Anemia 2013 July-8

 

Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease.

Clin Gastroenterol Hepatol. 2013 Mar;11(3):269-77.

Evstatiev R, Alexeeva O, Bokemeyer B, Chopey I, Felder M, Gudehus M, Iqbal T, Khalif I, Marteau P, Stein J, Gasche C; FERGI Study Group.

Department of Medicine 3, Division of Gastroenterology and Hepatology and Christian Doppler Laboratory for Molecular Cancer Chemoprevention, Medical University of Vienna, Vienna, Austria.

 

Abstract

BACKGROUND & AIMS: Iron-deficiency anemia is the most common systemic complication of inflammatory bowel diseases (IBD). Iron-deficiency anemia recurs frequently and rapidly after iron-replacement therapy in patients with IBD. We performed a randomized, placebo-controlled trial to determine if administration of ferric carboxymaltose (FCM) prevents anemia in patients with IBD and low levels of serum ferritin.

METHODS: We performed a single-blind, multicenter study of nonanemic patients who had completed the FERGIcor study. Serum levels of ferritin were assessed every second month, and patients were given FCM (total iron dose, 1181 ± 662 mg; n = 105) or placebo (n = 99) when levels decreased to less than 100 μg/L. The primary end point was time to recurrence of anemia within 8 months. Secondary end points included changes of quality of life, disease activity, results from laboratory tests, and adverse events.

RESULTS: Anemia recurred in 26.7% of subjects given FCM and in 39.4% given placebo. The time to anemia recurrence was longer in the FCM group (hazard ratio, 0.62; 95% confidence interval, 0.38-1.00; P = .049). Markers of body levels of iron increased or remained at normal levels in subjects given FCM (ferritin increased by 30.3 μg/L, transferrin saturation increased by 0.6%) but decreased in the group given placebo (ferritin decreased by 36.1 μg/L, transferrin saturation decreased by 4.0%). Changes in quality of life and disease activity were comparable between groups. Adverse events were reported in 59.0% of the FCM group and 50.5% of the placebo group, and serious adverse events were reported in 6.7% and 8.1%, respectively.

CONCLUSIONS: FCM prevents recurrence of anemia in patients with IBD, compared with placebo. Nevertheless, the high rate of anemia recurrence warrants optimization of the frequency and requirements for FCM treatment. Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

PMID: 23078888

 

Chris Gasche-png

Ferric Carboxymaltose in GastroIntestinal Disease – the FERGI trials

FERGIcor (Evstatiev R. et al. Gastroenterology 2011;141:846–853): This randomized, controlled, open-label, multicenter study included 485 patients with iron deficiency anemia (ferritin <100 ng/mL, hemoglobin [Hb] 7–12 g/dL [female] or 7–13 g/dL [male]) and mild-to-moderate or quiescent inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) at 88 hospitals and clinics in 14 countries. Patients received either Ferric Carboxymaltose (FCM) according to a simple scheme in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated Iron Sucrose dosages in up to 11 infusions of 200 mg iron. The primary end point was Hb response (Hb increase >2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12. The simple FCM dosing scheme turned out superior to Iron Sucrose.

FERGImain (Evstatiev R. et al. Clin Gastroenterol Hepatol 2013;11:269–277): This was a single-blind, multicenter study of non-anemic patients who had completed the FERGIcor study. Serum levels of ferritin were assessed every eight weeks, and patients were given FCM or placebo when levels decreased to less than 100 ng/mL. The primary end point was time to recurrence of anemia within 32 weeks. Secondary end points included changes of quality of life, disease activity, results from laboratory tests, and adverse events. FCM was superior to placebo in prevention of anemia recurrence. The time to anemia recurrence (Hb <12 [female]; <13 g/dL [male]) was longer in the FCM group (hazard ratio 0.62; 95% confidence interval 0.38 –1.00; p=0.049).

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