Two trade names of deferasirox (Osveral® and Exjade®) in reduction of iron overload parameters in major beta-thalassemia patients: A randomized open labeled clinical trial.

BACKGROUND

Beta-thalassemia major patients typically require chronic transfusion and iron-chelating agents to reduce serum iron overload. Osveral is an available Iranian brand name of deferasirox used by majority of thalassemic patients. The aim of this study was to compare the efficacy of Osveral vs. Exjade in major beta- thalassemia patients.

METHODS

In this randomized clinical trial, all patients received a single daily dose of 30 mg/kg either of Osveral or Exjade for 6 months. Primary outcome was the mean of bimonthly changes in serum ferritin concentration and secondary outcomes included mean changes of heart and liver MRI T2* after a year.

RESULTS

Finally, 80 patients completed the study. The mean serum ferritin level at the end of sixth month significantly decreased in Osveral and Exjade groups (p<0.01). After a year, means cardiac MRI T2* in Osveral group were changed from 25.9±9.6 ms to 25.4±9.7 ms and in Exjade group from 24.8±9.2 ms to 26.9±5.9 ms, with no significant difference (P=0.43). Mean liver MRI T2* for Osveral and Exjade groups were 8.6±6.4 ms (baseline 6.3±4.7) and 6.3±4 ms (baseline 4.9±3.5), respectively and there was no significant difference between two study arms (P=0.1).

CONCLUSION

Osveral decreased significantly the serum ferritin level and improved heart and liver iron overload as efficient as Exjade. It can be a suitable cost-effective alternative agent in beta-thalassemia major patients.