BACKGROUND & AIMS: Iron deficiency anemia (IDA) is common in chronic diseases 
and intravenous iron is an effective and recommended treatment. However, dose 
calculations and inconvenient administration may affect compliance and efficacy. 
We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose 
regimen (FCM) with individually calculated iron sucrose (IS) doses in patients 
with inflammatory bowel disease (IBD) and IDA.
METHODS: This randomized, controlled, open-label, multicenter study included 485 
patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7-12 g/dL [female] or 
7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and 
clinics in 14 countries. Patients received either FCM in a maximum of 3 
infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 
infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥ 2 
g/dL); secondary end points included anemia resolution and iron status 
normalization by week 12.
RESULTS: The results of 240 FCM-treated and 235 IS-treated patients were 
analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 
118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 
[61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life 
scores by week 12. Study drugs were well tolerated and drug-related adverse 
events were in line with drug-specific clinical experience. Deviations from 
scheduled total iron dosages were more frequent in the IS group.
CONCLUSIONS: The simpler FCM-based dosing regimen showed better efficacy and 
compliance, as well as a good safety profile, compared with the 
Ganzoni-calculated IS dose regimen.