Bernd Bokemeyer1, Annette Krummenerl2, Christian Maaser3, Stefanie Howaldt4, Michael Mroß5, Nick Mallard6. 1. Gastroenterology Practice Minden, Uferstr. 3, 32423, Minden, Germany. bernd.bokemeyer@t-online.de. 2. Krankenhaus Martha-Maria Halle-Dölau, Klinik für Innere Medizin I, Halle (Saale), Germany. 3. Städtisches Klinikum Lüneburg, Ambulanzzentrum Gastroenterologie am Klinikum Lüneburg, Lüneburg, Germany. 4. Schwerpunktpraxis CED, Hamburg, Germany. 5. Gastroenterologische Schwerpunktpraxis, Berlin, Germany. 6. Clinical Development, Shield TX (UK) Limited, Gateshead, UK.
Abstract
BACKGROUND: Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD). Oral ferric maltol improves and normalizes hemoglobin (Hb) in patients with IBD. AIM: This open-label, randomized Phase 1 study evaluated the pharmacokinetics of ferric maltol and its effect on iron indices in IBD patients with iron deficiency (with or without anemia). METHODS:Iron deficient adult IBD patients received ferric maltol 30, 60, or 90 mg twice daily during an 8-day period. Pharmacokinetics and iron uptake were assessed on days 1 and 8. RESULTS:Twenty-four patients were included: 13 with Crohn's disease and 11 with ulcerative colitis (mean age 39 years; 67 % female, mean Hb 13.0 g/dL; mean reticulocyte Hb content (CHr) 31.9 pg; mean ferritin 13.9 µg/L). Plasma maltol and maltol glucuronide increased rapidly at all doses, reaching maximum plasma concentration (C max) 1.0-1.5 h post-dose and declining to baseline after 3-6 h. Maltol and maltol glucuronide exposure (area under the concentration-time curve; AUC) appeared dose proportional with twice-daily dosing, with higher exposure to maltol glucuronide vs. maltol. Mean day 8/day 1 ratios for C max and AUC0-t indicated no accumulation after 7 days of twice-daily dosing. Serum iron and transferrin saturation (TSAT) increased with all doses (maximum values at 1.5-3.0 h post-dose). Serum ferritin and CHr increased by day 8, with greater improvements with 60 and 90 mg twice-daily doses than with 30 mg twice-daily doses. CONCLUSIONS: The key constituents of ferric maltol showed predictable pharmacokinetics, with no accumulation over 7 days and increased iron uptake and storage over time at 30-90 mg twice-daily doses.
RCT Entities:
BACKGROUND:Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD). Oral ferric maltol improves and normalizes hemoglobin (Hb) in patients with IBD. AIM: This open-label, randomized Phase 1 study evaluated the pharmacokinetics of ferric maltol and its effect on iron indices in IBDpatients with iron deficiency (with or without anemia). METHODS:Iron deficient adult IBDpatients received ferric maltol 30, 60, or 90 mg twice daily during an 8-day period. Pharmacokinetics and iron uptake were assessed on days 1 and 8. RESULTS: Twenty-four patients were included: 13 with Crohn's disease and 11 with ulcerative colitis (mean age 39 years; 67 % female, mean Hb 13.0 g/dL; mean reticulocyte Hb content (CHr) 31.9 pg; mean ferritin 13.9 µg/L). Plasma maltol and maltol glucuronide increased rapidly at all doses, reaching maximum plasma concentration (C max) 1.0-1.5 h post-dose and declining to baseline after 3-6 h. Maltol and maltol glucuronide exposure (area under the concentration-time curve; AUC) appeared dose proportional with twice-daily dosing, with higher exposure to maltol glucuronide vs. maltol. Mean day 8/day 1 ratios for C max and AUC0-t indicated no accumulation after 7 days of twice-daily dosing. Serum iron and transferrin saturation (TSAT) increased with all doses (maximum values at 1.5-3.0 h post-dose). Serum ferritin and CHr increased by day 8, with greater improvements with 60 and 90 mg twice-daily doses than with 30 mg twice-daily doses. CONCLUSIONS: The key constituents of ferric maltol showed predictable pharmacokinetics, with no accumulation over 7 days and increased iron uptake and storage over time at 30-90 mg twice-daily doses.
Authors: Gert Van Assche; Axel Dignass; Bernd Bokemeyer; Silvio Danese; Paolo Gionchetti; Gabriele Moser; Laurent Beaugerie; Fernando Gomollón; Winfried Häuser; Klaus Herrlinger; Bas Oldenburg; Julian Panes; Francisco Portela; Gerhard Rogler; Jürgen Stein; Herbert Tilg; Simon Travis; James O Lindsay Journal: J Crohns Colitis Date: 2012-10-03 Impact factor: 10.020
Authors: Jr Fraser Cummings; Aileen Fraser; Catherine Stansfield; Ian Beales; Shaji Sebastian; Sami Hoque Journal: BMJ Open Gastroenterol Date: 2021-02