Assessment of the extent of oxidative stress induced by intravenous ferumoxytol, ferric carboxymaltose, iron sucrose and iron dextran in a nonclinical model

Arzneimittel-Forschung/Drug Research

Volumn 61, Issue 7, 2011, Pages 399-410

  Toblli, Jorge E ^a   Cao, Gabriel ^a   Oliveri, Leda ^a   Angerosa, Margarita ^a  

^a UNIVERSIDAD DE BUENOS AIRES   (Argentina)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CATALASE; COPPER ZINC SUPEROXIDE DISMUTASE; CREATININE; FERRIC CARBOXYMALTOSE; FERRIC HYDROXIDE SUCROSE; FERRITIN; FERUMOXYTOL; GLUTATHIONE; HEMOGLOBIN; INTERLEUKIN 6; IRON; IRON DEXTRAN; MALONALDEHYDE; REACTIVE OXYGEN METABOLITE; THIOBARBITURIC ACID REACTIVE SUBSTANCE; TUMOR NECROSIS FACTOR ALPHA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CONTROLLED STUDY; CREATININE CLEARANCE; DIASTOLIC BLOOD PRESSURE; DRUG DETERMINATION; ENZYME ACTIVITY; FEMALE; HEART INJURY; HEART MUSCLE CELL; HEMOGLOBIN BLOOD LEVEL; IRON BLOOD LEVEL; KIDNEY INJURY; LIPID PEROXIDATION; LIVER INJURY; MALE; MOLECULAR WEIGHT; NONHUMAN; OXIDATIVE STRESS; PROTEINURIA; RAT; SINGLE DRUG DOSE; SYSTOLIC BLOOD PRESSURE; TISSUE LEVEL;

EID: 79961113223     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296218     Document Type: Article

References (69)

1. Silverberg DS, Wexler D, Blum M, Iaina A. The cardio renal anemia syndrome: correcting anemia in patients with resistant congestive heart failure can improve both cardiac and renal function and reduce hospitalizations. Clin Nephrol. 2003;60 Suppl 1:S93-102.
2. Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004;116 Suppl 7A:44S-49S.
3. Macdougall IC. The management of anaemia in chronic kidney disease - current and future issues. Eur Ren Genitourin Dis. 2006;1:35-6.
4. Auerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, et al. Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010;85:655-63.
5. Crichton R, Danielson B, Geisser P. Iron therapy with special emphasis on intravenous administration. 4th ed. Bremen: UNI-MED Verlag AG; 2008. p. 1-128.
6. Alleyne M, Horne MK, Miller JL. Individualized treatment for iron-deficiency anemia in adults. Am J Med. 2008;121:943-8.
7. Johnson DW. Intravenous versus oral iron supplementation in peritoneal dialysis patients. Perit Dial Int. 2007;27 Suppl 2:S255-60. (Pubitemid 350047711)
8. Macdougall IC. Strategies for iron supplementation: oral versus intravenous. Kidney Int Suppl. 1999;69:S61-6. (Pubitemid 29113585)
9. Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005;68:2846-56. (Pubitemid 43251032)
10. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21:378-82. (Pubitemid 43159991)
11. Nissenson AR, Charytan C. Controversies in iron management. Kidney Int Suppl. 2003:S64-S71. (Pubitemid 37315510)
12. Geisser P, Baer M, Schaub E. Structure/histotoxicity relationship of parenteral iron preparations. Arzneimittelforschung. 1992;42:1439-52. (Pubitemid 23007362)
13. Toblli JE, Cao G, Olivieri L, Angerosa M. Comparison of the renal, cardiovascular and hepatic toxicity data of original intravenous iron compounds. Nephrol Dial Transplant. 2010;25:3631-40.
14. Schellekens H, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJ. The therapeutic equivalence of complex drugs. Regul Toxicol Pharmacol. 2011;59:176-83.
15. Lu M, Cohen MH, Rieves D, Pazdur R. FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Am J Hematol. 2010;85:315-9.
16. Macdougall IC. Intravenous administration of iron in epoetin-treated haemodialysis patients-which drugs, which regimen? Nephrol Dial Transplant. 2000;15:1743-5.
17. Qunibi WY. The efficacy and safety of current intravenous iron preparations for the management of iron-deficiency anaemia: a review. Arzneimittelforschung. 2010;60:399-412.
18. United States Pharmacopeial Convention: Iron Sucrose Injection, Official monograph in: The United States Pharmacopeia. United States Pharmacopeial Convention, Rockville, MD, US 2008;31:2449-51.
19. Balakrishnan VS, Rao M, Kausz AT, Brenner L, Pereira BJ, Frigo TB, et al. Physicochemical properties of ferumoxytol, a new intravenous iron preparation. Eur J Clin Invest. 2009;39:489-6.
20. Feraheme TM (ferumoxytol) Injection Prescribing Information, Lexington, MA, USA, AMAG Pharmaceuticals, Inc. 11-2010.
21. Press release: AMAG Pharmaceuticals Announces Update to Feraheme® Label, Lexington, MA, USA, AMAG Pharmaceuticals, Inc. 29-11-2010.
22. Ternes N, Scheiber-Mojdehkar B, Landgraf G, Goldenberg H, Sturm B. Iron availability and complex stability of iron hydroxyethyl starch and iron dextran a comparative in vitro study with liver cells and macrophages. Nephrol Dial Transplant. 2007;22:2824-30. (Pubitemid 350093433)
23. Andrews NC, Schmidt PJ. Iron homeostasis. Annu Rev Physiol. 2007;69:69-85. (Pubitemid 46457636)
24. Evans RW, Rafique R, Zarea A, Rapisarda C, Cammack R, Evans PJ, et al. Nature of non-transferrin-bound iron: studies on iron citrate complexes and thalassemic sera. J Biol Inorg Chem. 2008;13:57-74. (Pubitemid 350198011)
25. Zanen AL, Adriaansen HJ, van Bommel EF, Posthuma R, de Jong GMTh. 'Oversaturation' of transferrin after intravenous ferric gluconate (Ferrlecit®) in haemodialysis patients. Nephrol Dial Transplant. 1996;11:820-4.
26. Anirban G, Kohli HS, Jha V, Gupta KL, Sakhuja V. The comparative safety of various intravenous iron preparations in chronic kidney disease patients. Ren Fail. 2008;30:629-38.
27. Burns DL, Mascioli EA, Bistrian BR. Parenteral iron dextran therapy: a review. Nutrition. 1995;11:163-8.
28. Cavill I. Intravenous iron as adjuvant therapy: a two-edged sword? Nephrol Dial Transplant. 2003;18 Suppl 8:viii24-8.
29. Michael B, Coyne DW, Fishbane S, Folkert V, Lynn R, Nissenson AR, et al. Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830-9. (Pubitemid 34437938)
30. Charytan C, Schwenk MH, Al-Saloum MM, Spinowitz BS. Safety of iron sucrose in hemodialysis patients intolerant to other parenteral iron products. Nephron Clin Pract. 2004;96: c63-6. (Pubitemid 38456612)
31. Funk F, Ryle P, Canclini C, Neiser S, Geisser P. The new generation of intravenous iron: chemistry, pharmacology, and toxicology of ferric carboxymaltose. Arzneimittelforschung. 2010;60:345-53.
32. Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009;4:386-93.
33. Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis. 2008;52:907-15.
34. Santosh S, Podaralla P, Miller B. Anaphylaxis with elevated serum tryptase after administration of intravenous ferumoxytol. NDT Plus. 2010;3:341-2.
35. Toblli JE, Cao G, Oliveri L, Angerosa M. Differences between the original iron sucrose complex Venofer® and the iron sucrose similar Generis®, and potential implications. Port J Nephrol Hypert. 2009;1:53-63.
36. Toblli JE, Cao G, Oliveri L, Angerosa M. Differences between original intravenous iron sucrose and iron sucrose similar preparations. Arzneimittelforschung. 2009;59:176-90.
37. Toblli JE, Stella I, de CE, Angerosa M, Inserra F, Ferder L. Enalapril prevents tubulointerstitial lesions by hyperoxaluria. Hypertension. 1999;33:225-31. (Pubitemid 29065664)
38. Toblli JE, Ferrini MG, Cao G, Vernet D, Angerosa M, Gonzalez-Cadavid NF. Antifibrotic effects of pioglitazone on the kidney in a rat model of type 2 diabetes mellitus. Nephrol Dial Transplant. 2009;24:2384-91.
39. Toblli J, Cao G, Rivas C, Munoz M, Giani J, Dominici F, et al. Cardiovascular protective effects of nebivolol in Zucker diabetic fatty rats. J Hypertens. 2010;28:1007-19.
40. Fergelot P, Ropert-Bouchet M, Abgueguen E, Orhant M, Radosavljevic M, Grimber G, et al. Iron overload in mice expressing HFE exclusively in the intestinal villi provides evidence that HFE regulates a functional cross-talk between crypt and villi enterocytes. Blood Cells Mol Dis. 2002;28:348-60.
41. Youn P, Kim S, Ahn JH, Kim Y, Park JD, Ryu DY. Regulation of iron metabolism-related genes in diethylnitrosamine-induced mouse liver tumors. Toxicol Lett. 2009;184:151-8.
42. Rossi R, Cardaioli E, Scaloni A, Amiconi G, Di Simplicio P. Thiol groups in proteins as endogenous reductants to determine glutathione-protein mixed disulphides in biological systems. Biochim Biophys Acta. 1995;1243:230-8.
43. Akerboom TP, Sies H. Assay of glutathione, glutathione disulfide, and glutathione mixed disulfides in biological samples. Methods Enzymol. 1981;77:373-82.
44. de Cavanagh EM, Inserra F, Toblli J, Stella I, Fraga CG, Ferder L. Enalapril attenuates oxidative stress in diabetic rats. Hypertension. 2001;38:1130-6. (Pubitemid 34252818)
45. Niehaus WG Jr, Samuelsson B. Formation of malonaldehyde from phospholipid arachidonate during microsomal lipid peroxidation. Eur J Biochem. 1968;6:126-30.
46. Toblli JE, Cao G, Olivieri L, Angerosa M. Comparative study of gastrointestinal tract and liver toxicity of ferrous sulfate, iron amino chelate and iron polymaltose complex in normal rats. Pharmacology. 2008;82:127-37.
47. Chandler G, Harchowal J, Macdougall IC. Intravenous iron sucrose: establishing a safe dose. Am J Kidney Dis. 2001;38:988-91. (Pubitemid 33022176)
48. Bastani B, Jain A, Pandurangan G. Incidence of side-effects associated with high-dose ferric gluconate in patients with severe chronic renal failure. Nephrology (Carlton). 2003;8:8-10. (Pubitemid 36237944)
49. Groman EV, Paul KG, Frigo TB, Bengele H, Lewis JM. Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohydrate derivatives. (US Patent 6,599,498). 29-7-2007. United States.
50. Simon GH, von Vopelius-Feldt J, Fu Y, Schlegel J, Pinotek G, Wendland MF, et al. Ultrasmall supraparamagnetic iron oxide-enhanced magnetic resonance imaging of antigen-induced arthritis: a comparative study between SHU 555 C, ferumoxtran-10, and ferumoxytol. Invest Radiol. 2006;41:45-51. (Pubitemid 44378278)
51. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant. 2004;19:1571-5. (Pubitemid 38796422)
52. Chertow GM, Winkelmayer WC. On the relative safety of intravenous iron formulations: new answers, new questions. Am J Hematol. 2010;85:643-4.
53. Olsson S, Lundvall O, Weinfeld A. Availability of iron stores built up by iron dextrin as studied with desferrioxamine and phlebotomy. Acta Med Scand. 1972;191:49-56.
54. Meier T, Schropp P, Pater C, Leoni AL, Khov-Tran VV, Elford P. Physicochemical and toxicological characterization of a new generic iron sucrose preparation. Arzneimittelforschung. 2011;61:112-9.
55. Caperna TJ, Failla ML, Steele NC, Richards MP. Accumulation and metabolism of iron-dextran by hepatocytes, Kupffer cells and endothelial cells in the neonatal pig liver. J Nutr. 1987;117: 312-20. (Pubitemid 17047078)
56. Beshara S, Lundqvist H, Sundin J, Lubberink M, Tolmachev V, Valind S, et al. Pharmacokinetics and red cell utilization of iron(III) hydroxide-sucrose complex in anaemic patients: a study using positron emission tomography. Br J Haematol. 1999;104:296-302. (Pubitemid 29083337)
57. Beshara S, Sorensen J, Lubberink M, Tolmachev V, Langstrom B, Antoni G, et al. Pharmacokinetics and red cell utilization of 52Fe/59Fe-labelled iron polymaltose in anaemic patients using positron emission tomography. Br J Haematol. 2003;120:853-9. (Pubitemid 36315111)
58. Henderson PA, Hillman RS. Characteristics of iron dextran utilization in man. Blood. 1969;34: 357-75.
59. Hausmann K, Wulfhekel U, Dullmann J, Kuse R. Iron storage in macrophages and endothelial cells. Histochemistry, ultrastructure, and clinical significance. Blut. 1976;32:289-95.
60. Danielson BG. Structure, chemistry, and pharmacokinetics of intravenous iron agents. J Am Soc Nephrol. 2004;15 Suppl 2:S93-8. (Pubitemid 39578822)
61. IV. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: update 2000. Am J Kidney Dis. 2001;37:S182-238.
62. Van Wyck DB, Anderson J, Johnson K. Labile iron in parenteral iron formulations: a quantitative and comparative study. Nephrol Dial Transplant. 2004;19:561-5. (Pubitemid 38263113)
63. Ramaiah SK. A toxicologist guide to the diagnostic interpretation of hepatic biochemical parameters. Food Chem Toxicol. 2007;45:1551-7. (Pubitemid 47103335)
64. Lim PS, Wei YH, Yu YL, Kho B. Enhanced oxidative stress in haemodialysis patients receiving intravenous iron therapy. Nephrol Dial Transplant. 1999;14:2680-7. (Pubitemid 32208386)
65. Ishiyama A, Atarashi K, Minami M, Takagi M, Kimura K, Goto A, et al. Role of free radicals in the pathogenesis of lipid-induced glomerulosclerosis in rats. Kidney Int 1999;55:1348-58. (Pubitemid 29157133)
66. Fishbane S. Safety in iron management. Am J Kidney Dis. 2003;41:18-26.
67. Hentze MW, Muckenthaler MU, Galy B, Camaschella C. Two to tango: regulation of Mammalian iron metabolism. Cell. 2010;142:24-38.
68. Ramey G, Deschemin JC, Durel B, Canonne-Hergaux F, Nicolas G, Vaulont S. Hepcidin targets ferroportin for degradation in hepatocytes. Haematologica. 2010;95:501-4.
69. Fontecave M, Pierre JL. Iron: metabolism, toxicity and therapy. Biochimie. 1993;75:767-73. (Pubitemid 23337715)