Ferric maltol (ST10): a novel oral iron supplement for the treatment of iron deficiency anemia in inflammatory bowel disease

2015 ◽  
Vol 16 (18) ◽  
pp. 2859-2867 ◽  
Author(s):  
Andreas Stallmach ◽  
Carsten Büning
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Bowel Disease ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Iron Supplement ◽  
Inflammatory Bowel

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.

scholarly journals P255 Efficacy and safety of a restrictive ferric carboxymaltose infusion strategy for iron deficiency anemia in inflammatory bowel disease patients

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S292-S292
Author(s):  
F Crispino ◽  
M Grova ◽  
M Maida ◽  
S Renna ◽  
A Casà ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Bowel Disease ◽  
Univariate Analysis ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Good Tolerability ◽  
Inflammatory Bowel ◽  
Rate Of Response

Abstract Background Iron deficiency anemia (IDA) is a common condition in patients with inflammatory bowel disease (IBD) and ferric carboxymaltose (FCM) has shown fast correction of hemoglobin (Hb) levels and good tolerability. We evaluated the response to FCM in IBD patients with IDA. The primary outcome was the assessment of the rate of response to single or multiple FCM infusions after 12 months from the first infusion. Secondary outcomes were the response to a single FCM infusion after 3 months and the assessment of FCM safety. Methods We retrospectively included 185 consecutive patients from IBD Unit of “Villa Sofia-V. Cervello” Hospital who received at least a dose of 500 mg FCM infusion between 2015 and 2018. Complete response (CR) was defined as Hb ≥13 g/dL (men) or ≥12 g/dL (women) or Hb increase ≥2 g/dL; partial response (PR) was defined as Hb increase ≥1 and &lt;2 g/dl, without anemia correction; response was considered either CR or PR. Failure was defined as Hb increase &lt;1 g/dl. A univariate analysis was performed among complete responders, partial responders and failures at 3 and 12 months. Results After 12 months the mean number of FCM infusions was 1.7 ± 1.1 and the rate of response was 139/185 (75.1%; CR: 48.6%; PR: 26.4%). Concerning our secondary endpoint, 169/185 patients received a single infusion of FCM within 3 months, and 134/169 patients (79.2%) achieved response (CR: 56.8%; PR: 22.4%). At univariate analysis low ferritin was the only variable associated with failure at 12 months (p &lt; 0.003). No adverse events were reported. Conclusion A restrictive FCM infusion strategy is effective in most IBD patients with IDA. Interestingly, no association was found with Hb and weight at baseline, so further studies are needed to assess their effective role in deciding dosage of FCM.

scholarly journals Safety and Efficacy of Intravenous Iron Sucrose for Iron-Deficiency Anemia in Children and Adolescents With Inflammatory Bowel Disease

2019 ◽  
Vol 6 ◽  
pp. 2333794X1987098
Author(s):  
Ramy Sabe ◽  
Anant Vatsayan ◽  
Amr Mahran ◽  
Ali S. Khalili ◽  
Sanjay Ahuja ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Bowel Disease ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Safety And Efficacy ◽  
Normal Ranges ◽  
Inflammatory Bowel

Background. Anemia is common in inflammatory bowel disease (IBD). Oral iron is widely used but efficacy can be reduced by poor compliance and insufficient absorption. Intravenous iron is safe and effective in adults but is not well studied in children. Purpose. To assess safety and efficacy of intravenous iron sucrose (IVIS) in children with IBD. Methods. We reviewed medical records of IBD patients <22 years of age who received IVIS at our institution between 2009 and 2014. Anemia was defined as hemoglobin (Hgb) level below normal for age and gender and iron-deficiency anemia as serum iron studies and red cell mean corpuscular volume below normal ranges. Each IVIS infusion was evaluated for safety. Efficacy was defined as ≥2 g/dL increase in Hgb ≤12 weeks from IVIS initiation. Results. We identified 88 patients (Crohn’s disease, n = 52; ulcerative colitis, n = 33; IBD-unclassified, n = 3) who underwent 329 IVIS infusions over 121 courses. No patient developed anaphylaxis. Six patients developed minor adverse reactions. Of the 121 IVIS courses, 80 were included in the efficacy evaluation. There was a significant rise in Hgb (mean 9.1 ±1.4 to 11.9 ± 1.8 g/dL; P < .0001, paired t test). Overall, 58.7% (47/80 courses) resulted in goal Hgb increase. Conclusions. IVIS is safe and effective in treating iron-deficiency anemia in pediatric IBD. There were only minor adverse events, and the observed rise in Hgb was clinically significant, with the majority achieving goal Hgb.

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