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1.
Cureus ; 16(5): e60185, 2024 May.
Article in English | MEDLINE | ID: mdl-38868236

ABSTRACT

OBJECTIVE: The objective is to investigate the effectiveness of intravenous (IV) iron infusion in increasing hemoglobin levels in gestational iron deficiency anemia (GIDA) patients in a tertiary-care hospital in Dubai emirate, United Arab Emirates (UAE). METHODS: This is a retrospective cohort study of GIDA patients who were exposed to IV iron infusion supplementation. Study data of 40 cases aged 25-45 in a tertiary-care hospital in the UAE between 2018 and 2019 were analyzed. Variables accounted for were maternal age, age of gestation when IV iron was administered, and IV iron dose. RESULTS: The average hemoglobin level before the intervention was 9 g/dL, and the average change after the intervention was 10.4 g/dL with a mean of 1.4 g/dL difference between before and after the intervention. CONCLUSION: Supplementation of IV iron infusion in GIDA patients was seen to have increased the hemoglobin level after the intervention; however, the increase did not meet the recommended range of 12-16 g/dL.

2.
Int J Womens Health ; 16: 797-809, 2024.
Article in English | MEDLINE | ID: mdl-38765207

ABSTRACT

Haemoglobin A1C (HbA1c) is fundamental in monitoring glycaemic control during pregnancy. However, several conditions could affect this test's accuracy, including iron deficiency anaemia (IDA). Hence, this systematic review delves into the underexplored connection between IDA, iron replacement therapy (IRT), and haemoglobin A1C (HbA1c) during pregnancy. An electronic search of the Cochrane, MEDLINE, and Embase databases was conducted by six authors. From a comprehensive search strategy, 968 records were obtained. After applying the inclusion and exclusion criteria, seven studies were included, comprising 365 women selected for analysis. Six studies indicated a positive correlation between IDA and HbA1c levels, while one found no correlation. The average HbA1c level of the included studies in pregnant women was 5.64%. In comparison, it was found that non-pregnant women had lower HbA1c levels. Among the included studies, the mean HbA1c levels decreased from 5.1% to 4.89% after treating pregnant women with IRT. The review emphasises the complexity of interpreting HbA1c levels in pregnant women with IDA, highlighting the influence of pregnancy-induced physiological changes. In addition, this suggests that HbA1c should not be the sole criterion for diabetes management in pregnant women with IDA. Future research should focus on alternative glycaemic monitoring methods unaffected by IDA.

3.
Int J Hematol ; 2024 May 28.
Article in English | MEDLINE | ID: mdl-38806795

ABSTRACT

Iron deficiency anemia is one of the most common types of anemia, but real-world clinical management practices in Japan are unclear. This study retrospectively explored iron prescription patterns, treatment effectiveness, and assessments. Patients with at least one treatment period between September 2020 and September 2022 were included and classified into three groups (ferric carboxymaltose [FCM]: 7437 patients, saccharated ferric oxide [SFO]: 98,648 patients, and oral iron: 359,547 patients). Iron-related laboratory values over time and testing proportions were evaluated. Median baseline hemoglobin levels were lowest with FCM (FCM: 8.10 g/dL, SFO: 8.70 g/dL, oral iron: 9.70 g/dL), but changes in hemoglobin levels by 12 weeks were greatest with FCM (FCM: 3.20 g/dL, SFO: 2.60 g/dL, oral iron: 1.70 g/dL). The median serum ferritin level at 8 weeks after FCM treatment was 43.70 ng/mL for ≤500 mg, versus 123.30 ng/mL for >500 to ≤1500 mg. All groups had a low proportion of serum ferritin and transferrin saturation (TSAT) testing at diagnosis (<38%), which decreased further for post-treatment assessment (<24%). This study suggests the importance of prescribing an appropriate total iron cumulative dose per the package insert, along with diagnosis and assessments based on serum ferritin/TSAT.

4.
Hematol Transfus Cell Ther ; 46 Suppl 1: S17-S23, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38523044

ABSTRACT

Managing anemia before surgery is extremely important as it is a clinical condition that can significantly increase surgical risk and affect patient outcomes. Anemia is characterized by a reduction in the number of red blood cells or hemoglobin levels leading to a lower oxygen-carrying capacity of the blood. Proper treatment requires a multifaceted approach to ensure patients are in the best possible condition for surgery and to minimize potential complications. The challenge is recognizing anemia early and implementing a timely intervention to correct it. Anemic patients are more susceptible to surgical complications such as increased infection rates, slower wound healing and increased risk of cardiovascular events during and after surgery. Additionally, anemia can exacerbate existing medical conditions, causing greater strain on organs and organ systems. To correct anemia and optimize patient outcomes, several essential measures must be taken with the most common being identifying and correcting iron deficiency.

5.
J Clin Med ; 13(3)2024 Jan 28.
Article in English | MEDLINE | ID: mdl-38337452

ABSTRACT

(1) Background: Postpartum anemia is a common maternal complication and is recognized as a cause of impaired quality of life, reduced cognitive abilities, and fatigue. Efficient iron supplementation for the treatment of postpartum anemia is an essential component of high-quality maternal care. The optimal mode of iron supplementation has not been determined yet, whether oral or intravenous. The objective of this study was to compare postpartum anemia treatment with intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate. (2) Methods: A single-center, open-label, randomized controlled trial. Women with hemoglobin < 100 g/L within 48 h postpartum were randomly allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose, or oral ferrous sulfate. Intravenous iron was given in one or two doses, while ferrous sulfate was given as two 80 mg tablets once daily. The primary outcome was maternal fatigue measured by the Multidimensional Fatigue Inventory (MFI) six weeks postpartum. Hemoglobin, ferritin, and transferrin saturation levels were analyzed as secondary outcomes. A Kruskal-Wallis test was used for group comparison (p < 0.05 significant). (3) Results: Three hundred women were included. The MFI score at six weeks postpartum did not differ between groups (median 38 (inter-quartile range (IQR) 29-47) in the ferric carboxymaltose group, median 34 (IQR 26-42) in the ferric derisomaltose group, and median 36 (IQR 25-47) in the ferrous sulfate group; p = 0.26). Participants receiving oral iron had lower levels of hemoglobin (135 (131-139) vs. 134 (129-139) vs. 131 (125-137) g/L; p = 0.008), ferritin (273 (198-377) vs. 187 (155-246) vs. 24 (17-37) µg/L; p < 0.001) and transferrin saturation (34 (28-38) vs. 30 (23-37) vs. 24 (17-37) %; p < 0.001) than those receiving ferric carboxymaltose or ferric derisomaltose. (4) Conclusions: Intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate had similar impacts on maternal fatigue at six weeks postpartum despite improved laboratory parameters in the intravenous groups.

6.
Int J Mol Sci ; 25(3)2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38338786

ABSTRACT

In vivo iron levels can be adjusted through intestinal iron absorption to be maintained at a suitable level; however, optimal iron levels in hemodialysis (HD) patients are unclear. In this study, we investigated total body iron (TBI), calculated as the sum of red blood cell (RBC) iron and iron stores, during courses of low-dose oral iron replacement therapy, and evaluated in vivo iron sufficiency and its indicators in HD patients. We analyzed data on 105 courses of low-dose iron replacement therapy administered to 83 patients on maintenance HD over 7 months. We evaluated changes in TBI, RBC iron, and iron stores from the initiation of treatment to month 7 in two groups of patients, namely, iron-therapy responders and non-responders. TBI showed significant increases until month 4 and plateaued thereafter in iron-therapy responders, and tended to increase and then reached a similar plateau in non-responders (month 7: 1900 ± 447 vs. 1900 ± 408 mg). Steady-state TBI was strongly correlated with body surface area (y = 1628.6x - 791.91, R2 = 0.88, p < 0.001). We observed constant TBI during oral iron replacement therapy suggesting the activation of a "mucosal block". The results suggest that body surface area has utility for estimating the required TBI with regression equations.


Subject(s)
Anemia, Iron-Deficiency , Erythropoietin , Kidney Failure, Chronic , Humans , Iron/metabolism , Retrospective Studies , Ferritins , Renal Dialysis/adverse effects , Anemia, Iron-Deficiency/drug therapy , Erythropoietin/metabolism , Kidney Failure, Chronic/etiology , Hemoglobins/metabolism
7.
Int J Lab Hematol ; 46(2): 345-353, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38041255

ABSTRACT

OBJECTIVES: Iron deficiency anemia (IDA) is the most common type of anemia in childhood and it leads to a hypercoagulable state. We investigated endogenous thrombin production in platelet-poor plasma before and after oral iron replacement in children with IDA using the thrombin generation assay (TGA). METHODS: A total of 72 children diagnosed with IDA (IDA group) and 60 healthy children (control group) were included in the study. Blood samples were collected from the patients before and 1 month after oral iron replacement. TGA parameters [lag time, time to peak, peak height, endogenous thrombin potential (ETP)] were studied. RESULTS: In the IDA group, the lag time and time to peak decreased by 8.3% and 10.6%, respectively, and the endogenous thrombin potential (ETP) and peak height both increased by 30% compared to those of the control group. Compared to the values before iron replacement, 1 month after iron replacement, the lag time and time to peak increased by 8.7% and 5%, respectively, and the ETP and peak height decreased by 31% and 31.3%, respectively, and became similar to those of the control group. CONCLUSION: Children with IDA have increased endogenous thrombin production in platelet-poor plasma and a tendency for hypercoagulability. These changes are reversible, and the ETP values become similar to those of healthy children 1 month after iron replacement.


Subject(s)
Anemia, Iron-Deficiency , Thrombophilia , Child , Humans , Thrombin , Blood Coagulation Tests , Iron
8.
Hematol., Transfus. Cell Ther. (Impr.) ; 46(supl.1): 17-23, 2024. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1557899

ABSTRACT

Abstract Managing anemia before surgery is extremely important as it is a clinical condition that can significantly increase surgical risk and affect patient outcomes. Anemia is characterized by a reduction in the number of red blood cells or hemoglobin levels leading to a lower oxygen-carrying capacity of the blood. Proper treatment requires a multifaceted approach to ensure patients are in the best possible condition for surgery and to minimize potential complications. The challenge is recognizing anemia early and implementing a timely intervention to correct it. Anemic patients are more susceptible to surgical complications such as increased infection rates, slower wound healing and increased risk of cardiovascular events during and after surgery. Additionally, anemia can exacerbate existing medical conditions, causing greater strain on organs and organ systems. To correct anemia and optimize patient outcomes, several essential measures must be taken with the most common being identifying and correcting iron deficiency.

9.
J Clin Med ; 12(23)2023 Nov 24.
Article in English | MEDLINE | ID: mdl-38068338

ABSTRACT

BACKGROUND: Several studies have reported that iron-deficiency anemia (IDA) and its treatment might lead to a distorted reading of glycated hemoglobin (HbA1c) value. Hence, this review aims to systematically investigate the effect of iron replacement therapy (IRT) on HbA1c levels, as the literature is deficient in assessing this clinical phenomenon. METHODS: An electronic search of the Cochrane, MEDLINE, and Embase databases was conducted by four independent authors. RESULTS: Among the 8332 articles identified using the search strategy, 10 records (with a total of 2113 participants) met the inclusion criteria and were analyzed. In nine of the studies, IRT was found to decrease HbA1c levels; in the remaining study, IRT was found to increase HbA1c levels. The effect size of the pooled standardized mean difference in HbA1c levels between the treatment and control groups with IDA was 1.8 (95% CI = -0.5, 2.31). Heterogeneity was assessed using the I2 and χ2 tests, and the resultant values were 98.46% and p = 0.09, respectively. Additionally, the mean difference between the HbA1c levels (pre-IRT and post-IRT) showed a drop in the HbA1c levels which ranged from 1.20 to 0.43 mg/dL. CONCLUSIONS: The results suggest that IRT decreases HbA1c levels, and it is helpful in treating IDA patients with poor glycemic control. Accordingly, the results provide an added perspective on antidiabetic medication dosing and physicians' interpretation of initially elevated HbA1c values.

10.
Clin Kidney J ; 16(11): 2082-2090, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37915900

ABSTRACT

Background: Oral iron is the predominant route of iron replacement (IRT) but its benefits and safety are unclear in patients with chronic kidney disease (CKD). Methods: We examined the association of oral IRT vs no IRT with end-stage kidney disease (ESKD) and mortality in a national cohort of US Veterans. We identified 17 413 incident new users of oral IRT with estimated glomerular filtration rates <60 mL/min/1.73 m2 and 32 530 controls who did not receive any IRT during 2004-18. We used propensity score-overlap weighting to account for differences in key baseline characteristics associated with the use of oral IRT. We examined associations using competing risk regression and Cox models. Results: In the cohort of 49 943 patients, 1616 (3.2%) patients experienced ESKD and 28 711 (57%) patients died during a median follow-up of 1.9 years. Oral IRT was not associated with ESKD [subhazard ratio (HR) (95% confidence interval, CI) 1.00 (0.84-1.19), P = .9] and was associated with higher risk of all-cause mortality [HR (95% CI) 1.06 (1.01-1.11), P = .01]. There was significant heterogeneity of treatment effect for mortality, with oral IRT associated with higher mortality in the subgroups of patients without congestive heart failure (CHF), anemia or iron deficiency. In patient with blood hemoglobin <10 g/dL oral IRT was associated with significantly lower mortality. Conclusion: Oral IRT was associated with lower mortality only in patients with anemia. In patients without anemia, iron deficiency or CHF, the risk-benefit ratio of oral IRT should be further examined.

11.
Eur J Haematol ; 111(6): 872-880, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37668586

ABSTRACT

OBJECTIVE: We investigated the association of oral iron replacement with the incidence of chronic kidney disease (CKD) in a population with normal kidney function to study the effects of iron replacement on the development of new onset CKD. METHODS: In a national cohort of US Veterans with no pre-existing CKD, we identified 33 894 incident new users of oral iron replacement and a comparable group of 112 780 patients who did not receive any iron replacement during 2004-2018. We examined the association of oral iron replacement versus no iron replacement with the incidence of eGFR <60 mL/min/1.73 m2 and the incidence of urine albumin creatinine ratio (UACR) ≥30 mg/g in competing risk regressions and in Cox models. We used propensity score weighing to account for differences in key baseline characteristics associated with the use of oral iron replacement. RESULTS: In the cohort of 146 674 patients, a total of 18 547 (13%) patients experienced incident eGFR <60 mL/min/1.73 m2 , and 16 117 patients (11%) experienced new onset UACR ≥30 mg/g. Oral iron replacement was associated with significantly higher risk of incident eGFR <60 mL/min/1.73 m2 (subhazard ratio, 95% confidence interval [CI]: 1.3 [1.22-1.38], p < .001) and incident albuminuria (subhazard ratio, 95% CI: 1.14 [1.07-1.22], p < .001). CONCLUSION: Oral iron replacement is associated with higher risk of new onset CKD. The long-term kidney safety of oral iron replacement should be tested in clinical trials.


Subject(s)
Renal Insufficiency, Chronic , Humans , Incidence , Creatinine , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/epidemiology , Kidney , Iron/adverse effects , Glomerular Filtration Rate
12.
Int J Mol Sci ; 24(17)2023 Aug 28.
Article in English | MEDLINE | ID: mdl-37686128

ABSTRACT

Following a diagnosis of iron deficiency anaemia in pregnancy, iron supplements are prescribed using UK guidelines; however, despite this, the condition remains highly prevalent, affecting up to 30% of pregnant women in the UK. According to the World Health Organisation, it globally accounts for 45% in the most vulnerable groups of pregnant women and infants (<5 years old). Recently, the efficacy of iron replacement therapy and the effectiveness of current standard testing of iron parameters have been reviewed in order to evaluate whether a more accurate diagnosis can be made using alternative and/or supplementary markers. Furthermore, many questions remain about the mechanisms involved in iron metabolism during pregnancy. The most recent studies have shed more light on serum hepcidin and raised questions on the significance of pregnancy related inflammatory markers including cytokines in iron deficiency anaemia. However, research into this is still scarce, and this review aims to contribute to further understanding and elucidating these areas.


Subject(s)
Anemia, Iron-Deficiency , Ferritins , Pregnancy , Infant , Female , Humans , Child, Preschool , Anemia, Iron-Deficiency/diagnosis , Cytokines , Hepcidins , Iron
13.
Cureus ; 15(8): e44020, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37746404

ABSTRACT

Hereditary hemorrhagic telangiectasia (HHT) is a rare autosomal dominant vascular dysplasia in which disrupted angiogenesis leads to increased formation of mucocutaneous telangiectasias or major vascular malformations. Iron deficiency anemia and recurrent abscesses are commonly reported in these patients, reinforcing screening and targeted therapies for these conditions. We report a 50-year-old man with HHT affected by repeated episodes of iron deficiency anemia secondary to recurrent epistaxis requiring frequent intravenous iron infusions. He eventually developed hypophosphatemia and hyperphosphaturia secondary to ferric carboxymaltose. He also had a history of recurrent multifocal abscesses, including a severe presentation of necrotizing fasciitis, requiring multiple surgical interventions. Despite the identification of hypogammaglobulinemia, only after consistent dental treatment and antibiotic prophylaxis did the abscesses stop recurring. We highlight the need for careful consideration of all possible complications inherent to the disease itself but also those related to comorbidities or existing treatments.

14.
Int J Gynaecol Obstet ; 162 Suppl 2: 89-92, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37538009

ABSTRACT

The symptom of heavy menstrual bleeding and the frequently associated condition of iron deficiency (ID) individually and collectively adversely impact the lives of women and girls of reproductive age in various ways. The insidious but sometimes profound effects of periconceptual ID on the developing fetus may continue throughout the individual's life with consequences that are also felt by families, friends, and society at large. Unfortunately, in most instances, current healthcare policies are not designed to address the plethora of issues in a fashion that will result in meaningful improvement in health and other outcomes that affect both individuals and society. Identification and prioritization of the many evidence gaps will be an essential component of the strategy for change. This article identifies and describes the evidence gaps and provides direction for investigators and those involved in healthcare policy.


Subject(s)
Anemia, Iron-Deficiency , Iron Deficiencies , Menorrhagia , Female , Humans , Anemia, Iron-Deficiency/epidemiology , Iron , Evidence Gaps , Menorrhagia/etiology
15.
Int J Gynaecol Obstet ; 162 Suppl 2: 68-77, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37538014

ABSTRACT

Iron deficiency (ID) is the world's most common disorder and one of the top five causes of years lived with disability. Whereas low serum ferritin is diagnostic of ID, ferritin-an acute phase reactant-may be elevated in inflammatory states and the first trimester of pregnancy even if ID exists. Consequently, in early pregnancy or chronic inflammation, percent transferrin saturation (TSAT) measurement is the best indicator of iron status. Unfortunately, current guidelines do not recommend routine screening for ID in either pregnant or nonpregnant women in the absence of anemia. This circumstance should be urgently reviewed based on available data. While oral formulations have long been the standard for iron replacement therapy and are widely available and inexpensive, oral iron is frequently associated with adverse gastrointestinal effects for the majority-a major reason for poor adherence, inadequate repletion, and persisting ID symptoms and sequellae. Although safe intravenous iron administration was introduced in the mid-1950s, formulations with cores binding the elemental iron more tightly became available in the 2000s, allowing complete and safe replacement, even in a single setting. Prospectively acquired neonatology evidence reports oral iron's failure to reach the developing fetus when the mother is iron deficient. Consequently, while oral iron remains frontline in the first trimester because of insufficient safety data for intravenous iron, the author recommends that the intravenous route should be the gold standard for second-trimester ID when hemoglobin concentrations are less than 10.5 g/dL and for all iron-deficient women in their third trimester.


Subject(s)
Anemia, Iron-Deficiency , Anemia , Iron Deficiencies , Pregnancy , Female , Humans , Anemia, Iron-Deficiency/diagnosis , Anemia, Iron-Deficiency/drug therapy , Iron/therapeutic use , Ferritins/therapeutic use , Hemoglobins/analysis
16.
J Cardiovasc Dev Dis ; 10(3)2023 Mar 11.
Article in English | MEDLINE | ID: mdl-36975880

ABSTRACT

(1) Background: Iron deficiency (ID) is an important adverse prognostic marker in patients with heart failure (HF); however, it is unclear whether intravenous iron replacement reduces cardiovascular mortality in this patient group. Here, we estimate the effect of intravenous iron replacement therapy on hard clinical outcomes following the publication of IRONMAN, the largest trial in this field. (2) Methods: In this systematic review and meta-analysis, prospectively registered with PROSPERO and reported according to PRISMA guidelines, we searched PubMed and Embase for randomized controlled trials investigating intravenous iron replacement in patients with HF and co-existing ID. The primary outcome was cardiovascular mortality and secondary outcomes were all-cause mortality, hospitalizations for HF and a combination of the primary outcome and hospitalizations for HF. (3) Results: A total of 1671 items were identified and after removal of duplicates we screened titles and abstracts of 1202 records. Some 31 studies were identified for full-text review and 12 studies were included in the final review. The odds ratio (OR) for cardiovascular death using a random effects model was 0.85 (95% CI 0.69 to 1.04) and for all-cause mortality it was 0.83 (95% CI 0.59 to 1.15). There was a significant reduction in hospitalizations for HF (OR 0.49, 95% CI 0.35 to 0.69) and the combination of hospitalizations for HF and cardiovascular death (OR 0.65, 95% CI 0.5 to 0.85). (4) Conclusions: This review supports the use of IV iron replacement reducing hospitalization rates for HF, however more research is required to determine the effect on cardiovascular mortality and to identify the patient population most likely to benefit.

17.
Cardiol Young ; 32(8): 1302-1309, 2022 Aug.
Article in English | MEDLINE | ID: mdl-34629125

ABSTRACT

INTRODUCTION: Iron deficiency is associated with worse outcomes in children and adults with systolic heart failure. While oral iron replacement has been shown to be ineffective in adults with heart failure, its efficacy in children with heart failure is unknown. We hypothesised that oral iron would be ineffective in replenishing iron stores in ≥50% of children with heart failure. METHODS: We performed a single-centre retrospective cohort study of patients aged ≤21 years with systolic heart failure and iron deficiency who received oral iron between 01/2013 and 04/2019. Iron deficiency was defined as ≥2 of the following: serum iron <50 mcg/dL, serum ferritin <20 ng/mL, transferrin >300 ng/mL, transferrin saturation <15%. Iron studies and haematologic indices pre- and post-iron therapy were compared using paired-samples Wilcoxon test. RESULTS: Fifty-one children with systolic heart failure and iron deficiency (median age 11 years, 49% female) met inclusion criteria. Heart failure aetiologies included cardiomyopathy (51%), congenital heart disease (37%), and history of heart transplantation with graft dysfunction (12%). Median dose of oral iron therapy was 2.9 mg/kg/day of elemental iron, prescribed for a median duration of 96 days. Follow-up iron testing was available for 20 patients, of whom 55% (11/20) remained iron deficient despite oral iron therapy. CONCLUSIONS: This is the first report on the efficacy of oral iron therapy in children with heart failure. Over half of the children with heart failure did not respond to oral iron and remained iron deficient.


Subject(s)
Anemia, Iron-Deficiency , Heart Failure, Systolic , Heart Failure , Iron Deficiencies , Adult , Anemia, Iron-Deficiency/drug therapy , Anemia, Iron-Deficiency/etiology , Child , Female , Heart Failure/complications , Heart Failure/drug therapy , Heart Failure, Systolic/complications , Heart Failure, Systolic/drug therapy , Humans , Iron/therapeutic use , Male , Retrospective Studies , Transferrin/therapeutic use
18.
Inflamm Bowel Dis ; 28(3): 373-384, 2022 03 02.
Article in English | MEDLINE | ID: mdl-33988236

ABSTRACT

BACKGROUND: Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. METHODS: In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center's standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. RESULTS: For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. CONCLUSIONS: Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.


Subject(s)
Anemia, Iron-Deficiency , Inflammatory Bowel Diseases , Administration, Intravenous , Administration, Oral , Adult , Anemia, Iron-Deficiency/drug therapy , Female , Ferric Compounds/administration & dosage , Ferric Compounds/adverse effects , Hemoglobins , Humans , Inflammatory Bowel Diseases/drug therapy , Male , Maltose/administration & dosage , Maltose/adverse effects , Maltose/analogs & derivatives , Pyrones/administration & dosage , Pyrones/adverse effects , Treatment Outcome
19.
Heart Lung Circ ; 31(3): 313-326, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34810088

ABSTRACT

BACKGROUND: Iron deficiency and depression are prevalent comorbidities in the setting of heart failure. Both conditions are associated with poorer patient outcomes including mortality, hospitalisation and quality of life. Iron replacement has come to the fore as a means to improve patient outcomes. This review aims to assess the current literature regarding the benefits of iron supplementation for iron deficient heart failure patients including potential improvements in depression. METHODS AND RESULTS: The databases of Medline, EMBASE, the Cochrane library of systematic reviews, Central Register of Controlled Trials, PubMed, Web of Science and ClinicalTrials.gov were searched for studies with relevant patient outcomes. A total of 18 studies were identified and included in the review. In essence, intravenous iron was found to be beneficial for New York Heart Association (NYHA) classification, quality of life measures, heart failure (HF) hospitalisation and aerobic capacity. Oral iron however was not beneficial. Research surrounding intravenous iron improving cardiovascular mortality, time to first hospitalisation and changes in depression status is lacking. CONCLUSIONS: Further research is required to elucidate the advantages of intravenous iron for iron deficient heart failure patients on their depression, mortality and first admission to hospital. Consensus is required regarding which form of iron and the treatment regime that should be adopted for future clinical guidelines.


Subject(s)
Heart Failure , Iron Deficiencies , Depression/drug therapy , Depression/epidemiology , Heart Failure/complications , Heart Failure/drug therapy , Heart Failure/epidemiology , Humans , Iron , Quality of Life , Systematic Reviews as Topic
20.
Rinsho Ketsueki ; 62(11): 1583-1592, 2021.
Article in Japanese | MEDLINE | ID: mdl-34866080

ABSTRACT

Patients with iron deficiency anemia (IDA) need to take oral iron preparations, which serve as the first-line treatment in IDA, for several months in order to replenish body iron stores after the improvement of anemia. However, existing oral iron preparations have concerns regarding its long-term use due to side effects, such as gastrointestinal symptoms. Previous clinical studies have shown that ferric citrate hydrate (FC) exhibits sufficient therapeutic efficacy in patients with IDA and lowers the risks of nausea and vomiting in comparison with existing oral iron preparations. In this study, we evaluated the efficacy and safety of FC administration at doses of 500 and 1,000 mg/day for up to 24 weeks as iron replacement therapy in patients with IDA. The results of this study showed that both the doses of FC improved anemia and iron-deficiency conditions and led to sufficient iron replacement response in most patients with IDA. No safety concerns were identified. Therefore, FC is expected to be a novel oral iron preparation for patients with IDA.


Subject(s)
Anemia, Iron-Deficiency , Iron , Anemia, Iron-Deficiency/drug therapy , Ferric Compounds , Humans , Iron Deficiencies , Japan
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