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Keywords = intravenous ferric carboxymaltose

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19 pages, 782 KB  
Article
Impact of Iron Supplementation on Clinical Outcomes in Iron-Deficient Heart Failure Patients: A Retrospective Cohort Study in Oman
by Dania Abunaser, Juhaina S. Al Maqbali, Salim Al Busaidi, Yousra Nomier and Yousuf Al Suleimani
J. Clin. Med. 2026, 15(16), 6142; https://doi.org/10.3390/jcm15166142 - 7 Aug 2026
Viewed by 306
Abstract
Objective: The prevalence and clinical impact of iron deficiency (ID) in patients with heart failure (HF) in Oman remain insufficiently characterized. This study aimed to evaluate the prevalence of ID and its association with clinical outcomes, as well as to assess the [...] Read more.
Objective: The prevalence and clinical impact of iron deficiency (ID) in patients with heart failure (HF) in Oman remain insufficiently characterized. This study aimed to evaluate the prevalence of ID and its association with clinical outcomes, as well as to assess the impact of iron supplementation on hospitalization and mortality among HF patients. Methods: A retrospective observational cohort study included adult patients (≥18 years) with HF who had ≥2 iron profiles; patients with end-stage renal disease were excluded. ID was defined using American Heart Association (AHA) and European Society of Cardiology (ESC) criteria. Results: Of 2246 patients screened, 211 met inclusion criteria (57.8% female; mean age 70 ± 12.7 years). ID prevalence was 68.3% (AHA) and 71.1% (ESC), with ESC criteria detecting more biochemical deficiencies. ID was associated with higher all-cause and HF-related readmissions (p < 0.01), longer length of stay (p = 0.045), and more atrial fibrillation (AF) (p < 0.01). All-cause mortality was similar, although the composite of mortality and readmission was slightly higher with ID (p = 0.052). Iron supplementation significantly increased ferritin (+32 ng/mL) and transferrin saturation (+2.8%) (p < 0.01) and was linked to fewer strokes (p = 0.049), with no major differences in other outcomes. Conclusions: The study found that ID was highly prevalent; however, systematic screening was not routinely practiced, which largely led to delayed initiation of appropriate management. Routine ESC-guided ID screening and management are recommended. However, given the retrospective, non-randomized study design, these findings should not be interpreted as evidence of a causal treatment effect and are likely influenced by confounding by indication. Prospective randomized studies are needed to confirm these observations. Full article
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16 pages, 1318 KB  
Review
Hypophosphatemia in Patients Receiving Intravenous Iron Supplementation for Iron-Deficiency Anemia: A Narrative Review
by Giovanni Inghilleri and Massimo Franchini
J. Clin. Med. 2026, 15(12), 4748; https://doi.org/10.3390/jcm15124748 - 18 Jun 2026
Cited by 1 | Viewed by 1170
Abstract
Intravenous (IV) iron is used to replenish iron stores in patients with iron-deficiency anemia (IDA) who do not benefit from oral iron supplementation. Hypophosphatemia is an increasingly recognized adverse event associated with certain IV iron formulations. Mild/moderate hypophosphatemia may be asymptomatic or present [...] Read more.
Intravenous (IV) iron is used to replenish iron stores in patients with iron-deficiency anemia (IDA) who do not benefit from oral iron supplementation. Hypophosphatemia is an increasingly recognized adverse event associated with certain IV iron formulations. Mild/moderate hypophosphatemia may be asymptomatic or present with symptoms similar to those seen in patients with IDA, including fatigue, malaise, and muscle weakness. Persistent hypophosphatemia can cause osteomalacia due to reduced bone mineralization, leading to bone pain and pseudofractures. Ferric carboxymaltose (FCM) can impact phosphate homeostasis through an increase in fibroblast growth factor 23, leading to increased urinary phosphate excretion and hypophosphatemia. In clinical trials, rates of hypophosphatemia were significantly higher in patients receiving FCM compared with other IV iron formulations, such as ferric derisomaltose and ferumoxytol. Treatment guidelines recommend monitoring serum phosphate levels in patients receiving FCM who are at risk for low phosphate or who require repeat infusions, and alternative iron formulations should be considered in at-risk patients. This narrative review summarizes current evidence regarding IV iron-induced hypophosphatemia in individuals with IDA and examines the underlying pathophysiology and clinical evidence for IV iron-induced hypophosphatemia, particularly with FCM, the populations most at risk, and the clinical consequences of persistent hypophosphatemia. Full article
(This article belongs to the Section Hematology)
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13 pages, 253 KB  
Article
Efficacy, Safety, and Hematologic Recovery Following Intravenous Ferric Carboxymaltose in Patients with Iron Malabsorption-Related Iron Deficiency Anemia: A Prospective Clinical Study
by Silvia Scalamonti, Giulia Pivetta, Francesco Paolo Schiavone, Micaela Magnante, Manuela Pompili, Marica Vavallo, Bruno Annibale and Edith Lahner
Nutrients 2026, 18(11), 1807; https://doi.org/10.3390/nu18111807 - 4 Jun 2026
Viewed by 657
Abstract
Background/Objectives: Autoimmune gastritis (AIG), celiac disease (CD), and gastric surgery (GS) often cause iron deficiency anemia (IDA) due to iron malabsorption. In this clinical context, IDA treatment is often challenging. The first-line IDA treatment is oral iron supplementation followed by intravenous (IV) [...] Read more.
Background/Objectives: Autoimmune gastritis (AIG), celiac disease (CD), and gastric surgery (GS) often cause iron deficiency anemia (IDA) due to iron malabsorption. In this clinical context, IDA treatment is often challenging. The first-line IDA treatment is oral iron supplementation followed by intravenous (IV) iron administration when ineffective or not tolerated. Ferric carboxymaltose (FCM) showed efficacy in various clinical settings. Prospective data evaluating the efficacy of IV FCM in IDA patients secondary to iron malabsorption are scant. The aim of the current study was to assess the tolerability, efficacy, and QoL impact of IV FCM for the treatment of IDA patients with iron malabsorption. Methods: Study design: single-center, prospective observational study: n = 37 adults with AIG, CD, or GS with IDA receiving IV FCM were consecutively included. Endpoints were (i) safety tolerability, (ii) efficacy on IDA recovery (Hb normalization), and (iii) QoL impact. At baseline (T0) and 12 weeks after treatment (T12), a QoL-SF12 questionnaire was assessed. Complete blood count (CBC) and iron status (ferritin, iron, transferrin, transferrin saturation (TS)) were assessed at T0, 4 weeks (T4), and T12 after treatment. Results: Of the 37 IDA patients, 19 (51.4%) had AIG, 9 (24.3%) CD, and 9 (24.3%) GS; Based on Ganzoni’s formula, 24 (64.9%) patients received a single IV FCM infusion (mean ± SEM dosage of 975 ± 12 mg); 13 (35.1%) required two IV infusion sessions with a mean ± SEM cumulative dose of 1400 ± 77 mg. One patient (2.7%) experienced mild adverse events without need for treatment interruption or hospitalization. At T0, anemia was moderate in 7 (18.9%) patients and severe in 1 (2.7%). IDA recovery was achieved in 26 (70.3%) patients at T4 and in 29 (78.4%) at T12. At T4, mean ± SEM Hb increased from 10.8 ± 0.2 g/dL to 12.7 ± 0.1 g/dL, ferritin from 28.5 ± 11.2 ng/mL to 188.2 ± 25.7 ng/mL, and TS from 6.7 ± 0.5% to 23.7 ± 1.9% (p < 0.0001). At T12, mean ± SEM Hb further increased to 13.1 ± 0.2 g/dL (p < 0.05 vs. T4), ferritin slightly decreased to 125 ± 26.7 ng/mL, and TS to 22.7 ± 2.8%. At T12, nonsignificant increases in QoL scores relative to baseline were observed. Conclusions: IV FCM is a safe and effective treatment leading to IDA recovery in nearly 80% of patients at T12. Thus, when oral iron treatment is not feasible or has failed, IV FCM treatment might be considered a first-line therapeutic option for IDA consequent to iron malabsorption. Full article
(This article belongs to the Section Micronutrients and Human Health)
12 pages, 697 KB  
Article
Impact of Adjunctive Intravenous Iron Therapy on Hemoglobin Recovery in Obstetric Patients: A Retrospective Cohort Study
by Mihaela Ichim, Mihaela Bot, Andreea Borislavschi and Alexandru Filipescu
J. Clin. Med. 2026, 15(10), 3766; https://doi.org/10.3390/jcm15103766 - 14 May 2026
Viewed by 391
Abstract
Background: Postpartum anemia frequently requires packed red blood cell (PRBC) transfusion; however, the contribution of intravenous iron to early hematologic recovery remains uncertain. This study evaluated hemoglobin dynamics following transfusion and the effect of adjunctive intravenous iron therapy. Methods: In this [...] Read more.
Background: Postpartum anemia frequently requires packed red blood cell (PRBC) transfusion; however, the contribution of intravenous iron to early hematologic recovery remains uncertain. This study evaluated hemoglobin dynamics following transfusion and the effect of adjunctive intravenous iron therapy. Methods: In this retrospective cohort study, 61 obstetric patients requiring PRBC transfusion were included. Hematologic parameters were assessed at admission, postoperatively, post-transfusion, and at day 7. Patients were stratified according to the administration of intravenous ferric carboxymaltose. Hemoglobin changes and reticulocyte response were analyzed, including a subgroup receiving two PRBC units. Results: Mean hemoglobin decreased from 9.36 ± 1.16 g/dL at admission to 6.33 ± 1.05 g/dL postoperatively, increased to 8.32 ± 0.78 g/dL after transfusion, and reached 8.75 ± 0.97 g/dL at day 7 (p < 0.001). No significant differences between groups were observed before or immediately after transfusion. At day 7, hemoglobin was significantly higher in patients receiving intravenous iron compared with those without supplementation (9.63 ± 1.03 vs. 8.03 ± 0.36 g/dL, p < 0.001). The increase in hemoglobin from post-transfusion to day 7 was greater in the iron group (1.14 ± 0.84 vs. −0.15 ± 0.33 g/dL, p < 0.001), accompanied by a higher reticulocyte response (2.56 ± 0.49% vs. 0.93 ± 0.26%, p < 0.001). Similar findings were observed in the two-unit subgroup. Conclusions: Adjunctive intravenous iron was associated with improved early hemoglobin recovery after transfusion without affecting immediate correction, supporting its clinical use in obstetric patients. Full article
(This article belongs to the Section Obstetrics & Gynecology)
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13 pages, 962 KB  
Article
Stability Assessment of Intravenous Iron–Carbohydrate Complexes in Commercial All-in-One Parenteral Nutrition: Potential for Therapeutic Iron Dose Admixing
by Valentina V. Huwiler, Peter J. Neyer, Christoph Saxer, Katja A. Schönenberger, Angelika Hammerer-Lercher, Zeno Stanga and Stefan Mühlebach
Pharmaceutics 2026, 18(2), 255; https://doi.org/10.3390/pharmaceutics18020255 - 18 Feb 2026
Viewed by 1520
Abstract
Background/Objectives: Iron deficiency and associated iron deficiency anaemia represent a major global health burden. Parenteral nutrition (PN) patients are at increased risk of iron deficiency due to inadequate iron supplementation. Currently, iron is added to all-in-one (AIO) PN mostly as low-dose ferric chloride [...] Read more.
Background/Objectives: Iron deficiency and associated iron deficiency anaemia represent a major global health burden. Parenteral nutrition (PN) patients are at increased risk of iron deficiency due to inadequate iron supplementation. Currently, iron is added to all-in-one (AIO) PN mostly as low-dose ferric chloride in trace element solutions, limited to 1–2 mg in adults, to ensure emulsion stability and prevent lipid peroxidation. The objective of this study was to evaluate the compatibility and stability of selected, widely used complex-bound iron products added to AIO PN over a 48 h period. Methods: Ferric carboxymaltose and iron sucrose were added as non-biological complex intravenous iron oxide carbohydrate products to two different commercial AIO PN admixtures for adults. The iron concentrations used were 100 and 400 mg/L (1.79 and 7.16 mmol/L), corresponding to approximately 200 mg (3.58 mmol) of iron dose per PN bag. Free and complex-bound iron were separated using 100 kDa dialysis tubes. Free and complex-bound iron were assessed at 4, 24, and 48 h after admixing. pH was measured before and at 0, 4, 24, and 48 h after admixture. Iron quantification was performed by inductively coupled plasma mass spectrometry (ICP-MS). Results: No significant changes in complex-bound iron concentration were observed over the 48 h incubation period (p-value = 0.449; estimate 0.060 mg/L per h, 95% CI −0.089, 0.201 mg/L per h). The concentration of free iron was very low and increased only slightly over time. Iron recovery ranged from 95.8% to 103.9%. The addition of the alkaline iron sucrose significantly increased the pH of the AIO admixture (p-value = 0.033), whereas the addition of ferric carboxymaltose did not affect the pH (p-value = 0.351). After the initial increase, the pH of all conditions remained stable over the 48 h incubation period (p-value = 0.07). Conclusions: Ferric carboxymaltose demonstrated stable intravenous iron admixtures within the PN formulations tested. Before the clinical application of these findings, further studies should specifically evaluate the lipid peroxidation and stability of the lipid emulsions, the most sensitive and important PN compatibility and safety characteristics of AIO PN. Full article
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28 pages, 1715 KB  
Article
The Significance of Hypophosphatemia in Deciding on an Optimal Clinical Choice of Parenteral Iron Therapy in Patients with Chronic Inflammatory Bowel Disease in Slovenia: An Umbrella Review and Economic Evaluation
by Rok Hren, Tamás Dóczi, Erika Országh and Tomaž Kocjan
Healthcare 2026, 14(3), 393; https://doi.org/10.3390/healthcare14030393 - 4 Feb 2026
Cited by 1 | Viewed by 1506
Abstract
Background/Objectives: Iron-deficiency anemia (IDA) is a common extraintestinal complication of inflammatory bowel disease (IBD). Among high-dose intravenous (IV) iron options, ferric carboxymaltose (FCM) carries a higher risk of treatment-emergent hypophosphatemia than ferric derisomaltose (FDI), with potential clinical consequences. Slovenia’s healthcare setting, characterized [...] Read more.
Background/Objectives: Iron-deficiency anemia (IDA) is a common extraintestinal complication of inflammatory bowel disease (IBD). Among high-dose intravenous (IV) iron options, ferric carboxymaltose (FCM) carries a higher risk of treatment-emergent hypophosphatemia than ferric derisomaltose (FDI), with potential clinical consequences. Slovenia’s healthcare setting, characterized by very low IV iron infusion tariffs and recent pricing in which FCM is substantially less expensive than FDI, warrants a setting-specific cost effectiveness evaluation. Methods: We integrated two methodological components: (i) a payer-perspective cost-effectiveness analysis using a patient-level microsimulation model with (ii) an umbrella review of systematic reviews and a targeted search of expert consensus statements on IV-iron-associated hypophosphatemia. Results: In the base case, FDI required fewer infusions than FCM (11.1 vs. 14.2 over 10 years) but generated only €95 in IV iron administration savings due to low tariffs, while drug procurement was €1166 higher with FDI than FCM. When incorporating the clinical impact of hypophosphatemia, incremental quality-adjusted life years (QALYs) were 0.136, yielding an incremental cost-effectiveness ratio (ICER) of €6590/QALY. The umbrella review consistently showed higher hypophosphatemia incidence with FCM (up to 92%) compared with other IV iron formulations (<10%), with recent recommendations emphasizing phosphate monitoring and risk mitigation through alternative formulations. Conclusions: Despite Slovenia’s low IV iron infusion tariffs and lower FCM price, FDI remained cost-effective in this model, largely due to its more favorable hypophosphatemia profile within the model. These findings suggest that hypophosphatemia risk should be considered when selecting IV iron therapy in routine IBD care. Full article
(This article belongs to the Special Issue Healthcare Economics, Management, and Innovation for Health Systems)
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14 pages, 349 KB  
Article
High-Dose Intravenous Ferric Carboxymaltose/Derisomaltose Without ESAs for Cancer-Related Anemia in Japan: A Retrospective Single-Center Cohort Study
by Shinya Kajiura, Yudai Ishikawa, Yoko Mizuno, Akihiro Yoshida, Ryutatsu Yuki, Toshihito Horikawa, Mutsuki Furukawa, Kohei Nagata, Iori Motoo, Takayuki Ando, Ichiro Yasuda, Atsushi Kato and Ryuji Hayashi
Cancers 2026, 18(3), 416; https://doi.org/10.3390/cancers18030416 - 28 Jan 2026
Cited by 1 | Viewed by 1604
Abstract
Background/Objectives: In Japan, cancer-related anemia (CRA) is common, and erythropoiesis-stimulating agents (ESAs) are not approved for chemotherapy-induced anemia. Modern intravenous (IV) iron formulations, such as ferric carboxymaltose (FCM) and ferric derisomaltose (FDI), enable high-dose repletion; however, real-world evidence in ESA-free oncology settings remains [...] Read more.
Background/Objectives: In Japan, cancer-related anemia (CRA) is common, and erythropoiesis-stimulating agents (ESAs) are not approved for chemotherapy-induced anemia. Modern intravenous (IV) iron formulations, such as ferric carboxymaltose (FCM) and ferric derisomaltose (FDI), enable high-dose repletion; however, real-world evidence in ESA-free oncology settings remains limited. Methods: This single-center retrospective study included patients with CRA (N = 55) who received high-dose IV iron (FCM or FDI). Iron phenotypes were classified as absolute iron deficiency (ID), functional ID, or non-ID. The primary endpoint was hemoglobin (Hb) change from baseline to approximately 1 month (21–45 days) in the non-transfused patients. Secondary endpoints included responder rate (ΔHb ≥ 1.0 g/dL), transfusion avoidance rate, dosing adequacy relative to Ganzoni-calculated iron deficit, and safety, particularly hypophosphatemia. Results: Among the non-transfused patients, mean Hb increased from 8.76 ± 1.34 g/dL to 9.73 ± 1.75 g/dL (mean ΔHb +0.92 ± 1.44 g/dL; p < 0.001). The responder and transfusion avoidance rates were 48.9% and 81.8%, respectively. Functional ID was most prevalent (52.7%), with clinically meaningful Hb responses. A total of 38.2% achieved approximately 1000 mg dosing. The safety profile was excellent, and no infusion reactions or symptomatic hypophosphatemia was observed (median serum phosphate changed from 3.4 [3.0–3.9] to 3.2 [2.7–3.8] mg/dL). Conclusions: In this real-world Japanese oncology setting where ESAs were not available for chemotherapy-induced anemia, high-dose IV iron monotherapy (FCM or FDI) was well tolerated and was associated with modest short-term Hb increases and a high observed rate of transfusion avoidance within a 21–45-day assessment window. These findings suggest that a proactive, TSAT-guided IV iron therapy approach may be a pragmatic option for selected patients; however, durability beyond 1 month, optimal re-dosing, and generalizability require confirmation in larger, longer prospective studies. Full article
(This article belongs to the Section Cancer Survivorship and Quality of Life)
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12 pages, 895 KB  
Article
Fetal Safety of Intravenous Ferric Carboxymaltose in Pregnancy: A Cardiotocography Study from a Tertiary Care Hospital in Italy
by Francesca Polese, Chiara Pesce, Giulia De Fusco, Gianni Tidore, Enza Coluccia, Raffaele Battista and Gianluca Gessoni
Hematol. Rep. 2026, 18(1), 7; https://doi.org/10.3390/hematolrep18010007 - 5 Jan 2026
Viewed by 2652
Abstract
Background: Iron-deficient anemia (IDA) in pregnant women is a significant health issue globally. Oral iron supplementation is the primary treatment for IDA during pregnancy. For women who do not respond to or cannot tolerate oral iron treatment, intravenous (IV) iron preparations may offer [...] Read more.
Background: Iron-deficient anemia (IDA) in pregnant women is a significant health issue globally. Oral iron supplementation is the primary treatment for IDA during pregnancy. For women who do not respond to or cannot tolerate oral iron treatment, intravenous (IV) iron preparations may offer a viable therapeutic option in the third trimester of pregnancy. Ferric carboxymaltose (FCM; Ferinject®) is an IV iron preparation that allows rapid administration of high single doses of iron with a favorable safety profile. This study evaluated the potential impact of FCM therapy on fetal well-being by recording cardiotocography (CTG) before, during, and after iron infusions. Materials and Methods: We examined 105 women with IDA in the third trimester of pregnancy. During the initial evaluation, each patient was assessed for complete blood count, iron metabolism, B12, folates, hemoglobinopathies, CRP, kidney and liver function, and glucose levels. Each subject received intravenous ferric carboxymaltose (FCM), 500 mg. The study focused on the maternal and fetal safety of FCM infusion. The primary endpoint for maternal safety was the observation of adverse effects of iron infusion. For fetal safety, the primary endpoint was the assessment of CTG. Results: We considered 105 women, comprising 101 singleton and 4 twin pregnancies. The median hemoglobin (Hb) at initial observation was 95 g/L and 117 g/L post-therapy. Regarding maternal safety, side effects were observed during or after FCM infusion in four subjects; three cases involved local symptoms, while one case included nausea and skin rash. Concerning fetal safety, 100% of the cardiotocography records were deemed “normal” using the Dawes–Redman criteria. Conclusions: In conclusion, FCM proved effective in treating anemia in this clinically complex population of pregnant women in the third trimester and appeared safe in this cohort, though larger prospective studies are warranted. Full article
(This article belongs to the Special Issue Anaemia in Focus: Challenges and Solutions in Haematology)
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10 pages, 339 KB  
Article
Risk of Hypophosphatemia Following Postpartum Anemia Treatment with IV Ferric Carboxymaltose, IV Ferric Derisomaltose, and Oral Ferrous Sulfate
by Lea Bombač Tavčar, Miha Lučovnik, Hana Hrobat, Lea Gornik and Irena Preložnik Zupan
J. Clin. Med. 2025, 14(23), 8393; https://doi.org/10.3390/jcm14238393 - 26 Nov 2025
Viewed by 2200
Abstract
Objective: To compare the effects of intravenous (IV) ferric carboxymaltose (FCM), IV ferric derisomaltose (FDI), and oral ferrous sulfate on hypophosphatemia in women with postpartum anemia. Methods: Single-centre, open-label, randomized trial. Women were randomly allocated to receive IV FCM, IV FDI, [...] Read more.
Objective: To compare the effects of intravenous (IV) ferric carboxymaltose (FCM), IV ferric derisomaltose (FDI), and oral ferrous sulfate on hypophosphatemia in women with postpartum anemia. Methods: Single-centre, open-label, randomized trial. Women were randomly allocated to receive IV FCM, IV FDI, or oral ferrous sulfate. IV iron was infused in one or two doses (on days 0 and 7 postpartum), while ferrous sulfate once daily. Serum phosphate level was measured at enrollment and 6 weeks postpartum. Serum phosphate level and the proportion of women with hypophosphatemia were analyzed. The Kruskal–Wallis test was used for comparison of phosphate levels and the Chi-squared test for comparison of proportions (p < 0.05). Results: Three-hundred women with postpartum anemia (Hb < 100 g/L within 48 h postpartum) were included. Phosphate levels at six weeks postpartum did not differ between groups: 1.24 mmol/L (inter-quartile range (IQR) 1.10–1.35; equivalent to 3.84 mg/dL, IQR 3.41–4.19) in the FCM group, 1.23 mmol/L (IQR 1.09–1.35; equivalent to 3.81 mg/dL, IQR 3.38–4.19) in the FDI group, and 1.25 mmol/L (IQR 1.15–1.34; equivalent to 3.88 mg/dL, IQR 3.57–4.15) in the ferrous sulfate group (p = 0.86). The proportion of women with hypophosphatemia was similarly low in all three groups (3 (3.1%) vs. 2 (2.2%) vs. 2 (2.2%); p = 0.89). At six weeks postpartum, hemoglobin levels were slightly higher in both IV iron groups compared with oral iron, but the differences were small and unlikely to be clinically meaningful. Conclusions: Treatment of postpartum anemia with IV FCM, IV FDI, and oral ferrous sulfate had similar impact on phosphate levels and incidence of hypophosphatemia at six weeks postpartum. Full article
(This article belongs to the Section Obstetrics & Gynecology)
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14 pages, 503 KB  
Review
Iron Deficiency in Heart Failure: Cellular Mechanisms and Therapeutic Implications
by Anastasios Tsarouchas, Vassilios P. Vassilikos, Dimitrios Mouselimis, Christodoulos E. Papadopoulos, Dimitrios Tachmatzidis, Aikaterini Vassilikou and Constantinos Bakogiannis
J. Cardiovasc. Dev. Dis. 2025, 12(11), 415; https://doi.org/10.3390/jcdd12110415 - 22 Oct 2025
Cited by 4 | Viewed by 4488
Abstract
Iron deficiency (ID) is a prevalent comorbidity in heart failure (HF), affecting 37–75% of patients and contributing significantly to symptom burden and adverse outcomes independent of anemia status. Current diagnostic criteria for ID in HF include absolute deficiency (ferritin <100 μg/L) and functional [...] Read more.
Iron deficiency (ID) is a prevalent comorbidity in heart failure (HF), affecting 37–75% of patients and contributing significantly to symptom burden and adverse outcomes independent of anemia status. Current diagnostic criteria for ID in HF include absolute deficiency (ferritin <100 μg/L) and functional deficiency (ferritin 100–299 μg/L with transferrin saturation <20%). Major clinical trials including AFFIRM-AHF, IRONMAN, HEART-FID, and FAIR-HF2 have demonstrated that intravenous iron therapy, particularly ferric carboxymaltose, reduces HF hospitalizations and improves quality of life and exercise capacity. The 2023 European Society of Cardiology guidelines recommend intravenous ferric carboxymaltose for symptomatic iron-deficient patients with heart failure with reduced ejection fraction. Despite these advances, significant knowledge gaps remain regarding optimal diagnostic approaches, the relationship between ID and ferroptosis in cardiac tissue, and the efficacy of newer iron formulations. This review synthesizes current understanding of ID in HF and highlights emerging therapeutic strategies. Full article
(This article belongs to the Special Issue Heart Failure: Clinical Diagnostics and Treatment, 2nd Edition)
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15 pages, 918 KB  
Article
Iron Deficiency in Heart Failure: From ESC Guidelines to Clinical Practice at a Romanian Hospital
by Oana Sirbu, Andreea Tirnoveanu, Raluca Ecaterina Haliga, Victorita Sorodoc, Miruna Sava, Cristina Bologa, Ovidiu Rusalim Petris, Bianca Codrina Morarasu, Alexandra Diana Diaconu, Alexandr Ceasovschih, Catalina Lionte, Paula Cristina Morariu, Branco Adrian Morariu, Cristian Statescu, Radu Andy Sascau, Mariana Floria and Laurentiu Sorodoc
Biomedicines 2025, 13(9), 2296; https://doi.org/10.3390/biomedicines13092296 - 19 Sep 2025
Cited by 2 | Viewed by 2006
Abstract
Background: Iron deficiency (ID) is a frequent comorbidity in heart failure (HF), associated with reduced functional capacity and poor prognosis. Although the European Society of Cardiology (ESC) guidelines recommend systematic screening and intravenous iron supplementation (IS), adherence in clinical practice remains limited. This [...] Read more.
Background: Iron deficiency (ID) is a frequent comorbidity in heart failure (HF), associated with reduced functional capacity and poor prognosis. Although the European Society of Cardiology (ESC) guidelines recommend systematic screening and intravenous iron supplementation (IS), adherence in clinical practice remains limited. This observational study aimed to evaluate how these recommendations are implemented into practice. Methods: We performed a retrospective study including 4348 patients hospitalized with HF (NYHA II-IV) in a tertiary internal medicine clinic in Eastern Europe between January 2018 and September 2022. Demographic data, comorbidities, laboratory parameters, echocardiographic findings were collected from electronic medical records. IS was defined as serum ferritin < 100 ng/mL. Results: Among HF patients, 2547 (58.7%) were screened for ID, and 1091 (42.8%) had absolute deficiency. Only 278 patients (25.5%) received intravenous ferric carbodymaltose. Treated patients were predominantly elderly (70.1% ≥ 70 years), female (60.4%), and often had ischemic or valvular disease. Patients receiving intravenous IS showed higher NT-proBNP and troponin levels. A progressive increase in IS use was observed during the study period, with a temporary decline during the COVID-19 pandemic. Conclusions: Despite relatively high screening rates, only one-quarter of HF patients with confirmed ID received intravenous IS. These findings highlight persistent gaps between guidelines and clinical practice, emphasizing the need for improved awareness and implementation of ESC recommendations to optimize outcomes in HF patients with ID. Full article
(This article belongs to the Special Issue Heart Failure: New Diagnostic and Therapeutic Approaches)
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11 pages, 441 KB  
Article
Intravenous Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia During Pregnancy: Effects on Maternal and Fetal Wellbeing—A Multicenter Retrospective Observational Study
by Eleonora Romani, Sara Zullino, Anna R. Speciale, Paola M. Villa, Veronica Bonaldo, Francesca Parisi, Chiara Lubrano, Felice Petraglia, Irene Cetin and Federico Mecacci
Nutrients 2025, 17(16), 2670; https://doi.org/10.3390/nu17162670 - 19 Aug 2025
Viewed by 9537
Abstract
Objectives: To assess the impact of intravenous ferric carboxymaltose (FCM) on fetal and maternal adverse effects in pregnant women diagnosed with iron deficiency anemia (IDA). Methods: This is a multicenter retrospective study on 472 pregnant women diagnosed with moderate to severe [...] Read more.
Objectives: To assess the impact of intravenous ferric carboxymaltose (FCM) on fetal and maternal adverse effects in pregnant women diagnosed with iron deficiency anemia (IDA). Methods: This is a multicenter retrospective study on 472 pregnant women diagnosed with moderate to severe IDA undergoing treatment with FCM between 2019 and 2025 at Careggi University Hospital (Florence) and Vittore Buzzi Children Hospital (Milan). Fetal wellbeing was assessed using computerized cardiotocography (cCTG) or ultrasound, based on gestational age at treatment. Maternal side effects were evaluated through clinical evaluation. Results: cCTG was performed in 377/472 patients (80%), with a mean short-term variability of 10.2 ms. Normal cCTG criteria were met in 98.4% of cases; six patients exhibited transient reduced variability, which resolved following intrauterine resuscitation. Ultrasound assessment was performed in 95 patients (20%), revealing no fetal heart rate abnormalities. Maternal side effects occurred in seven patients (1.4%). Hemoglobin concentrations increased by a median of 1.4 g/dL after five weeks, reaching up to 2.8 g/dL in women with a baseline Hb < 8 g/dL. Conclusions: Our findings support the potential safety and efficacy of intravenous FCM for the treatment of IDA during pregnancy, demonstrating low rates of maternal side effects and no adverse fetal heart rate patterns. However, prospective studies are necessary to confirm these results. Full article
(This article belongs to the Special Issue Maternal Diet, Body Composition and Offspring Health)
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17 pages, 741 KB  
Article
Changes in Cardiac Function and Exercise Capacity Following Ferric Carboxymaltose Administration in HFrEF Patients with Iron Deficiency
by Anastasios Tsarouchas, Constantinos Bakogiannis, Dimitrios Mouselimis, Christodoulos E. Papadopoulos, Efstratios K. Theofillogiannakos, Efstathios D. Pagourelias, Ioannis Kelemanis, Aristi. Boulmpou, Antonios P. Antoniadis, Nikolaos Fragakis, Georgios Efthimiadis, Theodoros D. Karamitsos and Vassilios P. Vassilikos
Diagnostics 2025, 15(15), 1941; https://doi.org/10.3390/diagnostics15151941 - 2 Aug 2025
Viewed by 1260
Abstract
Background/Objectives: Iron deficiency (ID) is a common and prognostically relevant comorbidity in heart failure with reduced ejection fraction (HFrEF). It contributes to reduced functional status, exercise capacity, and survival. Intravenous ferric carboxymaltose (FCM) improves symptoms, but its effect on cardiac structure and function [...] Read more.
Background/Objectives: Iron deficiency (ID) is a common and prognostically relevant comorbidity in heart failure with reduced ejection fraction (HFrEF). It contributes to reduced functional status, exercise capacity, and survival. Intravenous ferric carboxymaltose (FCM) improves symptoms, but its effect on cardiac structure and function remains incompletely understood. The aim of this study was to assess the impact of intravenous FCM on echocardiographic indices of left ventricular (LV), left atrial (LA), and right ventricular (RV) morphology and function in HFrEF patients with ID and determine whether these changes correlate with improvements in exercise capacity. Methods: This sub-analysis of the RESAFE-HF registry (NCT04974021) included 86 HFrEF patients with ID (median age 71.8 years, 83% male). Transthoracic echocardiography was performed at baseline and 12 months post-FCM. Parameters assessed included LV ejection fraction (LVEF), LV global longitudinal strain (GLS), LV diastolic function grade, LAVi, LA strain, TAPSE, and RV free wall strain (FWS). Peak VO2 was measured to assess exercise capacity. Results: LVEF improved from 29.3 ± 7.8% to 32.5 ± 10.6% (p < 0.001), LV GLS from −7.89% to −8.62%, and the LV diastolic dysfunction grade improved (p < 0.001). LAVi, peak LA strain, TAPSE, and RV FWS also showed significant improvement. Peak VO2 increased from 11.3 ± 3.2 to 12.1 ± 4.1 mL/min/kg (p < 0.001). Improvements in LVEF, RV FWS, and LV GLS were independent predictors of VO2 increase (p < 0.001, p < 0.001, and p = 0.01, respectively), explaining 42% of the variance. Conclusions: FCM therapy improves biventricular and atrial function, with echocardiographic gains correlating with an enhanced exercise capacity in HFrEF patients with ID. Full article
(This article belongs to the Section Clinical Diagnosis and Prognosis)
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13 pages, 664 KB  
Review
Evaluating the Risk of Hypophosphatemia with Ferric Carboxymaltose and the Recommended Approaches for Management: A Consensus Statement
by Giuseppe Rosano, Justin Ezekowitz, Elizabeta Nemeth, Piotr Ponikowski, Martina Rauner, Melvin Seid, Donat R. Spahn, Jurgen Stein, Jay Wish and Robert J. Mentz
J. Clin. Med. 2025, 14(14), 4861; https://doi.org/10.3390/jcm14144861 - 9 Jul 2025
Cited by 16 | Viewed by 9874
Abstract
Background/Objectives: The development of hypophosphatemia has been associated with intravenous iron products, with the rate of hypophosphatemia found to be higher with ferric carboxymaltose. This consensus statement provides clinical guidance on the risk of hypophosphatemia development with ferric carboxymaltose and the approaches for [...] Read more.
Background/Objectives: The development of hypophosphatemia has been associated with intravenous iron products, with the rate of hypophosphatemia found to be higher with ferric carboxymaltose. This consensus statement provides clinical guidance on the risk of hypophosphatemia development with ferric carboxymaltose and the approaches for management. To develop consensus recommendations regarding the clinical implications of hypophosphatemia after the administration of ferric carboxymaltose, the assessment of patient risk profile, and recommended approaches for risk reduction. Methods: Consensus statements were developed from an in-person meeting of specialists with expertise in iron pathophysiology and iron therapy and further supplemented with literature review. The multidisciplinary expert panel comprised global iron specialists spanning anesthesiology, cardiology, gastroenterology, obstetrics/gynecology, hematology, nephrology, and iron molecular biology. Structured discussions were held in an in-person meeting to gather expert opinion on the evidence base regarding intravenous iron and hypophosphatemia. Consolidated summary opinions underwent further iterations of panel review to form consensus recommendation statements. Results: The expert panel developed the following consensus statements: (1) Routine serum phosphate level measurement is not recommended for low-risk patients before or after treatment with ferric carboxymaltose, as most cases of hypophosphatemia that occur following the administration of ferric carboxymaltose are asymptomatic and transient; (2) patients receiving ferric carboxymaltose should be assessed for the degree of risk for developing symptomatic or severe hypophosphatemia prior to administration; (3) monitoring serum phosphate is recommended for patients at an increased risk for developing low serum phosphate or who require repeated courses of ferric carboxymaltose treatment at higher doses; (4) prophylactic oral phosphorus after ferric carboxymaltose is unlikely to effectively elevate phosphate and is not recommended for routine clinical practice; and (5) hypophosphatemic osteomalacia is rare and the risk of development after the administration of ferric carboxymaltose, in particular single infusion, is low. Conclusions: Hypophosphatemia following ferric carboxymaltose is predominantly asymptomatic and transient. Individuals at higher risk for developing hypophosphatemia with ferric carboxymaltose treatment include those who receive multiple infusions, higher cumulative doses, or long-term iron treatment or who have underlying clinical risk factors. These consensus statements provide structured guidance on the risk of hypophosphatemia with ferric carboxymaltose and the approaches to clinical management. Full article
(This article belongs to the Section Hematology)
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15 pages, 579 KB  
Article
The Effect of Preoperative Intravenous Iron Supplementation on Mortality and Blood Transfusion Requirements in Elderly Patients Undergoing Hip Fracture Surgery: A Prospective Randomized Controlled Trial
by Taha Kizilkurt, Mustafa Ozkaya, Mert Balli, Mehmet Demirel and Mehmet Asik
J. Clin. Med. 2025, 14(13), 4713; https://doi.org/10.3390/jcm14134713 - 3 Jul 2025
Cited by 5 | Viewed by 4211
Abstract
Background/Objectives: Elderly patients who suffer a hip fracture often have a high risk of complications and mortality, which can be made worse by anemia during and after surgery. Although restrictive transfusion strategies are recommended, the role of preoperative intravenous iron, particularly ferric [...] Read more.
Background/Objectives: Elderly patients who suffer a hip fracture often have a high risk of complications and mortality, which can be made worse by anemia during and after surgery. Although restrictive transfusion strategies are recommended, the role of preoperative intravenous iron, particularly ferric carboxymaltose (FCM), remains unclear. This study aimed to investigate whether preoperative IV FCM reduces mortality and transfusion requirements in geriatric hip fracture patients managed under a restrictive transfusion strategy. Methods: A study was conducted in which 220 patients aged 65 years and over who had undergone surgery for a hip fracture were included. These patients were allocated to receive either a single 1000 mg dose of intravenous FCM approximately 12 h before surgery or no iron supplementation. All the patients were managed with a standardized restrictive transfusion strategy. The primary outcome was all-cause mortality at 6 and 12 months. The secondary outcomes included perioperative transfusion requirement, hemoglobin trends, and length of hospital stay. Results: The FCM group demonstrated significantly lower mortality at both 6 months (22.9% vs. 39.0%, p = 0.011) and 12 months (28.4% vs. 42.9%, p = 0.028) compared to the control group. Multivariate logistic regression identified preoperative FCM administration as one of the independent protective factors for mortality. The FCM group had significantly lower transfusion rates (30.9% vs. 45.5%, p = 0.02). No significant difference was observed at the 6-week follow-up in terms of the higher discharge hemoglobin levels seen in the control group. The difference in hospital stay duration did not reach statistical significance. Conclusions: Preoperative intravenous FCM administration could reduce both short- and long-term mortality and transfusion needs in geriatric hip fracture patients managed under a restrictive transfusion protocol. These findings support further investigation of high dose IV iron as a component of perioperative blood management in this high-risk population. Full article
(This article belongs to the Special Issue Hip Fracture and Surgery: Clinical Updates and Challenges)
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