American Journal of Kidney Diseases
Volume 52, Issue 6, Supplement 1 , Pages S5-S13 , December 2008

The Controversy Surrounding Hemoglobin and Erythropoiesis-Stimulating Agents: What Should We Do Now?

  • Ajay K. Singh, MBBS, FRCP

      Affiliations

    • Corresponding Author InformationAddress correspondence to Ajay K. Singh, MBBS, FRCP, Renal Division, Brigham and Women's Hospital, Boston, MA

References 

  1. Revicki DA, Brown RE, Feeny DH, et al. Health-related quality of life associated with recombinant human erythropoietin therapy for predialysis chronic renal disease patients. Am J Kidney Dis. 1995;25:548–554
  2. Evans RW, Rader B, Manninen DL. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin (Cooperative Multicenter EPO Clinical Trial Group). JAMA. 1990;263:825–830
  3. Beusterien KM, Nissenson AR, Port FK, Kelly M, Steinwald B, Ware JE. The effects of recombinant human erythropoietin on functional health and well-being in chronic dialysis patients. J Am Soc Nephrol. 1996;7:763–773
  4. Collins AJ, Li S, St Peter W, et al. Death, hospitalization, and economic associations among incident hemodialysis patients with hematocrit values of 36 to 39%. J Am Soc Nephrol. 2001;12:2465–2473
  5. Collins AJ, Ma JZ, Ebben J. Impact of hematocrit on morbidity and mortality. Semin Nephrol. 2000;20:345–349
  6. 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;17:1181–1191
  7. National Kidney Foundation. DOQI Clinical Practice Guidelines for the Treatment of Anemia of Chronic Renal Failure. Am J Kidney Dis. 1997;30(suppl 3):S192–S240
  8. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: Update 2000. Am J Kidney Dis. 2001;37(suppl 1):S182–S238
  9. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease in Adults. Am J Kidney Dis. 2006;47(suppl 3):S16–S85
  10. National Kidney Foundation. KDOQI 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
  11. US Renal Data System. USRDS 2006 Annual Data Report. Bethesda, MD: The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2006;
  12. Coladonato JA, Frankenfield DL, Reddan DN, et al. Trends in anemia management among US hemodialysis patients. J Am Soc Nephrol. 2002;13:1288–1295
  13. US Government Accountability Office. Report to the Chairman, Committee on Ways and Means, House of Representatives (End-stage Renal Disease: Bundling Medicare′s Payment for Drugs With Payments for All ESRD Services Would Promote Efficiency and Clinical Flexibility). Washington, DC: GAO 07-77; 2006;
  14. Cotter D, Thamer M, Narasimhan K, Zhang Y, Bullock K. Translating epoetin research into practice: The role of government and the use of scientific evidence. Health Aff (Millwood). 2006;25:1249–1259
  15. Thamer M, Zhang Y, Kaufman J, et al. Dialysis facility ownership and epoetin dosing in patients receiving hemodialysis. JAMA. 2007;297:1667–1674
  16. 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;339:584–590
  17. Singh AK, Szczech L, Tang KL CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355:2085–2098
  18. Drüeke TB, Locatelli F, Clyne N CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006;355:2071–2084
  19. US Food and Drug Administration Advisory Committee. : Briefing Document, Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee (FDA, September 11, 2007). http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4315b1-01-FDA.pdfAccessed March 3, 2008
  20. Besarab A, Goodkin DA, Nissenson AR Normal Hematocrit Cardiac Trial Authors. The Normal Hematocrit Study—Follow-up. N Engl J Med. 2008;358:433–434
  21. Wolf RF, Gilmore LS, Friese P, Downs T, Burstein SA, Dale GL. Erythropoietin potentiates thrombus development in a canine arterio-venous shunt model. Thromb Haemost. 1997;77:1020–1024(abstr)
  22. 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;17:1181–1191
  23. Zhang Y, Thamer M, Stefanik K, et al. Epoetin requirements predict mortality in hemodialysis patients. Am J Kidney Dis. 2004;44:866–876
  24. US Food and Drug Administration and Center for Drug Evaluation and Research. Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA). http://www.fda.gov/cder/drug/InfoSheets/HCP/RHE2007HCP.htmAccessed February 25, 2008
  25. US Food and Drug Administration and Center for Drug Evaluation and Research. Questions and Answers for Erythropoiesis-Stimulating Agents (ESAs) Labeling Changes. http://www.fda.gov/CDER/drug/infopage/RHE/qa2007.htmAccessed February 25, 2008
  26. Oncologic Drugs Advisory Committee. FDA Briefing Document. www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4345b2-01-FDA.pdfAccessed June 29, 2008
  27. FDA. Aranesp (darbepoetin alfa) for injection: Prescribing information. Silver Spring, MD: US Food and Drug Administration; March 2008;
  28. FDA. Procrit (Epoetin alfa) for injection: Prescribing information. Silver Spring, MD: US Food and Drug Administration; March 2008;
  29. Centers for Medicare & Medicaid Services. CMS Manual System (Pub 100-04 Medicare Claims Processing. Transmittal 1307. Change Request 5700. 7-20-2007). http://www.cms.hhs.gov/Transmittals/Downloads/R1307CP.pdfAccessed January 3, 2008
  30. Keithi-Reddy SR, Addabbo F, Patel TV, Mittal BV, Goligorsky MS, Singh TAKV. Association of anemia and erythropoiesis stimulating agents with inflammatory biomarkers in chronic kidney disease. Kidney Int. 2008;74:782–790
  31. Kilpatrick RD, Critchlow CW, Fishbane S, et al. Greater epoetin alfa responsiveness is associated with improved survival in hemodialysis patients. Clin J Am Soc Nephrol. 2008;3:1077–1083
  32. Szczech LA, Barnhart H, Inrig JK, et al. Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int. 2008;74:791–798
  33. Coyne DW, Kapoian T, Suki W DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: Results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. J Am Soc Nephrol. 2007;18:975–984
  34. Kapoian T, O'Mara NB, Singh AK, et al. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008;19:372–379
  35. Taylor JE, Peat N, Porter C, Morgan AG. Regular low-dose intravenous iron therapy improves response to erythropoietin in haemodialysis patients. Nephrol Dial Transplant. 1996;11:1079–1083
  36. Sepandj F, Jindal K, West M, Hirsch D. Economic appraisal of maintenance parenteral iron administration in treatment of anaemia in chronic haemodialysis patients. Nephrol Dial Transplant. 1996;11:319–322
  37. Fishbane S, Frei GL, Maesaka J. Reduction in recombinant human erythropoietin doses by the use of chronic intravenous iron supplementation. Am J Kidney Dis. 1995;26:41–46

 This article was published as part of a supplement sponsored by an educational grant from Watson Pharmaceuticals.

PII: S0272-6386(08)01349-8

doi: 10.1053/j.ajkd.2008.09.010

American Journal of Kidney Diseases
Volume 52, Issue 6, Supplement 1 , Pages S5-S13 , December 2008