PMID- 22023452 OWN - NLM STAT- MEDLINE DCOM- 20120413 LR - 20231104 IS - 1600-0609 (Electronic) IS - 0902-4441 (Print) IS - 0902-4441 (Linking) VI - 88 IP - 3 DP - 2012 Mar TI - Deferasirox treatment of iron-overloaded chelation-naive and prechelated patients with myelodysplastic syndromes in medical practice: results from the observational studies eXtend and eXjange. PG - 260-8 LID - 10.1111/j.1600-0609.2011.01726.x [doi] AB - 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-naive 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-naive 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-naive 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. CI - (c) 2011 John Wiley & Sons A/S. FAU - Gattermann, Norbert AU - Gattermann N AD - Department of Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University, Dusseldorf, Germany. gattermann@med.uni-duesseldorf.de FAU - Jarisch, Andrea AU - Jarisch A FAU - Schlag, Rudolf AU - Schlag R FAU - Blumenstengel, Klaus AU - Blumenstengel K FAU - Goebeler, Mariele AU - Goebeler M FAU - Groschek, Matthias AU - Groschek M FAU - Losem, Christoph AU - Losem C FAU - Procaccianti, Maria AU - Procaccianti M FAU - Junkes, Alexia AU - Junkes A FAU - Leismann, Oliver AU - Leismann O FAU - Germing, Ulrich AU - Germing U LA - eng PT - Journal Article PT - Multicenter Study DEP - 20111124 PL - England TA - Eur J Haematol JT - European journal of haematology JID - 8703985 RN - 0 (Benzoates) RN - 0 (Iron Chelating Agents) RN - 0 (Triazoles) RN - 9007-73-2 (Ferritins) RN - V8G4MOF2V9 (Deferasirox) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Benzoates/administration & dosage/adverse effects/*therapeutic use MH - Deferasirox MH - Female MH - Ferritins/blood MH - Humans MH - Iron Chelating Agents/administration & dosage/adverse effects/*therapeutic use MH - Iron Overload/*complications/*drug therapy MH - Male MH - Middle Aged MH - Myelodysplastic Syndromes/*complications/therapy MH - Prospective Studies MH - Transfusion Reaction MH - Triazoles/administration & dosage/adverse effects/*therapeutic use PMC - PMC3505370 EDAT- 2011/10/26 06:00 MHDA- 2012/04/14 06:00 CRDT- 2011/10/26 06:00 PHST- 2011/10/26 06:00 [entrez] PHST- 2011/10/26 06:00 [pubmed] PHST- 2012/04/14 06:00 [medline] AID - 10.1111/j.1600-0609.2011.01726.x [doi] PST - ppublish SO - Eur J Haematol. 2012 Mar;88(3):260-8. doi: 10.1111/j.1600-0609.2011.01726.x. Epub 2011 Nov 24.