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An estimated 36% to 90% of people with inflammatory bowel disease (IBD) are iron deficient due to chronic inflammation and iron malabsorption
.
Iron deficiency is associated with symptoms such as fatigue, headache, dizziness, shortness of breath, and palpitation
An estimated 36% to 90% of people with inflammatory bowel disease (IBD) are iron deficient due to chronic inflammation and iron malabsorption
In this open-label Phase 3 clinical trial, adults with non-severe 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 [female/male]; transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous carboxymaltose according to each center's standard practice iron
.
The primary endpoint was hemoglobin response rate (≥2 g/dL increase or normalization) at week 12
Results of the study showed that for the intention-to-treat (iron maltol, n = 125/iron carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, the iron 12 weeks for patients receiving iron carboxymaltose injections The response rates were 67% and 68%, respectively, and the 12-week response rates for iron in patients receiving oral iron maltol were 84% and 85%, respectively
.
Mean increases in hemoglobin at weeks 12, 24, and 52 were 2.
Figure: Schematic diagram of the experiment
The results of this study demonstrate that iron maltol achieved a clinically relevant increase in iron content in hemoglobin, but did not show superiority over iron carboxymaltose at week 12
.
Both treatments had comparable long-term efficacy on hemoglobin and ferritin at 52 weeks and were well tolerated
The results of this study demonstrate that iron maltol achieved a clinically relevant increase in iron content in hemoglobin, but did not show superiority over iron carboxymaltose at week 12
Stefanie Howaldt.
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.
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