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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Tailoring iron chelation by iron intake and serum ferritin: The prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias
Haematologica, Volume 95, No. 4, Year 2010
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Description
Background: Following a clinical evaluation of deferasirox (Exjade®) it was concluded that, in addition to baseline body iron burden, ongoing transfusional iron intake should be considered when selecting doses. The 1-year EPIC study, the largest ever investigation conducted for an iron chelator, is the first to evaluate whether fixed starting doses of deferasirox, based on transfusional iron intake, with dose titration guided by serum ferritin trends and safety markers, provides clinically acceptable chelation in patients (aged ≥2 years) with transfusional hemosiderosis from various types of anemia. Design and Methods: The recommended initial dose was 20 mg/kg/day for patients receiving 2-4 packed red blood cell units/month and 10 or 30 mg/kg/day was recommended for patients receiving less or more frequent transfusions, respectively. Dose adjustments were based on 3-month serum ferritin trends and continuous assessment of safety markers. The primary efficacy end-point was change in serum ferritin after 52 weeks compared with baseline. Results: The 1744 patients enrolled had the following conditions; thalassemia (n=1115), myelodysplastic syndromes (n=341), aplastic anemia (n=116), sickle cell disease (n=80), rare anemias (n=43) and other transfused anemias (n=49). Overall, there was a significant reduction in serum ferritin from baseline (-264 ng/mL; P<0.0001), reflecting dosage adjustments and ongoing iron intake. The most common (>5%) adverse events were gastrointestinal disturbances (28%) and skin rash (10%). Conclusions: Analysis of this large, prospectively collected data set confirms the response to chelation ther- apy across various anemias, supporting initial deferasirox doses based on transfusional iron intake, with subsequent dose titration guided by trends in serum ferritin and safety markers (clinicaltrials.gov identifier: NCT00171821). © 2010 Ferrata Storti Foundation.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2857545/bin/2009.014696_index.html
https://efashare.b-cdn.net/share/pmc/articles/PMC2857545/bin/2009.014696_1.pdf
Authors & Co-Authors
Cappellini, Maria Teresa
Italy, Milan
Università Degli Studi Di Milano
Porter, John B.
United Kingdom, London
University College London
El-Beshlawy, Amal M.
Egypt, Giza
Cairo University
Li, Chi Kong
Hong Kong
Prince of Wales Hospital Hong Kong
Seymour, John Francis
Australia, Melbourne
Peter Maccallum Cancer Centre
ElAlfy, Mohsen Saleh
Egypt, Cairo
Ain Shams University
Gattermann, Norbert
Germany, Dusseldorf
Heinrich-heine-universität Düsseldorf
Giraudier, Stéphane
France, Creteil
Hôpital Henri Mondor
Lee, Jongwook
South Korea, Bucheon-si
The Catholic University of Korea
Chan, Lee Lee
Malaysia, Kuala Lumpur
University of Malaya Medical Centre
Lin, Kai Hsin
Taiwan, Taipei
National Taiwan University Hospital
Rose, Christian Sainte
France, Paris
Hopital Saint-vincent-de-paul
Taher, Ali T.
Lebanon, Beirut
American University of Beirut
Thein, Swee Lay
United Kingdom, London
King's College London
Viprakasit, Vip
Thailand, Bangkok
Siriraj Hospital
Habr, Dany
Switzerland, Basel
Novartis International ag
Domokos, Gabor
Switzerland, Basel
Novartis International ag
Roubert, Bernard
Switzerland, Basel
Novartis International ag
Kattamis, Antonis C.
Greece, Athens
National and Kapodistrian University of Athens
Statistics
Citations: 287
Authors: 19
Affiliations: 17
Identifiers
Doi:
10.3324/haematol.2009.014696
ISSN:
03906078
e-ISSN:
15928721
Study Design
Cohort Study