Continued improvement in myocardial T2(star) over two years of deferasirox therapy in beta-thalassemia major patients with cardiac iron overload

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dc.contributor.authorPennell, Dudley J.
dc.contributor.authorPorter, John B.
dc.contributor.authorCappellini, Maria Domenica
dc.contributor.authorChan, Lee Lee
dc.contributor.authorEl-Beshlawy, Amal
dc.contributor.authorAydinok, Yesim
dc.contributor.authorIbrahim, Hishamshah
dc.contributor.authorLi, Chi-Kong
dc.contributor.authorViprakasit, Vip
dc.contributor.authorElalfy, Mohsen Saleh
dc.contributor.authorKattamis, Antonis
dc.contributor.authorSmith, Gillian
dc.contributor.authorHabr, Dany
dc.contributor.authorDomokos, Gabor
dc.contributor.authorRoubert, Bernard
dc.contributor.authorTaher, Ali
dc.date.accessioned2019-10-27T21:27:15Z
dc.date.available2019-10-27T21:27:15Z
dc.date.issued2011
dc.departmentEge Üniversitesien_US
dc.description.abstractBackground The efficacy of cardiac iron chelation in transfusion-dependent patients has been demonstrated in one-year prospective trials. Since normalization of cardiac T2* takes several years, the efficacy and safety of deferasirox was assessed for two years in patients with beta-thalassemia major in the cardiac sub-study of the EPIC trial. Design and Methods Eligible patients with myocardial T2* greater than 5 to less than 20 ms received deferasirox, with the primary endpoint being the change in T2* from baseline to two years. Results Baseline myocardial T2* was severe (>5 to <10 ms) in 39 patients, and moderate-to-mild (10 to <20 ms) in 62 patients. Mean deferasirox dose was 33.1+/-3.7 mg/kg/d in the one-year core study increasing to 36.1+/-7.7 mg/kg/d during the second year of treatment. Geometric mean myocardial T2* increased from a baseline of 11.2 to 14.8 ms at two years (P<0.001). In patients with moderate-to-mild baseline T2*, an increase was seen from 14.7 to 20.1 ms, with normalization (20 ms) in 56.7% of patients. In those with severe cardiac iron overload at baseline, 42.9% improved to the moderate-to-mild group. The incidence of drug-related adverse events did not increase during the extension relative to the core study and included (>= 5%) increased serum creatinine, rash and increased alanine aminotransferase. Conclusions Continuous treatment with deferasirox for two years with a target dose of 40 mg/kg/d continued to remove iron from the heart in patients with beta-thalassemia major and mild, moderate and severe cardiac siderosis. (Clinicaltrials.gov identifier: NCT 00171821)en_US
dc.description.sponsorshipNovartis Pharma AG; British Heart FoundationBritish Heart Foundation [PG/09/074/27961]; National Institute for Health ResearchNational Institute for Health Research (NIHR) [NF-SI-0508-10081]en_US
dc.description.sponsorshipthis study was sponsored by Novartis Pharma AG. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals.en_US
dc.identifier.doi10.3324/haematol.2010.031468en_US
dc.identifier.endpage54en_US
dc.identifier.issn0390-6078
dc.identifier.issn1592-8721
dc.identifier.issue1en_US
dc.identifier.pmid21071497en_US
dc.identifier.startpage48en_US
dc.identifier.urihttps://doi.org/10.3324/haematol.2010.031468
dc.identifier.urihttps://hdl.handle.net/11454/45058
dc.identifier.volume96en_US
dc.identifier.wosWOS:000286902400010en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherFerrata Storti Foundationen_US
dc.relation.ispartofHaematologica-The Hematology Journalen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectbeta-thalassemia majoren_US
dc.subjectcardiac iron overloaden_US
dc.subjectdeferasiroxen_US
dc.subjectiron chelationen_US
dc.subjectmyocardial T2*en_US
dc.titleContinued improvement in myocardial T2(star) over two years of deferasirox therapy in beta-thalassemia major patients with cardiac iron overloaden_US
dc.typeArticleen_US

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