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Blood, 1 May 2006, Vol. 107, No. 9, pp. 3455-3462. Prepublished online as a Blood First Edition Paper on December 13, 2005December 15, 2005; DOI 10.1182/blood-2005-08-3430. This Article Full Text (PDF) All Versions of this Article: 2005-08-3430v1 2005-08-3430v2 107/9/3455    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Cappellini, M. D Articles by Alberti, D. Search for Related Content PubMed PubMed Citation Articles by Cappellini, M. D Articles by Alberti, D. Related Collections Related Letters in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted August 24, 2005 Accepted November 29, 2005 A Phase III study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with -thalassemia Maria D Cappellini*, Alan Cohen, Antonio Piga, Mohamed Bejaoui, Silverio Perrotta, Leyla Agaoglu, Yesim Aydinok, Antonis Kattamis, Yurdanur Kilinc, John Porter, Marcello Capra, Renzo Galanello, Slaheddine Fattoum, Guillermo Drelichman, Carmelo Magnano, Monica Verissimo, Miranda Athanassiou-Metaxa, Patricia Giardina, Alexandra Kourakli-Symeonidis, Gritta Janka-Schaub, Thomas Coates, Christiane Vermylen, Nancy Olivieri, Isabelle Thuret, Herbert Opitz, Catherine Ressayre-Djaffer, Peter Marks, and Daniele Alberti Universita di Milano, Fondazione Policlinico IRCCS, Milan, Italy Children's Hospital of Philadelphia, Philadelphia, PA, USA Ospedale Regina Margherita, Turin, Italy Centre National des Greffes de la Moelle Osseuse, Tunis, Tunisia I Policlinico II Universita di Napoli, Naples, Italy Istanbul Medical Faculty, Istanbul University, Istanbul, Turkey Ege University Medical Faculty, Izmir, Turkey First Department of Pediatrics, University of Athens, Athens, Greece Cukurova University Medical Faculty, Adana, Turkey University College Hospital, London, United Kingdom Ospedale Civico e Benefratelli G. Di Cristina M. Ascoli, Palermo, Italy Ospedale Regionale Microcitemie, Cagliari, Italy Hospital d'Enfants, Tunis, Tunisia Hospital de Ninos Ricardo Gutierrez, Buenos Aires, Argentina Az. Ospedale di Riliervo Nazionale e di Alta Spec. Garibaldi, Catania, Italy Centro Infantil de Investigacoes Hematologicas Dr. Boldrini, Campinas, Brazil "Hippokration" General Hospital of Thessaloniki, Thessaloniki, Greece New York Presbyterian Hospital, New York, NY, USA University Hospital of Patras, Patras, Greece Universitaetskrankenhaus Eppendorf, Hamburg, Germany Children's Hospital of Los Angeles, Los Angeles, CA, USA Cliniques Universtaires St. Luc, Brussels, Belgium Toronto General Hospital, Toronto, Canada Hopital de la Timone Enfants, Marseille, France Novartis Pharma AG, Basel, Switzerland * Corresponding author; email: maria.cappellini{at}unimi.it. Deferasirox (ICL670) is a once-daily oral iron chelator developed for the treatment of chronic iron overload from blood transfusions. A comparative Phase III trial was conducted to demonstrate the efficacy of deferasirox in regularly transfused patients with -thalassemia 2 years of age. 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 7 mg Fe/g dry weight (dw) 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 < 7 mg Fe/g dw. The most common adverse events included rash, gastrointestinal disturbances, and mild non-progressive 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. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Letters in Blood Online: Deferasirox versus deferoxamine Mike G. Martin, Murat O. Arcasoy, and Maria Domenica Cappellini Blood 2006 108: 774-776. [Full Text] [PDF] Does liver biopsy overestimate liver iron concentration? Roland Fischer, Paul Harmatz, and Peter Nielsen Blood 2006 108: 778. [Full Text] [PDF] Does liver biopsy overestimate liver iron concentration? Roland Fischer, Paul Harmatz, Peter Nielsen, and Maria Domenica Cappellini Blood 2006 108: 1775-1776. [Full Text] [PDF] This article has been cited by other articles: D. Chirnomas, A. L. Smith, J. 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