Institutional Usage of Ferric Pyrophosphate Citrate (FPC) Delivered Via Dialysate in Reducing Erythropoiesis Stimulating Agents (ESAs) and IV Iron Cost

2021 ◽  
pp. 001857872110323
Author(s):  
Shan Wang ◽  
Louis DellaFera ◽  
Lameesa Dhanani ◽  
Brian Malone ◽  
Paula Dutka ◽  
...  
Keyword(s):  
Cost Evaluation ◽  
Weekly Dose ◽  
Ferric Pyrophosphate ◽  
Iron Saturation ◽  
Iron Deficient ◽  
Before And After ◽  
Data Points ◽  
Iv Iron ◽  
Ferric Pyrophosphate Citrate ◽  
Iron Replacement

Dialysis patients are often iron deficient due to a multiple factors. Ferric pyrophosphate citrate is a complex iron salt that can be given via dialysate allowing maintenance of hemoglobin (Hgb) concentration and iron balance while reducing the need for IV iron. The purpose of this study is to perform a cost evaluation of FPC and the effect it has on lowering the dose/use of ESAs and IV iron therapy. This study reviewed the same 100 hemodialysis patient’s charts before and after the use of FPC. The data points that were collected and analyzed are as follows: hemoglobin, ferritin levels, average weekly ESA dosing, and IV iron replacement therapy dose. Out of 100 patients, there was no statistical difference in the average hemoglobin, ferritin, and iron saturation levels observed in the patients before and after FPC use. The average weekly dose of darbepoetin alfa per patient was 52.74 μg before the FPC group compared to 39.27 μg in the post FPC group ( P < .0001). The total dose of ferric gluconate per patient was 3290.01 mg in the before FPC group and 585.60 mg in the post FPC group ( P < .0001). The average total iron sucrose dose per patient in the before FPC group was 3097.92 mg versus 1216.67 mg in the post FPC group ( P < .1563). When comparing FPC’s cost and implementation into both of our outpatient dialysis centers, this yielded a net savings of $296 751.49.

scholarly journals Measuring Reticulocyte Hemoglobin Content As a Marker for Iron Deficiency and Response to Therapy Represents a Paradigm Shift in Care

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 42-43
Author(s):  
Michael Auerbach ◽  
Carlo Brugnara ◽  
Steve Staffa
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Biochemical Markers ◽  
Roc Analysis ◽  
Transferrin Saturation ◽  
Iron Administration ◽  
Iron Deficient ◽  
Ferritin Iron ◽  
Iv Iron ◽  
Iron Replacement

It is estimated anemia affects over 30% of the world's population, with iron deficiency (ID) the overwhelmingly most common cause. Whether absolute due to blood loss and/or iron sequestration to underlying morbidity, the need for repletion especially in females, is a formidable medical issue. The diagnosis of iron deficient erythropoiesis has been traditionally based on the biochemical parameters ferritin and percent transferrin saturation (TSAT), mean cell volume and hemoglobin (Hb) concentration. In recent years, reticulocyte Hb content has emerged as a parameter helpful in identifying iron deficient erythropoiesis and informing a need, or lack thereof, for replacement. 556 consecutive, non-selected patients referred for diagnosis and/or treatment of anemia were included in this diagnostic study to compare the performance of reticulocyte hemoglobin equivalent (RET-He) versus traditional biochemical markers for diagnosis and treatment of IDA. CBC, serum ferritin, iron and TSAT were performed as clinically indicated. RET-He was measured with a Sysmex XN-450 analyzer on the residual CBC sample. 556 patients were studied at baseline and 150 were subsequently treated with intravenous (IV) iron. 240/556 were seen at follow-up, with 57 treated and 183 not treated with IV iron. At baseline, ret-He, positively correlated with Hb (Spearman correlation (rho)=0.365, P &lt; 0.001), MCV (rho=0.576, P &lt; 0.001), MCH (rho=0.777, P &lt; 0.001), serum iron (rho=0.526, P &lt; 0.001) and TSAT (rho=0.492, P &lt; 0.001). Serum iron, and TSAT (but not serum ferritin or MCV, or absolute reticulocyte count) positively correlated with Hb concentrations. Based on either a serum ferritin &lt;30 ng/ml and/or a TSAT&lt; 20%, 241/556 (43.4%) patients were diagnosed as iron deficient. Anemia was present in 64/241 of the iron deficient patients (26.6%). Despite the limitations of the biochemical markers outlined above, we performed ROC analysis assessing the value of RET-He in identifying iron deficiency as defined by serum ferritin &lt;30 ng/mL or transferrin saturation &lt;20%. ROC analysis demonstrates a reasonable performance for RET-He (AUC= 0.733, 95% CI: 0.692, 0.775), with a cut-off value of &lt;30.7 pg yielding 68.2% sensitivity and 69.7% specificity. Using both Hb and RET-He in a multivariable ROC analysis does not provide an improved AUC, as compared to just using RET-He (AUC=0.605 vs.0.733). IV iron administration was associated with significant increases in Hb, MCV, MCH, RET-He, serum ferritin, iron and TSAT, whereas in the no-IV iron cohort, there was a small reduction in RET-He and small increases in MCV and MCH, with no significant variations in Hb and in the other parameters. Serum ferritin was below 30 ng/mL in 18/57 (32%) of the patients requiring IV iron and in 19/183 (10.4%) of those not requiring iron at visit 1. These values changed to 4/57 (7%) (P=0.002) and 23/183 (13%) (P=0.623) at visit 2, respectively. Regression analysis for Hb response following IV iron showed that baseline RET-He values are predictive of Hb response, with every unitary increase in RET-He corresponding to a blunting of the Hb change by -0.19 g/dl (95% CI: -0.27, -0.11; P &lt; 0.001). Changes in RE-He associated with IV iron administration are also predictive of the Hb response, with every additional unit increase in RET-He corresponding to a 0.21 g/dL increase in Hb (95% CI: 0.13, 0.28; P &lt; 0.009). ROC analysis for the capability to predict Hb response among the 57 patients receiving IV iron shows that a value of baseline RET-He &lt; 28.5 pg together with a baseline Hb value &lt; 10.3 g/dL provide the highest Youden's index for predicting Hb response &gt; 1.0 g/dl, with sensitivity of 84% and specificity of 78%. The Figure presents data for the 21/57 patients who had RET-He &lt; 28.5 pg and Hb &lt; 10.3 g/dL vs the 36/57 who did not. The present data show that an abnormally low ret-He value (&lt; 28.5 pg) identifies patients who will respond to iron replacement, obviating delays to obtain standard iron parameters. Baseline and changes in ret-He also associate with Hb response. Given the enormous prevalence of ID in the general population the use of the ret-He, which is available with the CBC on the autoanalyzer, informs need for iron replacement, or lack thereof, represents an increase in convenience for patient and physician, decreases costs, streamlines care and represents an improvement in the treatment paradigm of one of the commonest maladies on the planet. Figure 1 Disclosures Auerbach: AMAG: Research Funding; Sysmex: Research Funding. Brugnara:American Journal of Hematology: Other; Sysmex America Inc.: Consultancy.

scholarly journals Iron Supplementation: What's New?

Blood ◽  
2017 ◽  
Vol 130 (Suppl_1) ◽  
pp. SCI-43-SCI-43
Author(s):  
Iain C. Macdougall
Keyword(s):  
Research Funding ◽  
Iron Supplementation ◽  
Release Kinetics ◽  
Ferrous Sulphate ◽  
Oral Iron ◽  
Hypersensitivity Reactions ◽  
Iron Dextran ◽  
Ferric Pyrophosphate ◽  
Iv Iron ◽  
Ferric Pyrophosphate Citrate

Abstract Supplemental orally-administered iron has been available for centuries, but parenteral administration of iron as a therapeutic agent dates from the 1930s. The original agents were iron salts, and their administration to man was associated with severe and unacceptable side-effects even with doses of 4-8 mg. The modern-day practice of IV iron supplementation was transformed in the 1940s with the introduction of iron incorporated into a carbohydrate shell, to allow slow release in the circulation and rapid binding to plasma transferrin. The older iron-carbohydrate complexes included iron dextran, iron sucrose, and iron gluconate, with different iron release kinetics. Iron dextran had significant toxicity with possible anaphylactic reactions. Other iron preparations can also induce hypersensitivity reactions, although recent evidence suggests that these are not immunoglobulin-mediated, but may be due to free iron in circulation or mediated via complement, the so-called CARPA reactions (complement activation-related pseudo-allergy). Newer oral iron preparations include ferric citrate which is much more tolerable than ferrous sulphate, while newer IV iron compounds include ferric carboxymaltose, iron isomaltoside 1000 , and ferumoxytol. Iron supplementation has traditionally been used to ameliorate iron deficiency anaemia, and in the early 1990s, IV iron was found to be mandatory in dialysis patients to support erythropoiesis under stimulation with recombinant human erythropoietin. Recent data also suggest that IV iron may have benefits in chronic heart failure, independent of any effect on haemoglobin or red cell production, possibly by enhancing cardiac myocyte mitochondrial function. Although most RCTs suggest better efficacy with IV iron versus oral iron, there are some concerns regarding the safety of parenteral iron, not only in relation to hypersensitivity reactions, but also exacerbation of oxidative stress or infections. Several ongoing RCTs are seeking to provide further evidence in this regard, e.g. the PIVOTAL trial. Newer strategies for replenishing iron stores include HIF prolyl hydroxylase inhibitors (HIF PHIs), antagonists of the hepcidin pathway, or dialysate iron administration as ferric pyrophosphate citrate. HIF PHIs (such as roxadustat and vadaddustat) have been shown to reduce hepcidin, probably indirectly via stimulation of erythropoiesis, as well as by stimulating a number of iron-regulatory genes, and allowing greater amounts of iron to be absorbed orally. Many molecules designed to interfere with hepcidin activity are in varying stages of clinical development, including monoclonal antibodies against hepcidin or its signalling pathway, spiegelmers, anticalins, and antisense oligonucleotides. Administering ferric pyrophosphate citrate (Triferric™) across dialysis has recently become clinical reality in the US, although this is not available in Europe. Thus, strategies to supplement iron have developed considerably over the last two decades, with several novel approaches transitioning from bench to bedside. Disclosures Macdougall: Astellas: Honoraria, Research Funding; GlaxoSmithKline: Consultancy; Akebia: Consultancy; Vifor Pharma: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pharmacosmos: Honoraria; AMAG: Consultancy, Honoraria, Research Funding; FibroGen: Consultancy, Speakers Bureau.

Poor efficacy of oral iron replacement therapy in pediatric patients with heart failure

2021 ◽  
pp. 1-8
Author(s):  
Kriti Puri ◽  
Joseph A. Spinner ◽  
Jacquelyn M. Powers ◽  
Susan W. Denfield ◽  
Hari P. Tunuguntla ◽  
...  
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Transferrin Saturation ◽  
Systolic Heart Failure ◽  
Oral Iron ◽  
Wilcoxon Test ◽  
Iron Therapy ◽  
Oral Iron Therapy ◽  
Iron Deficient ◽  
Iron Replacement

Abstract Introduction: Iron deficiency is associated with worse outcomes in children and adults with systolic heart failure. While oral iron replacement has been shown to be ineffective in adults with heart failure, its efficacy in children with heart failure is unknown. We hypothesised that oral iron would be ineffective in replenishing iron stores in ≥50% of children with heart failure. Methods: We performed a single-centre retrospective cohort study of patients aged ≤21 years with systolic heart failure and iron deficiency who received oral iron between 01/2013 and 04/2019. Iron deficiency was defined as ≥2 of the following: serum iron <50 mcg/dL, serum ferritin <20 ng/mL, transferrin >300 ng/mL, transferrin saturation <15%. Iron studies and haematologic indices pre- and post-iron therapy were compared using paired-samples Wilcoxon test. Results: Fifty-one children with systolic heart failure and iron deficiency (median age 11 years, 49% female) met inclusion criteria. Heart failure aetiologies included cardiomyopathy (51%), congenital heart disease (37%), and history of heart transplantation with graft dysfunction (12%). Median dose of oral iron therapy was 2.9 mg/kg/day of elemental iron, prescribed for a median duration of 96 days. Follow-up iron testing was available for 20 patients, of whom 55% (11/20) remained iron deficient despite oral iron therapy. Conclusions: This is the first report on the efficacy of oral iron therapy in children with heart failure. Over half of the children with heart failure did not respond to oral iron and remained iron deficient.

Hematologic Abnormalities in Chronic Kidney Disease

2018 ◽  
Author(s):  
Michael Auerbach ◽  
John Anderson ◽  
Khalid Al Talib
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Oral Anticoagulants ◽  
Infusion Reaction ◽  
Nonvalvular Atrial Fibrillation ◽  
Novel Oral Anticoagulant ◽  
Before And After ◽  
Iv Iron ◽  
A Minor

The focus of this review is on information practical to the practicing nephrologist and internists managing patients with chronic kidney disease (CKD), with an emphasis on the quantitative aspects of risk, diagnosis, treatment, and prognosis. Consequently, anemia associated with non–dialysis-associated CKD is emphasized, with special attention to the role of erythropoiesis-stimulating agents and intravenous (IV) iron in treating the anemia of CKD, as well as sections on uremic bleeding and anticoagulation in CKD patients. Figures show a patient before and after a minor infusion reaction, an algorithm outlining grading and management of acute hypersensitivity reactions to IV iron infusions, and an algorithm for the management of uremic platelet dysfunction. Tables list Food and Drug Administration-recommended dose adjustments for novel oral anticoagulant (NOACs) in CKD patients, evidence for preprocedural withholding of NOACs, and management guidelines for anticoagulation in nonvalvular atrial fibrillation and venous thromboembolism. This review contains 2 highly rendered figures, 3 tables, and 101 references. Key words: Chronic kidney disease; CKD; Anemia of chronic kidney disease; Anemia of CKD; Uremic bleeding; Anticoagulation in CKD; Novel oral anticoagulants in CKD; NOAC CKD

scholarly journals Application of holography and automated image processing for laboratory experiments on mass and fall speed of small cloud ice crystals

2020 ◽  
Vol 20 (23) ◽  
pp. 14889-14901
Author(s):  
Maximilian Weitzel ◽  
Subir K. Mitra ◽  
Miklós Szakáll ◽  
Jacob P. Fugal ◽  
Stephan Borrmann
Keyword(s):  
Three Dimensional ◽  
Ice Crystals ◽  
Local Cooling ◽  
Ice Cloud ◽  
Before And After ◽  
Data Points ◽  
Melting Crystal ◽  
Cloud Ice ◽  
Automated Image Processing ◽  
The Relationship

Abstract. An ice cloud chamber was developed at the Johannes Gutenberg University of Mainz for generating several thousand data points for mass and sedimentation velocity measurements of ice crystals with sizes less than 150 µm. Ice nucleation was initiated from a cloud of supercooled droplets by local cooling using a liquid nitrogen cold finger. Three-dimensional tracks of ice crystals falling through the slightly supersaturated environment were obtained from the reconstruction of sequential holographic images, automated detection of the crystals in the hologram reconstructions, and particle tracking. Through collection of the crystals and investigation under a microscope before and after melting, crystal mass was determined as a function of size. The experimentally obtained mass versus diameter (m(D)) power law relationship resulted in lower masses for small ice crystals than from commonly adopted parameterizations. Thus, they did not support the currently accepted extrapolation of relationships measured for larger crystal sizes. The relationship between Best (X) and Reynolds (Re) numbers for columnar crystals was found to be X=15.3 Re1.2, which is in general agreement with literature parameterizations.

scholarly journals P0858A MULTICENTRE PROSPECTIVE DOUBLE BLIND RANDOMISED CONTROLLED TRIAL OF INTRAVENOUS IRON IN IRON DEFICIENT BUT NOT ANAEMIC PATIENTS WITH CHRONIC KIDNEY DISEASE ON FUNCTIONAL STATUS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Xenophon Kassianides ◽  
Ahmed Ziedan ◽  
Victoria Allgar ◽  
Archie Lamplugh ◽  
Philip A Kalra ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Functional Status ◽  
Exercise Capacity ◽  
Heart Function ◽  
Intravenous Iron ◽  
The Body ◽  
Multi Centre Study ◽  
Iron Deficient ◽  
Significant Difference ◽  
Iv Iron

Abstract Background and Aims Iron deficiency is common in patients with CKD due to inadequate dietary intake of iron, poor iron absorption from the gut, and increased iron losses from the body. In addition to preventing anaemia, iron is also important for normal heart function, being involved in processes that generate a necessary continuous energy supply. Post hoc analysis of studies of people with iron deficiency and advanced CKD suggest treatment with intravenous iron leads to improvement in heart function and feeling of wellbeing. The aim of the study was to investigate whether intravenous (IV) iron could improve exercise capacity in comparison to placebo over 3 months in non-anaemic CKD patients who have iron deficiency. Method The Iron and the Heart Study was a prospective double blinded explorative randomized, multi-centre study designed to assess the effect of IV iron supplementation (ferric derisomaltose/iron isomaltoside 1000 (FDI); Monofer®) in iron deficient but not anaemic patients with advanced CKD on functional status. Adults with established CKD stages 3b-5 and serum ferritin (SF) &lt; 100mcg/L and/or transferrin saturation (TS) &lt;20% were randomized in a 1:1 ratio to 1000 mg IV FDI or placebo solution. Each participant was followed up at months 1 and 3. The primary outcome was the difference in exercise capacity using the 6-minute walk test (6MWT) at 3 months. Secondary objectives included effects on haematinic profiles and haemoglobin (Hb) concentrations. Results are given as mean and standard deviations (SD). Data was analysed using ANCOVA adjusted for baseline. Results Between October 2016 and April 2018, 54 individuals from 3 UK centres were randomized to FDI (n=26; mean age 61.6 (10.1) years) or placebo (n=28; mean age 57.8 (12.9) years). Mean serum creatinine (167.0 (40.2) vs. 204.9 (67.3) and eGFR (32.1 (9.6) vs. 29.1 (9.6)) at baseline were similar in FDI and placebo groups respectively. Adjusting for baseline 6MWT, the 6MWT at 1-month showed no statistically significant difference between groups (p=0.736) (Figure), and no significant difference at 3 months (p=0.741). The absolute mean change from baseline to 1 month and 3 months, showed no statistically significant differences between group (p=0.952_, p=0.895). There was no statistically significant difference between groups in Hb at 3-months (p=0.152) but there were statistically significant differences in SF and TS, which both increased post FDI infusion at 1 and 3 months; p&lt;0.001 (Table). Conclusion The Iron and the Heart Trial showed a significant increase in iron parameters and maintenance of Hb concentration in iron treated patients. There was a numerical increase in functional capacity at 1-month and to lesser extent at 3 months post iron infusion. This finding was not significant, which reflects the limited sample size and possible differences in population during randomisation with the large difference in 6MWT at baseline. A larger study will be required to demonstrate a possible short-term functional benefit on exercise capacity of IV iron in CKD patients with biochemical functional or absolute iron deficiency without anaemia.

scholarly journals High Bioavailability from Ferric Pyrophosphate-Fortified Bouillon Cubes in Meals is Not Increased by Sodium Pyrophosphate: a Stable Iron Isotope Study in Young Nigerian Women

2019 ◽  
Vol 149 (5) ◽  
pp. 723-729 ◽  
Author(s):  
Ans Eilander ◽  
Olumakaiye M Funke ◽  
Diego Moretti ◽  
Michael B Zimmermann ◽  
Temilola O Owojuyigbe ◽  
...  
Keyword(s):  
Dose Response ◽  
Low Income ◽  
Iron Status ◽  
Iron Bioavailability ◽  
Sodium Pyrophosphate ◽  
Nigerian Women ◽  
Response Effect ◽  
Ferric Pyrophosphate ◽  
Iron Deficient ◽  
Dose Response Effect

ABSTRACT Background It is challenging to find an iron compound that combines good bioavailability with minimal sensory changes when added to seasonings or condiments. Ferric pyrophosphate (FePP) is currently used to fortify bouillon cubes, but its bioavailability is generally low. Previously, the addition of a stabilizer, sodium pyrophosphate (NaPP), improved iron bioavailability from a bouillon drink. Objective We assessed whether there is a dose-response effect of added NaPP on iron bioavailability from local meals prepared with intrinsically labeled FePP-fortified bouillon cubes in young Nigerian women using iron stable isotope techniques. Methods In a double-blind, randomized, cross-over trial, women (n = 24; aged 18–40 y; mean BMI 20.5 kg/m2) consumed a Nigerian breakfast and lunch for 5 d prepared with bouillon cubes containing 2.5 mg 57Fe (as FePP) and 3 different molar ratios of NaPP: 57Fe (0:1, 3:1, and 6:1). Iron bioavailability was assessed by measuring 57Fe incorporation into erythrocytes 16 d after each 5 d NaPP: 57Fe feeding period. Data were analyzed using a linear regression model of log iron absorption on NaPP ratio, with body weight and baseline body iron stores as covariates and subject as a random intercept. Results Of the women included, 46% were anemic and 26% were iron deficient. Iron bioavailability was 10.8, 9.8, and 11.0% for the 0:1, 3:1, and 6:1 NaPP:57Fe treatments, respectively. There was no dose-response effect of an increasing NaPP:57Fe ratio (β ± SE: 0.003 ± 0.028, P = 0.45). Conclusions In this study, the addition of NaPP did not increase iron bioavailability from FePP-fortified bouillon cubes. However, iron bioavailability from the Nigerian meals prepared with FePP-fortified bouillon cubes was higher than expected. These results are encouraging for the potential of bouillon cubes as a fortification vehicle. Further studies are needed to assess the effect of FePP-fortified bouillon cubes on improving iron status in low-income populations. This trial was registered at clinicaltrials.gov as NCT02815449.

scholarly journals Sucrosomial® Iron Supplementation in Mice: Effects on Blood Parameters, Hepcidin, and Inflammation

Nutrients ◽  
2018 ◽  
Vol 10 (10) ◽  
pp. 1349 ◽  
Author(s):  
Michela Asperti ◽  
Magdalena Gryzik ◽  
Elisa Brilli ◽  
Annalisa Castagna ◽  
Michela Corbella ◽  
...  
Keyword(s):  
Ferrous Sulfate ◽  
Iron Supplementation ◽  
Blood Parameters ◽  
Sucrose Esters ◽  
Ferric Pyrophosphate ◽  
Iron Deficient ◽  
Ionic Iron ◽  
The One ◽  
Low Dosage

Sucrosomial® Iron is a recently developed formulation to treat iron deficiency based on ferric pyrophosphate covered by a matrix of phospholipids plus sucrose esters of fatty acids. Previous data indicated that Sucrosomial® Iron is efficiently absorbed by iron-deficient subjects, even at low dosage, and without side effects. Its structural properties may suggest that it is absorbed by an intestinal pathway which is different to the one used by ionic iron. Although, studies in vitro showed that Sucrosomial® Iron is readily absorbed, no animal models have been established to study this important aspect. To this aim, we induced iron deficient anemia in mice by feeding them with a low-iron diet, and then we treated them with either Sucrosomial® Iron or sulfate iron by gavage for up to two weeks. Both iron formulations corrected anemia and restored iron stores in a two-week period, but with different kinetics. Ferrous Sulfate was more efficient during the first week and Sucrosomial® Iron in the second week. Of note, when given at the same concentrations, Ferrous Sulfate induced the expression of hepcidin and four different inflammatory markers (Socs3, Saa1, IL6 and CRP), while Sucrosomial® Iron did not. We conclude that anemic mice are interesting models to study the absorption of oral iron, and that Sucrosomial® Iron is to be preferred over Ferrous Sulfate because of similar absorption but without inducing an inflammatory response.

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