IRON PROTEIN SUCCINYLATE IN THE TREATMENT OF IRON-DEFICIENCY - POTENTIAL INTERACTION WITH H-2-RECEPTOR ANTAGONISTS

A prospective, open, multicenter clinical trial was set up to evaluate the potential interaction of ITF 282 with H-2-receptor antagonists in patients affected with iron deficiency. Patients treated with H-2 blo ckers and affected with iron deficiency or iron deficient anemia were given one tablet of ITF 282 (60 mg iron) twice daily for 60 days. A se cond group of iron deficient patients with no anti H-2 concurrent trea tment were admitted to the same iron treatment, lasting 60 days. To ev aluate the outcome of the iron treatment, a comprehensive assessment o f laboratory and clinical determinations was adopted in all the patien ts: special hematology, symptomatology, safety hematology and hematoch emistry, urinalysis. Fifty-three patients with iron deficiency and 47 patients affected with overt iron deficient anemia entered the study. After treatment, a significant trend toward the normalization of the m ain hematologic parameters in both groups was detected. The general to lerability was apparently more favorable in the patients who had also the antiulcer (1 event of diarrhoea) than in those who had ITF 282 alo ne (2 heartburn, 3 constipation, 2 abdominal pain). There were no indi cations of subgroups of patients particulary at risk of adverse events , all of which resulted reversible without the need to reduce the dose of medication or to take other medical action. ITF 282 resulted, also when administered together with H-2-receptor antagonists, in the expe cted therapeutic efficacy, with the expected clinical tolerability and biological safety, without signs of possible interaction, negative or positive. It is therefore, not necessary to modify the administration or dosage, or take any special precautions, or to resort to specific laboratory tests in the event of concurrent treatment with ITF 282 and H-2-receptor antagonists.