Deferasirox treatment of iron‐overloaded chelation‐naïve and prechelated patients with myelodysplastic syndromes in medical practice: results from the observational studies eXtend and eXjange
| Autor: | Christoph Losem, Klaus Blumenstengel, Norbert Gattermann, Rudolf Schlag, Andrea Jarisch, Maria Procaccianti, Oliver Leismann, Mariele Goebeler, Matthias Groschek, Alexia Junkes, Ulrich Germing |
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| Rok vydání: | 2011 |
| Předmět: |
safety
Adult Male medicine.medical_specialty Iron Overload Blood transfusion medicine.medical_treatment Iron Chelating Agents Benzoates oral Internal medicine medicine Humans Prospective Studies Prospective cohort study Adverse effect Serum ferritin Aged Aged 80 and over iron chelation business.industry Myelodysplastic syndromes Deferasirox serum ferritin Transfusion Reaction Original Articles Hematology General Medicine Middle Aged Triazoles medicine.disease Rash myelodysplastic syndromes Surgery Ferritins Female Observational study medicine.symptom business medicine.drug |
| Zdroj: | European Journal of Haematology |
| ISSN: | 1600-0609 0902-4441 |
| Popis: | EXtend and eXjange were prospective, 1-yr, non-interventional, observational, multicentre studies that investigated deferasirox, a once-daily oral iron chelator, in iron-overloaded chelation-naïve and prechelated 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 Summary of Product Characteristics. Haematological parameters and adverse events (AEs) were collected at two-monthly intervals. Data from 123 chelation-naïve patients with MDS (mean age 70.4 yrs) with median baseline serum ferritin level of 2679 (range 184-16,500) ng/mL, and 44 prechelated patients with MDS (mean age 69.6 yrs) 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/d, respectively. Treatment with deferasirox produced a significant reduction in median serum ferritin levels in chelation-naïve patients with MDS from 2679 to 2000 ng/mL (P = 0.0002) and a pronounced decrease in prechelated patients with MDS 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. |
| Databáze: | OpenAIRE |
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