PMID- 22615664
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20120823
LR  - 20211021
IS  - 2008-2231 (Electronic)
IS  - 1560-8115 (Print)
IS  - 1560-8115 (Linking)
VI  - 19
IP  - 3
DP  - 2011
TI  - Efficacy and safety of Iranian made Deferasirox (Osveral(R)) in Iranian major 
      thalassemic patients with transfusional iron overload: A one year prospective 
      multicentric open-label non-comparative study.
PG  - 240-8
AB  - PURPOSE OF THE STUDY: to determine the efficacy, adverse effects and safety of a 
      new Iranian generic product of deferasirox (Osveral(R)) in Iranian transfusion 
      dependent major thalassemic (TD-MT) patients. METHODS: In 9 main thalassemia 
      treatment centers, all of TD-MT patients (aged >/=2 yrs) with serum ferritin (SF) 
      levels>/=1000 ng/ml, or >100 ml/kg of RBC transfusion,who could not tolerate 
      parental iron chelating were recruited regardless of their previous iron 
      chelation therapy. Periodical clinical and laboratory evaluations were conducted 
      for adverse effects (AEs). Primary efficacy end point was Mean of Relative Change 
      of Serum Ferritin (MRC-SF) from the baseline level during one year. Analysis of 
      variance (ANOVA), t test, chi-square or Fisher exact test were used for statistic 
      analysis appropriately (P values <0.05 were considered as statistical 
      significant). RESULTS: In 407 cases the male/female ratio was 0.98. Mean age was 
      11.5+/-7.4 (2-58) years. The mean of initiating dose of Osveral(R) and mean usage 
      dose during the study was 23.5+/-4.9 mg/kg and 24.9+/-4.9 mg/kg respectively. MRC-SF 
      was -11.44% +/-38.92 and it showed significant decline in SF (P value<0.001) one 
      hundred and forty eight patients out of 407 patients experienced at least one. 
      AE, the most common of them were transient increase in serum creatinin (97;24.1%) 
      and>5 time increase in transaminases (24;5.89%).The causes of discontinuation of 
      treatment were non-satisfactory treatment ( 24; 5.8%), poor or non-compliance of 
      patients (21;5.1%), and adverse effects (13; 3.1%) CONCLUSION: A detailed 
      comparison with similar studies on deferasirox (Exjade(R)) shows a promising 
      efficacy and safety for its Iranian generic product (Osveral (R)).
FAU - Eshghi, P
AU  - Eshghi P
AD  - Department of Pediatric Hematology and Oncology, Mofid Children Hospital, Shahid 
      Beheshti University of Medical Science, Tehran.
FAU - Farahmandinia, Z
AU  - Farahmandinia Z
FAU - Molavi, M
AU  - Molavi M
FAU - Naderi, M
AU  - Naderi M
FAU - Jafroodi, M
AU  - Jafroodi M
FAU - Hoorfar, H
AU  - Hoorfar H
FAU - Davari, K
AU  - Davari K
FAU - Azarkeivan, A
AU  - Azarkeivan A
FAU - Keikhaie, B
AU  - Keikhaie B
FAU - Ansari, S
AU  - Ansari S
FAU - Arasteh, M
AU  - Arasteh M
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Daru
JT  - Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences
JID - 101125969
PMC - PMC3232111
OTO - NOTNLM
OT  - Deferasirox
OT  - Efficacy.
OT  - Iron Chelation,
OT  - Osveral (R)
OT  - Safety
OT  - Thalassemia
EDAT- 2011/01/01 00:00
MHDA- 2011/01/01 00:01
PMCR- 2011/01/01
CRDT- 2012/05/23 06:00
PHST- 2011/01/24 00:00 [received]
PHST- 2011/06/07 00:00 [revised]
PHST- 2011/06/11 00:00 [accepted]
PHST- 2012/05/23 06:00 [entrez]
PHST- 2011/01/01 00:00 [pubmed]
PHST- 2011/01/01 00:01 [medline]
PHST- 2011/01/01 00:00 [pmc-release]
AID - DARU-19-240 [pii]
PST - ppublish
SO  - Daru. 2011;19(3):240-8.