Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients

Journal of Clinical Epidemiology

Volumn 57, Issue 10, 2004, Pages 1086-1095

  Cotter, Dennis J ^a   Stefanik, Kevin ^a   Zhang, Yi ^a   Thamer, Mae ^a   Scharfstein, Daniel ^b   Kaufman, James ^c  

^a Med Technol Pract Patterns Inst   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c VA BOSTON HEALTHCARE SYSTEM   (United States)

Author keywords

Anemia, management of; Causal effect; End point, surrogate; Epoetin; Hematocrit, target; Outcome assessment; Survival

Indexed keywords

RECOMBINANT ERYTHROPOIETIN;

ANEMIA; ARTICLE; EVALUATION; HEMATOCRIT; HEMODIALYSIS; HUMAN; KIDNEY FAILURE; PRIORITY JOURNAL; SURVIVAL;

DOSE-RESPONSE RELATIONSHIP, DRUG; EPOETIN ALFA; HEMATINICS; HEMATOCRIT; HUMANS; KIDNEY FAILURE, CHRONIC; PROSPECTIVE STUDIES; REGRESSION ANALYSIS; RENAL DIALYSIS; SURVIVAL RATE;

EID: 7444268479     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2004.05.002     Document Type: Article

References (44)

1. J.W. Eschbach, and J.W. Adamson Anemia of end-stage renal disease (ESRD) Kidney Int 28 1985 1 5
2. R.W. Evans, B. Rader, and D.L. Manninen Cooperative Multicenter EPO Clinical Trial Group. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin JAMA 263 1990 825 830
3. E.G. Lowrie, W.H. Huang, N.L. Lew, and Y. Liu The relative contribution of measured variables to death risk among hemodialysis patients E.A. Friedman Death on hemodialysis: preventable or inevitable? 1994 Kluwer Academic Publishers Dordrecht (The Netherlands) 121 141
4. Centers for Medicare & Medicaid Services. 2001 Annual Report, ESRD Clinical Performance Measures Project 2001 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Beneficiary Choices Baltimore (MD)
5. National Institute of Diabetes and Digestive and Kidney Diseases. Research updates in kidney and urologic health, summer 2000 [Internet]. Available at http://kidney.niddk.nih.gov/about/Research_Updates/ sum00/1.htm. Accessed 18 October 2002.
6. F. Madore, E.G. Lowrie, C. Brugnara, N.L. Lew, J.M. Lazarus, K. Bridges, and W.F. Owen Anemia in hemodialysis patients: variables affecting this outcome predictor J Am Soc Nephrol 8 1997 1921 1929
7. J.Z. Ma, J. Ebben, H. Xia, and A.J. Collins Hematocrit level and associated mortality in hemodialysis patients J Am Soc Nephrol 10 1999 610 619
8. A.J. Collins, S. Li, W. St Peter, J. Ebben, T. Roberts, J.Z. Ma, and W. Manning Death, hospitalization, and economic associations among incident hemodialysis patients with hematocrit values of 36 to 39% J Am Soc Nephrol 12 2001 2465 2473
9. J.W. Eschbach, M.H. Abdulhadi, J.K. Browne, B.G. Delano, M.R. Downing, J.C. Egrie, R.W. Evans, E.A. Friedman, S.E. Graber, and N.R. Haley Recombinant human erythropoietin in anemic patients with end-stage renal disease: results of a phase III multicenter clinical trial Ann Intern Med 111 1989 992 1000
10. A. Besarab, W.K. Bolton, J.K. Browne, J.C. Egrie, A.R. Nissenson, D.M. Okamoto, S.J. Schwab, and D.A. Goodkin 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 1998 584 590
11. H. Furuland, T. Linde, J. Ahlmen, A. Christensson, U. Strombom, and B.G. Danielson A randomized controlled trial of haemoglobin normalization with epoetin alfa in pre-dialysis and dialysis patients Nephrol Dial Transplant 18 2003 353 361
12. U.S. Renal Data System USRDS 2003 annual data report: atlas of end-stage renal disease in the United States 2002 U.S. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases Bethesda (MD) [Available at http://www.usrds.org/adr.htm. ]
13. J.P. Boissel, J.P. Collet, P. Moleur, and M. Haugh Surrogate endpoints: a basis for a rational approach Eur J Clin Pharmacol 43 1992 235 244
14. National Kidney Foundation-Dialysis Outcomes Quality Initiative NFK-DOQI clinical practice guidelines for the treatment of anemia of chronic renal failure Am J Kidney Dis 30 4 Suppl 3 1997 S192 S240
15. National Kidney Foundation-Kidney Disease Outcomes Quality Initiative. IV. NKF-K/DOQI clinical practice guidelines for anemia of chronic kidney disease: update 2000 Am J Kidney Dis 37 1 Suppl 1 2001 S182 S238 [erratum: Am J Kidney Dis 2001;38:442.]
16. P.C. Gotzsche, A. Liberati, V. Torri, and L. Rossetti Beware of surrogate outcome measures Int J Technol Assess Health Care 12 1996 238 246
17. A.J. Collins, J.Z. Ma, E.G. Constantini, and S.E. Everson Dialysis unit and patient characteristics associated with reuse practices and mortality: 1989-1993 J Am Soc Nephrol 9 1998 2108 2117
18. L. Gordis Epidemiology 2nd edition 2000 W.B. Saunders Philadelphia 42-4
19. K. Johnston What are surrogate outcome measures and why do they fail in clinical research? Neuroepidemiology 18 1999 167 173
20. Cardiac Arrhythmia Suppression Trial (CAST) investigators Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction N Engl J Med 321 1989 406 412
21. B.L. Riggs, S.F. Hodgson, W.M. O'Fallon, E.Y. Chao, H.W. Wahner, J.M. Muhs, S.L. Cedel, and L.J. Melton 3rd Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis N Engl J Med 322 1990 802 809
22. International Chronic Granulomatous Disease Cooperative Study Group A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease N Engl J Med 324 1991 509 516
23. R. Temple Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 282 1999 790 795
24. T.R. Fleming, and D.L. DeMets Surrogate end points in clinical trials: are we being misled? Ann Intern Med 125 1996 605 613
25. R.L. Prentice Surrogate endpoints in clinical trials: definition and operational criteria Stat Med 8 1989 431 440
26. G.F.M. Strippoli, C. Manno, F.P. Schena, and J.C. Craig Haemoglobin and haematocrit targets for the anaemia of chronic kidney disease (Cochrane Review) The Cochrane Library, Issue 2 2004 John Wiley & Sons Chichester (UK)
27. C.R. Flamm, N. Aronson, R. Bohn, B. Finkelstein, M. Piper, J. Seidenfeld, C.J. Bonnell, M. Carter, M. Gere, and K.M. Ziegler Use of epoetin for anemia in chronic renal failure. Evidence Report/Technology Assessment No. 29. AHRQ Publication No. 01-E016 June 2001 Agency for Healthcare Research and Quality Rockville (MD)
28. J.W. Eschbach, A. Varma, and J.C. Stivelman Is it time for a paradigm shift? Is erythropoietin deficiency still the main cause of renal anaemia? Nephrol Dial Transplant 17 Suppl 5 2002 2 7
29. M. Tonelli, P.G. Blake, and N. Muirhead Predictors of erythropoietin responsiveness in chronic hemodialysis patients ASAIO J 47 2001 82 85
30. K. Kalantar-Zadeh, C.J. McAllister, R.S. Lehn, G.H. Lee, A.R. Nissenson, and J.D. Kopple Effect of malnutrition-inflammation complex syndrome on EPO hyporesponsiveness in maintenance hemodialysis patients Am J Kidney Dis 42 2003 761 773
31. O. Ifudu, J. Uribarri, I. Rajwani, V. Vlacich, K. Reydel, G. Delosreyes, and E.A. Friedman Adequacy of dialysis and differences in hematocrit among dialysis facilities Am J Kidney Dis 36 2000 1166 1174
32. W.F. Owen, N.L. Lew, Y. Liu, E.G. Lowrie, and J.M. Lazarus The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis N Engl J Med 329 1993 1001 1006
33. W.M. McClellan, J.M. Soucie, and W.D. Flanders Mortality in end-stage renal disease is associated with facility-to-facility differences in adequacy of hemodialysis J Am Soc Nephrol 9 1998 1940 1947
34. A.J. Collins, J.Z. Ma, A. Umen, and P. Keshaviah Urea index and other predictors of hemodialysis patient survival Am J Kidney Dis 23 1994 272 282 [erratum: Am J Kidney Dis 1994; 24:157.]
35. P.J. Held, F.K. Port, R.A. Wolfe, D.C. Stannard, C.E. Carroll, J.T. Daugirdas, W.E. Bloembergen, J.W. Greer, and R.M. Hakim The dose of hemodialysis and patient mortality Kidney Int 50 1996 550 556
36. P.B. Gilbert, V. DeGruttola, S.M. Hammer, and D.R. Kuritzkes Virologic and regimen termination surrogate end points in AIDS clinical trials JAMA 285 2001 777 784
37. N.D. Vaziri Cardiovascular effects of erythropoietin and anemia correction Curr Opin Nephrol Hypertens 10 2001 633 637
38. Amgen EPOGEN (epoetin alfa), full prescribing information for physicians 1999 Amgen Thousand Oaks (CA)
39. L. Stevens, C. Stigant, and A. Levin Should hemoglobin be normalized in patients with chronic kidney disease? Semin Dial 15 2002 8 13
40. N. Muirhead A rationale for an individualized haemoglobin target Nephrol Dial Transplant 17 Suppl 6 2002 2 7
41. E. Ritz, and K. Amann Optimal haemoglobin during treatment with recombinant human erythropoietin Nephrol Dial Transplant 13 Suppl 2 1998 16 22
42. R. Sridhara, M.A. Eisenberger, V.J. Sinibaldi, L.M. Reyno, and M.J. Egorin Evaluation of prostate-specific antigen as a surrogate marker for response of hormone-refractory prostate cancer to suramin therapy J Clin Oncol 13 1995 2944 2953
43. J.M. Robins, M.A. Hernan, and B. Brumback Marginal structural models and causal inference in epidemiology Epidemiology 11 2000 550 560
44. Blood Products Advisory Committee, 25th meeting [May 11, 1989]. Meeting transcripts Vol. 2 1989 U.S. Food and Drug Administration, Center for Biologics Evaluation and Research Rockville (MD) 10,43,51