ArticleInflammation & allergy drug targets2012
Comparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat model.
Article in Inflammation & allergy drug targets, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed, 62 citations in OpenAlex.
- The effect of iron loading and iron chelation on the innate immune response and subclinical organ injury during human endotoxemia: a randomized trial.Haematologica · 2014Trial
- Postoperative anemia: is there a role for iron replacement therapy?Blood transfusion = Trasfusione del sangue · 2025Article
- Safety of High-Dose Intravenous Iron in Hemodialysis Patients: Results from the National Health Insurance Service (2019-2020) in South Korea.Journal of clinical medicine · 2024Article
- Article
- Tackling the challenges of nanomedicines: are we ready?American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2021Review
- Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety.Frontiers in pharmacology · 2021Article
- Iron Sucrose: A Wealth of Experience in Treating Iron Deficiency.Advances in therapy · 2020Review
- In vitro and in vivo DFO-chelatable labile iron release profiles among commercially available intravenous iron nanoparticle formulations.Regulatory toxicology and pharmacology : RTP · 2018Article
- Medication practice in hospitals: are nanosimilars evaluated and substituted correctly?European journal of hospital pharmacy : science and practice · 2018Article
- Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization.Nanomaterials (Basel, Switzerland) · 2018Article
- Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products.The AAPS journal · 2017Review
- Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.The AAPS journal · 2017Review
- Performance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release From Intravenous Iron Formulations.Clinical and translational science · 2017Article
- Markers of oxidative/nitrosative stress and inflammation in lung tissue of rats exposed to different intravenous iron compounds.Drug design, development and therapy · 2017Article
- Cardiovascular, liver, and renal toxicity associated with an intravenous ferric carboxymaltose similar versus the originator compound.Drug design, development and therapy · 2017Article
- The Induction of Oxidative/Nitrosative Stress, Inflammation, and Apoptosis by a Ferric Carboxymaltose Copy Compared to Iron Sucrose in a Non-Clinical Model.Journal of clinical and diagnostic research : JCDR · 2015Article
- Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis.PloS one · 2015Article
- Maximal standard dose of parenteral iron for hemodialysis patients: an MRI-based decision tree learning analysis.PloS one · 2014Article
- How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider.The AAPS journal · 2014Review
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Iron sucrose originator (IS(ORIG)) has been used to treat iron deficiency and iron deficiency anemia for decades. Iron sucrose similars (ISSs) have recently entered the market. In this non-clinical study of non-anemic rats, five doses (40 mg iron/kg body weight) of six ISSs marketed in Asian countries, IS(ORIG) or saline solution (control) were administered intravenously over four weeks to compare their toxicologic effects. Vasodilatory effects, impaired renal function and hepatic damage were only observed in the ISS groups. Significantly elevated serum iron and transferrin saturation levels were observed in the ISS groups suggesting a higher release of iron resulting in higher amounts of non-transferrin bound (free) iron compared to IS(ORIG). This might explain the elevated oxidative stress and increased levels of inflammatory markers and antioxidant enzymes in the liver, heart and kidneys of ISS-treated animals. Physico-chemical analyses showed that the molecular structure of most of the ISSs differed greatly from that of the IS(ORIG). These differences may be responsible for the organ damage and oxidative stress observed in the ISS groups. Significant differences were also found between different lots of a single ISS product. In contrast, polarographic analyses of three different IS(ORIG) lots were identical, indicating that the molecular structure and thus the manufacturing process for IS(ORIG) is highly consistent. Data from this study suggest that ISSs and IS(ORIG) differ significantly. Therefore, before widespread use of these products it would be prudent to evaluate additional non-clinical and/or clinical data proving the safety, therapeutic equivalence and interchangeability of ISSs with IS(ORIG).
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