Simplifying anemia management in hemodialysis patients: ESAs administered at longer dosing intervals can enhance opportunities to provide patient-focused care

References

• US Renal Data System. USRDS 2008 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Chapter 2. ESRD Incidence and Prevalence. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2008:1-10. Available from http://www.usrds.org/adr_2008.htm [Last accessed 14 April 2011]
   Google Scholar
• US Renal Data System. USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Précis: An Introduction to ESRD in the U.S. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2010:209-23. Available from http://www.usrds.org/atlas.htm [Last accessed 14 April 2011]
   Google Scholar
• United States Renal Data System. USRDS 2007 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Chapter 2. ESRD Incidence and Prevalence. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2007:81-98. Available from http://www.usrds.org/adr.htm [Last accessed 7 November 2007]
   Google Scholar
• Ulrich B. An ANNA invitational summit: nephrology nursing shortage and solutions. Nephrol Nurs J 2003;30:360-3
   PubMedGoogle Scholar
• Rosenberg ME. Adult nephrology fellowship training in the United States: trends and issues. J Am Soc Nephrol 2007;18:1027-33
   PubMed Web of Science ®Google Scholar
• Council on Physician and Nurse Supply. CPNS Press releases and news coverage [press release]. 2009
   Google Scholar
• Collins AJ, Brenner RM, Ofman JJ, et al. Epoetin alfa use in patients with ESRD: an analysis of recent US prescribing patterns and hemoglobin outcomes. Am J Kidney Dis 2005;46:481-8
   PubMed Web of Science ®Google Scholar
• Di Iorio B, Cirillo M, Bellizzi V, et al. Prevalence and correlates of anemia and uncontrolled anemia in chronic hemodialysis patients – the Campania Dialysis Registry. Int J Artif Organs 2007;30:325-33
   PubMed Web of Science ®Google Scholar
• Basile JN. Clinical considerations and practical recommendations for the primary care practitioner in the management of anemia of chronic kidney disease. South Med J 2007;100:1200-7
   PubMed Web of Science ®Google Scholar
• Muzzarelli S, Pfisterer M, for the TIME Investigators. Anemia as independent predictor of major events in elderly patients with chronic angina. Am Heart J 2006;152:991-6
   PubMed Web of Science ®Google Scholar
• Regidor DL, Kopple JD, Kovesdy CP, et al. Associations between changes in hemoglobin and administered erythropoiesis-stimulating agent and survival in hemodialysis patients. J Am Soc Nephrol 2006;17:1181-91
   PubMed Web of Science ®Google Scholar
• Thomas R, Kanso A, Sedor JR. Chronic kidney disease and its complications. Primary Care 2008;35:329-44
   PubMed Web of Science ®Google Scholar
• Charytan C. Bundled-rate legislation for Medicare reimbursement for dialysis services: implications for anemia management with ESAs. Clin J Am Soc Nephrol 2010;5:2355-62
   PubMed Web of Science ®Google Scholar
• Macdougall IC. Novel erythropoiesis-stimulating agents: a new era in anemia management. Clin J Am Soc Nephrol 2008;3:200-7
   PubMed Web of Science ®Google Scholar
• Jones M, Ibels L, Schenkel B, et al. Impact of epoetin alfa on clinical end points in patients with chronic renal failure: a meta-analysis. Kidney Int 2004;65:757-67
   PubMed Web of Science ®Google Scholar
• Chan K, Moran J, Hlatky M, et al. Protocol adherence and the ability to achieve target haemoglobin levels in haemodialysis patients. Nephrol Dial Transplant 2009;24:1956-62
   PubMed Web of Science ®Google Scholar
• Chan KE, Lafayette RA, Whittemore AS, et al. Facility factors dominate the ability to achieve target hemoglobin levels in hemodialysis patients. Nephrol Dial Transplant 2008;23:2948-56
   PubMed Web of Science ®Google Scholar
• US Renal Data System. USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. Chapter 5. Clinical Indicators and Preventative Health. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2011:260-9. Available from http://www.usrds.org/atlas.htm [Last accessed 14 April 2011]
   Google Scholar
• Berns JS, Elzein H, Lynn RI, et al. Hemoglobin variability in epoetin-treated hemodialysis patients. Kidney Int 2003;64:1514-21
   PubMed Web of Science ®Google Scholar
• Fishbane S, Berns JS. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Int 2005;68:1337-43
   PubMed Web of Science ®Google Scholar
• Walker R, Pussell BA, on behalf of the Australian Renal Anemia Group. Fluctuations in haemoglobin levels in haemodialysis patients receiving intravenous epoetin alfa or intravenous darbepoetin alfa. Nephrology 2007;12:448-51
   PubMed Web of Science ®Google Scholar
• Yang W, Israni RK, Brunelli SM, et al. Hemoglobin variability and mortality in ESRD. J Am Soc Nephrol 2007;18:3164-70
   PubMed Web of Science ®Google Scholar
• Eckardt KU, Kim J, Kronenberg F, et al. Hemoglobin variability does not predict mortality in European hemodialysis patients. J Am Soc Nephrol 2010;21:1765-75
   PubMed Web of Science ®Google Scholar
• Weinhandl ED, Peng Y, Gilbertson DT, et al. Hemoglobin variability and mortality: confounding by disease severity. Am J Kidney Dis 2011;57:255-65
   PubMed Web of Science ®Google Scholar
• Pisoni RL, Bragg-Gresham JL, Fuller DS, et al. Facility-level interpatient hemoglobin variability in hemodialysis centers participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS): Associations with mortality, patient characteristics, and facility practices. Am J Kidney Dis 2011;57:266-75
   PubMed Web of Science ®Google Scholar
• Wish JB. Hemoglobin variability as a predictor of mortality: what's a practitioner to do? Am J Kidney Dis 2011;57:190-3
   PubMed Web of Science ®Google Scholar
• Klinger M, Arias M, Vargemezis V, et al. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis 2007;50:989-1000
   PubMed Web of Science ®Google Scholar
• Levin NW, Fishbane S, Canedo FV, et al. 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;370:1415-21
   PubMed Web of Science ®Google Scholar
• Wish JB. Past, present, and future of chronic kidney disease anemia management in the United States. Adv Chronic Kidney Dis 2009;16:101-8
   PubMed Web of Science ®Google Scholar
• Besarab A, Bolton WK, Browne JK, et al. 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;339:584-90
   PubMed Web of Science ®Google Scholar
• Drueke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006;355:2071-84
   PubMed Web of Science ®Google Scholar
• Pfeffer MA, Burdmann EA, Chen CY, et al. 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
• Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;355:2085-98
   PubMed Web of Science ®Google Scholar
• Besarab A, Frinak S, Yee J. What is so bad about a hemoglobin level of 12 to 13 g/dL for chronic kidney disease patients anyway? Adv Chronic Kidney Dis 2009;16:131-42
   PubMed Web of Science ®Google Scholar
• Coyne DW, Brennan DC. Seeking safe and efficacious anemia management. Semin Dial 2009;22:590-1
   PubMed Web of Science ®Google Scholar
• Brophy DF, Daniel G, Gitlin M, et al. Characterizing hospitalizations of end-stage renal disease patients on dialysis and inpatient utilization of erythropoiesis-stimulating agent therapy. Ann Pharmacother 2010;44:43-9
   PubMed Web of Science ®Google Scholar
• Solid CA, Foley RN, Gilbertson DT, et al. Perihospitalization hemoglobin-epoetin associations in U.S. hemodialysis patients, 1998 to 2003. Hemodial Int 2007;11:442-7
   PubMedGoogle Scholar
• Chan KE, Lazarus JM, Wingard RL, et al. Association between repeat hospitalization and early intervention in dialysis patients following hospital discharge. Kidney Int 2009;76:331-41
   PubMed Web of Science ®Google Scholar
• Rice L, Alfrey CP. The negative regulation of red cell mass by neocytolysis: physiologic and pathophysiologic manifestations. Cell Physiol Biochem 2005;15:245-50
   PubMed Web of Science ®Google Scholar
• Rice L, Alfrey CP, Driscoll T, et al. Neocytolysis contributes to the anemia of renal disease. Am J Kidney Dis 1999;33:59-62
   PubMed Web of Science ®Google Scholar
• Besarab A, Flaharty KK, Erslev AJ, et al. Clinical pharmacology and economics of recombinant human erythropoietin in end-stage renal disease: the case for subcutaneous administration. J Am Soc Nephrol 1992;2:1405-16
   PubMed Web of Science ®Google Scholar
• Besarab A. Optimizing anaemia management with subcutaneous administration of epoetin. Nephrol Dial Transplant 2005;20(Suppl 6):vi10-15
   PubMedGoogle Scholar
• Kaufman JS, Reda DJ, Fye CL, et al. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. N Engl J Med 1998;339:578-83
   PubMed Web of Science ®Google Scholar
• Carrera F, Disney A, Molina M. Extended dosing intervals with erythropoiesis-stimulating agents in chronic kidney disease: a review of clinical data. Nephrol Dial Transplant 2007;22(Suppl 4):iv19-30
   PubMedGoogle Scholar
• Jadoul M, Vanrenterghem Y, Foret M, et al. Darbepoetin alfa administered once monthly maintains haemoglobin levels in stable dialysis patients. Nephrol Dial Transplant 2004;19:898-903
   PubMed Web of Science ®Google Scholar
• Trachsler J, Gluck Z, Dickenmann M, et al. Parameters for successful monthly extended dosing of darbepoetin-alpha in patients undergoing hemodialysis. Clin Nephrol 2009;71:697-702
   PubMed Web of Science ®Google Scholar
• Carrera F, Lok CE, de Francisco A, et al. 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;25:4009-17
   PubMed Web of Science ®Google Scholar
• Fishbane S. Recombinant human erythropoietin: has treatment reached its full potential? Semin Dial 2006;19:1-4
   PubMed Web of Science ®Google Scholar
• Spinowitz B, Germain M, Benz R, et al. A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease. Clin J Am Soc Nephrol 2008;3:1015-21
   PubMed Web of Science ®Google Scholar
• Zhang Y, Thamer M, Stefanik K, et al. Epoetin requirements predict mortality in hemodialysis patients. Am J Kidney Dis 2004;44:866-76
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Robson R, Opatrna S, et al. Pharmacokinetics and pharmacodynamics of intravenous and subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) in patients with chronic kidney disease. Clin J Am Soc Nephrol 2006;1:1211-15
   PubMed Web of Science ®Google Scholar
• Sulowicz W, Locatelli F, Ryckelynck JP, et al. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2007;2:637-46
   PubMed Web of Science ®Google Scholar
• Choi P, Dalby E, Watson T, et al. Conversion of hemodialysis patients from weekly IV darbepoietin to monthly IV CERA results in less effective maintenance of hemoglobin level and increased transfusion requirement [abstract]. J Am Soc Nephrol 2009;20:663A
   Google Scholar
• Locatelli F, Villa G, de Francisco AL, et al. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin 2007;23:969-79
   PubMed Web of Science ®Google Scholar
• Mircera®(Methoxy Polyethylene Glycol-Epoetin Beta) Continuous Activity. Targeted Stability [monograph], 2009:1-47
   Google Scholar
• Fan Q, Leuther KK, Holmes CP, et al. Preclinical evaluation of Hematide, a novel erythropoiesis stimulating agent, for the treatment of anemia. Exp Hematol 2006;34:1303-11
   PubMed Web of Science ®Google Scholar
• Green JM, Mortensen RB, Schatz PJ, et al. Hematide™ demonstrates prolonged in vitro binding to the human erythropoietin receptor (ASN abstract SA-PO2430). J Am Soc Nephrol 2009;20:668A
   Google Scholar
• Schiller B, Locatelli F, Covic AC, et al. Primary results from two phase 3 randomized, active-controlled, open-label studies (EMERALD 1 and EMERALD 2) of the safety and efficacy of Hematide™/peginesatide for the maintenance treatment of anemia in patients with chronic renal failure who were receiving hemodialysis and were previously treated with epoetin alfa or epoetin beta. Am J Nephrol 2010;21:2b
   Google Scholar
• Saueressig U, Kwan JTC, De Cock E, et al. Healthcare resource utilization for anemia management: current practice with erythropoiesis-stimulating agents and the impact of converting to once-monthly C.E.R.A. Blood Purif 2008;26:537-46
   PubMed Web of Science ®Google Scholar
• Schiller B, Doss S, De Cock E, et al. Costs of managing anemia with erythropoiesis-stimulating agents during hemodialysis: a time and motion study. Hemodial Int 2008;12:441-9
   PubMed Web of Science ®Google Scholar
• Medicare program; end-stage renal disease prospective payment system. Final rule. Fed Regist 2010;75:49029-214
   Google Scholar
• Lee DE, Son W, Ha BJ, et al. The prolonged half-lives of new erythropoietin derivatives via peptide addition. Biochem Biophys Res Commun 2006;339:380-5
   PubMed Web of Science ®Google Scholar
• Hsieh MM, Linde NS, Wynter A, et al. HIF prolyl hydroxylase inhibition results in endogenous erythropoietin induction, erythrocytosis, and modest fetal hemoglobin expression in rhesus macaques. Blood 2007;110:2140-7
   PubMed Web of Science ®Google Scholar
• Mikhail A, Covic A, Goldsmith D. Stimulating erythropoiesis: future perspectives. Kidney Blood Press Res 2008;31:234-46
   PubMed Web of Science ®Google Scholar
• Bouman-Thio E, Franson K, Miller B, et al. A phase I, single and fractionated, ascending-dose study evaluating the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of an erythropoietin mimetic antibody fusion protein (CNTO 528) in healthy male subjects. J Clin Pharmacol 2008;48:1197-207
   PubMed Web of Science ®Google Scholar
• Bernhardt WM, Wiesener MS, Scigalla P, et al. Inhibition of prolyl hydroxylases increases erythropoietin production in ESRD. J Am Soc Nephrol 2010;21:2151-6
   PubMed Web of Science ®Google Scholar
• Besarab A, Hulter HN, Klaus S, et al. FG-4592, a novel oral HIF prolyl hydroxylase inhibitor, elevates hemoglobin in anemic stage 3/4 CKD patients [abstract]. J Am Soc Nephrol 2011;21:95A
   Google Scholar
• Brigandi RA, Russ SF, Al-Banna M, et al. Prolylhydroxylase inhibitor modulation of erythropoietin in a randomized placebo controlled trial [abstract]. J Am Soc Nephrol 2011;21:390A
   Google Scholar
• Nakano Y, Imagawa S, Matsumoto K, et al. Oral administration of K-11706 inhibits GATA binding activity, enhances hypoxia-inducible factor 1 binding activity, and restores indicators in an in vivo mouse model of anemia of chronic disease. Blood 2004;104:4300-7
   PubMed Web of Science ®Google Scholar
• Akagi S, Ichikawa H, Okada T, et al. The critical role of SRC homology domain 2-containing tyrosine phosphatase-1 in recombinant human erythropoietin hyporesponsive anemia in chronic hemodialysis patients. J Am Soc Nephrol 2004;15:3215-24
   PubMed Web of Science ®Google Scholar
• Gagnon L, Brabe J, Penney C, et al. Oral treatment with PBI-1402 increases hemoglobin level and red blood cell count: A novel approach to treating chemotherapy-induced anemia. Blood 2007;110:2211
   Web of Science ®Google Scholar
• Gagnon L, Leblond FA, Grouix B, et al. Oral treatment with PBI-1402 increases hemoglobin, hematocrit and red blood cell formation in 5/6-nephrectomized rats, a model mimicking human end-stage renal disease [poster]. J Am Soc Nephrol 2009;20:666A
   Google Scholar
• Perez-Garcia R, Martin-Malo A, Fort J, et al. Baseline characteristics of an incident haemodialysis population in Spain: results from ANSWER – a multicentre, prospective, observational cohort study. Nephrol Dial Transplant 2009;24:578-88
   PubMed Web of Science ®Google Scholar
• Tentori F, Hunt WC, Rohrscheib M, et al. Which targets in clinical practice guidelines are associated with improved survival in a large dialysis organization? J Am Soc Nephrol 2007;18:2377-84
   PubMed Web of Science ®Google Scholar
• Foley RN, Hakim RM. Why is the mortality of dialysis patients in the United States much higher than the rest of the world? J Am Soc Nephrol 2009;20:1432-5
   PubMed Web of Science ®Google Scholar
• Yaqub MS, Leiser J, Molitoris BA. Erythropoietin requirements increase following hospitalization in end-stage renal disease patients. Am J Nephrol 2001;21:390-6
   PubMed Web of Science ®Google Scholar
• Parker TF III, Glassock RJ, Steinman TI. Conclusions, consensus, and directions for the future. Clin J Am Soc Nephrol 2009;4(Suppl 1):S139-44
   PubMedGoogle Scholar
• Mircescu G, Garneata L, Ciocalteu A, et al. Once-every-2-weeks and once-weekly epoetin beta regimens: equivalency in hemodialyzed patients. Am J Kidney Dis 2006;48:445-55
   PubMed Web of Science ®Google Scholar
• de Francisco ALM, Sulowicz W, Klinger M, et al. Continuous Erythropoietin Receptor Activator (C.E.R.A.) administered at extended administration intervals corrects anaemia in patients with chronic kidney disease on dialysis: a randomised, multicentre, multiple-dose, phase II study. Int J Clin Pract 2006;60:1687-96
   PubMed Web of Science ®Google Scholar
• Fliser D, Kleophas W, Dellanna F, et al. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin 2010;26:1083-9
   PubMed Web of Science ®Google Scholar
• Weinreich T, Leistikow F, Hartmann HG, et al. Once monthly C.E.R.A. in hemodialysis patients provides stable Hb levels – results from the non-interventional SESAM study. Presented at: 48th Annual Congress of the European Renal Association and European Dialysis and Transplantation Association; 25–28 June 2010; Munich, Germany
   Google Scholar
• Meier P, Meier R. Efficacy of intravenous CERA administered once monthly on haemoglobin levels compared with epoetin beta administered once weekly in patients with end-stage kidney disease on hemodialysis: a randomized trial [abstract]. NDT Plus 2009;2(Suppl 2)
   Google Scholar
• Ponikvar R, Blanusa D, Ceglar Z, et al. Once monthly C.E.R.A. in unselected chronic hemodialysis patients following direct switch from shorter acting ESA's [abstract]. NDT Plus 2009;19(Suppl 2)
   Google Scholar
• Iatrou CE. Once-monthly continuous erythropoietin receptor activator (C.E.R.A.) chronic renal anemia on hemodialysis [abstract]. J Am Soc Nephrol 2009;20:663A
   Google Scholar
• Schuster SJ, Caro J. Erythropoietin: physiologic basis for clinical applications. Vox Sang 1993;65:169-79
   PubMed Web of Science ®Google Scholar
• Erslev AJ, Besarab A. Erythropoietin in the pathogenesis and treatment of the anemia of chronic renal failure. Kidney Int 1997;51:622-30
   PubMed Web of Science ®Google Scholar
• Papayannopoulou T, D'Andrea AD, Abkowitz JL, et al. Biology of erythropoiesis, erythroid differentiation, and maturation. In: Hoffman R, Benz EJ, Shattil SJ, et al, eds. Hematology: Basic Principles and Practice, 4th edn. Philadelphia: Elsevier Churchill Livingstone, 2005:267-88
   Google Scholar
• Hillman RS, Finch CA. General characteristics of the erythron. In: Hillman RS, Finch CA, eds. Red Cell Manual, 7th edn. Philadelphia: F.A. Davis Company, 1996:1-38
   Google Scholar