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Anemia  2013 

Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia

DOI: 10.1155/2013/169107

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Abstract:

Several intravenous iron complexes are available for the treatment of iron deficiency anemia (IDA). Iron dextran (DEX) is associated with an elevated risk of potentially serious anaphylactic reactions, whereas others must be administered in several small infusions to avoid labile iron reactions. Ferric carboxymaltose (FCM) is a nondextran intravenous iron which can be administered in high single doses. A randomized, open label, and multicenter comparison of FCM to DEX in adults with IDA and baseline hemoglobin of ≤11.0?g/dL was conducted. A total of 160 patients were in the safety population (FCM ; DEX ). Adverse events, including immune system disorders (0% in FCM versus 10.3% in DEX, ) and skin disorders (7.3% in FCM versus 24.4% in DEX, ), were less frequently observed in the FCM group. A greater portion of patients in the FCM group experienced a transient, asymptomatic decrease in phosphate compared to patients in the DEX group (8.5% in FCM versus 0% in DEX, ). In the FCM arm, the change in hemoglobin from baseline to the highest observed level was 2.8?g/dL, whereas the DEX arm displayed a change of 2.4?g/dL ( ). Treatment of IDA with FCM resulted in fewer hypersensitivity-related reactions than DEX. 1. Introduction Iron deficiency is one of the most common deficiencies in the world and can lead to anemia [1–3]. Patients with reduced absorption of dietary iron (e.g., patients with inflammatory bowel disease, gastrointestinal surgery, or who have had gastric bypass) or patients with increased utilization or loss of iron from the body (e.g., pregnancy/childbirth, heavy uterine bleeding, lactation, hemodialysis, or surgery) are particularly at risk [1, 4–6]. IDA may adversely affect cognitive function, physical activity, immune response, inflammatory conditions, and pregnancy outcomes [7]. Different kinds of therapies from oral iron to blood transfusion are currently used to treat IDA. The aim of the treatment is to return both hemoglobin and iron stores to normal levels. Oral iron therapy is the treatment of choice for the majority of patients with IDA because of its effectiveness, safety, and low cost. Even though many patients can tolerate oral iron without difficulty, up to 40% may have side effects attributable to oral iron replacement therapy [8]. The incidence of side effects increase with the dose and adversely affects compliance. Also, oral iron is often not capable of replenishing severe iron deficits [9]. As a treatment of last resort, blood transfusions are used, but they may lead to the transmission of known and unknown pathogens,

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