ferric-oxide--saccharated and Anemia

Iron supplementation and erythropoiesis-stimulating agent (ESA) administration represent the hallmark therapies in preoperative anemia treatment, as reflected in a set of evidence-based treatment recommendations made during the 2018 International Consensus Conference on Patient Blood Management. However, little is known about the safety of these therapies. This systematic review investigated the occurrence of adverse events (AEs) during or after treatment with iron and/or ESAs.. Five databases (The Cochrane Library, MEDLINE, Embase, Transfusion Evidence Library, Web of Science) and two trial registries (ClinicalTrials.gov, WHO ICTRP) were searched until 23 May 2022. Randomized controlled trials (RCTs), cohort, and case-control studies investigating any AE during or after iron and/or ESA administration in adult elective surgery patients with preoperative anemia were eligible for inclusion and judged using the Cochrane Risk of Bias tools. The GRADE approach was used to assess the overall certainty of evidence.. Data from 26 RCTs and 16 cohort studies involving a total of 6062 patients were extracted, on 6 treatment comparisons: (1) intravenous (IV) versus oral iron, (2) IV iron versus usual care/no iron, (3) IV ferric carboxymaltose versus IV iron sucrose, (4) ESA+iron versus control (placebo and/or iron, no treatment), (5) ESA+IV iron versus ESA+oral iron, and (6) ESA+IV iron versus ESA+IV iron (different ESA dosing regimens). Most AE data concerned mortality/survival (n=24 studies), thromboembolic (n=22), infectious (n=20), cardiovascular (n=19) and gastrointestinal (n=14) AEs. Very low certainty evidence was assigned to all but one outcome category. This uncertainty results from both the low quantity and quality of AE data due to the high risk of bias caused by limitations in the study design, data collection, and reporting.. It remains unclear if ESA and/or iron therapy is associated with AEs in preoperatively anemic elective surgery patients. Future trial investigators should pay more attention to the systematic collection, measurement, documentation, and reporting of AE data.

Topics: Adult; Anemia; Elective Surgical Procedures; Erythropoiesis; Ferric Oxide, Saccharated; Hematinics; Humans

A study was conducted to determine whether iron-based phosphate binders (IBPBs) need to be preferred for hyperphosphatemia and anemia management in patients on dialysis.. For this meta-analysis, we searched PubMed, Embase, and Cochrane Central Register of Controlled Trials for randomized controlled trials that evaluated the efficacy and safety of IBPBs in decreasing phosphate and correcting anemia in dialysis patients.. Nineteen trials comprising 4719 participants were included. Compared with placebo, serum phosphate decreased significantly after treatment with ferric citrate (FC), fermagate (one study), and SBR759 (one study). Hemoglobin increased significantly after treatment with FC and sucroferric oxyhydroxide (PA21). In addition, FC and PA21 reduced serum intact parathyroid hormone (iPTH) and increased ferritin and transferrin saturation, but SBR759 did not. Compared with active treatment, the non-inferiority of IBPBs in reducing serum phosphate and iPTH was demonstrated. FC significantly improved serum hemoglobin and iron-related parameters and decreased the use of intravenous iron and erythropoiesis-stimulating agent, whereas PA21 did not increase serum hemoglobin level. The incidences of infection and hospitalization were similar between the two groups, with FC having a higher risk of diarrhea than the placebo and active treatments.. FC was associated with the control of hyperphosphatemia and the improvement of anemia. However, PA21 did not show superiority for alleviating anemia compared with the active treatment. Other IBPBs, such as fermagate and SBR759, remained poorly understood due to the limited number of studies. Further trials are required to assess the effect of IBPBs on the risk of cardiovascular events and all-cause mortality.

Topics: Anemia; Carbonates; Drug Combinations; Ferric Compounds; Humans; Hyperphosphatemia; Iron; Magnesium; Randomized Controlled Trials as Topic; Renal Dialysis; Starch; Sucrose; Treatment Outcome

Anemia during pregnancy remains an important public health problem in developing countries like India. Anemia is the direct cause of 12-15% of maternal deaths. Iron deficiency is the commonest cause for anemia in the Indian subcontinent. Several preventive and therapeutic approaches are in practice. The available routes of iron supplementation are oral and intravenous. In spite of oral iron being least invasive, cheap and safe, the ineffectiveness of oral iron due to dietary inhibitors and poor compliance are well known. Intravenous iron sucrose can be a promising therapy for moderate to severely anemic pregnant women and has been in practice for quite some time in private and public health practices. In this article, we report the current evidence on the safety and efficacy of intravenous iron sucrose in anemic pregnant women on hematological and clinical outcomes. Though the evidence on its efficacy in improving hemoglobin and serum ferritin is convincing, its effect on maternal and fetal outcomes are unclear. This is primarily due to lack of well-designed and larger studies powered to detect difference in clinical outcomes. Hence, there is a need to gather evidence from a well-designed large randomized clinical trial conducted in a developing country. The results of such a study would feed into the national policy and would form the basis to frame guidelines for management of anemia in developing countries.

Topics: Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Treatment Outcome

Intravenous iron (IV Fe) as an adjunct to therapy with erythropoiesis- stimulatory agents (ESAs) is standard care in dialysis-associated anemia, adding huge increments in hemoglobin and hematopoietic responses and decreased transfusions without significant toxicity. Cost savings, decreased exposure to ESAs, and decreased times to reach target hemoglobins are realized. Although similar benefits have been seen in all studies performed in patients with chemotherapy-induced anemia (CIA), experts are reluctant to incorporate routine use of IV Fe into treatment, largely because of misinterpretation and misunderstanding of the clinical nature of adverse events reportedly associated with its administration. IV Fe is therefore underused in oncology patients with anemia. Published experience with more than 1000 patients in clinical trials involving the use of IV Fe suggests minimal toxicity and substantial benefit are experienced when high molecular weight iron dextran is avoided. This article presents evidence recommending routine incorporation of IV Fe into treatment for CIA.

Topics: Anemia; Antineoplastic Agents; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Injections, Intravenous; Iron-Dextran Complex; Neoplasms

In addition to more restrictive "transfusion triggers", presently available allogeneic blood conservation strategies in surgery include preoperative increase in red blood cells (RBC) mass, techniques or pharmaceutical agents that reduce blood loss, and perioperative blood salvage. Because of very important risk reduction in allogeneic blood, benefit/risk of preautologous blood donation (PAD) is quite questionable at this moment. Indeed, at this moment in France, we focus to avoid any transfusion (allogeneic and autologous blood). Therefore the most important techniques used are pharmacological: erythropoietin before surgery with a number of injections related to baseline Hb, and tranexamic acid during and after surgery. Cell saving is used only if bleeding is enough important like arthroplasty revisions. All blood conservation techniques carry their own efficiency limits, constraints and risks that, in addition to institutional considerations and individual patient characteristics are determinant to settle a blood conservation strategy. The choice of a technique should take into account (a) the delay before surgery, (b) the anticipated blood loss for the procedure that varies among institutions, (c) the tolerable blood loss without transfusion for the patient, and (d) the efficacy of the blood conservation technique in the given setting. Nevertheless, at this moment in France, it is quite important to notice that the risk of delay or lack of transfusion induces much more deaths that the transfusion itself during or after anesthesia [Anesthesiology 105, 1087-97].

Topics: Anemia; Aprotinin; Blood Loss, Surgical; Blood Transfusion; Blood Transfusion, Autologous; Drug Administration Schedule; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemodilution; Humans; Intraoperative Complications; Orthopedic Procedures; Postoperative Hemorrhage; Preoperative Care; Recombinant Proteins; Sucrose; Time Factors; Tranexamic Acid; Transfusion Reaction

In the majority of patients with chronic renal failure, it is essential to substitute erythropoietic agents and iron to maintain a haemoglobin level above 11 g dL-1. Intravenous iron is more effective than oral iron. Substitution of intravenous iron is mainly performed using iron(III)-hydroxide-sucrose complex (iron sucrose) and iron(III)-sodium-gluconate in sucrose (iron gluconate), and is, in general, well-tolerated. Nonetheless, intravenous iron therapy has effects on endothelial cells, polymorphonuclear leucocytes and cytokines which are most likely related to non-transferrin bound labile iron. These effects suggest a role of iron in infection or atherosclerosis. Yet, not all available data support the association of iron with infection and atherosclerosis. A recent trial showed that iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores. Nevertheless, iron therapy should be handled with caution but its use should not be feared whenever indicated.

Topics: Anemia; Cytokines; Endothelial Cells; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gluconates; Hematinics; Humans; Injections, Intravenous; Iron; Iron-Dextran Complex; Kidney Failure, Chronic; Neutrophils

In patients scheduled for major orthopedic surgery, the presence of anemia can preclude the donation of sufficient autologous blood (AB) to meet transfusion requirements. Although a number of studies have investigated the use of epoetin alfa (in conjunction with parenteral iron supplementation) to facilitate AB donation and reduce exposure to allogeneic blood in this patient population, the optimum treatment regimen and route of administration has yet to be defined. In rheumatoid arthritis (RA) patients with a low predonation hematocrit (Hct; < or = 39%), intravenous (i.v.) treatment with epoetin alfa 300 IU/kg twice weekly for 3 weeks was the optimum dosage for facilitation of AB donation and minimization of the decrease in Hct prior to elective orthopedic surgery. However, the subcutaneous (s.c.) route of epoetin alfa administration may allow lower dosages of epoetin alfa to be used. Indeed, epoetin alfa 100 IU/kg s.c. twice weekly for 3 weeks (in conjunction with a single i.v. bolus of 200 IU/ kg at the first s.c. dose) was as effective as 300 IU/kg i.v. administered according to the same schedule. The number of AB units collected, total red blood cell (RBC) volume donated, and peak proportion of reticulocytes were similar regardless of the route of administration. Both treatment groups were associated with a significant reduction in allogeneic blood exposure compared with historical controls. Findings consistent to all of these studies were that epoetin alfa was well tolerated, and that i.v. iron supplementation was necessary to maximize its beneficial effects.

Topics: Anemia; Arthritis, Rheumatoid; Blood Transfusion; Blood Transfusion, Autologous; Dose-Response Relationship, Drug; Double-Blind Method; Epoetin Alfa; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematocrit; Humans; Injections, Intravenous; Injections, Subcutaneous; Orthopedics; Premedication; Recombinant Proteins; Treatment Outcome

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

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

Our objective is to study the efficacy and safety of parenteral nutrition (PN) with iron sucrose to prevent anemia in preterm infants.. We performed a randomized, double-blind controlled trial in which preterm infants were divided into five groups randomly: a control group (PN without iron sucrose, namely group Iron-0), and intervention groups (PN with iron sucrose 100 μg/kg/d, 200 μg/kg/d, 300 μg/kg/d and 400 μg/kg/d, namely group Iron-1, 2, 3, and 4, respectively). The indicators were red blood cell (RBC) parameters, iron storage and oxidant stress.. One hundred infants completed this study. Excepting the RBC count in Iron-2, the value of erythrocyte parameters in intervention groups decreased less than that in the control group. And the decrease of RBC count in Iron-1 (-0.6×1012/L vs -0.9×1012/L, p=0.033), hemoglobin in Iron-4 (-26.0 g/L vs -41.0 g/L, p=0.03) and hematocrit in Iron-1(-9.5% vs -14.0%, p=0.014) was significantly less than in the control group. The change of ferritin in Iron-4 was significantly higher than in the control group (280 ng/ml vs 118 ng/ml, p=0.04). There was no difference in serum iron in intervention groups when compared to the control group (p>0.05). Except for the change of malondialdehyde (MDA) in Iron-1, the increase in other intervention groups was higher than in the control group (p>0.05).. PN with iron sucrose for prevention of anemia in preterm infants is safe and efficacious to some extent.

Topics: Anemia; Ferric Oxide, Saccharated; Humans; Infant; Infant, Newborn; Infant, Premature; Iron; Parenteral Nutrition

Anaemia in pregnancy is a public health concern because it is strongly associated with maternal and perinatal morbidity and mortality. An open label randomized controlled trial (RCT) was conducted in India across four government medical colleges, comparing intravenous (IV) iron sucrose and oral iron for the treatment of anaemia in pregnancy. This RCT failed to demonstrate superiority of IV iron sucrose compared with oral iron therapy in reducing adverse clinical (maternal and foetal/neonatal) outcomes in moderate-to-severe anaemia in pregnancy. However, IV iron sucrose seemed to reduce the need for blood transfusion among women with severe anaemia. The study objective was to conduct a cost-effectiveness analysis of IV iron sucrose over oral therapy for treatment of severe anaemia in pregnancy, alongside the RCT, to inform policy. The outcome of interest in our study was a 'safe delivery' defined by the absence of composite maternal and foetal/neonatal adverse clinical outcomes. Incremental cost-effectiveness ratio (ICER) was calculated from a limited societal perspective. IV iron sucrose was found to be more costly but more effective than the oral therapy for treatment of severe anaemia. The ICER was calculated at INR 31 951 (USD 445.2) per safe delivery. We considered a threshold of half the gross national income for decision-making. Considering this threshold of India (INR 57 230, USD 797.4), IV iron-sucrose remained cost-effective in 67% of the iterations in the model. At the current ICER, for every 32 severely anaemic pregnant woman treated with IV iron sucrose one additional pregnant woman will have a safe delivery. Such analyses can complement the national strategy to support evidence-based action.

Topics: Anemia; Cost-Benefit Analysis; Female; Ferric Oxide, Saccharated; Humans; India; Infant, Newborn; Iron; Pregnancy

Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited.. In a multicenter, open-label trial with blinded end-point evaluation, we randomly assigned adults undergoing maintenance hemodialysis to receive either high-dose iron sucrose, administered intravenously in a proactive fashion (400 mg monthly, unless the ferritin concentration was >700 μg per liter or the transferrin saturation was ≥40%), or low-dose iron sucrose, administered intravenously in a reactive fashion (0 to 400 mg monthly, with a ferritin concentration of <200 μg per liter or a transferrin saturation of <20% being a trigger for iron administration). The primary end point was the composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death, assessed in a time-to-first-event analysis. These end points were also analyzed as recurrent events. Other secondary end points included death, infection rate, and dose of an erythropoiesis-stimulating agent. Noninferiority of the high-dose group to the low-dose group would be established if the upper boundary of the 95% confidence interval for the hazard ratio for the primary end point did not cross 1.25.. A total of 2141 patients underwent randomization (1093 patients to the high-dose group and 1048 to the low-dose group). The median follow-up was 2.1 years. Patients in the high-dose group received a median monthly iron dose of 264 mg (interquartile range [25th to 75th percentile], 200 to 336), as compared with 145 mg (interquartile range, 100 to 190) in the low-dose group. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 IU in the high-dose group and 38,805 IU in the low-dose group (median difference, -7539 IU; 95% confidence interval [CI], -9485 to -5582). A total of 320 patients (29.3%) in the high-dose group had a primary end-point event, as compared with 338 (32.3%) in the low-dose group (hazard ratio, 0.85; 95% CI, 0.73 to 1.00; P<0.001 for noninferiority; P=0.04 for superiority). In an analysis that used a recurrent-events approach, there were 429 events in the high-dose group and 507 in the low-dose group (rate ratio, 0.77; 95% CI, 0.66 to 0.92). The infection rate was the same in the two groups.. Among patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was superior to a low-dose regimen administered reactively and resulted in lower doses of erythropoiesis-stimulating agent being administered. (Funded by Kidney Research UK; PIVOTAL EudraCT number, 2013-002267-25 .).

Topics: Administration, Intravenous; Adult; Aged; Anemia; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Ferric Oxide, Saccharated; Ferritins; Follow-Up Studies; Hematinics; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Renal Dialysis; Single-Blind Method; Transferrin

Patients with colorectal cancer (CRC) often present with associated anaemia which is usually present at the time of diagnosis and is aggravated during the postoperative period due to blood loss during the surgery process. Several guidelines advocate for the treatment of postoperative anaemia in these patients in order to prevent complications and allogeneic blood transfusions. However, there are no publications to shed light on the effectiveness of intravenous iron (IVI) administration after CRC surgery and the optimal dose and regimen. We have started a clinical trial with the objective of comparing the effectiveness of 1000 mg of ferric carboxymaltose with fractionated iron sucrose 200 g/48 h for the treatment of postoperative anaemia, by measuring the change of haemoglobin (Hb) levels from postoperative day (POD) 1 to POD 30.. We designed an open label randomised controlled trial to compare two postoperative IVI treatment regimens. Patients aged > 18 years undergoing CRC surgery, with Hb < 11 g/dL on POD 1 are randomly assigned to receive either 1000 mg of ferric carboxymaltose (single dose) or 200 g/48 h of iron sucrose. The main study endpoint will be the change from POD 1 to POD 30 in Hb levels and the key secondary endpoint the percentage of patients with Hb levels ≥ 13 g/dL at POD 30. Other secondary endpoints include: changes in iron metabolism parameters (Fe, ferritin, transferrin, % saturated trasferrin) at POD 30; total doses of iron received; number of postoperative transfusions; compliance with oral iron treatment; number of medical and surgical complications; adverse reactions reported by the patient; use of health resources after surgery; and changes in quality of life (QoL). It has been estimated that a sample of 48 patients per group will allow detecting a difference of 0.75 g/dL in Hb in the change in Hb levels from POD 1 to POD 30.. The results of this study will confirm if the single dose of 1000 mg ferric carboxymaltose should be preferred in front of the fractionated doses and in which type of patients this regimen should be used preferably.. European Union Clinical Trials Register, EudraCT 2015-001005-13 . Registered on 6 January 2015.

Topics: Anemia; Colorectal Neoplasms; Ferric Compounds; Ferric Oxide, Saccharated; Humans; Infusions, Intravenous; Maltose; Postoperative Complications; Randomized Controlled Trials as Topic

We assessed the efficacy of a screening protocol for postpartum anaemia diagnosis and treatment in the maternity ward. A prospective non-randomized before-and-after anaemia screening protocol implementation study during two consecutive periods was conducted. Women who were scheduled for vaginal birth were tested for haemoglobin (Hb) before delivery. During the first period (June 29-October 10, 2015; N = 803) Hb was measured postpartum for women with anaemia-related symptoms, postpartum haemorrhage, or pre-delivery severe anaemia (Hb < 8 g/dL; "symptoms" group). During the second period (October 11, 2015-January 27, 2016; N = 755) Hb was also measured in all women with pre-delivery anaemia [i.e., Hb < 10.5 g/dL] ("screening" group). The primary outcomes were the rates of women with (1) postpartum anaemia diagnosis (Hb < 10 g/dL) and (2) administration of parenteral iron sucrose (indicated for postpartum Hb ≤ 9.5 g/dL). The detection rate of postpartum anaemia was higher in the screening group compared with the symptoms group (140 (19%) versus 100 (12%), OR

Topics: Adult; Anemia; Female; Ferric Oxide, Saccharated; Hematinics; Humans; Mass Screening; Patient Care; Postpartum Period; Prospective Studies

anaemia following hip fracture is common and associated with worse outcomes. Intravenous iron is a potential non-transfusion treatment for this anaemia and has been found to reduce transfusion rates in previous observational studies. There is good evidence for its use in elective surgical populations.. to examine the impact of intravenous iron on erythropoiesis following hip fracture.. two-centre, assessor-blinded, randomised, controlled trial of patients with primary hip fracture and no contra-indications to intravenous iron.. the intervention group received three doses of 200 mg iron sucrose over 30 min (Venofer, Vifor Pharma, Bagshot Park, UK) on three separate days. Primary outcome was reticulocyte count at day 7 after randomisation. Secondary outcomes included haemoglobin concentration, complications and discharge destination. Eighty participants were randomised.. there was a statistically significantly greater absolute final reticulocyte count in the iron group (89.4 (78.9-101.3) × 109 cells l-1 (n = 39) vs. the control (72.2 (63.9-86.4)) × 109 cells l-1 (n = 41); P = 0.019; (mean (95% confidence intervals) of log-transformed data). There were no differences in final haemoglobin concentration (99.9 (95.7-104.2) vs. 102.0 (98.7-105.3) P = 0.454) or transfusion requirements in the first week (11 (28%) vs. 12 (29%); P = 0.899). Functional and safety outcomes were not different between the groups.. although intravenous iron does stimulate erythropoiesis following hip fracture in older people, the effect is too small and too late to affect transfusion rates. Trial Registry Numbers: ISRCTN:76424792; EuDRACT: 2011-003233-34.

Topics: Administration, Intravenous; Aged, 80 and over; Anemia; Dose-Response Relationship, Drug; Erythropoiesis; Female; Ferric Oxide, Saccharated; Fracture Fixation; Hematinics; Hemoglobins; Hip Fractures; Humans; Male; Single-Blind Method

Anaemia and iron deficiency are common after post-bariatric abdominoplasty, which can involve removal of large areas of skin with associated blood loss. Because the oral absorbability of iron is reduced after bariatric surgery (through reduced intake, reduction of gastric acid secretion for conjugation of iron, and separation of the iron-absorptive areas of the duodenum and jejunum), it has been hypothesised that postoperative intravenous iron supplementation might be used to treat anaemia and iron deficiency in patients submitted to post-bariatric plastic surgeries. We aimed to assess whether intravenous iron administered postoperatively in post-bariatric abdominoplasty could result in increased blood haemoglobin concentrations compared with oral iron supplementation.. From April 7, 2014, to June 27, 2016, 102 post-bariatric patients were assessed for eligibility. 56 patients were eligible and were randomly assigned, with 28 allocated to each group. Mean baseline haemoglobin concentration was slightly higher in the oral group than in the intravenous group (12·71 g/dL [SD 1·06] vs 12·24 g/L [1·09]), and by post-operative day 56 was 12·54 g/dL (SD 1·18) and 12·80 g/dL (0·81), respectively (mean difference of 0·26 g/dL, 95% CI -0·28 to 0·80; p=0·009 in favour of the intravenous group). The minimum clinically relevant difference in concentrations was not reached. No adverse events were recorded in the intravenous group, whereas in the oral group, constipation was recorded in five (18%) patients, diarrhoea in three (11%), and nausea in one (4%) patient.. Postoperative intravenous administration of iron increased haemoglobin concentrations at 56 days post-operatively and reduced iron deficiency, without adverse events. Although superiority of intravenous iron was not shown, intravenous administration might be useful in post-bariatric patients, especially in those who have body-contouring treatment involving a second surgery within a short period of time. Larger trials, and trials using higher intravenous doses of iron, are needed to further assess the potential efficacy and safety of intravenous iron administration after post-bariatric plastic surgery.. The São Paulo Research Foundation (FAPESP).

Topics: Abdominoplasty; Administration, Intravenous; Administration, Oral; Adult; Anemia; Bariatric Surgery; Biomarkers; Brazil; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron; Middle Aged; Risk Factors; Treatment Outcome; Young Adult

Anaemia and iron deficiency are common complications following post-bariatric abdominoplasty. Given the low oral absorbability of iron resulting from bariatric surgery, it has been hypothesised that postoperative intravenously administered iron supplementation could be used to treat anaemia and to prevent the development of iron deficiency in these patients.. In this multicentre open-label randomised clinical trial, 56 adult women undergoing post-bariatric anchor-line abdominoplasty will be allocated at a ratio of 1:1 for postoperative supplementation with two intravenously administered applications of 200 mg of iron saccharate or postoperative supplementation with 100 mg of iron polymaltose complex administered orally, twice a day for 8 weeks. The primary outcome is the difference in mean haemoglobin levels between the two groups at eight postoperative weeks. Secondary outcomes evaluated at one, four and eight postoperative weeks include iron profile, reticulocyte count, overall quality of life measured using the Short-Form 36 Health Survey (SF-36) questionnaire, fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), adverse effects and postoperative complications.. This randomised clinical trial aims to evaluate the haematopoietic effectiveness of intravenously administered iron supplementation in patients undergoing post-bariatric abdominoplasty. A more effective recovery of haemoglobin levels could help improve the patients' quality of life and could provide an improved haematological status in preparation for the subsequent and frequent plastic surgeries these patients undergo.. Clinicaltrials.gov Identifier: NCT01857011 (8 May 2013), Universal Trial Number U111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ .

Topics: Abdominoplasty; Administration, Intravenous; Administration, Oral; Adolescent; Adult; Anemia; Bariatric Surgery; Biomarkers; Brazil; Clinical Protocols; Drug Administration Schedule; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hematopoiesis; Hemoglobins; Humans; Middle Aged; Quality of Life; Research Design; Surveys and Questionnaires; Time Factors; Treatment Outcome; Young Adult

Topics: Anemia; Darbepoetin alfa; Drug Therapy, Combination; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Hematinics; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Humans; Injections, Intravenous; Sucrose; Survival Analysis; Transplantation, Autologous

To evaluate the efficacy of IV iron supplementation of anemic, critically ill trauma patients.. Multicenter, randomized, single-blind, placebo-controlled trial.. Four trauma ICUs.. Anemic (hemoglobin < 12 g/dL) trauma patients enrolled within 72 hours of ICU admission and with an expected ICU length of stay of more than or equal to 5 days.. Randomization to iron sucrose 100 mg IV or placebo thrice weekly for up to 2 weeks.. A total of 150 patients were enrolled. Baseline iron markers were consistent with functional iron deficiency: 134 patients (89.3%) were hypoferremic, 51 (34.0%) were hyperferritinemic, and 64 (42.7%) demonstrated iron-deficient erythropoiesis as evidenced by an elevated erythrocyte zinc protoporphyrin concentration. The median baseline transferrin saturation was 8% (range, 2-58%). In the subgroup of patients who received all six doses of study drug (n = 57), the serum ferritin concentration increased significantly for the iron as compared with placebo group on both day 7 (808.0 ng/mL vs 457.0 ng/mL, respectively, p < 0.01) and day 14 (1,046.0 ng/mL vs 551.5 ng/mL, respectively, p < 0.01). There was no significant difference between groups in transferrin saturation, erythrocyte zinc protoporphyrin concentration, hemoglobin concentration, or packed RBC transfusion requirement. There was no significant difference between groups in the risk of infection, length of stay, or mortality.. Iron supplementation increased the serum ferritin concentration significantly, but it had no discernible effect on transferrin saturation, iron-deficient erythropoiesis, hemoglobin concentration, or packed RBC transfusion requirement. Based on these data, routine IV iron supplementation of anemic, critically ill trauma patients cannot be recommended (NCT 01180894).

Topics: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anemia; APACHE; Critical Illness; Erythrocyte Transfusion; Erythropoiesis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Intensive Care Units; Male; Middle Aged; Protoporphyrins; Single-Blind Method; Transferrin; Trauma Centers; Young Adult

Anemia is common in older persons and is associated with substantial morbidity and mortality. One third of anemic older adults have unexplained anemia of the elderly (UAE). We carried out a randomized, wait list control trial in outpatients with UAE and serum ferritin levels between 20 and 200 ng/mL. Intravenous iron sucrose was given as a 200-mg weekly dose for 5 weeks either immediately after enrollment (immediate intervention group) or following a 12-week wait list period (wait list control group). The primary outcome measure was changed in 6-minute walk test (6MWT) distances from baseline to 12 weeks between the two groups. Hematologic, physical, cognitive, and quality of life parameters were also assessed. The study was terminated early after 19 subjects enrolled. The distance walked in the 6MWT increased a mean 8.05±55.48 m in the immediate intervention group and decreased a mean 11.45±49.46 m in the wait list control group (p=0.443). The hemoglobin increased a mean 0.39±0.46 g/dL in the immediate intervention group and declined a mean 0.39±0.85 g/dL in the wait list control group (p=0.026). Thus, a subgroup of adults with UAE may respond to intravenous iron. Enrollment of subjects into this type of study remains challenging.

Topics: Aged; Aged, 80 and over; Anemia; Cognition; Drug Administration Schedule; Exercise Test; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Injections, Intravenous; Male; Psychological Tests; Quality of Life; Walking

We conducted a randomized study analyzing the impact of darbepoetin alfa (DA) administration with or without intravenous (i.v.) iron on erythroid recovery after autologous hematopoietic cell transplantation (HCT). Patients were randomized between no DA (Arm 1), DA 300 μg every 2 weeks starting on Day 28 after HCT (Arm 2), or DA plus i.v. iron 200 mg on Days 28, 42, and 56 (Arm 3). The proportion achieving complete hemoglobin (Hb) response within 18 weeks (primary end point) was 21% in Arm 1 (n = 24), 79% in Arm 2 (n = 25), and 100% in Arm 3 (n = 23; P < 0.0001). Erythropoietic response was shown to be significantly higher in Arm 3 (n = 46) than in Arm 2 (n = 50; P = 0.008), resulting in lower DA use, reduced drug costs, and improved quality of life scores, but the effect on transfusions was not significant. In multivariate analysis, DA administration (P < 0.0001), i.v. iron administration (P = 0.0010), high baseline Hb (P < 0.0001), and low baseline creatinine (P = 0.0458) were independently associated with faster achievement of complete Hb response. In conclusion, DA is highly effective to ensure full erythroid reconstitution after autologous HCT when started on Day 28 post-transplant. I.v. iron sucrose further improves erythroid recovery.

Topics: Aged; Anemia; Blood Transfusion; Combined Modality Therapy; Darbepoetin alfa; Drug Therapy, Combination; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematopoietic Stem Cell Transplantation; Humans; Infusions, Intravenous; Injections, Subcutaneous; Lymphoma; Male; Middle Aged; Multiple Myeloma; Postoperative Complications; Quality of Life; Transferrin; Transplantation Conditioning; Transplantation, Autologous

Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population.. This is a single-centre randomized controlled parallel group trial, in a British university hospital.Randomization is achieved using a website and computer-generated concealed tables. Participants are 80 patients 70 years or over with acute hip fracture undergoing operative repair. The intervention group receive three daily infusions of 200 mg iron sucrose, starting within 24 hours of admission. The control group receive standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. The primary outcome is an increase in mean reticulocyte count in the intervention group at day 7. Secondary outcome measures include haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality.. This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron.. Current Controlled Trials ISRCTN76424792; UK Medicines and Healthcare products Regulatory Authority (EuDRACT: 2011-003233-34).

Topics: Aged; Anemia; Biomarkers; Clinical Protocols; Drug Administration Schedule; England; Erythrocyte Transfusion; Ferric Compounds; Ferric Oxide, Saccharated; Fracture Fixation; Glucaric Acid; Hematinics; Hemoglobins; Hip Fractures; Hospitals, University; Humans; Infusions, Intravenous; Pilot Projects; Postoperative Hemorrhage; Research Design; Reticulocyte Count; Time Factors; Treatment Outcome

To compare the efficacy of intravenous iron and oral iron for prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy.. Sixty-four non anemic gynecologic cancer patients receiving adjuvant platinum-based chemotherapy were stratified and randomized according to baseline hemoglobin levels and chemotherapy regimen. The study group received 200mg of intravenous iron sucrose immediately after each chemotherapy infusion. The control group received oral ferrous fumarate at a dose of 200mg three times a day. Complete blood count was monitored before each chemotherapy infusion. Blood transfusions were given if hemoglobin level was below 10mg/dl.. There were 32 patients in each group. No significant differences in baseline hemoglobin levels and baseline characteristics were demonstrated between both groups. Nine patients (28.1%) in the study group and 18 patients (56.3%) in the control group required blood transfusion through 6 cycles of chemotherapy (p=0.02). Fewer median number of total packed red cell units were required in the study group compared to the control group (0 and 0.5 unit, respectively, p=0.04). Serious adverse events and hypersensitivity reactions were not reported. However, constipation was significantly higher in the control group (3.1% and 40.6%, p=<0.001).. Intravenous iron is an effective, well-tolerated treatment for primary prevention of blood transfusions in gynecologic cancer patients receiving platinum-based chemotherapy, associated with less constipation than the oral formulation.

Topics: Anemia; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Genital Neoplasms, Female; Glucaric Acid; Hematinics; Hemoglobins; Humans; Middle Aged; Paclitaxel

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Blood Transfusion; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Male; Middle Aged; Postoperative Care

To investigate the effect of different intravenous iron treatment regimens on anemia and oxidative stress in maintenance hemodialysis (MHD) patients.. A total of 58 MHD patients were randomly divided into a multi-frequency low-dose intravenous iron group (iron sucrose 25 mg, twice a week for 8 weeks, n=19), a less-frequency regular-dose intravenous iron group (iron sucrose 100 mg, once every two weeks for 8 weeks, n=19), and a non-iron group (n=20). Another 20 healthy people served as a control group (n=20). The changes of hemoglobin (Hb), hematocrit (HCT), serum ferritin (SF) and transferrin saturation (TSAT), as well as the oxidative stress parameters of malon-dialdehyde (MDA), superoxide dismutase (SOD) and myeloperoxidase (MPO) were detected before and after the treatment.. After 8 weeks, compared with the non-iron group, the levels of Hb, HCT, SF and TSAT in the two iron groups were significantly elevated (P<0.01), but there was no difference between the two iron groups (P>0.05). After the single dialysis, the two iron groups had higher level of serum MDA, MPO and lower level of serum SOD than that of the non-iron supplementation group (P<0.01). The multi-frequency low-dose intravenous iron group had lower level of serum MDA [(5.37 ± 0.73) nmol/mL vs (6.37±1.67) nmol/mL], MPO [(81.41±7.60) U/L vs (96.75±16.97) U/L] and higher level of serum SOD [(84.77 ± 14.02) U/mL vs (68.23 ± 4.90) U/mL] than that of the less-frequency regular-dose intravenous iron group. After 8 weeks, there was no significant difference between the two iron groups (P>0.05).. Multi-frequency low-dose intravenous iron can effectively improve anemia in MHD patients, whose acute oxidative stress is lower than that of less-frequency regular-dose intravenous iron, and is a relatively safe and effective intravenous iron treatment regimen.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Oxidative Stress; Renal Dialysis; Sucrose; Young Adult

Most dialysis patients receiving erythropoesis-stimulating agents (ESA) also receive parenteral iron supplementation. There are few data on the risk of hemosiderosis in this setting.. We prospectively measured liver iron concentration by means of T1 and T2* contrast magnetic resonance imaging (MRI) without gadolinium, in a cohort of 119 fit hemodialysis patients receiving both parenteral iron and ESA, in keeping with current guidelines.. Mild to severe hepatic iron overload was observed in 100 patients (84%; confidence interval, [CI] 76%-90%), of whom 36% (CI, 27%-46%) had severe hepatic iron overload (liver iron concentration >201 μmol/g of dry weight). In the cross-sectional study, infused iron, hepcidin, and C-reactive protein values correlated with hepatic iron stores in both univariate analysis (P<.05, Spearman test) and binary logistic regression (P <.05). In 11 patients who were monitored closely during parenteral iron therapy, the iron dose infused per month correlated strongly with both the overall increase and the monthly increase in liver iron concentration (respectively, rho=0.66, P=.0306 and rho=0.85, P=0.0015, Spearman test). In the 33 patients with iron overload, iron stores fell significantly after iron withdrawal or after a major reduction in the iron dose (first MRI: 220 μmol/g (range: 60-340); last MRI: 50 μmol/g (range: 5-210); P <.0001, Wilcoxon's paired test).. Most hemodialysis patients receiving ESA and intravenous iron supplementation have hepatic iron overload on MRI. These findings call for a revision of guidelines on iron therapy in this setting, especially regarding the amount of iron infused and noninvasive methods for monitoring iron stores.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Biomarkers; Cross-Sectional Studies; Drug Therapy, Combination; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemosiderosis; Humans; Infusions, Intravenous; Iron; Kidney Failure, Chronic; Liver; Logistic Models; Longitudinal Studies; Magnetic Resonance Imaging; Male; Middle Aged; Prospective Studies; Renal Dialysis

The main objective of this study was to determine the efficacy of intravenous (IV) iron sucrose therapy reducing transfusion requirements in elderly patients undergoing hip fracture surgery.. This study was a prospective randomized controlled trial involving 200 patients undergoing hip fracture surgery. Group A (100 patients) received standard treatment, while Group B (100 patients) received iron sucrose (600 mg IV). The primary endpoint was the number of patients that were transfused postoperatively. The secondary endpoints were the rate of red blood cell units used, hematimetric variables of blood tests, mortality, infection rates, length of hospital stay, and appearance of side effects.. Differences in the percentage of patients requiring transfusion (Group A 41.3% vs. Group B 33.3%) and in the number of concentrates transfused (0.87±1.21 for Group A vs. 0.76±1.16 for Group B) were not significant for the patient group as a whole, but were significant for patients with intracapsular fractures (45.7% required transfusion in Group A vs. 14.3% in Group B; p<0.005) and in patients with a baseline hemoglobin (Hb) level of 12 g/dL or more (35.2% required transfusions in Group A vs. 19% in Group B; p<0.05).. Transfusion requirements in patients with intracapsular fracture or baseline Hb level of 12 g/dL or more appear to be reduced by IV iron sucrose therapy, but there was no difference in morbidity, mortality, or length of hospital stay. The treatment is safe and hastens recovery from blood loss.

Topics: Aged; Aged, 80 and over; Anemia; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hip Fractures; Humans; Infusions, Intraventricular; Male; Perioperative Period; Postoperative Complications

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

An optimal haemoglobin (Hb) response to erythropoietin requires elevated iron indices in dialysis patients; however, it is unknown if the same applies in chronic kidney disease (CKD).. One hundred patients [CKD Stages 3-5, Hb >or= 110 g/L, iron replete, erythropoietin-stimulating agent (ESA)-naive, 47% diabetic, median age 69.5 years] were block-randomized in an open-label study to receive up to 200 mg intravenous iron sucrose (Group A, n = 52) bimonthly or oral iron sulphate (Group B) to maintain raised and normal iron indices (respectively) over 12 months. The primary endpoint was the change in Hb concentration at 12 months or at termination after at least 6 months of treatment.. Eighty-five patients reached the primary endpoint (43, Group A; 42, Group B). Initial Hb was 119 +/- 7 vs 116 +/- 12 g/L (mean +/- standard deviation); ferritin 122 (71-176), median (inter-quartile range), vs 90 microg/L (58-150); transferrin saturation (TSat) 22 (18-26) vs 21% (15-24); and creatinine 240 (195-313) vs 230 micromol/L (184-352). Ferritin and TSat differed by month 2 [157 (103-220) vs 96 microg/L (73-162), P = 0.003] and month 6 [25 (20-31) vs 21% (17-27), P = 0.02], respectively. At study end, Hb did not differ between groups (121 +/- 10 vs 117 +/- 13 g/L). Ferritin was 362 (310-458) vs 125 microg/L (84-190), P < 0.001; TSat 30 (23-34) vs 21% (18-24), P < 0.001; and creatinine 229 (188-326) vs 272 micromol/L (195-413), P = NS. For patients (Groups A and B, n = 27 in each group) whose creatinine regression slope increased (indicating worsening function), the fall in Hb over 12 months also did not differ between groups despite adequate separation in iron indices. Serious adverse events overall did not differ between groups.. Elevated iron indices did not increase Hb synthesis in ESA-naive, iron replete, pre-dialysis patients with Hb >110 g/L.

Topics: Administration, Oral; Aged; Anemia; Chronic Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Iron; Kidney Diseases; Male; Middle Aged; Renal Dialysis; Severity of Illness Index

To compare the incidence of repeated red blood cell (RBC) transfusion in anemic gynecologic cancer patients receiving platinum-based chemotherapy comparing intravenous and oral iron.. Forty-four anemic gynecologic cancer patients (hemoglobin level below 10 mg/dl) who required RBC transfusion were stratified and randomized according to baseline hemoglobin levels and chemotherapy regimen. Study group received 200 mg of intravenous iron sucrose and control group received oral ferrous sulphate 600 mg/day. RBC transfusion requirement in the consecutive cycle of chemotherapy was the primary outcome. Quality of life was evaluated by validated Thai version of the Functional Assessment of Cancer Therapy-Anemia (FACT-An).. In a total of the 44 patients, there were 22 patients in each group. Five patients (22.7%) in the study group and 14 patients (63.6%) in the control group required RBC transfusion in consecutive cycle of chemotherapy (p=0.01). No significant difference in baseline hemoglobin and hematocrit levels was demonstrated in both groups. Significantly higher mean hemoglobin and hematocrit levels after treatment were reported in the study group (10.0+/-0.8 g/dl and 30.5+/-2.4%) than the control group (9.5+/-0.9 g/dl and 28.4+/-2.7%). No significant change of total FACT-An scores was noted between before and after treatment in both groups. No serious adverse events were reported and there was no significant difference among adverse events between both groups.. Intravenous iron is an alternative treatment for anemic gynecologic cancer patients receiving platinum-based chemotherapy and reduces the incidence of RBC transfusion without serious adverse events.

Topics: Adult; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Docetaxel; Endometrial Neoplasms; Erythrocyte Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Middle Aged; Neoplasms, Multiple Primary; Ovarian Neoplasms; Paclitaxel; Taxoids; Young Adult

To compare the effects of i.v. iron sucrose and Fe chloride on the iron indices of haemodialysis patients with anaemia.. One hundred and eight haemodialysis patients receiving recombinant human erythropoiesis-stimulating agent (ESA) (mean age 59.37 years) were enrolled and randomly assigned to an iron sucrose or an Fe chloride group. Iron supplements were administered at 100 mg/week during the first 4 weeks (loading dose). Ferritin and transferrin saturation (TSAT) were then measured and dose adjusted. Ninety-eight subjects completed treatment; 51 in the iron sucrose group and 47 in the Fe chloride group. Ferritin, TSAT, haematocrit (Hct), reticulocyte count, serum albumin, fractional clearance of urea (Kt/V) and intact parathyroid hormone (iPTH) were measured.. There was no significant difference in baseline characteristics between the groups. Significant differences between the groups were observed in both iron indices and ESA dosage. Hct at week 24 (31.1% vs 29.7%, P = 0.006) and ferritin at week 20 (731.3 vs 631.7 ng/mL, P = 0.006) in the iron sucrose group were significantly higher than in the Fe chloride group. ESA dosage used in the iron sucrose group at week 8 was significantly lower than in the Fe chloride group (244.9 vs 322.6 U/kg per month, P = 0.003), and iron sucrose group received significantly lower iron dose than the Fe chloride group at week 8 (P = 0.005).. Although the differences in ESA dosage, ferritin and iron dosage between two groups were found during the study period while similar results were shown at the end of 24 week study. Thus, iron sucrose and Fe chloride are safe and work equally well for haemodialysis patients.

Topics: Anemia; Chlorides; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Parenteral; Male; Middle Aged; Prospective Studies; Renal Dialysis

Patients with inflammatory bowel disease (IBD) often have low iron stores or anaemia. There is controversy about whether iron should be supplemented orally or intravenously (i.v.). The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron. The primary end-points were response and remaining anaemia at the end of treatment (EOT).. Ninety-one patients with IBD and anaemia (B-Hb <115 g/L) were randomized to oral iron sulphate (n=46) or intravenous iron sucrose (n=45) treatment for 20 weeks.. Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group (p=0.0009). Only 22 patients (48%) tolerated the prescribed oral dose, and 52% reduced the dose or withdrew from treatment because of poor tolerance. At EOT, 47% patients in the oral iron group increased their B-Hb by > or =20 g/L, compared with 66% in the intravenous iron group (p=0.07). In the oral iron group, 41% still had anaemia versus 16% of the patients in the intravenous iron group (p=0.007), and 22% versus 42% reached their reference B-Hb level (p=0.04). Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron (p=0.002). Under treatment with intravenous iron, 74% of the patients had no anaemia and normal S-ferritin levels (>25 microg/L) at EOT compared with 48% of patients receiving oral iron (p=0.013).. Treatment with intravenous iron sucrose is effective, safe, well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD.

Topics: Administration, Oral; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hematinics; Humans; Inflammatory Bowel Diseases; Injections, Intravenous; Male; Sweden; Treatment Outcome

The aim of this study was to compare the efficacy, safety and achievement of the target hemoglobin level (Hb >or=10 g/dl) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management.. Seventy-six patients with Hb levels <9.0 g/dl who were scheduled to undergo surgical treatment were randomized to receive either intravenous iron sucrose (based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week, beginning 3 weeks before surgery) or oral iron (80 mg/day of oral iron protein succinylate daily).. The intravenous iron group had higher increases in Hb (3.0 vs. 0.8 g/dl; p < 0.0001) and ferritin levels (170.1 vs. 4.1 microg/l; p < 0.0001) than the oral iron group. Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group (76.7 vs. 11.5%; p < 0.0001). There were tolerable adverse events in both groups.. Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia.

Topics: Administration, Oral; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Menorrhagia; Middle Aged; Preoperative Care; Prospective Studies

To evaluate the effectiveness of a stepwise use of recombinant human erythropoietin (rhEPO) in pregnant patients with severe anemia or nonresponsive to intravenously administered iron only.. All subjects had iron deficiency anemia, i.e., a hemoglobin (Hb) level <10.0 g/dl and ferritin < or =15 microg/l. Patients with an Hb level > or =9.0 g/dl and <10.0 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy was poor, patients additionally received 10,000 U rhEPO twice weekly. Patients with an Hb level <9.0 g/dl primarily received iron sucrose and rhEPO likewise.. Of the 84 patients, 59 had a baseline Hb level between 9.0 and 9.9 g/dl, of whom 32 responded poorly, thus receiving additional rhEPO. Twenty-five patients had a baseline Hb level <9.0 g/dl. The overall Hb level after therapy was 11.0 g/dl (+/-0.5, range 10.0-12.6 g/dl). Mean duration of therapy was 3.5 weeks (7 infusions).. This study shows an effective treatment regimen for patients with various degrees of anemia in pregnancy. Iron sucrose is a safe and effective treatment option. In cases of severe iron deficiency anemia or poor response to parenteral iron therapy additional administration of rhEPO might be considered. However, the mechanism for not responding to intravenous iron therapy despite iron deficiency anemia still remains unclear to a large extent.

Topics: Adult; Anemia; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron; Pregnancy; Recombinant Proteins; Treatment Outcome

To analyze the effect of intravenous ferrous sucrose compared with oral ferrous sulphate on hematological parameters and quality of life in women with postpartum anemia.. Open randomised controlled trial.. Multicentre study comprising five obstetrical departments in Norway.. Hundred and twenty-eight postpartum women with hemorrhagic anemia (Hb between 6.5 g/100 ml and 8.5 g/100 ml). The intervention group (59 women) received 600 mg iron sucrose intravenously followed by 200 mg iron sulphate daily from week 5. The control group (70 women) were given 200 mg iron sulphate daily.. Randomisation and start of treatment occurred within 48 hours of the delivery. Participants were followed up at 4, 8 and 12 weeks.. Hemoglobin, ferritin and quality of life assessed with the Medical Outcomes Study Short Form 36 (SF-36) and the Fatigue Scale.. After 4 weeks the mean hemoglobin values in both groups were similar (11.9 g/100ml vs. 12.3g/100ml, p=0.89). The mean serum ferritin value after 4 weeks was significantly higher in the intervention group with 13.7 microg/L vs. 4.2 microg/L in the control group (p<0.001). At 8 and 12 weeks the hematological parameters were similar. The total fatigue score was significantly improved in the intervention group at week 4, 8 and 12, whereas SF-36 scores did not differ.. Women who received 600 mg intravenous iron sucrose followed by standard oral iron after four weeks, replenished their iron stores more rapidly and had a more favorable development of the fatigue score indicating improved quality of life.

Topics: Administration, Oral; Adolescent; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Glucaric Acid; Hemoglobins; Humans; Infusions, Intravenous; Middle Aged; Postpartum Period; Prospective Studies; Quality of Life; Sucrose

Renal anemia is one of the commonest complications of chronic renal failure. Iron deficiency is the most common factor which affects the efficacy of recombinant human erythropoietin (EPO) therapy. Intravenous (i.v.) iron preparations are commonly used in Western countries, but iron sucrose is seldom used in Chinese patients on maintenance hemodialysis. The aim of the present study was to explore the safety and efficacy of i.v. iron sucrose in Chinese patients on maintenance hemodialysis and to explore the optimal administration frequency.. One hundred and thirty-six patients on maintenance hemodialysis were involved in this randomized, controlled, parallel-group, single-center trial. Seventy patients received i.v. iron sucrose (Venofer(R), delivering 100 mg iron) twice a week for 8 weeks, then once a week for another 4 weeks. The other 66 patients received oral (p.o.) ferrous succinate 200 mg t.i.d. for 12 weeks. Levels of serum ferritin (SF), transferrin saturation (TSAT), hemoglobin (Hb) and hematocrit (Hct) were assessed at baseline and then again after 4, 8 and 12 weeks of treatment.. There were no differences between i.v. and p.o. groups in terms of sex, age, duration of hemodialysis, dialysis frequency per week, EPO dosage per week, the level of intact parathyroid hormone, serum creatinine, blood urea nitrogen, or hematological parameters at baseline. After 8 and 12 weeks of treatment, mean Hb concentration and Hct were significantly increased in the i.v. group, and were also significantly higher than those in the p.o. group. Levels of SF and TSAT were also significantly increased in the i.v. group, and significantly higher than in the p.o. group. After 8 weeks, the response rate in the i.v. group was 88.6%, which was significantly higher than that in the p.o. group. The mean EPO dose was significantly lower in the i.v. group than the p.o. group. Hb, Hct, SF and TSAT levels were maintained between 8 and 12 weeks in the i.v. group despite the decrease in dose frequency. There were no adverse events related to i.v. iron administration. Twenty-two patients in the p.o. group had adverse gastrointestinal effects. After 12 weeks, the cost of EPO + i.v. iron was significantly higher than the cost of EPO + p.o. iron.. Intravenous iron sucrose can effectively increase serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and is well tolerated. Infusion of i.v. iron sucrose 100 mg per week can maintain serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and can permit reductions in the required dose of EPO. However, the total cost of i.v. iron is relatively high.

Topics: Adult; Aged; Anemia; China; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Hemoglobins; Humans; Iron; Kidney Failure, Chronic; Male; Middle Aged; Recombinant Proteins; Renal Dialysis; Treatment Outcome

The incidence of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy is estimated to be more than 50%. Transfusion has been the mainstay of hematologic support with its inherent hazards including infection and transfusion reaction. The aim of this study was to examine the impact of intravenously administered iron sucrose on the prevention of anemia in the cervical cancer patients undergoing concurrent chemoradiotherapy.. From Oct. 2003 to Dec. 2005, 75 patients were treated with platinum-based concurrent chemoradiotherapy. Thirty patients received 200 mg of iron sucrose intravenously (study group) and 45 patients did not receive it (control group).. In the study group, only 12 (40.0%) patients required blood transfusions, whereas 29 (64.0%) patients in the control group needed blood transfusions (P=0.04). Mean transfusion units were 1.87 units in the study group and 3.58 units in the control group (P=0.04).. This study showed that intravenous supply of iron sucrose could decrease transfusion requirement and increase serum hemoglobin level in patients with cervical carcinoma undergoing concurrent chemoradiotherapy. Therefore, intravenously administered iron sucrose would be effective in the prevention of anemia of cervical cancer patients receiving concurrent chemoradiotherapy.

Topics: Adult; Aged; Anemia; Antineoplastic Agents; Cisplatin; Combined Modality Therapy; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Middle Aged; Prospective Studies; Uterine Cervical Neoplasms

1. Patients with advanced chronic renal disease and anaemia have decreased serum paraoxonase-1 (PON1) activity and an increased degree of oxidative stress compared with normal subjects. The present study investigated the effects of treatment of anaemia with exogenous recombinant erythropoietin (EPO) beta and iron on levels of antibodies against oxidized low-density lipoproteins (ox-LDL), as well as on serum PON1 activity and concentration, in predialysis patients with chronic renal disease. 2. Forty-nine patients with chronic renal failure and haemoglobin (Hb) < 11 g/dL were treated over a period of 6 months with EPObeta (80-120 U/kg per week, s.c.) and variable doses of iron. Selected biochemical variables were determined before and after treatment. 3. Treatment with EPObeta and iron was associated with a significant increase in mean (+/-SD) blood Hb concentration compared with pretreatment values (12.8 +/- 1.5 vs 9.9 +/- 0.6 g/dL, respectively; P < 0.001). The average dose of EPObeta was 6160 +/- 3000 U/week. After 6 months of treatment, compared with pretreatment values, the median levels (95% confidence intervals) of antibodies against ox-LDL were decreased (17.5 (10.6-24.4) vs 24.8 (11.5-38.1) U/mL, respectively; P < 0.001), serum PON1 activity was slightly but significantly increased (123.6 (76.1-343.6) vs 101.0 (50.0-332.5) U/L, respectively; P = 0.016) and the concentration of PON1 was significantly decreased (37.3 (11.8-76.2) vs 46.7 (24.6-98.0) mg/L, respectively; P < 0.001). There were no significant changes in total cholesterol, triglycerides or cholesterol fraction concentrations before and after treatment. 4. We suggest that EPObeta and iron treatment of anaemia promotes significant changes in serum PON1 activity and concentration and has a beneficial effect on oxidative stress in predialysis patients with chronic renal disease.

Topics: Aged; Anemia; Antibodies; Aryldialkylphosphatase; Dose-Response Relationship, Drug; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Injections, Subcutaneous; Kidney Failure, Chronic; Lipid Peroxidation; Lipoproteins, LDL; Male; Middle Aged; Oxidative Stress; Recombinant Proteins; Renal Dialysis; Treatment Outcome

The objectives of the present trial were to compare the side effects and safety of two intravenous iron preparations (iron-dextran, iron-sucrose) in patients with end stage renal disease.. A total of 60 patients were randomized and assigned to one of two treatment groups (iron-dextran, n = 30; iron-sucrose, n = 30). A standard test dose of 25 mg of low molecular weight iron-dextran and iron-sucrose were administered over 15 minutes during the initial visit, monitoring very closely for adverse reactions. If this dose was well tolerated, 75 mg of iron diluted in 100 mL of normal saline was administered over 30 minutes. Adverse reactions were recorded.. The mean age of the patients was 51.5+/-17.4 years (range, 21 to 80 years). Of the 30 patients who received low molecular weight iron-dextran, 11 developed side effects (pruritus, 1 patient; wheezing, 1 patient; chest pain, 1 patient; nausea, 4 patients; hypotension, 1 patient; swelling, 1 patient; headache, 2 patients). Of the 30 patients who received iron-sucrose, 13 developed side effects (pruritus, 1 patient; wheezing, 1 patient; diarrhea, 1 patient; nausea, 4 patients; hypotension, 2 patients; swelling, 1 patient; headache, 3 patients). Adverse events occurred with similar frequency in the two treatment groups in our study (p > 0.05). We did not observe any serious reactions in the two groups.. We conclude that the incidence of side effects associated with iron-dextran was not different than that of iron-sucrose in our study. Large scale randomized studies are needed to compare the full side effect profile of intravenous iron preparations more precisely.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intra-Arterial; Iron-Dextran Complex; Kidney Failure, Chronic; Male; Middle Aged

To determine if early recovery from severe post-operative anemia is accelerated by iv iron therapy alone or in combination with recombinant erythropoietin (EPO).. In this double-blinded, placebo-controlled randomized study, consenting adult patients without preoperative anemia whose hemoglobin concentration (Hb) was 70 to 90 g x L(-1) on the first day after cardiac or orthopedic surgery (POD 1) were assigned to one of three groups: control, iv iron alone (200 mg of iron sucrose on POD 1, 2, and 3) or in combination with EPO (600 U x kg(-1) on POD 1 and 3). The primary outcome was increase in Hb (adjusted for red blood cell transfusions) from POD 1 to 7. Analysis was by intention-to-treat in patients for whom the primary outcome was available. Group effect was analyzed by the ANOVA test, and between-group differences were specified with a Duncan multiple-range test.. The primary outcome was available in 31 of 38 randomized patients. The average POD 1 Hb was 84 +/- 4 g x L(-1). There were no between-group differences in outcomes except for higher reticulocyte counts on POD-7 in the combination group. The average adjusted one-week increases in Hb were 7 +/- 8 g x L(-1) in the control group (n = 10), 9 +/- 9 g x L(-1) in the iv iron group (n = 11), and 10 +/- 14 g x L(-1) in the combination group (n = 10). The average adjusted six-week increases in Hb were 37 +/- 14 g x L(-1) in the control group, 40 +/- 7 g x L(-1) in the iv iron group, and 45 +/- 12 g x L(-1) in the combination group.. Early postoperative treatment with iv iron alone or in combination with EPO does not appear to accelerate early recovery from postoperative anemia.

Topics: Analysis of Variance; Anemia; Cardiac Surgical Procedures; Double-Blind Method; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Male; Middle Aged; Orthopedic Procedures; Postoperative Care; Recombinant Proteins; Time Factors; Treatment Outcome

An important percentage of patients undergoing total hip replacement (THR) receive allogeneic blood transfusion (ABT) to avoid the risks of acute anaemia. However, concerns about the risks of ABT have led to the search for alternatives, such as stimulation of erythropoiesis. We prospectively investigated the effect of postoperative administration of 300 mg of intravenous iron sucrose on ABT requirements in THR patients (group 2; n = 24). A previous series of 22 THR patients served as the control group (group 1). All patients were operated on by the same surgeon, using the same implant, and a set of clinical data was gathered. No adverse reactions to iron administration were observed. The group-given iron showed a trend to a lower transfusion rate (46 vs. 73%; P = 0.067) and lower transfusion index (0.96 vs. 1.68 units/patient; P = 0.038). Moreover, amongst the non-transfused patients, admission haemoglobin levels were lower in those coming from the iron group than those from the control group (12.7 +/- 0.9 vs. 14.0 +/- 1.2 g dL(-1), respectively; P = 0.017). Postoperative parenteral iron administration could be a safe and effective way to reduce ABT requirements in the THR patients. A large, randomized controlled trial to confirm these results is warranted.

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Parenteral; Male; Pilot Projects; Retrospective Studies

To assess the efficacy and safety of treatment with intravenous iron for postpartum anemia or postoperative anemia after gynecological surgery.. A prospective study enrolling patients entering our recovery care unit from June through December 2004 with hemoglobin levels less than 10 g x dL(-1) after vaginal childbirth or cesarean section or after another form of gynecological surgery. Three 200 mg doses of intravenous iron sucrose (Venofer) were administered on consecutive days. Fifteen days after the last dose, the patient came for follow-up tests and was asked about side effects. The results were analyzed with a Student t test for matched samples.. A total of 250 obstetric and 52 gynecological surgery patients were enrolled; 156 and 33 completed the study in each group, respectively. Hemoglobin increased after treatment by 3.2 g x dL(-1) in the obstetric patients and by 2.7 g x dL(-1) in patients who underwent gynecological surgery. The increase was significant in both groups (P<0.001); the 95% confidence interval was 2.918-3.519 for the obstetric patients and 2.220-3.071 for the gynecological surgery patients. The incidence of side effects was low (13 obstetric patients and 1 gynecological surgery patient). Most side effects were related to pain at the injection site (in 12 of the 14 women).. Intravenous iron sucrose is safe and effective for treating puerperal anemia and following gynecological surgery. The low incidence of serious side effects and the rapid recovery of hemoglobin levels make this a safe, effective drug for treating anemia.

Topics: Adolescent; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Gynecologic Surgical Procedures; Humans; Injections, Intravenous; Prospective Studies; Puerperal Disorders; Sucrose

This study was undertaken to assess the hematologic, clinical, and biochemical response to intravenous iron in patients with chronic heart failure (CHF) and anemia.. Anemia is common in patients with CHF and is associated with higher morbidity and mortality. The combination of erythropoietin (EPO) and iron increases hemoglobin (Hb) and improves symptoms and exercise capacity in anemic CHF patients. It is not known whether intravenous iron alone is an effective treatment for anemia associated with CHF.. Sixteen anemic patients (Hb < or =12 g/dl) with stable CHF (age 68.3 +/- 11.5 years, 12 men, 9 participants New York Heart Association [NYHA] functional class II and the remainder class III, left ventricular ejection fraction 26 +/- 13%) received a maximum of 1 g of iron sucrose by bolus intravenous injections over a 12-day treatment phase in an outpatient setting. Mean follow-up was 92 +/- 6 days.. Hemoglobin rose from 11.2 +/- 0.7 to 12.6 +/- 1.2 g/dl (p = 0.0007), Minnesota Living with Heart Failure (MLHF) score fell (denoting improvement) from 33 +/- 19 to 19 +/- 14 (p = 0.02), 6-min walk distance increased from 242 +/- 78 m to 286 +/- 72 m (p = 0.01), and all patients recorded NYHA class II at study end (p < 0.02). Changes in MLHF score and 6-min walk distance related closely to changes in Hb (r = 0.76, p = 0.002; r = 0.56, p = 0.03, respectively). Of all baseline measurements, only iron and transferrin saturation correlated with increases in Hb (r = 0.60, p = 0.02; r = 0.60, p = 0.01, respectively). There were no adverse events relating to drug administration or during follow-up.. Intravenous iron sucrose, when used without concomitant EPO, is a simple and safe therapy that increases Hb, reduces symptoms, and improves exercise capacity in anemic patients with CHF. Further assessment of its efficacy should be made in a multicenter, randomized, placebo-controlled trial.

Topics: Aged; Anemia; Cardiac Output, Low; Chronic Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Gastrointestinal Diseases; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Iron; Male; Middle Aged; Physical Endurance; Prospective Studies; Transferrin; Walking

In unilateral total knee replacement (TKR), perioperative blood loss, low transfusion thresholds and short hospital stay result in patients being discharged with low haemoglobin (Hb). We assessed the effects of perioperative administration of intravenous iron, with or without erythropoietin, plus a restrictive transfusion threshold (Hb < 80 g L(-1)) both on transfusion rate and recovery from post-operative anaemia. TRK patients received iron sucrose (2 x 200 mg per 48 h, iv) (Group IVI, n = 129). Patients with admission Hb < 130 g L(-1), also received erythropoietin (1 x 40 000 IU, sc) (Group EPO, n = 19). Perioperative clinical and laboratory data were obtained. Mean Hb loss was 36 g L(-1), but only seven patients were transfused (5%). Pre-operatively, 66 (45%) patients did not have enough stored iron to compensate Hb loss. At post-operative day 30, only 15% were anaemic, 70% of Hb loss and 92% of pre-operative Hb were recovered and ferritin increased by 73 microg L(-1) (P < 0.01), although erythropoietic response was higher in patients receiving erythropoietin (P < 0.05). No adverse effects of iron sucrose or erythropoietin were witnessed. This protocol seems to reduce allogeneic blood transfusion rate and may hasten the recovery from post-operative anaemia in TKR patients, without depleting iron stores. Further studies are needed to ascertain which patients may benefit of extended intravenous iron and/or erythropoietin administration.

Topics: Aged; Anemia; Arthroplasty, Replacement, Knee; Blood Component Transfusion; Blood Loss, Surgical; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Male; Perioperative Care; Postoperative Hemorrhage; Receptors, Transferrin; Recombinant Proteins; Reticulocyte Count; Treatment Outcome

Anaemia is the main complication following haemodilution in paediatric cardiac surgery. Iron oral therapy is ineffective to improve anaemia. The aim of this study is to assess the effect of a single dose of intravenous iron saccharate Venofer.. Open, randomized.. 93 patients were randomized in two groups. The first one is the control group without iron supplementation and the second one received a 5 mg/kg injection of Venofer administered at day 1. Three biological factors were studied on day 1 and day 5 following surgery: haemoglobin, ferrritin and reticulocyte rate. Student test was used for statistical analysis of results.. Age, weight, haemoglobin, ferritine and reticulocyte on day 1 were similar in both group (no significant difference). On day 5 ferritin was higher in the treated group 215+/-87 vs 101+/-55 mug/l in the non treated group (P<0.001). Reticulocyte rate was also higher in the treated group 3.25+/-1.16 vs 2.65+/-0.97% (P<0.005) in the untreated group.. Postoperative systemic inflammation is probably the factor which impaired the effect of oral iron therapy. Parenteral iron may act by treating a functional iron deficiency and/or by increasing endogenous erythropoietin synthesis. Faster reversibility of anaemia following iron injection improves quality of the postoperative recovery.

Topics: Anemia; Cardiac Surgical Procedures; Child; Child, Preschool; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemodilution; Hemoglobins; Humans; Infant; Infusions, Intravenous; Male; Postoperative Complications; Reticulocyte Count; Sucrose

There are concerns about adverse vascular effects of intravenous iron by inducing oxidative stress. We therefore examined the effect of a single high dose of intravenous iron on endothelial function and biochemical markers of iron homeostasis.. In a randomized, placebo-controlled, double-blind, parallel-group study, forearm blood flow (FBF) was assessed by strain-gauge plethysmography in 38 peritoneal dialysis patients before and after a single intravenous infusion of 300 mg iron sucrose.. Iron infusion increased total (Delta 601 microg/100 mL, CI 507, 696) and non-transferrin-bound iron (Delta 237.2 micromol/L, CI 173.6, 300.8) approximately 10-fold, as well as redox-active iron nearly five-fold (Delta 0.76 micromol/L, CI 0.54, 0.98). After iron infusion basal FBF was 59% higher than after placebo. FBF response to acetylcholine before and after iron infusion was 263 +/- 32% and 310 +/- 33%, corresponding to 304 +/- 43% and 373 +/- 29% in the placebo group, respectively. Before and after iron or placebo infusion, glyceryl-trinitrate increased resting FBF to 232 +/- 22% and 258 +/- 21% in the iron group, and to 234 +/- 18% and 270 +/- 30% in the placebo group. L-N-monomethyl-arginine decreased FBF to 70 +/- 4% and 72 +/- 3% before and after iron, and to 74 +/- 4% and 73 +/- 4% before and after placebo infusions, respectively. Despite higher basal FBF after iron infusion, absolute and relative FBF changes in response to vasoactive substances were not significantly different between iron and placebo groups.. Our data suggest that 300 mg intravenous iron sucrose has a vasodilatory effect, but does not impair vascular reactivity in dialysis patients, despite a significant increase in non-transferrin-bound and redox-active iron.

Topics: Adult; Aged; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Forearm; Glucaric Acid; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Oxidative Stress; Peritoneal Dialysis; Prospective Studies; Regional Blood Flow; Vasodilation

Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD (ND-CKD), the comparative treatment value of IV iron infusion and oral iron supplementation has not been established.. In a randomized, controlled multicenter trial, we compared the efficacy of iron sucrose, given as 1 g in divided IV doses over 14 days, with that of ferrous sulfate, given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5, Hb < or =11 g/dL, TSAT < or =25%, and ferritin < or =300 ng/mL. Epoetin/darbepoetin therapy, if any, was not changed for eight weeks prior to or during the study.. The proportion of patients achieving the primary outcome (Hb increase > or =1 g/dL) was greater in the IV iron treatment group than in the oral iron treatment group (44.3% vs. 28.0%, P= 0.0344), as was the mean increase in Hb by day 42 (0.7 vs. 0.4 g/dL, P= 0.0298). Compared to those in the IV iron group, patients in the oral iron treatment group showed a greater decline in GFR during the study (-4.40 vs. -1.45 mL/min/1.73m2, P= 0.0100). No serious adverse drug events (ADE) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes, but drug-related hypotension, including one event considered serious, occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours.. IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices.

Topics: Administration, Oral; Aged; Anemia; Erythropoiesis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Iron; Male; Middle Aged; Patient Compliance; Quality of Life; Renal Insufficiency, Chronic; Treatment Outcome

Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.. In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.. Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.. Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Drug Hypersensitivity; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Sepsis

Congestive heart failure is extremely common in octogenarians and is associated with severe fatigue, shortness of breath, recurrent hospitalizations, and death. These patients, many of whom are anemic, are often resistant to standard CHF therapy including angiotensin-converting enzyme inhibitors, beta-blockers and diuretics.. To examine whether correction of the anemia (hemoglobin < 12 g/dl) in CHF patients can improve their clinical condition.. Forty octogenarians with anemia and severe resistant CHF were administered a combination of subcutaneous erythropoietin and intravenous iron sucrose.. This combination therapy led to a marked improvement in cardiac function, shortness of breath and fatigue, a marked reduction in the rate of hospitalization and a stabilizing of renal function.. Anemia appears to be an important but ignored contributor to the progression of CHF, and its correction may improve cardiac and renal status as well as the quality of life in elderly patients.

Topics: Age Factors; Aged; Aged, 80 and over; Anemia; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glomerular Filtration Rate; Glucaric Acid; Heart Failure; Hemodynamics; Humans; Infusions, Intravenous; Male; Renal Insufficiency; Severity of Illness Index; Time Factors

Iron is essential for the formation of hemoglobin. During long-term treatment with human recombinant erythropoietin (rhEPO), the majority of end-stage renal disease (ESRD) patients will not respond adequately to rhEPO unless substituted with intravenous iron. However, concern exists about possible detrimental effects of parenteral iron on cellular host defense and iron-mediated increments of oxidative stress.. We analyzed phagocytic functions of polymorphonuclear leukocytes (PMN) isolated from 20 ESRD patients on peritoneal dialysis in response to 300 mg of iron sucrose or placebo administered intravenously over two hours in a randomized, double-blind manner. We evaluated Fc gamma R-dependent phagocytosis and killing (primary outcome variable) of opsonized Escherichia coli, Fc gamma R-dependent oxidative burst capacity, and complement receptor 3 (CR3, Mac1, CD11b/CD18)/tumor necrosis factor alpha (TNFalpha)-mediated release of bactericidal lactoferrin before, during, one hour, and two days after administration.. The absolute count and the percentage of E. coli killed by PMN of iron sucrose-treated peritoneal dialysis patients decreased significantly over time in comparison to placebo-treated patients (F = 3.48, df = 4, P = 0.008; F = 3.99, df = 4, P = 0.006, respectively). All secondary outcome variables were not different between both groups over time.. Killing capacity of PMN isolated from ESRD patients decreases in response to high-dose parenteral iron sucrose, possibly in part explaining reported higher hospitalization rates and lower survival rates of dialysis patients receiving frequent and high-dose parenteral iron.

Topics: Anemia; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Injections, Intravenous; Kidney Failure, Chronic; Neutrophils; Peritoneal Dialysis; Phagocytosis; Prospective Studies; Respiratory Burst

Provision of adequate iron to support erythropoiesis in patients with chronic kidney disease (CKD) is time consuming and may present adherence problems for patients in the outpatient setting. We studied an accelerated regimen of high-dose intravenous iron sucrose therapy in a cohort of iron-deficient, anemic CKD patients.. Intravenous iron sucrose 500 mg was infused over three hours on two consecutive days in 107 CKD patients (glomerular filtration rate, 32.3 +/- 19.6 mL/min/1.73m2, baseline hemoglobin 10.2 +/- 1.7 g/dL). Iron indices (transferrin saturation, ferritin) were measured at baseline and at two and seven days after completion of the iron regimen. Blood pressures were monitored immediately prior to, and hourly throughout the iron sucrose infusions.. Transferrin saturation and serum ferritin increased from 18.5 +/- 8.5% and 177 +/- 123.8 ng/mL at baseline to 40.2 +/- 22.3% and 811 +/- 294.1 ng/mL in 102 evaluated patients (P < 0.015). In 55 patients with additional measurements at 7 days post-dosing, the transferrin saturation and ferritin had fallen to 26.3 +/- 10.6% and 691 +/- 261.8 ng/mL (P < 0.015 compared to two days' post-dose). Blood pressure rose slightly, but not significantly, throughout the infusions, and altering the infusion rate was not necessary. Two patients had seven adverse events that were considered related to iron sucrose.. An accelerated regimen of high-dose intravenous iron sucrose therapy in CKD patients is safe and effective in restoring iron stores, and may potentially save time and improve patient adherence.

Topics: Aged; Anemia; Blood Pressure; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Transferrin; Treatment Outcome

Many haemodialysis patients treated with recombinant human erythropoietin (r-HuEPO) receive intravenous iron supplementation on a regular basis. It has been shown previously that this may result in a transient "oversaturation" of transferrin.. Ten stable haemodialysis patients on r-HuEPO treatment received 100 mg iron saccharate in 60 min, and 1 week later 100 mg in 6 min. Conventional iron metabolism parameters and nontransferrin-bond iron, detected with HPLC after addition of nitrilotriacetate and pretreatment with cobalt, were measured. Also, iron was measured in dialysate.. Serum iron increased from 9.6 +/- 6.2 to 213.7 +/- 49.4 micromol L(-1) (P < 0.001) when iron was given in 60 min, and from 11.1 +/- 4.7 to 219.3 +/- 43.7 micromol L(-1) (P < 0.001) when iron was given in 6 min. Transferrin saturation increased from 0.22 +/- 0.18 to 4.75 +/- 1.35 in protocol 1 and 0.26 +/- 0.16 to 4.91 +/- 1.38 in protocol 2. Nontransferrin-bound iron increased from 0.74 +/- 0.69 to 3.79 +/- 1.41 micromol L(-1) in protocol 1, and from 0.90 +/- 0.92 to 2.90 +/- 0.96 micromol L(-1) in protocol 2. No significant iron concentrations were found in dialysate before or during the iron saccharate infusion.. Nontransferrin-bound iron exists in plasma of dialysis patients after infusion of iron saccharate. There was no difference when 100 mg iron was given in 60 min or in 6 min. Before iron infusion, appreciable concentrations of nontransferrin-bound iron could already be detected. The clinical significance is not clear, but the findings may be important since nontransferrin-bound iron can act as a catalytic agent in the formation of hydroxyl radicals, thus potentially inducing cell damage and atherosclerosis.

Topics: Anemia; Dialysis Solutions; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Infusions, Intravenous; Iron; Kidney Failure, Chronic; Male; Protein Binding; Renal Dialysis; Transferrin

We conducted a prospective study to determine the effect of intravenous low-dose iron administration in chronic hemodialysis patients treated with recombinant human erythropoietin (rHuEPO). Sixteen hemodialysis patients (8 males and 8 females; mean age 63.1+/-9.8 years) on maintenance rHuEPO therapy were included in the study. Patients with <100 ng/ml of ferritin received 50 mg iron during every hemodialysis session. Patients with 100-200 ng/ml of ferritin were given 50 mg iron fortnightly. Iron was not supplemented in patients with ferritin levels >200 ng/ml. Mean hematocrit, serum iron levels and transferrin saturations were significantly higher at 6 and 12 months. There was a significant reduction in weekly rHuEPO doses between the start and the 6th and 12th months. Our study shows intravenous iron administration of 100 mg/month may be sufficient to achieve a satisfactory iron status in dialysis patients on maintenance rHuEPO therapy.

Topics: Aged; Anemia; Dose-Response Relationship, Drug; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Recombinant Proteins; Renal Dialysis

It is now more and more evident that anemia of predialysis chronic renal failure (CRF) should be actively treated, since long-standing anemia may cause irremediable damage to the heart. The most common form of treatment of this anemia is subcutaneous erythropoietin (EPO). iron (Fe) deficiency can also contribute to anemia in predialysis CRF, and intravenous iron (i.v. Fe) can frequently improve it. It is possible, therefore, that the combination of EPO and i.v. Fe may have an additive effect, and cause a rapid improvement in anemia with relatively small doses of EPO.. The purpose of this study was an initial study: to assess the ability of a combination of low-dose EPO and i.v. Fe, given weekly for 5 doses, to correct the anemia of predialysis CRF patients compared to the use of i.v. Fe alone in a randomized study. In the follow-up study: to assess the ability of the maintenance of adequate iron stores for one year to achieve and maintain the target Hct of 35% with the minimum dose of EPO. Initial study:. Ninety predialysis CRF patients (creatinine clearance 10-40 ml/min/1.73 m2 received either: Group A (45 patients): 200 mg i.v. Fe as Fe sucrose (Venofer, Vifor Int.) once per week for 5 doses in combination with 2,000 international units (IU) EPO (Eprex, Cilag-Janssen), subcutaneously given simultaneously also for 5 doses. Group B (45 patients): the same dose of i.v. Fe as in Group A but without EPO.. The mean increase in hematocrit (Hct) and hemoglobin (Hb) by one week after the last dose was greater in group A, 4.54 +/- 2.64% (p < 0.01) and 1.37 +/- 0.84 g% (p < 0.01), respectively, than in Group B, 2.74 +/- 2.72% (p < 0.05) and 0.91 +/- 0.78 g% (p < 0.05), respectively. 80% of those in Group A had an increase in Hct of 3 vol% or more compared to 48.9% in Group B (p < 0.01). 40% of those in Group A reached the target Hct of 35% compared to 28.9% in Group B (p > 0.05). Follow-up study: During a 12-month follow-up period, enough i.v. iron was given to maintain the Hct at 35%, while keeping the serum ferritin at < 400 ug/l and % Fe Sat at < 40%. If the i.v. Fe alone was not capable of maintaining the target Hct, EPO was given in increasing doses. Eighteen patients required dialysis. Of the 72 patients who did not require dialysis, 24 (33.3%) maintained the target Hct with i.v. Fe alone, without EPO. All the remaining 48 patients (66.7%) continued to receive EPO in addition to the i.v. Fe, and 47 achieved and maintained the target Hct with a mean EPO dose of 2,979 +/- 1,326 IU/week.. The combination of low-dose EPO and i.v. Fe had a rapid and additive effect on the correction of anemia in CRF predialysis patients. Maintaining adequate iron stores with i.v. Fe during a subsequent maintenance phase allowed the target Hct of 35% to be reached and maintained with low-dose EPO in two-thirds of the predialysis patients and with no EPO at all in one-third.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematocrit; Humans; Infusions, Intravenous; Injections, Subcutaneous; Kidney Failure, Chronic; Male; Middle Aged; Recombinant Proteins; Renal Dialysis; Sucrose

To investigate whether treatment of anemia of chronic disease (ACD) in patients with rheumatoid arthritis (RA) with recombinant human erythropoietin (rHu-Epo) in combination with intravenous (i.v.) iron influences health related quality of life (HRQoL) and clinical outcome including disease activity.. Thirty patients with ACD and RA were treated with 150 IU/kg rHu-Epo twice weekly for 12 weeks. As well, in case of functional iron deficiency 200 mg of iron-sucrose per week was given intravenously. Vitality and fatigue as dimensions of HRQoL were evaluated by the vitality subscale of the Short Form-36 (SF-36-VT) and the Multidimensional Assessment of Fatigue (MAF). Muscle strength was measured by the Muscle Strength Index.. All 28 patients completing the study responded to treatment; 23/28 patients developed functional iron deficiency and received i.v. iron (mean absolute dose 710 +/- 560 mg). Average hemoglobin concentration increased from 10.7 +/- 1.1 to 13.2 +/- 1.0 g/dl after a mean treatment period of 8.7 +/- 2.3 weeks. Muscle strength increased from 43.5 +/- 11.2 to 49.1 +/- 12.9 and SF-36-VT from 28.2% +/- 14.3% to 47.1% +/- 20.8%. while fatigue decreased (MAF from 34.7 +/- 9.3 to 25.0 +/- 11.3). Among the disease activity variables the number of swollen/tender joints, erythrocyte sedimentation rate, Disease Activity Score, and RA Disease Activity Index improved significantly during treatment.. Treatment of ACD in RA patients with rHu-Epo and i.v. iron is safe and effective in correction of anemia, increases muscle strength. improves vitality, and lowers fatigue. In addition we observed a reduction of disease activity.

Topics: Adult; Aged; Anemia; Arthritis, Rheumatoid; Disability Evaluation; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Health Status; Humans; Injections, Intravenous; Injections, Subcutaneous; Male; Middle Aged; Quality of Life; Recombinant Proteins; Severity of Illness Index; Treatment Outcome

Iron deficiency constitutes the major cause of erythropoietin hyporesponse in uremic patients receiving erythropoietin therapy; therefore, iron supplementation is necessary for these patients. Recent data suggested that intravenous iron supply is a preferable route for iron supplementation. However, it remains unclear whether a single large dose or multiple small doses are a better way of administering an intravenous iron supply.. To determine the effect of different dosing schedules of intravenous iron therapy on the hematocrit level, we randomly assigned 18 patients to 3 groups. The first group of patients (n = 6) received a single dose of 800 mg intravenous fesin (ferric saccharate). The second group of patients (n = 6) received 400 mg intravenous fesin once weekly for 2 successive weeks. The third group of patients (n = 6) received 120 mg of intravenous fesin for 7 successive hemodialysis sessions. EPO was given at a fixed dose for all individuals in the study period.. The results showed that all 3 groups of patients had a progressive increase in hematocrit (Hct) level following intravenous iron therapy. Serum ferritin levels increased rapidly following iron therapy and then declined gradually in all 3 groups. But no statistical significance could be found among the 3 groups because of the small patient number. Also, no differences were observed in Hct or serum ferritin levels among these 3 groups of patients at all stages.. In this study, we found that a large single dose as well as small multiple doses of parenteral iron therapy had similar effects in correcting the iron deficiency in hemodialysis patients treated with erythropoietin. To save manpower and costs, we recommend the large single dosing schedule.

Topics: Anemia; Drug Administration Schedule; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematocrit; Humans; Infusions, Intravenous; Injections, Intravenous; Iron Deficiencies; Middle Aged; Recombinant Proteins; Renal Dialysis; Uremia

Some chronic renal failure patients respond poorly to recombinant human erythropoietin (rHuEPO). In continuous ambulatory peritoneal dialysis (CAPD) patients, such a poor response may indicate inadequate dialysis or low body iron stores. To correct iron deficiency, once-a-week intravenous iron supplementation is recommended. However, hemodialysis patients receive iron supplements three times a week. This study was designed to compare the efficacy of iron supplementation between once-weekly and twice-weekly regimens. In both groups, rHuEPO doses were similar. Seventeen CAPD patients were studied. All had hemoglobin levels less than 10 g/dL. Ten patients were given 100 mg intravenous iron once weekly, and 7 were given 50 mg intravenous iron twice weekly until a total iron dose of 600 mg was achieved (stage I). The patients were crossed over to receive another 600 mg iron (stage II). Hematocrit increased significantly in patients receiving twice-a-week iron supplementation (+3.8% and 6%) compared to those receiving once-a-week iron supplementation (+1.3% and 1.4%) during stages I and II. The ferritin levels were not different between the groups. In conclusion, rHuEPO is more effective when administered with intravenous iron.

Topics: Adult; Anemia; Drug Administration Schedule; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematocrit; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Organization and Administration; Peritoneal Dialysis, Continuous Ambulatory; Recombinant Proteins; Sucrose; Transferrin

In patients scheduled for major orthopedic surgery, the presence of anemia can preclude the donation of sufficient autologous blood (AB) to meet transfusion requirements. Although a number of studies have investigated the use of epoetin alfa (in conjunction with parenteral iron supplementation) to facilitate AB donation and reduce exposure to allogeneic blood in this patient population, the optimum treatment regimen and route of administration has yet to be defined. In rheumatoid arthritis (RA) patients with a low predonation hematocrit (Hct; < or = 39%), intravenous (i.v.) treatment with epoetin alfa 300 IU/kg twice weekly for 3 weeks was the optimum dosage for facilitation of AB donation and minimization of the decrease in Hct prior to elective orthopedic surgery. However, the subcutaneous (s.c.) route of epoetin alfa administration may allow lower dosages of epoetin alfa to be used. Indeed, epoetin alfa 100 IU/kg s.c. twice weekly for 3 weeks (in conjunction with a single i.v. bolus of 200 IU/ kg at the first s.c. dose) was as effective as 300 IU/kg i.v. administered according to the same schedule. The number of AB units collected, total red blood cell (RBC) volume donated, and peak proportion of reticulocytes were similar regardless of the route of administration. Both treatment groups were associated with a significant reduction in allogeneic blood exposure compared with historical controls. Findings consistent to all of these studies were that epoetin alfa was well tolerated, and that i.v. iron supplementation was necessary to maximize its beneficial effects.

Topics: Anemia; Arthritis, Rheumatoid; Blood Transfusion; Blood Transfusion, Autologous; Dose-Response Relationship, Drug; Double-Blind Method; Epoetin Alfa; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematocrit; Humans; Injections, Intravenous; Injections, Subcutaneous; Orthopedics; Premedication; Recombinant Proteins; Treatment Outcome

A low predonation hematocrit (Hct) can preclude the collection of sufficient autologous blood (AB) to meet the transfusion requirements of patients scheduled for orthopedic surgery. Subcutaneous (s.c.) administration of epoetin alfa, in conjunction with intravenous (i.v.) iron supplementation, has proved effective for the facilitation of AB donation by such patients. Compared with untreated controls and patients treated with i.v. iron alone, epoetin alfa 50 to 150 IU/kg SC plus i.v. iron twice weekly for 3 weeks prior to surgery significantly increased total red blood cell (RBC) production (P < .01) and the volume of RBCs donated (P < .05). Epoetin alfa was particularly effective in females and patients with a predicted blood volume (PBV) less than 5 L. Treatment with epoetin alfa led to an increase (albeit nonsignificant) in the number of AB units predonated compared with i.v. iron alone. However, in patients with a PBV less than 5 L, a substantially greater percentage of epoetin alfa-treated patients donated > or = 4 AB units (80% v 30%). Allogeneic blood requirements were reduced, albeit not significantly (P = .051), in patients treated with epoetin alfa. However, in comparison with untreated controls, there was a significant reduction in the mean volume of allogeneic blood transfused per transfused patient in the epoetin alfa groups. The optimum s.c. dose of epoetin alfa in patients with a low predonation Hct scheduled for orthopedic surgery appears to be between 100 and 150 IU/kg twice weekly for 3 weeks.

Topics: Anemia; Blood Transfusion; Blood Transfusion, Autologous; Epoetin Alfa; Erythropoiesis; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematocrit; Humans; Male; Orthopedics; Premedication; Recombinant Proteins; Reticulocyte Count; Sex Characteristics; Treatment Outcome

In the present prospective study we examined the long-term effect of intravenous supplementation with ferric saccharate (IV Fe) in the treatment of the anemia of chronic dialysis patients. All patients, 64 on chronic hemodialysis (HD) and 9 on chronic ambulatory peritoneal dialysis (CAPD), were treated intravenously with this preparation in a dose of 100 mg elemental iron twice monthly. There were five groups. Group 1: 41 HD patients who were receiving erythropoietin (EPO) for at least 6 months prior to the addition of IV Fe. In this group, when IV Fe was given over 6 months, the hematocrit (Hct) increased from a mean of 28.7 to 33.7%. Over the next 6 months, the EPO dose was gradually reduced by a mean of 61.1%, but the mean Hct remained unchanged. Group 2: 11 HD patients who started IV EPO simultaneously with the IV Fe. In this group, over 6 months, the mean Hct increased from 28.1 to 34.1. Over the next 6 months, the EPO dose was gradually reduced by 75.7%, but the mean Hct remained unchanged. Group 3: 12 HD patients who received IV Fe alone for 12 months. The mean Hct increased from 30.5 to 37.9%. Group 4: 4 CAPD patients who had been receiving subcutaneous EPO for at least 6 months prior to IV Fe therapy. Over the subsequent 6 months of IV Fe, the mean Hct increased from 28.4 to 33.3%. Group 5: 5 CAPD patients not on EPO who received IV Fe for 6 months. The mean Hct increased from 27.7 to 35.6%. No adverse effects were seen in any patients throughout the study. In conclusion, adequate Fe supplementation may allow the target Hct of about 33% to be reached without, or with only very low doses of EPO. IV Fe as ferric saccharate is a new and safe form of parenteral iron therapy of the anemia of chronic dialysis patients.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Drug Combinations; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Injections, Intravenous; Iron; Kidney Failure, Chronic; Male; Middle Aged; Peritoneal Dialysis, Continuous Ambulatory; Prospective Studies; Renal Dialysis

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

Chronic kidney disease (CKD) is often complicated by anemia, which seriously affects the quality-of-life and prognosis of patients. These patients usually need iron replacement therapy. Oral iron affects the composition and abundance of intestinal flora by increasing intestinal iron concentration.. We undertook an interventional study to investigate the effects of oral versus intravenous iron therapy on the gut microbiota. Oral ferrous succinate tablets (n = 14) or intravenous iron sucrose (n = 14) was administered to anemic maintenance hemodialysis (MHD) patients for 2 months.. Oral and intravenous iron treatments had different effects on gut microbial composition and diversity. After oral iron treatment, the α-diversity was decreased, while at the phylum level, the abundance of Firmicutes was reduced and the abundance of Bacteroides was increased. At the genus level, the abundance of Blautia and Coprococcus was decreased, and the abundance of Bacteroidetes was increased. Oral iron therapy was associated with a higher abundance of Lactobacillus compared with that measured in intravenous iron-treated patients. According to metagenome function prediction analysis, oral iron increased the metabolic processes of phenylalanine, valine, leucine, and isoleucine. These changes may increase uremic toxin levels, thereby increasing the progression of renal disease.. Iron therapy affects the diversity and composition of gut flora in MHD patients. Oral iron affects the number of bacteria and increases amino acid metabolism compared with intravenous iron. These results indicate that intravenous iron may be more appropriate for MHD patients.

Topics: Anemia; Ferric Oxide, Saccharated; Gastrointestinal Microbiome; Humans; Iron; Renal Dialysis; Renal Insufficiency, Chronic

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

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

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

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

Decreased erythropoietin levels and impaired iron metabolism due to excessive hepcidin levels are responsible for renal anaemia in patients undergoing haemodialysis. Recently, erythroferrone (ERFE) has been identified as a factor that regulates hepcidin. In addition, fibroblast growth factor 23 (FGF23), which has been recognized as a phosphorus-regulating hormone, appears to be involved in haematopoietic regulation. Clarification of the detailed mechanism of haematopoiesis could lead to the improvement of renal anaemia treatment.. Epoetin beta pegol (CERA) was administered to patients undergoing haemodialysis at week 0, and the same amount of CERA with saccharated ferric oxide (SFO) was administered at week 4. The changes in haematopoiesis-related biomarkers, including ERFE, intact FGF23 (iFGF23), C-terminal FGF23 (cFGF23), and inflammatory markers, were examined.. Administration of CERA increased ERFE levels, decreased hepcidin levels, and stimulated iron usage for haematopoiesis, leading to an increase in reticulocytes (Ret) and haemoglobin (Hb). Simultaneous administration of SFO with CERA (CERA + SFO) significantly attenuated the responses of ERFE, Ret, and Hb compared with CERA alone. Although iFGF23 levels were not affected by either CERA or CERA + SFO, cFGF23 was significantly elevated from baseline after CERA. Since cFGF23 levels were not affected by CERA + SFO, cFGF23 levels after CERA + SFO were significantly lower than those after CERA alone. The ratio of iFGF23 to cFGF23 (i/cFGF23 ratio) was significantly higher after CERA + SFO than that after CERA alone. In addition, high-sensitivity C-reactive protein (hsCRP) levels were significantly higher after CERA + SFO than after CERA alone.. Administration of SFO suppressed haematopoietic responses induced by CERA. Elevation of i/cFGF23 ratio and hsCRP could account for the inhibitory effects of SFO on haematopoiesis.. This study was registered with the University Hospital Medical Information Network (ID UMIN000016552 ).

Topics: Aged; Anemia; Biomarkers; Erythropoiesis; Erythropoietin; Female; Ferric Oxide, Saccharated; Fibroblast Growth Factor-23; Humans; Iron; Male; Peptide Hormones; Polyethylene Glycols; Renal Dialysis; Renal Insufficiency, Chronic

Scientific data regarding intravenous iron supplementation in peritoneal dialysis (PD) patients are scarce. In attempting to administer the minimum monthly IV iron dose that could improve erythropoiesis, we wanted to assess the safety and efficacy of monthly maintenance intravenous administration of 100 mg iron sucrose in PD patients.. In a 9-month prospective study, all clinically stable PD patients received intravenously 200 mg of iron sucrose as a loading dose, followed by monthly doses of 100 mg for five consecutive months. Levels of hemoglobin (Hb), ferritin, transferrin saturation (TSAT), reticulocyte hemoglobin content (CHr) and C-reactive protein (CRP) were measured before each administration and 3 months after the last iron infusion. Also, doses of concurrent erythropoietin administration were recorded.. Eighteen patients were eligible for the study. Mean levels of Hb and ferritin increased significantly (from 10.0 to 10.9 mg/dL, p = 0.01 and from 143 to 260 ng/mL, p = 0.005), as well as the increase in TSAT levels approached borderline significance (from 26.2 to 33.1%, p = 0.07). During the 6 months of iron administration, the erythropoietin dose was reduced in five patients and discontinued in one. During the 3 months following the last iron infusion, three of them again raised the erythropoietin dose to previous levels. None of the patients experienced any side effects related to IV iron administration.. A monthly maintenance intravenous dose of 100 mg iron sucrose may be a practical, effective, and safe in the short term, treatment of anemia in PD patients resulting in improved hemoglobin levels, iron indices, and erythropoietin response.

Topics: Administration, Intravenous; Aged; Aged, 80 and over; Anemia; C-Reactive Protein; Erythropoiesis; Erythropoietin; Female; Ferric Oxide, Saccharated; Ferritins; Hematinics; Hemoglobins; Humans; Male; Middle Aged; Peritoneal Dialysis; Prospective Studies; Renal Insufficiency, Chronic; Reticulocytes; Transferrin

Topics: Administration, Intravenous; Administration, Oral; Adult; Anemia; Blood Transfusion; Cardiac Surgical Procedures; Erythrocyte Count; Erythropoietin; Female; Ferric Oxide, Saccharated; Hemoglobins; Humans; Male; Middle Aged; Postoperative Complications; Retrospective Studies; Thoracotomy; Treatment Outcome

Sucroferric oxyhydroxide (SOH) is an iron-based phosphate binder (PB), and its use has been widely expanded since its initial approval in 2014. Based on the existing data, however, it remains yet unclear whether its long-term administration is followed by iron overload in dialysis patients. The purpose of this observational study was to evaluate the longstanding effects of SOH on the anemia and iron indices in patients on dialysis.. A total of 110 patients from 3 dialysis centers were included in the study; 49 were under chronic treatment with SOH (cohort A), while 61 were either receiving other PB or no treatment for hyperphosphatemia (cohort B). We initially compared the hematologic profile of patients in 2 cohorts (phase I), and subsequently, we evaluated modifications of the above parameters in the SOH treated patients over a period of 6 months (phase II).. There were no statistically significant differences between 2 cohorts in terms of hemoglobin (Hb; 11.4 ± 1.3 vs. 11.6 ± 0.9 g/dL, p = 0.375), ferritin (473 ± 230 vs. 436 ± 235 ng/mL, p = 0.419) and transferrin saturation (TSAT;26.6 ± 13.2 vs. 26.5 ± 10.6%, p = 0.675), serum phosphate concentration (4.57 ± 1.05 vs. 4.3 ± 0.96 mg/dL, p = ns), and intact PTH (286 ± 313 vs. 239 ± 296 pg/mL, p = ns). Marginally, but significantly higher calcium levels were found in cohort A compared to cohort B (9.18 ± 0.58 vs. 8.9 ± 0.51 mg/dL, respectively, p = 0.008). In phase II, no significant changes were observed in hematological parameters after a 6-month treatment with SOH (Hb: from 11.5 ± 1.1 to 11.4 ± 1.3 g/dL, p = 0.4, serum ferritin levels: from 475 ± 264 to 473 ± 230 ng/mL, p = 0.951, TSAT: from 26.5 ± 16.7 to 26.6 ± 13.2%, p = 0.933). There were also no significant changes in the administration of iron supplements or erythropoietin dose during this period.. SOH is an effective PB, and its long-term use is not complicated by iron overload.

Topics: Aged; Aged, 80 and over; Anemia; Biomarkers; Drug Combinations; Female; Ferric Compounds; Ferritins; Humans; Hyperphosphatemia; Iron; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Sucrose

The iron-based phosphate binders, sucroferric oxyhydroxide (SFOH) and ferric citrate (FC), effectively lower serum phosphorus in clinical studies, but gastrointestinal iron absorption from these agents appears to differ. We compared iron uptake and tissue accumulation during treatment with SFOH or FC using experimental rat models.. Iron uptake was evaluated during an 8-h period following oral administration of SFOH, FC, ferrous sulphate (oral iron supplement) or control (methylcellulose vehicle) in rat models of anaemia, iron overload and inflammation. A 13-week study evaluated the effects of SFOH and FC on iron accumulation in different organs.. In the pharmacokinetic experiments, there was a minimal increase in serum iron with SFOH versus control during the 8-h post-treatment period in the iron overload and inflammation rat models, whereas a moderate increase was observed in the anaemia model. Significantly greater increases (P < 0.05) in serum iron were observed with FC versus SFOH in the rat models of anaemia and inflammation. In the 13-week iron accumulation study, total liver iron content was significantly higher in rats receiving FC versus SFOH (P < 0.01), whereas liver iron content did not differ between rats in the SFOH and control groups.. Iron uptake was higher from FC versus SFOH following a single dose in anaemia, iron overload and inflammation rat models and 13 weeks of treatment in normal rats. These observations likely relate to different physicochemical properties of SFOH and FC and suggest distinct mechanisms of iron absorption from these two phosphate binders.

Topics: Administration, Oral; Anemia; Animals; Drug Combinations; Female; Ferric Compounds; Inflammation; Iron; Iron Overload; Kinetics; Male; Rats; Rats, Sprague-Dawley; Rats, Wistar; Sucrose; Tissue Distribution

Anemia is a common complication of inflammatory bowel diseases (IBD), as well as a predictor of poor outcomes. The aim of this study was to determine the prevalence of anemia over time and the management of moderate to severe anemia at a tertiary referral IBD center.. We retrospectively reviewed the occurrence of anemia at the time of referral or diagnosis and during follow-up at the McGill University Health Centre IBD center. Consecutive patients presenting with an outpatient visit between July and December 2016 and between December 2018 and March 2019 were included. Disease characteristics, biochemistry and medical management, including the need for intravenous iron therapy were recorded.. 1,356 Crohn's disease (CD) and 1,293 ulcerative colitis (UC) patients [disease duration: 12 (IQR: 6-22) and 10 (IQR: 5-19) years respectively] were included. The prevalence of moderate to severe anemia at referral/diagnosis (15.4% and 8.5%) and during follow-up (11.1% and 8.1%) were higher in CD than in UC patients. In CD, previous resective surgery, perianal disease and elevated C-reactive protein (CRP) at assessment, while in UC steroid therapy, an elevated CRP and fecal calprotectin at assessment were associated with anemia in a multivariate analysis. Anemia improved by >2g/dL in 56.5% after 4-6 weeks (intravenous iron dose >1000 mg in 87% of patients).. Anemia occurred frequently in this IBD cohort, at referral to the center and during follow-up, and contributes to the burden of IBD in referral populations. Most patients were assessed for anemia regularly and with accurate anemia workup; however, the targeted management of moderate to severe anemia was suboptimal.

Topics: Anemia; Colitis, Ulcerative; Crohn Disease; Female; Ferric Oxide, Saccharated; Hematinics; Humans; Infusions, Intravenous; Male; Prevalence; Quebec; Retrospective Studies; Severity of Illness Index; Tertiary Care Centers; Time Factors

Intravenous iron and erythropoiesis-stimulating agents are used to manage anemia in chronic hemodialysis patients. The interchangeability between intravenous iron sucrose preparations is still debated. We evaluated how cost and effectiveness were impacted when chronic hemodialysis patients were switched from an original iron sucrose product to an iron sucrose similar preparation.. A single center sequential observational retrospective study was conducted at a French hospital. The same patients were followed during two 24-week periods (iron sucrose in period P1; and iron sucrose similar in period P2). Anemia-related treatment costs were assessed in P1 and P2 from a hospital perspective. Sensitivity analyses were performed to assess the robustness of the results.. Our study included 109 patients (105 analyzed patients and 4 patients with missing data). The mean hemoglobin level was not different between P1 and P2 (p = 0.92). The mean differential cost per patient was + €13.90 (P2 - P1). The factors with the biggest impact on this result were the prices of epoetin alfa and iron sucrose.. This cost minimization analysis suggests that for chronic hemodialysis patients, iron sucrose and iron sucrose similar have the same efficacy and that using iron sucrose similar was more expensive in 66.7% of iterations.

Topics: Administration, Intravenous; Aged; Anemia; Costs and Cost Analysis; Drug Costs; Epoetin Alfa; Female; Ferric Oxide, Saccharated; France; Hematinics; Humans; Male; Middle Aged; Renal Dialysis; Retrospective Studies

Topics: Anemia; Female; Ferric Oxide, Saccharated; Health Services; Humans; India; Iron; Pregnancy

To explore the clinical efficacy of iron sucrose combined with recombinant human erythropoietin(EPO) for the treatment of anemia in elderly patients with hip fracture.. From February 2016 to April 2018, 96 elderly anemia patients who underwent hip fracture surgery were divided into three groups according to the treatment methods. All the three groups received anti-anemia treatment 3 days before operation. Among them, 32 cases in group A were treated with iron sucrose alone, 32 cases in group B were treated with recombinant human erythropoietin alone, and 32 cases in group C were treated with iron sucrose combined with recombinant human erythropoietin. The therapeutic effects of the three groups were observed and compared.. The clinical effective rate in group C was significantly higher than that in group A and B (. Compared with single drug, the combined use of sucrose and iron and recombinant human erythropoietin in the treatment of elderly hip fracture anemia has a definite effect. It can not only effectively improve the level of hemoglobin, ensure the smooth operation, but also reduce the blood transfusion rate of patients and promote their recovery after operation.

Topics: Aged; Anemia; Erythropoietin; Ferric Oxide, Saccharated; Hemoglobins; Hip Fractures; Humans; Recombinant Proteins

to study efficacy of various schemes of therapy of patients with chronic heart failure (CHF) and anemia.. We included in this study 208 patients with CHF of ishemic etiology (mean age 60.6±1.4 years, 174 with and 34 without anemia). According to therapeutic regimen of the use of methoxy polyethylene glycol-epoetin beta (MEB, 0.60 mсg/kg) and intravenous (IV) iron hydroxide sucrose complex all patients were divided into 4 groups. In all patients before and after treatment we determined Hb, Ht, plasma levels of ferritin, erythropoietin (EPO), NT-proBNP, IL-1, IL-6, TNF-α, transferrin saturation (TS), total vascular peripheral resistance, and parameters of systolic and diastolic function of left ventricular (LV) myocardium (by echocardiography and doppler echocardiography).. In patients with NYHA class I-IV CHF and anemia increases of Hb, Ht, TS, levels of EPO and ferritin occurred during treatment by basic drugs combained with MEB. In subgroups of patients with NYHA class I-II and III-IV the 6-minute walk distance significantly increased by 25.1 and 38.3%, and GFR- by 24.5 and 14.9%, respectively. At the background of therapy with IV iron we observed significant increases of Hb, plasma level of ferritin, and TS. Combined treatment with MEB and IV iron was associated with positive dynamics of Hb, Ht, levels of ferritin, EPO, NT-proBNP, and IL-6. In this group in subgroups of patients with NYHA class I-II and III-IV the 6-minute walk distance significantly increased by 21.6 (p.

Topics: Anemia; Chronic Disease; Ferric Oxide, Saccharated; Heart Failure; Humans; Iron; Middle Aged

Sucroferric oxyhydroxide, a novel iron-based phosphate-binder, has been shown to have beneficial effects in lowering serum phosphorus levels and improving renal anemia in clinical studies. Although an effect of this agent on fibroblast growth factor 23 (FGF23) has been reported in an animal study, there is little clinical data supporting this finding. This study aimed to evaluate the effect on chronic kidney disease-mineral and bone disorder, FGF23, renal anemia, iron-related parameters, adverse events of sucroferric oxyhydroxide in hemodialysis patients.. Hemodialysis patients, receiving existing hyperphosphatemia drugs with insufficient benefit, were administered sucroferric oxyhydroxide with/without calcium carbonate for 16 weeks. Serum phosphorus level declined rapidly in Week 8 (p < 0.0001) and this decrease persisted until Week 16 (p < 0.0001). FGF23 decreased (p = 0.0412, Week 16), and hemoglobin increased (p < 0.0001, Week 16). Cumulative dose of erythropoiesis-stimulating agents (p = 0.0122, Week 16), and intravenous iron (p = 0.0233, Week 12) decreased. All adverse reactions were mild, and diarrhea was the most frequently observed adverse reaction (16.7%). Therefore, hyperphosphatemia treatment with sucroferric oxyhydroxide may safely improve serum phosphorus level, renal anemia, FGF23, and other factors that affect the prognosis of hemodialysis patients.

Topics: Aged; Anemia; Demography; Drug Combinations; Female; Ferric Compounds; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Male; Phosphates; Renal Dialysis; Sucrose; Treatment Outcome

Topics: Anemia; Blood Transfusion; Edema; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Foot; Glucaric Acid; Hematinics; Humans; Infant; Male; Oxygen Inhalation Therapy; Pica

No studies have been performed comparing intravenous (IV) iron with transfused red blood cells (RBCs) for treating anemia during infection. In a previous report, transfused older RBCs increased free iron release and mortality in infected animals when compared to fresher cells. We hypothesized that treating anemia during infection with transfused fresh RBCs, with minimal free iron release, would prove superior to IV iron therapy.. Purpose-bred beagles (n = 42) with experimental Staphylococcus aureus pneumonia rendered anemic were randomized to be transfused RBCs stored for 7 days or one of two IV iron preparations (7 mg/kg), iron sucrose, a widely used preparation, or ferumoxytol, a newer formulation that blunts circulating iron levels.. Both irons increased the alveolar-arterial oxygen gradient at 24 to 48 hours (p = 0.02-0.001), worsened shock at 16 hours (p = 0.02-0.003, respectively), and reduced survival (transfusion 56%; iron sucrose 8%, p = 0.01; ferumoxytol 9%, p = 0.04). Compared to fresh RBC transfusion, plasma iron measured by non-transferrin-bound iron levels increased with iron sucrose at 7, 10, 13, 16, 24, and 48 hours (p = 0.04 to p < 0.0001) and ferumoxytol at 7, 24, and 48 hours (p = 0.04 to p = 0.004). No significant differences in cardiac filling pressures or performance, hemoglobin (Hb), or cell-free Hb were observed.. During canine experimental bacterial pneumonia, treatment of mild anemia with IV iron significantly increased free iron levels, shock, lung injury, and mortality compared to transfusion of fresh RBCs. This was true for iron preparations that do or do not blunt circulating free iron level elevations. These findings suggest that treatment of anemia with IV iron during infection should be undertaken with caution.

Topics: Anemia; Animals; Disease Models, Animal; Dogs; Erythrocyte Transfusion; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Iron; Lung Injury; Mortality; Pneumonia, Bacterial; Pneumonia, Staphylococcal

Topics: Aged, 80 and over; Anemia; Biomarkers; Carnosine; Darbepoetin alfa; Deficiency Diseases; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemoglobins; Humans; Kidney Failure, Chronic; Organometallic Compounds; Renal Dialysis; Treatment Outcome; Zinc; Zinc Compounds

This report describes the results of an observational, retrospective cohort study, evaluating the use of iron sucrose (IS) and red blood cell (RBC) transfusions in patients with cancer in routine clinical practice in France. A parallel investigated cohort treated with ferric carboxymaltose (FCM) has been reported earlier.. Data of patients with a solid tumour or haematological malignancy who have received IS or an RBC transfusion during 2010 from 3 months prior (M. Both IS and RBC transfusions effectively increased Hb levels in patients with cancer. IS was safe and well tolerated in this population. Considering prior reported results with FCM, using FCM may reduce ESA dose requirements and the required number of infusions.

Topics: Adult; Aged; Anemia; Erythrocyte Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; France; Glucaric Acid; Hematologic Neoplasms; Hemoglobins; Humans; Male; Maltose; Middle Aged; Neoplasms; Retrospective Studies

Controversy exists about any differences in longer-term safety across different intravenous iron formulations routinely used in hemodialysis (HD) patients. We exploited a natural experiment to compare outcomes of patients initiating HD therapy in facilities that predominantly (in ≥90% of their patients) used iron sucrose versus sodium ferric gluconate complex.. Retrospective cohort study of incident HD patients.. Using the US Renal Data System, we hard-matched on geographic region and center characteristics HD facilities predominantly using ferric gluconate with similar ones using iron sucrose. Subsequently, incident HD patients were assigned to their facility iron formulation exposure.. Facility-level use of iron sucrose versus ferric gluconate.. Patients were followed up for mortality from any, cardiovascular, or infectious causes. Medicare-insured patients were followed up for infectious and cardiovascular (stroke or myocardial infarction) hospitalizations and for composite outcomes with the corresponding cause-specific deaths.. HRs.. We matched 2,015 iron sucrose facilities with 2,015 ferric gluconate facilities, in which 51,603 patients (iron sucrose, 24,911; ferric gluconate, 26,692) subsequently initiated HD therapy. All recorded patient characteristics were balanced between groups. Over 49,989 person-years, 10,381 deaths (3,908 cardiovascular and 1,209 infectious) occurred. Adjusted all-cause (HR, 0.98; 95% CI, 0.93-1.03), cardiovascular (HR, 0.96; 95% CI, 0.89-1.03), and infectious mortality (HR, 0.98; 95% CI, 0.86-1.13) did not differ between iron sucrose and ferric gluconate facilities. Among Medicare beneficiaries, no differences between ferric gluconate and iron sucrose facilities were observed in fatal or nonfatal cardiovascular events (HR, 1.01; 95% CI, 0.93-1.09). The composite infectious end point occurred less frequently in iron sucrose versus ferric gluconate facilities (HR, 0.92; 95% CI, 0.88-0.96).. Unobserved selection bias from nonrandom treatment assignment.. Patients initiating HD therapy in facilities almost exclusively using iron sucrose versus ferric gluconate had similar longer-term outcomes. However, there was a small decrease in infectious hospitalizations and deaths in patients dialyzing in facilities predominantly using iron sucrose. This difference may be due to residual confounding, random chance, or a causal effect.

Topics: Administration, Intravenous; Aged; Anemia; Cardiovascular Diseases; Cause of Death; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infections; Kidney Failure, Chronic; Male; Middle Aged; Mortality; Proportional Hazards Models; Renal Dialysis; Retrospective Studies

To compare the oxidative stress induced by IV iron infusion in critically ill patients and in healthy volunteers.. Multicenter, interventional study.. Two ICUs and one clinical research center.. Anemic critically ill patients treated with IV iron and healthy volunteers.. IV infusion of 100 mg of iron sucrose.. Thirty-eight anemic patients (hemoglobin, median [interquartile range] = 8.4 g/dL [7.7-9.2]) (men, 25 [66%]; aged 68 yr [48-77]; Simplified Acute Physiology Score II, 48.5 [39-59]) and 39 healthy volunteers (men, 18 [46%]; aged 42.1 yr [29-50]) were included. Blood samples were drawn before (H0) and 2, 6, and 24 hours (H2, H6, and H24) after a 60-minute iron infusion for the determination of nontransferrin bound iron, markers of lipid peroxidation-8α-isoprostanes, protein oxidation-advanced oxidized protein product, and glutathione reduced/oxidized. Iron infusion had no effect on hemodynamic parameter in patients and volunteers. At baseline, patients had much higher interleukin-6, C-reactive protein, and hepcidin levels. 8α-isoprostanes was also higher in patients at baseline (8.5 pmol/L [6.5-12.9] vs 4.6 pmol/L [3.5-5.5]), but the area under the curve above baseline from H0 to H6 was not different (p = 0.38). Neither was it for advanced oxidized protein product and nontransferrin bound iron. The area under the curve above baseline from H0 to H6 (glutathione reduced/oxidized) was lower in volunteers (p = 0.009). Eight patients had a second set of dosages (after the fourth iron infusion), showing higher increase in 8α-isoprostanes.. In our observation, IV iron infusion does not induce more nontransferrin bound iron, lipid, or protein oxidation in patients compared with volunteers, despite higher inflammation, oxidative stress, and hepcidin levels and lower antioxidant at baseline. In contrary, iron induces a greater decrease in antioxidant, compatible with higher oxidative stress in volunteers than in critically ill patients.

Topics: Adult; Aged; Anemia; Antioxidants; Area Under Curve; C-Reactive Protein; Case-Control Studies; Critical Illness; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Healthy Volunteers; Humans; Infusions, Intravenous; Interleukin-6; Lipid Peroxidation; Male; Middle Aged; Oxidative Stress

Anemia management, based on erythropoiesis stimulating agents (ESA) and iron supplementation, has become an increasingly challenging problem in hemodialysis patients. Maintaining hemodialysis patients within narrow hemoglobin targets, preventing cycling outside target, and reducing ESA dosing to prevent adverse outcomes requires considerable attention from caregivers. Anticipation of the long-term response (i.e. at 3 months) to the ESA/iron therapy would be of fundamental importance for planning a successful treatment strategy. To this end, we developed a predictive model designed to support decision-making regarding anemia management in hemodialysis (HD) patients treated in center. An Artificial Neural Network (ANN) algorithm for predicting hemoglobin concentrations three months into the future was developed and evaluated in a retrospective study on a sample population of 1558 HD patients treated with intravenous (IV) darbepoetin alfa, and IV iron (sucrose or gluconate). Model inputs were the last 90 days of patients' medical history and the subsequent 90 days of darbepoetin/iron prescription. Our model was able to predict individual variation of hemoglobin concentration 3 months in the future with a Mean Absolute Error (MAE) of 0.75 g/dL. Error analysis showed a narrow Gaussian distribution centered in 0 g/dL; a root cause analysis identified intercurrent and/or unpredictable events associated with hospitalization, blood transfusion, and laboratory error or misreported hemoglobin values as the main reasons for large discrepancy between predicted versus observed hemoglobin values. Our ANN predictive model offers a simple and reliable tool applicable in daily clinical practice for predicting the long-term response to ESA/iron therapy of HD patients.

Topics: Aged; Anemia; Darbepoetin alfa; Disease Management; Erythropoiesis; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemoglobins; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Models, Statistical; Neural Networks, Computer; Renal Dialysis; Retrospective Studies

According to recent clinical trial data, correction of iron deficiency with intravenous (i.v.) iron has favorable outcomes on cardiac function. We evaluated whether i.v. iron treatment of anemic rats has favorable effect on the left ventricular (LV) performance and remodeling and the role of oxidative/nitrosative stress and inflammation in the process.. After weaning, Sprague-Dawley rats were fed low iron diet for 16weeks, after which the treatment group received five weekly doses of i.v. iron sucrose (10mg Fe/kg body weight). Echocardiography of LV was performed and hematology parameters were assessed before treatment (baseline, day 0) and at the end of the study (day 29). On day 29, rats were sacrificed and extracellular expansion and fibrosis in LV and interventricular septum were evaluated together with oxidative/nitrosative stress, pro-inflammatory, and repair process markers.. Although iron sucrose treatment did not fully correct the anemia, it reversed anemia-induced cardiac remodeling as indicated by echocardiographic and tissue Doppler parameters. Treatment with iron sucrose also prevented anemia-induced myocardial fibrosis as indicated by extracellular expansion and fibrosis markers. Anemia-induced inflammation was prevented by iron sucrose as indicated by the levels of proinflammatory (TNF-α, NF-κB65) and repair process markers (HSP27, HSP70). In addition, iron sucrose treatment significantly reduced (p<0.01) anemia-induced oxidative and nitrosative stress.. Intravenous iron sucrose treatment reversed anemia-induced remodeling of LV, prevented myocardial fibrosis, and improved cardiac function by attenuating oxidative/nitrosative stress and inflammation in the heart.

Topics: Anemia; Animals; Cardiotonic Agents; Ferric Compounds; Ferric Oxide, Saccharated; Fibrosis; Glucaric Acid; Inflammation; Infusions, Intravenous; Male; Myocardium; Oxidative Stress; Rats; Rats, Sprague-Dawley; Tyrosine; Ventricular Remodeling

To investigate the impact of anemia correction with erythropoiesis stimulants on the serum level of the circulating morphogenetic protein α-Klotho in patients with Stages 3B--4 chronic kidney disease (CKD).. 64 patients aged 42±8 years with Stages 3B--4 nondiabetic CKD were examined and divided into 2 groups: 1) 32 patients with anemia (the target hemoglobin levels could be achieved and kept with erythropoietin and iron saccharate in 20 patients (Group A) and those could not be done in 12 patients (Group 1B). A control group (Group 2) consisted of 32 non-anemic patients matched for gender, age, and degree of a glomerular filtration rate (GFR) reduction. Along with iron exchange indicators, the time course of changes in serum Klotho levels were examined in all the 64 patients during screening and one year after the end of the study. For correction of anemia, 32 patients with this condition (Groups 1A and 1B) took short-acting epoetin (hypodermic recormon 2,000 IU thrice per week + iron (intravenous venofer 5 ml of 100 mg once per week)) under control of hemoglobin levels and serum transferrin iron and ferritin saturation. After achieving the target hemoglobin level of 110-120 g/l, for its keeping, all the patients received, instead of short-acting epoetin, long-acting hypodermic darbepoetin-α 1.5 µg once every 2 months and intravenous iron saccharate 100 mg once every 2 weeks.. Among the 32 anemic patients in Group 1, 20 (63%) (Group 1 A) could achieve the target hemoglobin level (110--120 g/l) and maintain it within this range, by performing therapy with epoitin-β + iron saccharate; anemia (the hemoglobin level of <110 g/l) persisted in 12 (37%) patients (Group 1B) despite the fact that epoetin and iron saccharate had been administered. Group 1A was noted to have an increase in α-Klotho concentrations by an average of 100±11.6-pg/ml as compared to Group 1B (by only 72±4.2 pg/ml). At the same time, the α-Klotho levels in the control group by the end of the follow-up decreased by an average of 210±12.9 pg/ml as compared to the prescreening value. There was a direct correlation between hemoglobin and serum ferritin concentrations and iron ferritin saturation percentage and α-Klotho levels. It was ascertained that the hemoglobin concentration of ≥110 g/l with a sensitivity of 89% and a specificity of 75% could predict higher serum α-Klotho levels in CKD. The same patients were found to have an inverse relationship between the serum level of α-Klotho and the risk of cardiovascular events.. The serum level of the protein Klotho is not only a marker for the severity of CKD and its complications (anemia, left ventricular hypertrophy, and heart failure), but also a pathogenetic factor of CKD progression. Anemia correction with erythropoiesis stimulants has been shown to enhance the renal and extrarenal production of α-Klotho.. Цель исследования. Изучить влияние коррекции анемии препаратами, стимулирующими эритропоэз, на уровень в сыворотке крови циркулирующей формы морфогенетического белка α-Klotho у больных хронической болезнью почек (ХБП) 3Б-4 стадии. Материалы и методы. Обследовали 64 больных ХБП недиабетической этиологии 3Б-4 стадии в возрасте 42±8 лет, которых распределили в 2 группы: 1-я - 32 больных с анемией (у 20 с помощью эритропоэтина и железа сахарата удалось достичь и поддерживать целевой уровень гемоглобина - группа 1А, и 12, которым назначенная терапия не позволила достигнуть целевого уровня гемоглобина - группа 1Б). Группу контроля (2-я) составили 32 больных без анемии, сопоставимых с больными 1-й группы по полу, возрасту и степени снижения скорости клубочковой фильтрации (СКФ). У всех 64 больных во время скрининга и через 1 год после окончания исследования наряду с показателями обмена железа изучена динамика уровня Klotho в сыворотке. Для коррекции анемии 32 пациента с анемией (группы 1А и 1Б) получали эпоэтин короткого действия (рекормон по 2000 ЕД 3 раза в неделю подкожно) + железо (венофер 5 мл 100 мг 1 раз в неделю внутривенно) под контролем уровня гемоглобина, насыщения трансферрина железом и ферритина сыворотки. После достижения целевого уровня гемоглобина 110-120 г/л для его поддержания всем пациентам вместо эпоэтина короткого действия вводили эпоэтин длительного действия дабепоэтин-α 1,5 мкг на 1 кг 1 раз в 2 мес подкожно и железа сахарат 100 мг 1 раз в 2 нед внутривенно. Результаты. Среди 32 больных 1-й группы с анемией у 20 (63%) (группа 1А) терапия эпоэтином-β + железа сахаратом позволила достигнуть целевого уровня гемоглобина (110-120 г/л) и поддерживать его в этом диапазоне; у 12 (37%) больных (группа 1Б), несмотря на введение эпоэтина и железа сахарата, сохранялась анемия (уровень гемоглобина <110 г/л). У больных группы 1А отмечено увеличение концентрации α-Klotho в среднем на 100±11,6 пг/мл по сравнению с таковой у больных группы 1Б (только на 72±4,2 пг/мл). В то же время в контрольной группе к концу наблюдения уровень α-Klotho уменьшился в среднем на 210±12,9 пг/мл по сравнению с таковой до скрининга. Отмечена прямая связь между концентрацией гемоглобина, ферритина в сыворотке крови и процентом насыщения железом трансферрина и уровнем α-Klotho. Выявлено, что концентрация гемоглобина ≥110 г/л с чувствительностью 89% и специфичностью 75% позволяет прогнозировать выявление более высокого уровня α-Klotho в сыворотке крови при ХБП. У тех же больных о

Topics: Adult; Anemia; Biomarkers; Disease Progression; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Glucuronidase; Hematinics; Hemoglobins; Humans; Iron; Klotho Proteins; Male; Middle Aged; Outcome Assessment, Health Care; Renal Dialysis; Renal Insufficiency, Chronic; Severity of Illness Index

Anemia is a major cause of morbidity in patients with cancer resulting in poor physical performance, prognosis and therapy outcome. The aim of this study is to assess the efficacy of intravenous (iv) iron administration for the correction of anemia, for the prevention of exacerbation of anemia, for decreasing blood transfusion rates, and for the survival of cancer patients.. Patients with different solid tumor diagnosis who received iv iron during their cancer treatment were evaluated retrospectively. Sixty-three patients with hemoglobin (Hgb) levels between ≥ 9 g/dL, and ≤ 10 g/dL, and no urgent need for red blood cell transfusion were included in this retrospective analysis. The aim of cancer treatment was palliative for metastatic patients (36 out of 63), or adjuvant or curative for patients with localized disease (27 out of 63). All the patients received 100 mg of iron sucrose which was delivered intravenously in 100 mL of saline solution, infused within 30 min, 5 infusions every other day. Complete blood count, serum iron, and ferritin levels before and at every 1 to 3 months subsequently after iv iron administration were followed regularly.. Initial mean serum Hgb, serum ferritin and serum iron levels were 9.33 g/dL, 156 ng/mL, and 35.9 μg/dL respectively. Mean Hgb, ferritin, and iron levels 1 to 3 months, and 6 to 12 months after iv iron administration were 10.4 g/dL, 11.2 g/dL, 298.6 ng/mL, 296.7 ng/mL, and 71.6 μg/dL, 67.7 μg/dL respectively with a statistically significant increase in the levels (p < 0.001). Nineteen patients (30 %) however had further decrease in Hgb levels despite iv iron administration, and blood transfusion was necessary in 18 of these 19 patients (28.5 %). The 1-year overall survival rates differed in metastatic cancer patients depending on their response to iv iron; 61.1 % in responders versus 35.3 % in non-responders, (p = 0.005), furthermore response to iv iron correlated with tumor response to cancer treatment, and this relation was statistically significant, (p < 0.001).. Iv iron administration in cancer patients undergoing active oncologic treatment is an effective and safe measure for correction of anemia, and prevention of worsening of anemia. Amelioration of anemia and increase in Hgb levels with iv iron administration in patients with disseminated cancer is associated with increased tumor response to oncologic treatment and overall survival. Response to iv iron may be both a prognostic and a predictive factor for response to cancer treatment and survival.

Topics: Administration, Intravenous; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Agents; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Male; Middle Aged; Neoplasm Metastasis; Neoplasms; Prognosis; Retrospective Studies; Survival Analysis; Treatment Outcome

To assess the impact of implementing a Patient Blood management program (PBM) on transfusion rates, hospital stay, and complications for total hip arthroplasty (THA) and total knee arthroplasty (TKA).. A retrospective, observational study was conducted in Araba University Hospital from 2006 to 2011. All THA and TKA were included. The percentage of patients transfused with allogeneic blood was the primary endpoint. The mean of transfused blood bags, overall transfusion, complications (both overall and specific), patient age and sex, pre-operative and discharge hemoglobin, and hospital stay were recorded.. A total of 825 THA and 875 TKA were included. Both THA (47.6% in 2006 and 30.6% in 2011; P=.013) and TKA (33.6% in 2006 and 16.2% in 2011; P<.001) showed a significant decrease of allogeneic transfusion. The overall transfusion rate was also reduced in THA (65.7% in 2006 and 39.5% in 2011; P<.001) and TKA (38.3% in 2006 and 17.2% in 2011; P<.001). Hospital stay was reduced in both types of surgeries (P<.038 in THA and P<.0001 in TKA). In 2006 it was 9.2±2.9 days for THA and 11.1±4.7 days for TKA, whereas in 2011 it was 8.7±4.2 and 9.5±3.4 days for THA and TKA, respectively.. Our patient blood management has decreased the percentage of patients that need both allogeneic and autologous transfusion in a statistically significant way. Although the mean hospital stay decreased, the impact of the PBM cannot be established.

Topics: Aged; Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Biomarkers; Blood Banks; Blood Loss, Surgical; Blood Transfusion; Blood Transfusion, Autologous; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Hospitals, University; Humans; Length of Stay; Male; Middle Aged; Operative Blood Salvage; Orthopedics; Postoperative Hemorrhage; Program Evaluation; Retrospective Studies; Spain; Tranexamic Acid

Topics: Aged; Anemia; Aortic Aneurysm, Abdominal; Blood Loss, Surgical; Critical Illness; Epoetin Alfa; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Iron Compounds; Jehovah's Witnesses; Male; Recombinant Proteins; Salvage Therapy

Ferumoxytol was first approved for clinical use in 2009 solely based on data from trial comparisons with oral iron on biochemical anemia efficacy end points. To compare the rates of important patient outcomes (infection, cardiovascular events and death) between facilities predominantly using ferumoxytol versus iron sucrose (IS) or ferric gluconate (FG) in patients with end-stage renal disease (ESRD)-initiating hemodialysis (HD).. Using the United States Renal Data System, we identified all HD facilities that switched (almost) all patients from IS/FG to ferumoxytol (July 2009-December 2011). Each switching facility was matched with three facilities that continued IS/FG use. All incident ESRD patients subsequently initiating HD in these centers were studied and assigned their facility exposure. They were followed for all-cause mortality, cardiovascular hospitalization/death or infectious hospitalization/death. Follow-up ended at kidney transplantation, switch to peritoneal dialysis, transfer to another facility, facility switch to another iron formulation and end of database (31 December 2011). Cox proportional hazards regression was then used to estimate adjusted hazard ratios [HR (95% confidence intervals)].. In July 2009-December 2011, 278 HD centers switched to ferumoxytol; 265 units (95.3%) were matched with 3 units each that continued to use IS/FG. Subsequently, 14 206 patients initiated HD, 3752 (26.4%) in ferumoxytol and 10 454 (73.6%) in IS/FG centers; their characteristics were very similar. During 6433 person-years, 1929 all-cause, 726 cardiovascular and 191 infectious deaths occurred. Patients in ferumoxytol (versus IS/FG) facilities experienced similar all-cause [0.95 (0.85-1.07)], cardiovascular [0.99 (0.83-1.19)] and infectious mortality [0.88 (0.61-1.25)]. Among 5513 Medicare (Parts A + B) beneficiaries, cardiovascular events [myocardial infarction, stroke and cardiovascular death; 1.05 (0.79-1.39)] and infectious events [hospitalization/death; 0.96 (0.85-1.08)] did not differ between the iron exposure groups.. In incident HD patients, ferumoxytol showed similar short- to mid-term safety profiles with regard to cardiovascular, infectious and mortality outcomes compared with the more commonly used intravenous iron formulations IS and FG.

Topics: Administration, Intravenous; Aged; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Glucaric Acid; Hematinics; Humans; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Prognosis; Proportional Hazards Models; Renal Dialysis; Renal Insufficiency, Chronic; Stroke; United States

Topics: Anemia; Critical Illness; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Intensive Care Units; Male

Anemia in patients with cancer who are undergoing active therapy is commonly encountered and may worsen quality of life in these patients. The effect of blood transfusion is often temporary and may be associated with serious adverse events. Erythropoiesis-stimulating agents are not effective in 30%-50% of patients and may have a negative effect on overall survival.. To assess the efficacy and feasibility of intravenous iron therapy in patients with cancer who have non-iron-deficiency anemia and who are undergoing treatment with chemotherapy without the use of erythropoiesis-stimulating agents.. Adult patients with solid cancers and non-iron-deficiency anemia were included. Ferric sucrose at a dose of 200 mg was given in short intravenous infusions weekly for a total of 12 weeks. Hemoglobin level was measured at baseline, every 3 weeks, and 2 weeks after the last iron infusion (week 14). Adverse events related to intravenous iron were prospectively reported.. Of 25 patients included, 19 (76.0%) completed at least three iron infusions and 14 (56.0%) finished the planned 12 weeks of therapy. The mean hemoglobin level of the 25 patients at baseline was 9.6 g/dL (median, 9.9 g/dL; range, 6.9 g/dL 10.9 g/dL). The mean change in hemoglobin level for the 15 patients who completed at least 9 treatments was 1.7 g/dL (median, 1.1 g/dL; range, -1.9 g/dL to 3.2 g/dL); it reached 2.1 g/dL (median, 1.3 g/dL; range, -0.2 g/dL to 4.6 g/dL; P = 0.0007) for the 14 patients who completed all 12 weekly treatments. Five (20.0%) patients were transfused and considered as treatment failures. No treatment-related adverse events were reported.. Intravenous iron treatment alone is safe and may reduce blood transfusion requirements and improve hemoglobin level in patients with cancer who are undergoing anticancer therapy. Further randomized studies are needed to confirm these findings.

Topics: Adult; Aged; Anemia; Antineoplastic Agents; Blood Transfusion; Feasibility Studies; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Male; Middle Aged; Neoplasms; Pilot Projects; Prospective Studies; Quality of Life; Treatment Outcome

Topics: Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Pregnancy; Pregnancy Complications, Hematologic

Iron deficiency anaemia (IDA) is the most common nutritional deficiency in pregnancy. Prophylactic oral iron is recommended during pregnancy to meet the increased requirement. In India, women become pregnant with low baseline haemoglobin level resulting in high incidence of moderate to severe anaemia in pregnancy where oral iron therapy cannot meet the requirement. Pregnant women with moderate anaemia are to be treated with parentral iron therapy. This study was undertaken to evaluate the response and effect of intravenous iron sucrose complex (ISC) given to pregnant women with IDA.. A prospective study was conducted (June 2009 to June 2011) in the department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi. One hundred pregnant women with haemoglobin between 5-9 g% with diagnosed iron deficiency attending antenatal clinic were given intravenous iron sucrose complex in a dose of 200 mg twice weekly schedule after calculating the dose requirement.. The mean haemoglobin raised from 7.63 ± 0.61 to 11.20 ± 0.73 g% (P<0.001) after eight wk of therapy. There was significant rise in serum ferritin levels (from 11.2 ± 4.7 to 69 ± 23.1 μg/l) (P<0.001). Reticulocyte count increased significantly after two wk of starting therapy (from 1.5 ± 0.6 to 4.6 ± 0.8%).Other parameters including serum iron levels and red cell indices were also improved significantly. Only one woman was lost to follow up. No major side effects or anaphylactic reactions were noted during study period.. Parentral iron therapy was effective in increasing haemoglobin, serum ferritin and other haematological parameters in pregnant women with moderate anaemia. Intravenous iron sucrose can be used in hospital settings and tertiary urban hospitals where it can replace intramuscular therapy due to injection related side effects. Further, long-term comparative studies are required to recommend its use at peripheral level.

Topics: Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Pregnancy; Pregnancy Complications, Hematologic; Prospective Studies

The aim of this study was to determine the influence of inflammatory markers, predictive values of CRP and target hemoglobin (Hb) in patients on chronic hemodialysis.. Made is a cross-sectional study of inflammatory agents serum levels-CRP, fibrinogen and ferritin before hemodialysis in 114 patients divided into two groups according to the achieved or unachieved target hemoglobin level in the Cantonal Hospital in Zenica.. The 57 patients (test group) did not reached the target hemoglobin in the range from 10-12 g/dl and CRP values were significantly higher compared to the control group (57 patients) who had reached targeted hemoglobin values. Levels of fibrinogen and ferritin were not significantly different between the control and the test group. CRP values are in negative correlation with the Hb concentration, while fibrinogen and ferritin values had a positive correlation. Significant negative correlation was only found in case of CRP, respectively, higher CRP was at lower levels of blood Hb. It was found that the predictive value of CRP is 6.5 mg/L to achieve target Hb level. If the CRP increases by 1 mg/L, possibilities to achieve the target Hb level in dialysis patients is reduced by 7.5%, with a sensitivity of 51% and specificity of 77%. Ferritin was elevated due to iatrogenic iron saturation, because all patients received intravenous iron and was treated with erythropoietin. By identification and analysis of inflammatory agents and duration ofhemodialysis, are explored the primary influence on hematopoiesis, of course, with the primary application of erythropoietin and adjuvant agents. It has been shown that CRP alone has an impact on the target Hb level, depending on the hemodialysis duration.. The research results show how what looks as routine findings may be helpful in the timely detection of threatening complications and their treatment, and provide extended and improved quality of life for patients on hemodialysis.

Topics: Aged; Anemia; Biomarkers; C-Reactive Protein; Case-Control Studies; Cross-Sectional Studies; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Fibrinogen; Glucaric Acid; Hemoglobins; Humans; Inflammation; Kidney Failure, Chronic; Male; Middle Aged; Predictive Value of Tests; Renal Dialysis; ROC Curve; Sucrose

With the recent implementation of bundling reimbursement policy, the use of intravenous (IV) iron preparations for the management of anemia in the end-stage renal disease (ESRD) population has dramatically increased. Iron overload increases the risk of infections in individuals with or without kidney disease. IV iron administration in ESRD patients impairs bacteriocidal capacity of polymorphonuclear leukocytes (PMNs) against Escherichia coli. These preparations consist of an elemental iron core and a carbohydrate shell. In addition to the iron core, the carbohydrate shell may affect PMNs. We therefore examined the effect of iron sucrose, a commonly used preparation, on phagocytic capacity of PMNs from a group of normal individuals against Gram-positive (Staphylococcus aureus) and Gram-negative (E. coli) bacteria.. Iron sucrose was added to heparinized blood samples at pharmacologically-relevant concentrations and incubated for 4 and 24 h at 37°C to simulate in vivo condition. Blood samples mixed with equal volume of saline solution served as controls. To isolate the effects of the carbohydrate shell, blood samples were co-treated with the iron chelator, desferrioxamine.. Iron sucrose caused significant PMN apoptosis and dose-dependent suppression of phagocytic function against both Gram-positive and Gram-negative bacteria. These abnormalities were prevented by desferrioxamine which precluded contribution of the carbohydrate shell to the PMN dysfunction.. At pharmacologically-relevant concentrations, iron sucrose promotes apoptosis and inhibits phagocytic activities of PMNs. The deleterious effect of iron sucrose is mediated by its elemental iron core, not its carbohydrate shell, and as such may be shared by other IV iron preparations.

Topics: Adult; Anemia; Apoptosis; Carbohydrates; Escherichia coli; Female; Ferric Compounds; Ferric Oxide, Saccharated; Flow Cytometry; Glucaric Acid; Hematinics; Humans; Kidney Failure, Chronic; Male; Neutrophils; Phagocytosis; Staphylococcus aureus; Time Factors

Preoperative anemia is a risk factor for postoperative morbidity and in-hospital mortality in cardiac surgery. However, it is not known whether treatment of anemia before cardiac surgery by administering recombinant human erythropoietin (rhEPO) plus iron improves postoperative outcomes and decreases red blood cell transfusions in these patients. In 1998 a collection of consecutive data for patients who underwent valve replacement was initiated and the inclusion criterion was anemia. Treatment with rhEPO was given at a dose of 500 IU/kg/day every week for 4 weeks and the fifth dose 48 hours before valve replacement. During each rhEPO session, patients received intravenous iron sucrose supplementation. The intervention cohort (2006 to 2011) included 75 patients and the observation cohort was composed of 59 patients who did not receive any treatment (1998 to 2005). Multivariable logistic regression analysis showed that administration of combined therapy was independently associated with decreased postoperative morbidity (odds ratio [OR] 0.13, 95% confidence interval [CI] 0.03 to 0.59 p = 0.008) and in-hospital mortality (OR 0.16, 95% CI 0.28 to 0.95 p = 0.04) after adjusting for logistic European System for Cardiac Operative Risk Evaluation score, type of intervention, time of cardiopulmonary bypass, and year of surgery. Individually, this treatment also decreased postoperative renal failure (OR 0.23, 95% CI 0.06 to 0.88, p = 0.03). Rate of red blood cell transfusion decreased from 93% in the observation cohort to 67% in the intervention cohort as did days of hospitalization (median, 15 days, 10 to 27, versus 10 days, 8 to 14, respectively, p = 0.01 for all comparisons). In conclusion, administration of intravenous rhEPO plus iron in anemic patients before valve replacement improves postoperative survival, decreases blood transfusions, and shortens hospitalization.

Topics: Aged; Anemia; Dose-Response Relationship, Drug; Drug Therapy, Combination; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Hematinics; Hospital Mortality; Humans; Infusions, Intravenous; Male; Postoperative Period; Preoperative Care; Prospective Studies; Recombinant Proteins; Risk Factors; Spain; Sucrose; Survival Rate; Treatment Outcome

Erythropoiesis-stimulating agents and adjuvant intravenous iron have been the primary treatment for anemia in chronic kidney disease. Recent clinical and policy-related events have challenged this traditional paradigm, particularly in regard to erythropoiesis-stimulating agents. Less is known about the impact of these events on intravenous iron use.. United States Renal Data System data (2002-2008) on Medicare hemodialysis patients were examined. For each patient, monthly intravenous iron dose, erythropoiesis-stimulating agent dose, and hemoglobin values were determined. Data were summarized by calendar quarter and plotted for the entire sample and by demographic, clinical, and facility-level subgroups. Marginal means for these variables also were computed to account for changes in patient characteristics over time.. Quarterly iron use increased from 64% in 2002 to 76% in 2008. Mean quarterly iron dose increased from 500 mg in 2002 to 650 mg in 2008. Mean monthly erythropoiesis-stimulating agent dose (per quarter) increased from 2002 to 2006 and then declined. Mean hemoglobin values followed a pattern similar to erythropoiesis-stimulating agent dose. The same patterns in iron, erythropoiesis-stimulating agent dose, and hemoglobin were generally observed across demographic, clinical, facility, and geographic subgroups, with some important differences between subgroups, specifically race and dialysis vintage.. Anemia management patterns have changed markedly between 2002 and 2008, with a steady increase in intravenous iron use even after declines in erythropoiesis-stimulating agent dose and hemoglobin. The clinical impacts of these changes need further evaluation.

Topics: Adolescent; Adult; Aged; Anemia; Child; Child, Preschool; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Iron Compounds; Kidney Failure, Chronic; Male; Middle Aged; Practice Patterns, Physicians'; Renal Dialysis; Time Factors; United States

Oral iron substitution has shown to be insufficient for treatment of severe iron deficiency anemia in pregnancy. Ferric carboxymaltose is a new intravenous (i.v.) iron formulation promising to be more effective and as safe as iron sucrose. We aimed to assess side effects and tolerance of ferric carboxymaltose compared to i.v. iron sucrose in pregnant women.. We performed a retrospective analysis of 206 pregnant women who were treated either with ferric carboxymaltose or iron sucrose for iron-deficiency anemia with intolerability to oral iron substitution, or insufficient hemoglobin increase after oral iron treatment, or need for rapid hemoglobin reconstitution. Primary endpoint was to evaluate the maternal safety and tolerability. Secondary endpoint was to assess efficacy of the treatment and exclude safety concerns for the fetus.. The incidence of drug-related adverse events was low and mostly mild in both groups. Mild adverse events occurred in 7.8% for ferric carboxymaltose and in 10.7% for iron sucrose. The mean rise of hemoglobin value was 15.4 g/L for ferric carboxymaltose and 11.7 g/L for iron sucrose.. Ferric carboxymaltose administration in pregnant women is well tolerated and is not associated with any relevant clinical safety concerns. Ferric carboxymaltose has a comparable safety profile to iron sucrose but offers the advantage of a much higher iron dosage at a time reducing the need for repeated applications and increasing patients' comfort. Ferric carboxymaltose is the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.

Topics: Administration, Intravenous; Adolescent; Adult; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Maltose; Middle Aged; Pregnancy; Pregnancy Complications, Hematologic; Retrospective Studies; Young Adult

Anemia is a common and important complication of chronic kidney disease. Treatment includes the use of erythropoiesis-stimulating agents (ESAs) and iron supplementation. However, the optimal schedule of iron supplementation remains to be defined. Thirty-one long-term hemodialysis patients were treated for 1 year (period 1) with ESAs and an intermittent pulse regimen consisting of 100 mg of iron sucrose administered after different dialysis sessions depending on serum ferritin and other laboratory values, but no more than once per week. During the next 3 years (period 2), patients were treated with ESAs and need-based, continuous, low-dose iron. Iron doses were determined on the basis of values and changes of serum ferritin and transferrin saturation every fourth week after the longest interdialysis time interval. Iron doses ranged from 10 to 60 mg of iron sucrose and were given 1-3 times per week. If grounded, we gradually reduced or even abolished the iron doses. A significant increase in the hemoglobin concentration and hematocrit during period 2 in comparison with period 1 was observed. The use of ESAs did not change significantly during period 2 in comparison with period 1, while the use of iron was significantly lower in period 2. Significantly lower values were obtained for serum ferritin, saturation of transferrin, serum iron, and total serum iron-binding capacity during period 2. A better response to ESA therapy (increase in hemoglobin and hematocrit) is achieved with need-based, continuous, low-dose iron replacement.

Topics: Adult; Aged; Aged, 80 and over; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis

Both erythropoiesis-stimulating agents and iron treatments are underutilized in peritoneal dialysis (PD) patients. Studies to evaluate safety profiles of various intravenous iron preparations are limited in PD patients compared to hemodialysis. No study in the literature compared safety of low-molecular-weight iron dextran (LMW-ID) with that of iron sucrose in PD patients. We aimed to compare adverse-effect profiles of LMW-ID and iron sucrose with varying dosing schedules in PD patients with a hope to foster use of parenteral iron solutions in PD patients.. We retrospectively reviewed patient charts and included patients who were administered iron sucrose or LMW-ID parenterally. Sociodemographic characteristics, clinical features, and pertinent laboratory data were collected. Adverse events which were deemed to be related to infusion of parenteral iron were recorded. We double-checked both physician records and nursing documents for observed adverse events.. A total of 167 chronic PD patients were included in the study, and 92 patients were administered LMW-ID, whereas 75 patients were administered iron sucrose. Only one adverse event occurred in a patient who was administered 500 mg iron sucrose in a single infusion.. This study showed the comparable safety of LMW-ID in varying doses over that of iron sucrose in PD patients.

Topics: Adult; Aged; Anemia; Dextrans; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Middle Aged; Peritoneal Dialysis

Topics: Adult; Aged; Aged, 80 and over; Anemia; Costs and Cost Analysis; Elective Surgical Procedures; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Male; Maltose; Middle Aged; Preoperative Care

Topics: Anemia; Blood Proteins; Case-Control Studies; Clinical Protocols; Drug Monitoring; Erythropoiesis; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Oxidation-Reduction; Prospective Studies; Renal Dialysis

Erythropoietin combined with parenteral iron sucrose therapy is an alternative to blood transfusion in anemic patients. It was shown to be effective in surgical patients in several previous studies when used in conjunction with other methods. However, there are no guidelines about safety limits in dosage amounts or intervals. In this study, we report a case of significant postoperative hemorrhage managed with high dose parenteral iron sucrose, low dose erythropoietin, vitamin B(12), vitamin C, and folic acid. An 80-year-old female patient presented for severe anemia after a total hip arthroplasty and refused an allogenic blood transfusion as treatment. The preoperative hemoglobin of 12.2 g/dL decreased to 5.3 g/dL postoperatively. She received the aforementioned combination of iron sucrose, erythropoietin, and vitamins. A total of 1,500 mg of intravenous iron sucrose was given postoperatively for 6 consecutive days. Erythropoietin was also administered at 2,000 IU every other day for a total of 12,000 IU. The patient was discharged in good condition on the twelfth postoperative day with a hemoglobin of 8.5 g/dL. Her hemoglobin was at 11.2 g/dL on the twentieth postoperative day.

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Blood Transfusion; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans

In patients treated by maintenance hemodialysis the relationship to survival of hemoglobin level and administered epoetin-alfa and intravenous iron is controversial. The study aim was to determine effects on patient survival of administered epoetin-alfa and intravenous iron, and of hemoglobin and variables related to iron status.. The patients were 1774 treated by maintenance hemodialysis in 3 dialysis units in New York, NY from January 1998 to June, 2007. A patient-centered, coded, electronic patient record used in patient care enabled retrospective analysis of data collected prospectively. For survival analysis, patients were censored when transplanted, transferred to hemodialysis at home or elsewhere, peritoneal dialysis. Univariate Kaplan-Meier analysis was followed by multivariate analysis with Cox's regression, using as variables age, race, gender, major co-morbid conditions, epoetin-alfa and intravenous iron administered, and 15 laboratory tests.. Median age was 59 years, epoetin-alfa (interquartile range) 18,162 (12,099, 27,741) units/week, intravenous iron 301 (202, 455) mg/month, survival 789 (354, 1489) days. Median hemoglobin was 116 (110, 120)g/L, transferrin saturation 29.7 (24.9, 35.1)%, serum ferritin 526 (247, 833) microg/L, serum albumin 39.0 (36.3, 41.5) g/L. Survival was better the higher the hemoglobin, best with > 120 g/L. Epoetin-alfa effect on survival was weak but had statistically significant interaction with intravenous iron. For intravenous iron, survival was best with 1-202 mg/month, slightly worse with 202-455 mg/month; it was worst with no intravenous iron, only slightly better with > 455 mg/month. Survival was worst with transferrin saturation < or = 16%, serum ferritin < or = 100 microg/L, best with transferrin saturation > 25%, serum ferritin > 600 microg/L The effects of each of hemoglobin, intravenous iron, transferrin saturation, and serum ferritin on survival were independently significant and not mediated by other predictors in the model.. Long term survival of maintenance hemodialysis patients was favorably affected by a relatively high hemoglobin level, by moderate intravenous iron administration, and by indicators of iron sufficiency. It was unfavorably influenced by a low hemoglobin level, and by indicators of iron deficiency.

Topics: Adult; Aged; Anemia; Comorbidity; Drug Therapy, Combination; Epoetin Alfa; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Infusions, Intravenous; Iron-Dextran Complex; Kaplan-Meier Estimate; Kidney Failure, Chronic; Male; Middle Aged; Proportional Hazards Models; Prospective Studies; Recombinant Proteins; Renal Dialysis; Retrospective Studies; Survival Analysis; Transferrin

The effects of i.v. iron formulations on serum ferritin concentration (SFC) and transferrin saturation (TSAT) are compared in adult hemodialysis patients with anemia receiving erythropoiesis-stimulating agents (ESAs).. This study consisted of 215 patients who were receiving chronic hemodialysis, ESAs, and i.v. iron supplementation from November 2005 to November 2006. All patients received iron sucrose therapy from November 2005 to April 2006. Patients were then switched to sodium ferric gluconate. If the patient's SFC was <100 ng/mL and TSAT was <20%, then iron sucrose 100 mg i.v. at every hemodialysis for 10 doses or sodium ferric gluconate 125 mg i.v. at every hemodialysis for 8 doses was administered as loading doses. Maintenance doses of iron sucrose 60 mg or sodium ferric gluconate 62.5 mg were administered every two weeks if the SFC was 100-499 ng/mL and the TSAT was 20-29% or every four weeks if the SFC was 500-600 ng/mL and the TSAT was 30-45%. SFC and TSAT were measured every three months.. More treatment courses resulted in target SFC and TSAT values during treatment with sodium ferric gluconate than iron sucrose, but neither difference was significant. The proportion of treatment courses resulting in SFCs of >600 ng/mL (above the target range) was significantly greater during treatment with iron sucrose than sodium ferric gluconate.. There was no significant difference between iron sucrose and sodium ferric gluconate in the frequency in which SFC and TSAT values were within target ranges in hemodialysis patients with anemia receiving ESAs. Of the two drugs, iron sucrose was more likely to produce an SFC above the target range.

Topics: Adult; Anemia; Cohort Studies; Darbepoetin alfa; Drug Therapy, Combination; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Humans; Injections, Intravenous; Renal Dialysis; Retrospective Studies; Transferrin

The prognosis in elderly patients with advanced chronic heart failure (CHF) and cardio-renal anemia syndrome (CRAS) is ominous, and treatment alternatives in this subset of patients are scarce.. To assess the long-term influence of combined therapy with intravenous (IV) iron and erythropoietin (rHuEPO) on hemoglobin (Hb), natriuretic peptides (NT-proBNP), and clinical outcomes in elderly patients with advanced CHF and mild-to-moderate renal dysfunction and anemia (CRAS) who are not candidates for other treatment alternatives, 487 consecutive patients were evaluated. Of them, 65 fulfilling criteria for entering the study were divided into 2 groups and treated in an open-label, nonrandomized fashion: intervention group (27, combined anemia therapy) and control group (38, no treatment for anemia). At baseline, mean age was 74 +/- 8 years, left ventricular ejection fraction was 34.5 +/- 14.1, Hb was 10.9 +/- 0.9 g/dL, creatinine was 1.5 +/- 0.5 mg/dL, NT-proBNP was 4256 +/- 4952 pg/mL, and 100% were in persistent New York Heart Association (NYHA) Class III or IV. At follow-up (15.3 +/- 8.6 months), patients in the intervention group had higher levels of hemoglobin (13.5 +/- 1.5 vs. 11.3 +/- 1.1; P < .0001), lower levels of natural log of NT-proBNP (7.3 +/- 0.8 vs. 8.0 +/- 1.3, P = .016), better NYHA functional class (2.0 +/- 0.6 vs. 3.3 +/- 0.5; P < .001), and lower readmission rate (25.9% vs. 76.3%; P < .001). In the multivariate Cox proportional hazards model, combined therapy was associated with a reduction of the combined end point all-cause mortality or cardiovascular hospitalization (HR 95%CI 0.2 [0.1-0.6]; P < .001).. Long-term combined therapy with IV iron and rHuEPO may increase Hb, reduce NT-proBNP, and improve functional capacity and cardiovascular hospitalization in elderly patients with advanced CHF and CRAS with mild to moderate renal dysfunction.

Topics: Aged; Aged, 80 and over; Anemia; Chronic Disease; Cohort Studies; Drug Evaluation; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Heart Failure; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Male; Neurotransmitter Agents; Pilot Projects; Prospective Studies; Recombinant Proteins; Survival Rate; Syndrome; Time Factors; Treatment Outcome

For reasons of religious belief, Jehova's Witnesses do not accept blood transfusions or the infusion of blood products. In situations in which severe, life-threatening anemia develops, patient refusal to receive a transfusion can create serious ethical and legal problems. The principle of patient autonomy, which implies the freedom to accept or reject treatment, comes into conflict with the physician's obligation to safeguard the patient's life using all means possible. We report 2 cases of severe anemia in Jehova's Witnesses. One was due to menorrhagia and the other to postpartum bleeding. The physician should be aware of alternatives to infusion of blood products and know how to cope with an unexpected critical event in these patients. The measures we took were effective in our patients. In the case of menorrhagia, hormone treatment is effective when the woman wishes to preserve the ability to conceive and avoid surgery (endometrial ablation and hysterectomy). In postpartum bleeding refractory to conservative treatment, selective embolization of bleeding vessels may make it unnecessary to resort to more aggressive treatment, such as obstetric hysterectomy.

Topics: Adult; Anemia; Anti-Anxiety Agents; Anticoagulants; Cervix Uteri; Combined Modality Therapy; Contraceptives, Oral, Hormonal; Dalteparin; Embolization, Therapeutic; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Immobilization; Jehovah's Witnesses; Menorrhagia; Oxygen Inhalation Therapy; Parenteral Nutrition; Postpartum Hemorrhage; Pregnancy; Recombinant Proteins; Thromboembolism; Treatment Refusal; Young Adult

Topics: Anemia; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Orthopedic Procedures; Preoperative Care

To assess the cost-effectiveness and the budget impact of a Blood Saving Program (BSP) in patients older than 65 undergoing perthrocanteric hip fracture surgery.. Two groups of patients with perthrocanteric fracture were included. Group 1: patients not receiving treatment for perisurgical anaemia or treated with oral iron; Group 2: patients included in a BSP (treatment with endovenous iron sucrose and alfa epoetin, plus restrictive transfusional criteria). Effectiveness issues were: transfusion rate and number of red blood cell units transfused, length of postoperative stay and infection rate. Treatment cost was calculated using drug and transfused red blood cell unit prizes in 2003. We calculated potential patient population according to 2003 data.. 144 patients were included, 43 of which were in the BSP. Both groups were comparable in gender, age, preoperative length of stay, ASA and haemoglobin level at admission. Patients included in the BSP were less transfused and had less infections but postoperative stay was similar in both groups. The budget impact was 239,148 euros 95% [confidence interval (CI) 202,312-311,980] at group 1 and 311,980 euros [95% CI 275,288-348,672] at the BSP group. Including the whole potential population in the BSP (during one year 400 patients) would mean a cost increase of 72,832 euros, avoiding transfusion in 92 patients, infection in 70 patients, and saving 328 red blood cell units.. The cost increase due to endovenous iron sucrose and alfa-epoetin can be considered affordable for the hospital budget. BSP provides lower transfusion and infection rates and saves red blood cell units, compared to the standard procedure. Differences in postoperative stay should be analyzed in further larger and prospective studies including more patients.

Topics: Administration, Oral; Age Factors; Aged, 80 and over; Anemia; Budgets; Confidence Intervals; Cost-Benefit Analysis; Costs and Cost Analysis; Data Interpretation, Statistical; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hip Fractures; Humans; Iron; Length of Stay; Male; Recombinant Proteins

Topics: Anemia; Drug Approval; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Iron; Iron-Dextran Complex; Molecular Weight; Renal Dialysis; United States; United States Food and Drug Administration

Anemia of critical illness is common among intensive care unit patients. A blood management pilot program was initiated to study the pharmacodynamic response of epoetin alfa in critically ill patients and assess the impact of the use of a standardized order set of pharmaceuticals, including epoetin alfa and intravenous iron sucrose, on the quantity of red blood cell units transfused in the adult intensive care unit.. A pre-printed order set was developed which included baseline and follow-up laboratory monitoring and pharmaceutical options for iron, either intravenous and/or oral, folic acid, ascorbic acid, cyancobalamin, and weight-based epoietin alfa. Laboratory studies included: hemoglobin/hematocrit, reticulocyte count, absolute reticulocyte count, immature reticulocyte fraction obtained at baseline, and on day three and day five; in addition, iron, total iron binding capacity, transferrin saturation, and ferritin were obtained at baseline and on day five. An average hemoglobin response of 0.8 g/dL five days after administration of epoetin alfa was demonstrated in a diverse population of critically ill patients. Patients who received intravenous iron did not have a difference in mortality as compared to those patients who did not receive intravenous iron; however, there was a significantly longer length of stay. The cost of epoetin alfa was $64,000 over 10 months (approximately 8-10 patients/month). Transfusions of RBCs in adult intensive care unit decreased over the initial five months of the pilot study.. Use of erythropoiesis stimulating agents (ESAs) in the critically ill is controversial. Implementing a standardized approach in the pharmaceutical management of anemia in the critically ill patient is possible. Limitations with the order set and standardized protocol included errors in selection of dose/weight, incomplete laboratory/monitoring, and inconsistent prospective/concurrent review to guide therapy. The determination of the cost-effectiveness of epoetin alfa therapy in anemia of critical illness was not the purpose of this project, but will be the focus of future studies.

Topics: Adult; Aged; Anemia; Baltimore; Blood; Blood Chemical Analysis; Clinical Protocols; Critical Care; Critical Illness; Drug Costs; Drug Monitoring; Epoetin Alfa; Erythrocyte Transfusion; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hospital Mortality; Humans; Intensive Care Units; Length of Stay; Male; Middle Aged; Outcome and Process Assessment, Health Care; Pilot Projects; Recombinant Proteins

This article provides information and a commentary on trials relevant to the pathophysiology, prevention and treatment of heart failure, presented at the European Society of Cardiology heart failure meeting held in June 2006. All reports should be considered as preliminary data, as analyses may change in the final publication. In a sub-group analysis of the TNT study, intensive treatment with high-dose atorvastatin significantly reduced hospitalisations for heart failure in patients with stable coronary heart disease, compared with low-dose atorvastatin; this benefit was most evident in patients with a history of heart failure at baseline. In a combined analysis of two studies of darbepoetin alfa, which included 475 patients, treatment increased and maintained haemoglobin levels and produced non-significant improvements in symptoms and morbidity in anaemic heart failure patients compared to placebo. In the FERRIC-HF study (n=35), intravenous iron sucrose therapy improved exercise capacity and symptom status in iron-deficient heart failure patients. In a combined analysis of two studies (n=186), the adenosine A(1) receptor antagonist KW-3902 showed diuretic properties and appeared to enhance response to loop diuretics in heart failure patients hospitalised with fluid overload.

Topics: Anemia; Atorvastatin; Cardiology; Clinical Trials as Topic; Congresses as Topic; Darbepoetin alfa; Diuretics; Erythropoietin; Europe; Exercise Tolerance; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pyrroles; Societies, Medical; Xanthines

Therapy of anemia raises hemoglobin (Hb) level which in turn improves quality of life. Venofer was tested in 20 anemic (grade 1) patients with various malignancies. The drug was administered in 3 courses, i/v, 200 mg at a 4-5 week interval during chemotherapy. Hb levels rose or remained unchanged in 75%; they fell mostly in cases of tumor progression. There was no correlation between Hb concentration and chemotherapy regimen--with or without platinum. Venofer treatment was followed by improvement in quality of life or by stabilization only in 73.3%. Quality of life improved by 9,3% (FACT-An) after an 1g/dl increase in Hb level. Venofer treatment prevented further anemia.

Topics: Adult; Aged; Anemia; Disease Progression; Drug Administration Schedule; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Sucrose; Time Factors; Treatment Outcome

An important percentage of patients affected by hip fracture require the administration of allogenic blood transfusion (ABT) to avoid the risks of perioperative acute anaemia. However, concerns about ABT risks have led to the search for alternatives, especially in elective orthopaedic surgery.. We have prospectively investigated the effect of preoperative intravenous 200-300 mg (group 2; n=20) iron sucrose on ABT requirements and postoperative morbid-mortality in patients undergoing surgery for displaced subcapital hip fracture (DSHF) repair. A previous series of 57 DSHF patients served as the control group (group 1). All patients were older than 65 years, were operated on the 3rd day after admission to the hospital, by the same medical team, and using the same implant. Age, gender, ASA classification, surgical procedure, perioperative haemoglobin, requirements for ABT, postoperative infection, length of hospital stay (LOS) and 30-day mortality rate were examined.. No adverse reactions to the iron administration were observed. The iron group had a lower transfusion rate (15% vs 36.8%), lower transfusion index (0.26 vs 0.77 units per patient), lower 30d mortality rate (0 vs 19.3%), shorter LOS (11.9 vs 14.1 days), as well as a trend to a lower postoperative infection rate (15% vs 33%).. Preoperative parenteral iron administration could be a safe and effective way to reduce the ABT requirements in DSHF patients. This reduction in the ABT requirements is accompanied by a reduction in the morbid-mortality rate and LOS. A large, randomised, controlled trial to confirm these results is warranted.

Topics: Aged; Aged, 80 and over; Anemia; Arthroplasty, Replacement, Hip; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hip Fractures; Humans; Infusions, Intravenous; Male; Postoperative Complications; Prospective Studies

Topics: Anemia; Antioxidants; Ascorbic Acid; Drug Therapy, Combination; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Injections, Intravenous; Kidney Failure, Chronic; Renal Dialysis

To investigate the effects of intravenous (i.v.) iron replacement on hepatic functions of hepatitis C virus (HCV)-positive haemodialysis patients.. The present retrospective study included 89 HCV-positive and 57 HCV-negative haemodialysis patients. Alanine aminotransferase (ALT) levels were accepted as sustained high if the last three values were >/=20 U/L. All patients and the HCV-positive group were dichotomised into subgroups by the median for dialysis duration, the amounts of i.v. iron administered per year and totally.. Sustained high levels of ALT were significantly more frequent in the HCV-positive group (P < 0.001). In HCV-positive patients, the subgroup with ALT levels >/=20 U/L had significantly higher serum iron levels and mean amounts of i.v. iron administered per year and totally (P < 0.001) and the subgroup with the high mean total amount of i.v. iron had significantly higher serum ALT and iron levels (P < 0.001). Significant positive correlations were found in HCV-positive patients between ALT and serum iron levels (P < 0.001), as well as between ALT both with the mean amounts of i.v. iron administered per year (P = 0006) and totally (P = 0.015). Regression analysis showed that the main parameters effecting ALT were the serum iron level (P < 0.0001) and the mean amount of parenteral iron administered per year (P = 0.032).. We conclude that parenteral iron replacement might contribute to hepatocellular injury in HCV-positive haemodialysis patients.

Topics: Adolescent; Adult; Aged; Alanine Transaminase; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hepatic Insufficiency; Hepatitis C, Chronic; Humans; Injections, Intravenous; Kidney Failure, Chronic; Liver; Male; Middle Aged; Renal Dialysis; Retrospective Studies

To define the adverse events following two different rates and methods of intravenous iron sucrose infusions in children with anaemia due to chronic renal impairment.. Two prospective observational studies were undertaken to characterize the adverse events following iron sucrose administration in children with renal impairment and on erythropoietin. Between January 1999 and April 2003, 5 mg/kg of intravenous (IV) iron sucrose was given over 90 min and repeated 24 h later. Between May 2003 and September 2004, in children with better venous access, a single dose of 2 mg/kg of IV iron sucrose was administered over 3 min during an outpatient clinic visit and haemodialysis sessions. Following infusions, children were monitored for immediate and delayed adverse events. All such events were documented and dealt with appropriately. Test doses were not used.. A total of 870 infusions over 90 min were administered to 72 children. Three children developed abdominal pain. One child developed worsening of hypertension (not related to iron sucrose). Sixty-five doses were administered over 3 min to 20 children, and six minor adverse events were documented.. Although 90 min infusion is associated with fewer adverse events, no life-threatening events were documented in either method.

Topics: Anemia; Child; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Kidney Failure, Chronic; Prospective Studies; Recombinant Proteins

Topics: Aged; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Humans; Injections, Intravenous; Kidney Failure, Chronic; Male; Nandrolone; Nandrolone Decanoate; Sucrose

Inflammatory bowel disease (IBD)-associated anaemia usually responds to intravenous iron. If not, additive treatment with erythropoietin has been proposed. The objective of the present retrospective study was to evaluate the effectiveness of treatment with iron sucrose alone.. Sixty-one patients with IBD and anaemia (average haemoglobin 97 g/L) were treated with iron sucrose (iron dose 1.4 +/- 0.5 g). The indications for iron sucrose were poor response and/or intolerance to oral iron. Treatment response was defined as an increase in haemoglobin of > or = 20 g/L or to normal haemoglobin levels (> or = 120 g/L). Two independent investigators retrospectively assessed laboratory variables, clinical findings, and concomitant medication.. Two patients were transferred to other hospitals after treatment and therefore could not be evaluated. Fifty-four of the remaining 59 patients (91%) responded within 12 weeks. Sixty percent of the patients had responded within 8 weeks. Five patients had no or only a partial response to iron sucrose of which three had prolonged gastrointestinal blood losses. Eight patients with normal or elevated levels of ferritin could be considered to have anaemia of chronic disease, and all of them responded to iron sucrose. During a follow-up period of 117 +/- 85 (4-291) (mean +/- s (standard deviation) (range)) weeks 19 patients (32%) needed at least one second course of iron sucrose because of recurrent disease.. Anaemia associated with IBD can be successfully treated with intravenously administered iron sucrose, provided that bowel inflammation is treated adequately and enough iron is given. Treatment with iron sucrose is safe. Follow-up of haemoglobin and iron parameters to avoid further iron deficiency anaemia is recommended.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anemia; Colitis, Ulcerative; Crohn Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Humans; Infusions, Intravenous; Male; Middle Aged; Retreatment; Retrospective Studies; Sucrose; Treatment Outcome

Two patients with chronic kidney disease presented with severe anemia and iron deficiency. Because of their religious beliefs, red blood cell transfusions were not possible, and an aggressive therapeutic regimen of iron replenishment was instituted.. The regimen included epoetin, folic acid and high-dose intravenous iron sucrose infusions over multiple successive days (total dosages of 2 and 3.5 g).. The patients' iron stores were replenished and an erythropoietic response ensued subsequent to this aggressive and unique therapeutic regimen. There were no side effects observed which could be attributed to iron sucrose, and both patients stabilized and were discharged after 3 - 4 weeks.. In patients with chronic kidney disease who are severely anemic and iron-deficient and where transfusions are not possible, an aggressive regimen of multiple high-dose iron sucrose infusions may be both safe and effective.

Topics: Aged; Anemia; Chronic Disease; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Infusions, Intravenous; Iron Deficiencies; Jehovah's Witnesses; Kidney Diseases; Middle Aged; Severity of Illness Index; Time Factors

An important percentage of patients with hip fracture need allogeneic transfusion to resolve their perioperative anemia. Our goal was to determine the safety profile and usefulness of parenteral iron in order to avoid allogeneic transfusions in trochanteric hip fracture (THF).. A pseudo-experimental study was performed comparing a historic THF group (n = 104) with another group (n = 23) treated with parenteral iron (Venofer) (doses of 100 mg). Patients who had primary blood diseases or were receiving anticoagulation therapy were excluded. Age, gender, elapsed time, type of THF (international AO classification), surgical procedure, transfusion procedure and quantity, hemoglobin and hematocrit at days 0 and +2 (if a surgical procedure was not performed) and postoperatively were examined. We also analyzed the morbidity (post-surgical infection) and hospital stay and mortality rate at the first month.. We have not observed any adverse reactions upon iron administration. The iron group was transfused less times (39.1% vs. 56.7%) and had lower morbidity (infection) (20.3% vs. 35.4%) (p = 0.04), lower mortality (13% vs. 16.3%), less blood consumption (0.87 vs. 1.31 units) and less stay (13.7 vs. 14.3 days).. Parenteral administration of iron could be a safe and effective way to avoid or reduce allogeneic blood transfusions in THF patients. The reduction in the transfusional rate in the iron treated group is also accompanied by a reduction in the morbidity, infection rate, mortality rate and hospital stay.

Topics: Aged; Aged, 80 and over; Anemia; Blood Loss, Surgical; Blood Transfusion; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematinics; Hip Fractures; Humans; Infusions, Intravenous; Iron; Male; Sucrose

Parenteral iron-polysaccharide complexes are increasingly applied. The pharmacokinetics of iron sucrose have been assessed by our group using positron emission tomography (PET). A single intravenous injection of 100 mg iron as iron (III) hydroxide-polymaltose complex, labelled with a tracer in the form of 52Fe/59Fe, was similarly assessed in six patients using PET for about 8 h. Red cell utilization was followed for 4 weeks. Iron polymaltose was similarly distributed to the liver, spleen and bone marrow. However, a larger proportion of this complex was rapidly distributed to the bone marrow. The shorter equilibration phase for the liver, about 25 min, indicates the minimal role of the liver for direct distribution. Splenic uptake also reflected the reticuloendothelial handling of this complex. Red cell utilization ranged from 61% to 99%. Despite the relatively higher uptake by the bone marrow, there was no saturation of marrow transport systems at this dose level. In conclusion, high red cell utilization of iron polymaltose occurred in anaemic patients. The major portion of the injected dose was rapidly distributed to the bone marrow. In addition, the reticuloendothelial uptake of this complex may reflect the safety of polysaccharide complexes. Non-saturation of transport systems to the bone marrow indicated the presence of a large interstitial transport pool, which might possibly be transferrin.

Topics: Adult; Aged; Anemia; Erythrocytes; Female; Ferric Compounds; Ferric Oxide, Saccharated; Follow-Up Studies; Glucaric Acid; Hemoglobins; Humans; Iron Radioisotopes; Liver; Male; Middle Aged; Reticulocyte Count; Spleen; Tomography, Emission-Computed

Topics: Aged; Aged, 80 and over; Anemia; Cost-Benefit Analysis; Drug Costs; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron; Kidney Failure, Chronic; Male; Middle Aged; Renal Dialysis; Spain; Sucrose

We report the case of a patient with a severe chronic radiation enteropathy. She had been dependent on red cell transfusions for many years. On admission, she displayed anemia (8.6 g/dL) resulting from both inadequate EPO production and a functional iron deficiency. A 3-wk IV iron sucrose treatment (200 mg once weekly) resulted in an increased reticulocyte count, but did not raise the hemoglobin (Hb) level. The adjunction of epoetin alpha (10,000 IU three times a week) made it possible to reach the normal range (12.9 g/dL) after a 17-wk treatment. As the anti-anemic treatment discontinued, the Hb level decreased to 11.1 g/dL within 2 wk. Giving EPO again (10,000 IU twice a week) failed to maintain the Hb level, which dropped under basal values (7.8 g/dL). In contrast, a second combination EPO/iron sucrose did restore a normal Hb level and maintained it. This case report supports the combination of EPO and IV iron supplementation in patients with anemia of chronic disease and either an impaired iron absorption or intolerance to oral iron.

Topics: Anemia; Chronic Disease; Drug Therapy, Combination; Epoetin Alfa; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hematinics; Hemoglobins; Humans; Infusions, Intravenous; Middle Aged; Radiation Injuries; Recombinant Proteins; Reticulocyte Count

Both Congestive Heart Failure (CHF) and Chronic Renal Failure (CRF) are increasing steadily in the community. We propose that there is a vicious circle established whereby CHF and CRF both cause anemia and the anemia then worsens both the CHF and CRF causing more anemia and so on. We call this the Cardio Renal Anemia (CRA) syndrome. By the combination of active treatment of the CHF and control of the anemia with subcutaneous erythropoietin and intravenous iron, the progression of both the CHF and the CRF can be slowed or stopped in most cases, the quality of life improved and the need for recurrent hospitalization reduced. This will involve cooperation between internists, cardiologists, and nephrologists to allow early and maximal therapy of both the CHF and the anemia.

Topics: Aged; Anemia; Disease Progression; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Heart Failure; Hospitalization; Humans; Injections, Intravenous; Injections, Subcutaneous; Kidney Failure, Chronic; Male; Oxygen Consumption; Recombinant Proteins; Stroke Volume

The prevalence of congestive heart failure (CHF) is increasing rapidly in the community. We and others have shown that the prevalence and severity of both anemia and chronic renal failure (CRF) increase steadily with increasing severity of CHF. We have also shown that CHF patients may be resistant to standard drug therapy for CHF as long as the associated anemia is not corrected, and that correction of the anemia with subcutaneous erythropoietin and intravenous iron sucrose (Venofer: Vifor International, St. Gallen, Switzerland) may improve both the CHF and CRF and markedly reduce hospitalizations without causing side effects. We report here our experience with correcting anemia in this manner in 126 cases of anemic-resistant CHF patients. As in our previous studies, correction of the anemia improved both CHF and CRF, and reduced hospitalizations. Our studies suggest that correction of even mild anemia in CHF may be an important addition to the treatment of patients with the combination of CHF and CRF.

Topics: Aged; Anemia; Disease Progression; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glomerular Filtration Rate; Glucaric Acid; Heart Failure; Humans; Kidney Failure, Chronic; Male; Recombinant Proteins; Stroke Volume; Sucrose

The pharmacokinetics of a single intravenous injection of 100 mg iron hydroxide-sucrose complex labelled with a tracer in the form of 52Fe/59Fe was followed in six anaemic patients for a period ranging from 6 to 8 3 h using positron emission tomography (PET). Red cell utilization of the labelled iron was followed for 4 weeks. PET data showed radioactive uptake by the liver, spleen and bone marrow. The uptake by the macrophage-rich spleen demonstrated the reticuloendothelial uptake of this iron preparation, with subsequent effective release of that iron for marrow utilization. Red cell utilization, followed for 4 weeks, ranged from 59% to 97%. The bone marrow influx rate constant was independent of blood iron concentration, indicating non-saturation of the transport system in bone marrow. This implied that higher doses of the iron complex can probably be used in the same setting. A higher influx rate into the marrow compared with the liver seemed to be consistent with higher red cell utilization. This would indicate that early distribution of the injected iron complex may predict the long-term utilization.

Topics: Adult; Anemia; Erythrocytes; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Male; Middle Aged; Sucrose; Tomography, Emission-Computed; Transferrin

Spinal fusion surgery often leeds to massive bleeding responsible for anemia in the postoperative period. The aim of this study was to compare the effect of IV iron III hydroxide sucrose complex (Venofer) versus oral iron fumarate administration in postoperative anemia. The efficacy of both treatments was evaluated by comparing hemoglobin level in the postoperative period.. Two groups of sixteen patients, scheduled for anterior and/or posterior spinal fusion, were compared. Group 1, historical, was treated by supplementation of 10 mg/kg/day oral iron fumarate. Administration was started when hemoglobin level fell below 9 g/100 ml. Group 2 was treated by intravenous iron sucrose complex using same criteria as in group 1 for starting administration. The dosage of iron was individually adapted according to a target hemoglobin level of 13 g/100 ml and to the actual lowest hemoglobin level measured. The total iron deficit was calculated with the following formula: total iron deficit (mg) = 0.24 x body weight (kg) x (target Hb-actual Hb)(g/l). The patients were supplemented by 3 mg/kg/day until the calculated iron deficit was compensated.. Both groups were identical regarding age and lowest hemoglobin level reached in the postoperative period. Hemoglobin increased by 0.25 g/day in group 1, and by 0.36 g/day in group 2. In others words, the beneficial effect of IV iron versus oral iron administration was as high as 45 per cent (p = 0.003).. Intravenous iron therapy as ferric sucrose complex is a new and more effective form of iron therapy than oral iron therapy to restore postoperative hemoglobin after spinal surgery in children.

Topics: Administration, Oral; Adolescent; Adult; Anemia; Blood Loss, Surgical; Child; Child, Preschool; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Injections, Intravenous; Iron; Postoperative Complications; Spinal Fusion; Sucrose

Topics: Anemia; Arthritis, Rheumatoid; Blood Donors; Blood Transfusion, Autologous; Erythropoietin; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hematocrit; Humans; Recombinant Proteins

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

An 81-year-old woman was hospitalised because of pneumonia in December 1989. In February 1991, an iliac bone biopsy was performed on the suspicion of disturbed bone metabolism due to chronic renal failure. Since she developed anemia due to continuous bleeding from the surgical wounds, saccharated iron oxide was administered beginning in March. Hypophosphatemia was noted 23 days after the beginning of administration. Due to the possibility of osteomalacia, active vitamin D was given but the hypophosphatemia persisted. Following an EDTA-2 Na load test performed to evaluate the reabsorption of phosphorus in the renal tubules, it was considered that the patient had a functional disorder of the parathyroid glands and that reabsorption of phosphorus was interrupted in the renal tubules. Furthermore, abnormal distributions of phosphorus seemed to occur in the same areas where sucrose was metabolized and iron was stored. Therefore, it was considered that these abnormalities induced hypophosphatemia following the intravenous administration of saccharated iron oxide. In addition to these actions, the possibility remained that phosphate absorption was inhibited in the small intestine by calcium lactate.

Topics: Aged; Aged, 80 and over; Anemia; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Hypophosphatemia; Injections, Intravenous

Topics: Adult; Anemia; Duodenal Ulcer; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iatrogenic Disease; Malabsorption Syndromes; Middle Aged; Osteomalacia

Topics: Anemia; Arthritis, Rheumatoid; C-Reactive Protein; Drug Administration Schedule; Erythrocyte Count; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Iron; Time Factors

Oral iron replacement therapy with Chromagen, containing ferrous fumarate, and Niferex, containing polysaccharide iron complex, can successfully maintain hematologic and iron indices in dialysis clients and demonstrated fewer adverse effects in selected clients. Their multiple ingredient dose forms, which further support erythropoiesis, and their possible decrease in distressing side effects should enhance client compliance, making these two drugs excellent alternatives to traditional iron therapies.

Topics: Administration, Oral; Anemia; Contraindications; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Humans; Kidney Diseases; Renal Dialysis

In the present study, we have evaluated the relationship between serum ferritin (SF) levels, 'hemochromatosis allele(s)', blood transfusions and iron parenteral administration in 69 hemodialysis patients. We demonstrated significantly higher SF levels in patients with hemochromatosis allele(s) (HA+) than in patients without hemochromatosis alleles (HA-). In addition, HA+ patients who had received blood transfusions up to 15 months prior to the study had SF levels even higher than those without blood transfusions. On the other hand, HA- patients had normal levels of SF, independent of blood transfusions. After intravenous administration of 1 g iron saccharate, SF levels were significantly higher only in HA+ transfused patients. In conclusion, our study demonstrated that HA+ patients are at a higher risk of iron overload and therefore the use of transfusional and/or parenteral iron should be strictly limited.

Topics: Adolescent; Adult; Aged; Alleles; Anemia; Child; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Hemochromatosis; Humans; Male; Renal Dialysis; Risk; Transfusion Reaction; Uremia

Topics: Anemia; Culture Media; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Iron; Legionella

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

Topics: Anemia; Anemia, Hypochromic; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hemoglobins; Humans; Iron; Pregnancy

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; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Iron Compounds; Pregnancy; Pregnancy Complications

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

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

Topics: Anemia; Anemia, Sickle Cell; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Humans; Iron; Sucrose