An expert opinion on the current treatment of anemia in patients with kidney disease

Bibliography

• Levin A, Thompson CR, Ethier J, Left ventricular mass index increase in early renal disease: impact of decline in hemoglobin. Am J Kidney Dis 1999;34(1):125-34
   PubMed Web of Science ®Google Scholar
• Astor BC, Muntner P, Levin A, Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988 – 1994). Arch Intern Med 2002;162(12):1401-8
   PubMed Web of Science ®Google Scholar
• Anand IS, Chandrashekhar Y, Ferrari R, Pathogenesis of oedema in chronic severe anaemia: studies of body water and sodium, renal function, haemodynamic variables, and plasma hormones. Br Heart J 1993;70:357-62
   PubMedGoogle Scholar
• Ma J, Ebben J, Xia H, Collins A. Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol 1999;10:610-19
   PubMed Web of Science ®Google Scholar
• Collins AJ, Li S, St Peter W, Death, hospitalization, and economic associations among incident hemodialysis patients with hematocrit values of 36 to 39%. J Am Soc Nephrol 2001;12(11):2465-73
   PubMed Web of Science ®Google Scholar
• Pisoni RL, Bragg-Gresham JL, Young EW, Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 2004;44(1):94-111
   PubMed Web of Science ®Google Scholar
• Locatelli F, Pisoni RL, Combe C, Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2004;19(1):121-32
   PubMed Web of Science ®Google Scholar
• Volkova N, Arab L. Evidence-based systematic literature review of hemoglobin/hematocrit and all-cause mortality in dialysis patients. Am J Kidney Dis 2006;47(1):24-36
   PubMed Web of Science ®Google Scholar
• Winearls CG, Oliver DO, Pippard MJ, Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet 1986;2:1175-8
   PubMed Web of Science ®Google Scholar
• Eschbach JW, Egrie JC, Downing MR, Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med 1987;316:73-8
   PubMed Web of Science ®Google Scholar
• Storring PL, Tiplady RJ, Gaines Das RE, Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties. Br J Haematol 1998;100:79-89
   PubMed Web of Science ®Google Scholar
• Powell JS, Berkner KL, Lebo RV, Human erythropoietin gene: high level expression in stably transfected mammalian cells and chromosome localization. Proc Natl Acad Sci USA 1986;83:6465-9
   PubMed Web of Science ®Google Scholar
• Nimtz M, Martin W, Wray V, Structures of sialylated oligosaccharides of human erythropoietin expressed in recombinant BHK-21 cells. Eur J Biochem 1993;213:39-56
   PubMedGoogle Scholar
• Minghetti P, Rocco P, Cilurzo F, The regulatory framework of biosimilars in the European Union. Drug Discov Today 2012;17(1-2):63-70
   PubMedGoogle Scholar
• Lonnemann G, Wrenger E. Biosimilar epoetin zeta in nephrology: a single-dialysis center experience. Clin Nephrol 2011;75(1):59-62
   PubMedGoogle Scholar
• Schellekens H. Assessing the bioequivalence of biosimilars The Retacrit case. Drug Discov Today 2009;14(9-10):495-9
   PubMed Web of Science ®Google Scholar
• Brinks V, Hawe A, Basmeleh AH, Quality of original and biosimilar epoetin products. Pharm Res 2011;28(2):386-9
   PubMed Web of Science ®Google Scholar
• Kaufman JS, Reda DJ, Fye CL, Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. N Engl J Med 1998;339:578-83
   PubMed Web of Science ®Google Scholar
• Egrie JC, Browne KJ. Development and characterisation of novel erythropoiesis stimulating protein (NESP). Nephrol Dial Transplant 2001;16:Suppl 3):3-13
   PubMedGoogle Scholar
• Locatelli F, Olivares J, Walker R, European/Australian NESP 980202 Study Group. Novel erythropoiesis stimulating protein for treatment of anemia in chronic renal insufficiency. Kidney Int 2001;60(2):741-7
   PubMedGoogle Scholar
• Locatelli F, Canaud B, Giacardy F, Treatment of anaemia in dialysis patients with unit dosing of darbepoetin alfa at a reduced dose frequency relative to recombinant human erythropoietin (rHuEpo). Nephrol Dial Transplant 2003;18(2):362-9
   PubMed Web of Science ®Google Scholar
• Vanrenterghem Y, Barany P, Mann JF, European/Australian NESP 970200 Study Group. Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients. Kidney Int 2002;62(6):2167-75
   PubMed Web of Science ®Google Scholar
• Mann J, Kessler M, Villa G, Darbepoetin alfa once every 2 weeks for treatment of anemia in dialysis patients: a combined analysis of eight multicenter trials. Clin Nephrol 2007;67(3):140-8
   PubMedGoogle Scholar
• Aranesp Summary of Product Characteristics. 2006. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/aranesp/H-332-PI-en.pdf
   Google Scholar
• Aarup M, Bryndum J, Dieperink H, Clinical implications of converting stable haemodialysis patients from subcutaneous to intravenous administration of darbepoetin alfa. Nephrol Dial Transplant 2006;21(5):1312-16
   PubMedGoogle Scholar
• Brandt M, Lazendorfer M, Frische J, Different receptor binding activity of C.E.R.A. (continuous erythropoietin receptor activator) compared with epoetin beta determined by surface plasmon resonance and competition assay on UT-7 cells [abstract SO018). Nephrol Dial Transplant 2006;21(Suppl 4):iv9
   Google Scholar
• Macdougall IC. CERA (Continuous Erythropoietin Receptor Activator): a new erythropoiesis-stimulating agent for the treatment of anemia. Curr Hematol Rep 2005;4(6):436-40
   PubMedGoogle Scholar
• Locatelli F, Villa G, De Francisco ALM, Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis. Curr Med Res Opin 2007;23:969-79
   PubMed Web of Science ®Google Scholar
• Levin NW, Fishbane S, Canedo FV, MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet 2007;370(9596):1415-21
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Walker R, Provenzano R, ARCTOS Study Investigators. C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol 2008;3(2):337-47
   PubMed Web of Science ®Google Scholar
• Roger SD, Locatelli F, Woitas RP, C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis. Nephrol Dial Transplant 2011;26(12):3980-6
   PubMedGoogle Scholar
• Carrera F, Lok CE, de Francisco A, PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant 2010;25(12):4009-17
   PubMed Web of Science ®Google Scholar
• Mann JF, de Francisco A, Nassar G, Canaud B. Fewer dose changes with once-monthly C.E.R.A. in patients with chronic kidney disease. Clin Nephrol 2011;76(1):9-15
   PubMed Web of Science ®Google Scholar
• Alfrey CP, Fishbane S. Implications of neocytolysis for optimal management of anaemia in chronic kidney disease. Nephron Clin Pract 2007;106(4):c149-56
   Google Scholar
• Del Vecchio L, Pozzoni P, Andrulli S, Locatelli F. Inflammation and resistance to treatment with recombinant human erythropoietin. J Ren Nutr 2005;15(1):137-41
   PubMedGoogle Scholar
• Locatelli F, Andrulli S, Memoli B, Nutritional-inflammation status and resistance to erythropoietin therapy in haemodialysis patients. Nephrol Dial Transplant 2006;21(4):991-8
   PubMed Web of Science ®Google Scholar
• Streja E, Kovesdy CP, Greenland S, Erythropoietin, iron depletion, and relative thrombocytosis: a possible explanation for hemoglobin-survival paradox in hemodialysis. Am J Kidney Dis 2008;52(4):727-36
   PubMed Web of Science ®Google Scholar
• Szczech LA, Barnhart HX, Inrig JK, Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int 2008;74(6):791-8
   PubMed Web of Science ®Google Scholar
• Locatelli F, Del Vecchio L. Erythropoietic response to erythropoiesis-stimulating agents and outcome: should we give up the haemoglobin target approach? Nephrol Dial Transplant 2011;26(7):2069-71
   PubMed Web of Science ®Google Scholar
• Solomon SD, Uno H, Lewis EF, Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Investigators. Erythropoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med 2010;363(12):1146-55
   PubMed Web of Science ®Google Scholar
• Drueke TB, Locatelli F, Clyne N, Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006;335:2071-84
   Web of Science ®Google Scholar
• Unger EF, Thompson AM, Blank MJ, Erythropoiesis-stimulating agents: time for a revaluation. N Engl J Med 2010;362:189-92
   PubMed Web of Science ®Google Scholar
• Lawler EV, Bradbury BD, Fonda JR, Transfusion burden among patients with chronic kidney disease and anemia. Clin J Am Soc Nephrol 2010;5(4):667-72
   PubMed Web of Science ®Google Scholar
• Strippoli GF, Navaneethan SD, Craig JC. Haemoglobin and haematocrit targets for the anaemia of chronic kidney disease. Cochrane Database Syst Rev 2006(4):CD003967
   Google Scholar
• Anaemia Work Group for National Kidney Foundation – Dialysis Outcomes Quality Initiative (NKF-DOQI). Clinical practice guidelines for the treatment of anaemia of chronic renal failure. Am J Kidney Dis 1997;30(Suppl 3):192-240
   Google Scholar
• KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease, 2007 Update of Hemoglobin Target. Am J Kidney Dis 2007;49(Suppl):S1-S182
   PubMedGoogle Scholar
• Singh AK, Szczech L, Tang KL, Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;335:2085-98
   Web of Science ®Google Scholar
• Messana JM, Chuang CC, Turenne M, Association of quarterly average achieved hematocrit with mortality in dialysis patients: a time-dependent comorbidity-adjusted model. Am J Kidney Dis 2009;53:503-12
   PubMed Web of Science ®Google Scholar
• Pfeffer MA, Burdmann EA, Chen CY, TREAT investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009;361:2019-32
   PubMed Web of Science ®Google Scholar
• Winkelmayer WC. Against TREATing all patients alike: lessons from an FDA advisory committee meeting. J Am Soc Nephrol 2011;22(1):2
   Google Scholar
• Locatelli F, Del Vecchio L. Debate: CON Position. Should hemoglobin targets for anemic patients with chronic kidney disease be changed? Am J Nephrol 2010;31(6):557-60; discussion 561-562
   PubMed Web of Science ®Google Scholar
• Locatelli F, Del Vecchio L, Casartelli D. Darbepoetin alfa and chronic kidney disease. N Engl J Med 2010;362(7):654-5
   PubMed Web of Science ®Google Scholar
• Locatelli F, Aljama P, Canaud B, Anaemia Working Group of European Renal Best Practice (ERBP). Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study. Nephrol Dial Transplant 2010;25(9):2846-50
   PubMed Web of Science ®Google Scholar
• Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260670.htm [Last visited 21 October 2011]
   Google Scholar
• Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia ‘epidemic': mystery completely revealed? Perit Dial Int 2007;27(Suppl 2):S303-7
   PubMedGoogle Scholar
• Del Vecchio L, Cavalli A, Tucci B, Locatelli F. Chronic kidney disease-associated anemia: new remedies. Curr Opin Investig Drugs 2010;11(9):1030-8
   PubMedGoogle Scholar
• Locatelli F, Aljama P, Barany P, European Best Practice Guidelines Working Group. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004;19(Suppl 2):ii1-47
   PubMedGoogle Scholar