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International sentinel site surveillance of patients with transfusional hemosiderosis treated with deferasirox in actual practice setting
El-Beshlawy, Amal (Cairo University)
Inusa, Baba (Evelina Children's Hospital)
Beneitez Pastor, David (Hospital Universitari Vall d'Hebron. Departament d'Hematologia)
Xicoy, Blanca (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Duran Nieto, Maria Soledad (Hospital Materno Infantil de Jaén)
Bruederle, Andreas (Novartis Pharma AG)
Azmon, Amin (Novartis Pharma AG, Switzerland)
Gilotti, Geralyn (Novartis Pharmaceuticals Corporation, USA)
Elalfy, Mohsen (Ain Shams University, Cairo)
Universitat Autònoma de Barcelona

Fecha: 2019
Resumen: Objective:The study evaluates the long-term deferasirox treatment of adult and pediatricpatients with chronic transfusional iron overload in clinical practice. Methods:In this non-interventional study, patients were observed for up to 3 years frominitiation of deferasirox treatment both prospectively and retrospectively for up to 1 yearprior to enrollment. The primary end points were the proportion of patients with≥1 notableincrease in serum creatinine (SCr), and≥1 notable increase in alanine aminotransferase (ALT). Results:Overall, 120 patients were enrolled and 51 completed the study, with a limited 3-yeardropout rate of 12. 5% due to adverse events (AEs). Increase in SCr > 33% above baseline and theage-adjusted ULN (upper limit of normal) was observed in 14 patients (95%CI, 7. 1–19. 2). The ALTlevels >5 × ULN was observed in 1 patient. Most frequent AEs reported during treatment withdeferasirox include gastrointestinal disturbances. Conclusions:The long-term treatment with deferasirox was manageable in most transfusion-dependent patients with no unexpected safetyfindings. Regular monitoring and an adjusteddeferasirox dosing strategy per local labels allowed continued iron chelation treatment andcontrol of transfusional iron in the majority of patients on study.
Nota: Funding: This study was funded by Novartis Pharma AG
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. Creative Commons
Lengua: Anglès.
Documento: article ; recerca ; publishedVersion
Materia: Deferasirox ; Iron overload ; Iron chelation therapy ; Safety
Publicado en: Hematology, 2019 , ISSN 1607-8454

DOI: 10.1080/16078454.2018.155875


10 p, 1.6 MB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Artículos > Artículos de investigación
Artículos > Artículos publicados

 Registro creado el 2019-04-02, última modificación el 2019-04-04



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