Ferric Carboxymaltose Better for Intravenous Iron Replacement in IBDA novel regimen was superior to standard iron sucrose at increasing hemoglobin levels in patients with inflammatory bowel disease and iron deficiency — at less overall cost.
Intravenous iron is commonly used to correct iron deficiency anemia in patients with inflammatory bowel disease (IBD). Prior studies have demonstrated its greater efficacy, tolerability, and quality-of-life improvement compared with oral iron therapy. Now, investigators have tested the efficacy and safety of an alternative intravenous regimen — ferric carboxymaltose (FCM) — against standard intravenous iron sucrose (IS) therapy.
In an industry-sponsored, randomized, controlled, multicenter trial, researchers randomized 485 patients with IBD and iron deficiency anemia to receive 1 to 3 weekly infusions of 500 or 1000 mg of FCM or 200 mg of IS up to twice weekly for a maximum of 11 infusions. The total (cumulative) dose of FCM was calculated using a simple formula based on hemoglobin (Hb) deficit and body weight, whereas the total dose of IS was based on the Ganzoni formula (total iron dose = [body weight x target Hb – actual Hb] x 2.4 + iron storage depot). Target Hb was 15 g/dL, and iron storage depot was 500 mg.
At week 12, more patients in the FCM than the IS group achieved the primary endpoint of Hb increase ?2 g/dL (65.8% vs. 53.6%; P=0.004) as well as normalized Hb and ferritin levels (31% vs. 17%; P<0.001), and they required fewer infusions (2.1 vs. 5.8; P<0.001). Safety profiles of the two drugs were similar. Several patients experienced rash, dermatitis, and pruritus, but no true hypersensitivity reactions occurred. Although the per-infusion drug cost of FCM is about twice that of IS, the lower number of infusions made FCM more cost-effective.
Citation(s):Evstatiev R et al. FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Gastroenterology 2011 Sep; 141:846.
