Oral Iron Group Research Articles

Comparison of the Anaemia and Transfusion Rates of Pregnant Women Treated with Intravenous versus Oral Iron in the Third Trimester.

To evaluate and compare the blood transfusion requirements during delivery in third-trimester pregnant women with iron deficiency anaemia (IDA) who were treated with intravenous (IV) ferric carboxymaltose (FCM) versus those treated with oral iron supplementation. Comparative study. Place and Duration of the Study: Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkiye, from January 2017 to December 2022. Pregnant women with haemoglobin (Hb) levels <10 g/dL in their third trimester were included. One group (n = 50) received IV FCM, while the other group (n = 96) received oral iron therapy. Key outcome measures included Hb levels at delivery and the need for a postpartum blood transfusion. Inclusion criteria were third-trimester pregnancy with IDA, and exclusion criteria included haematological or chronic systemic diseases and high-risk pregnancies. The mean initial Hb levels in the third trimester of pregnancy in the FCM group and oral iron group were 8.31 ± 0.96 g/dL and 9.29 ± 1.20 g/dL, respectively (p <0.001). The mean Hb levels in the delivery room were 11.09 ± 1.38 and 9.44 ± 1.16 g/dL, respectively (p <0.001). The rates of postpartum erythrocyte transfusion requirement were 6% (n = 3) and 18.75% (n = 18), respectively (p = 0.037). IV FCM administration to pregnant patients with IDA during the third trimester was found to be more effective than oral iron treatment in reducing blood transfusion rates. Anaemia, Ferric carboxymaltose, Pregnancy, Iron deficiency, Intravenous iron.

Efficacy of daily versus intermittent oral iron supplementation for prevention of anaemia among pregnant women: a systematic review and meta-analysis

The World Health Organization recommends daily oral supplementation of iron for prevention of maternal anaemia. However, the adverse effects due to daily supplementation leads to poor compliance among pregnant women. Also, the mucosal block theory suggests that intermittent oral iron may be more efficient than daily iron with respect to optimum absorption. Our meta-analysis reviewed the existing clinical studies for the efficacy of daily versus intermittent oral iron supplementation. In this systematic review and meta-analysis [PROSPERO ID:CRD42024498180], we searched PubMed, Google Scholar, Scopus, Science Direct and Cochrane database for studies published from 1st January 1970 to 31st December, 2023. Studies comparing daily and intermittent iron supplementation in pregnant women were included. The median intermittent iron dose was 120mg/day and daily iron dose was 60mg/day. The primary outcome was endpoint haemoglobin levels after iron supplementation. The data was analysed using the 'meta' and 'metafor' packages in RStudio using random effects model. The heterogeneity, publication bias, risk of bias and certainty of evidence were assessed using I2 statistics, funnel plots, Cochrane Risk of Bias 2 (ROB2) tool, and the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach respectively. Of 4615 search results, 26 studies (n=4365 participants) were included in this meta-analysis. There was no significant difference (p=0.18) between the endpoint mean haemoglobin levels of the daily versus intermittent oral iron groups (standardized mean difference (SMD): 0.51, 95% CI:-0.23 to 1.24, I2=97%, low certainty evidence) irrespective of baseline anaemic status. However, the endpoint ferritin levels were significantly higher in the daily supplementation group (SMD: 0.85, 95% CI: 0.15-1.54, p=0.02, I2=97%, low certainty evidence). The adjusted odds ratio for nausea, (adjusted odds ratio (OR) 3.56, 95% CI: 2.23-5.69, p<0.001, I2=9%, moderate certainty evidence), diarrhoea (adjusted OR 5.40, 95% CI: 1.90-15.33, p=0.002, I2=0%, low certainty evidence) and constipation (adjusted OR 1.95, 95% CI: 1.21-3.14, p=0.006, I2=0%, moderate certainty evidence) was significantly higher in daily oral iron supplementation group. Intermittent oral iron supplementation with a median dose of 120mg/day demonstrates comparable efficacy to daily oral iron supplementation median dose of 60mg/day in increasing haemoglobin levels among pregnant women with a significant reduction in adverse events. There was no funding for this study.

#653 Changes in iron markers and D-dimer levels during enarodustat treatment depends on different iron prescription patterns in hemodialysis patients

Abstract Background and Aims Iron preparations are commonly administered with erythropoiesis-stimulating agents or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PH inhibitors) in hemodialysis patients to promote hematopoiesis and prevent iron deficiency. A recent study highlighted the causal relationship between thrombosis and upregulated serum transferrin levels due to iron deficiency. Additionally, rapid increase of hemoglobin (Hb) during HIF-PH inhibitor use is also considered a risk factor for the development of thromboembolism. Therefore, monitoring iron parameters and Hb is essential for managing anemia and thrombosis risk. We investigated the impact of practice patterns of iron supplementation on iron metabolism in patients receiving a HIF-PH inhibitor enarodustat. Changes in D-dimer levels, a thrombosis-related factor, were also assessed. Method We performed a post-hoc analysis using pooled data from two phase 3 clinical studies of enarodustat in Japanese maintenance hemodialysis patients, SYMPHONY HD and SYMPHONY HD-Long studies. We divided the subjects into three groups according to practice patterns of iron administration: subjects who did not receive iron at all during the enarodustat administration period (Non-Iron Group), subjects who received intravenous iron at least once (IV Iron Group), and subjects who continuously received oral iron-containing preparations including ferric citrate (Oral Iron Group). The time courses of transferrin saturation (TSAT), serum ferritin, and D-dimer levels were compared across these three groups using mixed effects models for repeated measures (MMRM) (with an unstructured covariance structure for the dependent variables). Results The Non-Iron Group, IV Iron Group, and Oral Iron Group consisted of 60, 69, and 73 cases, respectively. Figures show the time courses of TSAT, serum ferritin levels, and changes in D-dimer levels for each practice pattern. MMRM analysis revealed that TSAT levels in the Non-Iron Group and IV Iron Group during the enarodustat administration period were significantly lower than those in the Oral Iron Group (p &amp;lt; 0.01 and p &amp;lt; 0.01, respectively). Similar results were observed for serum ferritin levels (p &amp;lt; 0.01 and p &amp;lt; 0.01, respectively). Moreover, the rate of D-dimer increase in the Non-Iron Group was significantly higher than in the Oral Iron Group (p = 0.029). There was a trend toward a higher rate of D-dimer increase in IV Iron Groups compared to the Oral Iron Group (p = 0.11). Conclusion These findings suggest the superiority of continuous oral iron supplementation over intermittent IV iron supplementation or no iron supplementation during HIF-PH inhibitor administration in terms of preventing thrombosis through maintaining TSAT levels. The association between iron-related parameters and the occurrence of thrombosis needs to be analyzed.

Effectiveness of Oral Iron Therapy in Anemic Inpatient Pregnant Women: A Single Center Retrospective Cohort Study.

Background and aim Oral iron therapy is effective in treating iron deficiency anemia in outpatient pregnant womenbut has not been studied in inpatient pregnant women. We aimed to evaluate the effect of oral iron therapy versus no therapy during hospitalization on maternal and neonatal outcomes in women with anemia who are hospitalizedfor pregnancy-related morbidities (i.e., preterm premature rupture of membranes, preterm labor, pre-eclampsia, abnormal placentation, or fetal monitoring). Methods A retrospective, single-center study was conducted in hospitalized pregnant women (2018 to 2020)with inpatient stays of more than three days. The primary outcome was a change in hemoglobin level from admission to delivery in women treated with oral iron compared with those left untreated. Secondary outcomes included the total amount of iron administered before delivery, the time interval from admission to delivery, and neonatal effects. Results Two hundred sixty-three women were admitted, 79 women had anemia, and 29 (36.7%) received at least one dose of oral iron. Baseline patient characteristics were similar between groups. The median (interquartile range) dose of iron in the oral iron group was 1185.0 (477.0, 1874.0) mg. Neither absolute hemoglobin before delivery (control group: 10.0±1.2 g/dL; iron group: 10.1±1.1 g/dL; p=0.774)nor change in hemoglobin from admission to delivery (control group: -0.1±1.1 g/dL vs. iron group: 0.4±1.1 g/dL; p=0.232) differed between groups. Women in the control group had shorter length of stay (LOS) median (IQR) than women in the iron group (control group: 7.1 (5.0, 13.7) days; iron group: 11.4 (7.4, 25.9) days; p=0.03). There were no differences in maternal mode of delivery, though each group had high rates of cesarean delivery (control group: 53.7%; iron group: 72.4%; p=0.181). There were no differences in estimated blood loss at delivery (control group: 559±401; iron group: 662.1±337.4;p=0.264) in either group. Neonatal birthweight (control group: 1.9±0.7 kg; iron group:1.9±0.7 kg; p=0.901), birth hemoglobin (control group: 16.3±2.2 g/dL; iron group: 16±2.2 g/dL; p=0.569), neonatal intensive care unit (NICU) admission (control group: 93.3%; iron group: 84.8%;p=0.272 ), or neonatal death (control group: 8.9%; iron group: 3%; p=0.394) were not different between groups. Conclusions Oral iron administered to anemic inpatient pregnant women was not associated with higher hemoglobin concentrations before delivery. Lack of standardized iron regimens and short hospital stays may contribute to the inefficacy of oral iron for this inpatient pregnant population. The small sample size and retrospective nature of this study are limiting factors in drawing conclusive evidence from this study.

Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial

Iron-deficiency anemia in pregnancy is highly prevalent and presents significant risk to patients. Initial treatment is often with oral medication. We hypothesized that intravenous ferumoxytol would result in superior treatment of anemia as compared to oral ferrous sulfate. This study aimed to investigate whether 2 infusions of intravenous ferumoxytol are superior to the use of twice-daily oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy. A randomized controlled trial was performed in which participants with anemic (hemoglobin <11 g/dL and hematocrit <33%) were allocated to receive either 2 infusions of 510 mg of intravenous ferumoxytol approximately 7 days apart, or 325 mg oral ferrous sulfate twice daily from enrollment to the end of their pregnancy. Participants were randomized in a 1:1 ratio to each treatment. Our primary outcome was the change in maternal hemoglobin. Secondary outcomes included maternal iron indices, maternal safety, and maternal tolerability. There were 124 participants (N=62 per group). In the intravenous iron group, the mean change in hemoglobin was 1.86 g/dL (95% confidence interval, 1.57 g/dL-2.14 g/dL) and in the oral group was 0.79 g/dL (95% confidence interval, 0.42 g/dL-1.17 g/dL) (P<.0001). The median change in ferritin between groups was 64.5 (range, 31-364) vs 8 (range, -436 to +167) (P=.0001). The median change in iron between groups was also statistically significant with 47.5 ug/dL (range, -133 ug/dL to +664 ug/dL) in the intravenous group vs 8.5 ug/dL (range, -313 ug/dL to +437 ug/dL) in the oral iron group (P=.001). Intravenous ferumoxytol was well tolerated, and it was associated with statistically significant increases in maternal hemoglobin, hematocrit, iron, and ferritin compared to oral ferrous sulfate.

The efficacy and safety of intravenous sucrose iron therapy for recurrent iron deficiency anemia

Objective: To evaluate the efficacy and safety of intravenous iron supplementation in patients with recurrent iron deficiency anemia (IDA) . Methods: This retrospective analysis of 90 patients with recurrent IDA from May 2012 to December 2021 was conducted, comparing the efficacy and safety of the intravenous iron therapy group and the oral iron therapy group. Results: Among the 90 patients with recurrent IDA, 20 were males and 70 were females, with a median age of 40 (range: 14-85) years. A total of 60 patients received intravenous iron supplementation and 30 received oral iron supplementation. The hematologic response rates in the intravenous iron group were significantly higher than those in the oral iron group at 4 and 8 weeks after treatment [80.0% (48/60) vs 3.3% (1/30) and 96.7% (58/60) vs 46.7% (14/30), all P<0.001, respectively]. The median increase in hemoglobin levels was also significantly higher in the intravenous iron group than in the oral iron group [38 (4, 66) g/L vs 7 (1, 22) g/L at week 4 and 44.5 (18, 80) g/L vs 19 (3, 53) g/L at week 8, all P<0.001]. The intravenous iron group had a significantly higher proportion of patients who achieved normal hemoglobin levels than the oral iron group (55.0% vs 0 and 90% vs 43.3%, all P<0.001, respectively). Iron metabolism indicators were tested before and after 8 weeks of treatment in 26 and 7 patients in the intravenous and oral iron groups, respectively. The median increase in serum ferritin (SF) levels in the intravenous iron group 8 weeks after treatment was 113.7 (49.7, 413.5) μg/L, and 54% (14/26) of these patients had SF levels of ≥100 μg/L, which was significantly higher than the median increase in SF levels in the oral iron group [14.0 (5.8, 84.2) μg/L, t=4.760, P<0.001] and the proportion of patients with SF levels of ≥100 μg/L (P=0.013). The incidence of adverse reactions was 3.3% (2/60) in the intravenous iron group, which was significantly lower than that in the oral iron group [20.0% (6/30), P=0.015]. Conclusion: Intravenous iron supplementation is more effective for hematologic response, faster hemoglobin increase, and higher iron storage replenishment rates compared with oral iron supplementation in patients with recurrent IDA, and it is well tolerated by patients.

A Randomized Controlled Trial to Compare Intraveous Ferric Carboxymaltose with Oral Iron for Treatment of Post-Partum Anemia

Objectives: To compare the efficacy of ferric carboxymaltose (FCM) with oral iron in management of post-partum anemia. Materials and Methods: A total of 230 post-partum women aged &gt;18 years having Hb level &lt;10 g/dl on post-natal day 1 were randomized to receive either oral iron (ferrous fumarate tablets 200 mg for 06 weeks) or intravenous FCM (dose calculated by Ganzoni’s Formula, total iron dose = [actual body weight x (15 - actual Hb)] x 2.4 + iron stores). Demographic, obstetric and hematological profile (Hb and serum iron profile) was estimated at the time of enrolment. The women were followed up after six weeks. Non-complying women were excluded from the study. Change in Hb levels, serum iron profile and number of women achieving Hb&gt;10 g/dl was noted. Data was compared using Chi-square and Independent samples ‘t’-test respectively. Results: A total of 218 women (107 in FCM and 111 in oral iron group) completed the study. Mean age of women was 26.67±4.31 years. Mean pre-intervention Hb level was 9.11±0.62 and 9.15±0.61 g/dl respectively in FCM and oral iron groups (p=0.630). At follow-up these values were 11.11±0.89 and 10.78±0.88 g/dl respectively in the corresponding groups (p=0.006). Mean change in Hb level and number of women achieving targeted Hb level were significantly higher in FCM as compared to that in oral iron group (p&lt;0.05). Serum iron reserves were also found to be significantly higher in FCM as compared to oral iron group. Conclusion: Intravenous FCM had an edge over oral iron in management of post- partum anemia.

What is the best treatment for anemia in pregnant women in the third trimester: Ferric carboxymaltose or oral iron therapy?

Objective: Iron deficiency anemia (IDA) is a significant health problem in pregnant women. We aimed to evaluate the effect of gestational IDA and to compare the results of iron therapy in pregnant women. Methods: This retrospective cohort study of pregnant women in the third trimester analyzed the records of 63 women not taking any iron supplements, 70 women receiving intravenous ferric carboxymaltose therapy (FCM), and 73 pregnant women receiving oral iron therapy. It compared maternal and neonatal outcomes of the three groups. Results: The mean age of the 206 pregnant women included in the study was 29.19±4.34 (19-44; min–max). Only 1% of anemic women received a blood transfusion in the postpartum period. There was no difference between the groups' mean age and gestational week. The median values of gravida and parity were the same in all 3 groups (Gravida=2, Parity=1). Maternal hemoglobin (Hb) value of the non-iron group was lower than that of the other groups (p&lt;0.001). Although the mothers' Hb levels at birth were different, the newborns' Hb values were not affected (p=0.547). Neonatal height and weight were lower in the non-iron group than in the FCM and oral iron groups (p=0.048 and p&lt;0.001, respectively). Neonatal head circumference, 1-minute Apgar, and 5-minute Apgar scores were similar in all three groups. Conclusion: FCM is effective in pregnant women with IDA in late pregnancy and women undergoing this treatment deliver healthier newborns.

Comparing the Efficacy of Intermittent Versus Continuous Oral Iron Supplementation in Non–Anemic Pregnant Women Presenting for Routine Antenatal Care

Anemia in pregnancy is a major health concern all over the world. Daily iron supplementation is used to prevent and correct iron deficiency anemia during pregnancy. Intermittent iron supplementation is proposed as an alternative to daily supplementation. This study was undertaken to compare the efficacy of Intermittent versus Continuous oral iron supplementation in non-anemic pregnant women presenting for routine antenatal care. A Prospective cross sectional study was conducted among one hundred and two non-anemic pregnant women at BP Koirala Institute of Health Sciences for one year. They were allocated alternatively to continuous oral iron and intermittent (4 days in a week) iron supplementation group. Baseline hemoglobin and serum ferritin was done and women having more than 10.5gm/dl hemoglobin were recruited in the study at 14-16 weeks period of gestation. Repeat hemoglobin and ferritin was done at 28 weeks period of gestation and hemoglobin at the time of delivery was noted. Maternal and perinatal outcome were analyzed among the two groups by appropriate statistical analysis. The repeat hemoglobin done at 28 weeks period of gestation and at the time of delivery was comparable between the groups. Though more women in the intermittent group developed anemia in 3rd trimester (11.46%), it was not statistically significant and none of the women in either group required blood transfusion intermittent iron supplementation is a good alternative to continuous oral iron supplementation as a prophylaxis in non-anemic pregnant women with similar efficacy

Comparative study of safety and efficacy of intravenous iron sucrose complex and oral ferrous sulphate in treatment of iron deficiency anaemia during puerperium

Background: Consequences of postpartum iron deficiency anaemia have been associated with fatigue, depression, cognitive dysfunction, stress, and anxiety. It can also interrupt mother-child bonding. Present study was aimed to compare safety and efficacy of intravenous iron sucrose complex and oral ferrous sulphate in treatment of iron deficiency anaemia during puerperium. Material and Methods: Present study was single randomized control trial, conducted in postpartum female, &gt;18 years, diagnosis of postpartum anemia within the first 48 hours postpartum with a hemoglobin level 8 – 10 gm/dl. Results: Oral iron group had a mean baseline Hb of 8.86 ±0.54 and post treatment mean Hb after 2 weeks was 9.39 ± 0.48 and after 4 weeks was 10.35 ± 0.46. Statistically significant difference was noted in baseline and post treatment Hb levels at 2 and 4 weeks score (p&lt;0.05). For the I.V iron group Hb score shows that the baseline mean was 8.70 ± 0.50 and post treatment mean Hb after 2 weeks and 4 weeks was 9.94 ± 0.48 and 11.19 ± 0.57 respectively. Statistically significant difference was noted in baseline and post treatment Hb levels at 2 and 4 weeks score (p&lt;0.05).

Efficacy of Oral Versus Injectable Iron in Patients With Chronic Kidney Disease: A Two-Year Cross-Sectional Study Conducted at a Rural Teaching Hospital.

AimAnaemia (particularly iron deficiency) is of important concern in patients with chronic kidney disease (CKD) as it reflects the outcome of the disease. Current recommendations for the use of intravenous iron (IV) therapy in the management of anaemia in such patients are limited. This study highlights the comparison of oral to intravenous iron in patients with chronic kidney disease.Materials and methodsThis is a prospective case-control study comparing intravenous iron to oral iron in chronic kidney disease patients admitted to the Medicine Department of Acharya Vinoba Bhave Rural Hospital, in central India from October 2018 to October 2020. A total of 150 patients were divided into two groups of 75 each, one receiving oral iron (ferrous sulfate 325 mg tablets) and the other intravenous iron (IV iron sucrose).ResultsSerum iron, serum ferritin, and transferrin saturation (TS) showed increased levels in the IV iron group than in the oral iron group. In the IV group, a statistically significant increase was found in haemoglobin levels after therapy among all stages of kidney disease (p<0.05) while the same was not reported in the oral iron group.ConclusionIV iron sucrose therapy had been found to be effective, well-tolerated, and more successful than oral iron treatment in chronic kidney disease patients as far as the parameter of iron deficiency anaemia is concerned.

Comparison between Intravenous Iron and Oral Iron Treatment in Term of Efficacy in cases of Postpartum Anemia

Objective: To compare intravenous iron and oral iron treatment in term of efficacy in cases of postpartum anemia. Material and methods: Between July 2021 to December 2021, total 90 patients of post-partum anemia having age 20-35 year either primi or multi paras were recruited for this randomized controlled trial. Place of study was Department of Obstetrics &amp; Gynecology, Qazi Hussain Ahmed Medical Complex Nowshera Medical College. Efficacy between IV iron and oral iron was compared. Results: Total 90 cases of post-partum anemia was recruited for this study. Age of the cases was between 20-35 years with mean age 27.34 ± 4.88 years, in IV iron group (A) and oral iron group (B), mean age was 27.53 ±4.94 years and 27.16 ± 4.87 years respectively. Study group A (IV iron group) and group B (oral iron group) was compared in term of efficacy by applying chi-square test. After applying chi-square test, significantly (P = 0.034) high proportion of efficacy was noted in IV iron group as compared to oral iron group (37/82.22% vs 28/62.22%). Conclusion: Results of this study showed that IV iron therapy had significantly higher efficacy rate as compared to oral iron in cases of postpartum anemia. Most of the women were between 20-25 years. Primiparas had higher proportion and most of the women belonged to rural area. Key words: Postpartum anemia, hemoglobin, neonate, morbidity

Randomized controlled trial to compare injection ferric carboxymaltose and oral iron in reducing postpartum anemia: A multicenter, pilot study

Introduction: Iron-deficiency anemia (IDA) in pregnancy is common due to the increase demand for iron during pregnancy and is aggravated by blood loss associated with delivery. Intravenous iron formulations offer an alternative approach in the presence of moderate and severe anemia, due to intolerance of or nonadherence to oral iron and malabsorption status, to correct and prevent IDA. Ferric carboxymaltose (FCM) is a newer dextran-free iron formulation which allows for single and higher dose (up to 1000 mg) of IV iron infusion, making it a potentially ideal candidate for the treatment of postpartum anemia (PPA). Materials and Methods: A randomized control trial was conducted at two tertiary care centers involving 800 women (400 women in oral iron group and 400 women in the injection FCM group) to compare the efficacy of each in protecting the women from anemia in the postpartum period. Results: The compliance was 100% in the FCM group as the injection was given before the patient was sent on discharge after delivery. The mean rise in the hemoglobin levels in the FCM group and oral iron group was 3.76 g% and 2.476 g%, respectively. The mean rise in the serum ferritin levels in the FCM group was 214.265 mg% as noted at the end of 6 weeks. Conclusion : Injection FCM in the dose of 1000 mg given in a single dose before discharge in postpartum women helps in reducing PPA without any significant adverse effects.

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

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 &lt;11 gm/dl (7.45 mmol/L) and hematocrit less than 33% (WHO).&#x0D; 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.&#x0D; Material &amp; Methods: This was a prospective randomized comparative clinical trial single center study conducted on 200 postpartum women aged &gt;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.&#x0D; 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.&#x0D; 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.&#x0D; Keywords: Iron deficiency anemia, Intravenous iron sucrose, Serum ferritin, Maternal mortality.

Baseline Hepcidin Does Not Predict the Response to Iron Therapy in Pregnant Women with Iron Deficiency

▪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<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. [Display omitted] DisclosuresNo 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.

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

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.

Preoperative Single-Dose Intravenous Iron Formulation to Reduce Postsurgical Complications in Patients Undergoing Major Abdominal Surgery: A Randomized Control Trial Feasibility Study (PIRCAS Trial Pilot).

BackgroundPreoperative anemia is associated with an increased need for blood transfusion, complications, and prolonged hospital stay. Iron deficiency anemia (IDA) may be treated with oral or intravenous (IV) iron. IV iron repletes iron stores more rapidly. Its impact on perioperative blood transfusion, postoperative complications, patients’ recovery, and long-term quality of life is unclear. Newer agents, such as ferric carboxymaltose (FCM), are costly but have higher maximum approved doses and a very low incidence of anaphylactic-type reactions. This study aims to explore the feasibility of a randomized control trial to compare the preoperative treatment of IDA with IV FCM versus oral ferrous fumarate, in patients undergoing elective major abdominal surgery.Experimental designThis is an open-label pilot randomized controlled trial. A total of 30 adults with IDA scheduled for elective major abdominal surgery were recruited for the study. They were randomized into two groups to receive either oral iron or IV FCM. Primary outcomes are defined as the time from enrollment to study drug administration, recruitment rate, and follow-up rate up to three months. Secondary outcomes are hemoglobin rise from recruitment to surgery, perioperative blood transfusion, postoperative complications, EQ-5D-3L scores at baseline, and three months and adverse events related to IV FCM therapy.ResultsAll patients received study drugs within five days of enrollment; 30 patients were recruited within four months, 15 patients in each group. Two in each group were withdrawn for surgery postponement. All patients were followed up for three months and there was no crossover of patients. Per protocol, analysis was performed. No severe adverse events related to IV FCM therapy occurred. Both groups had similar baseline characteristics, similar hemoglobin rise from enrollment to the day of surgery [0.2 (+1.6) g/dL in the FCM group and 0.8 (+0.7) g/dL in the Oral Iron group, p=0.3] and similar mean units of perioperative blood transfused (recruitment to discharge) per patient [1.3 (+ 2.1) in the FCM group and 0.9 (+1.3) in the Oral Iron group, p=0.6]. Postoperatively, there was a similar hospital length of stay [11.5 (+13.6 days) in the FCM group and 9.0 (+9.8 days) in the Oral Iron group, p=0.6]; there were similar postoperative complications as reflected by the average Comprehensive Complication Index [12.8 (+19.6) in the FCM group and 22.6 (+30.7) in the Oral Iron group, p=0.3]; similar postoperative health-related quality of life as reflected by mean EQ-5D-3L scores at one month [70.4 (+21.8) in the FCM group and 84.5 (+12.1) in the Oral Iron group] and three months [80.0 (+18.4) in the FCM group and 85.9 (+10.7) in the Oral Iron group].ConclusionsA full-scale randomized controlled trial to evaluate the effectiveness of preoperative IV FCM compared to oral iron in patients with IDA undergoing major abdominal surgery is feasible.

Comparison of intravenous iron sucrose versus oral iron for the treatment of iron deficiency anaemia in pregnancy

Background: Iron deficiency anemia (IDA) is the most common medical problem in pregnancy. Parenteral iron is a useful treatment, although iron dextran use decreased due to anaphylaxis. Iron sucrose is a newer agent that has overcome the shortcomings of iron dextran. Objective: The aim of this study was to compare the safety and efficiency of intravenous iron sucrose with oral iron administration for the treatment of iron deficiency anaemia in pregnancy. Materials and Methods: 100 women with gestational age between 14 and 35 weeks with iron deficiency anaemia & Haemoglobin between 6-8g/dL were randomised to receive either oral iron (ferrous sulphate) 200 mg thrice daily or required dose of intravenous iron sucrose. Haemoglobin, haematocrit, mean corpuscular volume, reticulocyte count were measured at recruitment and on 2nd week, 4th week and at 37 weeks of gestation. Adverse drug reactions were also noted in both these groups. Results: Haemoglobin values varied significantly with time between the two groups at second week, 4th week and at 37 weeks. The mean difference in mean corpuscular volume from the recruitment value was not significant at 2nd week of treatment. When compared to iron sucrose group, oral iron group had significant gastro-intestinal adverse effects. Conclusion: Intravenous iron sucrose treated iron deficiency anaemia of pregnancy faster, and more effectively than oral iron therapy, with no serious adverse drug reactions.

Oral and Intravenous Iron Therapy Differentially Alter the On- and Off-Tumor Microbiota in Anemic Colorectal Cancer Patients.

Simple SummaryAnemia is commonly associated with colorectal cancer and often requires intervention with therapeutic iron. However, iron is required for growth by the majority of colonic bacteria, leading to competition for free luminal iron. Hence, this leaves the potential for the route of iron administration to lead to differential gut bacterial populations. This study aimed to investigate the differences in on- and off-tumor bacterial populations following oral and intravenous therapy in anemic colorectal cancer patients. The following iron therapies were shown to be differential to bacterial diversity, microbial populations, and predictive metagenomics, inferring that oral iron-treated patients may have a potentially more procarcinogenic microbiota compared to intravenous iron-treated patients. Overall, this suggests that intravenous iron may be a more beneficial treatment for anemia in colorectal cancer, in order to limit microbial perturbations associated with oral iron.Iron deficiency anemia is a common complication of colorectal cancer and may require iron therapy. Oral iron can increase the iron available to gut bacteria and may alter the colonic microbiota. We performed an intervention study to compare oral and intravenous iron therapy on the colonic tumor-associated (on-tumor) and paired non-tumor-associated adjacent (off-tumor) microbiota. Anemic patients with colorectal adenocarcinoma received either oral ferrous sulphate (n = 16) or intravenous ferric carboxymaltose (n = 24). On- and off-tumor biopsies were obtained post-surgery and microbial profiling was performed using 16S ribosomal RNA analysis. Off-tumor α- and β-diversity were significantly different between iron treatment groups. No differences in on-tumor diversity were observed. Off-tumor microbiota of oral iron-treated patients showed higher abundances of the orders Clostridiales, Cytophagales, and Anaeroplasmatales compared to intravenous iron-treated patients. The on-tumor microbiota was enriched with the orders Lactobacillales and Alteromonadales in the oral and intravenous iron groups, respectively. The on- and off-tumor microbiota associated with intravenous iron-treated patients infers increased abundances of enzymes involved in iron sequestration and anti-inflammatory/oncogenic metabolite production, compared to oral iron-treated patients. Collectively, this suggests that intravenous iron may be a more appropriate therapy to limit adverse microbial outcomes compared to oral iron.

Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial

Iron deficiency anaemia is of major concern in low-income settings, especially for women of childbearing age. Oral iron substitution efficacy is limited by poor compliance and iron depletion severity. We aimed to assess the efficacy and safety of intravenous ferric carboxymaltose versus oral iron substitution following childbirth in women with iron deficiency anaemia in Tanzania. This parallel-group, open-label, randomised controlled phase 3 trial was done at Bagamoyo District Hospital and Mwananyamala Hospital, Tanzania. Eligible participants were close to delivery and had iron deficiency anaemia defined as a haemoglobin concentration of less than 110 g/L and a ferritin concentration of less than 50 μg/L measured within 14 days before childbirth. Participants were randomly assigned 1:1 to receive intravenous ferric carboxymaltose or oral iron, stratified by haemoglobin concentration and site. Intravenous ferric carboxymaltose was administered at a dose determined by the haemoglobin concentration and bodyweight (bodyweight 35 kg to <70 kg and haemoglobin ≥100 g/L: 1000 mg in one dose; bodyweight 35 kg to <70 kg and haemoglobin <100 g/L, or bodyweight ≥70 kg and haemoglobin ≥100 g/L: 1500 mg in two doses at least 7 days apart; bodyweight ≥70 kg and haemoglobin <100 g/L: 2000 mg in two doses at least 7 days apart). Oral iron treatment consisted of three dried ferrous sulphate tablets of 200 mg containing 60 mg of elementary iron and 5 mg of folic acid every morning. Oral treatment was to be taken for 3 months after haemoglobin normalisation. The primary outcome was haemoglobin normalisation (>115 g/L) at 6 weeks. Follow-up visits were at 6 weeks, and 3, 6, and 12 months. Analyses were done in the modified intention-to-treat population of participants who had a 6-week haemoglobin concentration result, using logistic and linear regression models for binary and continuous outcomes, adjusted for baseline haemoglobin concentration and site. This trial is registered with ClinicalTrials.gov, NCT02541708. Between Oct 8, 2015, and March 14, 2017, 533 individuals were screened and 230 were enrolled and randomly assigned to a study group (114 to intravenous iron, 116 to oral iron). At 6 weeks, 94 (82%) participants in the intravenous iron group and 92 (79%) in the oral iron group were assessed for the primary outcome. 75 (80%) participants in the intravenous iron group and 47 (51%) in the oral iron group had normalised haemoglobin (odds ratio 4·65, 95% CI 2·33-9·27). There were two mild to moderate infusion-related adverse events; and five serious adverse events (three in the intravenous iron group, two in the oral iron group), unrelated to the study medication. Intravenous iron substitution with ferric carboxymaltose was safe and yielded a better haemoglobin response than oral iron. To our knowledge, this is the first study to provide evidence of the benefits and safety of intravenous iron substitution in a low-income setting. Vifor Pharma, R Geigy-Stiftung, Freiwillige Akademische Gesellschaft, and Swiss Tropical and Public Health Institute.