Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery

Purpose Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery. Materials and methods Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia. Results The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed. Conclusions In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated. Graphical abstract

Comparative study of efficacy and safety of parenteral iron sucrose versus ferric carboxymaltose in treatment of postpartum iron deficiency anaemia

Background: Postpartum anaemia often leads to multiple clinical complications in mother as well as infant and iron supplementation with parenteral iron is the preferred treatment modality. The present study was planned to compare the efficacy and tolerability of IV iron sucrose and IV ferric carboxymaltose in treatment of postpartum iron deficiency anaemia.Methods: This randomized, parallel, open label, prospective 4-weeks study was conducted from June 2019 to December 2020 in women with postpartum anaemia admitted to obstetrics and gynaecology inpatient department of a tertiary care hospital. Women with postpartum iron deficiency anaemia (N=60) were randomly divided into two groups; receiving Injection iron sucrose (N=30, maximum dose 500 mg) or Injection ferric carboxymaltose (N=30, maximum dose 500 mg). Change in haemoglobin and serum ferritin levels from baseline to the end of 2 and 4 weeks of treatment were evaluated.Results: The results showed early, sustained and significant increase in the haemoglobin levels in both the groups. However, the difference was not significant between groups (p=0.2). Evaluation of replenishment of iron stores (serum ferritin) showed improvement in both the groups, however in FCM group the rise was found to be significant (p<0.05).Conclusions: FCM in a lower dose of 500mg was found to be safe and effective in significantly improving haemoglobin concentration as well as in replenishing iron stores in patients with postpartum anaemia.

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 <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.

A comparative study of efficacy, safety and compliance of intravenous ferric carboxymaltose versus iron sucrose in the treatment of iron deficiency anaemia of pregnancy

Iron deficiency is the most common cause of anaemia worldwide and is associated with significant maternal and fetal morbidity. Current options for treatment include oral iron supplementation which can be ineffective and poorly tolerated, intravenous iron which can be used in patients who are intolerant to or unresponsive to oral iron and red blood cell transfusions which carry an inherent risk because of which it should be avoided. Intravenous iron therapy may reduce the requirement for allogenic blood transfusion. Ferric carboxymaltose is a new intravenous iron formulation promising to be more effective and as safe as iron sucrose. It may even have a better compliance as it offers the administration of a much higher iron dosage at a time.The study was designed to compare the efficacy and safety of IV ferric carboxymaltose versus iron sucrose in the treatment of iron deficiency anaemia of pregnant women with moderate anaemia in the second and third trimester.A hospital based randomized prospective study was done from July 2013 to June 2015 in the department of Obstetrics and Gynaecology, A.J. Institute of Medical Sciences, Mangalore. Baseline haemoglobin, peripheral smear and serum ferritin levels were measured to diagnose iron deficiency anaemia. 60 pregnant women who met the inclusion criteria and who formed the study subjects were randomly allocated into two groups comprising of 30 in Group C (Received ferric carboxymaltose) and 30 in Group S (Received iron sucrose). Outcome was assessed by measuring haemoglobin 3 weeks after treatment and a comparison of the safety and efficacy between the two groups was made. In the present study the commonest age group was 21 to 30 years: 80% in group C and 73.3% in group S and mean age of the study population in group C and S was comparable (25.2±3.54 vs 24.8±4.58 years). The socio demographic characteristics, obstetric history, vitals and pretreatment haemoglobin were comparable in both the groups (p&#62;0.050). The post treatment haemoglobin levels in 63.3% of the women in group C compared to 46.7% in group S were found to be 11 or more and mean post treatment haemoglobin levels were comparable in group C and group S (11.016±0.789 vs 10.73±0.821 gm%; p=0.174). In the present study, post treatment mean increase in haemoglobin levels was noted between 2.0 to 2.5 gm% in 43.3% of the women in group C compared to 50.0% in group S. Ferric carboxymaltose administration in pregnant women in the second and third trimesters is well tolerated and is not associated with any clinical safety concerns. Both ferric carboxymaltose and iron sucrose have a comparable safety profile even when ferric carboxymaltose was administered in a much higher dosage compared to iron sucrose. Ferric carboxymaltose should be considered as the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.

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

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