Effect of Maintenance Intravenous Iron Treatment on Erythropoietin Dose in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial

Background: There is no consensus on intravenous (IV) iron supplement dose, schedule, and serum ferritin target in functional iron deficiency anemia to maintain optimum target levels of iron stores by several guidelines. Objective: To examine the effect of IV iron supplementation to different targets of serum ferritin on erythropoietin dose and inflammatory markers in chronic hemodialysis (HD) patients with functional iron deficiency anemia. Design: A multicenter, randomized, open-label study. Setting: In a developing country, Thailand. Patients: Chronic HD patients with functional iron deficiency anemia. Measurements: Erythropoietin resistance index, high-sensitivity C-reactive protein, and fibroblast growth factor 23. Methods: Two hundred adult chronic HD patients with transferrin saturation less than 30% and serum ferritin of 200 to 400 ng/mL were randomized 1:1 to maintain serum ferritin 200 to 400 ng/mL (low-serum ferritin group, N = 100) or 600 to 700 ng/mL (high-serum ferritin group, N = 100). During a 6-week titration period, participants randomized to the high-serum ferritin group initially received 600 mg IV iron (100 mg every week), while the participants in the low-serum ferritin group did not receive IV iron. During the 6-month follow-up period, the dose of IV iron was adjusted by protocol. Results: The mean dose of IV iron was 108.3 ± 28.2 mg/month in the low-serum ferritin group and 192.3 ± 36.2 mg/month in the high-serum ferritin group. The mean serum ferritin was 367.0 ± 224.9 ng/mL in the low ferritin group and 619.6 ± 265.2 ng/mL in the high ferritin group. The erythropoietin resistance index was significantly decreased in the high-serum ferritin group compared to the low-serum ferritin group after receiving IV iron in the 6-week titration period (mean difference: −113.43 ± 189.14 vs 41.08 ± 207.38 unit/week/g/dL; P < .001) and 3-month follow-up period (mean differences: −88.88 ± 234.43 vs −10.48 ± 217.75 unit/week/g/dL; P = .02). Limitations: Short follow-up period. Conclusion: Maintaining a serum ferritin level of 600 to 700 ng/mL by IV iron administration of approximately 200 mg per month as a maintenance protocol can decrease erythropoietin dose requirements in chronic HD patients with functional iron deficiency anemia. Trials registration: The study was registered with the Thai Clinical Trials Registry TCTR20180903003.

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

Blood ◽

10.1182/blood.v116.21.5149.5149 ◽

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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Iron Deficiency Anemia in Cancer Patients

Oncology & Hematology Review (US) ◽

10.17925/ohr.2012.08.2.74 ◽

2012 ◽

Vol 08 (02) ◽

pp. 74

Author(s):

Mark Janis ◽

Keyword(s):

Iron Deficiency ◽

Cancer Patients ◽

Iron Deficiency Anemia ◽

Iron Transport ◽

The Body ◽

Deficiency Anemia ◽

Functional Iron Deficiency ◽

Iron Stores ◽

Iv Iron ◽

Absolute Iron Deficiency

Anemia is highly prevalent, affecting approximately 40 % of cancer patients, and results in a significant decrease in health-related quality of life while also being associated with shorter cancer survival times. A recent survey of 15,000 cancer patients in Europe found that 39 % were anemic at the time of enrolment. In addition, anemia is a recognized complication of myelosuppressive chemotherapy, and it has been estimated that, in the US, around 1.3 million cancer patients who are not anemic at the time of diagnosis will develop anemia during the course of their disease. The etiology of anemia in cancer patients is variable and often multifactorial, and may be the result of an absolute or a functional iron deficiency. Cancer produces an enhanced inflammatory state within the bodycausing hepcidin levels to increase and erythropoietin production to decreaseand results in a reduction in erythropoiesis due to impaired iron transport. This type of anemia is known as functional iron deficiency, where the body has adequate iron stores but there are problems with mobilization and transport of the iron. Absolute iron deficiency is when both iron stores and iron transport are low. The National Comprehensive Cancer Network (NCCN) treatment guidelines for cancer-related anemia recommend intravenous (IV) iron products alone for iron repletion in cancer patients with absolute iron deficiency, and erythropoiesis-stimulating agents (ESAs) in combination with IV iron in cancer patients (currently undergoing palliative chemotherapy) with functional iron deficiency. Although IV iron has been demonstrated to enhance the hematopoietic response to ESA therapy, the use of supplemental iron has not yet been optimized in oncology. Here we discuss the significance of iron deficiency anemia in cancer patients and the need to implement tools to properly diagnose this condition, and we provide an overview of the management strategies and recommendations for patients with iron deficiency anemia as outlined in the NCCN guidelines.

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A COMPARATIVE STUDY OF INTRAVENOUS IRON SUCROSE VERSUS ORAL IRON THERAPY IN IRON DEFICIENCY ANEMIA DURING POSTPARTUM PERIOD

International Journal of Medical and Biomedical Studies ◽

10.32553/ijmbs.v5i12.2345 ◽

2021 ◽

Vol 5 (12) ◽

Author(s):

Satish Kumar

Keyword(s):

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Serum Ferritin ◽

Intravenous Iron ◽

Hemoglobin Level ◽

Oral Iron ◽

Iron Sucrose ◽

Deficiency Anemia ◽

Iron Group ◽

Iv Iron

Introduction: Anemia is the commonest major contributing factor in maternal mortality and morbidity in developing countries and according to World Health Organization (WHO) criteria, it contributes to 20% of maternal deaths. Anemia in pregnancy defined as hemoglobin level <11 gm/dl (7.45 mmol/L) and hematocrit less than 33% (WHO). Aim: To compare the efficacy of oral iron ferrous sulphate therapy with intravenous iron sucrose therapy in the treatment of iron deficiency anemia during postpartum period. Material & Methods: This was a prospective randomized comparative clinical trial single center study conducted on 200 postpartum women aged >18 years (after normal delivery or LSCS) within 10 days of delivery with Hb level more or equal to 6 gm/dl but less than 10 gm/dl were included in the study. This was a one year study conducted during 1st December 2018 to 30th November 2019. Results : There was a significant increase in the hemoglobin level in both the groups i.e. in IV iron group, from 8.26 ±1.03gm/dl on day 1 to 11.62±0.94gm/dl on day 45 as compared to oral iron group, from 8.24±1.09gm/dl on day 1 to 11.07±1.14gm/dl on day 45; and serum ferritin level from 41.69±40.45ng/ml on day 1 to 77.34±41.60ng/ml on day 45 in IV iron group as compared to the oral iron group from 22.20±8.82ng/ml on day 1 to 31.72±9.72 ng/ml on day 45. So, there was a rapid increase in both hemoglobin and serum ferritin levels in IV iron group as compared to the oral iron group. Conclusion: Intravenous iron sucrose administration increases the hemoglobin level and serum ferritin more rapidly in compare to the oral intake of ferrous sulphate in women with iron deficiency anemia in postpartum women in our study. Keywords: Iron deficiency anemia, Intravenous iron sucrose, Serum ferritin, Maternal mortality.

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Zinc protoporphyrin as screening test in female blood donors

Clinical Chemistry ◽

10.1093/clinchem/44.4.800 ◽

1998 ◽

Vol 44 (4) ◽

pp. 800-804 ◽

Cited By ~ 14

Author(s):

Else J Harthoorn-Lasthuizen ◽

Jan Lindemans ◽

Mart M A C Langenhuijsen

Keyword(s):

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Serum Ferritin ◽

Blood Donors ◽

Deficiency Anemia ◽

Zinc Protoporphyrin ◽

Ferritin Concentration ◽

Iron Deficient ◽

Serum Ferritin Concentration ◽

Low Serum

Abstract Erythrocyte zinc protoporphyrin (ZPP) was measured in 102 women blood donors to evaluate its usefulness in screening for evolving iron deficiency anemia, a reason for the deferral of donors. The results were compared with serum ferritin determinations. Five women were deferred before their first donation and eight women were deferred after one or two donations. Women with increased ZPP values all had low serum ferritin concentrations, indicating iron-deficient erythropoiesis that was caused by iron depletion. The positive predictive value of an increased ZPP in predicting deferral of the donor after one or two donations was 75%, whereas a serum ferritin concentration ≤12 μg/L predicted deferral in 26% of the donors. The results indicate that the ZPP test can be recommended as a feasible and inexpensive predonation test to determine a subset of donors with iron-deficient erythropoiesis at risk of developing iron deficiency anemia.

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High Prevalence of Helicobacter pylori in the Alaska Native Population and Association with Low Serum Ferritin Levels in Young Adults

Clinical and Diagnostic Laboratory Immunology ◽

10.1128/cdli.7.6.885-888.2000 ◽

2000 ◽

Vol 7 (6) ◽

pp. 885-888 ◽

Cited By ~ 89

Author(s):

Alan J. Parkinson ◽

Benjamin D. Gold ◽

Lisa Bulkow ◽

Robert B. Wainwright ◽

Balasubra Swaminathan ◽

...

Keyword(s):

Helicobacter Pylori ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Serum Ferritin ◽

Alaska Native ◽

Deficiency Anemia ◽

Native Population ◽

Specific Igg ◽

H Pylori ◽

Low Serum

ABSTRACT Iron deficiency anemia is a common public health problem in the Alaska Native population. Yet, a clear etiology has eluded researchers for decades. Previous studies suggested a link betweenHelicobacter pylori infection, gastrointestinal blood loss due to hemorrhagic gastritis, and generalized iron deficiency anemia in adult Alaska Natives. Therefore, we examined the association between the prevalence of H. pylori-specific immunoglobulin G (IgG) and serum ferritin levels, a marker of iron deficiency. A random sample of 2,080 serum samples from Alaska Native residents drawn between 1980 and 1986 from residents in 13 regions was selected, and the samples were stratified by age, sex, and region. Overall, 75% were positive for H. pylori-specific IgG. The rate of H. pylori seropositivity increased with age; by age 14 years, 78% of the residents were positive. There were no gender differences inH. pylori seropositivity. However, marked regional differences were observed. Serum ferritin levels of <12 ng/ml were found most commonly among persons <20 years of age and among women of childbearing age. A significant association between low serum ferritin levels and prevalence of H. pylori-specific IgG was found, particularly for people aged less than 20 years. H. pylorimay be a factor contributing to the iron deficiency anemia in the Alaska Native population.

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Relationship of Iron Deficiency Anemia with Simple Febrile Seizure in Children

Journal of Bangladesh College of Physicians and Surgeons ◽

10.3329/jbcps.v35i2.33367 ◽

2017 ◽

Vol 35 (2) ◽

pp. 75-79

Author(s):

Sharmistha Ghosal

Keyword(s):

Risk Factor ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Serum Ferritin ◽

Febrile Seizure ◽

Deficiency Anemia ◽

Significant Difference ◽

Rbc Indices ◽

Relationship Of ◽

Low Serum

Background and objective: Febrile Seizure (FS) is the commonest seizure disorder among under 5 children. Iron deficiency is a documented risk factor of FS and as the data about the relationship of iron deficiency with FS among Bangladeshi children is scanty, this study was undertaken to assess the association of Serum Ferritin to simple FS.Materials and Methods: This case control study was conducted at the department of pediatrics of SSMC & Mitford Hospital during 7th May 2011 to 6th January 2012 on consecutive 120 children aged between five months to six years who fulfilled the inclusion criteria were considered as cases. Similar number of age and sex matched children admitted with fever without seizures were taken as controls. All candidates were gone through CBC with RBC indices and serum ferritin and iron deficiency anemia was diagnosed on the basis of mentioned tests.Results: The results showed that majority of the cases were male (66.7%) and most of them were between 13-24 months of age (51.7%). Mean duration of convulsion was less than 5 minutes in 70% of the cases. Level of Hb was low in both the cases and controls but the other RBC indices for anemia like MCV, MCH, MCHC and serum ferritin were significantly lower among the febrile seizures group in comparison to controls. The chi-square test is indicated as a significant difference between two groups and odds ratio is 6.0 which signifies that febrile seizure group were 6.0 times more likely to develop iron deficiency anemia compared to control group.Conclusion: The findings suggest that children with febrile seizure have association with iron deficiency anemia (which is evident by microcytic hypochromic anemia and low serum ferritin level) .This means low serum ferritin and presence of anemia can serve as a risk factor for febrile seizure in children.J Bangladesh Coll Phys Surg 2017; 35(2): 75-79

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Management of Severe Iron Deficiency Anemia in the Pediatric Emergency Department: A Comparison of IV Iron Vs Transfusions

Blood ◽

10.1182/blood-2021-153916 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 2011-2011

Author(s):

Matthew Speckert ◽

Lana Ramic ◽

Nicholas Mitsakakis ◽

Mira Liebman ◽

Elaine W. Leung

Keyword(s):

Emergency Department ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Pediatric Emergency ◽

Iron Sucrose ◽

Deficiency Anemia ◽

Pediatric Emergency Department ◽

Iv Iron ◽

Parenteral Iron

Abstract Introduction: Severe iron deficiency anemia (IDA) is a problem that often presents to the pediatric emergency department (ED). Recently published ASH-ASPHO Choosing Wisely recommendations suggest avoidance of transfusion in hemodynamically stable, asymptomatic children with IDA 1. Little is known about the use of parenteral iron in this pediatric setting. Methods: We undertook a retrospective review of patients with severe IDA treated in the pediatric ED at the Children's Hospital of Eastern Ontario (CHEO) from September 2017 to June 2021. During this period there were an estimated 75000 patients seen annually. Patients with severe IDA were defined as those presenting with hemoglobin (Hb) less than <70 g/L and low mean corpuscular volume. Results: There were 56 patients that met this criterion with presenting Hb ranging from 17-69 g/L (IQR 41- 62). Median age at presentation was 3.75 yrs (IQR 1.68- 15.5), with a bimodal peak at age 1 yr and again in the teen years (Fig 1). 42 (75%) patients were female. The most common causes of IDA were nutritional and heavy menstrual bleeding. 14 (24.6%) received packed red blood cell (PRBC) transfusion with or without parenteral iron (iron sucrose), and 11 (19.3%) were treated with parenteral iron alone. Almost all (55, 98.2%) were prescribed oral iron supplementation. The lower the presenting Hb, the more likely that transfusion or parenteral iron was used as initial therapy (Fig 2). 19 (33.9%) patients were admitted to hospital and 37 (66.1%) were discharged home from the ED. Nine recipients of parenteral iron alone had follow-up at CHEO, six had follow-up within 10 days with Hb increases of at least 20 g/L and all nine patients had follow-up by day 41 showing increases ranging from 20-97 g/L. Three recipients of parenteral iron alone had presenting Hb <30 g/L and by 9 days following ED encounter all three had increased their Hb by at least 20 (20-32) g/L. Three patients were discharged from ED after IV iron, and none presented to the ED again. Six recipients of PRBCs had follow up within 10 days showing Hb increase ranging from 33-62 g/L, only five had follow-up by day 41 showing increases of 42-79 g/L. Five patients received >1 transfusion, and transfused volumes ranged from 5-25 mL/kg. Minor infusion reactions occurred in 2 (17%) recipients of parenteral iron, and no patient was suspected to have anaphylaxis. Four (28.5%) patients experienced minor transfusion reactions to packed cells. One recipient of multiple PRBC transfusions had transfusion-associated cardiac overload (TACO) requiring ICU admission. Conclusions: This study demonstrates that patients with severe IDA can be safely and effectively managed in the ED setting with parenteral iron therapy alone without PRBC transfusion. The use of parenteral iron avoids the potential short and long-term complications associated with transfusion, whilst ensuring rapid restoration of iron stores without the tolerability issues associated with oral iron. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: IV iron sucrose is indicated for treatment of iron deficiency in patients 2 and older with CKD. The use of it outside of this context would be considered off label.

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A comparative study of intravenous iron sucrose versus oral iron therapy in iron deficiency anemia during postpartum period

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20201773 ◽

2020 ◽

Vol 9 (5) ◽

pp. 1878

Author(s):

Santosh Khajotia ◽

Shubha Meena ◽

Deepak Naraniya

Keyword(s):

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Serum Ferritin ◽

Ferrous Sulphate ◽

Intravenous Iron ◽

Oral Iron ◽

Iron Sucrose ◽

Deficiency Anemia ◽

Iron Group ◽

Iv Iron

Background: Anemia is the commonest major contributing factor in maternal mortality and morbidity in developing countries and according to World Health Organization (WHO) criteria, it contributes to 20% of maternal deaths. Anemia in pregnancy defined as haemoglobin level <11 gm/dl (7.45 mmol/L) and haematocrit less than 33% (WHO). Aim of this study was to compare the efficacy of oral iron ferrous sulphate therapy with intravenous iron sucrose therapy in the treatment of iron deficiency anemia during postpartum period.Methods: This was a prospective randomized comparative clinical trial single center study conducted on 200 postpartum women aged >18 years (after normal delivery or LSCS) within 10 days of delivery with Hb level more or equal to 6 gm/dl but less than 10 gm/dl were included in the study. This was a one-year study conducted during 1st December 2018 to 30th November 2019.Results: There was a significant increase in the hemoglobin level in both the groups i.e. in IV iron group, from 8.26±1.03 gm/dl on day 1 to 11.62±0.94 gm/dl on day 45 as compared to oral iron group, from 8.24±1.09 gm/dl on day 1 to 11.07±1.14 gm/dl on day 45; and serum ferritin level from 41.69±40.45 ng/ml on day 1 to 77.34±41.60 ng/ml on day 45 in IV iron group as compared to the oral iron group from 22.20±8.82 ng/ml on day 1 to 31.72±9.72 ng/ml on day 45. So, there was a rapid increase in both hemoglobin and serum ferritin levels in IV iron group as compared to the oral iron group.Conclusions: Intravenous iron sucrose administration increases the hemoglobin level and serum ferritin more rapidly in compare to the oral intake of ferrous sulphate in women with iron deficiency anemia in postpartum women in our study.

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Iron Dextran Versus Iron Sucrose for Non-Hemodialysis Adult Outpatients with Iron Deficiency Anemia: Assessment of Safety and Feasibility for A Randomized Controlled Trial

Blood ◽

10.1182/blood.v118.21.2107.2107 ◽

2011 ◽

Vol 118 (21) ◽

pp. 2107-2107

Author(s):

Martha L Louzada ◽

Cyrus C. Hsia ◽

Fiona Ralley ◽

Janet Martin ◽

Sarah Connelly ◽

...

Keyword(s):

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Iron Sucrose ◽

Adult Patients ◽

Deficiency Anemia ◽

Iron Dextran ◽

Iv Iron ◽

Time Required ◽

Lost To Follow Up

Abstract Abstract 2107 Introduction: Iron deficiency is the most common cause of anemia worldwide affecting 50% of children under 5 years of age and 25% of women under the age of 50 (11% in the USA) worldwide. Standard treatment is oral iron supplementation, however this route of administration is associated with several adverse drug reactions (ADRs), the most common being epigastralgia and constipation leading to lack of compliance or dose reduction in 30% of patients. Intravenous (IV) iron is an alternative treatment for patients intolerant or non-responsive to oral formulations. Of the two most common formulations available in Canada, IV iron dextran is less expensive but may be associated with more overall ADRs compared to IV iron sucrose. Methods: We conducted a single centre, double-blinded pilot RCT to assess the feasibility of a full RCT to compare ADRs between iron dextran and iron sucrose in non-hemodialysis and IV iron treatment naïve adult patients with iron deficiency anemia. The incidence of immediate (during outpatient hospital visit) and delayed (within 24 hours after patient discharged) ADRs for each iron formulation were compared. Baseline characteristics of participants were analyzed by means of descriptive statistics. Demographic and clinical characteristics of study participants were evaluated by adverse reaction status. They were compared using a two-sample t-test for continuous variables and a two-way contingency table using Chi square or Fisher's exact test for categorical variables, as appropriate. Patients were contacted 24 hours after discharge to answer a standardized questionnaire. Assessment of ADRs and severe ADRs were done using the standardized World Health Organization and International Conference on Harmonisation definitions. Grading of severity was done independently by three individuals from an independent Drug Safety Monitoring Board. Results: 143 adult patients with iron deficiency anemia were were approached and erolled in the study between January 2008 and January 2009 (100% enrolment). Baseline characteristics of patients is depicted in Table 1. All patients received IV iron (73 iron dextran and 70 iron sucrose) and none were lost to follow-up. Immediate ADRs were similar between the two study arms; iron dextran 8/73 (11%) and iron sucrose 5/70 (7%), p=0.568. The average additional nursing time required to manage immediate ADRs was approximately 30 minutes. Delayed ADRs approached statistical significance with a higher rate of ADRs in the iron sucrose group [ iron dextran 9/73 (12%) and iron sucrose 18/70 (26%), p=0.0541]. Details in Table 2. Four patients were considered to have serious adverse reactions (shortness of breath, bronchospasm and diaphoresis). Two form each study arm. Conclusions: A RCT to compare adverse drug reaction rates between iron dextran and iron sucrose in non-hemodialysis adult patients with iron deficiency anemia is feasible. In our pilot study we were able to get 100% enrolment rate, in a timely fashion with no patients lost to follow up. The design of the study with a one point in time evaluation and a short follow up that did not require extra hospital visits and blood tests were probably attractive features that maximized patient participation. The incidence and severity of ADRs to both IV iron preparations studied were similar with greater than 25% of patients experiencing either immediate or delayed ADRs. However, a striking higher rate of delayed ADRs, albeit not severe, was slightly more pronounced in patients receiving iron sucrose therapy. The elevated level of ADRs to IV iron suggests the need for alternative formulations and a full RCT to compare the rate of ADRs between iron preparations is warranted. The choice of IV iron formulation in the adult non-hemodialysis population should take into account factors other than cost of the medication such as incidence and severity of ADRs, extra time required by Healthcare professionals, and patient preferences. Disclosures: No relevant conflicts of interest to declare.

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