Author/Authors :
Eshghi, P. shahid beheshti university of medical sciences - Mofid Children Hospital - Pediatric Hematology and Oncology ward, تهران, ايران , Farahmandinia, Z. kerman university of medical sciences - Afzalipour Hospital - Department of Pediatric Hematology and Oncology, كرمان, ايران , Molavi, M. hormozgan university of medical sciences - Bandar Abbas Thalassemia Center - Department of Pediatric Hematology and Oncology, ايران , Naderi, M. zahedan university of medical sciences - Ali Asghar Hospital - Department of Pediatric Hematology and Oncology, زاهدان, ايران , Jafroodi, M. guilan university of medical sciences - 17 Shahrivar Hospital - Department of Pediatric Hematology and Oncology, رشت, ايران , Hoorfar, H. Seid-ol-Shohada Hospital - treatment center for special diseases, ايران , Davari, K. zanjan university of medical sciences - A Mousavi Hospital - Department of Pediatric Hematology and Oncology, زنجان, ايران , Azarkeivan, A. Iranian Blood Transfusion Organization - Zafar treatment center for thalassemia, ايران , Keikhaie, B. Ahwaz Jondishapour Research center for Thalassemia Hemoglobinopathy, ايران , Ansari, S. tehran university of medical sciences tums - Ali Asghar Hospital - Department of Pediatric Hematology and Oncology, تهران, ايران , Arasteh, M. Samen-ol-Hojaj center for special disease, ايران
Abstract :
Purpose of the study: to determine the efficacy, adverse effects and safety of a new Iranian generic product of deferasirox (Osveral®) 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 pm7.4 (2-58) years. The mean of initiating dose of Osveral® and mean usage dose during the study was 23.5 pm4.9 mg/kg and 24.9 pm 4.9 mg/kg respectively. MRC-SF was -11.44% pm 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®) shows a promising efficacy and safety for its Iranian generic product (Osveral ®)
