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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Aphase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with β-thalassemia
Blood, Volume 107, No. 9, Year 2006
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Description
Deferasirox (ICL670) is a once-daily oral iron chelator developed for the treatment of chronic iron overload from blood transfusions. A comparative phase 3 trial was conducted to demonstrate the efficacy of deferasirox in regularly transfused patients with β-thalassemia aged 2 years or older. Patients were randomized and received treatment with deferasirox (n = 296) or deferoxamine (n = 290), with dosing of each according to baseline liver iron concentration (LIC). The primary endpoint was maintenance or reduction of LIC; secondary endpoints included safety and tolerability, change in serum ferritin level, and net body iron balance. In both arms, patients with LIC values of 7 mg Fe/g dry weight (dw) or higher had significant and similar dose-dependent reductions in LIC and serum ferritin, and effects on net body iron balance. However, the primary endpoint was not met in the overall population, possibly due to the fact that proportionally lower doses of deferasirox relative to deferoxamine were administered to patients with LIC values less than 7 mg Fe/g dw. The most common adverse events included rash, gastrointestinal disturbances, and mild nonprogressive increases in serum creatinine. No agranulocytosis, arthropathy, or growth failure was associated with deferasirox administration. Deferasirox is a promising once-daily oral therapy for the treatment of transfusional iron overload. © 2006 by The American Society of Hematology.
Authors & Co-Authors
Cappellini, Maria Teresa
Italy, Milan
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Cohen, Alan R.
Unknown Affiliation
Piga, Antonio Giulio
Unknown Affiliation
Béjaoui, Mohamed
Unknown Affiliation
Perrotta, Silverio
Unknown Affiliation
Aǧaoǧlu, Leyla
Unknown Affiliation
Aydınok, Yeşim
Unknown Affiliation
Kattamis, Antonis C.
Unknown Affiliation
Kılınç, Yurdanur
Unknown Affiliation
Porter, John B.
Unknown Affiliation
Capra, Marcello
Unknown Affiliation
Galanello, Renzo
Unknown Affiliation
Fattoum, Slaheddine
Unknown Affiliation
Drelichman, Guillermo I.
Unknown Affiliation
Giardina, Patricia Jane V.
Unknown Affiliation
Coates, Thomas D.
Unknown Affiliation
Vermylen, Christiane G.
Unknown Affiliation
Olivieri, Nancy F.
Unknown Affiliation
Thuret, Isabelle
Unknown Affiliation
Opitz, Herbert
Unknown Affiliation
Ressayre-Djaffer, Catherine
Unknown Affiliation
Marks, Peter W.
Unknown Affiliation
Alberti, Daniele
Unknown Affiliation
Statistics
Citations: 617
Authors: 23
Affiliations: 1
Identifiers
Doi:
10.1182/blood-2005-08-3430
ISSN:
00064971
Research Areas
Health System And Policy
Study Design
Cross Sectional Study