Overview of clinical trials in the treatment of iron deficiency with iron-acetyl-aspartylated casein.

Iron therapy is necessary in a wide variety of clinical situations, and new formulations with improved tolerability and efficacy would be a welcome alternative to ferrous sulfate. A trivalent iron protein complex has been developed using an N-acetyl-aspartylated derivative of casein (Fe-ASP) for oral iron therapy. This paper provides an overview of the pharmacokinetic and clinical data on Fe-ASP use. To date, 704 paediatric and adult patients affected by iron deficiency anaemia with a wide variety of clinical histories (dietary, iron absorption defects, pregnancy, chronic or acute gastrointestinal haemorrhage) have been treated with Fe-ASP in 16 clinical trials including nine open and seven controlled trials. In healthy volunteers, Fe-ASP proved to be an efficient vehicle for providing iron with high bioavailability and more rapid and persistent increases in serum iron levels than ferritin. In open clinical trials, highly significant improvements in clinical and haematological parameters were observed after treatment with Fe-ASP in all categories of patients with iron deficiency anaemia. In controlled clinical trials, the changes in clinical and haematological profiles observed with Fe-ASP were virtually identical to those seen with iron protein succinylate (IPS), and Fe-ASP also compared well with parenteral iron gluconate. No safety considerations were raised.Fe-ASP shows high efficacy in iron-deficient anaemia treatment, and it is an extremely well tolerated iron vehicle. Fe-ASP represents a valid alternative to IPS and shows promise as a substitute for parenteral iron therapy in selected clinical situations.