Evaluation of Oral Therapy Based on Ferric Sodium EDTA, in Combination With Vitamin C, Folic Acid, Copper Gluconate, ZincGluconate and Selenomethionine, in Iron-Deficiency Anemia: AReal-Life Study

Abstract

Iron deficiency (ID) and iron-deficiency anemia (IDA) are still frequent conditions in several patients’ settings. Oral iron supplementation is one of available treatments of IDA, representing a convenient strategy since is cost-saving, effective and does not require intravenous (IV) access. However, often traditional oral iron therapies, mainly based on ferrous sulphate, are poorly tolerated, and with low iron absorption, causing gastrointestinal adverse events and limiting adherence to treatment and efficacy. The aim of this study is to evaluate the efficacy and safety of a new oral iron supplementation based on Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) for IDA treatment in real-life clinical practice. Patients (N=103) were allocated to treatment with this new formulation at dosage of 1 tab/day, containing 30 mg of iron for 72 days. Patients were evaluated at basal conditions (T0), after 24 and 72 days of therapy (T1 and T2, respectively), collecting blood parameters of hemoglobin (Hb) and sideremia, evaluated as primary objective. The secondary outcomes were symptoms improvement (evaluated through a 4-points score) and safety profile of oral therapy. Treatment with Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte®) showed improvements statistically significant (P < 0.001) of Hb and sideremia levels both at time T1 and T2. Symptoms evaluation showed an almost total resolution of symptomatology after only 72 days of therapy, and treatment was safe and well tolerated. In conclusion, this study confirmed the efficacy and the safety of the new oral iron formulation evaluated, for IDA patients in real-life clinical practice.