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Efficacy and Safety of Deferasirox (Exjade®) in β-Thalassemia Patients with Myocardial Siderosis: 2-Year Results From the EPIC Cardiac Sub-Study

Abstract 4062 Poster Board III-997 Over 70% of deaths in regularly transfused patients with β-thalassemia major (TM) are related to iron-induced cardiomyopathy. Deferasirox (Exjade®), in a sub-study of the 1-year multicenter prospective EPIC trial, demonstrated efficacy in reducing myocardial iron i...

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Bibliographic Details
Published in:Blood 2009-11, Vol.114 (22), p.4062-4062
Main Authors: Pennell, Dudley J., Porter, John B., Cappellini, M. Domenica, Chan, Lee Lee, El-Beshlawy, Amal, Aydinok, Yesim, Ibrahim, Hishamshah, Li, Chi-Kong, Viprakasit, Vip, Elalfy, Mohsen Saleh, Kattamis, Antonis, Smith, Gillian, Habr, Dany, Domokos, Gabor, Roubert, Bernard, Taher, Ali
Format: Article
Language:English
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Summary:Abstract 4062 Poster Board III-997 Over 70% of deaths in regularly transfused patients with β-thalassemia major (TM) are related to iron-induced cardiomyopathy. Deferasirox (Exjade®), in a sub-study of the 1-year multicenter prospective EPIC trial, demonstrated efficacy in reducing myocardial iron in TM patients with mild, moderate and severe cardiac siderosis, as evidenced by a statistically significant improvement in myocardial T2*. We herein report the extension phase results from the same study in patients who have received up to 2 years of deferasirox therapy. Patients aged ≥10 years with myocardial T2* >5–2500 ng/mL, MR (R2) LIC >10 mg Fe/g dry weight (dw), and a lifetime minimum of 50 transfused blood units were included in the cardiac sub-study. Deferasirox was initiated at 30 mg/kg/day and increased to 40 mg/kg/day by the time patients had entered the 1-year extension. Dose decreases were allowed for safety reasons. The primary endpoint was change in myocardial T2* from baseline to 2 years. Out of 100 patients who entered the 1-year extension phase, 85 completed (85%); 24-month CMR data are available for 81 patients. Mean age was 20.6 ±7.3 years. Baseline cardiac T2* was
ISSN:0006-4971
1528-0020
DOI:10.1182/blood.V114.22.4062.4062