scholarly journals REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women

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.

2018 ◽  
Vol 36 (04) ◽  
pp. 366-376 ◽  
Author(s):  
Richard Burwick ◽  
Shravya Govindappagari

Objective To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the benefits of intravenous (IV) iron in pregnancy. Study Design Systematic review was registered with PROSPERO and performed using PRISMA guidelines. PubMed, MEDLINE, Web of Science, ClinicalTrials.gov, Cochrane Library, and Google Scholar were searched. Eleven RCTs, comparing IV to oral iron for treatment of iron-deficiency anemia in pregnancy, were included. Meta-analyses were performed with Stata software (College Station, TX), utilizing random effects model and method of DerSimonian and Laird. Outcomes were assessed by pooled odds ratios (OR) or pooled weighted mean difference (WMD). Sensitivity analyses were performed for heterogeneity. Results We found that pregnant women receiving IV iron, compared with oral iron, had the following benefits: (1) Achieved target hemoglobin more often, pooled OR 2.66 (95% confidence interval [CI]: 1.71–4.15), p < 0.001; (2) Increased hemoglobin level after 4 weeks, pooled WMD 0.84 g/dL (95% CI: 0.59–1.09), p < 0.001; (3) Decreased adverse reactions, pooled OR 0.35 (95% CI: 0.18–0.67), p = 0.001. Results were unchanged following sensitivity analyses. Conclusion In this meta-analysis, IV iron is superior to oral iron for treatment of iron-deficiency anemia in pregnancy. Women receiving IV iron more often achieve desired hemoglobin targets, faster and with fewer side effects.


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.


2017 ◽  
Vol 45 (4) ◽  
Author(s):  
Christian Breymann ◽  
Nils Milman ◽  
Anna Mezzacasa ◽  
Roubert Bernard ◽  
Joachim Dudenhausen

AbstractObjective:To compare the efficacy and safety of intravenous ferric carboxymaltose (FCM) with first-line oral ferrous sulfate (FS) in pregnant women with iron deficiency anemia (IDA).Materials and methods:Pregnant women (n=252; gestational weeks 16–33) with IDA were randomized 1:1 to FCM (1000–1500 mg iron) or FS (200 mg iron/day) for 12 weeks. The primary objective was to compare efficacy; secondary objectives included safety and quality of life.Results:Hemoglobin (Hb) levels improved at comparable rates across both treatments; however, significantly more women achieved anemia correction with FCM vs. FS [Hb ≥11.0 g/dL; 84% vs. 70%; odds ratio (OR): 2.06, 95% confidence interval (CI): 1.07, 3.97; P=0.031] and within a shorter time frame (median 3.4 vs. 4.3 weeks). FCM treatment significantly improved vitality (P=0.025) and social functioning (P=0.049) prior to delivery. Treatment-related adverse events were experienced by 14 (FCM; 11%) and 19 (FS; 15%) women, with markedly higher rates of gastrointestinal disorders reported with FS (16 women) than with FCM (3 women). Newborn characteristics were similar across treatments.Conclusions:During late-stage pregnancy, FCM may be a more appropriate option than first-line oral iron for rapid and effective anemia correction, with additional benefits for vitality and social functioning.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2121-2121
Author(s):  
Pooja Mehra ◽  
Surabhi Palkimas ◽  
Laura Parsons ◽  
Theresa Libby ◽  
Leslie Ward ◽  
...  

Background: Anemia in pregnancy increases the need for blood transfusion during and after delivery and is associated with an increased risk of maternal and fetal mortality, therefore preventing maternal anemia may improve outcomes. Iron deficiency is the most common pathologic cause of anemia in pregnancy and is estimated to affect about 30% of pregnant women in the third trimester in the US. The baseline peripartum blood transfusion rate at our institution is 3.2%. Historically, patients who may have benefited from intravenous (IV) iron were continued on oral iron and subsequently delivered with persistent iron deficiency anemia. If identified to need IV iron, these patients were usually referred to a hematologist. However, in the absence of a structured protocol, referral was provider-dependent. Objective: We formed a multidisciplinary work group consisting of members from the departments of Hematology, Obstetrics, Pharmacy, Nursing, and Blood Bank to reduce peripartum blood transfusions by developing a process to manage pregnant patients with iron deficiency anemia. The treatment algorithm utilized at our institution was adapted from "How I treat anemia in pregnancy: iron, cobalamin, and folate" (Achebe & Gafter-Gvili, 2017), which recommends IV iron for hemoglobin less than 11 g/dL and ferritin less than 30 µg/dL in the third trimester and for hemoglobin less than 10.5 g/dL and ferritin less than 30 µg/dL in the second trimester along with recommendations for iron repletion in the first trimester. The primary endpoint was the utilization of blood transfusion. Secondary endpoints included an increase in maternal hemoglobin after treatment and evaluating the safety of IV ferric carboxymaltose as measured by side effects and frequency of hypophosphatemia. Five months after initiation of the IV iron recommendations, we performed an audit to assess its use. Methods: A retrospective IRB-approved chart review of anemic, iron-deficient pregnant women who received IV ferric carboxymaltose from 1/30/19 - 6/30/19 was performed. Thirty-six patients were identified and their charts were reviewed to determine the hemoglobin and ferritin levels prior to IV iron, the number of IV iron infusions received with any side effects, phosphorus levels on days of IV iron, hemoglobin level after IV iron, and need for peripartum blood transfusion. Results: Of the 36 patients who received IV iron for anemia in pregnancy, post-IV iron hemoglobin and blood transfusion information was only available for 26 patients. The remaining 10 patients had not delivered as yet or had delivered at another institution so data were not available. Of these 26 patients, the median age was 26.0 years and all received IV iron during their third trimester. No patients required a blood transfusion peripartum. The average hemoglobin prior to IV iron was 9.3 g/dL and the average hemoglobin after 1-2 IV iron infusions was 11.3 g/dL, an increase of 2.0 g/dL across the total group (Figure 1) (p<0.0001). Of these 26 patients, 7 patients received 1 dose of IV iron and 2 patients experienced heartburn or nausea during or soon after the IV iron infusion. Phosphorus levels were checked in 24 patients and 6 experienced hypophosphatemia with no attributable side effects. No patient experienced a serious adverse effect or reaction requiring discontinuation of IV iron therapy. Conclusion: Results from the first 5 months of this project suggest using a standardized iron deficiency anemia treatment protocol including IV iron to reduce the need for peripartum blood transfusion and increase hemoglobin levels. Additionally, our data suggest IV ferric carboxymaltose is well-tolerated in these patients. These results also support using multi-professional teams to improve the quality of healthcare delivery to pregnant patients with iron deficiency anemia. We have created an IRB-approved database to study more patient-centered postpartum outcomes such as quality of life among IV iron recipients as well as lactation rates and fetal outcomes. We plan to expand this strategy to other patients who have a predictable and likely preventable need for intermittent blood transfusion, such as patients with chronic gynecologic blood loss. Reference: Achebe, M. M., & Gafter-Gvili, A. (2017). How I treat anemia in pregnancy: iron, cobalamin, and folate. Blood, 129(8), 940-949. https://doi.org/10.1182/blood-2016-08-672246. Disclosures Davidson: ABIM: Other: American Board of Internal Medicine.


Author(s):  
Adam K. Lewkowitz ◽  
Molly J. Stout ◽  
Emily Cooke ◽  
Seon C. Deoni ◽  
Viren D'Sa ◽  
...  

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points


2017 ◽  
Vol 66 (5) ◽  
pp. 56-63
Author(s):  
Anna S. Atajanyan

The review article defines iron deficiency anemia, the mechanisms determining iron deficiency in pregnancy, the complications of pregnancy, childbirth and the postpartum period, the methods of correction and prevention of iron deficiency, including a modern alternative to oral iron intake-its intravenous forms, which contribute to a rapid increase of iron levels. And also do not have toxicity and are easily tolerated.


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