Journal of Pediatric Perspectives

Current Issue

By Issue

By Author

By Subject

Author Index

Keyword Index

About Journal

Aims and Scope

Editorial Board

Publication Ethics

Indexing and Abstracting

Related Links

FAQ

Peer Review Process

News

Comparison of the Effects of Deferasirox (Nanojade®) and Deferoxamine (Desferal®) on Serum Ferritin Level Changes in Major Beta-Thalassemia Patients: A Randomized Clinical Trial

Document Type : original article

Authors

1 Resident of Pediatrics, Department of Pediatrics, Faculty of Medicine. Birjand University of Medical Sciences, Birjand, South Khorasan Province, Iran.

2 Assistante professor of Social Medicine, Birjand University of Medical Sciences(BUMS

3 Resident of Pediatrics, Department of Pediatrics, Faculty of Medicine. Birjand University of Medical Sciences (BUMS), Birjand, South Khorasan Province, Iran

Abstract

Background: Different drugs with different mechanisms have been used to remove iron overload in thalassemia patients. This study aimed to compare the effects of Nanojade and Deferoxamine in reducing serum ferritin levels.
Methods: This randomized clinical trial was conducted on 41 major thalassemia patients. The selected patients were allocated to two groups by the permuted block randomization method. The first group was treated with Deferasirox (Nanojade) and the second group was treated with Deferoxamine (Desferal). All patients received the drugs at 14 mg/kg. Blood samples were collected at baseline, after 3 and 6 months after intervention. Chi-square test, Mann-Whitney U-test, and Friedman test were used for analytical statistics at the significance level of 0.05.
Results: 51.9% of patients in the Nanojade group and 40% in the Desferal group were females. Before the intervention, no difference was observed in terms of basic and demographic information. Before the intervention, as well as 3 months, and 6 months after the intervention, none of the blood parameters in the studied groups were significantly different (p> 0.05). The overall mean ferritin levels had a significant decrease, in both groups, 6 months after the intervention (PDeferasirox = 0.001 vs PDeferoxamine = 0.043); However, in the comparison between the two groups, no significant difference was observed between the levels of ferritin and creatinine at any of the time points (p> 0.05).
Conclusions: Deferasirox oral tablet (Nanojade®) is as effective as an injectable form (deferoxamine (Desferal®)) in reducing serum ferritin in patients with beta-thalassemia major without causing nephrotoxic effects. Therefore, it can be a suitable alternative to its injectable form.

Keywords

References
  1. Mobasheri L, Chahkandi T, Talebpour A, Sarab GA. Red blood cell immunization among transfusion-dependent thalassemia major patients in Northeastern Iran. Asian Journal of Transfusion Science. 2023.
  2. Galanello R, Origa R. Beta-thalassemia. Orphanet journal of rare diseases. 2010; 5:1-15.
  3. de Dreuzy E, Bhukhai K, Leboulch P, Payen E. Current and future alternative therapies for beta-thalassemia major. Biomedical journal. 2016; 39(1):24-38.
  4. Rachmilewitz EA, Giardina PJ. How I treat thalassemia. Blood, the Journal of the American Society of Hematology. 2011; 118(13):3479-88.
  5. Chahkandi T, Norouziasl S, Farzad M, Ghanad F. Endocrine disorders in beta thalassemia major patients. International Journal of Pediatrics. 2017; 5(8):5531-8.
  6. Mishra AK, Tiwari A. Iron overload in beta thalassaemia major and intermediate patients. Maedica. 2013; 8(4):328.
  7. Taher AT, Saliba AN. Iron overload in thalassemia: different organs at different rates. Hematology 2014, the American Society of Hematology Education Program Book. 2017; 2017(1):265-71.
  8. McDowell LA, Kudaravalli P, Sticco KL. Iron overload. 2018.
  9. Motta I, Bou-Fakhredin R, Taher AT, Cappellini MD. Beta thalassemia: new therapeutic options beyond transfusion and iron chelation. Drugs. 2020; 80:1053-63.
  10. Hajigholami A, Ansari H, Honarmand S. Comparing the efficacy of Dexeroyx (Osveral) and Deferoxamine (Desferal) in reducing serum ferritin level in patients with thalassemia major. Middle East J Fam Med. 2018; 7(10):218-22.
  11. Mobarra N, Shanaki M, Ehteram H, Nasiri H, Sahmani M, Saeidi M, Goudarzi M, Pourkarim H, Azad M. A review on iron chelators in treatment of iron overload syndromes. International journal of hematology-oncology and stem cell research. 2016; 10(4):239.
  12. Rafati M, Karami H, Lashtoo-Aghaee B, Lashtoo-Aghaee B, Dabirian M, Avan R. Two trade names of deferasirox (Osveral® and Exjade®) in reduction of iron overload parameters in major beta-thalassemia patients: A randomized open labeled clinical trial. Caspian Journal of Internal Medicine. 2022; 13(1):61.
  13. Cunningham MJ, Macklin EA, Neufeld EJ, Cohen AR, Network TCR. Complications of β-thalassemia major in North America. Blood. 2004; 104(1):34-9.
  14. Bayanzay K, Alzoebie L. Reducing the iron burden and improving survival in transfusion-dependent thalassemia patients: current perspectives. Journal of blood medicine. 2016:159-69.
  15. Fathi A, Vafaie M, Amani F, Mohebbi N. Evaluation of Osveral efficacy in reducing ferritin levels in patients with thalassemia major. International Journal of Basic & Clinical Pharmacology. 2017; 6(11):2556-60.
  16. Saleem A, Waqar E, Shuja SH, Naeem U, Moeed A, Rais H, Ahmed J. No difference in myocardial iron concentration and serum ferritin with deferasirox and deferiprone in pediatric patients with hemoglobinopathies: A systematic review and meta-analysis. Transfusion Clinique et Biologique. 2022.
  17. Cappellini MD, Cohen A, Piga A, Bejaoui M, Perrotta S, Agaoglu L, Aydinok Y, Kattamis A, Kilinc Y, Porter J, Capra M, Galanello R, Fattoum S, Drelichman G, Magnano C, Verissimo M, Athanassiou-Metaxa M, Giardina P, Kourakli-Symeonidis A, Janka-Schaub G, Coates T, Vermylen C, Olivieri N, Thuret I, Opitz H, Ressayre-Djaffer C, Marks P, Alberti D. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with β-thalassemia. Blood. 2006; 107(9):3455-62.
  18. Taher A, El‐Beshlawy A, Elalfy MS, Al Zir K, Daar S, Habr D, Kriemler-Krahn U, Hmissi A, Al Jefri A. Efficacy and safety of deferasirox, an oral iron chelator, in heavily iron‐overloaded patients with β‐thalassaemia: the ESCALATOR study. European journal of haematology. 2009; 82(6):458-65.
  19. Cheng WY, Said Q, Hao Y, Xiao Y, Vekeman F, Bobbili P, Sheng Duh M, Nandal S, Blinder M. Adherence to iron chelation therapy in patients who switched from deferasirox dispersible tablets to deferasirox film-coated tablets. Current Medical Research and Opinion. 2018; 34(11):1959-66.
  20. Falahati V, Ghasemi A, Safari MR, Ghaffari K, Yousefichaijan P, Zamanian M. Renal function in patients with thalassemia major receiving Exjade® dispersible tablets and a new film-coated tablet formulation of deferasirox (Nanojade®). Advanced Biomedical Research. 2022; 11(1):84.
  21. Kolnagou A, Kontoghiorghe CN, Kontoghiorghes GJ. Transition of Thalassaemia and Friedreich ataxia from fatal to chronic diseases. World Journal of Methodology. 2014; 4(4):197.
  22. Telfer PT, Warburton F, Christou S, Hadjigavriel M, Sitarou M, Kolnagou A, Angastiniotis M. Improved survival in thalassemia major patients on switching from desferrioxamine to combined chelation therapy with deferoxamine and deferiprone. Haematologica. 2009; 94(12):1777.
  23. Angulo IL, Covas DT, Carneiro AA, Baffa O, Elias Junior J, Vilela G. Determination of iron-overload in thalassemia by hepatic MRI and ferritin. Revista Brasileira de Hematologia e Hemoterapia. 2008; 30:449-52.
  24. Elalfy MS, Saber MM, Adly AAM, Ismail EA, Tarif M, Ibrahim F, Elalfy OM. Role of vitamin C as an adjuvant therapy to different iron chelators in young β‐thalassemia major patients: efficacy and safety in relation to tissue iron overload. European journal of haematology. 2016; 96(3):318-26.
  25. Kwiatkowski JL. Clinical Challenges with Iron Chelation in Beta Thalassemia. Hematology/Oncology Clinics. 2023; 37(2):379-91.
  26. Elalfy MS, Berdoukas V, Tricta F, Adly A, Hazza N, Awed H, et al. A Randomized Trial on the Safety and Efficacy of Early Start of Iron Chelation Therapy with Deferiprone in Newly Diagnosed Children with Transfusion Dependent Thalassemia. Blood. 2016; 128(22):1286.
  27. Arya A, Jokar S, Etemadfar P, Malekzadeh JM, Jannesar R, Rohani M, Mohamadi T, Kharaman F, Yosefi6 M, Hatamipour S, Roozbehi A. Comparison of Deferoxamine, Deferiprone and Deferasirox Iron-Chelating Agents in Reducing Serum Ferritin Levels in Patients with Thalassemia Major %J Journal of Clinical Care and Skills. 2020; 1(4):189-93.
  28. Farmakis D, Giakoumis A, Angastiniotis M, Eleftheriou A. The changing epidemiology of the aging thalassaemia populations: a position statement of the Thalassaemia International Federation. European journal of haematology. 2020; 105(1):16-23.
  29. Hassan MAM, Tolba OA. Iron chelation monotherapy in transfusion-dependent beta-thalassemia major patients: a comparative study of deferasirox and deferoxamine. Electronic physician. 2016 ;8(5):2425.
  30. Cappellini MD, Bejaoui M, Agaoglu L, Canatan D, Capra M, Cohen A, Drelichman G, Economou M, Fattoum S, Kattamis A, Kilinc Y, Perrotta S, Piga A, Porter JB, Griffel L, Dong V, Clark J, Aydinok Y. Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up. Blood, The Journal of the American Society of Hematology. 2011; 118(4):884-93.
  31. Ahmed A, Kamran M, Mukhtar M, Ali M, Umair M. Comparison of deferasirox and desferrioxamine as iron chelators in multi-transfused patients of β-thalassemia major. Biological and clinical sciences research journal. 2023; 2023(1):270-.
  32. Bird ST, Swain RS, Tian F, Okusanya OO, Waldron P, Khurana M, Durmowicz EL, Ma Y, Major JM, Gelperin K. Effects of deferasirox dose and decreasing serum ferritin concentrations on kidney function in pediatric patients: an analysis of clinical laboratory data from pooled clinical studies. The Lancet Child & Adolescent Health. 2019; 3(1):15-22.
  33. Yang SK, Xiao L, Song PA, Xu XX, Liu FY, Sun L. Is lead chelation therapy effective for chronic kidney disease? A meta-analysis. Nephrology (Carlton, Vic). 2014; 19(1):56-9.
  34. Jayalakshmi S, Venkatesan R, Deepa S, A. Vetcher A, Ansar S, Kim S-C. The effect of chelators on additives in the surface characterization and electrochemical properties of an eco-friendly electroless copper nano deposition. Scientific Reports. 2023; 13(1):11062.
  35. Unal S, Hazirolan T, Eldem G, Gumruk F. The effects of deferasirox on renal, cardiac and hepatic iron load in patients with β-thalassemia major: preliminary results. Pediatric hematology and oncology. 2011; 28(3):217-21.
Journal of Pediatric Perspectives
Volume 11, Issue 12
December 2023
Pages 18413-18423
Files
Share
How to cite
Statistics