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* = Presenting author

P521 Correcting iron deficiency anaemia in IBD with oral ferric maltol: Use of proton pump inhibitors does not affect efficacy

C. Büning*1, T. Ahmad2, B. Bokemeyer3, F. Cummings4

1Krankenhaus Waldfriede, Internal Medicine, Berlin, Germany, 2Royal Devon and Exeter NHS Foundation Trust, Gastroenterology, Exeter, United Kingdom, 3Gastroenterology Practice Minden, Gastroenterology , Minden, Germany, 4University Hospital Southampton, Gastroenterology, Southampton, United Kingdom

Background

Ferric maltol (ST10) has been shown to correct iron deficiency anaemia (IDA) in a group of IBD subjects intolerant of oral ferrous sulphate. Ferrous iron products work most effectively in an acid environment in the stomach, where the iron remains in an oxidized 2+ form, and raised pH reduces iron absorption. Ferric maltol has been shown to be stable and soluble at a wide range of pH. Use of proton pump inhibitors (PPI) raises gastric pH and has been linked to reduced effectiveness of oral iron. Ferric maltol has been shown in a randomised study (AEGIS) to be effective in raising Hb in IBD subjects with IDA. The aim of this subgroup analysis was to examine Hb change following ferric maltol treatment in patients taking PPIs.

Methods

In a previously reported double blind randomised controlled trial (AEGIS) of 128 IBD subjects with IDA, and intolerant of ferrous sulphate (Hb 9.5 - 12.0g/dL female, 9.5-13.0g/dL male; and ferritin <30µg/L), were randomised to receive oral 30mg ferric maltol twice a day for 12 weeks or identical placebo. The primary endpoint of the initial study was change in Hb compared to baseline, at week 12. PPI intake was recorded at baseline. The subgroups (PPI vs no PPI) were analysed by UC or CD for Hb change at week 12 compared to baseline, using the intent to treat population.

Results

128 subjects were randomised 1:1 and all included in the ITT population. Mean age was approximately 40 years in both UC and CD groups and 64% female. Overall Hb increased by 2.25 g/dL in the ferric maltol group compared to 0 g/dL in the placebo-group at week 12 (p<0.0001). PPI use was 14% in UC- and 24% in CD-patients. We did not observe a significant difference in Hb increase in the PPI vs no-PPI subgroups (see table; mean Hb change and lower 97.5% confidence interval).

nUCnCD
Mean Hb change g/dL (ferric maltol vs placebo, at w12)Lower 97.5% CI *Mean Hb change g/dL (ferric maltol vs placebo, at w12)Lower 97.5% CI *
All subjects ITT582.451.68701.981.66
Taking PPI14%2.431.5124%1.650.89
No PPI86%2.501.6176%2.141.70

Conclusion

Increase in Hb in IBD subjects with IDA following 12 weeks of ferric maltol treatment did not appear to be affected by concomitant PPI use in UC subjects. However there was a greater difference in the CD group. The numbers in each subgroup are modest and further studies are needed to confirm these findings. So far these data support the appropriate use of ferric maltol irrespective of PPI treatment.