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 ◽  
...  

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.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5157-5157
Author(s):  
Allen Poma ◽  
Karen Diana ◽  
Justin McLaughlin ◽  
Annamaria Kausz

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.


Author(s):  
Satish Kumar

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.


Author(s):  
Apurva Garg ◽  
Manju Agarwal ◽  
Uma Shankar ◽  
Shrikant Shetty

Background: The aim of this study was to compare the efficacy and safety of iron sucrose with oral iron in the treatment of iron deficiency anemia of pregnancy.Methods: An interventional comparative study was conducted at Jhalawar Medical College, Jhalawar involving 80 pregnant women with iron deficiency anemia from March 2016 to August 2016. Inclusion criteria were gestational age between 24-32 weeks with established iron deficiency anemia, with hemoglobin between 7-10g/dl. Target Hemoglobin was 11 g/dl. In intravenous iron sucrose group iron sucrose dose was calculated from following formula: total iron dose required (mg) = 2.4 x body weight in Kg x (target Hb – Patient’s Hb g/dl) + 500. In oral iron, group patient received ferrous-sulphate 335 mg daily BD. Hb level were reviewed at 2, 4, 6 weeks.Results: Change in Hemoglobin level from baseline significantly higher in IV iron group than oral iron group. In IV iron, group mean value of baseline Hb was 8.07±0.610 g/dl and in oral iron group was 8.48±0.741 g/dl. At the end of 6-week mean hemoglobin in IV iron sucrose was 10.66±0.743 g/dl and in oral iron group was 10.08±0.860 g/dl.Conclusions: Intravenous iron sucrose elevates more Hb than oral iron, with less adverse effects.


Author(s):  
Santosh Khajotia ◽  
Shubha Meena ◽  
Deepak Naraniya

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. 


2009 ◽  
Vol 94 (1) ◽  
pp. 151-156 ◽  
Author(s):  
Hakan Cinemre ◽  
Cemil Bilir ◽  
Feyzi Gokosmanoglu ◽  
Talat Bahcebasi

Abstract Context: In patients with coexisting iron-deficiency anemia and subclinical hypothyroidism, anemia does not adequately respond to oral iron therapy. Objective: We studied whether iron-deficiency anemia might indicate treatment of subclinical hypothyroidism. Design: Patients were assigned to a control or experimental group: 240 mg/d oral iron alone (iron group) or 240 mg/d oral iron plus 75 μg/d levothyroxine (iron/levothyroxine group). Levels of hemoglobin, hematocrit, red blood cell count, serum iron levels, ferritin, total iron-binding capacity, TSH, and free T4 were measured before and after treatment. Setting: The study was conducted at a university hospital outpatient clinic. Patients: Fifty-one patients with coexisting iron-deficiency anemia and subclinical hypothyroidism participated in the study. Intervention: Patients were treated as described above in either the iron group or the iron/levothyroxine group. Main Outcome Measure: A clinically satisfactory increase in hemoglobin was regarded as successful. Results: Mean hemoglobin levels increased by 0.4 g/dl in the iron group [95% confidence interval (CI) 0.2–0.7, P = 0.001], whereas it increased by a mean of 1.9 g/dl in the iron/levothyroxine group (95% CI 1.5–2.3, P &lt; 0.0001). The increase in serum iron was greater in the iron/levothyroxine group by a mean of 47.6 μg/dl (95% CI 34.5–60.6, P &lt; 0.0001). Increases in hemoglobin, red blood cells, hematocrit, and serum ferritin levels after treatment were statistically significantly greater in the iron/levothyroxine group (P &lt; 0.0001). Starting hemoglobin and increase in hemoglobin were negatively correlated in the iron/levothyroxine group (r = −0.531, P = 0.006). Conclusions: Subclinical hypothyroidism should be treated in iron-deficiency anemia patients when both conditions coexist. This would provide a desired therapeutic response to oral iron replacement and prevent ineffective iron therapy.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3076-3076
Author(s):  
Rebecka Hansen ◽  
Joergen Kurtzhals ◽  
Bjarne Styrishave ◽  
Charlotte Holm

Abstract Introduction: Hepcidin, the master regulator of iron economy, is decreased during pregnancy to facilitate adequate iron transfer across the placenta. Conversely, iron need increases substantially during pregnancy often leading to iron deficiency and subsequently anemia. The PREG-01 Study compared the efficacy and safety of intravenous (IV) ferric derisomaltose (FDI) vs. oral iron in treating persistent iron deficiency in pregnant women. The study found FDI to be efficacious and well-tolerated in pregnancy and the proportion of non-anaemic patients throughout the course of the study was significantly lower in the FDI group. In this analysis, we investigated the effect of baseline hepcidin on the response to IV and oral iron therapy. Methods: PREG-01 was a single-centre, open-label, randomized controlled trial. Women 14-21 weeks pregnant with persistent iron deficiency (ferritin&lt;30 µg/L despite oral iron treatment) received a single intravenous 1000 mg dose of FDI (n=100) or 100 mg elemental oral iron daily combined with ascorbic acid (n=101). Hemoglobin (Hb), ferritin and transferrin saturation (TSAT%) levels were captured at baseline and monitored throughout the study. The effect of baseline hepcidin on achieving non-anemic status (Hb ≥ 11 g/dL) at all study visits and the effect on change in Hb, ferritin and TSAT% were investigated by estimating odds ratios from a logistic regression model with treatment as factor and interaction between treatment and baseline hepcidin. The odds ratio estimate is for an increment in baseline hepcidin of 1 ng/mL. Results: Mean [standard deviation (SD)] baseline Hb was 11.97 (0.93) g/dL in the FDI group and 11.75 (0.91) g/dL in the oral iron group. Baseline hepcidin was 6.42 ng/mL in the FDI and 5.32 ng/mL in the oral iron group. Baseline hepcidin was not associated with the ability to achieve non-anaemic status either in the FDI (OR 0.98; 95% CI: 0.87-1.09) or the oral iron group (OR 0.96; 95% CI: 0.88-1.05). No statistically significant associations were found between baseline hepcidin and change in Hb, ferritin or TSAT% throughout the study (Figure 1). Conclusions: In a population of pregnant women with iron deficiency, but otherwise healthy, baseline hepcidin was overall low. Although there was a trend for an association between baseline hepcidin and Hb response to oral iron only, baseline hepcidin did not predict the response to iron therapy. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Ferric Derisomaltose is an IV iron preparation indicated for the treatment of iron deficiency anemia in the US.


Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Saleema Wani ◽  
Mariyam Noushad ◽  
Shabana Ashiq

Iron deficiency anemia (IDA) during pregnancy arises because of preexisting inadequate stores or complex physiological changes and can lead to serious maternal and fetal complications. Oral iron, either as iron sulfate or fumarate, with or without folic acid, is the most commonly used treatment for IDA in pregnancy. Intravenous (IV) iron has a role in the treatment of IDA in pregnancy, particularly in women who present late, display severe anemia (Hb ≤ 9 g/dL), or risk factors, and are intolerant/noncompliant of oral iron. Previously, administration of IV iron was minimal, owing to potentially serious anaphylactic reactions. Recently, new IV iron products have been developed, offering better compliance, tolerability, efficacy, and a good safety profile. Our study aimed to assess the effectiveness, safety, and tolerability of IV ferric carboxymaltose (FCM) in the treatment of IDA in pregnant women in the UAE. Data from 1001 pregnant women who received at least one administration of FCM (500, 1000, or 1500 mg) during their second or third trimester of pregnancy (2 years backward from study initiation) were collected retrospectively from electronic medical records at Corniche Hospital, Abu Dhabi, UAE. Results showed that 41.4% of the women were able to achieve an increase of ≥2 g/dL in blood hemoglobin overall. A change of ≥2 g/dL was achieved by 27.5% of women administered a dose of 500 mg, 39.2% of women administered a dose of 1000 mg, and 63.9% of women administered a dose of 1500 mg of IV FCM. This indicates a directly proportional relationship between increasing IV FCM dose and the increase of ≥2 g/dL in blood hemoglobin. A total of 7 (0.7%) women reported mild, nonserious adverse events during the study. Within the limits of this retrospective study, IV FCM therapy was safe and effective in increasing the mean hemoglobin of pregnant women with IDA.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 39-40
Author(s):  
Hussam A Almasri ◽  
Ashraf Tawfiq Soliman ◽  
Vincenzo Desanctis ◽  
Arwa E Alsaud ◽  
Ruoa Alhashimy ◽  
...  

Introduction Iron deficiency anemia (IDA) is the most common cause of anemia in both developed and developing countries, particularly affecting females in the child bearing age and children. The treatment of IDA is a major health goal, it consists of treating the underlying cause and iron supplements. Iron replacement comes in form of oral or intravenous, there are certain side effects of this therapy including constipation and allergy. Leukopenia as a side effect of iron therapy is under reported in the literature as only sporadic cases were prescribed. We conducted a study to clarify this issue and to check for its clinical significance. Objective: To assess the relationship between iron therapy (intravenous) and leukopenia, neutropenia or lymphocytopenia, and its impact on patient's clinical settings. Materials and Methods We retrospectively reviewed the electronic medical records of patients attended Haematology clinic for iron deficiency anemia and treated with intravenous iron (ferric carboxymaltose or iron saccharide) over 2 years in Hamad Medical Corporation, Doha/Qatar. Adult female patients with IDA cases who received IV iron were included. anemia due to other nutrients deficienciesa nd conditions (including other medications) that may alter WBCs count were excluded.Age, Ethnicity, BMI, Complete blood count and iron studies data were collected before and after treatment with IV iron therapy. Infection occurrence at the time of IDA and leukopenia, the use of antibiotics and infection related complications were also collected. Leukopenia was defined as WBCs count to be less than 4000/microlitre, Neutropenia as ANC less than 1500/microlitre and lymphocytopenia as lymphocytes less than 1000/mocrolitre. Statistical analysis was done using mean , SD and t test. Results After iron therapy, out of 1567 case of iron deficiency anemia, 30 cases (1.914%) have leukopenia,15 cases (0.957%) have neutropenia and 12 cases (0.765%) have lymphocytopenia. All had normal readings before treatment. 2 patients (6.66%) had infection, 1 had upper respiratory tract infection and 1 urinary tract infection, the latter was treated with antibiotics, none reported infection related complications Discussion Leukocytopenia is defined as low WBCs circulating in the blood and this can be caused by low neutrophils count, low lymphocytes count, other WBCs components or combined. Some previous reported cases generated the idea of a possible connection between iron supplement therapy and leukopenia, Brito-Babapulle et al reported a case of fatal bone marrow suppression linked to ferric carboxymaltose therapy in a patient with IDA. The pathophysiology is not well understood but thought to be a toxic effect of iron on bone marrow and it can affect all cell lineages. Our findings suggest possible iron replacement side effect as there was significant drop of the WBCs count after treating IDA patients with IV iron, however this association was not common. There was no life threatening or serious infections in the affected patients, which can suggest that most of these cases are mild and transient. More studies are needed to address this issue, particularly on larger scales. Patient education also may be appreciated before treatment with IV iron. Conclusions: Leukopenia in form of neutropenia or lymphocytopenia maybe a side effect of IV iron therapy. Clinical significance is limited in view of current literature further studies needed to elaborate more in this important adverse event. Disclosures No relevant conflicts of interest to declare.


Author(s):  
Muzafar Naik ◽  
Tariq Bhat ◽  
Ummer Jalalie ◽  
Arif Bhat ◽  
Mir Waseem ◽  
...  

Background: Low dose (200 mg) extended Intravenous iron sucrose remains the most common treatment option in patients who are intolerant to oral iron therapy in patients with Iron deficiency anemia (IDA). The objective of this study was to evaluate the efficacy and safety of high dose accelerated intravenous iron sucrose (IS) in the treatment of adults with iron deficiency anemiaMethods: One hundred adult patients with iron deficiency anemia, who had intolerance or showed no effect with oral iron therapy, received daily doses of 500 mg of intravenous iron sucrose until the hemoglobin level was corrected or until receiving the total dose of intravenous iron calculated for each patient.Results: The mean and median Hb (g/dL) 6.47±1.656 and 6.6 (2) at baseline, 9.61±1.629 and 9.6 (2) at 2 weeks of treatment, 11.85±1.277 and 12 (1) at 4 weeks of treatment respectively. The mean rise of Hb was 3.13±1.41 and 5.37±1.50 after 2 and 4 weeks of treatment respectively (p<0.000). A total of 303 intravenous infusions of iron sucrose were administered and iron sucrose was generally well tolerated with twenty-six patients developing mild and one patient developing moderate adverse drug reactions. There was no serious adverse event recorded.Conclusions: Accelerated high dose intravenous iron sucrose is a safe and cost effective option minimizing frequent hospital visits in the treatment of adults with iron deficiency anemia who are intolerant or lack satisfactory response to oral iron therapy.


Author(s):  
Anusha Natarajan ◽  
Priyadarsini Baskaran

Background: Pregnancy significantly increases the need for iron. The prevalence of anemia in pregnant women is high, affecting 41.8% of all pregnant women worldwide. In patients with low tolerance to oral iron, it is recommended to start them on parenteral iron therapy but with variable degree of efficacy. Hence this meta-analysis was done with the following aim. This study aimed to assess the efficacy of various iron preparations in pregnant women with iron deficiency anemia (IDA).Methods: Randomised controlled trials (RCTs) (available as full free text) which included iron therapy in pregnant women with iron deficiency anemia were retrieved from electronic databases viz. PubMed, Google scholar and IndMed, with specific search terms. Qualities of RCTs were assessed using JADAD score and four RCTs with high score were included for analysis using RevMan 5.3 software. Outcome measures were change in hemoglobin levels and serum ferritin concentration after one month of therapy.Results: In the four RCTs included, a total of 267 patients were treated with oral iron and 267 patients were treated with parenteral iron therapy. Change in the hemoglobin levels between the 2 groups had a standard mean difference of 0.73, 95% CI (-0.05-1.52), with the p-value of 0.07. To assess the change in the serum ferritin concentration a total of 188 patients in oral iron and 197 patients in parenteral iron therapy were included. There was a standard mean difference of 0.88, 95% CI (0.60-1.66), with a p value of<0.00001.Conclusions: In the present meta-analysis we found that oral and parenteral iron therapy showed similar efficacy in improving the hemoglobin level in pregnant women.


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