Efficacy and safety of Iranian made Deferasirox (Osveral?) in Iranian major thalassemic patients with transfusional iron overload: A one year prospective multicentric open-label non-comparative study

摘要

Purpose of the studyto determine the efficacy, adverse effects and safety of a new Iranian generic product of deferasirox (Osveral?) in Iranian transfusion dependent major thalassemic (TD-MT) patients.MethodsIn 9 main thalassemia treatment centers, all of TD-MT patients (aged ≥2 yrs) with serum ferritin (SF) levels≥1000 ng/ml, or >100 ml/kg of RBC transfusion,who could not tolerate parental iron chelating were recruited regardless of their previous iron chelation therapy. Periodical clinical and laboratory evaluations were conducted for adverse effects (AEs). Primary efficacy end point was Mean of Relative Change of Serum Ferritin (MRC-SF) from the baseline level during one year. Analysis of variance (ANOVA), t test, chi-square or Fisher exact test were used for statistic analysis appropriately (P values 5 time increase in transaminases (24;5.89%).The causes of discontinuation of treatment were non-satisfactory treatment ( 24; 5.8%), poor or non-compliance of patients (21;5.1%), and adverse effects (13; 3.1%)ConclusionA detailed comparison with similar studies on deferasirox (Exjade?) shows a promising efficacy and safety for its Iranian generic product (Osveral ?).