A Head-to-Head Comparison of the Safety and Efficacy of Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5157-5157
Author(s):  
Allen Poma ◽  
Karen Diana ◽  
Justin McLaughlin ◽  
Annamaria Kausz
Keyword(s):  
Iron Deficiency ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Safety And Efficacy ◽  
Oral Iron Therapy ◽  
The Us ◽  
Iv Iron ◽  
Iron Replacement

Abstract Abstract 5157 BACKGROUND: Iron replacement therapy is essential for increasing iron stores and raising hemoglobin levels in patients with iron deficiency anemia (IDA). Oral iron supplements have limited absorption and are commonly associated with gastrointestinal (GI) side effects that reduce compliance, resulting in limited increases in hemoglobin. In patients without chronic kidney disease (CKD), oral iron therapy is frequently used to treat IDA. However, when oral iron therapy is unsatisfactory or cannot be tolerated, intravenous (IV) iron therapy may be appropriate. In the US, iron dextrans are the only approved IV iron products indicated for the treatment of IDA in non-CKD patients, and have limitations around convenience because they require a test dose and as many as 10 administrations via a slow infusion; iron dextrans have also been associated with a relatively high rate of serious adverse reactions compared to other IV iron products. Other IV irons, such as iron sucrose and sodium ferric gluconate, are only approved in the US for the treatment of IDA in patients with CKD. Like the iron dextrans, both of these products are limited by administration, requiring 5 to 10 clinic visits for the administration of a full therapeutic dose (1 gram of iron). Feraheme® (ferumoxytol) Injection is an IV iron product approved in the US for the treatment of IDA in adult subjects with CKD. Its carbohydrate coating is designed to minimize immunological sensitivity, and it has less free iron than other IV iron preparations. Ferumoxytol is administered as two IV injections of 510 mg (17 mL) 3 to 8 days apart for a total cumulative dose of 1.02 g. METHODS: To date, there have been a limited number of studies that have examined the safety and efficacy of IV irons in a head-to-head manner for the treatment of IDA, and no study has done so in a large number of subjects or in a broad patient population. AMAG, therefore, has initiated a randomized, controlled trial (ClinicalTrials.gov NCT01114204) to compare ferumoxytol with iron sucrose. Iron sucrose is approved in many countries outside the US for the treatment of IDA in patients intolerant to oral iron therapy, and is considered a safer alternative to IV iron dextran. This open-label trial (n=600) will evaluate the efficacy and safety of a 1.02 g of IV ferumoxytol, administered as 2 doses of 510 mg each, compared with 1.0 g of IV iron sucrose, administered as 5 doses of 200 mg each. Enrolled subjects will have IDA associated with a variety of underlying conditions including abnormal uterine bleeding, GI disorders, cancer, postpartum anemia, and others (eg, nutritional deficiency). Endpoints include changes in hemoglobin and transferrin saturation at Week 5, as well as evaluation of the requirement for erythropoiesis stimulating agent therapy and blood transfusion. Patient reported outcomes instruments will be employed to assess the impact of IV iron therapy on anemia symptoms and health-related quality of life (fatigue, energy, etc). Additionally, detailed information on healthcare utilization will be collected. CONCLUSION In the US, non-CKD patients with IDA who have a history of unsatisfactory oral iron therapy have limited options for iron replacement therapy. Study NCT01114204 will provide novel information comparing the safety and efficacy of two IV iron therapies for the treatment of IDA in a broad patient population. Disclosures: Poma: AMAG Pharmaceuticals, Inc.: Employment. Diana:AMAG Pharmaceuticals, Inc.: Employment. McLaughlin:AMAG Pharmaceuticals, Inc.: Employment. Kausz:AMAG Pharmaceuticals, Inc.: Employment.

Economic, Transfusion, and Efficacy Outcomes with the Addition of IV Iron Sucrose to Oral Iron Therapy in Pregnancy Associated Iron Deficiency Anemia

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4737-4737
Author(s):  
Nilupa Gaspe Mudiyanselage ◽  
Tarek Elrafei ◽  
Beth Lewis ◽  
Mary King ◽  
Marianna Strakhan ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Iron Group ◽  
Iv Iron ◽  
Iron Replacement

Abstract Background: Prior studies have indicated that transfusion is unusual (2%) in pregnant women with iron deficiency anemia. Nonetheless, compliance with oral iron replacement can be an issue and physicians may wish to use IV iron therapy in markedly anemic pregnant women. Objectives: to evaluate the effectiveness of adding intravenous iron sucrose concentrate (ISC) to pregnant patients already taking oral iron in terms of effect on hemoglobin, effect on ferritin levels, rates of transfusion, and cost. Methods: We analyzed all referrals from Obstetrics to Hematology clinic and Obstetrics consultation (Internal medicine) clinic from January 2014 to June 2016. Of the 176 pregnant patients, 98 were referred for anemia, including 81 patients with Hgb < 12 g/dl and ferritin < 20 ug/L. All had previously been given oral ferrous sulfate prescriptions. Patients with hemoglobinopathy were excluded. All 81 patients were advised to continue on the oral iron, and 40 were given IV iron sucrose (ISC group). Results: The average cumulative dose of iron sucrose was 700 mg, a mean of 5.575 doses (initiated in the third trimester in 38 of 40 patients). The lowest antepartum Hgb was 8.18 g/dl in the ISC group and 9.58 in the oral only group; there was an average Hgb increase of 2.17 vs 1.76 g/dl respectively (p=.107 NS and the 0.41 g/dl difference was considered to be of no clinical consequence). 89% in the ISC group vs 30% in the oral achieved a ferritin >20 (p=0.000015). No adverse events in the IV iron group were reported. There was 1 transfusion in the oral iron group attributable to iron deficiency (2.4%) vs none in the IV iron group (p = 0.107 NS). Two patients were transfused in the antenatal period before IV iron was started and 1 transfused because of post-partum hemorrhage. The total cost of the IV iron therapy would add an average of $1,500 per patient. Thus, and additional cost of $60,000 in IV iron would be required to prevent 1 transfusion [40:1]. Conclusions: ISC corrects ferritin in more patients than oral iron replacement, but did not significantly increase Hgb levels or have a meaningful impact on the transfusion rate. The additional cost and lack of clinically improved outcomes with IV iron argue against its use and in favor of strategies to ensure compliance with oral iron. Disclosures No relevant conflicts of interest to declare.

scholarly journals Efficacy and safety of high dose accelerated intravenous iron sucrose in patients of iron deficiency anemia

2017 ◽  
Vol 5 (8) ◽  
pp. 3359
Author(s):  
Muzafar Naik ◽  
Tariq Bhat ◽  
Ummer Jalalie ◽  
Arif Bhat ◽  
Mir Waseem ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
High Dose ◽  
Oral Iron Therapy ◽  
The Mean

Background: Low dose (200 mg) extended Intravenous iron sucrose remains the most common treatment option in patients who are intolerant to oral iron therapy in patients with Iron deficiency anemia (IDA). The objective of this study was to evaluate the efficacy and safety of high dose accelerated intravenous iron sucrose (IS) in the treatment of adults with iron deficiency anemiaMethods: One hundred adult patients with iron deficiency anemia, who had intolerance or showed no effect with oral iron therapy, received daily doses of 500 mg of intravenous iron sucrose until the hemoglobin level was corrected or until receiving the total dose of intravenous iron calculated for each patient.Results: The mean and median Hb (g/dL) 6.47±1.656 and 6.6 (2) at baseline, 9.61±1.629 and 9.6 (2) at 2 weeks of treatment, 11.85±1.277 and 12 (1) at 4 weeks of treatment respectively. The mean rise of Hb was 3.13±1.41 and 5.37±1.50 after 2 and 4 weeks of treatment respectively (p<0.000). A total of 303 intravenous infusions of iron sucrose were administered and iron sucrose was generally well tolerated with twenty-six patients developing mild and one patient developing moderate adverse drug reactions. There was no serious adverse event recorded.Conclusions: Accelerated high dose intravenous iron sucrose is a safe and cost effective option minimizing frequent hospital visits in the treatment of adults with iron deficiency anemia who are intolerant or lack satisfactory response to oral iron therapy.

scholarly journals Clinical Criteria for Transitioning from Oral to IV Iron Replacement Therapy in Patients with Iron Deficiency Anemia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 211-211 ◽  
Author(s):  
Maureen Okam ◽  
Todd Koch ◽  
Minh Ha Tran
Keyword(s):  
Reticulocyte Count ◽  
Pooled Analysis ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Oral Iron Therapy ◽  
Iron Treatment ◽  
Iv Iron ◽  
Iron Replacement

Abstract Introduction: Oral iron supplementation is an effective means of iron replacement. Nevertheless, there is a frequent need to transition patients with iron deficiency anemia (IDA) from oral to intravenous (IV) iron therapy for inadequate response. No definitive guidance on the optimal timing for this change in therapy exists. Serum hepcidin may be a marker in predicting response to oral iron therapy, but currently, hepcidin assays are not commercially available. We evaluated the ability of various early response characteristics to accurately predict for an overall hemoglobin (Hb) response to oral iron. Our objective was to identify an early predictor of overall Hb response in patients on oral iron treatment as a guide to the decision to switch from oral to IV iron in patients unlikely to benefit from continued oral iron. Methods: Proprietary datasets from 6 published randomized studies in which oral iron (325 mg of ferrous sulfate containing 65 mg of elemental iron, t.i.d.[4 studies], 304.3 mg capsules containing 100 mg bivalent iron b.i.d [1 study] and as prescribed by the investigator [1 study]) was used as a comparator to ferric carboxymaltose were analyzed. Five studies were pooled into one primary analysis dataset and one study was analyzed separately due to differences in study design that precluded pooling. Patients were grouped by the underlying etiology of their IDA (postpartum, heavy uterine bleeding, gastrointestinal, and others) and stratified by those who had ≥ 1 g/dL Hb change after 14 days of oral iron therapy (responders) and those who did not (non-responders). Further analyses evaluated Hb response at various time points based on initial 14 day Hb response (≥ 1 g/dL change vs < 1 g/dL). We systemically evaluated changes in hemoglobin, absolute reticulocyte count, % reticulocyte count, ferritin, and transferrin saturation at specific time points to determine their ability to predict overall Hb response. Results: A total of 738 patients who were randomized to oral iron were included in the pooled study analysis. In the separate study, a total of 253 patients, all non-responders, were included. The mean baseline values for the 6 studies were Hb 9.9 g/dL, ferritin 19.9 ng/mL, and TSAT 16.9%. The vast majority of patients (96%) were females with a mean age of 36 years. In the pooled analysis, by day 14 of oral iron treatment, 27.2% (201/738) of patients had a Hb increase of < 1 g/dL (non-responders). Of these 201 patients, less than half (46.8%, 94/201) achieved an increase in Hb ≥ 1 g/dL from baseline after 2 additional weeks of oral iron (by day 28) and only 63.2% (127/201) had an increase in Hb ≥ 1g/dL from baseline after 6 to 8 weeks of oral iron (42 to 56 days). Furthermore, only 27.4% (55/201) and 5.5% (11/201) had an increase in Hb of 2 or 3 g/dL respectively at the Day 42 or 56 measurement. In comparison, responders (those who had a Hb increase ≥ 1 g/dL by 14 days of treatment) sustained a robust Hb response with continued dosing of oral iron. After 4 weeks of oral iron (28 days), 84.9% of the responders had a ≥ 2 g/dL increase in Hb from baseline. After 6 to 8 weeks of oral iron (42 or 56 days), 92.9% of the patients had ≥ 2 g/dL Hb increase from baseline, significantly different from non-responders (p < 0.0001). Patients with etiology of postpartum anemia had the most robust Hb response to oral iron. Results observed in the sixth study were similar to the pooled analysis. Only 10.2% (17/167) of non-responders who continued oral iron after day 14 achieved a Hb ≥ 2g/dL by Day 35, whereas 38.8% (57/147) who were switched to IV ferric carboxymaltose achieved a Hb > 2/dL by Day 35 (p =0.0001). Hb response after 14 days of oral iron was a strong predictor of overall response (sensitivity = 90.1%, specificity = 79.3%, positive predictive value = 92.9%, negative predictive value= 72.7%), surpassing other parameters evaluated in this study. Conclusion: In the absence of significant continuous blood loss, Hb measurements taken 14 days after initiation of oral iron therapy can reliably predict overall response in Hb to oral iron therapy. Accordingly, day 14 Hb may be a useful tool for clinicians in determining when to switch patients from oral to IV iron. Disclosures Koch: Luitpold Pharmaceuticals: Employment.

Potential New Treatment Option for Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy- Results of a Phase III, Randomized, Open-Label, Active-Controlled Trial of Ferumoxytol.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2099-2099 ◽  
Author(s):  
David Hetzel ◽  
Audrone Urboniene ◽  
Kristine Bernard ◽  
William Strauss ◽  
Michael Cressman ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Controlled Trial ◽  
Treatment Options ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
History Of ◽  
Iv Iron

Abstract Abstract 2099 Background: While oral iron is the preferred first-line treatment for patients with iron deficiency anemia (IDA), there are patients who cannot take oral iron, do not tolerate it or do not adequately respond to oral iron. In the US and Canada, the only approved treatment options for these patients are the iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Therefore, many of these anemic patients do not receive IV iron, and remain inadequately treated and symptomatic. In the EU, several IV irons, including iron sucrose (IS), are approved for second line use. Few studies have evaluated the IV irons in head-to-head studies. Ferumoxytol (FER) is a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD) that is formulated to allow for bolus IV injection. This randomized, controlled trial was designed to investigate the efficacy and safety of FER compared to IS for the treatment of IDA in patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Methods: The study was designed to demonstrate non-inferiority and consisted of a 14 day screening period, treatment and a 5 week follow-up period. Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) < 20%. Patients were randomized 2:1 to receive either FER, administered as 2 injections of 510 mg 5±3 days apart, or IS, administered as 5 infusions or injections of 200 mg on 5 non-consecutive days over a 14 day period. Results: A total of 605 subjects were randomized to the 2 treatment arms (FER, n= 406; IS, n=199). FER demonstrated non-inferiority to IS in the proportion of subjects with a >2.0 g/dL increase in Hgb at any time from Baseline to Week 5 (the primary efficacy endpoint), compared to those treated with IS, (FER, 84%; IS 81%) with the lower bound of the 95% CI [-3.89%] above the predefined non inferiority margin [-15%]. In addition at each post-treatment time point, a higher percentage of FER-treated subjects achieved a >2.0 g/dL increase in Hgb compared to those treated with IS. FER also achieved non-inferiority to IS in the mean change in Hgb from Baseline to Week 5 with a robust 2.7g/dL increase in Hgb compared to 2.4g/dL with IS (the lower bound of the 95% CI [0.06g/dL] was above the predefined non-inferiority margin [-0.5g/dL]); this treatment difference (0.3 g/dL) was statistically significant (p=0.0124), and FER actually achieved superiority over IS. The overall rates of adverse events (AEs) and related AEs were lower in the FER group compared to IS-treated subjects. The serious adverse event (SAE) rate was higher in FER-treated subjects (FER, 4.2%; IS, 2.5%), but no pattern or safety trend was observed to suggest a specific safety signal; treatment-related SAEs were reported in 2 (0.5%) FER-treated subjects (1 anaphylactoid reaction and 1 hypertension). Protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were reported at a higher rate in IS-treated subjects compared to the FER treatment group (IS, 5.0%; FER, 2.7%). Cardiovascular AE rates were comparable in the 2 treatment groups (1.0%). Overall, the safety profile of FER was comparable to that of IS and no new safety signals were identified. Conclusion: In this randomized, controlled trial, the efficacy and safety of 2 doses of FER were shown to be comparable to IS in treating IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. For this IDA patient population, which has limited treatment options in the US and Canada, FER may offer an important, new treatment option with a convenient 2 dose regimen. Disclosures: Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

scholarly journals Oral Iron Therapy-Induced Neutropenia in Patient with Iron Deficiency Anemia

2020 ◽  
Vol 13 (2) ◽  
pp. 721-724 ◽  
Author(s):  
Mohammad N. Kloub ◽  
Mohamed A. Yassin
Keyword(s):  
Iron Deficiency ◽  
Replacement Therapy ◽  
Iron Deficiency Anemia ◽  
Male Patient ◽  
Hematological Parameters ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
Iron Replacement

Iron deficiency anemia is common and worldwide distributed, particularly among females; however, it can also occur among males. Iron deficiency anemia is commonly associated with thrombocytosis; little is known about the effect of iron therapy (oral or intravenous) on other hematological parameters. We report a 29-year-old male patient with iron deficiency anemia, who received oral iron replacement therapy and developed neutropenia which recovered spontaneously 1 month later.

Ferumoxytol Treatment Results in Robust Hemoglobin Increases in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy in a Phase III, Randomized, Placebo-Controlled Trial.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2098-2098
Author(s):  
Saroj Vadhan Raj ◽  
Michael Cressman ◽  
David Ford ◽  
William Strauss ◽  
Gerri Poss ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Group Treatment ◽  
Oral Iron ◽  
Phase Iii ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
History Of ◽  
Iv Iron

Abstract Abstract 2098 Background: Although oral iron therapy is often the initial approach to the treatment of iron deficiency anemia (IDA), many patients fail to adequately respond or do not tolerate oral iron. Unfortunately for these patients, approved treatment options are limited in the US and Canada to only the IV iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Many of these patients, therefore, do not get IV iron, and remain inadequately treated and symptomatic. Ferumoxytol (FER), a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD), is being investigated to treat IDA patients without CKD who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. This randomized, placebo-controlled, double blind trial was designed to assess the efficacy and safety of FER for the treatment of these IDA patients. Methods: Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) <20%. Subjects were randomized 3:1 to receive 2 injections of either FER (510 mg, 5±3 days apart) or placebo (IV normal saline). Efficacy assessments included comparisons of the change in Hgb, TSAT and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in the 2 treatment groups between Baseline and Week 5. Results: A total of 808 subjects were randomized to the 2 treatment arms (FER, n=608; placebo, n=200). FER demonstrated superiority to placebo with 81.1% of subjects achieving an increase in Hgb of >2.0 g/dL from Baseline to Week 5 compared to only 5.5% in the placebo group (treatment difference: 75.6%, p<0.0001). At each post-FER treatment time point, a larger percentage of FER-treated subjects had a >2.0 g/dL increase in Hgb compared with those treated with placebo. The superiority of FER was also demonstrated for the mean change in Hgb from Baseline to Week 5 with a robust 2.7 g/dL increase compared to only 0.1 g/dL in the placebo group (treatment difference: 2.54 g/dL, p<0.0001). An increase in TSAT from Baseline to Week 5 was only observed in FER-treated subjects (mean change: FER, 11.0%; placebo −0.1%). In addition, a statistically significant improvement in fatigue from Baseline to Week 5, as measured by the FACIT-Fatigue, was shown for FER-treated subjects compared to placebo (p<0.0001). The rates of adverse events (AEs) and related AEs were higher in the FER group, although no pattern or safety trend was observed to suggest a specific safety signal. The overall rate of serious adverse events (SAEs) was comparable between the 2 treatment groups (FER, 2.6%; placebo, 3.0%), and treatment-related SAEs associated with the class of IV iron products were reported in 4 (0.7%) FER-treated subjects. As expected, protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were noted at a higher rate in FER-treated subjects (FER, 3.6%; placebo, 1.0%). All cardiovascular AEs were considered unrelated by the investigators. Overall, FER was well tolerated and no new safety signals were identified. Conclusion: In this randomized, placebo-controlled Phase III trial, 2 doses of FER were shown to be highly effective in raising hemoglobin and iron parameters in non-CKD patients with IDA who had a history of unsatisfactory oral iron therapy. FER also significantly reduced fatigue, and was generally well tolerated with no new safety signals being identified. Therefore, FER could provide an important, new treatment option for IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Disclosures: Vadhan Raj: AMAG Pharmaceuticals, Inc.: Research Funding. Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

scholarly journals IRON ABSORPTION AND RESPONSE TO ORAL IRON THERAPY IN IRON DEFICIENCY ANEMIA ASSOCIATED TO ASYMPTOMATIC GIARDIASIS.

1993 ◽  
Vol 33 (6) ◽  
pp. 661-661
Author(s):  
Helena U Suzuki ◽  
Mauro B Morais ◽  
Jose N Corral ◽  
Ulisses Fagundes-Neto ◽  
Nelson L Machado
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Iron Absorption ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy

Poor efficacy of oral iron replacement therapy in pediatric patients with heart failure

2021 ◽  
pp. 1-8
Author(s):  
Kriti Puri ◽  
Joseph A. Spinner ◽  
Jacquelyn M. Powers ◽  
Susan W. Denfield ◽  
Hari P. Tunuguntla ◽  
...  
Keyword(s):  
Heart Failure ◽  
Iron Deficiency ◽  
Transferrin Saturation ◽  
Systolic Heart Failure ◽  
Oral Iron ◽  
Wilcoxon Test ◽  
Iron Therapy ◽  
Oral Iron Therapy ◽  
Iron Deficient ◽  
Iron Replacement

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.

scholarly journals Comparative Study of the Effects of Lactoferrin versus Oral Iron Therapy in Obese Children and Adolescents with Iron Deficiency Anemia

2021 ◽  
pp. 104-114
Author(s):  
Manal Mahmoud Atia ◽  
Rasha Mohamed Gama ◽  
Mohamed Attia Saad ◽  
Mohammed Amr Hamam
Keyword(s):  
Iron Deficiency ◽  
Children And Adolescents ◽  
Iron Deficiency Anemia ◽  
Interleukin 6 ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Obese Children ◽  
Oral Iron Therapy ◽  
Serum Hepcidin

Greater prevalence of iron deficiency (ID) has been observed in overweight and obese children and adolescents. Hepcidin acts as a key regulator of iron metabolism. Hepcidin synthesis increases in response inflammatory cytokines especially Interleukin-6 (IL-6). Considering that obesity represents a low grade chronic inflammatory state, a high concentration of hepcidin has been found in obese children. Elevated hepcidin level in obese children is associated with diminished response to oral iron therapy. Lactoferrin is an iron-binding multifunctional glycoprotein and has strong capacity to modulate the inflammatory response by its capacity to reduce pro-inflammatory cytokine expression in vivo, including IL-6 and hepcidin. Aim of the Work: To compare the efficacy of lactoferrin versus oral iron therapy in treatment of obese children and adolescents with iron deficiency anemia and the effect of therapy on serum hepcidin and interleukin 6 levels. Methodology: This prospective randomized clinical trial was conducted on 40 obese children and adolescents aged between 6 –18 years suffering from iron deficiency anemia (IDA). They were equally randomized into one of 2 groups. Group A received regular oral lactoferrin in a dose of 100 mg/day. Group B received regular oral iron supplementation (Ferric hydroxide polymaltose) in a dose of 6 mg elemental iron/kg /day.Baseline investigations included complete blood count (CBC), iron profile (Serum ferritin, serum iron, total iron binding capacity (TIBC), transferrin saturation), serum Interleukin 6, and serum hepcidin. Reevaluation of CBC was done monthly while iron status parameters, serum IL-6 and serum hepcidin were reevaluated after 3 months of receiving regular therapy. Results: Significant elevations in hemoglobin, MCV, MCH, Serum ferritin, serum iron and transferrin saturation with lactoferrin therapy compared to oral iron therapy. Significantly Lower TIBC after 3 months of lactoferrin therapy while the decrease in TIBC was insignificant in the iron therapy group.Lower serum hepcidin and IL6 after 3 months of lactoferrin therapy with no significant change in serum hepcidin and IL6 after iron therapy. Conclusion: This study clearly demonstrated the superiority of lactoferrin over iron use as oral in the treatment of iron deficiency anemia in obese children not only for the better response of hematological and iron status parameters and less gastrointestinal side effects but also for its effect on decreasing inflammatory biomarkers as hepcidin and IL6.

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