Intravenous Iron Sucrose Group Research Articles

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial

Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. WHO, India.

Parenteral Versus Oral Iron for Treatment of Iron Deficiency Anaemia During Pregnancy and post-partum: A Systematic Review

The burden of iron deficiency anaemia during pregnancy and post-partum continues to remain high especially in India. Challenges to treatment include gastrointestinal side effects and non compliance to oral iron therapy. Newer parenteral formulations need to be explored as alternatives. Meta-analysis of randomized controlled trials published between years 2011 and 2018 comparing anaemic pregnant and post-partum women treated with intravenous iron sucrose versus oral iron was performed. The primary outcomes were mean maternal haemoglobin, serum ferritin and haematocrit at the end of 1st, 2nd, 4th and 6th weeks and comparison of adverse effects. Eighteen studies including 1633 antenatal women were randomly assigned to intravenous iron sucrose (n = 821) or oral iron [ferrous sulphate, ferrous ascorbate or fumarate] group (n = 812) in ten trials . Another eight studies compared iron sucrose infusion with oral iron in 713 post-partum women who were randomly assigned to intravenous iron sucrose group (n = 351) or oral iron group (n = 362). Cumulative analysis of all the time points indicates that the estimated mean values of Hb in the intravenous iron sucrose and oral iron groups were 10.11g/dl and 9.33g/dl, respectively, in antenatal group, while it was 10.57g/dl and 9.74g/dl in post-partum. The estimated mean ferritin level from first week to six weeks was 63.1μg/l and 28.6μg/l, respectively, in intravenous and oral iron groups. Cumulative estimate of haematocrit in the intravenous sucrose and oral iron over 6weeks showed that the mean values in the respective groups were 30.5% and 29.5% in antenatal and 33.8% and 31.6%, respectively, in post-partum groups. Sensitivity analysis confirmed the reliability and consistency of the results. Oral iron was associated with significant gastrointestinal side effects. There was no significant difference in birthweight between the groups. This meta-analysis demonstrates that intravenous iron sucrose is more effective than oral iron therapy for pregnant and post-partum women with iron deficiency anaemia. It is an effective and safe alternative to address the problem of iron deficiency especially in those who require rapid replacement of iron stores though medical personnel for intravenous administration of drug is required.Trial registration CRD42015024343.

High-dose Accelerated vs Low-dose Frequent Regime of Iron Sucrose Therapy in Antenatal and Postnatal Women with Iron Deficiency

ABSTRACT Objective To compare an accelerated high-dose (500 mg) vs low-dose (200 mg) regimen of intravenous iron sucrose in a cohort of iron-deficient anemic antenatal patients in terms of efficacy, safety, and compliance. Materials and methods In a prospective hospital-based study, antenatal and postnatal women with anemia attending Jawaharlal Nehru Medical College and Hospital, Aligarh, India, between December 2010 and December 2012 were enrolled. The inclusion criteria were all outpatient and admitted anemic antenatal women ≤ 36 weeks gestation and postnatal women with hemoglobin (Hb) below 10 gm/dL, or serum ferritin ≤ 30 μg/L or transferrin saturation ≤ 40% irrespective of prior oral iron therapy. Patients were excluded from the study if they were hemodynamically unstable, actively bleeding, having fever, or were nauseated or vomiting. Participants were assigned to control and study groups according to simple random sampling. Intravenous iron sucrose group I (500 mg)/group II (200 mg) was infused after test dose on alternate days for the calculated total dose in the study population. Blood and iron indices were measured at baseline and after 2 weeks of administration of last dose. The primary outcome of the study was to assess the rise in Hb and safety of high-dose intravenous iron sucrose. Results There was a statistically significant increase in Hb level in patients receiving either regimen, with larger mean increase in group I (2.7 ± 0.4) compared with group II (2.25 ± 6.39). Serum iron and serum ferritin also increased in both fortnightly (p < 0.001). Blood transfusion was avoided by 90.1% in severely anemic cases with Hb < 7. Hospital stay was reduced by 50% in group I. Conclusion The accelerated regimen of high-dose (500 mg) intravenous iron sucrose in anemic antenatal patients appears to be safe and effective in correcting anemia, restoring iron stores, and avoiding blood transfusion. How to cite this article Anjum S, Garg N, Beriwal S, Parvez A. High-dose Accelerated vs Low-dose Frequent Regime of Iron Sucrose Therapy in Antenatal and Postnatal Women with Iron Deficiency. World J Anemia 2017;1(2):31-35.

English

To compare effectiveness of intravenous iron-sucrose versus oral ferrous sulphate in pospartum anemia in rural area. METHODS AND MATERIAL: In this study, 120 women with postpartum anemia with hemoglobin (Hb) less than 10 g/dl within 48 h postpartum were randomised into two groups. Group I consisted of 60 women who received 300-600 mg of intravenous iron-sucrose every alternate day for 3 days. Group II consisted of 60 women who were given 300 mg ferrous sulphate orally daily for a month. Data collected after 1 month for Hb estimation and other postpartum parameters are assessed. RESULTS: The mean Hb was significantly increased in the intravenous iron sucrose group in 4th week of treatment but there was minimal change observed in mean Hb in patients treated with oral ferrous sulphate. Women treated with intravenous iron sucrose has shown significantly higher Hb as compared to those treated with oral iron. CONCLUSIONS: Overall intravenous iron sucrose appears to be an effective and safe mode of treatment in postpartum patients with no serious side effects than oral iron therapy.

Iron Sucrose Versus Oral Iron Therapy in Pregnancy Anemia

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 efficacy and tolerance of intravenous iron sucrose (IVIS) therapy with oral iron (OI) therapy in pregnant women with IDA and to study the factors influencing treatment.Materials and Methods:This prospective, randomized clinical trial included pregnant women between 14 and 36 weeks with established IDA who were treated with IVIS or OI (ferrous fumarate). All patients were monitored for laboratory response and adverse effects. Independent sample-t test, Chi square test and ANOVA were used for statistical analysis. P < 0.05 was considered significant.Results:Although hemoglobin increased in both the groups, increase in the reticulocyte count and percentage increase in hemoglobin was significantly higher in the IVIS group than in the OI group (23.62% vs. 14.11%). Serum ferritin was significantly higher in the IVIS group than in the OI group (P = 0.000). The IVIS group had no major side-effects. Compliance was good with OI, although 23% had gastrointestinal side-effects. Patient weight, gestation at diagnosis, initial hemoglobin and ferritin levels did not influence the response to treatment.Conclusion:IVIS is safe and effective in the treatment of IDA during pregnancy. Iron stores increased better with IVIS compared with OI.

Intravenous Iron Therapy versus Oral Iron in Postpartum Patients in Rural Area

ABSTRACTObjectivesThe aim of this study is to evaluate the efficiency and safety of intravenous iron sucrose complex and comparison with oral iron therapy in postpartum period in rural area.Materials and methodsIt is a prospective, randomized, hospital-based clinical study carried out in over 150 patients, having Hb &lt; 8 mg/dl after 24 hours of delivery. 600 to 800 mg iron sucrose has been given in divided doses, 200 mg on alternate day in 100 ml of normal saline to half of the patients whereas rest of the patients given 200 mg bd dose of ferrous sulphate by oral route for one month. Data was collected after 1st, 2nd, 3rd and 4th week for the hemoglobin estimation and assessment of the impact of intravenous iron sucrose treatment on the postpartum parameters.ResultsThe mean Hb was significantly increased in the intravenous iron sucrose group in 7 days (7.42 ± 1.04 gm/dl to 9.8 ± 0.76 gm/dl) of treatment but there was no change observed in mean Hb in the patients treated with oral ferrous sulphate. Women treated with intravenous iron sucrose has shown significantly higher Hb on day 7, day 15 and day 30 as compared to the women those were treated with oral iron (p &lt; 0.0001).ConclusionOverall intravenous iron sucrose appears to be an effective mode of treatment in postpartum patients with no serious side effects and associated with faster recovery in shorter duration of hospital stay than oral iron treatment.

Intravenous iron sucrose in maintenance dialysis patients with renal anemia: a clinical study

To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose. One hundred and ninety-four patients on maintenance dialysis with the hemoglobin (Hb) level of 60 - 100 g/L and hematocrit (Hct) of 18% - 30% were randomly divided into 2 sex, age, duration of dialysis, weekly erythropoietin dosage, and hematological parameters-matched groups: intravenous iron sucrose group (n = 102) and oral medication group (n = 92). The intravenous iron sucrose group were sub-divided into 2 subgroups: (1) hemodialysis (HD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks, and (2) peritoneal dialysis (PD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks. The oral medication group received ferrous succinate 200 mg tid for 12 weeks. The levels of serum ferritin (SF), transferrin saturation (TSAT), Hb, and Hct were examined before treatment and 4, 8, and 12 weeks after treatment. (1) Compared with baseline levels, the levels of Hb, Hct, SF, and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group, and 4 weeks after treatment in the oral medication group (all P < 0.05). (2) The Hb, Hct, SF, and TSAT levels 4, 6, 8, and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group (all P < 0.05). (3) The Hb, Hct, SF, and TSAT levels 12 weeks after treatment 6, 8, and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group (all P > 0.05). (4) The response rate of the intravenous iron sucrose group was 95.09%, significantly higher than that of the oral medication group (55.44%, P < 0.05). (5) The mean EPO doses 6, 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group (all P < 0.05). (6) The Hb, Hct, SF, and TSAT levels maintained stable during the period 6, 8, and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency. (7) The Hb, Hct, SF, and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup. (8) No adverse event was found in the intravenous iron sucrose group, and adverse gastrointestinal effects occurred in 12 patients of the oral medication group. (9) After 12 weeks, the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate. Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated. Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO. However, the total cost of intravenous iron treatment is relatively high.