2009: A requiem for rHuEPOs - But should we nail down the coffin in 2010?

Clinical Journal of the American Society of Nephrology

Volumn 5, Issue 5, 2010, Pages 929-935

  Goldsmith, David ^a  

^a GUY S HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

KIRIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ANEMIA; CHRONIC KIDNEY DISEASE; CLINICAL MEDICINE; CLINICAL TRIAL; DISEASE SEVERITY; DRUG EFFICACY; HEMODIALYSIS; HUMAN; KIDNEY FAILURE; REVIEW; RISK BENEFIT ANALYSIS; TREATMENT OUTCOME;

ANEMIA; BIOLOGICAL MARKERS; ERYTHROPOIESIS; ERYTHROPOIETIN, RECOMBINANT; EVIDENCE-BASED MEDICINE; HEMATINICS; HEMOGLOBINS; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; KIDNEY FAILURE, CHRONIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 77952298270     PISSN: 15559041     EISSN: 1555905X     Source Type: Journal    
DOI: 10.2215/CJN.09131209     Document Type: Review

References (38)

1. Courtney AE, Maxwell AP: Critiques of clinical guidelines in nephrology: Anaemia. Nephron Clin Pract 110: c115-c125, 2008
2. Projan SJ, Gill D, Lu Z, Herrmann SH: Small molecules for small minds? The case for biologic pharmaceuticals. Expert Opin Biol Ther 4: 1345-1350, 2004 (Pubitemid 39005739)
3. Mikhail A, Covic A, Goldsmith D: Stimulating erythropoiesis: Future perspectives. Kidney Blood Press Res 31: 234-246, 2008
4. Curran MP, McCormack PL: Methoxy polyethylene glycolepoetin beta: A review of its use in the management of anaemia associated with chronic kidney disease. Drugs 68: 1139-1156, 2008
5. Covic A, Cannata-Andia J, Cancarini G, Coppo R, Frazão JM, Goldsmith D, Ronco P, Spasovski GB, Stenvinkel P, Utas C, Wiecek A, Zoccali C, London G: Biosimilars and biopharmaceuticals: What the nephrologists need to know - A position paper by the ERA-EDTA Council. Nephrol Dial Transplant 23: 3731-3737, 2008
6. Winearls CG, Oliver DO, Pippard MJ, Reid C, Downing MR, Cotes PM: Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet 2: 1175-1178, 1986
7. Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving HH, Remuzzi G, Singh AK, Solomon SD, Toto R, TREAT Investigators: A trial of darbepoetinalfa in type 2 diabetes and chronic kidney disease. N Engl J Med 361: 1-14, 2009
8. Winearls CG. Erythropoietin. Nephrol Dial Transplant 4: 323-326, 1989
9. Winearls CG: In the wake of progress: Ethical problems of renal failure treated by dialysis. Clin Med 6: 76-80, 2006 (Pubitemid 43302604)
10. Levin A, Djurdjev O, Thompson C, Barrett B, Ethier J, Carlisle E, Barre P, Magner P, Muirhead N, Tobe S, Tam P, Wadgymar JA, Kappel J, Holland D, Pichette V, Shoker A, Soltys G, Verrelli M, Singer J: Canadian randomized trial of hemoglobin maintenance to prevent or delay left ventricular mass growth in patients with CKD. Am J Kidney Dis 46: 799-811, 2005
11. London GM, Zins B, Pannier B, Naret C, Berthelot JM, Jacquot C, Safar M, Drueke TB: Vascular changes in hemo-dialysis patients in response to recombinant human erythropoietin. Kidney Int 36: 878-882, 1989
12. Macdougall IC, Lewis NP, Saunders MJ, Cochlin DL, Davies ME, Hutton RD, Fox KA, Coles GA, Williams JD: Long-term cardiorespiratory effects of amelioration of renal anaemia by erythropoietin. Lancet 335: 489-493, 1990 (Pubitemid 20073052)
13. Eckardt KU, Scherhag A, Macdougall IC, Tsakiris D, Clyne N, Locatelli F: Left ventricular geometry predicts cardiovascular: Outcomes associated with anemia correction in CKD. J Am Soc Nephrol 20: 2651-2660, 2009
14. National Kidney Foundation: KDOQI clinical practice guidelines for the treatment of anemia of chronic renal failure. Am J Kidney Dis 30[Suppl 3]: S192-S240, 1997
15. KDOQI: KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis 50: 471-530, 2007
16. Port FK, Pisoni RL, Bommer J, Locatelli F, Jadoul M, Eknoyan G, Kurokawa K, Canaud BJ, Finley MP, Young EW: Improving outcomes for dialysis patients in the international Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 1: 246-255, 2006
17. Covic A, Seica A, Gusbeth-Tatomir P, Goldsmith D: Hemoglobin normalization trials in chronic kidney disease: What should we learn about quality of life as an end point? J Nephrol 21: 478-484, 2008
18. Foley RN, Curtis BM, Parfrey PS: Erythropoietin therapy, hemoglobin targets and quality of life in healthy hemodialysis patients: A randomized trial. Clin J Am Soc Nephrol 4: 726-733, 2009
19. Locatelli F, Aljama P, Bárány P, Canaud B, Carrera F, Eckardt KU, Hörl WH, Macdougal IC, Macleod A, Wiecek A, Cameron S, 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 19[Suppl 2]: ii1-ii47, 2004
20. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, Schwab SJ, Goodkin DA: 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 339: 584-590, 1998 (Pubitemid 28385655)
21. Drüeke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A, CREATE Investigators: Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 355: 2071-2084, 2006 (Pubitemid 44749316)
22. Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D: Correction of anemia with epoetin alfa in chronic kidney disease. CHOIR Investigators. N Engl J Med 355: 2085-2098, 2006 (Pubitemid 44749317)
23. FDA strengthens safety information for erythropoiesis-stimulating agents (ESAs), 2007. Available at: http:// www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ 2007/ucm108864.htm. Accessed January 2010
24. Goldsmith DJ, Covic A: Time to reconsider evidence of anaemia treatment (TREAT): Essential safety assessment (ESA). Nephrol Dial Transplant March 2, 2010 [epub ahead of print]
25. Tonelli M, Hemmelgarn B, Reiman T, Manns B, Reaume MN, Lloyd A, Wiebe N, Klarenbach S: Benefits and harms of erythropoiesis stimulating agents for anemia related to cancer: A meta-analysis. CMAJ 180: E62-E71, 2009
26. Bohlius J, Schmidlin K, Brillant C, Schwarzer G, Trelle S, Seidenfeld J, Zwahlen M, Clarke MJ, Weingart O, Kluge S, Piper M, Napoli M, Rades D, Steensma D, Djulbegovic B, Fey MF, Ray-Coquard I, Moebus V, Thomas G, Untch M, Schumacher M, Egger M, Engert A: Erythropoietin or darbepoietin for patients with cancer: Meta-analysis based on individual patient data. Cochrane Database Syst Rev (3): CD007303, 2009
27. Heinze G, Kainz A, Hörl WH, Oberbauer R: Mortality in renal transplant recipients given erythropoietins to increase haemoglobin concentration: Cohort study. BMJ 339: b4018, 2009
28. McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB, RED-HF Committees and Investigators: Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): A Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail 11: 795-801, 2009
29. Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, FAIR-HF Trial Investigators: Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 361: 2436-2448, 2009
30. Shushakova N, Park JK, Menne J, Fliser D: Chronic erythropoietin treatment affects different molecular pathways of diabetic cardiomyopathy in mouse. Eur J Clin Invest 39: 755-760, 2009
31. Brines M, Cerami A: Erythropoietin-mediated tissue protection: Reducing collateral damage from the primary injury response. J Intern Med 264: 405-432, 2008
32. Ehrenreich H, Weissenborn K, Prange H, Schneider D, Weimar C, Wartenberg K, Schellinger PD, Bohn M, Becker H, Wegrzyn M, Jähnig P, Herrmann M, Knauth M, BährM, Heide W, Wagner A, Schwab S, Reichmann H, Schwendemann G, Dengler R, Kastrup A, Bartels C, EPO Stroke Trial Group: Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke 40: e647-e655, 2009
33. Endre ZH, Walker RJ, Pickering JW, Shaw GM, Frampton CM, Henderson SJ, Hutchison R, Mehrtens JE, Robinson JM, Schollum JB, Westhuyzen J, Celi LA, McGinley RJ, Campbell IJ, George PM: Early intervention with erythropoietin does not affect the outcome of acute kidney injury (the EARLYARF trial). Kidney Int February 17, 2010 [epub ahead of print]
34. Macdougall IC, Rossert J, Casadevall N, Stead RB, Duliege AM, Froissart M, Eckardt KU: A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med 361: 1848-1855, 2009
35. Clement FM, Klarenbach S, Tonelli M, Johnson JA, Manns BJ: The impact of selecting a high hemoglobin target level on health-related quality of life for patients with chronic kidney disease: A systematic review and meta-analysis. Arch Intern Med 169: 1104-1112, 2009
36. Duh MS, Weiner JR, White LA, Lefebvre P, Greenberg PE: Management of anaemia: A critical and systematic review of the cost effectiveness of erythropoiesis-stimulating agents. Pharmacoeconomics 26: 99-120, 2008
37. Unger FE, Thompson AM, Blank MJ, Temple R: Erythropoiesis stimulating agents: It's time for a re-evaluation. N Engl J Med 362: 189-193, 2010
38. Fishbane S, Besarab A: Mechanism of increased mortality risk with erythropoietin treatment to higher hemoglobin targets. Clin J Am Soc Nephrol 2: 1274-1282, 2007