatment Outcome

Optimizing i.v. iron management is essential to the overall health of hemodialysis patients. Establishing an i.v. iron protocol, administering a safe and effective i.v. iron supplement, and developing a strong nurse/patient relationship are all indispensable to an effective and efficient hemodialysis program.

Topics: Aged; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Infusions, Intravenous; Iron; Nurse-Patient Relations; Time Factors; Treatment Outcome

Identical National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) hematologic and iron targets apply to chronic kidney disease (CKD), peritoneal dialysis (PD), and hemodialysis (HD) patients, yet intravenous (i.v.) nondextran iron therapy is FDA approved only in HD patients. This is because oral iron has been considered adequate in CKD and PD patients, and delivering a parenteral therapy on a frequent basis to an outpatient population with notoriously poor vascular access presents logistical complexities. However, recognition of the need for more aggressive treatment of anemia in the CKD and PD population is growing. This awareness, along with the improved safety profiles of the new, nondextran irons, is tipping the risk-benefit ratio toward more widespread use of i.v. iron in these patients. This article provides a summary of the literature and of our own experience using i.v. iron therapy in CKD and PD patients. Our protocol relies on early monitoring and intervention with i.v. ferric gluconate before severe iron deficiency develops. The proactive approach allows for relatively infrequent treatments at only moderately "high" doses (250 mg) of ferric gluconate. The convergence of convenience and safety may expedite more energetic anemia prevention and treatment in PD and CKD patients.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Iron; Iron-Dextran Complex; Kidney Failure, Chronic; Peritoneal Dialysis

The aim of this study was to evaluate the safety and efficacy of intravenous iron saccharate administration in iron-deficient anemic children, under long-term parenteral nutrition, who are unable to tolerate oral iron supplementation or are unresponsive to oral supplementation because of gastrointestinal dysfunction or iron malabsorption.. Twenty-two infants and children aged 5 months-17 years (median: 38 months) receiving long-term parenteral nutrition and presenting with iron deficiency anemia were included. Total iron to be infused was determined by the formula: total iron (mg) = 0.6 x W (100 - Hb x 100/12) (W: weight, Hb: hemoglobin). Intravenous iron saccharate was given at the hospital. Each patient received a test dose of 25 mg of iron saccharate prior to the initiation of the infusion. Hemoglobin values, reticulocytes count, serum iron, and serum ferritin were determined before iron administration (day 1), as well as 15 and 45 days after iron administration.. Tolerance of intravenous iron saccharate was good except in one patient who developed transient exanthema and hypotension after completion of the last iron saccharate infusion. Intravenous iron led to a significative increase in hemoglobin concentration of 2.2 g/dl within 45 days (range: 0.4-4.3 g/dl).. Intravenous iron supplementation with iron saccharate is an efficient procedure, replenishing iron body stores and significantly increasing the hemoglobin concentration. The possible occurrence of allergic reactions emphasizes the need for close medical supervision.

Topics: Adolescent; Anemia, Iron-Deficiency; Child; Child, Preschool; Erythrocyte Indices; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Infant; Infusions, Intravenous; Iron; Parenteral Nutrition; Reticulocyte Count; Time Factors

(1) To determine an alternative iron supplementation with better efficacy, compliance & safety in treatment of iron deficiency anemia during pregnancy, (2) to reduce blood transfusion during pregnancy, labor and puerperium.. A prospective comparative study. A total number of 60 pregnant women with the gestational age of 12-34 weeks were included in the study who were suffering from iron deficiency anemia. They were divided in 3 groups (A, B and C). Group A (n = 15) received intravenous iron sucrose according to recommended dose containing 500 mg of iron sucrose for storage, in group B (n = 20) iron sucrose was administered according to deficit calculated as per formula but 200 mg of iron was given for storage instead of 500 mg, to reduce cost. While group C received intra muscular iron Sorbitol in the dose used as practice.. Mean hemoglobin in group A and B was 8.0 +/- 1.1 g/dl and 8.9 +/- 0.7 respectively, in group C, it was 8.8 +/- 0.9 g/dl. In group A & B initial hemoglobin was assessed 3 weeks post therapy which showed an average rise of 2.8 g/dl (group A) and 1.9 g/dl (group B) and second assessment of Hemoglobin was done prior to delivery (ave: 6.6 weeks) showed a total rise of 3.8 g/dl (group A) and 2.4 g/dl (group B). Pre delivery mean Hemoglobin in group A and B was 11.8 g/dl and 11.3 g/dl respectively. In group C, the Hemoglobin was assessed only prior to delivery (average: 8.4 weeks from the start of therapy), and a rise of 1.4 g/dl was observed with pre delivery mean Hemoglobin of 10.2 g/dl. Target hemoglobin levels i.e. 11 g/dl was achieved by 80% in Group A, 70% in Group B and 28% in Group C by the time of delivery. Blood transfusion was not required in any group. In group A and B one patient had moderate abdominal pain, 2 had weakness and shivering and 3 had phlebitis at the site where intravenous canula was retained. None of patient discontinued the therapy due to any adverse effect. In group C majority complained of pain at injection site while 5 patients dropped out from the study due to intolerance.. Intravenous iron therapy is safe, convenient and more effective then intramuscular iron therapy in treatment of iron deficiency anemia during pregnancy. The intravenous iron therapy can replace blood transfusion in antenatal period.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Gestational Age; Glucaric Acid; Hemoglobins; Humans; Injections, Intramuscular; Injections, Intravenous; Pregnancy; Pregnancy Complications; Prospective Studies; Treatment Outcome

An autologous blood donation with cryopreservation in a pregnant woman with natural antibody against a high frequency alloantigen is reported. A natural anti Gerbich antibody and a rare erythrocyte phenotype at high risk of polyimmunization was discovered during the third month of pregnancy. This leads to recommend the constitution of an autologous blood reserve. Before first sampling a moderate iron deficiency anaemia (10.3 g.dL-1) was treated with 600 mg of intravenous iron sucrose. Four blood packs of 350 mL were taken; after every sampling 200 mg of iron sucrose were injected intravenously. No maternal or foetal adverse effects occurred. Five weeks before delivery, an autologous blood reserve consisting in 4 cryopreserved red cells packs and 4 fresh frozen plasma was constituted. Epidural analgesia was used for delivery. No haemorrhage occurred. The reserve was not used and remained available for future use (one year for fresh frozen plasma and without limit for red cells).

Topics: Adult; Anemia, Iron-Deficiency; Autoantibodies; Blood Preservation; Blood Transfusion, Autologous; Cryopreservation; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infant, Newborn; Injections, Intravenous; Iron; Pregnancy; Pregnancy Complications, Hematologic

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Iron

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Injections, Intravenous; Renal Dialysis; Sucrose; Terminology as Topic

Topics: Anemia, Iron-Deficiency; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Iron; Iron Overload; Kidney Failure, Chronic; Male; Middle Aged; Recombinant Proteins; Renal Dialysis

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Inflammatory Bowel Diseases; Infusions, Intravenous; Pregnancy; Pregnancy Complications; Pregnancy Complications, Hematologic; Pregnancy Outcome

Topics: Anemia, Iron-Deficiency; Child; Epidermolysis Bullosa Dystrophica; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Male; Recombinant Proteins; Sucrose

Anaemia caused by iron deficiency and dental caries are still among the most prevalent diseases in some developing countries. Anaemia can be prevented by iron fortification of food. Previous studies demonstrated that iron-sucrose, which has been used for prevention of anaemia, reduces the incidence of caries in rats. The aim of the present study was to compare the influence of ferrous sulphate and ferric glycerophosphate co-crystallized with sucrose on the incidence of dental caries in rats. Forty-eight desalivated rats were caged in a programmed feeder and received their essential nutrition by gavage. The animals were fed 17 meals per day at hourly intervals of 88 parts/10(6) Fe++ or Fe co-crystallized with sucrose. Plain sucrose and calcium glycerophosphate with sucrose were used as control groups. Both ferric- and ferrous-sucrose meals reduced the incidence of smooth-surface and sulcal caries in rats. Stain formation, organic acid production and acidogenic activity of dental plaque in animals receiving iron-sucrose meals were also investigated. Ferric glycerophosphate did not induce extrinsic staining on the tooth surface. The concentration of organic acids did not differ significantly among the groups. The acidogenic activity of plaque in animals receiving either of the iron-sucrose meals tended to be lower than that of the control groups. The possibility that iron-sucrose might reduce the prevalence of two major public health problems, dental caries and anaemia, makes this preventive approach extremely attractive for additional investigation.

Topics: Acids; Anemia, Iron-Deficiency; Animals; Crystallization; Dental Caries; Dental Plaque; Diet, Cariogenic; Dietary Sucrose; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Glycerophosphates; Hydrogen-Ion Concentration; Incidence; Prevalence; Rats; Rats, Sprague-Dawley; Reactive Oxygen Species; Salivary Glands; Tooth Discoloration

Topics: Administration, Oral; Anemia, Iron-Deficiency; Dose-Response Relationship, Drug; Drug Administration Schedule; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Iron-Dextran Complex

Iron deficiency may develop in hemodialysis patients, especially when erythropoietin is given. The role of iron deficiency in the anemia of predialysis chronic renal failure (CRF), however, is much less clear. We have intravenously (IV) administered iron as ferric saccharate in a total dose of 200 mg elemental iron monthly for 5 months to 33 CRF patients who remained anemic despite oral iron supplementation and who had no laboratory signs of iron overload. None was receiving erythropoietin therapy. In 22 of the patients there was an increase in the hematocrit values by the end of the study. These patients were considered responders to intravenous iron (IV Fe) therapy. In 11 patients the iron administration was not associated with improvement of the anemia (nonresponders). Before onset of the IV Fe therapy there were no differences between the responders and nonresponders with regard to degree of anemia, serum ferritin, iron saturation, renal function, or blood pressure. One additional patient was excluded from the study because of a mild reaction during an IV test dose before the study. No worsening of kidney function and no other side effects were noted. In four patients (three responders and one nonresponder) the control of blood pressure necessitated antihypertensive drug therapy adjustment. In conclusion, IV Fe supplementation in two thirds of anemic CRF patients not receiving dialysis resulted in a significant improvement of the anemia, thus avoiding the necessity of erythropoietin or blood administration. This could be achieved by increasing the plasma ferritin levels to 200 to 400 microns/L and/or increasing the iron saturation to 25% to 35%. Intravenous ferric saccharate appears to be a safe and effective method of administering iron for the correction of anemia in CRF patients not receiving dialysis.

Topics: Administration, Oral; Adult; Aged; Anemia; Anemia, Iron-Deficiency; Delayed-Action Preparations; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Follow-Up Studies; Glucaric Acid; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Time Factors

Topics: Anemia, Iron-Deficiency; Animals; Dextrans; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Intracellular Membranes; Kupffer Cells; Lysosomes; Microscopy, Electron; Rabbits

Topics: Anemia; Anemia, Hypochromic; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Iron; North Carolina

Study was made of groups of pregnant patients who were given various hematinic agents from the seventh month of gestation to term.Dilute hydrochloric acid given with meals in usual doses produced no appreciable increase in the hemoglobin concentration, erythrocyte count or packed cell volume. Iron therapy in the form of orally administered ferrous sulfate, or orally administered ferrous sulfatemolybdenum oxide, or as intravenously administered saccharated iron oxide had a beneficial effect on these three factors in the blood.

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Hematocrit; Hemoglobins; Humans; Iron; Pregnancy; Pregnancy Complications

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Iron; Iron Compounds

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Iron; Iron Compounds; Pregnancy

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron

Topics: Anemia; Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gynecology; Humans; Iron

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gynecology; Humans; Iron; Obstetrics; Pregnancy