Efficacy of Deferasirox (Exjade®) versus Osveral® in Treatment of Iron Overload in Patients with Beta- thalassemia Major in Iran; A Non-randomized Controlled Trial

Background: Iron chelators are an important part of management of patients with thalassemia. It is prudent to compare efficacy of different iron chelators in treatment of iron overload in these patients who receive regular blood transfusion. We aimed to compare the efficacy and safety of available oral iron chelator; Deferasirox (Exjade®) with Deferasirox (Osveral®) in reducing iron overload in patients with β-thalassemia major. Methods: Children suffering from β-thalassemia major referring to Mofid Children Hospital were enrolled in this non-randomized clinical trial. The patients were divided into two groups receiving Deferasirox (Exjade®) versus Deferasirox (Osveral®) and their response to either treatment was assessed by measurement of serum ferritin levels and estimation of cardiac and liver iron by MRI T2* of heart and liver. Efficacy of either medication was compared before and after 12 months of treatment. Serum ferritin levels were measured every three months. Mean serum ferritin at baseline was compared with post-treatment values. MRI T2* of heart and liver was performed before and after treatment. Results: Out of 69 patients with a mean age of 13.6±7.4 years, 42 (60.9%) were male. 30 patients were assigned to take Deferasirox (Exjade®) and 39 patients to take Deferasirox (Osveral®). The groups were not different regarding the age and the gender (P=0.18 and 0.621, respectively). There was no statistically significant difference in post-treatment serum ferritin level measurements between the two groups. In patients who received Osveral®, decrease in liver iron overload was significant (0.99 ms in Exjade® group vs 1.16 ms in Osveral® group, p=0.007). In the group of patients who received Exjade®, decrease in cardiac iron overload was significant (4.52 in Exjade group vs. 1.71 in Osveral group, P<0.001). Conclusion: Deferasirox (Osveral®), the iron chelator manufactured in Iran, was as efficient as Deferasirox (Exjade®) in iron removal and could be a substitute for Deferasirox (Exjade®)