High-dose intravenous iron supplementation after preoperative autologous blood donation is useful to prevent post-donation/preoperative anemia.

To estimate the effectiveness of high-dose intravenous (IV) iron supplementation for iron deficiency anemia after preoperative autologous blood donation (PAD), 155 donors who visited the donation office of the University of Tokyo Hospital from December 2020 to June 2021 and showed suspected post-donation anemia were analyzed. The participants were treated with high-dose intravenous (IV) iron supplementation (high-dose group, n = 30) or a combination of low-dose IV iron and oral iron supplementation (low-dose group, n = 125). The preoperative hemoglobin (Hb) and Hb decreasing ratios during PAD (ΔHb) were compared between the two groups. Multivariate linear regression analyses were also performed to identify the confounding factors associated with preoperative Hb and ΔHb as well as high-dose IV iron supplementation. Preoperative Hb level was slightly higher in the high-dose group than in the low-dose group (12.1 ±â€¯1.1 vs. 11.9 ±â€¯1.1 g/dL, p = 0.27). ΔHb was significantly higher in the high-dose group than in the low-dose group (3.7 % ± 8.8 % vs. 7.7 % ± 6.5 %, p = 0.011). On the multivariate linear regression analyses, high-dose IV iron supplementation was significantly associated with higher preoperative Hb and lower ΔHb levels (p = 0.021 and 0.017, respectively) as well as the donation available period (period from the first visit to the donation office to the operation) and administration of erythropoiesis-stimulating agents. High-dose IV iron supplementation after PAD will be useful in the treatment of post-donation anemia.

Efficacy and safety of intravenous iron with different frequencies for renal anaemia: A systematic review and meta-analysis.

WHAT IS KNOWN AND OBJECTIVE: To evaluate the efficacy and safety of intravenous iron supplementation in patients with renal anaemia. METHODS: We searched the PubMed, Embase, Cochrane Library, and Web of Science from their inception until 17 September 2021, for randomized controlled trials (RCTs) to evaluate the efficacy and safety of intravenous iron at different frequencies. The observed efficacy indicators included transfer saturation (TSAT), serum ferritin (SF) and haemoglobin (HGB). Outcomes of interest included allergies, infections, all-cause mortality and cardiovascular events. RESULTS AND DISCUSSION: Of the 751 eligible studies, 7 RCTs met the inclusion criteria. The RCTs showed that there were no significant differences between the low-frequency high-dose group (1-2 doses, >200 mg/dose) and the high-frequency low-dose group (4-5 doses, ≤200 mg/dose) in the increase in TSAT (WMD = 1.90; 95% CI = -2.04 to 5.84; I2  = 0%), SF (WMD = 15.70; 95% CI = -32.20 to 70.61; I2  = 0%) and HGB (WMD = -0.00; 95% CI = -0.43 to 0.42; I2  = 0%). There was also no significant difference in the occurrence of outcome events, including allergies (RR = 1.84; 95% CI = 0.95 to 3.57; I2  = 45%), infections (RR = 0.61; 95% CI = 0.20-1.86; I2  = 0%), cardiovascular events (RR = 0.88; 95% CI = 0.67-1.15; I2  = 48%) and all-cause mortality (RR = 0.74; 95% CI = 0.40-1.35; I2  = 0%). WHAT IS NEW AND CONCLUSION: Frequencies of intravenous iron supplementation with similar doses share similar safety and efficacy in patients with renal anaemia. However, a single dose or two doses of intravenous iron are more cost-effective and patient friendly. These findings may provide evidence for the clinical application of intravenous iron supplementation for patients with renal anaemia.

Gestational iron deficiency anemia is associated with preterm birth, fetal growth restriction, and postpartum infections.

OBJECTIVES: Gestational IDA has been linked to adverse maternal and neonatal outcomes, but the impact of iron supplementation on outcome measures remains unclear. Our objective was to assess the effects of gestational IDA on pregnancy outcomes and compare outcomes in pregnancies treated with either oral or intravenous iron supplementation. METHODS: We evaluated maternal and neonatal outcomes in 215 pregnancies complicated with gestational IDA (Hb<100 g/L) and delivered in our tertiary unit between January 2016 and October 2018. All pregnancies from the same period served as a reference group (n=11,545). 163 anemic mothers received oral iron supplementation, and 52 mothers received intravenous iron supplementation. RESULTS: Gestational IDA was associated with an increased risk of preterm birth (10.2% vs. 6.1%, p=0.009) and fetal growth restriction (FGR) (1.9% vs. 0.3%, p=0.006). The gestational IDA group that received intravenous iron supplementation had a greater increase in Hb levels compared to those who received oral medication (18.0 g/L vs. 10.0 g/L, p<0.001), but no statistically significant differences in maternal and neonatal outcomes were detected. CONCLUSIONS: Compared to the reference group, prematurity, FGR, postpartum infections, and extended hospital stays were more common among mothers with gestational IDA, causing an additional burden on the families and the healthcare system.

Intravenous iron therapy for patients with iron deficiency and heart failure: a systematic review and meta-analysis of randomized controlled trials.

Introduction: Heart failure (HF) presents a significant health challenge, with intravenous (IV) iron therapy considered a potential treatment avenue. Method: We assessed IV iron therapy's efficacy in HF patients with concurrent iron deficiency versus standard of care. Primary outcomes included the composite of HF hospitalizations or cardiovascular-related mortality, HF hospitalizations, and all-cause, HF, and cardiovascular mortality rates. Secondary measures encompassed improvements in New York Heart Association functional classification, quality of life, 6-minute walk test, left ventricular ejection fraction, and adverse events. We used a random-effects model to compute relative risk (RR) or mean difference (MD) with 95% confidence intervals (CIs). Results: Based on an analysis of 14 randomized controlled trials involving 6614 patients, IV iron therapy significantly reduced composite outcome (RR: 0.84, 95% CI: 0.73, 0.96; P = 0.01) and HF hospitalizations (RR: 0.74, 95% CI: 0.61, 0.89; P = 0.002) compared to standard of care. Mortality rates showed no significant difference. IV iron therapy improved New York Heart Association functional classification, quality of life, and 6-minute walk test, with no major impact on left ventricular ejection fraction. Adverse events remained stable. Conclusions: IV iron therapy holds promise for diminishing HF hospitalizations and enhancing quality of life and 6-minute walk test in HF patients. Yet, its effect on all-cause or cardiovascular mortalities appears limited.

Is It Time to Alter the Standard of Care for Iron Deficiency/Iron Deficiency Anemia in Reproductive-Age Women?

Two billion people worldwide suffer from anemia, with reproductive-age women being disproportionately affected. Iron plays a crucial role in cellular function and impacts cognition, physical function, and quality of life. Iron deficiency (ID) and iron deficiency anemia (IDA) are associated with adverse effects on pregnancy and fetal development. Oral iron supplementation has been the standard treatment for decades, often producing sub-optimal outcomes. Many babies are still being born with ID and suffer adverse sequelae due to inadequate iron levels in the mothers. Is it time to consider a broad scale-up of parenteral iron as a new standard of care?

Effect of IV ferric carboxy maltose for moderate/severe anemia: a systematic review and meta-analysis.

Introduction: Anemia remains a prevalent global health issue with varying severity. Intravenous iron supplementation, particularly with ferric carboxymaltose (FCM), has appeared as a possible therapeutic intervention for individuals with moderate to severe anemia. The study aimed to assess the efficacy and safety of ferric carboxymaltose (FCM) in reducing anemia. Methods: We searched electronic databases, registries, websites, e-libraries, reference lists of reviews, citations, etc. We included randomized control trials (RCTs), non-RCTs, and single-arm studies, while observational studies, case series, and case studies were excluded. Two reviewers independently screened the studies and extracted the data. We included studies of moderate-to-severely anemic Indians and excluded Indians with other comorbidities. We assessed the risk of bias and the overall quality of evidence (QoE) using GRADE GDT. Result: We identified 255 studies and included 14 studies (11 RCT, one non-RCT, and two single-arm studies) with 1,972 participants for qualitative analysis and 10 studies in the meta-analysis. All the included studies detailed the use of FCM for anemia. The primary outcomes assessed in the included studies were anemia, hemoglobin, and adverse events. The outcomes assessed ranged from 2 weeks to 12 weeks. The risk of bias varied across different studies with different outcomes. FCM is consistent with a fewer number of adverse events as compared to other interventions and provides "moderate" to "very low" QoE. Conclusion: A slow single infusion of 1 gram of FCM is well-tolerated, safe, and effective in treating iron deficiency anemia (IDA) and surpasses other interventions (Iron Sucrose Complex (ISC), Iron sucrose, and ferrous ascorbate) in elevating hemoglobin levels and replenishing iron stores. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=459363, CRD42023459363.

[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.

Overview of iron deficiency and iron deficiency anemia in women and girls of reproductive age.

Over 50% of pregnant women are anemic and the majority of these are iron deficient. Micronutrient deficiency, the symptom of heavy menstrual bleeding in nonpregnant individuals, and loss of blood associated with pregnancy and obstetric delivery contribute to iron deficiency (ID). Poor outcomes with low maternal iron can affect not only the pregnancy but can also have major bearings on the offspring. Correction of ID and iron deficiency anemia (IDA) in pregnant and prepregnant populations with single-dose intravenous iron supplementation may offer improved outcomes. A harmonization process that incorporates all major randomized controlled trials studying the use of single-dose IV iron compared with oral iron may suggest actions for changing the global trajectory of ID/IDA for women and girls of reproductive age.

Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study.

Patients undergoing hemodialysis with iron deficiency anemia (IDA) receiving treatment with erythropoiesis-stimulating agents (ESAs) who were intolerant or non-responsive to intravenous (i.v.) ferric gluconate (FG) (hemoglobin; Hb values < 10.5 g/dL or increase in <1 g/dL) or % transferrin saturation; TSAT of <20%) in the previous 6 months were switched to i.v. ferric carboxymaltose (FCM). Changes in iron status parameters, economic and safety measures were also assessed. Seventy-seven hemodialysis patients aged 68 ± 15 years were included. Erythropoietin resistance index decreased from 24.2 ± 14.6 at pre-switch to 20.4 ± 14.6 after 6 months of FCM treatment and Hb levels ≥10.5 g/dL improved from 61% to 75.3% patients (p = 0.042). A 1 g/dL increase in Hb levels was also seen in 26% of patients as well as a 37.7% increase in patients achieving >20% increase in TSAT after FCM. Levels of Hb, TSAT and ferritin parameters increased during FCM treatment with a concomitant decrease in ESA. A mixed-model analysis, which also considered gender, confirmed these trends. Safety variables remained stable, no hypersensitivity reaction was recorded and only one patient reported an adverse event after FCM. FCM treatment was associated with a cost saving of 11.11 EUR/patient/month. These results confirm the efficacy, safety and cost-effectiveness of FCM in correcting IDA in hemodialysis patients.

Economic impact of ferric carboxymaltose in haemodialysis patients / Impatto economico dell'utilizzo di carbossimaltosio ferrico nei pazienti in emodialisi

Intravenous iron supplementation is essential in hemodialysis (HD) patients to recover blood loss and to meet the requirements for erythropoiesis and, in patients receiving erythropoietin, to avert the development of iron deficiency. In a recent real-world study, Hofman et al. showed that a therapeutic shift from iron sucrose (IS) to ferric carboxymaltose (FCM) in HD patients improves iron parameters while reducing use of iron and erythropoietin. The objective of this economic analysis is to compare the weekly cost of treatment of FCM vs IS in hemodialysis patients in Italy. The consumption of drugs (iron and erythropoietin) was derived from Hofman's data, while the value was calculated at Italian ex-factory prices. The analysis was carried on the total patient sample and in two subgroups: patients with iron deficiency and patients anemic at baseline. In addition, specific sensitivity analyses considered prices currently applied at the regional level, simulating the use of IS vs iron gluconate (FG) and epoetin beta vs epoetin alfa. In the base-case analysis, the switch to FCM generates savings of -€12.47 per patient/week (-21%) in all patients, and even greater savings in the subgroups with iron deficiency -€17.28 (-27%) and in anemic patients -€23.08 (-32%). Sensitivity analyses were always favorable to FCM and confirmed the robustness of the analysis. FCM may represent a cost-saving option for the NHS, and Italian real-world studies are needed to quantify the real consumption of resources in dialysis patients.