The Comparison of Efficacy of Original Brand Deferoxamine with Generic Iranian Made Deferoxamine in Urinary Iron Excretion in Patients with Thalassemia Major
Journal Title: Iranian Journal of Blood and Cancer - Year 2017, Vol 9, Issue 4
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/m2 , 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/m2, 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).
Authors and Affiliations
Peyman Eshghi, Ali Amin Asnafi, Ahmadreza Shamshiri, Samin Alavi, Mohammad Molavi, Ahmad Tamaddoni, Bijan Keikhaie, Majid Naderi, Hamid Hoorfar, Shahla Ansari, Azita Azarkeivan, Zahra Kourorian
Keywords
Related Articles
- EP ID EP281304
- DOI -
- Views 78
- Downloads 0
Hypoxia Preconditioning Promotes Survival And Clonogenic Capacity Of Human Umbilical Cord Blood Mesenchymal Stem Cells
Background: In recent decade, human umbilical cord blood derived mesenchymal stem cells (hUCB-MSCs) provide enormous potential for appropriate cell therapy, but they have limited growth potential and cease to proliferate...
Psychological Therapies: The Missing Link in Improving Treatment Adherence in Patients with β-thalassemia Major
This article has no abstract.
Taq1 Polymorphism (rs731236) of Vitamin D Receptor Gene in Children with Acute Lymphoblastic Leukemia
Background: Acute lymphoblastic leukemia (ALL) is the most common childhood cancer. Several studies have shown that ALL occurs as a result of genetic abnormalities. 1, 25-Dihydroxyvitamin D3 as a secosteroid hormone play...
Molecular Characterization of the Factor IX Gene in 28 Iranian Hemophilia B Patients
Background: Heterogeneous mutations in the human coagulation factor IX gene lead to an X-linked recessive bleeding disorder known as hemophilia B. The disease is distributed worldwide with no ethnic or geographical prior...
Obituary: Professor Parvaneh Vossough
This article has no abstract.