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Title: Deferasirox for up to 3 years leads to continued improvement of myocardial T2* in patients with β-thalassemia major
Authors: Dudley J. Pennell
John B. Porter
Maria Domenica Cappellini
Lee Lee Chan
Amal El-Beshlawy
Yesim Aydinok
Hishamshah Ibrahim
Chi Kong Li
Vip Viprakasit
Mohsen S. Elalfy
Antonis Kattamis
Gillian Smith
Dany Habr
Gabor Domokos
Bernard Roubert
Ali Taher
Royal Brompton Hospital
Universita degli Studi di Milano
University of Malaya Medical Centre
Cairo University
Ege Universitesi
Kuala Lumpur Hospital
Prince of Wales Hospital Hong Kong
Mahidol University
Ain Shams University
University of Athens
Novartis Pharmaceuticals
Novartis International AG
American University of Beirut
Keywords: Medicine
Issue Date: 1-Jun-2012
Citation: Haematologica. Vol.97, No.6 (2012), 842-848
Abstract: Background Prospective data on cardiac iron removal are limited beyond one year and longer-term studies are, therefore, important. Design and Methods Seventy-one patients in the EPIC cardiac substudy elected to continue into the 3 rd year, allowing cardiac iron removal to be analyzed over three years. Results Mean deferasirox dose during year 3 was 33.6±9.8 mg/kg per day. Myocardial T2*, assessed by cardiovascular magnetic resonance, significantly increased from 12.0 ms ±39.1% at baseline to 17.1 ms ±62.0% at end of study (P < 0.001), corresponding to a decrease in cardiac iron concentration (based on ad hoc analysis of T2*) from 2.43±1.2 mg Fe/g dry weight (dw) at baseline to 1.80 ±1.4 mg Fe/g dw at end of study (P < 0.001). After three years, 68.1% of patients with baseline T2* 10 to < 20 ms normalized (≥20 ms) and 50.0% of patients with baseline T2* > 5 to < 10 ms improved to 10 to < 20 ms. There was no significant variation in left ventricular ejection fraction over the three years. No deaths occurred and the most common investigator-assessed drugrelated adverse event in year 3 was increased serum creatinine (n=9, 12.7%). Conclusions Three years of deferasirox treatment along with a clinically manageable safety profile significantly reduced cardiac iron overload versus baseline and normalized T2* in 68.1% (32 of 47) of patients with T2* 10 to < 20 ms. © 2012 Ferrata Storti Foundation.
ISSN: 15928721
Appears in Collections:Scopus 2011-2015

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