| Deferasirox Treatment of Iron-Overloaded Chelation-Naïve and Pre-chelated Patients with MDS in Medical Practice: Results from the Observational Studies eXtend and eXjange. | |
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MedLine Citation:
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PMID: 22023452 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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EXtend and eXjange were prospective, 1-year, non-interventional, observational, multicentre studies that investigated deferasirox, a once-daily oral iron chelator, in iron-overloaded chelation-naïve and pre-chelated patients with myelodysplastic syndromes (MDS), respectively; treated in the daily-routine setting of office-based physicians. No inclusion or exclusion criteria or additional monitoring procedures were applied. Deferasirox was administered as recommended in the European SPC. Haematological parameters and adverse events (AEs) were collected at 2-monthly intervals. Data from 123 chelation-naïve MDS patients (mean age 70.4 years) with median baseline serum ferritin level of 2679 (range 184-16,500) ng/mL, and 44 pre-chelated MDS patients (mean age 69.6 years) with median baseline serum ferritin level of 2442 (range 521-8565) ng/mL, were assessed. The mean prescribed daily dose of deferasirox at the first visit was 15.7 and 18.7 mg/kg/day, respectively. Treatment with deferasirox produced a significant reduction in median serum ferritin levels in chelation-naïve MDS patients from 2679 to 2000 ng/mL (P=0.0002), and a pronounced decrease in pre-chelated MDS patients from 2442 to 2077 ng/mL (P=0.06). The most common drug-related AEs were gastrointestinal, increased serum creatinine levels and rash. These studies demonstrate that deferasirox used in physicians' medical practices is effective in managing iron burden in transfusion-dependent patients with MDS. |
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Authors:
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N Gattermann; A Jarisch; R Schlag; K Blumenstengel; M Goebeler; M Groschek; C Losem; M Procaccianti; A Junkes; O Leismann; U Germing |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-10-24 |
Journal Detail:
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Title: European journal of haematology Volume: - ISSN: 1600-0609 ISO Abbreviation: - Publication Date: 2011 Oct |
Date Detail:
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Created Date: 2011-10-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8703985 Medline TA: Eur J Haematol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2011 John Wiley & Sons A/S. |
Affiliation:
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Heinrich-Heine-University, Düsseldorf, Germany Johann Wolfgang Goethe-University, Hospital for Children and Adolescents, Frankfurt am Main, Germany Hematology and Oncology Practice, Würzburg, Germany Internal Medicine, Hematology and Oncology Practice, Eisenach, Germany Department of Hematology and Oncology, University Hospital Würzburg, Würzburg, Germany Internal Medicine, Hematology and Internal Oncology Practice, Würselen, Germany Hematology and Oncology Practice, Neuss, Germany Hematology, Oncology and Infection Practice, Karlsruhe, Germany Business Unit Oncology, Novartis Pharma GmbH, Nuremberg, Germany. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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