Ferric Maltol: A New Oral Iron Formulation for the Treatment of Iron Deficiency in Adults

2020 ◽  
Vol 55 (2) ◽  
pp. 222-229 ◽  
Author(s):  
Adonice Khoury ◽  
Kaley A. Pagan ◽  
Michelle Z. Farland
Keyword(s):  
Chronic Kidney Disease ◽  
Inflammatory Bowel Disease ◽  
Kidney Disease ◽  
Iron Deficiency ◽  
Bowel Disease ◽  
Oral Iron ◽  
Data Sources ◽  
Deficiency Anemia ◽  
Iv Iron ◽  
Inflammatory Bowel

Objective: To review the pharmacology, efficacy, and safety of ferric maltol (FM), an oral iron formulation, for iron deficiency anemia (IDA). Data Sources: A MEDLINE/PubMed and EMBASE (January 1, 1985, to June 19, 2020) literature search was performed using the terms ferric maltol, accrufer, feraccru, iron maltol, ferric trimaltol, iron deficiency, iron deficiency anemia, inflammatory bowel disease, and chronic kidney disease. Additional data sources included prescribing information, abstracts, and the National Institutes of Health Clinical Trials Registry. Study Selection/Data Extraction: English language literature evaluating FM pharmacology, pharmacokinetics, efficacy, or safety in the treatment of IDA were reviewed. Data Synthesis: FM is a ferric, non–salt-based oral iron formulation demonstrating improved tolerance in patients with previous intolerance to other iron formulations. Phase 3 trials demonstrated significant improvements in anemia and serum iron parameters in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Common adverse effects were gastrointestinal intolerance. Relevance to Patient Care and Clinical Practice: FM is an effective and well-tolerated alternative to oral iron salts for patients with IBD or CKD and IDA. Emerging data suggest that FM is noninferior to intravenous (IV) ferric carboxymaltose in patients with IBD and IDA. Prior to selecting FM over IV iron products, consideration should be given to time to normalization of Hb, ease of administration, cost, and tolerability. Conclusion: FM is a relatively safe, effective oral iron therapy that may be better tolerated than other oral iron formulations. FM may be an effective alternative to IV iron in patients with IBD.

P020 PRACTICE PATTERNS OF PRIMARY CARE AND GASTROENTEROLOGY PHYSICIANS IN THE MANAGEMENT OF IRON DEFICIENCY ANEMIA IN INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S54-S54
Author(s):  
Francis Wade ◽  
Florence-Damilola Odufalu ◽  
Gretchen Grosch ◽  
Melissa Chambers ◽  
Katie Schroeder
Keyword(s):  
Primary Care ◽  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Bowel Disease ◽  
Practice Patterns ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Poor Knowledge ◽  
Iv Iron ◽  
Inflammatory Bowel

Abstract Introduction Iron deficiency Anemia (IDA) is a common complication of inflammatory bowel disease (IBD). High prevalence of IDA in IBD suggests suboptimal surveillance and treatment. Oral iron is poorly tolerated, associated with worsened disease activity, and often insufficient to reverse anemia in IBD patients. Intravenous (IV) iron is favored for treatment of IDA in IBD in most clinical scenarios and many guidelines recommend IV iron as first line for IBD patients. Regardless, oral iron is prescribed commonly for IDA in IBD. The objective of this study is to determine practice patterns of primary care physicians (PCP) and gastroenterologists (GI) in the management of IDA in IBD. Methods We anonymously surveyed GI and PCP attendings and trainees at Saint Louis University School of Medicine in St. Louis, Missouri, using paper self-administered instruments. We asked about practice patterns in the management of IDA in IBD patients and knowledge of IV iron. The study questionnaire was developed based on United States expert opinion consensus statements and European guideline recommendations published in the Journal of Crohn’s and Colitis and Inflammatory Bowel Diseases. Results Of GI responders, 92.3% were fellows, 7.7% were attendings; of PCP responders, 81.8% were residents, 18.2% were attendings. 15.4% GIs, 12.7% PCPs were very comfortable managing IBD patients with IDA; 76.9% GIs, 58.2% PCPs were somewhat comfortable; 7.7% GIs, 29.1% PCPs were not comfortable (p=0.275). 61.5% GIs, 25.5% PCPs always check iron studies when evaluating anemic IBD patients; 30.1% GIs, 21.8% PCPs check most of the time; 7.7% GIs, 34.5% PCPs sometimes check; 0% GIs, 12.7% PCPs rarely check; 0% GIs, 5.4% PCPs never check (p =0.05). In mild Crohn’s disease with severe anemia, 15.4% GIs, 41.8% PCPs would prescribe oral iron daily; 15.4% GIs, 12.7% PCPs would prescribe oral iron every other day; 69.2% GIs, 45.5% PCPs would prescribe IV iron (p=0.58). 0% GIs reported good knowledge of IV iron, 53.8% reported acceptable knowledge, and 46.1% reported poor knowledge. 7.7% GIs, 10.9% PCPs reported good knowledge of how to order IV iron; 53.8% GIs, 7.3% PCPs reported acceptable knowledge; 38.5% GIs, 81.8% PCPs reported poor knowledge (p=0.000215). 23.1% GIs, 61.8% PCPs thought PCPs were responsible for screening for IDA in IBD patients; 76.9% GIs, 36.4% PCPs thought GIs were responsible (p= 0.0131). Discussion Both PCPs and GIs perceived responsibility to manage IDA in IBD patients. PCPs were less likely than GIs to screen for IDA in anemic IBD patients or to report adequate knowledge of clinic processes to order IV iron. Future efforts to reinforce gastroenterologists’ role in the management of IDA in IBD and to bolster familiarity with IV iron and its indications might improve outcomes and quality of life for IBD patients.

VP151 Endovenous Iron Deficiency Anemia Treatment In Inflammatory Bowel Disease: Hospital-based Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 219-220
Author(s):  
Jovana Stojanovic ◽  
Flavia Kheiraoui ◽  
Enrica Maria Proli ◽  
Franco Scaldaferri ◽  
Massimo Volpe ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Technology Assessment ◽  
Bowel Disease ◽  
Health Technology ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Iv Iron ◽  
Inflammatory Bowel

INTRODUCTION:Iron Deficiency Anemia (IDA), a common cause of anemia in the world, is a frequently neglected disease that represents the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD) (1). The release of new intravenous (IV) iron compounds represents a great opportunity for both physicians and patients, but the higher costs might hold back their optimal diffusion. A Health Technology Assessment (HTA) approach was used to provide insights on the sustainability of the IV iron formulations in a hospital setting, with a special focus on ferric carboxymaltose.METHODS:Epidemiology of IBD, as well as IDA associated with these conditions, was assessed with a systematic appraisal of the published literature. Data on efficacy and safety of IV iron formulations currently used in Italy were retrieved from the available medical electronic databases. A hospital based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed.RESULTS:The reported prevalence of anemia in patients with IBD varies markedly from 10 to 73 percent for Crohn's Disease and from 9 to 67 percent for Ulcerative Colitis. Although there are no studies on direct comparison of different IV iron preparations, the literature indicates good efficacy and safety profiles of these formulations. However, ferric carboxymaltose seemed to provide a better and faster correction of hemoglobin and serum ferritin levels in iron-deficient patients (2,3). Our analyses indicated that ferric carboxymaltose, in spite of a greater price, would have positive benefits for the hospital, in terms of reduced costs related to individual patient management, and for the patients themselves, by reducing the number of infusions and accesses to health facilities.CONCLUSIONS:This hospital-based HTA reports an overall positive organizational, economic and ethical evaluation for the sustainable introduction of ferric carboxymaltose in the Italian outpatient setting.

scholarly journals Sucrosomial Iron Supplementation for the Treatment of Iron Deficiency Anemia in Inflammatory Bowel Disease Patients Refractory to Oral Iron Treatment

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1770
Author(s):  
Guillermo Bastida ◽  
Claudia Herrera-de Guise ◽  
Alicia Algaba ◽  
Yolanda Ber Nieto ◽  
Jose Manuel Soares ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Bowel Disease ◽  
Clinical Symptoms ◽  
Good Health ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Inflammatory Bowel ◽  
Almost All

Iron deficiency anemia (IDA) is a common manifestation of Inflammatory Bowel Disease (IBD). Oral iron supplements are the treatment of choice, but are not always well tolerated. Sucrosomial® iron (SI) may represent an alternative. This prospective study assessed the tolerability and effectiveness of SI, and quality of life (QoL) of IDA-IBD patients who were intolerant to oral iron salts. The study included 52 individuals treated with 1 capsule/day for 12 weeks. Tolerability was assessed through a gastrointestinal symptom severity questionnaire. Hemoglobin (Hb) levels and clinical symptoms of IDA were analyzed. QoL was assessed using IBDQ-9 and EuroQoL questionnaires. The percentage of patients with excellent/good health increased from 42.9% to 94.3%. Mean Hb concentration significantly increased at all follow-up visits (p < 0.05). Almost all participants (96.9%) were adherent to the study medication. Patients’ QoL improved (IBDQ-9: from 60.9 to 65.5). Patients also improved in mobility (71.8% to 78.1%), usual activities (51.3% to 68.7%), pain/discomfort (41.0% to 53.1%), and extreme depression/anxiety problems (7.7% to 3.2%); they worsened in self-care (100% to 90.6%), but perceived an enhancement in their global health [EQ-VAS score: 61.9 (±26.1) to 66.9 (±20.3)]. SI was well tolerated and improved IDA symptoms, IBD activity, and patients’ QoL. In conclusion, SI should be considered in IDA–IBD patients.

scholarly journals Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial

2021 ◽  
Author(s):  
Stefanie Howaldt ◽  
Eugeni Domènech ◽  
Nicholas Martinez ◽  
Carsten Schmidt ◽  
Bernd Bokemeyer
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Primary Endpoint ◽  
Bowel Disease ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Inflammatory Bowel ◽  
Intent To Treat

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, &lt;30 ng/mL/&lt;100 ng/mL with transferrin saturation &lt;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.

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