Iron protein succinylate in the treatment of iron deficiency: controlled, double-blind, multicenter clinical trial on over 1,000 patients.

Abstract

A prospective, controlled, double-blind, double-dummy, multicenter clinical trial was made to assess the efficacy and tolerability of iron-protein-succinylate (ITF 282) in comparison with a well known iron preparation in the treatment of iron deficiency or iron deficient anemia. One thousand and ninety-five patients affected with iron deficiency or overt iron deficient anemia were randomized to receive either two ITF 282 tablets/day (60 mg iron each) or a commercially available ferrous sulphate controlled release tablet (one tablet containing 105 mg iron/day). Five hundred and forty-nine patients received ITF 282; 546 patients were treated with ferrous sulphate. Both treatments lasted 60 days. The treatment outcome was checked by evaluating special hematology, symptomatology, safety hematology and hematochemistry. After two months of treatment, the normalization of the main hematologic parameters in both groups was detected. Although in the first month the reference treatment appears to provide somewhat faster results, at the end of the observation, the values of hematocrit, hemoglobin and ferritin were greater in the ITF 282 group, indicating a more progressive and steady therapeutic effect. The overall clinical rating was significantly in favor of ITF 282, with 78.9% of favorable results vs 67.6%. By dividing the patient population according to pathological conditions (iron deficiency or overt anemia), or according to the etiopathogenesis of the iron deficiency (increased requirement, or increased loss in adults and in the elderly), separate analyses on the treatment outcome were made (and have been included). The general tolerability, although favorable with both treatments, was significantly more favorable with ITF 282. With this medication, 63 patients (11.5%) complained of 69 adverse reactions (25 heartburn, 19 constipation, 25 abdominal pain) vs 141 events reported by 127 patients (26.3%) with the reference medication (33 heartburn, 31 epigastric pain, 23 constipation, 32 abdominal pain, 8 skin rash, 14 nausea). These observations confirm that, although the most modern preparations of ferrous sulphate exhibit a relatively low frequency of adverse events of limited clinical concern, it is nevertheless possible to decrease both the prevalence and the duration of such events without prejudice for the clinical efficacy, with the use of more "physiological" preparations in which the iron is reversibly bound to a protein carrier, thus effectively removing one of the main obstacles to the correct compliance with treatments that must be administered for prolonged periods of time.