Safety issues related to erythropoiesis-stimulating agents used to treat anemia in patients with chronic kidney disease

Bibliography

• 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
• 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
• Besarab A, Bolton WK, Browne JK, The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998;339(9):584-90
   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 Eng J Med 2006;335:2071-84
   Web of Science ®Google Scholar
• Singh AK, Szczech L, Tang KL, Correction of anemia with epoetin alfa in chronic kidney disease. N Eng J Med 2006;335:2085-98
   Web of Science ®Google Scholar
• KDOQI ADVISARY BOARD MEMBERS, Clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis 2007;50:471-530
   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
• Yamada M, Burke C, Colditz P, Erythropoietin protects against apoptosis and increases expression of non-neuronal cell markers in the hypoxia-injured developing brain. J Pathol 2011;224(1):101-9
   PubMed Web of Science ®Google Scholar
• Cherian L, Goodman JC, Robertson C. Improved cerebrovascular function and reduced histological damage with darbepoietin alfa administration after cortical impact injury in rats. J Pharmacol Exp Ther 2011;337(2):451-6
   PubMed Web of Science ®Google Scholar
• Lee ST, Chu K, Park JE, Erythropoietin improves memory function with reducing endothelial dysfunction and amyloid-beta burden in Alzheimer's disease models. J Neurochem 2012;120(1):115-24
   PubMed Web of Science ®Google Scholar
• Merelli A, Caltana L, Lazarowski A, Brusco A. Experimental evidence of the potential use of erythropoietin by intranasal administration as a neuroprotective agent in cerebral hypoxia. Drug Metabol Drug Interact 2011;26(2):65-9
   PubMedGoogle Scholar
• Zhou QH, Hui EK, Lu JZ, Brain penetrating IgG-erythropoietin fusion protein is neuroprotective following intravenous treatment in Parkinson's disease in the mouse. Brain Res 2011;1382:315-20
   PubMed Web of Science ®Google Scholar
• Robertson CS, Cherian L, Shah M, Neuroprotection with an erythropoietin mimetic peptide (pHBSP) in a model of mild traumatic brain injury complicated by hemorrhagic shock. J Neurotrauma 2011; Epub ahead of print
   Web of Science ®Google Scholar
• Ehrenreich H, Weissenborn K, Prange H, EPO Stroke Trial Group. Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke 2009;40(12):e647-56
   PubMed Web of Science ®Google Scholar
• Abramson JL, Jurkovitz CT, Vaccarino V, Chronic kidney disease, anemia, and incident stroke in a middle-aged, community-based population: the ARIC Study. Kidney Int 2003;64(2):610-15
   PubMed Web of Science ®Google Scholar
• Parfrey PS, Foley RN, Wittreich BH, Double-blind comparison of full and partial anemia correction in incident hemodialysis patients without symptomatic heart disease. J Am Soc Nephrol 2005;16(7):2180-9
   PubMed Web of Science ®Google Scholar
• Skali H, Parving HH, Parfrey PS, TREAT Investigators. Stroke in patients with type 2 diabetes mellitus, chronic kidney disease, and anemia treated with Darbepoetin Alfa: the trial to reduce cardiovascular events with Aranesp therapy (TREAT) experience. Circulation 2011;124(25):2903-8
   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
• Winkelmayer WC. Against TREATing all patients alike: lessons from an FDA Advisory Committee Meeting. J Am Soc Nephrol 2011;22(1):1-2
   PubMed Web of Science ®Google Scholar
• Zakai NA, Lange L, Longstreth WT Jr, Association of coagulation-related and inflammation-related genes and factor VIIc levels with stroke: the Cardiovascular Health Study. J Thromb Haemost 2011;9(2):267-74
   PubMed Web of Science ®Google Scholar
• Palmer SC, Navaneethan SD, Craig JC, Meta-analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med 2010;153(1):23-33
   PubMed Web of Science ®Google Scholar
• Seliger SL, Zhang AD, Weir MR, Erythropoiesis-stimulating agents increase the risk of acute stroke in patients with chronic kidney disease. Kidney Int 2011;80(3):288-94
   PubMed Web of Science ®Google Scholar
• Imai E, Yamamoto R, Suzuki H, Watanabe T. Incidence of symptomatic stroke and cancer in chronic kidney disease patients treated with epoetins. Clin Exp Nephrol 2010;14(5):445-52
   PubMed Web of Science ®Google Scholar
• Ruifrok WP, de Boer RA, Westenbrink BD, Erythropoietin in cardiac disease: new features of an old drug. Eur J Pharmacol 2008;585(2-3):270-7
   PubMed Web of Science ®Google Scholar
• Klopsch C, Furlani D, Gäbel R, Intracardiac injection of erythropoietin induces stem cell recruitment and improves cardiac functions in a rat myocardial infarction model. J Cell Mol Med 2009;13(4):664-79
   PubMed Web of Science ®Google Scholar
• Ruifrok WP, de Boer RA, Westenbrink BD, Erythropoietin in cardiac disease: new features of an old drug. Eur J Pharmacol 2008;13:585(2-3):270-7
   Google Scholar
• Fiordaliso F, Chimenti S, Staszewsky L, A nonerythropoietic derivative of erythropoietin protects the myocardium from ischemia-reperfusion injury. Proc Natl Acad Sci USA 2005;102(6):2046-51
   PubMed Web of Science ®Google Scholar
• Kanellakis P, Pomilio G, Agrotis A, Darbepoetin-mediated cardioprotection after myocardial infarction involves multiple mechanisms independent of erythropoietin receptor-common beta-chain heteroreceptor. Br J Pharmacol 2010;160(8):2085-96
   PubMed Web of Science ®Google Scholar
• Carraway MS, Suliman HB, Jones WS, Erythropoietin activates mitochondrial biogenesis and couples red cell mass to mitochondrial mass in the heart. Circ Res 2010;106(11):1722-30
   PubMed Web of Science ®Google Scholar
• Shushakova N, Park JK, Menne J, Fliser D. Chronic erythropoietin treatment affects different molecular pathways of diabetic cardiomyopathy in mouse. Eur J Clin Invest 2009;39(9):755-60
   PubMed Web of Science ®Google Scholar
• Phrommintikul A, Haas SJ, Elsik M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Lancet 2007;369(9559):381-8
   PubMed Web of Science ®Google Scholar
• Parfrey PS, Lauve M, Latremouille-Viau D, Lefebvre P. Erythropoietin therapy and left ventricular mass index in CKD and ESRD patients: a meta-analysis. Clin J Am Soc Nephrol 2009;4(4):755-62
   PubMed Web of Science ®Google Scholar
• Bahlmann J, Schoter KH, Scigalla P, Morbidity and mortality in hemodialysis patients with and without erythropoietin treatment: a controlled study. Contrib Nephrol 1991;88:90-106
   PubMedGoogle Scholar
• Klinkmann H, Schmidt R, Wieczorek L, Scigalla P. Adverse events of subcutaneous recombinant human erythropoietin therapy. Contrib Nephrol 1992;100:127-38
   PubMedGoogle Scholar
• Sobota JT. Recombinant human erythropoietin in patients with anemia due to end-stage renal disease. US multicenter trials. Contrib Nephrol 1989;76:166-78
   PubMedGoogle Scholar
• Furuland H, Linde T, Ahlmen J, A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients. Nephrol Dial Transplant 2003;18:353-61
   PubMed Web of Science ®Google Scholar
• Del Vecchio L, Lusenti T, Del Rosso G, on behalf of Gruppo di Studio dell'Ipertensione Arteriosa Società Italiana Nefrologia. Prevalence of hypertension in a large cohort of Italian hemodialysis patients: results of a cross-sectional study. submitted
   Google Scholar
• Zhu X, Perazella MA. Nonhematologic complications of erythropoietin therapy. Semin Dial 2006;19:279-84
   PubMed Web of Science ®Google Scholar
• Krapf R, Hulter HN. Arterial hypertension induced by erythropoietin and erythropoiesis-stimulating agents (ESA). Clin J Am Soc Nephrol 2009;4(2):470-80
   PubMed Web of Science ®Google Scholar
• Schulz EG, Neumann CL, Menne J, An erythropoietin gene polymorphism in the hypoxia-responsive element at position 3434 is possibly associated with hypertension. Kidney Blood Press Res 2012;35(2):71-6
   PubMed Web of Science ®Google Scholar
• Della Ragione F, Cucciolla V, Borriello A, Erythropoietin receptors on cancer cells: a still open question. J Clin Oncol 2007;25:1812-13
   PubMed Web of Science ®Google Scholar
• Swift S, Ellison AR, Kassner P, Absence of functional EpoR expression in human tumor cell lines. Blood 2010;115(21):4254-63
   PubMed Web of Science ®Google Scholar
• Dicato M, Plawny L. Erythropoietin in cancer patients: pros and cons. Curr Opin Oncol 2010;22(4):307-11
   PubMed Web of Science ®Google Scholar
• Osterborg A, Aapro M, Cornes P. Preclinical studies of erythropoietin receptor expression in tumour cells: impact on clinical use of erythropoietic proteins to correct cancer-related anaemia. Eur J Cancer 2007;43:510-19
   PubMed Web of Science ®Google Scholar
• Bohlius J, Schmidlin K, Brillant C, Recombinant human erythropoietin stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. Lancet 2009;373:1532-42
   PubMed Web of Science ®Google Scholar
• Glaspy J, Crawford J, Vansteenkiste J, Erythropoiesis-stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. Br J Cancer 2010;102:301-15
   PubMed Web of Science ®Google Scholar
• FDA Briefing Document. Oncologic Drugs Advisory Committee. Continuing reassessment of the risks of erythropoiesis-stimulating agents (ESAs) administered for the treatment of anemia associated with cancer chemotherapy. 2007. Available from: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b2-02-FDA.pdf
   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
• Casadevall N, Nataf J, Viron B, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346(7):469-75
   PubMed Web of Science ®Google Scholar
• Hermeling S, Schellekens H, Crommelin DJ, Jiskoot W. Micelle-associated protein in epoetin formulations: a risk factor for immunogenicity? Pharm Res 2003;20(12):1903-7
   PubMed Web of Science ®Google Scholar
• Shimizu H, Saitoh T, Ota F, Pure red cell aplasia induced only by intravenous administration of recombinant human erythropoietin. Acta Haematol 2011;126(2):114-18
   PubMed Web of Science ®Google Scholar
• Haag-Weber M, Eckardt KU, Hörl WH, Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol 2012;77(1):8-17
   PubMed Web of Science ®Google Scholar
• Seidl A, Hainzl O, Richter M, Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res 2012;29(6):1454-67
   PubMed Web of Science ®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 561-62
   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, 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
• 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
• Locatelli F, Nissenson AR, Barrett BJ, Clinical practice guidelines for anemia in chronic kidney disease: problems and solutions. A position statement from Kidney disease: improving Global Outcomes (KDIGO). Kidney Int 2008;74(10):1237-40
   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 02 April, 2012]
   Google Scholar
• Kilpatrick RD, Critchlow CW, Fishbane S, Greater epoetin alfa responsiveness is associated with improved survival in hemodialysis patients. Clin J Am Soc Nephrol 2008;3(4):1077-83
   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
• Zhang Y, Thamer M, Stefanik K, Epoetin requirements predict mortality in hemodialysis patients. Am J Kidney Dis 2004;44(5):866-76
   PubMed Web of Science ®Google Scholar