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The Comparison of Efficacy of Original Brand Deferoxamine With Generic Iranian Made Deferoxamine in Urinary Iron Excretion in Patients With Thalassemia Major



Eshghi P1 ; Amin Asnafi A2 ; Shamshiri A1 ; Alavi S1 ; Molavi M3 ; Tamaddoni A4 ; Keikhaie B2 ; Naderi M5 ; Hoorfar H6 ; Ansari S7 ; Azarkeivan A8 ; Arasteh M9 ; Kourorian Z10
Authors
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Authors Affiliations
  1. 1. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2. Ahwaz Jondishapour University, Research center for Thalassemia & Hemoglobinopathy, Ahwaz, Iran
  3. 3. Department of Pediatric Hematology and Oncology, Bandar Abbas Thalassemia Center, Hormozgan University of Medical Science, Bandar Abbas, Iran
  4. 4. Department of Pediatric Hematology and Oncology, Amir Kola Hospital, Babol University of Medical Science, Mazandaran, Iran
  5. 5. Department of Pediatric Hematology and Oncology, Ali Asghar Hospital, Zahedan University of Medical Science, Zahedan, Iran
  6. 6. Seid-ol-Shohada Hospital, Treatment Center for Special Diseases, Isfahan, Iran
  7. 7. Department of Pediatric Hematology and Oncology, Ali Asghar Hospital, Tehran University of Medical Science, Tehran, Iran
  8. 8. Zafar center for thalassemia, Iranian Blood Transfusion Organization, Tehran, Iran
  9. 9. Samen-ol-Hojaj Center for Special Disease, Kerman, Iran
  10. 10. Pharmacovigilance and Medical Information Manager of Ronac Pharmaceutical Company, Tehran, Iran

Source: Iranian Journal of Blood and Cancer Published:2018

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.
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