A comparative study of efficacy of single dose of intravenous ferric carboxymaltose over oral iron therapy in severe iron deficiency Anemia

2019 ◽  
Vol 10 (2) ◽  
pp. 162-164
Author(s):  
Makarand Balwant Mane ◽  
◽  
Priyanka Makarand Mane ◽  
Akshay Shirshat ◽  
Tejas Uttamrao Bhosale ◽  
...  
Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 484-484
Author(s):  
Lawrence T. Goodnough ◽  
David Morris ◽  
Todd Koch ◽  
Andy He ◽  
David Bregman

Abstract Abstract 484 Background Treatment options for individuals diagnosed with iron deficiency anemia (IDA) include oral or intravenous iron. Oral iron may not increase patient hemoglobin levels adequately, due to poor compliance and/or suboptimal gastrointestinal absorption due to inflammation-mediated induction of hepcidin, which regulates iron homeostasis. This study evaluated whether hepcidin levels can be used to identify patients with IDA who are unresponsive to oral iron therapy. Methods Hepcidin levels were assessed in a subset of subjects enrolled in a randomized trial comparing oral iron (ferrous sulfate) to intravenous iron (Injectafer®[ferric carboxymaltose, FCM]) in subjects with IDA (Hemoglobin [Hb] ≤ 11 g/dL; and ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL when transferrin saturation (TSAT) was ≤ 30%) (Szczech et al Amer Soc Nephrol 2011; 22:405A). Subjects who met the inclusion criteria underwent a 14-day (run-in) course of ferrous sulfate 325 mg, three times per day. Subjects with an increase in Hb ≥ 1 g/dL were considered to be “responders” and not randomized. “Non-responders” were randomized to ferric carboxymaltose (2 injections of 750 mg given on Day 0 [day of randomization] and Day 7) or oral iron for 14 more days. Hb levels and markers of iron status were assessed at screening (day-15), day-1 and day 35. Hepcidin levels were analyzed at screening (Day -15) in an initial Cohort (I) of 44 patients, 22 responders and 22 non-responders. A hepcidin value of >20 ng/mL was identified for further analysis for predictive values for non-responsiveness to 14 day oral iron run-in in 240 patients (Cohort II). Hepcidin levels were also analyzed at Day -1 and Day 35 in a Cohort (III) of patients who were then randomized to FCM vs. oral iron therapy. Results Hepcidin screening levels in Cohort I were significantly higher in the non-responders vs. responders (33.2 vs. 8.7 ng/mL, p < 0.004). Twenty one of 22 non-responders had hepcidin values > 20 ng/mL. For Cohort II, mean hepcidin levels were again significantly higher in the non-responders vs. responders (38.4 vs. 11.3 ng/mL, p = 0.0002). Utilizing a hepcidin criterion of > 20 ng/mL, we found a sensitivity of 41.3% (26 of 150), specificity of 84.4% (76 of 90), and a positive predictive value (PPV) of 81.6% (62 of 76) for non-responsiveness to oral iron (Figure: The Receiver Operator Characteristic curves present plots of sensitivity vs. (1-specificity) for hepcidin, ferritin, and TSAT at the various cutoff levels indicated near the respective curves in the same color as the respective curves). While ferritin < 30ng/mL or TSAT <15% had greater sensitivity (77.3% and 64.7%, respectively), their PPVs (59.2% and 55%) were inferior to PPVs for hepcidin. Patients subsequently randomized to FCM vs. oral iron responded with Hgb increases of ≥1 g/dL for 65.3% vs. 20.8% (p <0.0001)and mean Hgb increases of 1.7 ± 1.3 vs. 0.6 ± 0.9 g/dL (p = 0.0025), respectively. Conclusion Our analysis provides evidence that non-responsiveness to oral iron in patients with iron deficiency anemia can be predicted from patients' baseline hepcidin levels, which have superior positive predictive values compared to transferrin saturation or ferritin levels. Furthermore, non-response to oral iron therapy does not rule out iron deficiency, since two thirds of these non-responders to oral iron responded to IV iron. Disclosures: Goodnough: Luitpold: Consultancy. Off Label Use: ferric carboxymaltose for treatment of iron deficiency anemia. Morris:Luitpold: Consultancy. Koch:Luitpold: Employment. He:Luitpold: Employment. Bregman:Luitpold: Employment.


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

Author(s):  
Manal Mahmoud Atia ◽  
Rasha Mohamed Gama ◽  
Mohamed Attia Saad ◽  
Mohammed Amr Hamam

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.


PEDIATRICS ◽  
2013 ◽  
Vol 131 (2) ◽  
pp. e620-e625 ◽  
Author(s):  
D.-A. Khuong-Quang ◽  
J. Schwartzentruber ◽  
M. Westerman ◽  
P. Lepage ◽  
K. E. Finberg ◽  
...  

2016 ◽  
Vol 32 (3) ◽  
Author(s):  
Cigdem Gereklioglu ◽  
Süheyl Asma ◽  
Asli Korur ◽  
Ferit Erdogan ◽  
Altug Kut

2013 ◽  
Vol 88 (2) ◽  
pp. 97-101 ◽  
Author(s):  
David B. Bregman ◽  
David Morris ◽  
Todd A. Koch ◽  
Andy He ◽  
Lawrence T. Goodnough

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2163-2163
Author(s):  
Jacquelyn M. Powers ◽  
Deborah I Thompson

INTRODUCTION Iron deficiency anemia (IDA) affects approximately 3% of children 1 to 3 years of age and is associated with poor neurocognitive outcomes. Children of Hispanic/Latino ethnicity, from primarily Spanish-speaking homes, and/or those of low socioeconomic status, are disproportionately affected. Oral iron therapy for 3 to 6 months is considered standard care therapy and mitigates these effects. Yet non-adherence often results in treatment failure, prolonging the treatment course and negative health consequences of IDA. Limited previous work has focused on interventions to improve adherence to iron therapy. Behavior change interventions, particularly when designed within a theoretical framework, can improve rates of treatment adherence. Our objective was to design a theoretically-based behavioral intervention to improve adherence to oral iron therapy in young children with nutritional IDA. METHODS Formative research was conducted via a mixed-methods study of 20 children with nutritional IDA and their primary caretaker. Demographic information, including number of children and caregivers in the home, was obtained from the primary caregiver. Clinical aspects of patients' IDA diagnosis and iron therapy were obtained from the electronic medical record. Semi-structured interviews with caregivers were conducted to characterize barriers to and facilitators of iron therapy. A framework for a technology-based intervention, named IRONCHILD, was created to coincide with clinical visit time points over a three-month period. Results from the formative research, along with constructs from the self-determination theory of motivation (autonomy, competence, relatedness), informed message content for the intervention scripts. This theory was selected because the degree to which its three principle constructs (basic psychological needs) are met drives levels of motivation to perform a specific behavior such as medication adherence. Three scripted online intervention sessions were developed, professionally translated into Spanish, and then animated by a professional animation and web design studio. Audio recording with a professional bilingual voice actor provided the narration for online sessions. RESULTS IRONCHILD is an interactive website with specific message content designed to be delivered at three standard of care clinical visits (Figure). At the initial visit, participants are introduced to a relational agent or virtual health educator, Maria, who is a pediatric nurse and mother of a child formerly treated for IDA. Maria provides an introduction to the overall program format and content and guides each session. Participants next view a Topic Introduction animation that provides an overview of the diagnosis of IDA, its clinical consequences, and a typical treatment course with oral iron therapy. This is followed by two unique content segments that provide information on (1) dietary counseling and (2) administration of oral iron therapy. Following each of the content segment, participants view question/response options, make a selection, and receive feedback. At the end of the session, participants select goal(s) related to therapy adherence for the interval between clinical visits. The second session provides two additional content segments that focus on (1) problem-solving for difficulties related to medication administration and (2) identifying motivating factors to adhere to therapy. The third session allows users to access all previous content and provides closing information about adhering to any ongoing treatment recommendations from their child's provider. Between visits, access to the website occurs via a unique username and password caregivers can use to logon to the website and view previous sessions. All aspects of IRONCHILD are available in both English and Spanish. Finally, an administrative dashboard for IRONCHILD captures program usage information as families log onto the program and navigate the sessions (e.g., number of log-ins; responses to question prompts; goals set; goal attainment). CONCLUSIONS IRONCHILD is a theoretically-based online intervention designed to improve adherence to oral iron therapy in caregivers of young children with nutritional IDA. Further research is needed to assess the effectiveness of the intervention on adherence as well as factors that affect implementation into routine clinical care.


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