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Comparison of two trade names of deferasirox (Osveral® and Exjade®) in reduction of iron overload parameters in patients with major beta-thalassemia: a randomized open labeled clinical trial
Mohammadreza Rafati , Hossein Karami , Bita Lashtoo-Aghaee , Bahareh Lashtoo-Aghaee , Mojdeh Dabirian , Razieh Avan *
Department of Clinical Pharmacy, Medical Toxicology and Drug Abuse Research Center (MTDRC), Faculty of Pharmacy, Birjand University of Medical Sciences, Birjand, Iran. , avanr91@gmail.com
Abstract:   (274 Views)

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 to use by majority of thalassemic patients. The aim of this study was to compare 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.

Keywords: Deferasirox, Osveral, Exjade, Ferritin, MRI T2*
     
Type of Study: Original Article | Subject: pharmacology
Received: 2020/09/12 | Accepted: 2021/05/22
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Caspian Journal of Internal Medicine
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