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Efficacy and Safety of Iranian Made Deferasirox (Osveral®)In Iranian Major Thalassemic Patients With Transfusional Iron Overload: A One Year Prospective Multicentric Open-Label Non-Comparative Study



Eshghi P1 ; Farahmandinia Z2 ; Molavi M3 ; Naderi M4 ; Jafroodi M5 ; Hoorfar H6 ; Davari K7 ; Azarkeivan A8 ; Keikhaie B9 ; Ansari S10 ; Arasteh M11
Authors
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Authors Affiliations
  1. 1. Department of Pediatric Hematology and Oncology, Mofd Children Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
  2. 2. Department of Pediatric Hematology and Oncology, Afzalipour Hospital, Kerman University of Medical Science, Kerman, Iran
  3. 3. Department of Pediatric Hematology and Oncology, Bandar Abbas Thalassemia Center, Hormozgan University of Medical Science, Bandar Abbas, Iran
  4. 4. Department of Pediatric Hematology and Oncology, Ali Asghar Hospital, Zahedan University of Medical Science, Zahedan, Iran
  5. 5. Department of Pediatric Hematology and Oncology, 17 Shahrivar Hospital, Gilan University of Medical Science, Rasht, Iran
  6. 6. Seid-ol-Shohada Hospital, Treatment center for special diseases, Isfahan, Iran
  7. 7. Department of Pediatric Hematology and Oncology, A. Mousavi Hospital, Zanjan University of Medical Science, Zanjan, Iran
  8. 8. Zafar treatment center for thalassemia, Iranian Blood Transfusion Organization, Tehran, Iran
  9. 9. Ahwaz Jondishapour Research center for Thalassemia and Hemoglobinopathy, Ahwaz, Iran
  10. 10. Department of Pediatric Hematology and Oncology, Ali Asghar Hospital, Tehran University of Medical Science, Tehran, Iran
  11. 11. Samen-ol-Hojaj center for special disease, Kerman, Iran

Source: DARU, Journal of Pharmaceutical Sciences Published:2011

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±7.4 (2-58) years. The mean of initiating dose of Osveral® 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®) shows a promising efficacy and safety for its Iranian generic product (Osveral ®).
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