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.

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.

Iron Deficiency Anemia in Cancer Patients

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 body—causing hepcidin levels to increase and erythropoietin production to decrease—and 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.

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

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.

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

2020 ◽  
Vol 7 ◽  
pp. 205435812093339
Author(s):  
Paweena Susantitaphong ◽  
Monchai Siribumrungwong ◽  
Kullaya Takkavatakarn ◽  
Kamonrat Chongthanakorn ◽  
Songkiat Lieusuwan ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Serum Ferritin ◽  
Resistance Index ◽  
High Serum ◽  
Deficiency Anemia ◽  
Functional Iron Deficiency ◽  
Iv Iron ◽  
Low Serum

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.

scholarly journals Serum transferrin receptor: a quantitative measure of tissue iron deficiency

Blood ◽  
1990 ◽  
Vol 75 (9) ◽  
pp. 1870-1876 ◽  
Author(s):  
BS Skikne ◽  
CH Flowers ◽  
JD Cook
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Transferrin Receptor ◽  
Iron Status ◽  
Serum Transferrin ◽  
Mean Cell Volume ◽  
Functional Iron Deficiency ◽  
Iron Stores ◽  
Serum Transferrin Receptor ◽  
Tissue Iron

Abstract This study was undertaken to evaluate the role of serum transferrin receptor measurements in the assessment of iron status. Repeated phlebotomies were performed in 14 normal volunteer subjects to obtain varying degrees of iron deficiency. Serial measurements of serum iron, total iron-binding capacity, mean cell volume (MCV), free erythrocyte protoporphyrin (FEP), red cell mean index, serum ferritin, and serum transferrin receptor were performed throughout the phlebotomy program. There was no change in receptor levels during the phase of storage iron depletion. When the serum ferritin level reached subnormal values there was an increase in serum receptor levels, which continued throughout the phlebotomy program. Functional iron deficiency was defined as a reduction in body iron beyond the point of depleted iron stores. The serum receptor level was a more sensitive and reliable guide to the degree of functional iron deficiency than either the FEP or MCV. Our studies indicate that the serum receptor measurement is of particular value in identifying mild iron deficiency of recent onset. The iron status of a population can be fully assessed by using serum ferritin as a measure of iron stores, serum receptor as a measure of mild tissue iron deficiency, and hemoglobin concentration as a measure of advanced iron deficiency.

Iron Deficiency Anemia: Adverse Effects on Infant Psychomotor Development

PEDIATRICS ◽  
1989 ◽  
Vol 84 (1) ◽  
pp. 7-17 ◽  
Author(s):  
Tomas Walter ◽  
Isidora De Andraca ◽  
Patricia Chadud ◽  
Carmen G. Perales
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Iron Status ◽  
Oral Iron ◽  
Iron Therapy ◽  
Psychomotor Development ◽  
Deficiency Anemia ◽  
Placebo Control ◽  
Double Blind ◽  
Iron Deficient

In a double-blind, placebo-control prospective cohort study of 196 infants from birth to 15 months of age, assessment was made at 12 months of age of the relationship between iron status and psychomotor development, the effect of a short-term (10-day) trial of oral iron vs placebo, and the effect of long-term (3 months) oral iron therapy. Development was assessed with the mental and psychomotor indices and the infant behavior record of the Bayley Scales of Infant Development in 39 anemic, 30 control, and 127 nonanemic iron-deficient children. Anemic infants had significantly lower Mental and Psychomotor Developmental Index scores than control infants or nonanemic iron-deficient infants (one-way analysis of variance, P &lt; .0001). Control infants and nonanemic iron-deficient infants performed comparably. No difference was noted between the effect of oral administration of iron or placebo after 10 days or after 3 months of iron therapy. Among anemic infants a hemoglobin concentration &lt; 10.5 g/dL and duration of anemia of &gt; 3 months were correlated with significantly lower motor and mental scores (P &lt; .05). Anemic infants failed specifically in language capabilities and body balance-coordination skills when compared with controls. These results, in a design in which intervening variables were closely controlled, suggest that when iron deficiency progrsses to anemia, but not before, adverse influences in the performance of developmental tests appear and persist for at least 3 months despite correction of anemia with iron therapy. If these impairments prove to be long standing, prevention of iron deficiency anemia in early infancy becomes the only way to avoid them.

Potential New Treatment Option for Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy- Results of a Phase III, Randomized, Open-Label, Active-Controlled Trial of Ferumoxytol.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2099-2099 ◽  
Author(s):  
David Hetzel ◽  
Audrone Urboniene ◽  
Kristine Bernard ◽  
William Strauss ◽  
Michael Cressman ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Controlled Trial ◽  
Treatment Options ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
History Of ◽  
Iv Iron

Abstract Abstract 2099 Background: While oral iron is the preferred first-line treatment for patients with iron deficiency anemia (IDA), there are patients who cannot take oral iron, do not tolerate it or do not adequately respond to oral iron. In the US and Canada, the only approved treatment options for these patients are the iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Therefore, many of these anemic patients do not receive IV iron, and remain inadequately treated and symptomatic. In the EU, several IV irons, including iron sucrose (IS), are approved for second line use. Few studies have evaluated the IV irons in head-to-head studies. Ferumoxytol (FER) is a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD) that is formulated to allow for bolus IV injection. This randomized, controlled trial was designed to investigate the efficacy and safety of FER compared to IS for the treatment of IDA in patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Methods: The study was designed to demonstrate non-inferiority and consisted of a 14 day screening period, treatment and a 5 week follow-up period. Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) < 20%. Patients were randomized 2:1 to receive either FER, administered as 2 injections of 510 mg 5±3 days apart, or IS, administered as 5 infusions or injections of 200 mg on 5 non-consecutive days over a 14 day period. Results: A total of 605 subjects were randomized to the 2 treatment arms (FER, n= 406; IS, n=199). FER demonstrated non-inferiority to IS in the proportion of subjects with a >2.0 g/dL increase in Hgb at any time from Baseline to Week 5 (the primary efficacy endpoint), compared to those treated with IS, (FER, 84%; IS 81%) with the lower bound of the 95% CI [-3.89%] above the predefined non inferiority margin [-15%]. In addition at each post-treatment time point, a higher percentage of FER-treated subjects achieved a >2.0 g/dL increase in Hgb compared to those treated with IS. FER also achieved non-inferiority to IS in the mean change in Hgb from Baseline to Week 5 with a robust 2.7g/dL increase in Hgb compared to 2.4g/dL with IS (the lower bound of the 95% CI [0.06g/dL] was above the predefined non-inferiority margin [-0.5g/dL]); this treatment difference (0.3 g/dL) was statistically significant (p=0.0124), and FER actually achieved superiority over IS. The overall rates of adverse events (AEs) and related AEs were lower in the FER group compared to IS-treated subjects. The serious adverse event (SAE) rate was higher in FER-treated subjects (FER, 4.2%; IS, 2.5%), but no pattern or safety trend was observed to suggest a specific safety signal; treatment-related SAEs were reported in 2 (0.5%) FER-treated subjects (1 anaphylactoid reaction and 1 hypertension). Protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were reported at a higher rate in IS-treated subjects compared to the FER treatment group (IS, 5.0%; FER, 2.7%). Cardiovascular AE rates were comparable in the 2 treatment groups (1.0%). Overall, the safety profile of FER was comparable to that of IS and no new safety signals were identified. Conclusion: In this randomized, controlled trial, the efficacy and safety of 2 doses of FER were shown to be comparable to IS in treating IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. For this IDA patient population, which has limited treatment options in the US and Canada, FER may offer an important, new treatment option with a convenient 2 dose regimen. Disclosures: Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

Economic, Transfusion, and Efficacy Outcomes with the Addition of IV Iron Sucrose to Oral Iron Therapy in Pregnancy Associated Iron Deficiency Anemia

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4737-4737
Author(s):  
Nilupa Gaspe Mudiyanselage ◽  
Tarek Elrafei ◽  
Beth Lewis ◽  
Mary King ◽  
Marianna Strakhan ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Iron Group ◽  
Iv Iron ◽  
Iron Replacement

Abstract Background: Prior studies have indicated that transfusion is unusual (2%) in pregnant women with iron deficiency anemia. Nonetheless, compliance with oral iron replacement can be an issue and physicians may wish to use IV iron therapy in markedly anemic pregnant women. Objectives: to evaluate the effectiveness of adding intravenous iron sucrose concentrate (ISC) to pregnant patients already taking oral iron in terms of effect on hemoglobin, effect on ferritin levels, rates of transfusion, and cost. Methods: We analyzed all referrals from Obstetrics to Hematology clinic and Obstetrics consultation (Internal medicine) clinic from January 2014 to June 2016. Of the 176 pregnant patients, 98 were referred for anemia, including 81 patients with Hgb < 12 g/dl and ferritin < 20 ug/L. All had previously been given oral ferrous sulfate prescriptions. Patients with hemoglobinopathy were excluded. All 81 patients were advised to continue on the oral iron, and 40 were given IV iron sucrose (ISC group). Results: The average cumulative dose of iron sucrose was 700 mg, a mean of 5.575 doses (initiated in the third trimester in 38 of 40 patients). The lowest antepartum Hgb was 8.18 g/dl in the ISC group and 9.58 in the oral only group; there was an average Hgb increase of 2.17 vs 1.76 g/dl respectively (p=.107 NS and the 0.41 g/dl difference was considered to be of no clinical consequence). 89% in the ISC group vs 30% in the oral achieved a ferritin >20 (p=0.000015). No adverse events in the IV iron group were reported. There was 1 transfusion in the oral iron group attributable to iron deficiency (2.4%) vs none in the IV iron group (p = 0.107 NS). Two patients were transfused in the antenatal period before IV iron was started and 1 transfused because of post-partum hemorrhage. The total cost of the IV iron therapy would add an average of $1,500 per patient. Thus, and additional cost of $60,000 in IV iron would be required to prevent 1 transfusion [40:1]. Conclusions: ISC corrects ferritin in more patients than oral iron replacement, but did not significantly increase Hgb levels or have a meaningful impact on the transfusion rate. The additional cost and lack of clinically improved outcomes with IV iron argue against its use and in favor of strategies to ensure compliance with oral iron. Disclosures No relevant conflicts of interest to declare.

A Prospective Randomised Trial of Intravenous Iron Therapy Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Australian Women

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3750-3750 ◽  
Author(s):  
Alhossain A. Khalafallah ◽  
Amanda Dennis ◽  
Joan Bates ◽  
Gerald Bates ◽  
Lauern Smith ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Serum Ferritin ◽  
Iron Deficiency Anaemia ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anaemia ◽  
Iv Iron ◽  
Intravenous Iron Therapy

Abstract To date, limited data is available regarding prevalence of iron deficiency during pregnancy in Australia. There is little if any data currently available regarding comparative efficacy of IV iron versus oral iron therapy in pregnant women. In Australia the prevalence of iron deficiency anaemia (IDA) is approximately 5% in the general population with higher rates in pregnant women. At a single site, the Launceston General Hospital (LGH), we prospectively investigated 200 pregnant women between January and July 2007 with FBC and iron studies at the first or second antenatal visit. Among those, 40 women (20%) had iron deficiency anaemia, and were recruited to a prospective randomised trial to determine whether intravenous iron therapy (iron polymaltose) is superior to oral iron (ferrous sulphate) for the management of IDA associated with pregnancy. The patients’ median age was 28 years old (range; 19–40) with a median gestational age at recruitment of 27 weeks (range; 13–29) and a median body weight of 74 kg (range; 47–130). At recruitment median Hb was 106 g/L (range; 90–114, normal range; 120–160 g/L), while median serum ferritin was 11.5 μg/L and mean ferritin was 19 μg/L normal range; 30–460). After four weeks of treatment the Hb level increased by a mean of 6g/L on oral iron and by 10.5 g/L after IV iron. Mean/Median serum ferritin did not increase significantly in women on oral iron, but increased to a median of 96.5 μg/L and a mean of 224 μg/L in those received IV iron. Multi-variate analysis using general linear modelling for continuous variables showed a significant increase in serum ferritin after treatment with IV iron versus oral iron (p=0.017). There was no statistically significant difference in terms of Hb increment, patients’ parity, weight, and date of last pregnancy between groups. Analysis of quality of life questionnaires to assess patients’ well-being, ability to perform activities, and symptoms of anaemia showed improvement in both groups of patients with a trend to greater and faster improvement after IV iron. Both treatments were well tolerated without major side effects. The preliminary data indicate IDA is a common finding during pregnancy in the LGH population, and intravenous iron therapy appears a safe and effective treatment in this cohort of patients. This research received a grant from the Clifford Craig Medical Research Trust, Tasmania, Australia.

Ferumoxytol Treatment Results in Robust Hemoglobin Increases in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy in a Phase III, Randomized, Placebo-Controlled Trial.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2098-2098
Author(s):  
Saroj Vadhan Raj ◽  
Michael Cressman ◽  
David Ford ◽  
William Strauss ◽  
Gerri Poss ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Group Treatment ◽  
Oral Iron ◽  
Phase Iii ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
History Of ◽  
Iv Iron

Abstract Abstract 2098 Background: Although oral iron therapy is often the initial approach to the treatment of iron deficiency anemia (IDA), many patients fail to adequately respond or do not tolerate oral iron. Unfortunately for these patients, approved treatment options are limited in the US and Canada to only the IV iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Many of these patients, therefore, do not get IV iron, and remain inadequately treated and symptomatic. Ferumoxytol (FER), a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD), is being investigated to treat IDA patients without CKD who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. This randomized, placebo-controlled, double blind trial was designed to assess the efficacy and safety of FER for the treatment of these IDA patients. Methods: Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) <20%. Subjects were randomized 3:1 to receive 2 injections of either FER (510 mg, 5±3 days apart) or placebo (IV normal saline). Efficacy assessments included comparisons of the change in Hgb, TSAT and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in the 2 treatment groups between Baseline and Week 5. Results: A total of 808 subjects were randomized to the 2 treatment arms (FER, n=608; placebo, n=200). FER demonstrated superiority to placebo with 81.1% of subjects achieving an increase in Hgb of >2.0 g/dL from Baseline to Week 5 compared to only 5.5% in the placebo group (treatment difference: 75.6%, p<0.0001). At each post-FER treatment time point, a larger percentage of FER-treated subjects had a >2.0 g/dL increase in Hgb compared with those treated with placebo. The superiority of FER was also demonstrated for the mean change in Hgb from Baseline to Week 5 with a robust 2.7 g/dL increase compared to only 0.1 g/dL in the placebo group (treatment difference: 2.54 g/dL, p<0.0001). An increase in TSAT from Baseline to Week 5 was only observed in FER-treated subjects (mean change: FER, 11.0%; placebo −0.1%). In addition, a statistically significant improvement in fatigue from Baseline to Week 5, as measured by the FACIT-Fatigue, was shown for FER-treated subjects compared to placebo (p<0.0001). The rates of adverse events (AEs) and related AEs were higher in the FER group, although no pattern or safety trend was observed to suggest a specific safety signal. The overall rate of serious adverse events (SAEs) was comparable between the 2 treatment groups (FER, 2.6%; placebo, 3.0%), and treatment-related SAEs associated with the class of IV iron products were reported in 4 (0.7%) FER-treated subjects. As expected, protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were noted at a higher rate in FER-treated subjects (FER, 3.6%; placebo, 1.0%). All cardiovascular AEs were considered unrelated by the investigators. Overall, FER was well tolerated and no new safety signals were identified. Conclusion: In this randomized, placebo-controlled Phase III trial, 2 doses of FER were shown to be highly effective in raising hemoglobin and iron parameters in non-CKD patients with IDA who had a history of unsatisfactory oral iron therapy. FER also significantly reduced fatigue, and was generally well tolerated with no new safety signals being identified. Therefore, FER could provide an important, new treatment option for IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Disclosures: Vadhan Raj: AMAG Pharmaceuticals, Inc.: Research Funding. Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

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