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Background: In low- and middle-income countries, women experiencing anemia during pregnancy are recommended to take 30 mg to 60 mg of oral iron daily throughout pregnancy. However, oral iron tablets are often poorly tolerated and slow in correcting anemia, resulting in low adherence, prolonged anemia, and increased risk of adverse maternal and fetal outcomes. An alternative to oral iron is intravenous (IV) iron, commonly used in high-income countries to restore the body's iron stores rapidly. A randomized controlled trial was conducted to investigate the effectiveness and safety of IV iron compared to standard-of-care oral iron supplementation for pregnant women with moderate and severe anemia in the third trimester in Malawi (REVAMP-TT). Using an experience-based co-design approach, our study aimed to identify barriers and facilitators to IV iron use to treat anemia in pregnancy in the primary healthcare system of Malawi, and develop mitigating strategies for the successful implementation of REVAMP-TT. Methodology: The co-design process involved two phases: i) We conducted an information-gathering exercise to identify barriers and facilitators to IV iron use to treat anemia in pregnancy in the primary healthcare system of Malawi. We interviewed key informants (n = 53) including the policymakers, government partners, healthcare managers, and healthcare providers. We also gathered previous research findings from a formative qualitative study on the perceptions and experiences of IV iron treatment for pregnant women experiencing anemia in Malawi (n = 29). ii) We conducted two co-design workshops with end-users (n = 20) and healthcare providers (n = 20) to confirm and identify the key barriers and facilitators and developed mitigating strategies to inform the successful implementation of the REVAMP-TT trial. We mapped the emerging barriers to the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0) and matched the mitigating strategies to the corresponding Expert Recommendations for Implementing Change (ERIC) compilation. Results: The following were identified as key barriers to IV iron use to treat anemia in pregnancy in the primary healthcare system of Malawi: the cost of IV iron, the lack of available resources and knowledge, local attitudes including myths and misconceptions about IV iron and keeping pregnancy a secret, local conditions, the lack of political will and buy-in from high-level leaders, the lack of capability of healthcare providers to deliver IV iron, and the lack of male involvement to support pregnant women's access to antenatal care. The proposed strategies to mitigate the barriers for the successful implementation of the REVAMP TT trial included providing financial strategy, developing stakeholder relationships, training and educating stakeholders, supporting clinicians, and engaging end-users. Conclusion: The use of the experience-based co-design approach in our study provided a valuable method to expose the potential barriers and facilitators to IV iron use and develop mitigating strategies to successfully implement the REVAMP-TT trial. Engaging both the key informants and end users promoted ownership and consensus among stakeholders and ensured a collaborative environment for sharing deeply rooted real-world experiences and insights. Not only do these findings address the needs of this study, but they also, lay a groundwork for the possible integration of IV iron into routine care in Malawi and provide knowledge for policymakers to make informed decisions on the management of anemia in the primary healthcare systems of Malawi. [ABSTRACT FROM AUTHOR]

Background/objectives: Iron deficiency anemia is common in patients with colorectal cancer and affects postoperative outcomes. Preoperative intravenous iron supplementation corrects anemia effectively; however, the effect on the postoperative clinical course is unclear. The aim of this study was to investigate the effects of implementing a screening program for iron deficiency anemia and correction in patients with colorectal cancer. Methods: This was a retrospective single-institutional quality-assurance study that included patients undergoing elective surgery for colorectal cancer between January 2019 and December 2021. On 1 March 2020, screening for iron deficiency was implemented. Anemia was corrected by intravenous ferricarboyxmaltose. Patients with hemoglobin <7mmol/L and ferritin <30 µg/L or ferritin 30–100 µg/L and TSAT < 0.2 were divided into iron- and non-iron groups. The primary outcome was a change in hemoglobin concentration, and secondary outcomes included blood transfusion, complications, length of stay, mortality, and implementation efficacy. Data from the patients were extracted from digital patient charts and entered into a database. Results: A total of 532 patients were included, of which 177 patients (33.3%) were anemic, 63 were in the iron group, and 114 were in the non-iron group. Adherence to the screening program was 86.3%. Hemoglobin (iron group) increased from a mean of 5.7 mmol/L (SD 0.8) to 6.9 (0.8) mmol/L, p < 0.001. Iron treatment decreased transfusion rates from 27.7% to 9.1%, p = 0.007, and increased the rate of patients without complications from 53.2% to 79.6%, p < 0.001, which held true after controlling for confounding. In addition, 90-day mortality was lower in the iron group; however, this was not significant. Conclusions: Administration of intravenous iron increased hemoglobin, leading to reduced use of blood transfusion and fewer complications. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Limited evidence exists on the optimal strategy to correct iron deficiency anemia after variceal bleeding (VB) in cirrhosis. This trial compared the efficacy and safety of intravenous ferric carboxymaltose (IVFCM) with those of oral iron therapy in this cohort. METHODS: In this open-label, single-center, randomized controlled trial, eligible patients with hemoglobin <10 g/dL and iron deficiency (ferritin <100 ng/mL) after VB received either IV-FCM (1,500-2,000 mg) divided into 2 doses (n 5 48) or oral carbonyl iron (100 mg elemental iron/day) (n 5 44) for 3 months. The primary outcome was change in hemoglobin at 3 months. Secondary outcomes included improvement in anemia (last hemoglobin >12 g/dL), normalization of iron stores (ferritin >100 ng/mL), liver-related adverse events, adverse drug reactions, and changes in quality of life (CLDQOL questionnaire). RESULTS: Baseline characteristics, including median Child-Turcotte-Pugh score 7 (interquartile range [IQR] 6-9), Model for End-Stage Liver Disease score 12 (IQR 10-17), blood hemoglobin (8.2561.06 g/dL), and ferritin (30.00 ng/mL [15.00-66.50]), were comparable in both arms. The median increase in hemoglobin at 3 months in the IV and oral arms was 3.65 g/dL (IQR 2.55-5.25) and 1.10 g/dL (IQR 0.05-2.90 g/dL) (P < 0.001), respectively. Iron stores normalized in 84.6% and 21% of the IV and oral arms, respectively (P < 0.001). Anemia improved in 50% and 21.9% in the IV and oral arms, respectively (P < 0.009). Patients in the IV arm showed a significant improvement in all domains of CLDQOL. Liver-related adverse events were comparable in both arms. Transient mild/moderate hypophosphatemia developed in 43% of patients receiving IV-FCM. DISCUSSION: Intravenous iron replacement is efficacious and safe to treat iron deficiency anemia after VB in patients with cirrhosis. [ABSTRACT FROM AUTHOR]

Anemia is the most common extraintestinal symptom of colorectal cancer, with a prevalence of 30–75%. While the preoperative anemia in this patient population has been well studied and its correction 4–6 weeks prior to surgery is recommended when feasible, there is a paucity of data regarding the management of postoperative anemia, which has a prevalence of up to 87% in these patients. To address this issue, we conducted an observational cohort study of surgically treated postoperative anemic patients with colorectal cancer. The objective of this study was to evaluate the effect of intravenous ferric carboxymaltose on the correction of postoperative anemia by postoperative day 30 (POD30). The primary outcome was the change in hemoglobin on POD30, while the secondary outcomes were the change in iron and other laboratory parameters, postoperative complications and transfusions. The results demonstrated that patients treated with intravenous iron exhibited a significant increase in hemoglobin levels by POD30, along with a concomitant increase in hematocrit, ferritin, and transferrin saturation levels, compared to the control group. The findings imply that patients undergoing colorectal cancer surgery with anemia that was not corrected in the preoperative setting may benefit from early postoperative intravenous iron infusion. [ABSTRACT FROM AUTHOR]

Abstract Background In low- and middle-income countries, women experiencing anemia during pregnancy are recommended to take 30 mg to 60 mg of oral iron daily throughout pregnancy. However, oral iron tablets are often poorly tolerated and slow in correcting anemia, resulting in low adherence, prolonged anemia, and increased risk of adverse maternal and fetal outcomes. An alternative to oral iron is intravenous (IV) iron, commonly used in high-income countries to restore the body’s iron stores rapidly. A randomized controlled trial was conducted to investigate the effectiveness and safety of IV iron compared to standard-of-care oral iron supplementation for pregnant women with moderate and severe anemia in the third trimester in Malawi (REVAMP-TT). Using an experience-based co-design approach, our study aimed to identify barriers and facilitators to IV iron use to treat anemia in pregnancy in the primary healthcare system of Malawi, and develop mitigating strategies for the successful implementation of REVAMP-TT. Methodology The co-design process involved two phases: i) We conducted an information-gathering exercise to identify barriers and facilitators to IV iron use to treat anemia in pregnancy in the primary healthcare system of Malawi. We interviewed key informants (n = 53) including the policymakers, government partners, healthcare managers, and healthcare providers. We also gathered previous research findings from a formative qualitative study on the perceptions and experiences of IV iron treatment for pregnant women experiencing anemia in Malawi (n = 29). ii) We conducted two co-design workshops with end-users (n = 20) and healthcare providers (n = 20) to confirm and identify the key barriers and facilitators and developed mitigating strategies to inform the successful implementation of the REVAMP-TT trial. We mapped the emerging barriers to the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0) and matched the mitigating strategies to the corresponding Expert Recommendations for Implementing Change (ERIC) compilation. Results The following were identified as key barriers to IV iron use to treat anemia in pregnancy in the primary healthcare system of Malawi: the cost of IV iron, the lack of available resources and knowledge, local attitudes including myths and misconceptions about IV iron and keeping pregnancy a secret, local conditions, the lack of political will and buy-in from high-level leaders, the lack of capability of healthcare providers to deliver IV iron, and the lack of male involvement to support pregnant women's access to antenatal care. The proposed strategies to mitigate the barriers for the successful implementation of the REVAMP TT trial included providing financial strategy, developing stakeholder relationships, training and educating stakeholders, supporting clinicians, and engaging end-users. Conclusion The use of the experience-based co-design approach in our study provided a valuable method to expose the potential barriers and facilitators to IV iron use and develop mitigating strategies to successfully implement the REVAMP-TT trial. Engaging both the key informants and end users promoted ownership and consensus among stakeholders and ensured a collaborative environment for sharing deeply rooted real-world experiences and insights. Not only do these findings address the needs of this study, but they also, lay a groundwork for the possible integration of IV iron into routine care in Malawi and provide knowledge for policymakers to make informed decisions on the management of anemia in the primary healthcare systems of Malawi.

Previous meta-analyses of intravenous iron supplementation for reducing red blood cell (RBC) transfusion risk after cardiac surgery were inconclusive because of limited data. This updated meta-analysis incorporates recent evidence. Major databases were searched on May 2, 2024 for randomised controlled trials comparing the incidence of RBC transfusion between adult patients receiving intravenous iron supplementation and those receiving controls (i.e. oral iron or placebo) after cardiac surgery. The secondary outcomes included the number of RBC units transfused, postoperative haemoglobin levels, iron status, complications, and length of hospital stay. Trial sequential analysis was conducted to examine the robustness of evidence. Fourteen randomised controlled trials including 2043 subjects were identified. Intravenous iron supplementation was found to reduce the RBC transfusion risk compared with controls (relative risk 0.77, 95% confidence interval [CI] 0.65–0.91, P =0.002, n =1955, I 2=61%, certainty of evidence: moderate). The trial sequential analysis supported the robustness of the evidence. Furthermore, haemoglobin levels were higher in the intravenous iron supplementation group on postoperative days 4–10 (mean difference 0.17 g dl−1, 95% CI 0.06–0.29, n =1989) and >21 days (mean difference 0.66 g/dl−1, 95% CI 0.36–0.95, n =1008). Postoperative iron status also improved with Intravenous iron supplementation, particularly on postoperative days 4–10. There were no significant differences in other outcomes, including mortality. Intravenous iron supplementation can reduce RBC transfusion risk and improve postoperative haemoglobin level and iron status after cardiac surgery, supporting the implementation of Intravenous iron supplementation in perioperative blood management strategies. CRD42024542206 (PROSPERO). [ABSTRACT FROM AUTHOR]

Objective: To determine maternal and neonatal outcomes in individuals with iron deficiency receiving antepartum intravenous (IV) iron supplementation, stratified by the degree of anemia. Study Design: Retrospective cohort study of iron‐deficient pregnant patients who received at least one IV infusion of iron (iron sucrose, low molecular weight iron dextran [LMWID], or ferric carboxymaltose) during their pregnancy from January 1, 2011 through June 16, 2022. Our primary outcomes included both neonatal composite morbidity and maternal composite morbidity in the context of maternal anemia. Results: Patients who received LMWID had fewer infusion visits, received higher total doses of iron and had a more substantial correction of hemoglobin compared to those who received iron sucrose (p < 0.01). Maternal anemia at the time of admission was not associated with neonatal composite morbidity. However, there was a significant association between anemia status and maternal composite outcome (p = 0.05). Anemia at time of delivery was associated with the likelihood of requiring a blood transfusion (p = 0.01). Conclusion: This study reinforces previous findings emphasizing the adverse effects of iron deficiency on maternal health and the role of IV iron in reducing these risks. [ABSTRACT FROM AUTHOR]

Abstract Aims To explore the potential interaction between use of SGLT2 inhibitors and the increase in haemoglobin in patients randomized to intravenous iron or the control group in the IRONMAN (Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency) trial. Methods and results This was a post hoc exploratory analysis of the IRONMAN trial which randomized patients with heart failure, a left ventricular ejection fraction (LVEF) ≤ 45% and iron deficiency (transferrin saturation 16.5 g/dL [men] or >16 g/dL [women]). Conclusions In the IRONMAN trial, there was a trend to a greater increase in haemoglobin with ferric derisomaltose in iron‐deficient patients taking an SGLT2 inhibitor at baseline, as compared with those not taking one.

Abstract Background Iron deficiency anaemia is common among pregnant women in Nigeria. The standard treatment is oral iron therapy, which can be sub-optimal due to side effects. Intravenous ferric carboxymaltose (FCM) is an evidenced-based alternative treatment with a more favourable side effect profile requiring administration according to a standardized protocol. In this study, we assessed the fidelity of administering a single dose of FCM according to protocol and identified factors influencing implementation fidelity. Methods We used a mixed-method approach with a sequential explanatory design nested in a clinical trial across 11 facilities in Lagos and Kano States, Nigeria. Guided by a conceptual framework of implementation fidelity, we quantitatively assessed adherence to protocol by directly observing every alternate FCM administration, using an intervention procedure checklist, and compared median adherence by facility and state. Qualitative fidelity assessment was conducted via in-depth interviews with 14 skilled health personnel (SHP) from nine purposively selected health facilities, using a semi-structured interview guide. We analyzed quantitative data using descriptive and inferential statistics in Stata and used thematic analysis to analyze the transcribed interviews in NVivo. Results A total of 254 FCM administrations were observed across the 11 study sites, with the majority in secondary (63%), followed by primary healthcare facilities (PHCs) (30%). Overall, adherence to FCM administration as per protocol was moderate (63%) and varied depending on facility level. The lowest level of adherence was observed in PHCs (36%). Median, adherence level showed significant differences by facility level (p = 0.001) but not by state (p = 0.889). Teamwork and availability of protocols are facilitation strategies that contributed to high fidelity. However, institutional/ logistical barriers are contextual factors that influenced the varied fidelity levels observed in some facilities. Conclusions Collaborative teams and access to operating protocols resulted in high fidelity in some facilities. However, in some PHCs, fidelity to FCM was low due to contextual factors and intervention complexities, thereby influencing the quality of delivery. In Nigeria, scale-up of FCM will require attention to staff strength, teamwork and availability of administration protocols, in order to optimize its impact on anaemia in pregnancy.

Aims: To explore the potential interaction between use of SGLT2 inhibitors and the increase in haemoglobin in patients randomized to intravenous iron or the control group in the IRONMAN (Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency) trial. Methods and results: This was a post hoc exploratory analysis of the IRONMAN trial which randomized patients with heart failure, a left ventricular ejection fraction (LVEF) ≤ 45% and iron deficiency (transferrin saturation <20% or ferritin <100 μg/L) to open label intravenous ferric derisomaltose or usual care. Of the 1137 randomized patients, 29 (2.6%) were taking an SGLT2 inhibitor at baseline. The mean (SD) change in haemoglobin from baseline at 4 weeks in those taking an SGLT2 inhibitor at baseline was 1.3 (1.2) g/dL in patients randomized to ferric derisomaltose and 0.1 (0.7) g/dL in the usual care group; between‐group difference = 1.0 g/dL (95% CI 0.1, 1.8). The equivalent numbers in the no SGLT2 inhibitor group were 0.6 (0.9) g/dL in those randomized to ferric derisomaltose and 0.1 (0.8) g/dL in the usual care group; between‐group difference = 0.4 g/dL (95% CI 0.3, 1.6); interaction P value = 0.10. No patient receiving an SGLT2 inhibitor at baseline developed polycythaemia during follow‐up (defined as haemoglobin >16.5 g/dL [men] or >16 g/dL [women]). Conclusions: In the IRONMAN trial, there was a trend to a greater increase in haemoglobin with ferric derisomaltose in iron‐deficient patients taking an SGLT2 inhibitor at baseline, as compared with those not taking one. [ABSTRACT FROM AUTHOR]

Background: Iron deficiency anaemia is common among pregnant women in Nigeria. The standard treatment is oral iron therapy, which can be sub-optimal due to side effects. Intravenous ferric carboxymaltose (FCM) is an evidenced-based alternative treatment with a more favourable side effect profile requiring administration according to a standardized protocol. In this study, we assessed the fidelity of administering a single dose of FCM according to protocol and identified factors influencing implementation fidelity. Methods: We used a mixed-method approach with a sequential explanatory design nested in a clinical trial across 11 facilities in Lagos and Kano States, Nigeria. Guided by a conceptual framework of implementation fidelity, we quantitatively assessed adherence to protocol by directly observing every alternate FCM administration, using an intervention procedure checklist, and compared median adherence by facility and state. Qualitative fidelity assessment was conducted via in-depth interviews with 14 skilled health personnel (SHP) from nine purposively selected health facilities, using a semi-structured interview guide. We analyzed quantitative data using descriptive and inferential statistics in Stata and used thematic analysis to analyze the transcribed interviews in NVivo. Results: A total of 254 FCM administrations were observed across the 11 study sites, with the majority in secondary (63%), followed by primary healthcare facilities (PHCs) (30%). Overall, adherence to FCM administration as per protocol was moderate (63%) and varied depending on facility level. The lowest level of adherence was observed in PHCs (36%). Median, adherence level showed significant differences by facility level (p = 0.001) but not by state (p = 0.889). Teamwork and availability of protocols are facilitation strategies that contributed to high fidelity. However, institutional/ logistical barriers are contextual factors that influenced the varied fidelity levels observed in some facilities. Conclusions: Collaborative teams and access to operating protocols resulted in high fidelity in some facilities. However, in some PHCs, fidelity to FCM was low due to contextual factors and intervention complexities, thereby influencing the quality of delivery. In Nigeria, scale-up of FCM will require attention to staff strength, teamwork and availability of administration protocols, in order to optimize its impact on anaemia in pregnancy. [ABSTRACT FROM AUTHOR]

Introduction: The prevalence of preoperative anemia is the highest in the group of colorectal cancer (CRC) patients and may reach over 75%. The prevalence of anemia in CRC patients increases even further following surgery. Approximately 75–80% of anemic CRC patients present with absolute or functional iron deficiency (ID). Preoperative anemia constitutes an independent risk factor for allogeneic blood transfusion (ABT), postoperative complications, prolonged length of hospital stay, and increased mortality. ABT is itself associated with increased morbidity and mortality. Aim: The aim of this review article was to present the pathophysiology and the current approach to the diagnostics and treatment of preoperative iron deficiency anemia (IDA) in CRC patients. Material and methods: Extensive search of medical literature databases was performed (Pubmed, Embase). The key words that were used were as follows: CRC, colorectal surgery, ID, IDA, intravenous iron, Patient Blood Management (PBM). Results: There are several laboratory parameters that can be used for IDA diagnosis, however, the simplest and most cost- -effective is reticulocyte hemoglobin equivalent (RET-He). Pathophysiologic features of IDA in CRC patients favor treatment with intravenous, as opposed to oral, iron formulations. Applying PBM strategies minimizes the exposure to ABT. Conclusions: Preoperative IDA is highly prevalent among CRC patients. Preoperative anemia is an independent risk factor for ABT, increased morbidity and mortality, as well as prolonged hospital length of stay. The same negative consequences are associated with ABT. Therefore, preoperative IDA in CRC patients needs to be screened for, diagnosed, and treated before surgery. Effective treatment of preoperative IDA in CRC patients is with intravenous iron formulations. ABT should be the treatment of last resort due to the risk of negative clinical consequences, including an increased rate of cancer recurrence. [ABSTRACT FROM AUTHOR]

Iron deficiency and heart failure frequently co-occur, sparking clinical research into the role of iron repletion in this condition over the last 20 years. Although early nonrandomized studies and subsequent moderate-sized randomized controlled trials showed an improvement in symptoms and functional metrics with the use of intravenous iron, 3 recent larger trials powered to detect a difference in hard cardiovascular outcomes failed to meet their primary endpoints. Additionally, there are potential concerns related to side effects from intravenous iron, both in the short and long term. This review discusses the basics of iron biology and regulation, the diagnostic criteria for iron deficiency and the clinical evidence for intravenous iron in heart failure, safety concerns, and alternative therapies. We also make practical suggestions for the management of patients with iron deficiency and heart failure and outline key areas in need of future research. [Display omitted] • Iron deficiency and heart failure frequently occur concurrently and are associated with adverse cardiovascular outcomes. • Early trials of intravenous iron repletion in patients with heart failure found improvements in symptoms and functional capacity, but subsequent large trials failed to confirm objective consistent benefit. • Side effects of and alternatives to intravenous iron repletion warrant careful consideration. [ABSTRACT FROM AUTHOR]

A high prevalence of iron deficiency exists in athlete populations. Various mechanisms, including increased losses through sweat, haemolysis, haematuria, and gastrointestinal micro-ischemia; inadequate dietary intake; and transient exercise-induced increases in the regulatory hormone, hepcidin, contribute to the increased prevalence in athletes. Indeed, hepcidin has been shown to peak around 3–6 hours post-exercise, limiting iron absorption from the gut. As the practitioner's ability to control losses is limited, the key to treatment of iron deficiency in athletes is optimal timing of dietary and oral iron supplementation around these periods of reduced gut absorption. While timing and dosing schedule strategies might be sufficient to treat iron deficiency non-anaemia, the significant lag to impact iron status is relatively long. Therefore, in iron deficiency anaemia, the use of parenteral iron has the benefit of rapid repletion of iron stores and normalisation of haemoglobin status, while bypassing the action of hepcidin at the gut. Furthermore, newer intravenous formulations can be administered as a single total dose over 15–60 min and have a similar safety profile to oral treatment. This review discusses the existing evidence for parenteral iron use in athletes and the unique context for consideration when choosing the parenteral route in this population. [ABSTRACT FROM AUTHOR]

Background: Patients with advanced ovarian cancer (AOC) undergoing surgery are often subjected to red blood cell (RBC) transfusions. Both anemia and RBC transfusion are associated with increased morbidity. The aim was to evaluate patient recovery after the implementation of patient blood management (PBM) strategies. Methods: This retrospective cohort study included 354 patients with AOC undergoing surgery at Skane University Hospital Lund, Sweden, between January 2016 and December 2021. The gradual implementation of PBM strategies included restrictive RBC transfusion, tranexamic acid as standard medication before laparotomies and intravenous iron administered to patients with iron deficiency. Severe complications were defined as Clavien-Dindo (CD) grade ≥ 3a. Logistic and linear regression analyses were used to evaluate the differences between three consecutive periods. Results: After the implementation of new strategies, 52% of the patients had at least one transfusion compared to 83% at baseline (p

Patients with heart failure (HF) and iron deficiency are at increased risk of adverse clinical outcomes.We searched databases for randomised controlled trials that compared IV iron to placebo, in patients with HF with reduced ejection fraction (HFrEF). A total of 7,813 participants, all having HFrEF with 3,998 receiving IV iron therapy, and 3,815 control recipients were included. There was a significant improvement in Kansas City Cardiomyopathy Questionnaire favouring IV iron with MD 7.39, 95% CI [3.55, 11.22], p = 0.0002. Subgroup analysis, based on acute and chronic HF, has displayed a sustained statistical significance. Additionally, a significant increase in the left ventricular ejection fraction % was observed, with MD 3.76, 95% CI [2.32, 5.21], p < 0.00001. A significant improvement in 6-min walk test was noted, with MD 34.87, 95% CI [20.02, 49.72], p < 0.00001. Furthermore, IV iron showed significant improvement in NYHA class, peak VO2, serum ferritin, and haemoglobin levels. Finally, despite the lack of difference in terms of all-cause hospitalisation and HF-related death, IV iron was associated with a significant reduction in HF-related, any cardiovascular reason hospitalisations, and all-cause death; which supports the need for implementation of IV iron as a standard of care in patients with HF and iron deficiency. [ABSTRACT FROM AUTHOR]

Introduction: Ferric citrate (FC) is an FDA-approved iron-based phosphate binder for adults with dialysis-dependent chronic kidney disease. This study investigated the impact of FC as the primary phosphate-lowering therapy on utilization of erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron. Methods: In this randomized, open-label, active-controlled, multicenter study (NCT04922645), patients on dialysis and receiving ESAs were randomized to receive FC or remain on standard of care (SOC) phosphate-lowering therapy for up to 6 months. Primary endpoints were the difference in change from baseline to efficacy evaluation period (EEP) in mean monthly ESA and IV iron doses. Secondary endpoints included treatment differences in hemoglobin, phosphate, TSAT, and ferritin levels. Results: Two hundred nine patients were randomized to FC and had a day 1 dosing visit (n = 103) or SOC (n = 106). The two groups had similar baseline laboratory characteristics; however, atherosclerotic CV disease, peripheral vascular disease, and congestive heart failure were more common in the SOC group. The mean treatment difference in ESA monthly dose was −30.8 μg (FC vs. SOC; p = 0.02). An absolute though non-statistically significant change in mean monthly IV iron dose of −37.2 mg (p = 0.17) was observed with FC. Mean hemoglobin, TSAT, and ferritin all increased from baseline to the EEP with FC versus SOC. Serious adverse events occurred in 28% of patients receiving FC versus 37% in those receiving SOC. Conclusions: In patients receiving dialysis, treatment with FC as compared to remaining on SOC phosphate binders resulted in reductions in mean monthly ESA and IV iron dose. [ABSTRACT FROM AUTHOR]

Introduction: Iron deficiency anemia and iron deficiency are usual clinical conditions in daily clinical practice, requiring iron replacement therapy. The study objective was to evaluate the appropriateness of intravenous iron treatment in hospitalized patients and to identify the main causes of inappropriate prescription. Method: This is a retrospective observational study. Adult patients who received intravenous iron therapy at their hospital during the study period were included. Appropriate treatment was considered when patient presented iron deficiency, either due to absolute (ferritin <100 ng/mL) or functional iron deficiency (transferrin saturation index < 20 % and ferritin < 300 ng/mL). The main variable of the study was patient percentage with adequate prescription or parenteral iron. Results: The study included 250 patients. The use of iron was adequate in 41.6 % (104) of the 250 patients analyzed. The main cause of inadequacy in 46.4 % of patients was the lack of analytical data which corroborated iron deficiency. Conclusions: Our center has a deficiency in the appropriateness of the prescription of parenteral iron despite the existence of a protocol for its use. The main point of improvement would be the creation of an analytical profile that allows the adequate diagnosis of iron deficiency prior to the prescription of intravenous iron. In some pathologies, the lack of clinical guidelines with specific cut-off points for analytical markers indicative of iron deficiency in the available literature may contribute to this situation. [ABSTRACT FROM AUTHOR]

Iron deficiency (ID) is by far the most common nutritional disorder in developing and developed countries. When left untreated, ID leads to anemia. Although the usually recommended treatment for iron deficiency anemia (IDA) is oral iron therapy with countless products, such therapy necessitates administration for >3–6 months with questionable patient compliance since most oral iron products have an unpleasant metallic aftertaste and cause intestinal side effects. In addition, in certain gastrointestinal conditions, such as inflammatory bowel diseases or untreated gluten-sensitive enteropathy, oral iron therapy is contraindicated or unsuccessful. Intravenous iron is considered safe in adults, where adverse events are mild and easily managed. The experience with parenteral iron in children is much more limited, and many pediatricians appear reluctant to use it because of uncorroborated fears of serious anaphylactic reactions. In the current article, we thoroughly review the available pediatric literature on the use of all commercially available parenteral iron products except ferumoxytol, which was recently removed from the market. We conclude that parenteral iron appears to be safe in children; it works faster than oral iron, and the newer third-generation products allow replacement of the total iron deficit in a single sitting. [ABSTRACT FROM AUTHOR]

Background & Objective: The aim of the current study was comparison of the effectiveness of intravenous iron sucrose versus oral ferrous fumarate for the treatment of iron deficiency anemia during pregnancy. Materials & Methods: This is a prospective randomized clinical trial enrolling 100 pregnant women with iron deficiency anemia who visited the Al-diwaniya Educational Hospital for maternity and children from October 2022 to July 2023 whose ferritin level was less than 15 ng/ml and Hb level was between 70-10.9g/L. They were treated with either intravenous iron sucrose or oral ferrous fumarate for four weeks. Formerly, patients were allocated into two groups. The patients in the group I received ferrous fumarate pills, each enclosed with elemental Iron 100 mg. Group II got 100 ml of 0.9% NaCl containing a dose of iron sucrose dissolved in it and calculated by a specific equation. After four weeks, serum ferritin and hemoglobin levels were assessed, and the adverse effects were also monitored. Results: Comparing hemoglobin levels produces a substantial pre- and post-treatment difference (P=0.001). Serum Ferritin Level harvest significant differences pre- and posttreatment (P=0.001). The post-treatment comparison of the two groups showed a significant difference in each group (P= 0.001). Conclusion: Maternal iron reserves are more effectively increased by intravenous ferrous sucrose than by oral ferrous fumarate. [ABSTRACT FROM AUTHOR]

Abstract Background Intravenous iron is commonly used in patients with non-dialysis-dependent chronic kidney disease (CKD). Modern intravenous iron compounds (e.g. ferric derisomaltose (FDI), ferric carboxymaltose (FCM)) are increasingly utilized with similar efficacy. A differential effect in terms of hypophosphatemia has been noted following administration of FCM, which may be related to fibroblast growth factor 23 (FGF23). This study was designed to examine the comparative effects of FDI and FCM on FGF23, phosphate and other markers of bone turnover. Methods The single-center double-blind randomized controlled trial “Iron and Phosphaturia – ExplorIRON-CKD” primarily assessed the effects of FCM and FDI on intact FGF23 and phosphate, whilst also studying the impact on vitamin D, parathyroid hormone and phosphaturia. Bone markers including alkaline phosphatase, bone-specific alkaline phosphatase, procollagen type 1 N-terminal propeptide and carboxy-terminal collagen cross-linked telopeptide were monitored. Non-dialysis-dependent CKD patients (stage 3a-5) with iron deficiency with/without anemia (serum ferritin < 200 µg/L or transferrin saturation = 20% and serum ferritin 200-299 µg/L) were randomized to receive FDI or FCM in a 1:1 ratio. At baseline 1000 mg of intravenous iron was administered followed by 500-1000 mg at 1 month to achieve replenishment. Measurements were performed at baseline, 1–2 days following iron administration, 2 weeks, 1 month (second iron administration), 1–2 days following second administration, 2 months and 3 months following initial infusion. Results Twenty-six patients participated in the trial; 14 randomized to FDI and 12 to FCM. Intact FGF23 increased following administration of iron, and the increase was significantly higher with FCM compared to FDI (Baseline to 1–2 days following 1st administration: FDI: 3.0 (IQR: - 15.1 - 13.8) % vs. FCM: 146.1 (IQR: 108.1–203.1) %; p < 0.001 and Baseline to 1–2 days following 2nd administration: FDI: 3.2 (IQR: - 3.5 – 25.4) % vs. FCM: 235.1 (138.5–434.6) %; p = 0.001). Phosphate levels decreased in the FCM group, causing a significant difference versus FDI 2 weeks following administration of the first dose. A significantly greater decrease in 1,25 (OH)2 Vitamin D was noted with FCM. Several markers of bone turnover significantly changed following administration of FCM but not FDI. Conclusions The study suggests a differential effect on FGF23 following administration of FCM compared to FDI in non-dialysis-dependent CKD patients, similar to other patient groups. This may lead to changes consistent with hypovitaminosis D and alterations in bone turnover with potential clinical consequences. Further definitive studies are required to understand these differences of intravenous iron compounds. Trial registration European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) number: 2019–004370-26 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004370-26/GB ) (First date of trial registration: 03/12/2019).

Abstract Background Anaemia in pregnancy causes a significant burden of maternal morbidity and mortality in sub-Saharan Africa, with prevalence ranging from 25 to 45% in Nigeria. The main treatment, daily oral iron, is associated with suboptimal adherence and effectiveness. Among pregnant women with iron deficiency, which is a leading cause of anaemia (IDA), intravenous (IV) iron is an alternative treatment in moderate or severe cases. This qualitative study explored the acceptability of IV iron in the states of Kano and Lagos in Nigeria. Methods We purposively sampled various stakeholders, including pregnant women, domestic decision-makers, and healthcare providers (HCPs) during the pre-intervention phase of a hybrid clinical trial (IVON trial) in 10 healthcare facilities across three levels of the health system. Semi-structured topic guides guided 12 focus group discussions (140 participants) and 29 key informant interviews. We used the theoretical framework of acceptability to conduct qualitative content analysis. Results We identified three main themes and eight sub-themes that reflected the prospective acceptability of IV iron therapy. Generally, all stakeholders had a positive affective attitude towards IV iron based on its comparative advantages to oral iron. The HCPs noted the effectiveness of IV iron in its ability to evoke an immediate response and capacity to reduce anaemia-related complications. It was perceived as a suitable alternative to blood transfusion for specific individuals based on ethicality. However, to pregnant women and the HCPs, IV iron could present a higher opportunity cost than oral iron for the users and providers as it necessitates additional time to receive and administer it. To all stakeholder groups, leveraging the existing infrastructure to facilitate IV iron treatment will stimulate coherence and self-efficacy while strengthening the existing trust between pregnant women and HCPs can avert misconceptions. Finally, even though high out-of-pocket costs might make IV iron out of reach for poor women, the HCPs felt it can potentially prevent higher treatment fees from complications of IDA. Conclusions IV iron has a potential to become the preferred treatment for iron-deficiency anaemia in pregnancy in Nigeria if proven effective. HCP training, optimisation of information and clinical care delivery during antenatal visits, uninterrupted supply of IV iron, and subsidies to offset higher costs need to be considered to improve its acceptability. Trial registration ISRCTN registry ISRCT N6348 4804. Registered on 10 December 2020 Clinicaltrials.gov NCT04976179. Registered on 26 July 2021

Iron deficiency (ID) is by far the most common nutritional disorder in developing and developed countries. When left untreated, ID leads to anemia. Although the usually recommended treatment for iron deficiency anemia (IDA) is oral iron therapy with countless products, such therapy necessitates administration for >3–6 months with questionable patient compliance since most oral iron products have an unpleasant metallic aftertaste and cause intestinal side effects. In addition, in certain gastrointestinal conditions, such as inflammatory bowel diseases or untreated gluten-sensitive enteropathy, oral iron therapy is contraindicated or unsuccessful. Intravenous iron is considered safe in adults, where adverse events are mild and easily managed. The experience with parenteral iron in children is much more limited, and many pediatricians appear reluctant to use it because of uncorroborated fears of serious anaphylactic reactions. In the current article, we thoroughly review the available pediatric literature on the use of all commercially available parenteral iron products except ferumoxytol, which was recently removed from the market. We conclude that parenteral iron appears to be safe in children; it works faster than oral iron, and the newer third-generation products allow replacement of the total iron deficit in a single sitting.

Abstract Background Iron deficiency (ID) is often associated with other comorbidities in older patients and is a factor of morbimortality. However, the prevalence of ID remains poorly documented in this population. Methods The CARENFER PA study was a French multicenter cross-sectional study whose objective was to evaluate ID in patients (> 75 years) admitted to a geriatric unit. The primary endpoint was the ID prevalence defined as: serum ferritin

Anemia is the most common extraintestinal symptom of colorectal cancer, with a prevalence of 30–75%. While the preoperative anemia in this patient population has been well studied and its correction 4–6 weeks prior to surgery is recommended when feasible, there is a paucity of data regarding the management of postoperative anemia, which has a prevalence of up to 87% in these patients. To address this issue, we conducted an observational cohort study of surgically treated postoperative anemic patients with colorectal cancer. The objective of this study was to evaluate the effect of intravenous ferric carboxymaltose on the correction of postoperative anemia by postoperative day 30 (POD30). The primary outcome was the change in hemoglobin on POD30, while the secondary outcomes were the change in iron and other laboratory parameters, postoperative complications and transfusions. The results demonstrated that patients treated with intravenous iron exhibited a significant increase in hemoglobin levels by POD30, along with a concomitant increase in hematocrit, ferritin, and transferrin saturation levels, compared to the control group. The findings imply that patients undergoing colorectal cancer surgery with anemia that was not corrected in the preoperative setting may benefit from early postoperative intravenous iron infusion.

Background: Anaemia in pregnancy causes a significant burden of maternal morbidity and mortality in sub-Saharan Africa, with prevalence ranging from 25 to 45% in Nigeria. The main treatment, daily oral iron, is associated with suboptimal adherence and effectiveness. Among pregnant women with iron deficiency, which is a leading cause of anaemia (IDA), intravenous (IV) iron is an alternative treatment in moderate or severe cases. This qualitative study explored the acceptability of IV iron in the states of Kano and Lagos in Nigeria. Methods: We purposively sampled various stakeholders, including pregnant women, domestic decision-makers, and healthcare providers (HCPs) during the pre-intervention phase of a hybrid clinical trial (IVON trial) in 10 healthcare facilities across three levels of the health system. Semi-structured topic guides guided 12 focus group discussions (140 participants) and 29 key informant interviews. We used the theoretical framework of acceptability to conduct qualitative content analysis. Results: We identified three main themes and eight sub-themes that reflected the prospective acceptability of IV iron therapy. Generally, all stakeholders had a positive affective attitude towards IV iron based on its comparative advantages to oral iron. The HCPs noted the effectiveness of IV iron in its ability to evoke an immediate response and capacity to reduce anaemia-related complications. It was perceived as a suitable alternative to blood transfusion for specific individuals based on ethicality. However, to pregnant women and the HCPs, IV iron could present a higher opportunity cost than oral iron for the users and providers as it necessitates additional time to receive and administer it. To all stakeholder groups, leveraging the existing infrastructure to facilitate IV iron treatment will stimulate coherence and self-efficacy while strengthening the existing trust between pregnant women and HCPs can avert misconceptions. Finally, even though high out-of-pocket costs might make IV iron out of reach for poor women, the HCPs felt it can potentially prevent higher treatment fees from complications of IDA. Conclusions: IV iron has a potential to become the preferred treatment for iron-deficiency anaemia in pregnancy in Nigeria if proven effective. HCP training, optimisation of information and clinical care delivery during antenatal visits, uninterrupted supply of IV iron, and subsidies to offset higher costs need to be considered to improve its acceptability. Trial registration ISRCTN registry ISRCT N6348 4804. Registered on 10 December 2020 Clinicaltrials.gov NCT04976179. Registered on 26 July 2021 Plain language summary: Low blood level in pregnancy is of public health importance and with common occurrence worldwide, but with a higher rate in low resource settings where its burden greatly affects both the mother and her baby. This low blood level is usually caused by poor intake of an iron-rich diet. It could lead to fatigue, decreased work capacity, and dizziness if not detected. Without treatment, this condition could affect the baby, possibly leading to its sudden demise in the womb, immediately after birth, or even the woman's death. The use of oral iron has been the primary treatment; however, it is associated with significant side effects, which have led to poor compliance. Fortunately, an alternative therapy in the form of a drip has been shown to overcome these challenges. However, it is not routinely used in countries like Nigeria. Moreover, being effective is different from being utilised. Therefore, this study was conducted to understand the factors that will make this treatment widely accepted. We interviewed pregnant women, family support and health care providers in 10 health facilities in Lagos and Kano States, Nigeria. Our findings revealed good attitudes to iron drip. However, its inclusion into routine antenatal health talk, training of health care providers, availability of space, drugs and health workers who will provide this care, and ensuring this drug is of low cost are some of the efforts needed for this treatment to be accepted. [ABSTRACT FROM AUTHOR]

Background: Intravenous iron is commonly used in patients with non-dialysis-dependent chronic kidney disease (CKD). Modern intravenous iron compounds (e.g. ferric derisomaltose (FDI), ferric carboxymaltose (FCM)) are increasingly utilized with similar efficacy. A differential effect in terms of hypophosphatemia has been noted following administration of FCM, which may be related to fibroblast growth factor 23 (FGF23). This study was designed to examine the comparative effects of FDI and FCM on FGF23, phosphate and other markers of bone turnover. Methods: The single-center double-blind randomized controlled trial "Iron and Phosphaturia – ExplorIRON-CKD" primarily assessed the effects of FCM and FDI on intact FGF23 and phosphate, whilst also studying the impact on vitamin D, parathyroid hormone and phosphaturia. Bone markers including alkaline phosphatase, bone-specific alkaline phosphatase, procollagen type 1 N-terminal propeptide and carboxy-terminal collagen cross-linked telopeptide were monitored. Non-dialysis-dependent CKD patients (stage 3a-5) with iron deficiency with/without anemia (serum ferritin < 200 µg/L or transferrin saturation = 20% and serum ferritin 200-299 µg/L) were randomized to receive FDI or FCM in a 1:1 ratio. At baseline 1000 mg of intravenous iron was administered followed by 500-1000 mg at 1 month to achieve replenishment. Measurements were performed at baseline, 1–2 days following iron administration, 2 weeks, 1 month (second iron administration), 1–2 days following second administration, 2 months and 3 months following initial infusion. Results: Twenty-six patients participated in the trial; 14 randomized to FDI and 12 to FCM. Intact FGF23 increased following administration of iron, and the increase was significantly higher with FCM compared to FDI (Baseline to 1–2 days following 1st administration: FDI: 3.0 (IQR: - 15.1 - 13.8) % vs. FCM: 146.1 (IQR: 108.1–203.1) %; p < 0.001 and Baseline to 1–2 days following 2nd administration: FDI: 3.2 (IQR: - 3.5 – 25.4) % vs. FCM: 235.1 (138.5–434.6) %; p = 0.001). Phosphate levels decreased in the FCM group, causing a significant difference versus FDI 2 weeks following administration of the first dose. A significantly greater decrease in 1,25 (OH)2 Vitamin D was noted with FCM. Several markers of bone turnover significantly changed following administration of FCM but not FDI. Conclusions: The study suggests a differential effect on FGF23 following administration of FCM compared to FDI in non-dialysis-dependent CKD patients, similar to other patient groups. This may lead to changes consistent with hypovitaminosis D and alterations in bone turnover with potential clinical consequences. Further definitive studies are required to understand these differences of intravenous iron compounds. Trial registration: European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) number: 2019–004370-26 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004370-26/GB) (First date of trial registration: 03/12/2019). [ABSTRACT FROM AUTHOR]

Background: While guidelines suggest intravenous (IV) iron to improve functional status and quality of life (QoL) in patients with NYHA class II-III heart failure (HF), continuous flow left ventricular assist device (CF-LVAD) recipients were not included in early IV iron studies. Our study compared outcomes between patients who did and did not receive IV iron during the index admission following Abbott HeartMate III™ (HM 3) CF-LVAD placement. Methods: Thirty-three adult patients with a HM3 placed at our institution who received early post-operative IV iron (n = 20) or no IV iron replacement (n = 13) were compared. The co-primary outcomes were mean change in quality of life (by the Minnesota Living with Heart Failure Questionnaire [MLHFQ]) and 6-minute walk distance (6MWD) from baseline to first >90 day clinic follow-up. Results: At first clinic follow-up there was no significant difference between the IV iron and no-IV iron groups in MLHFQ (−27 ± 38 vs −21 ± 41, P =.8822) or 6MWD (360 ± 740 vs 786 ± 722, P =.208). Conclusion: Patients receiving IV iron during index admission following HM3 implantation did not experience an improvement in quality of life or functional capacity when compared to those who did not receive IV iron. [ABSTRACT FROM AUTHOR]

Iron deficiency (ID) and ID anemia (IDA) pose significant public health concerns in China. Although iron sucrose (IS) treatment is well-established in the country, ferric carboxymaltose (FCM) offers the advantage of higher doses and fewer infusions. This open label, randomized, controlled, non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM (maximum of 2 doses, 500 or 1000 mg iron) and IS (up to 11 infusions, 200 mg iron) treatments in subjects with IDA. The primary endpoint was the achievement of hemoglobin (Hb) response (an increase of ⩾2 g/dL from baseline) within 8 weeks, whereas secondary endpoints included changes in Hb, transferrin saturation, and serum ferritin levels. Among the 371 randomized subjects, a similar percentage of subjects treated with FCM and IS achieved Hb-response (FCM 99.4%, IS 98.3%), thereby confirming the non-inferiority of FCM compared with IS (difference 1.12 (−2.15, 4.71; 95% confidence interval (CI))). Furthermore, a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2 (FCM 85.2%, IS 73.2%; difference 12.1 (3.31, 20.65; 95% CI)). Additionally, the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects. The safety profiles of FCM and IS were comparable, with the exception of transient hypophosphatemia and pyrexia, which are consistent with FCM's known safety profile. In conclusion, FCM proves to be an efficacious treatment for IDA, providing faster Hb-response and correction of ID with fewer administrations than IS. [ABSTRACT FROM AUTHOR]

Background: Iron deficiency (ID) is often associated with other comorbidities in older patients and is a factor of morbimortality. However, the prevalence of ID remains poorly documented in this population. Methods: The CARENFER PA study was a French multicenter cross-sectional study whose objective was to evaluate ID in patients (> 75 years) admitted to a geriatric unit. The primary endpoint was the ID prevalence defined as: serum ferritin < 100 µg/L and/or transferrin saturation coefficient (TSAT) < 20%. The Short Physical Performance Battery (SPPB) test was used to identify older patients at high risk of adverse events (e.g., disability, falls, hospitalization, death). Results: A total of 888 patients (mean age, 85.2 years; women, 63.5%) from 16 French centers were included from October 2022 to December 2022. The prevalence of ID was 57.6% (95% CI, 54.3–60.9) in the cohort of older patients (62.6% in anemic and 53.3% in non-anemic patients; p = 0.0062). ID prevalence increased significantly with the presence of more than three comorbidities (65.6% vs. 55.9%; p = 0.0274), CRP ≥ 12 mg/L (73.0% vs. 49.3%; p < 0.001) and treatment that may influence ID/anemia (60.5% vs. 49.6%; p = 0.0042). In multivariate analysis, only CRP ≥ 12 mg/L was an independent predictive factor of ID (odds ratio, 2.78; 95% CI, 1.92–4.08; p < 0.001). SPPB scores were low (0–6) in 60.5% of patients with ID versus 48.6% of patients without ID (p = 0.0076). Conclusion: More than half of older patients had ID, including non-anemic patients. ID was associated with the presence of inflammation and a low SPPB score. Trial registration: NCT05514951. [ABSTRACT FROM AUTHOR]

Iron deficiency is the most common nutritional deficiency worldwide, with significant adverse health consequences in the presence or absence of anaemia. Total dose intravenous iron replacement is recommended for replacement of iron in patients with severe iron deficiency, especially in the presence of anaemia, intolerance or inefficacy following oral iron, or states of inflammation where upregulation of hepcidin may impair gastrointestinal absorption of iron. Currently, available intravenous iron formulations have been demonstrated to have an excellent overall safety profile, but potential adverse effects, including skin staining, infusion‐related reactions and hypophosphataemia, have been described. Knowledge of differences in administration and safety profiles of currently available iron formulations will allow appropriate prescription, counselling, as well as recognition and management of adverse events in patients requiring intravenous iron. [ABSTRACT FROM AUTHOR]

Aims: Intravenous (IV) iron increases haemoglobin/haematocrit and improves outcomes in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. Sodium–glucose cotransporter 2 inhibitors (SGLT2i) also increase haemoglobin/haematocrit and improve outcomes in heart failure by mechanisms linked to nutrient deprivation signalling and reduction of inflammation and oxidative stress. The effect of IV iron among patients using SGLT2i has not yet been studied. The aim of this study was to evaluate the changes in haemoglobin, haematocrit, and iron biomarkers in HFrEF patients treated with IV iron with and without background SGLT2i treatment. Secondary outcomes included changes in natriuretic peptides, kidney function and heart failure‐associated outcomes. Methods and results: Retrospective, single‐centre analysis of HFrEF patients with iron deficiency treated with IV iron using (n = 60) and not using (n = 60) SGLT2i, matched for age and sex. Mean age was 73 ± 12 years, 48% were men, with more than 65% of patients having chronic kidney disease and anaemia. After adjustment for all baseline differences, SGLT2i users experienced a greater increase in haemoglobin and haematocrit compared to SGLT2i non‐users: haemoglobin +0.57 g/dl (95% confidence interval [CI] 0.04–1.10, p = 0.036) and haematocrit +1.64% (95% CI 0.18–3.11, p = 0.029). No significant differences were noted for iron biomarkers or any of the secondary outcomes. Conclusion: Combined treatment with IV iron and background SGLT2i was associated with a greater increase in haemoglobin and haematocrit than IV iron without background SGLT2i. These results suggest that in HFrEF patients treated with IV iron, SGLT2i may increase the erythropoietic response. Further studies are needed to ascertain the potential benefit or harm of combining these two treatments in heart failure patients. [ABSTRACT FROM AUTHOR]

Abstract Objective: We conducted a meta-analysis of randomized clinical trials evaluating the clinical effects of ferric carboxymaltose therapy compared to other intravenous iron in improving hemoglobin and serum ferritin in pregnant women. We also assessed the safety of ferric carboxymaltose vs. other intravenous iron. Data source: EMBASE, PubMed, and Web of Science were searched for trials related to ferric carboxymaltose in pregnant women, published between 2005 and 2021. We also reviewed articles from google scholar. The keywords "ferric carboxymaltose," "FCM," "intravenous," "randomized," "pregnancy," "quality of life," and "neonatal outcomes" were used to search the literature. The search was limited to pregnant women. Selection of studies: Studies related to ferric carboxymaltose in pregnancy were scanned. Observational studies, review articles, and case reports were excluded. Randomized studies in pregnant women involving ferric carboxymaltose and other intravenous iron formulations were shortlisted. Of 256 studies, nine randomized control trials were selected. Data collection: Two reviewers independently extracted data from nine selected trials Data synthesis: The final effect size for increase in hemoglobin after treatment was significant for ferric carboxymaltose vs. iron sucrose/iron polymaltose (standard mean difference 0.89g/dl [95% confidence interval 0.27,1.51]). The final effect size for the increase in ferritin after treatment was more for ferric carboxymaltose vs. iron sucrose/iron polymaltose (standard mean difference 22.53µg/L [-7.26, 52.33]). No serious adverse events were reported with ferric carboxymaltose or other intravenous iron. Conclusion: Ferric carboxymaltose demonstrated better efficacy than other intravenous iron in increasing hemoglobin and ferritin levels in treating iron deficiency anemia in pregnant women.

Abstract Background Postoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of treatment of postoperative iron deficiency anaemia (IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery in older patients. Methods This is a randomized placebo-controlled double-blind multi-centre trial. In total, 310 patients aged ≥ 70 years with moderate IDA on postoperative day 1 (haemoglobin 85–110 g/L and ferritin concentration

Abstract Background In pancreaticoduodenectomy (PD), the duodenum and upper jejunum responsible for iron absorption are removed, which can lead to massive hemorrhage during surgery and cause iron deficiency anemia after PD. The aim of this study was to evaluate overall changes in hematologic profiles of patients who underwent pancreaticoduodenectomy. Effect of preoperative intravenous iron treatment on recovery of anemia after surgery was also investigated. Methods From March 2021 to December 2021, patients who underwent curative PD at our institution due to periampullary lesions were enrolled. They were divided into two groups according to whether or not iron was administered before surgery. In the IV iron group, all patients had been routinely administered with 1000 mg of ferric carboxymaltose intravenously once about 3–7 days before the operation day. Contrarily, patients in the control group did not receive intravenous iron before PD. Changes in hematological profile were measured preoperatively and at 5, 14, and 30 days postoperatively. Clinical results of the two groups were compared and analyzed. Additionally, a subgroup analysis was performed for selected non-anemic patients who had preoperative hemoglobin level of 12.0 g/dl or higher to compare changes in hematologic profiles between the two groups. Results Thirty patients of the IV iron group and 34 patients of the control group were analyzed. Although no difference was observed in postoperative complications or mortality, hemoglobin and iron levels were recovered significantly faster at two weeks postoperatively in the IV iron group than in the control group. Iron levels were significantly higher in the IV iron group throughout the postoperative period. In subgroup analysis conducted for non-anemic patients, hemoglobin levels were recovered significantly faster and maintained higher in the IV iron group throughout the postoperative period, although baseline levels of hemoglobin were similar between the two groups. In addition, the length of intensive care unit stay was significantly shorter in the IV iron group than in the control group. Conclusions Preoperative intravenous iron treatment might be effective in facilitating recovery of hematologic profiles of patients during the recovery period after PD regardless of the presence of preoperative anemia, thus preventing postoperative iron deficiency anemia.

Shanlian Hu,1 Depei Wu,2 Jing Wu,3 Yabing Zhang,4 Mette Bøgelund,5 Johannes Pöhlmann,6 Richard F Pollock6 1School of Public Health, Fudan University, Shanghai, People’s Republic of China; 2First Affiliated Hospital of Soochow University, Soochow University, Suzhou, People’s Republic of China; 3School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, People’s Republic of China; 4Shanghai Institute of Technology, Shanghai, People’s Republic of China; 5Incentive Partners ApS, Holte, Denmark; 6Covalence Research Ltd, Harpenden, United KingdomCorrespondence: Richard F Pollock, Covalence Research Ltd, Rivers Lodge, West Common, Harpenden, AL5 2JD, United Kingdom, Tel +44 20 8638 6525, Email pollock@covalence-research.comPurpose: Treatment process attributes can affect health state utilities associated with therapy. For intravenous iron, used to treat iron deficiency and iron deficiency anemia, research into process attributes is still lacking. This study estimated utilities associated with process attributes for intravenous iron infusions.Methods: An online survey including seven health state vignettes and time trade-off tasks was administered to participants, who were not patients living with iron deficiency or iron deficiency anemia, from a Chinese online panel. Vignettes used an identical description of iron deficiency and iron deficiency anemia but differed in the annual number of infusions, infusion duration, and infusion-associated risk of hypophosphatemic osteomalacia. Disutilities and their rate of change as the number of infusions increased were examined using a power model.Results: The survey was completed by 1091 participants. The highest utilities were observed for one annual infusion of 15– 30 minutes or 30– 60 minutes, without risk of hypophosphatemic osteomalacia (0.754 and 0.746, respectively). In comparison, more infusions and infusions with a risk of hypophosphatemic osteomalacia were associated with lower utilities. Utility continued to decrease, but at a diminishing rate, as the annual number of infusions increased, with utility decrements of 0.006 and 0.002, respectively, when going from zero to one and from four to five infusions per year. All marginal disutilities were small (values < 0.01).Conclusion: This study suggested that treatment attributes of intravenous iron infusions affect health state utilities. Using intravenous iron formulations that allow for fewer and shorter infusions without the risk of hypophosphatemic osteomalacia can reduce the number of visits required and increase patients’ quality of life.Plain Language Summary: A lack of iron in the body can be treated successfully using intravenous infusions of iron, but it is not yet known how different intravenous iron formulations affect patients’ quality of life.Intravenous iron formulations differ in how often and for how long (per infusion) they need to be administered; for example, while one available intravenous iron formulation allows most iron deficits to be corrected in a single visit, others can require several visits. Formulations also seem to differ in the risk of complications relating to low phosphate and bone softening.This study presented descriptions of treatment options, differing in the number and duration of infusions as well as in risk, to more than 1000 Chinese respondents. Based on their answers, the differences between intravenous iron administration regimes could be valued and linked to quality of life. Intravenous iron treatment with fewer, shorter infusions and without risk of bone softening was found to come with a better quality of life. Each additional infusion reduced quality of life, but less so if treatment already involved several infusions. These findings can help patients and physicians to make clinical decisions that focus not only on efficacy and safety but also on the quality of life.Keywords: China, disutility, health-related quality of life, intravenous iron, iron deficiency, time trade-off

Background: In India prevalence of anemia in pregnancy is 65-75 %. Dietary iron deficiency is responsible for 90-95% of these cases, which is a preventable condition. In India since 1970 oral IFA, through national programme is used to control anemia in pregnancy. But different studies show superiority of IV iron sucrose over oral IFA in improving Hb level in anemia cases. Objectives: This study has taken up to compare efficacy of oral IFA and IV iron sucrose in moderate anemia in pregnancy. Methods: This comparative prospective study was carried out from July 2021 to June 2022 in the department of obstetrics and gynaecology, Assam Medical College & Hospital, Dibrugarh. 140 pregnant women with moderate iron deficiency anemia were selected following thorough investigations between 14th weeks to 28th weeks of gestation. The cases were divided into two groups by randomized method with 70 patients in each group. Hb measured after 4 weeks of intravenous and oral iron therapy. Results: In this study the mean rise of haemoglobin after 4 weeks in IV iron group were 1.83 gm/dl (22.99% increase from baseline) (p

Winghan J Kwong,1 Syed Numan,2 Tina D Hunter,3 Dalila Alves,3 Anish Patel,4 Satish Shanbhag5 1Daiichi Sankyo, Inc, Basking Ridge, NJ, USA; 2American Regent, Norristown, PA, USA; 3CTI Clinical Trial & Consulting Services, Covington, KY, USA; 4Brooke Army Medical Center, San Antonio, TX, USA; 5Cancer Specialists of North Florida, Jacksonville, FL, USACorrespondence: Tina D Hunter, CTI Clinical Trial & Consulting Services 100 E. Rivercenter Blvd, Covington, KY, 41011, USA, Tel +1 513-598-9290, Fax +1 859-261-3757, Email thunter@ctifacts.comBackground: Iron deficiency anemia (IDA) is a common cause of fatigue and impaired quality of life. The present study aimed to evaluate the impact of intravenous iron supplementation with ferric carboxymaltose (FCM) on fatigue, physical function, and general health among patients with IDA attending routine clinical care.Methods: This was a prospective, single arm, observational study of adult patients prescribed with intravenous FCM for the treatment of IDA during routine clinical care. We used Patient-Reported Outcomes Measurement Information System (PROMIS) instruments to evaluate fatigue (PROMIS Short Form v1.0 13a [FACIT-Fatigue]), general health status (PROMIS Scale v1.2), and physical function (PROMIS Short Form v2.0 4a) before and at 3 and 6 months after FCM treatment.Results: A total of 152 patients were enrolled. Mean age was 47.4 ± 16.0 years and 82.2% were female. Mean serum hemoglobin was 10.2 ± 1.4 g/dL at baseline. All patients were treated with at least one FCM dose at baseline, with 77.6% receiving a two-dose treatment course. The mean baseline FACIT-Fatigue score was 61.0 ± 9.0, improving significantly to 50.2 ± 9.5 at 3 months after FCM treatment. A minimum 5-point improvement, pre-defined as clinically meaningful, was seen in the FACIT-Fatigue, PROMIS Global Physical Health, Global Mental Health and PROMIS Physical Function scores for 72.7%, 52.8%, 41.7% and 39.8% of patients at 3 months (p < 0.0001 for each change from baseline), with statistically significant improvement continuing at 6 months. Mean serum hemoglobin was significantly increased at both 3 and 6 months (12.8 g/dL [N = 44] and 12.4 g/dL [N = 54], respectively).Conclusion: IDA patients attending routine clinical practice reported substantial levels of fatigue and impairments in physical function and global health prior to intravenous iron treatment. Patients experienced significant improvements in fatigue symptoms, physical function, and global health at 3 months after treatment with FCM, which were sustained at 6 months.Keywords: iron deficiency anemia, quality of life, patient-reported outcomes, ferric carboxymaltose, intravenous iron

Abstract Background Postoperative anemia is a risk factor for adverse surgical outcomes. Our study aimed to assess the role of intravenous iron and erythropoietin therapy for the rapid correction of anemia following orthopedic surgery. Methods Patients undergoing elective orthopedic surgery were prospectively enrolled and randomly divided into three groups: Control (placebo), Group 1 (IV iron monotherapy), and Group 2 [combined IV iron and recombinant human erythropoietin (rHuEPO) therapy]. Blood tests were performed preoperative (baseline) and on postoperative days (PODs) 1, 3, and 7. Results All groups demonstrated significantly lower hemoglobin (Hb) concentrations compared to baseline, with no significant inter-group differences in postoperative Hb concentrations (p > 0.05). Serum erythropoietin, ferritin, and vitamin B12 levels, and reticulocyte count increased beyond normal ranges in all groups. Significantly lower serum iron levels were observed postoperatively in all groups (p 0.05). Conclusion Postoperative treatment with combined intravenous iron and rHuEPO was ineffective in correcting postoperative anemia among orthopedic surgery patients, besides achieving higher reticulocyte counts in the first week of surgery. No improvement in mobilization of storage iron was achieved with rHuEPO. We further suggest against vitamin B12 administration during the early postoperative period.

Abstract Background Anemia is associated with impaired physical performance and adverse perioperative outcomes. Iron-deficiency anemia is increasingly treated with intravenous iron before elective surgery. We explored the relationship between exercise capacity, anemia, and total hemoglobin mass (tHb-mass) and the response to intravenous iron in anemic patients prior to surgery. Methods A prospective clinical study was undertaken in patients having routine cardiopulmonary exercise testing (CPET) with a hemoglobin concentration ([Hb])

Introduction: Iron deficiency anemia (IDA) is a significant public health issue in Pakistan, affecting up to 63% of children, as revealed by the Pakistan National Nutritional Survey 2018. While oral iron remains the primary choice, challenges in compliance have led to the consideration of intravenous (IV) iron therapy, particularly iron sucrose. The study discusses the safety and efficacy of IV iron therapy in Pakistani children and aims to broaden our understanding of treating IDA in resource-constrained regions. Aims & Objectives: To determine the average hemoglobin (Hb) increase in iron-deficient-anemic children aged 01 to 12 years after treatment with intravenous iron sucrose. Place and Duration of Study: A quasi-experimental study was undertaken at Fauji Foundation Hospital in Rawalpindi, spanning from September 2021 to September 2022. Material & Methods: The study focused on a cohort of pediatric patients aged between 1 and 12 years, all of whom were diagnosed with iron deficiency anemia and had previously encountered ineffective outcomes with oral iron therapy. In this investigation, the patients received treatment involving intravenous iron sucrose. Subsequently, their progress was diligently monitored after a period of 8 weeks. Improvement in hemoglobin level was assessed at the end of treatment to evaluate its efficacy.Data processing and statistical analysis were carried out using SPSS version 23,p-value of

Background: Postoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of treatment of postoperative iron deficiency anaemia (IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery in older patients. Methods: This is a randomized placebo-controlled double-blind multi-centre trial. In total, 310 patients aged ≥ 70 years with moderate IDA on postoperative day 1 (haemoglobin 85–110 g/L and ferritin concentration < 100 μg/L or iron saturation < 20%) after uncomplicated elective cardiac surgery (aortic valve repair or coronary artery bypass graft surgery) will be included. Patients will be randomly allocated to receive either IVI (ferric derisomaltose) or placebo (sodium chloride 0.9%) on postoperative day 1 in a 1:1 ratio, stratified by centre and type of cardiac surgery. The primary outcome is disability measured by the 12-item World Health Organization Disability Assessment score 2.0 after 90 days. Secondary outcome measures are the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte haemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications, dyspnoea (assessed with the Rose Dyspnoea Scale) and health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) after 90 days and days alive and out of hospital after 90 days. Lastly, the functional outcomes (e.g. steep ramp or 6-min walk test) and Hb level after 90 days will be assessed as an exploratory endpoint. Discussion: The results of this study will demonstrate whether early treatment of postoperative IDA with IVI improves disability at 90 days in older cardiac surgery patients. Trial registration: ClinicalTrials.gov NCT04913649. Registered on June 4, 2021. [ABSTRACT FROM AUTHOR]

Background: In pancreaticoduodenectomy (PD), the duodenum and upper jejunum responsible for iron absorption are removed, which can lead to massive hemorrhage during surgery and cause iron deficiency anemia after PD. The aim of this study was to evaluate overall changes in hematologic profiles of patients who underwent pancreaticoduodenectomy. Effect of preoperative intravenous iron treatment on recovery of anemia after surgery was also investigated. Methods: From March 2021 to December 2021, patients who underwent curative PD at our institution due to periampullary lesions were enrolled. They were divided into two groups according to whether or not iron was administered before surgery. In the IV iron group, all patients had been routinely administered with 1000 mg of ferric carboxymaltose intravenously once about 3–7 days before the operation day. Contrarily, patients in the control group did not receive intravenous iron before PD. Changes in hematological profile were measured preoperatively and at 5, 14, and 30 days postoperatively. Clinical results of the two groups were compared and analyzed. Additionally, a subgroup analysis was performed for selected non-anemic patients who had preoperative hemoglobin level of 12.0 g/dl or higher to compare changes in hematologic profiles between the two groups. Results: Thirty patients of the IV iron group and 34 patients of the control group were analyzed. Although no difference was observed in postoperative complications or mortality, hemoglobin and iron levels were recovered significantly faster at two weeks postoperatively in the IV iron group than in the control group. Iron levels were significantly higher in the IV iron group throughout the postoperative period. In subgroup analysis conducted for non-anemic patients, hemoglobin levels were recovered significantly faster and maintained higher in the IV iron group throughout the postoperative period, although baseline levels of hemoglobin were similar between the two groups. In addition, the length of intensive care unit stay was significantly shorter in the IV iron group than in the control group. Conclusions: Preoperative intravenous iron treatment might be effective in facilitating recovery of hematologic profiles of patients during the recovery period after PD regardless of the presence of preoperative anemia, thus preventing postoperative iron deficiency anemia. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14–21 weeks pregnant with persistent iron deficiency (ferritin < 30 µg/L). Methods: In a single-centre, open-label, randomised controlled trial at a Danish hospital, women with persistent iron deficiency after routine oral iron treatment were allocated to receive 1000 mg IV iron (single-dose) or 100 mg elemental oral iron daily. Outcomes were assessed during an 18-week follow-up period. The primary endpoint was the proportion of non-anaemic (haemoglobin [Hb] ≥ 11 g/dL) women throughout follow-up. Other outcomes included changes in haematological parameters, patient-reported fatigue, and quality of life (QoL). Safety was assessed by recording adverse events. Results: From July 2017 to February 2020, 100 women were randomised to IV iron and 101 to oral iron. Throughout follow-up, 91% of women were non-anaemic in the IV iron group compared with 73% in the oral iron group (18% difference [95% confidence interval 0.10–0.25]; p < 0.001). The mean Hb increase was significantly greater with IV iron versus oral iron at Weeks 6 (0.4 versus − 0.2 g/dL; p < 0.001), 12 (0.5 versus 0.1 g/dL; p < 0.001), and 18 (0.8 versus 0.5 g/dL; p = 0.01). Improvements in fatigue and QoL were greater with IV iron versus oral iron at Weeks 3 and 6. The incidence of treatment-related adverse events was comparable between treatment groups. Conclusion: IV iron was superior in preventing anaemia compared with oral iron in pregnant women with persistent iron deficiency; biochemical superiority was accompanied by improved fatigue and QoL. Clinical trial registration: European Clinical Trials Database: EudraCT no.: 2017-000776-29 (3 May 2017); ClinicalTrials.gov: NCT03188445 (13 June 2017). The trial protocol has been published: https://dx.doi.org/10.1186%2Fs13063-020-04637-z. [ABSTRACT FROM AUTHOR]

Iron deficiency anemia is the most common and preventable cause of anemia. Oral and parenteral iron preparations can be used for treatment. There are some concerns about the effect on oxidative stress of parenteral preparations. In this study, we aimed to investigate the effect of ferric carboxymaltose and iron sucrose on short- and long-term oxidant-antioxidant status. The study was designed as a prospective, single-center, observational study. Patients diagnosed with iron deficiency anemia and receiving intravenous iron therapy were included. Patients were divided into 3 groups as those receiving 1000 mg iron sucrose, 1000 mg ferric carboxymaltose, and 1500 mg ferric carboxymaltose. Blood samples were collected for blood tests before treatment, at the 1st hour of the first infusion, and at the 1st month of follow-up. The total oxidant and total antioxidant status were analyzed to evaluate oxidative stress and antioxidant status. Fifty-eight patients are included. Nineteen patients received iron sucrose 1000 mg (G1), 21 patients received ferric carboxymaltose 1000 mg (G2), and 18 patients received ferric carboxymaltose 1500 mg (G3). First hour total antioxidant status was higher in the iron sucrose group than in the ferric carboxymaltose group [G1 and G2 (p = 0.027), G1 and G3 (p = 0.004)]. At the 1st hour, total oxidant status was higher in iron sucrose group than in ferric carboxymaltose group [G1 and G2 (p = 0.016), G1 and G3 (p = 0.011)]. There was no difference in total oxidant and antioxidant stress between the three treatment groups at the 1st month evaluation [p: 0.19 and p: 0.12]. Total oxidant and antioxidant status in iron sucrose and ferric carboxymaltose formulations were found to be higher in the iron sucrose group in the acute period at the 1st hour after infusion. There was no significant difference between antioxidant and oxidant total status in all three treatment groups at the 1st month of long-term control. The fact that total oxidant status was lower in the ferric carboxymaltose group containing high-dose treatment compared to iron sucrose according to the 1st hour change showed that high-dose iron did not significantly affect oxidant stress in the short term. In addition, long-term oxidant stress evaluation at the 1st month did not show any difference between iron preparations. In conclusion, it has been shown that high-dose intravenous iron therapy, which is easier to use in clinical practice, has no effect on the oxidant-antioxidant system. [ABSTRACT FROM AUTHOR]