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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
A 1-year randomized controlled trial of deferasirox vs deferoxamine for myocardial iron removal in β-thalassemia major (CORDELIA)
Blood, Volume 123, No. 10, Year 2014
Notification
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Description
Randomized comparison data on the efficacy and safety of deferasirox for myocardial iron removal in transfusion dependent patients are lacking. CORDELIA was a prospective, randomized comparison of deferasirox (target dose 40 mg/kg per day) vs subcutaneous deferoxamine (50-60 mg/kg per day for 5-7 days/week) for myocardial iron removal in 197 β-thalassemia major patients with myocardial siderosis (T2*6-20 milliseconds) and no signs of cardiac dysfunction (mean age, 19.8 years). Primary objective was to demonstrate noninferiority of deferasirox for myocardial iron removal, assessed by changes in myocardial T2*after 1 year using a per-protocol analysis. Geometric mean (Gmean) myocardial T2*improved with deferasirox from 11.2 milliseconds at baseline to 12.6 milliseconds at 1 year (Gmeans ratio, 1.12) and with deferoxamine (11.6 milliseconds to 12.3 milliseconds; Gmeans ratio, 1.07). The between-arm Gmeans ratio was 1.056 (95% confidence interval [CI], 0.998, 1.133). The lower 95% CI boundary was greater than the prespecified margin of 0.9, establishing noninferiority of deferasirox vs deferoxamine (P = .057 for superiority of deferasirox). Left ventricular ejection fraction remained stable in both arms. Frequency of drug-related adverse events was comparable between deferasirox (35.4%) and deferoxamine (30.8%). CORDELIA demonstrated the noninferiority of deferasirox compared with deferoxamine for myocardial iron removal. This trial is registered at www.clinicaltrials.gov as #NCT00600938. © 2014 by The American Society of Hematology.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3945858/bin/supp_123_10_1447__index.html
https://efashare.b-cdn.net/share/pmc/articles/PMC3945858/bin/supp_blood-2013-04-497842_blood-2013-04-497842-1.pdf
Authors & Co-Authors
Pennell, Dudley John
United Kingdom, London
Royal Brompton Hospital
Porter, John B.
United Kingdom, London
Ucl Cancer Institute
Piga, Antonio Giulio
Italy, Turin
Università Degli Studi Di Torino
Lai, Yongrong
China, Nanning
Guangxi Medical University
El-Beshlawy, Amal M.
Egypt, Cairo
Cairo University Hospitals
Belhoul, Khawla M.
United Arab Emirates, Dubai
Latifa Hospital
ElAlfy, Mohsen Saleh
Egypt, Cairo
Ain Shams University Children's Hospital
Yeşilipek, Mehmet Akif M.
Turkey, Antalya
Akdeniz Üniversitesi
Kılınç, Yurdanur
Turkey, Adana
Çukurova Üniversitesi
Lawniczek, Tomasz
Switzerland, Basel
Novartis International ag
Habr, Dany
Switzerland, Basel
Novartis International ag
Weisskopf, Marianne
Switzerland, Basel
Novartis International ag
Zhang, Yiyun
Switzerland, Basel
Novartis International ag
Aydınok, Yeşim
Turkey, Izmir
Ege University Medical School
Statistics
Citations: 121
Authors: 14
Affiliations: 11
Identifiers
Doi:
10.1182/blood-2013-04-497842
ISSN:
00064971
Research Areas
Noncommunicable Diseases
Study Design
Cohort Study
Study Approach
Quantitative