scholarly journals Patient Factors Associated with Prescribing of Iron for IV Administration: A Descriptive Study

2021 ◽  
Vol 74 (1) ◽  
Author(s):  
Thomas Brownlee ◽  
Deonne Dersch-Mills ◽  
Ginny Cummings ◽  
Tanya Fischer ◽  
Rhonda Shkrobot ◽  
...  
Keyword(s):  
Mean Corpuscular Volume ◽  
Laboratory Data ◽  
Primary Objective ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Corpuscular Volume ◽  
Soins Intensifs ◽  
Iv Iron ◽  
Acute Care Facilities ◽  
Pratique Clinique

Background: IV administration of iron is appropriate for the treatment of iron deficiency anemia (IDA) when orally administered iron has not been effective, tolerated, or clinically appropriate. In Calgary, Alberta, high levels of IV iron utilization required review, because of significant health care resource utilization, high cost, and reduced accessibility. Objectives: The primary objective was to describe the population of adult patients in Calgary with estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 for whom IV iron was dispensed from acute care facilities, in terms of pretreatment laboratory data, previous use of oral iron, and treatment location, as well as to characterize dose and product selection for IV iron. The secondary objective was to determine the proportion of inpatients whose treatment was in alignment with the Toward Optimized Practice clinical practice guideline for IDA. Methods: A retrospective review of electronic charts was used to obtain data about patients with a first dose of IV iron dispensed in Calgary hospitals between March 1 and December 31, 2018. The data were analyzed descriptively. Results: A total of 1352 patients met the inclusion criteria. These patients received a total of 3532 doses of IV iron, 97.1% of which were iron sucrose, at a median of 300 mg per infusion. Laboratory indices assessed before the first infusion were hemoglobin (mean 92, standard deviation [SD] 19.6 g/L), mean corpuscular volume (mean 81 [SD 10.3] fL), and ferritin (median 18 [interquartile range 9–48] μg/L). Among the included patients, 233 (17.2%) had oral iron dispensed within 90 days before their first IV dose of iron. Only 146 (20.1%) of the 726 inpatients had treatment that was in alignment with the Toward Optimized Practice IDA guideline. Conclusions: There was substantial variation in baseline hemoglobin, mean corpuscular volume, and ferritin, and in the use of oral iron before initiation of IV iron treatment. Provision of educational tools and stewardship initiatives may help in ensuring alignment of iron prescribing with current guidelines. RÉSUMÉ Contexte : L’administration de fer par intraveineuse (IV) convient au traitement de l’anémie ferriprive lorsque son administration par voie orale n’a pas été efficace, tolérée ou appropriée d’un point de vue clinique. À Calgary (Alberta), il a fallu réviser les quantités de fer administrées par IV en raison de la mobilisation importante des ressources de soins de santé et des coûts élevés que cela exigeait ainsi que de l’accessibilité réduite au produit. Objectifs : L’objectif principal consistait à décrire la population de patients adultes, dont le taux estimé de filtration glomérulaire était supérieur ou égal à 30 mL/min/1,73 m2 et à qui on administrait du fer par IV dans des installations de soins intensifs de Calgary. La description devait se faire en termes de données de laboratoire préalables au traitement, d’administration antérieure de fer par voie orale et de lieu du traitement; il s’agissait aussi de décrire la dose et la sélection du produit pour l’administration de fer par IV. L’objectif secondaire consistait à déterminer la proportion de patients hospitalisés, dont le traitement s’alignait sur les directives de pratique clinique Toward Optimized Practice relatives à l’anémie ferriprive. Méthodes : Un examen rétrospectif des tableaux électroniques a permis d’obtenir des données sur les patients, ayant reçu une première dose de fer par IV dans les hôpitaux de Calgary, entre le 1er mars et le 31 décembre 2018. Les données ont fait l’objet d’une analyse descriptive. Résultats : Au total, 1352 patients répondaient au critère d’inclusion. Ils ont reçu 3532 doses de fer par IV, dont 97,1 % de saccharose de fer à raison d’une médiane de 300 mg par perfusion. Les indices de laboratoire évalués avant la première perfusion concernaient l’hémoglobine (moyenne 92, écart-type [ET] 19,6 g/L), le volume corpusculaire moyen (moyenne 81 [ET 10,3] fL) et la ferritine (moyenne 18 [écart interquartile 9-48] μg/L). Parmi les patients de l’étude, 233 (17,2 %) avaient reçu du fer par voie orale 90 jours avant la première dose de fer administrée par IV. Seuls 146 (20,1 %) des 726 patients hospitalisés avaient reçu un traitement conforme aux directives de pratique clinique Toward Optimized Practice relatives à l’anémie ferriprive. Conclusions : On a constaté une variation importante de l’hémoglobine de base, du volume corpusculaire moyen et de la ferritine, ainsi que de l’utilisation du fer par voie orale avant le début du traitement par IV. Des outils pédagogiques et des initiatives de gestion pourraient aider à assurer l’alignement de la prescription de fer sur les directives actuelles.

scholarly journals 810 Intravenous Iron Versus Oral Iron in Anemia Management for Perioperative Patients: A Systemic Review and Meta-Analysis

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
A Alshantti
Keyword(s):  
Clinical Trials ◽  
Mean Corpuscular Volume ◽  
Intravenous Iron ◽  
Perioperative Period ◽  
Oral Iron ◽  
Iron Therapy ◽  
Corpuscular Volume ◽  
Iron Group ◽  
Adverse Side Effects ◽  
Iv Iron

Abstract Introduction Perioperative anemia commonly occurs in patients undoing major surgery. We aimed to assess the efficacy and safety of intravenous iron therapy (IVIT) given compared to standard practice of oral iron in the perioperative period. Design The search strategy was conducted in Medline, Embase, and Cochrane for only eligible clinical trials (randomized controlled trials) comparing IV over oral iron therapy up to July 2019. The primary outcome was the effect of IVIT on the change of hemoglobin level. The secondary outcomes were the effects of IVIT compared to oral iron on ferritin level, mean corpuscular volume, and adverse side effects. Data were collected from each trial and where applicable meta-analyzed using RevMan. Results Six randomized clinical trials that fit our inclusion criteria were included in the study.We found that IVIT increases the level of hemoglobin compared to oral iron (MD: Mean difference 0.90, 95% confidence interval [CI]: 0.44–1.36, P = 0.000). Serum ferritin levels increased significantly in favor of the IV iron group compared to the oral iron group at posttreatment (MD: 106.95, 95% CI: 73.29, 140.62 ng/mL). In addition, marked increases in the pooled mean corpuscular volume (MCV) level were observed in favor of the IVIT (MD: 6.07, 95% CI: −0.88–13.02). There was no significant difference in the rate of adverse effects in both the groups. Conclusions IV iron therapy is more effective than oral iron on increasing hemoglobin, ferritin, and MCV in the perioperative period and is also as safe with no diffidence in the risk of developing adverse side effects.

Intravenous versus Oral iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial

2021 ◽  
Author(s):  
Adam K. Lewkowitz ◽  
Molly J. Stout ◽  
Emily Cooke ◽  
Seon C. Deoni ◽  
Viren D'Sa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Adverse Reactions ◽  
Controlled Trial ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Randomized Controlled ◽  
Iv Iron ◽  
Severe Adverse Reactions

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

Too Much of a Good Thing? Cerebral Sinovenous Thrombosis Due to Excessive Milk Intake Associated Anemia

2020 ◽  
Vol 35 (9) ◽  
pp. 585-590
Author(s):  
Raquel Farias-Moeller ◽  
Sara Siddiqui ◽  
Megan Orr ◽  
Lileth Mondok
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Mean Corpuscular Volume ◽  
Milk Intake ◽  
Deficiency Anemia ◽  
Cow’S Milk ◽  
Corpuscular Volume ◽  
Cow's Milk ◽  
Cerebral Sinovenous Thrombosis ◽  
Sinovenous Thrombosis

Introduction: In young children, excessive cow’s milk intake causes iron-deficiency anemia, which is associated with hypercoagulable states. We present a case series of 4 toddlers with excessive milk intake iron-deficiency anemia and cerebral sinovenous thrombosis. Methods: Retrospective chart review of 4 patients was performed for patients with cerebral sinovenous thrombosis and iron-deficiency anemia secondary to excessive milk intake. Iron-deficiency anemia was defined as hemoglobin <11 mg/dL, mean corpuscular volume <70 fL, and serum ferritin <12 μg/L. Excessive milk intake was defined as consumption of >24 oz daily. Clinical, laboratory, and radiographic features were reviewed. Results: Age ranged from 12 to 24 months. Average hemoglobin, hematocrit, mean corpuscular volume, and ferritin levels were 6.1 g/dL, 22.7 g/dL, 52.7 fL, and 3.2 ng/mL, respectively. Daily milk consumption ranged from 40 to 60 oz. All patients presented with focal neurologic deficits, including seizures in 3. The location of cerebral sinovenous thrombosis varied, and 3 patients had venous infarcts, one of them hemorrhagic. All patients had a limited diet and were described as “picky eaters” by their parents, and only 1 had transitioned of a bottle. All patients were treated with anticoagulation, iron supplementation, and extensive dietary counseling to reduce cow’s milk intake. Conclusion: Iron-deficiency anemia due to excessive milk intake is an important and preventable etiology of pediatric cerebral sinovenous thrombosis. Focused anticipatory guidance is necessary for at-risk groups to prevent this neurologic emergency.

Iron Deficiency Anemia Following Prenatal Nutrition Interventions

2007 ◽  
Vol 68 (4) ◽  
pp. 222-225
Author(s):  
Caroline P. Leblanc ◽  
France M. Rioux
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Low Income ◽  
Mean Corpuscular Volume ◽  
Serum Iron ◽  
Transferrin Saturation ◽  
Deficiency Anemia ◽  
Corpuscular Volume ◽  
Prevalence Of Anemia

Purpose: Iron deficiency anemia (IDA) during pregnancy and infancy is still common in developed countries, especially in low-income groups. We examined the prevalence of anemia and IDA in healthy low-income pregnant women participating in the Early Childhood Initiatives (ECI) program, and in their infants when they reached six months of age. Methods: Pregnant women were recruited by nutritionists. In mothers, hemoglobin (Hb), mean corpuscular volume, and serum ferritin (SF) were measured at 36 ± 2 weeks of gestation. In infants, Hb, mean corpuscular volume, SF, serum iron, total iron binding capacity (TIBC), and transferrin saturation (TS) were measured at six months of age. Thirty-one mother-infant pairs participated. Results: Among the 31 pregnant women participating in the ECI program, six (19.4%) were anemic (Hb <110 g/L) and five (16.1%) suffered from IDA (Hb <110 g/L and SF <10 µg/L). Among infants, seven of 23 (30.4%) were anemic (Hb <110 g/L) and five of 23 (21.7%) suffered from IDA (Hb <110 g/L plus two of the following: TIBC >60 µmol/L, SF <10 µg/L, serum iron <5.3 µmol/L, TS ≤15%). Conclusions: The prevalence of anemia in this group of lowincome pregnant women is comparable to that in privileged women. The prevalence of IDA in infants is comparable to that observed in other high-risk groups. Effective strategies are needed to prevent IDA in vulnerable groups.

Treatment of Iron Deficiency Anemia in Pregnancy with Intravenous versus Oral Iron: Systematic Review and Meta-Analysis

2018 ◽  
Vol 36 (04) ◽  
pp. 366-376 ◽  
Author(s):  
Richard Burwick ◽  
Shravya Govindappagari
Keyword(s):  
Systematic Review ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Meta Analysis ◽  
Oral Iron ◽  
Sensitivity Analyses ◽  
Deficiency Anemia ◽  
Iv Iron ◽  
Anemia In Pregnancy ◽  
In Pregnancy

Objective To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the benefits of intravenous (IV) iron in pregnancy. Study Design Systematic review was registered with PROSPERO and performed using PRISMA guidelines. PubMed, MEDLINE, Web of Science, ClinicalTrials.gov, Cochrane Library, and Google Scholar were searched. Eleven RCTs, comparing IV to oral iron for treatment of iron-deficiency anemia in pregnancy, were included. Meta-analyses were performed with Stata software (College Station, TX), utilizing random effects model and method of DerSimonian and Laird. Outcomes were assessed by pooled odds ratios (OR) or pooled weighted mean difference (WMD). Sensitivity analyses were performed for heterogeneity. Results We found that pregnant women receiving IV iron, compared with oral iron, had the following benefits: (1) Achieved target hemoglobin more often, pooled OR 2.66 (95% confidence interval [CI]: 1.71–4.15), p < 0.001; (2) Increased hemoglobin level after 4 weeks, pooled WMD 0.84 g/dL (95% CI: 0.59–1.09), p < 0.001; (3) Decreased adverse reactions, pooled OR 0.35 (95% CI: 0.18–0.67), p = 0.001. Results were unchanged following sensitivity analyses. Conclusion In this meta-analysis, IV iron is superior to oral iron for treatment of iron-deficiency anemia in pregnancy. Women receiving IV iron more often achieve desired hemoglobin targets, faster and with fewer side effects.

scholarly journals Prevalence and causes of iron deficiency anemias in infants aged 9 to 12 months in Estonia

Medicina ◽  
2007 ◽  
Vol 43 (12) ◽  
pp. 947 ◽  
Author(s):  
Neve Vendt ◽  
Heli Grünberg ◽  
Sirje Leedo ◽  
Vallo Tillmann ◽  
Tiina Talvik
Keyword(s):  
Risk Factor ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Mean Corpuscular Volume ◽  
Ferritin Level ◽  
Solid Food ◽  
Deficiency Anemia ◽  
Corpuscular Volume ◽  
Main Risk Factor ◽  
Ferritin Concentration

Objective. To investigate the prevalence and causes of iron deficiency anemia in infants aged 9 to 12 months in Estonia. Material and methods. Every second child aged 9–12 months was randomly selected from primary medical centers in seven counties from all over Estonia. A questionnaire concerning eating habits and lifestyle was sent to their parents. Sixty-five percent (n=195) of contacted families agreed to participate in the study. Mean corpuscular volume and hemoglobin, serum ferritin, and soluble transferrin receptor levels were measured in 171 infants. Anemia was defined when hemoglobin level was lower than 105 g/L, and iron deficiency when ferritin level and mean corpuscular volume were lower than 12 µg/L and 74 fL, respectively. Results. The prevalence of iron deficiency was 14.0% and iron deficiency anemia 9.4%. Birthweight less than 3000 g was the main risk factor for iron deficiency (OR=9.4; P<0.0005). Infants fed with breast milk and solid food had lower ferritin concentration (18.5 µg/L, 95% CI 14.0–23.0) than infants fed with formula and solid food (32.8 µg/L, 95% CI 26.6–39) (P<0.005). Conclusion. Iron deficiency anemia is common among 9–12-month-old Estonian infants. The main risk factor for iron deficiency was birthweight less than 3000 g.

P020 PRACTICE PATTERNS OF PRIMARY CARE AND GASTROENTEROLOGY PHYSICIANS IN THE MANAGEMENT OF IRON DEFICIENCY ANEMIA IN INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S54-S54
Author(s):  
Francis Wade ◽  
Florence-Damilola Odufalu ◽  
Gretchen Grosch ◽  
Melissa Chambers ◽  
Katie Schroeder
Keyword(s):  
Primary Care ◽  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Bowel Disease ◽  
Practice Patterns ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Poor Knowledge ◽  
Iv Iron ◽  
Inflammatory Bowel

Abstract Introduction Iron deficiency Anemia (IDA) is a common complication of inflammatory bowel disease (IBD). High prevalence of IDA in IBD suggests suboptimal surveillance and treatment. Oral iron is poorly tolerated, associated with worsened disease activity, and often insufficient to reverse anemia in IBD patients. Intravenous (IV) iron is favored for treatment of IDA in IBD in most clinical scenarios and many guidelines recommend IV iron as first line for IBD patients. Regardless, oral iron is prescribed commonly for IDA in IBD. The objective of this study is to determine practice patterns of primary care physicians (PCP) and gastroenterologists (GI) in the management of IDA in IBD. Methods We anonymously surveyed GI and PCP attendings and trainees at Saint Louis University School of Medicine in St. Louis, Missouri, using paper self-administered instruments. We asked about practice patterns in the management of IDA in IBD patients and knowledge of IV iron. The study questionnaire was developed based on United States expert opinion consensus statements and European guideline recommendations published in the Journal of Crohn’s and Colitis and Inflammatory Bowel Diseases. Results Of GI responders, 92.3% were fellows, 7.7% were attendings; of PCP responders, 81.8% were residents, 18.2% were attendings. 15.4% GIs, 12.7% PCPs were very comfortable managing IBD patients with IDA; 76.9% GIs, 58.2% PCPs were somewhat comfortable; 7.7% GIs, 29.1% PCPs were not comfortable (p=0.275). 61.5% GIs, 25.5% PCPs always check iron studies when evaluating anemic IBD patients; 30.1% GIs, 21.8% PCPs check most of the time; 7.7% GIs, 34.5% PCPs sometimes check; 0% GIs, 12.7% PCPs rarely check; 0% GIs, 5.4% PCPs never check (p =0.05). In mild Crohn’s disease with severe anemia, 15.4% GIs, 41.8% PCPs would prescribe oral iron daily; 15.4% GIs, 12.7% PCPs would prescribe oral iron every other day; 69.2% GIs, 45.5% PCPs would prescribe IV iron (p=0.58). 0% GIs reported good knowledge of IV iron, 53.8% reported acceptable knowledge, and 46.1% reported poor knowledge. 7.7% GIs, 10.9% PCPs reported good knowledge of how to order IV iron; 53.8% GIs, 7.3% PCPs reported acceptable knowledge; 38.5% GIs, 81.8% PCPs reported poor knowledge (p=0.000215). 23.1% GIs, 61.8% PCPs thought PCPs were responsible for screening for IDA in IBD patients; 76.9% GIs, 36.4% PCPs thought GIs were responsible (p= 0.0131). Discussion Both PCPs and GIs perceived responsibility to manage IDA in IBD patients. PCPs were less likely than GIs to screen for IDA in anemic IBD patients or to report adequate knowledge of clinic processes to order IV iron. Future efforts to reinforce gastroenterologists’ role in the management of IDA in IBD and to bolster familiarity with IV iron and its indications might improve outcomes and quality of life for IBD patients.

A Head-to-Head Comparison of the Safety and Efficacy of Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5157-5157
Author(s):  
Allen Poma ◽  
Karen Diana ◽  
Justin McLaughlin ◽  
Annamaria Kausz
Keyword(s):  
Iron Deficiency ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Safety And Efficacy ◽  
Oral Iron Therapy ◽  
The Us ◽  
Iv Iron ◽  
Iron Replacement

Abstract Abstract 5157 BACKGROUND: Iron replacement therapy is essential for increasing iron stores and raising hemoglobin levels in patients with iron deficiency anemia (IDA). Oral iron supplements have limited absorption and are commonly associated with gastrointestinal (GI) side effects that reduce compliance, resulting in limited increases in hemoglobin. In patients without chronic kidney disease (CKD), oral iron therapy is frequently used to treat IDA. However, when oral iron therapy is unsatisfactory or cannot be tolerated, intravenous (IV) iron therapy may be appropriate. In the US, iron dextrans are the only approved IV iron products indicated for the treatment of IDA in non-CKD patients, and have limitations around convenience because they require a test dose and as many as 10 administrations via a slow infusion; iron dextrans have also been associated with a relatively high rate of serious adverse reactions compared to other IV iron products. Other IV irons, such as iron sucrose and sodium ferric gluconate, are only approved in the US for the treatment of IDA in patients with CKD. Like the iron dextrans, both of these products are limited by administration, requiring 5 to 10 clinic visits for the administration of a full therapeutic dose (1 gram of iron). Feraheme® (ferumoxytol) Injection is an IV iron product approved in the US for the treatment of IDA in adult subjects with CKD. Its carbohydrate coating is designed to minimize immunological sensitivity, and it has less free iron than other IV iron preparations. Ferumoxytol is administered as two IV injections of 510 mg (17 mL) 3 to 8 days apart for a total cumulative dose of 1.02 g. METHODS: To date, there have been a limited number of studies that have examined the safety and efficacy of IV irons in a head-to-head manner for the treatment of IDA, and no study has done so in a large number of subjects or in a broad patient population. AMAG, therefore, has initiated a randomized, controlled trial (ClinicalTrials.gov NCT01114204) to compare ferumoxytol with iron sucrose. Iron sucrose is approved in many countries outside the US for the treatment of IDA in patients intolerant to oral iron therapy, and is considered a safer alternative to IV iron dextran. This open-label trial (n=600) will evaluate the efficacy and safety of a 1.02 g of IV ferumoxytol, administered as 2 doses of 510 mg each, compared with 1.0 g of IV iron sucrose, administered as 5 doses of 200 mg each. Enrolled subjects will have IDA associated with a variety of underlying conditions including abnormal uterine bleeding, GI disorders, cancer, postpartum anemia, and others (eg, nutritional deficiency). Endpoints include changes in hemoglobin and transferrin saturation at Week 5, as well as evaluation of the requirement for erythropoiesis stimulating agent therapy and blood transfusion. Patient reported outcomes instruments will be employed to assess the impact of IV iron therapy on anemia symptoms and health-related quality of life (fatigue, energy, etc). Additionally, detailed information on healthcare utilization will be collected. CONCLUSION In the US, non-CKD patients with IDA who have a history of unsatisfactory oral iron therapy have limited options for iron replacement therapy. Study NCT01114204 will provide novel information comparing the safety and efficacy of two IV iron therapies for the treatment of IDA in a broad patient population. Disclosures: Poma: AMAG Pharmaceuticals, Inc.: Employment. Diana:AMAG Pharmaceuticals, Inc.: Employment. McLaughlin:AMAG Pharmaceuticals, Inc.: Employment. Kausz:AMAG Pharmaceuticals, Inc.: Employment.

Relationship Between Iron Indices and Iron Responsiveness Following IV Ferumoxytol or Oral Iron In Patients with CKD Not on Dialysis

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5149-5149
Author(s):  
John Adamson ◽  
Zhu Li ◽  
Paul Miller ◽  
Annamaria Kausz
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Iron Status ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Functional Iron Deficiency ◽  
Iron Stores ◽  
Iv Iron ◽  
Definition Of

Abstract Abstract 5149 BACKGROUND Iron deficiency anemia (IDA) is associated with reduced physical functioning, cardiovascular disease, and poor quality of life. The measurement of body iron stores is essential to the management of IDA, and the indices most commonly used to assess iron status are transferrin saturation (TSAT) and serum ferritin. Unfortunately, serum ferritin is not a reliable indicator of iron status, particularly in patients with chronic kidney disease (CKD), because it is an acute phase reactant and may be elevated in patients with iron deficiency in the presence of inflammation. Recent clinical trials have shown that patients with iron indices above a strict definition of iron deficiency (TSAT >15%, serum ferritin >100 ng/mL), do have a significant increase in hemoglobin (Hgb) when treated with iron. These results are consistent with recent changes to the National Cancer Comprehensive Network (NCCN) guidelines, which have expanded the definition of functional iron deficiency (relative iron deficiency) to include a serum ferritin <800 ng/mL; previously, the serum ferritin threshold was <300 ng/mL. Additionally, for patients who meet this expanded definition of functional iron deficiency (TSAT <20%, ferritin <800 ng/mL), it is now recommended that iron replacement therapy be considered in addition to erythropoiesis-stimulating agent (ESA) therapy. Ferumoxytol (Feraheme®) Injection, a novel IV iron therapeutic agent, is indicated for the treatment of IDA in adult patients with CKD. Ferumoxytol is composed of an iron oxide with a unique carbohydrate coating (polyglucose sorbitol carboxymethylether), is isotonic, has a neutral pH, and evidence of lower free iron than other IV irons. Ferumoxytol is administered as two IV injections of 510 mg (17 mL) 3 to 8 days apart for a total cumulative dose of 1.02 g; each IV injection can be administered at a rate up to 1 mL/sec, allowing for administration of a 510 mg dose in less than 1 minute. METHODS Data were combined from 2 identically designed and executed Phase III randomized, active-controlled, open-label studies conducted in 606 patients with CKD stages 1–5 not on dialysis. Patients were randomly assigned in a 3:1 ratio to receive a course of either 1.02 g IV ferumoxytol (n=453) administered as 2 doses of 510 mg each within 5±3 days or 200 mg of oral elemental iron (n=153) daily for 21 days. The main IDA inclusion criteria included a Hgb ≤11.0 g/dL, TSAT ≤30%, and serum ferritin ≤600 ng/mL. The mean baseline Hgb was approximately 10 g/dL, and ESAs were use by approximately 40% of patients. To further evaluate the relationship between baseline markers of iron stores and response to iron therapy, data from these trials were summarized by baseline TSAT and serum ferritin levels. RESULTS Overall, results from these two pooled trials show that ferumoxytol resulted in a statistically significant greater mean increase in Hgb relative to oral iron. When evaluated across the baseline iron indices examined, statistically significant (p<0.05) increases in Hgb at Day 35 were observed following ferumoxytol administration, even for subjects with baseline iron indices above levels traditionally used to define iron deficiency. Additionally, at each level of baseline iron indices, ferumoxytol produced a larger change in Hgb relative to oral iron. These data suggest that patients with CKD not on dialysis with a wide range of iron indices at baseline respond to IV iron therapy with an increase in Hgb. Additionally, ferumoxytol consistently resulted in larger increases in Hgb relative to oral iron across all levels of baseline iron indices examined. Disclosures: Adamson: VA Medical Center MC 111E: Honoraria, Membership on an entity's Board of Directors or advisory committees. Li:AMAG Pharmaceuticals, Inc.: Employment. Miller:AMAG Pharmaceuticals, Inc.: Employment. Kausz:AMAG Pharmaceuticals, Inc.: Employment.

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