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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Continued improvement in myocardial T2* over two years of deferasirox therapy in β-thalassemia major patients with cardiac iron overload
Haematologica, Volume 96, No. 1, Year 2011
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Description
Background The efficacy of cardiac iron chelation in transfusion-dependent patients has been demonstrated in one-year prospective trials. Since normalization of cardiac T2* takes several years, the efficacy and safety of deferasirox was assessed for two years in patients with β-thalassemia major in the cardiac sub-study of the EPIC trial. Design and Methods Eligible patients with myocardial T2* greater than 5 to less than 20 ms received deferasirox, with the primary endpoint being the change in T2* from baseline to two years. Results Baseline myocardial T2* was severe (>5 to <10 ms) in 39 patients, and moderate-to-mild (10 to <20 ms) in 62 patients. Mean deferasirox dose was 33.1±3.7 mg/kg/d in the one-year core study increasing to 36.1±7.7 mg/kg/d during the second year of treatment. Geometric mean myocardial T2* increased from a baseline of 11.2 to 14.8 ms at two years (P<0.001). In patients with moderate-to-mild baseline T2*, an increase was seen from 14.7 to 20.1 ms, with normalization (≥20 ms) in 56.7% of patients. In those with severe cardiac iron overload at baseline, 42.9% improved to the moderate-to-mild group. The incidence of drug-related adverse events did not increase during the extension relative to the core study and included (≥5%) increased serum creatinine, rash and increased alanine aminotransferase. Conclusions Continuous treatment with deferasirox for two years with a target dose of 40 mg/kg/d continued to remove iron from the heart in patients with β-thalassemia major and mild, moderate and severe cardiac siderosis. © 2011 Ferrata Storti Foundation.
Authors & Co-Authors
Pennell, Dudley John
United Kingdom, London
Royal Brompton Hospital
Porter, John B.
United Kingdom, London
University College London
Cappellini, Maria Teresa
Italy, Milan
Università Degli Studi Di Milano
Chan, Lee Lee
Malaysia, Kuala Lumpur
University of Malaya Medical Centre
El-Beshlawy, Amal M.
Egypt, Giza
Cairo University
Aydınok, Yeşim
Turkey, Izmir
Ege University Medical School
Ibrahim, Hishamshah
Malaysia, Kuala Lumpur
Kuala Lumpur Hospital
Li, Chi Kong
Hong Kong
Prince of Wales Hospital Hong Kong
Viprakasit, Vip
Thailand, Bangkok
Siriraj Hospital
ElAlfy, Mohsen Saleh
Egypt, Cairo
Ain Shams University
Kattamis, Antonis C.
Greece, Athens
National and Kapodistrian University of Athens
Smith, Gillian C.
United Kingdom, London
Royal Brompton Hospital
Habr, Dany
Switzerland, Basel
Novartis International ag
Domokos, Gabor
Switzerland, Basel
Novartis International ag
Roubert, Bernard
Switzerland, Basel
Novartis International ag
Taher, Ali T.
Lebanon, Beirut
American University of Beirut
Statistics
Citations: 81
Authors: 16
Affiliations: 13
Identifiers
Doi:
10.3324/haematol.2010.031468
ISSN:
03906078
e-ISSN:
15928721
Research Areas
Noncommunicable Diseases
Study Design
Cohort Study