Lens opacity as a serious side effect following chelation therapy in beta thalassemia: A comparison between deferoxamine and deferasirox; randomized double-blinded clinical trial

Abstract

Introduction: Ocular toxicity is a serious side effect following chelation therapy in patients suffering from major beta-thalassemia. Objectives: We aimed to assess ocular toxicity (lens opacity) of the Iranian brand of deferasirox named "Osveral" marketed by an Iranian company and also to compare it with deferoxamine. Patients and Methods: This randomized double-blinded clinical trial was performed on 50 major betathalassemia patients who were candidate for chelation therapy for the first time. Patients were randomly (using a computerized random number table) assigned to receive deferoxamine (50 mg/kg subcutaneous daily, 5 days per week, for 24 months) (25 patients) or Osveral (30 mg/kg orally for 24 months) (25 patients). After a year, patients were reassessed with regard to the appearance of lens opacity. Results: In the group receiving deferoxamine, 4 patients (16.0%) suffered from mild opacity, 1 (4%) from moderate opacity and 2 (8%) from severe opacity, while in the group receiving Osveral, only 4 patients (16%) had mild lens opacity indicating no significant difference across the two groups (P = 0.456). Conclusion: The rate of lens opacity appeared following administration of deferasirox and desferrioxamine is similar and in the range globally reported.

Keywords

• chelation therapy
• beta thalassemia
• deferasirox
• deferoxamine