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CLINICAL TRIAL article

Front. Pharmacol.
Sec. Obstetric and Pediatric Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1438611

Comparison of the effects of Deferasirox Film-Coated Tablets (Jadenu®) and Deferasirox Dispersible Tablets (Exjade®) in patients with beta thalassemia major: A Preliminary Report of the Effects on the satisfaction, convenience, Cardiac/liver MRI T2*, Serum Ferritin Level, and Biochemical Profiles

Provisionally accepted
Mahya M. Khaledi Mahya M. Khaledi 1Vahid Falahati Vahid Falahati 1Amin Tajerian Amin Tajerian 1Amir A. Hashiani Amir A. Hashiani 1Kazem Ghaffari Kazem Ghaffari 2*Ali Ghasemi Ali Ghasemi 3*
  • 1 Arak University of Medical Sciences, Arak, Markazi, Iran
  • 2 Khomein University of Medical Sciences, khomein, Iran
  • 3 Semnan University of Medical Sciences, Semnan, Semnan, Iran

The final, formatted version of the article will be published soon.

    Background: Defrasirox (DFX) is a once-daily oral iron chelator with proven dose-dependent efficacy in patients with thalassemia major. The reason for switching from DFX Dispersible Tablets (Exjade®) to DFX Film-Coated Tablets (Jadenu®) was intolerance. Many also reported that Deferasirox® did not taste good. In this study, we compared the effect of Jadenu® and Exjade® on the satisfaction, convenience, cardiac/liver MRI T2*, serum ferritin level, and biochemical profiles in patients with thalassemia major.Method: Sixty-two patients with thalassemia over 2 years of age with iron overload indicated by chelation therapy were randomly divided into two groups. The first group (n = 32) is treated with Exjade® and the second group (n = 30) is treated with Jadenu®. Lab investigations included alkaline phosphatase (ALK), alanine transferase (ALT), aspartate transferase (AST) and serum ferritin level,. Cardiac/liver MRI T2* and satisfaction, convenience, before and one year after starting therapy, were also assessed.The study found that 53.3% of Jadenu® patients were satisfied with the taste of the medication compared to only 12.5% of Exjade® patients, which was statistically significant (P=0.001). Additionally, 40% of Jadenu® patients were satisfied with the way of taking the medication compared to 28.1% of Exjade® patients, and again, the difference was statistically significant (P=0.047). Comparison of cardiac MRI T2* level between the two studied groups showed that there is no significant difference between the two groups (P=0.851).Conclusions: Jadenu® offers patients an improved formulation that can be taken on an empty stomach, has a better taste, and minimal gastrointestinal tolerability concerns. Overall, patient satisfaction is higher with Jadenu®, which may improve adherence and reduce the frequency and severity of complications associated with iron overload. This, in turn, may help mitigate cardiovascular and hepatic complications from iron overload in the long term.

    Keywords: Thalassemia major, Deferasirox, Liver, Heart, Iron Overload, Satisfaction, Convenience

    Received: 26 May 2024; Accepted: 04 Nov 2024.

    Copyright: © 2024 Khaledi, Falahati, Tajerian, Hashiani, Ghaffari and Ghasemi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Kazem Ghaffari, Khomein University of Medical Sciences, khomein, Iran
    Ali Ghasemi, Semnan University of Medical Sciences, Semnan, 56131-56491, Semnan, Iran

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.