Repository of Research and Investigative Information

Repository of Research and Investigative Information

Hormozgan University of Medical Sciences

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

(2011) 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. DARU, Journal of Pharmaceutical Sciences.

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Official URL: https://www.scopus.com/inward/record.uri?eid=2-s2....

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 ®).

Item Type: Article
Additional Information: cited By 3
Keywords: deferasirox; ferritin; osveral; unclassified drug, adolescent; adult; alanine aminotransferase blood level; article; aspartate aminotransferase blood level; child; creatinine blood level; drug dose regimen; drug efficacy; drug safety; drug withdrawal; erythrocyte transfusion; ethnic group; female; ferritin blood level; human; Iranian; iron chelation; iron overload; liver dysfunction; liver function test; major clinical study; male; multicenter study; patient compliance; patient monitoring; preschool child; prospective study; recommended drug dose; school child; sex ratio; side effect; thalassemia major
Subjects: History of Medicine. Medical Miscellany > WZ 305-350 Miscellany Relating to Medicine
Depositing User: مهندس هدی فهیم پور
URI: http://eprints.hums.ac.ir/id/eprint/5359

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