A prospective, open, multicenter clinical trial was set up to evaluate the potential interaction of
ITF 282 with H2-receptor antagonists in patients affected with
iron deficiency. Patients treated with H2 blockers 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 second group of
iron deficient patients with no anti H2 concurrent treatment were admitted to the same
iron treatment, lasting 60 days. To evaluate the outcome of the
iron treatment, a comprehensive assessment of laboratory and clinical determinations was adopted in all the patients: special hematology, symptomatology, safety hematology and hematochemistry, 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 main hematologic parameters in both groups was detected. The general tolerability was apparently more favorable in the patients who had also the antiulcer (1 event of diarrhoea) than in those who had
ITF 282 alone (2
heartburn, 3
constipation, 2
abdominal pain). There were no indications of subgroups of patients particularly 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 H2-receptor antagonists, in the expected therapeutic efficacy, with the expected clinical tolerability and
biological safety, without signs of possible interaction, negative or positive.(ABSTRACT TRUNCATED AT 250 WORDS)