Differences between the original iron sucrose complex Venofer and the iron sucrose similar Sucrofer
نویسنده
چکیده
Sucrofer (an Iron Sucrose complex) is one of the widely used Indian preparations for treatment of Iron deficiency anemia. The study was conducted to determine the possible efficacy and safety differences between the innovator’s Venofer and Indian similar (Sucrofer). Thirty rats were divided into three groups and assigned to receive Sucrofer, Venofer or isotonic saline solution (control). Five single intravenous doses of iron (40 mg iron/kg) or saline (equivalent volume) were administered every 7 days for 4 weeks. Blood and urine samples were collected for biological assessment prior to sacrifice (day 28) after which kidney, liver, and heart homogenates were collected for determination of antioxidant enzyme levels. Immmunohistochemistry techniques were used to identify tissue ferritin, TNFα and IL-6. Systolic blood pressure, creatinine clearance as well as proteinuria were not significantly altered by sucrofer as compared to Venofer throughout the study. Post 28 days treatment, serum levels of AST, ALT and ALP were also not altered by sucrofer as compared to both vehicle and Venofer group. Liver, heart and kidney catalase, thiobarbituric reactive species, CuZn-superoxide dismutase and glutathione peroxidase activity, and reduced to oxidized glutathione ratio were also not significantly altered by sucrofer as compared to venofer at 4 weeks of treatment. Serum iron and percentage transferrin saturation were elevated in both treatment groups (except control) and no differences in haemoglobin concentration were observed. Liver, kidney and heart TNFα and IL-6 were not significantly altered in both treatment groups as compared to control group on day 28. These findings suggest that both Venofer and Sucrofer have similar safety and efficacy profile.
منابع مشابه
Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD.
CONTEXT Severe iron deficiency requires intravenous iron supplementation to replenish iron stores. Intravenous iron sucrose has been used for decades for the treatment of anemia. New generic iron sucrose products are now marketed for the use in several countries and there is an ongoing discussion about the safety and efficacy of iron sucrose similars. OBJECTIVE In this study, we compared the ...
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