FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease

2011;141:846–853

 

FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease

 

Rayko Evstatiev,1 Phillppe Marteau,2 Tariq Iqbal,3 Igorl. Khalif,Jurgen Stein, 5Bernd Bokemeyer,6Ivan V. Chopey,7 Florian S. Gutzwiller,8 Lise Riopel,9 and Christoph Gasche,1 for the FERGI Study Group

 

1Department of Medicine 3, Division of Gastroenterology and Hepatology, Christian Doppler Laboratory for Molecular Cancer Chemoprevention, Medical University of Vienna, Vienna, Austria; 2AP-HP, Département medico-chirurgical de pathologie digestive Hôpital Lariboisière & Université Denis Diderot- Paris7, Paris, France; 3University Hospital, Birmingham, United Kingdom; 4State Scientific Centre of Coloproctology, Moscow, Russia; 5Department of Gastroenterology and Clinical Nutrition and Crohn Colitis Centre Rhein Main, Frankfurt/Main, Germany; 6Gastroenterologische Gemeinschaftspraxis, Minden, Germany; 7National University, Uzhgorod, Ukraine; 8Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland; and 9Vifor Pharma, Glattbrugg, Switzerland

 

Background and 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 ≥2g/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.

 

Conclusion

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.

 

View this article’s video abstract at www.gastrojournal.org.

 

(Reference link : www.gastrojournal.org/article/S0016-5085(11)00762-1/pdf )