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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of deferasirox at low and high iron burdens: Results from the EPIC magnetic resonance imaging substudy
Annals of Hematology, Volume 92, No. 2, Year 2013
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Description
The effect of deferasirox dosing tailored for iron burden and iron loading based on liver iron concentration (LIC) was assessed over 1 year in less versus more heavily iron-overloaded patients in a substudy of the Evaluation of Patients' Iron Chelation with Exjade®. Deferasirox starting dose was 10-30 mg/kg/day, depending on blood transfusion frequency, with recommended dose adjustments every 3 months. Therapeutic goals were LIC maintenance or reduction in patients with baseline LIC <7 or ≥7 mg Fe/g dry weight (dw), respectively. Changes in LIC (R2-magnetic resonance imaging) and serum ferritin after 1 year were assessed. Adverse events (AEs) and laboratory parameters were monitored throughout. Of 374 patients, 71 and 303 had baseline LIC <7 and ≥7 mg Fe/g dw, respectively; mean deferasirox doses were 20.7 and 27.1 mg/kg/day (overall average time to dose increase, 24 weeks). At 1 year, mean LIC and median serum ferritin levels were maintained in the low-iron cohort (-0.02 ± 2.4 mg Fe/g dw, -57 ng/mL; P = not significant) and significantly decreased in the high-iron cohort (-6.1 ± 9.1 mg Fe/g dw, -830 ng/mL; P < 0.0001). Drug-related gastrointestinal AEs, mostly mild to moderate, were more frequently reported in the <7 versus ≥7 mg Fe/g dw cohort (39.4 versus 20.8 %; P = 0.001) and were not confounded by diagnosis, dosing, ethnicity, or hepatitis B and/or C history. Reported serum creatinine increases did not increase in low- versus high-iron cohort patients. Deferasirox doses of 20 mg/kg/day maintained LIC <7 mg Fe/g dw and doses of 30 mg/kg/day were required for net iron reduction in the high-iron cohort, with clinically manageable safety profiles. The higher incidence of gastrointestinal AEs at lower iron burdens requires further investigation. © 2012 The Author(s).
Authors & Co-Authors
Porter, John B.
United Kingdom, London
Ucl Cancer Institute
ElAlfy, Mohsen Saleh
Egypt, Cairo
Ain Shams University
Taher, Ali T.
Lebanon, Beirut
American University of Beirut
Aydınok, Yeşim
Turkey, Izmir
Ege Üniversitesi
Chan, Lee Lee
Malaysia, Kuala Lumpur
University of Malaya Medical Centre
Lee, Szu Hee
Australia, Adelaide
Institute of Medical and Veterinary Science Australia
Sutcharitchan, Pranee
Thailand, Bangkok
Chulalongkorn University
Habr, Dany
Switzerland, Basel
Novartis International ag
Martin, Nicholas G.
Switzerland, Basel
Novartis International ag
El-Beshlawy, Amal M.
Egypt, Giza
Cairo University
Statistics
Citations: 35
Authors: 10
Affiliations: 9
Identifiers
Doi:
10.1007/s00277-012-1588-x
ISSN:
09395555
e-ISSN:
14320584
Research Areas
Infectious Diseases
Study Design
Cohort Study