Efficiency of original versus generic intravenous iron formulations in patients on haemodialysis

PLoS ONE

Volumn 10, Issue 8, 2015, Pages

  Agüera, Maria Luisa ^a,b,c   Martin Malo, Alejandro ^a,b,c   Alvarez Lara, Maria Antonia ^a,b,c   Garcia Montemayor, Victoria Eugenia ^d   Canton, Petra ^d   Soriano, Sagrario ^a,b,c   Aljama, Pedro ^a,b,c  

^a HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^b UNIVERSITY OF CÓRDOBA   (Spain)

^c INSTITUTO DE SALUD CARLOS III   (Spain)

^d Dialysis Unit   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ERYTHROPOIETIN; FERRITIN; GENERIC DRUG; HEMOGLOBIN; IRON; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; TRANSFERRIN; ANTIANEMIC AGENT;

AGED; ANEMIA; ARTICLE; CHRONIC KIDNEY DISEASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FORMULATION; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; FERRITIN BLOOD LEVEL; FOLLOW UP; HEMODIALYSIS; HEMOGLOBIN BLOOD LEVEL; HUMAN; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MORTALITY; OBSERVATIONAL STUDY; TREATMENT OUTCOME; ANEMIA, IRON-DEFICIENCY; BLOOD; INTRAVENOUS DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; METABOLISM; PROCEDURES; PROSPECTIVE STUDY;

ADMINISTRATION, INTRAVENOUS; AGED; ANEMIA, IRON-DEFICIENCY; CHEMISTRY, PHARMACEUTICAL; DRUGS, GENERIC; ERYTHROPOIETIN; FEMALE; FERRITINS; FOLLOW-UP STUDIES; HEMATINICS; HEMOGLOBINS; HUMANS; IRON; MALE; PROSPECTIVE STUDIES; RENAL DIALYSIS; TRANSFERRIN;

EID: 84943339694     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0135967     Document Type: Article

References (45)

1. Locatelli F, De Francisco A, Deray G, Fliser D, Armstrong G, Dougherty FS, et al. Mortality and Cardiovascular Morbidity associated with Haemoglobin Levels: a pooled analysis of randomized controlled trials. Nephron Clin Pract 2014;128:323-332; doi: 10.1159/000366478
2. Jing Z, Wei-jie Y, Nan Z, Yi Z, Ling W. Hemoglobin Targets for Chronic Kidney Disease Patients with Anemia: A Systematic Review and Meta-analysis. PloS ONE 2012;7(8):e43655. doi: 10.1371/journal.pone.0043655 PMID: 22952731
3. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N EnglJ Med 1998;339:584-590; doi: 10.1056/NEJM199808273390903 PMID: 9718377
4. Staufferme, Fan T. Prevalence of anemiaen Chronic Kidney Disease in the United States. PLoS ONE 2014;9(1):e84943. doi: 10.1371/journal.pone.0084943 PMID: 24392162
5. Brookhart MA, Schneeweiss S, Avorn J, Bradbury BD, Liu J, Winkelmayer WC. Comparative Mortality Risk of Anemia Management Practices in Incident Hemodialysis Patients. JAMA 2010;303:857-864; doi: 10.1001/jama.2010.206 PMID: 20197532
6. Koulouridis I, Alfayez M, Trikalinos TA, Balk EM, Jaber BL. Dose of Erythropoiesis-Stimulating Agents and Adverse Outcomes in CKD: A Metaregression Analysis. Am J Kidney Dis 2013;61(1):44-56; doi: 10.1053/j.ajkd.2012.07.014 PMID: 22921639
7. Freburger JK, Ng LJ, Bradbury BD, Kshirsagar AV, Brookhart MA. Changing patterns of anemia management in US hemodialysis patients. Am J Med 2012;12, 909-914; doi: 10.1016/j.amjmed.2012.03. 011
8. Gaweda AE, Ginzburg YZ, Chait Y, Germain MJ, Aronoff GR, Rachmilewitz E. Iron dosing in kidney disease: inconsistency of evidence and clinical practice. Nephrol Dial Transplant 2014; doi: 10.1093/ndt/gfu104
9. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guidelines for anaemia in chronic kidney disease. Kidney IntSuppl 2012;2:279-335; doi: 10.1038/kisup. 2012.37
10. Locatelly F, Bárány P, Covic A, De Francisco A, Del Vecchio L, Goldsmith D, et al. ERA-EDTAERBP Advisory Board Kidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: a European Renal Best Practice position statement. Nephrol Dial Transplant 2013;28:1346-1359; doi: 10.1093/ndt/gft033 PMID: 23585588
11. Vaziri ND. Understanding iron: promoting its safe use in patients with chronic kidney failure treated by hemodialysis. Am J Kidney Dis 2013;61:992-1000; doi: 10.1053/j.ajkd.2012.10.027 PMID: 23375852
12. Rostoker G, Griuncelli M, Loridon C, Magna T, Janklewicz P, et al. Maximal Standard Dose of Parenteral Iron for Hemodialysis Patients: An MRI-Based DecisionTree Learning Analysis. PLoSONE 2014;9(12):e115096. doi: 10.1371/journal.pone.0115096 PMID: 25506921
13. Brissot P, Ropert M, Le Lan C, Loréal O. Non-transferrin bound iron: a key role in iron overload and iron toxicity. Biochim Biochys Acta 2012;1820:403-410; doi: 10.1016/j.bbagen. 2011.07.014
14. Pai AB, Conner T, McQuade CR, Olp J, Hicks P. Non-transferrin bound iron, cytokine activation and intracellular reactive oxygen species generation in hemodialysis patients receiving Intravenous iron dextran or iron sucrose. Biometals 2011;24:603-613; doi: 10.1007/s10534-011-9409-6 PMID: 21229380
15. Ichii H, Masuda Y, Hassanzadeh T, Saffarian M, Gollapudi S, Vaziri ND. Iron sucrose impairs phagocytic function and promotes apoptosis in polymorphonuclear leukocytes. Am J Nephol 2012;36:50-57; doi: 10.1159/000339285
16. Fell LH, Zawada AM, Rogacev KS, Seiler S, Fliser D, Heine GH. Distinct immunologic effects of different Intravenous iron formulations on monocytes. Nephrol Dial Transplant 2014;29:809-832; doi: 10. 1093/ndt/gft524 PMID: 24523357
17. Martin-Malo A, Merino A, Carracedo J, Álvarez-Lara MA, Ojeda R, Soriano S, et al. Effects of Intravenous iron on mononuclear cells during the haemodialysis session. Nephrol Dial Transplant 2012;27:2465-2471; doi: 10.1093/ndt/gfr711 PMID: 22207322
18. Connor JR, Zhang X, Nixon AM, Webb B, Perno JR. Comparative evaluation of Nephrotoxicity and Management by macrophages of intravenous pharmaceutical iron formulations. PLoSONE 2015;10(5):e0125272; doi: 10.1371/journal.pone.0125272
19. Ramsey S. WHO Guideline on country pharmaceutical pricing policies. Recommendation 5.5. Promotion of the use of generic medicines. Geneva: World Health Organization. 2013. NBK258631
20. Van Der Meersch A, Dechartres A, Ravaud P. Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review. PLoS ONE 2011, 6(8):e23611. doi: 10.1371/journal.pone.0023611 PMID: 21858184
21. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between Generic drugs and their originator counterparts, including economic benefits associated with usage of Generic medicines, using Ireland as a case study. BMC PharmacolToxicol 2013;14:1. doi: 10.1186/2050-6511-14-1
22. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT. Comparing Generic and Innovator Drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother 2009;43(10):1583-97; doi: 10.1345/aph.1M141 PMID: 19776300
23. Rottembourg J, Kadri A, Leonard E, Dansaert A, Lafuma A. Do two Intravenous iron sucrose formulations have the same efficacy? Nephrol Dial Transplant 2011;26:3262-3267; doi: 10.1093/ndt/gfr024 PMID: 21355067
24. Gaweda AD, Aronoff GR, Jacobs AA, Rai SN, Brier ME. Individualized Anemia Management Reduces Hemoglobin Variability in Hemodialysis Patients. J Am SocNephrol 2014;25:159-166; doi: 10.1681/ASN.2013010089
25. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, et al. Clinical equivalence of Generic and brand-name drugs used in Cardiovascular Disease. A systematic review and meta-analysis. JAMA 2008;300(21):2514-2526; doi: 10.1001/jama.2008.758 PMID: 19050195
26. Harrison JJ, Schiff JR, Coursol CJ, Daley CJ, Dipchand AI, Heywood NM, et al. Generic Immunosuppression in Solid Organ Transplantation: A Canadian Perspective. Transplantation 2012;93:657-665; doi: 10.1097/TP.0b013e3182445e9d PMID: 22267158
27. Toblli JE, Cao G, Oliveri L, Angerosa M. Comparison of oxidative stress and inflammation induced by different Intravenous iron sucrose similar formulations in a rat model. Inflamm Allergy Drug Targets 2012;11:66-78; doi: 10.2174/187152812798889358 PMID: 22309085
28. Fuller DS, Pisoni RL, Bieber BA, Port FK, Robinson BM. The DOPPS Practice monitor for US Dialysis Care: update on trends in anemia management 2 years into the bundle. Am J Kidney Dis 2013;62:1213-6. doi: 10.1053/j.ajkd.2013.09.006 PMID: 24140369
29. Agarwal R, Kusek JW, Pappas MK. A randomized trial of intravenous and oral iron in chronic kidney disease. Kidney Int. 2015 Jun. 17; doi: 10.1038/ki.2015.163 [Epub ahead of print].
30. Charytan DM, Pai AB, Chan CT, Coyne DW, Hung AM, Kovesdy CP, et al. Considerations and Challenges in Defining Optimal Iron Utilization in Hemodialysis. J Am SocNephrol 2015;26:1238-1247, 2015. doi: 10.1681/ASN.2014090922
31. Szczech LA, Barnhart HX, Inrig JK, Reddan DN, Sapp S, et al. Secondary analysis of the CHOIR trial epoetin-alphadose and achieved hemoglobin outcomes. Kidney Int 2008;74:791-798; doi: 10.1038/ki.2008.295 PMID: 18596733
32. Zitt E, Sturm G, Kronenberg F, Neyer U, Knoll F, et al. Iron Supplementation and Mortality in Incident Dialysis Patients: An Observational Study. PLoSONE 2014;9(12):e114144. doi: 10.1371/journal. pone.0114144 PMID: 25462819
33. Kalantar-Zadeh K, Regidor DL, McAllister CJ, Michael B, Warnock DG. Time-dependent associations between iron and mortality in hemodialysis patients. J Am SocNephrol 2005;16:3070-3080; doi: 10. 1681/asn. 2005040423
34. Feldman HI, Joffe M, Robinson B, Knauss J, Cizman B, et al. Administration of parenteral iron and mortality among hemodialysis patients. J Am SocNephrol 2004;15:1623-1632; doi: 10.1097/01.asn. 0000128009.69594.be
35. Kshirsagar AV, Freburger JK, Ellis AR, Wang L, Winkelmayer WC, et al. Intravenous Iron Supplementation Practices and Short-Term Risk of Cardiovascular Events in Hemodialysis Patients. PLoS ONE 2013;8(11):e78930. doi: 10.1371/journal.pone.0078930 PMID: 24223866
36. Bailie GR, Larkina M, Goodkin DA, Li Y, Pisoni RL, Bieber B, et al. Data from the Dialysis Outcomes and Practice Patterns Study validate an association between high intravenous iron doses and mortality. Kidney Int 2015;87:162-8; doi: 10.1038/ki.2014.275 PMID: 25075769
37. Miskulin DC, Tangri N, Bandeen-Roche K, Zhou J, McDermott A, Meyer KB, et al. DEcIDE Network Patient Outcomes in End Stage Renal Disease Study Investigators. Intravenous Iron Exposure and Mortality in Patients on Hemodialysis. Clin J Am SocNephrol 2014;9:1930-9; doi: 10.2215/CJN. 03370414
38. EU Clinical Trials Register: Proactive IV Iron Therapy for Haemodialysis patients (PIVOTAL), 2013. Available: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-002267-25/GB.
39. Panichi V, Rosati A, Bigazzi R, Paoletti S, Mantuano E, Beati S, et al. Anaemia and resistance to erythropoiesis-stimulating agents as prognostic factors in haemodialysis patients: results from the RISCA-VID study. Nephrol Dial Transplant 2011;26:2641-2648; doi: 10.1093/ndt/gfq8002 PMID: 21325348
40. Rosati A, Tetta C, Merello JI, Palomares I, Pérez-García R, Maduell R, et al. Cumulative iron dose and resistance to erythropoietin. J Nephrol 2014; doi: 10.1007/s40620-014-0127-3
41. Nishio A, Chhatkuli BP, Ma JZ, Kalantari K. Higher Doses of Erythropoietin-Stimulating Agents and Hyporesponsiveness to Their Effects are associated with increased mortality among prevalent hemodialysis patients. Blood Purif 2013;36:29-36; doi: 10.1159/000350583 PMID: 23735569
42. López-Gómez JM, Portoles JM, Aljama P on behalf of the MAR Study Group. Factors that condition the response to erythropoietin in patients on hemodialysis and their relation to mortality. Kidney IntSuppl 2008;74:S75-81; doi: 10.1038/ki.2008.523
43. Slotki I, Cabantchik ZI. The Labile Side of Iron Supplementation in CKD. J Am SocNephrol. 2015 May 21. doi: 10.1681/ASN.2015010052 [Epub ahead of print]
44. Schellekens G, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJA. The therapeutic equivalence of complex drugs. RegulToxicolPharmacol 2011;59:176-183; doi: 10.1016/j.yrtph.2010.09.021
45. Fishbane S, Mathew A, Vaziri ND. Iron toxicity: relevance for dialysis patients. Nephrol Dial Transplant 2014;29:255-259; doi: 10.1093/ndt/gft269 PMID: 24166458