The comparison of efficacy of original brand deferoxamine with generic iranian made deferoxamine in urinary iron excretion in patients with thalassemia major

Abstract

Background: Deferoxamine mesylate is still the conventional and well-known iron chelator for patients with thalassemia major. However, due to some marketing issues the well-known original brand, Desferal®, produced by Novartis Pharmaceuticals Company is not as available as before. The generic brands of Deferoxamine have been introduced in many parts of the world including Iran; however, they are not well accepted by the physicians and patients yet. This triple-blind randomized controlled trial was designed to compare the efficacy and safety of a new Iranian generic and the original brand product of Deferoxamine mesylate in Iranian patients. Methods: The present Randomized triple-blind controlled trial research was carried on in nine centers throughout Iran. They were randomly divided into two similar groups and a Cross-over study was designed. 24-hour urine was collected after subcutaneous infusion of either drugs and urinary iron excretion was measured via atomic absorption spectrophotometer device. Acute adverse events during and after drug infusion were recorded. Mack Nara test and p-pair test were applied to compare two cross over interventions. Results: 154 patients from 9 centers were enrolled in this study. There were 95 women and 59 men aged 6-34 years (mean age of 21.1years). Mean urinary iron concentration for Desferal (intervention A) vs. Desfonak (intervention B) groups was 22.5±22.6 vs. 21.5±16.9 mg/m 2 , respectively. Mean urinary iron excretion/ Kg body weight for Desferal (intervention A) vs. Desfonak (intervention B) groups was 0.48±0.48 vs. 0.47±0.40 mg/m 2 , respectively. Conclusion: According to the results of this study, there was similarity between efficacy and safety of the original and generic brands of deferoxamine (desferal vs. desfonac). © 2018, Iranian Pediatric Hematology and Oncology Society. All rights reserved.