Epoetin Alfa: Clinical Evolution of a Pleiotropic Cytokine

Archives of Internal Medicine

Volumn 164, Issue 3, 2004, Pages 262-276

  Henry, David H ^a   Bowers, Peter ^b   Romano, Michael T ^c   Provenzano, Robert ^d  

^a PENNSYLVANIA HOSPITAL   (United States)

^b Ortho Biotech Products LP   (United States)

^c JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^d ST JOHN HOSPITAL AND MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; CYTOKINE; ERYTHROPOIETIN; HEMOGLOBIN; IRON; REBETRON; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; APOPTOSIS; BONE MARROW SUPPRESSION; BREATHING DISORDER; CENTRAL NERVOUS SYSTEM; CHRONIC KIDNEY DISEASE; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CRITICAL ILLNESS; DIARRHEA; DISEASE ASSOCIATION; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFECT; EDEMA; ERYTHROPOIESIS; FEVER; HEPATITIS C; HORMONAL THERAPY; HUMAN; METABOLISM; MORTALITY; NEUROPROTECTION; PARESTHESIA; PATHOPHYSIOLOGY; PHYSIOLOGY; PLEIOTROPY; PRIORITY JOURNAL; QUALITY OF LIFE; RETICULOCYTOSIS; REVIEW; SURVIVAL; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION; VOMITING;

ANEMIA; CLINICAL TRIALS; CYTOKINES; EPOETIN ALFA; ERYTHROPOIESIS; HEART FAILURE, CONGESTIVE; HEMATINICS; HEMOGLOBINS; HUMANS; KIDNEY FAILURE, CHRONIC; QUALITY OF LIFE; UNITED STATES;

EID: 0842305685     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.164.3.262     Document Type: Review

References (205)

1. Lin F-K, Suggs S, Lin C-H, et al. Cloning and expression of the human erythropoietin gene. Proc Natl Acad Sci U S A. 1985;82:7580-7584.
2. Egrie JC, Strickland TW, Lane J, et al. Characterization and biological effects of recombinant human erythropoietin. Immunobiology. 1986;172:213-224.
3. 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 hae modialysis. Lancet. 1986;2:1175-1178.
4. Bommer J, Kugel M, Schoeppe W, et al. Dose-related effects of recombinant human erythropoietin on erythropoiesis: results of a multicenter trial in patients with end-stage renal disease. Contrib Nephrol. 1988;66:85-93.
5. Eschbach JW, Downing MR, Egrie JC, Browne JK, Adamson JW. USA multicenter clinical trial with recombinant human erythropoietin (Amgen): results in hemodialysis patients. Contrib Nephrol. 1989;76:160-165.
6. Eschbach JW, Kelly MR, Haley NR, Abels RI, Adamson JW. Treatment of the anemia of progressive renal failure with recombinant human erythropoietin. N Engl J Med. 1989;321:158-163.
7. Fischl M, Galpin JE, Levine JD, et al. Recombinant human erythropoietin for patients with AIDS treated with zidovudine. N Engl J Med. 1990;322:1488-1493.
8. Henry DH, Beall GN, Benson CA, et al. Recombinant human erythropoietin in the treatment of anemia associated with human immunodeficiency virus (HIV) infection and zidovudine therapy: overview of four clinical trials. Ann Intern Med. 1992;117:739-748.
9. Spivak JL, Barnes DC, Fuchs E, Quinn TC. Serum immunoreactive erythropoietin in HIV-infected patients. JAMA. 1989;261:3104-3107.
10. Goodnough LT, Skikne B, Brugnara C. Erythropoietin, iron, and erythropoiesis. Blood. 2000;96:823-833.
11. Fink JC, Blahut SA, Reddy M, Light PD. Use of erythropoietin before the initiation of dialysis and its impact on mortality. Am J Kidney Dis. 2001;37:348-355.
12. Moore RD, Keruly JC, Chaisson RE. Anemia and survival in HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;19:29-33.
13. Littlewood TJ, Bajetta E, Nortier JWR, Vercammen E, Rapoport B, for the Epoetin Alfa Study Group. Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2001;19:2865-2874.
14. Sirén A-L, Fratelli M, Brines M, et al. Erythropoietin prevents neuronal apoptosis after cerebral ischemia and metabolic stress. Proc Natl Acad Sci U S A. 2001;98:4044-4049.
15. Lacombe C, Mayeux P. The molecular biology of erythropoietin. Nephrol Dial Transplant. 1999;14(suppl 2):22-28.
16. Wojchowski DM, Gregory RC, Miller CP, Pandit AK, Pircher TJ. Signal transduction in the erythropoietin receptor system. Exp Cell Res. 1999;253:143-156.
17. Jacobson LO, Goldwasser E. Role of the kidney in erythropoiesis [letter]. Proc Soc Exp Biol Med. 1957;179:633-634.
18. Gregory CJ, Eaves AC. Human marrow cells capable of erythropoietic differentiation in vitro: definition of three erythroid colony responses. Blood. 1977;49:855-864.
19. Gregory CJ, Eaves AC. Three stages of erythropoietic progenitor cell differentiation distinguished by a number of physical and biologic properties. Blood. 1978;51:527-537.
20. Hillman RS, Finch CA. Red Cell Manual. 7th ed. Philadelphia, Pa: FA Davis Co; 1996.
21. Flaharty KK, Caro J, Erslev A, et al. Pharmacokinetics and erythropoietic response to human recombinant erythropoietin in healthy men. Clin Pharmacol Ther. 1990;47:557-564.
22. Jacobs K, Shoemaker C, Rudersdorf R, et al. Isolation and characterization of genomic and cDNA clones of human erythropoietin. Nature. 1985;313:806-810.
23. Mulcahy L. The erythropoietin receptor. Semin Oncol. 2001;28(suppl 8):19-23.
24. Okada A, Kinoshita Y, Maekawa T, et al. Erythropoietin stimulates proliferation of rat-cultured gastric mucosal cells. Oigestion. 1996;57:328-332.
25. Ammarguellat F, Gogusev J, Dueke TB. Direct effect of erythropoietin on rat vascular smooth-muscle cell via a putative erythropoietin receptor. Nephrol Dial Transplant. 1996;11:687-692.
26. Koshimura K, Murakami Y, Sohmiya M, Tanaka J, Kato Y. Effects of erythropoietin on neuronal activity. J Neurochem. 1999;72:2565-2572.
27. Masuda S, Okano M, Yamagishi K, Nagao M, Ueda M, Sasaki R. A novel site of erythropoietin production: oxygen-dependent production in cultured rat astrocytes. J Biol Chem. 1994;269:19488-19493.
28. Bernaudin M, Marti HH, Roussel S, et al. Potential role for erythropoietin in focal permanent cerebral ischemia in mice. J Cereb Blood Flow Metab. 1999;19:643-651.
29. Sadamoto Y, Igase K, Sakanaka M, et al. Erythropoietin prevents place navigation disability and cortical infarction in rats with permanent occlusion of the middle cerebral artery. Biochem Biophys Res Commun. 1998;253:26-32.
30. Koury MJ, Bondurant MC. Erythropoietin retards DNA breakdown and prevents programmed death in erythroid progenitor cells. Science. 1990;248:378-381.
31. Chattopadhyay A, Choudhury TD, Bandyopadhyay D, Datta AG. Protective effect of erythropoietin on the oxidative damage of erythrocyte membrane by hydroxyl radical. Biochem Pharmacol. 2000;59:419-425.
32. Campana WM, Misasi R, O'Brien JS. Identification of a neurotrophic sequence in erythropoietin. Int J Mol Med. 1998;1:235-241.
33. Kaufman JS, Reda DJ, Fye CL, et al, for the Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. N Engl J Med. 1998;339:578-583.
34. Rutherford CJ, Schneider TJ, Dempsey H, et al. Efficacy of different dosing regimens for recombinant human erythropoietin in a simulated postsurgical setting: the importance of iron availability in optimizing response. Am J Med. 1994;96:139-145.
35. Goldberg MA, McCutchen JW, Jove M, et al. A safety and efficacy comparison study of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery. Am J Orthop. 1996;25:544-552.
36. Cheung WK, Goon BL, Guilfoyle MC, Wacholtz MC. Pharmacokinetics and pharmacodynamics of recombinant human erythropoietin after single and multiple subcutaneous doses to healthy subjects. Clin Pharmacol Ther. 1998;64:412-423.
37. Cheung W, Minton N, Gunawardena K. Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly. Eur J Clin Pharmacol. 2001;57:411-418.
38. Provenzano R, Morrison L. Once-weekly (QW) treatment with epoetin alfa in patients (pts) with anemia due to chronic kidney disease (CKD): preliminary analysis [abstract A1227] J Am Soc Nephrol. 2001;12:238a.
39. Gabrilove JL, Cleeland CS, Livingston RB, Sarokhan B, Winer E, Einhom LH. Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: improvements in hemoglobin and quality of life similar to three-times-weekly dosing. J Clin Oncol. 2001;19:2875-2882.
40. Shasha D, George MJ, Harrison LB. Once-weekly dosing of epoetin alfa increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy. Cancer. 2003;98:1072-1079.
41. George MJ, Vahdat LT, Shasha D, Haririson LB. Increased hemoglobin and improved quality of life with once-weekly epoetin alfa in anemic breast cancer patients receiving concomitant or sequential chemoradiation [abstract 2997]. Proc Am Soc Clin Oncol. 2001;20(pt 2):311b.
42. + patients [abstract]. In: Proceedings of the 39th Annual Meeting of the Infectious Diseases Society of America (IDSA); October 27, 2001; San Francisco, Calif. Abstract 708.
43. Grossman H, Bowers P, Leitz G, for the 010 Study Group. Once-weekly dosing of 40,000 U epoetin alfa is as effective as thrice-weekly dosing among anemic HIV+ patients. J Acquir Immune Defic Syndr. In press.
44. Sulkowski M, Wasserman R, Brau N, Hassanein T, Bini E, Dieterich D. Once-weekly recombinant human erythropoietin (epoetin alfa) facilitates optimal ribavirin (RBV) dosing in hepatitis C virus-infected patients receiving interferon-α-2b(IFN)/RBV therapy. Am J Gastroenterol. In press.
45. Chap L, George M, Glaspy J. Evaluation of epoetin alfa (Procrit) 60,000 U once weekly in anemic cancer patients receiving chemotherapy [abstract 2873]. Proc Am Soc Clin Oncol. 2002;21:264b.
46. Patton J, Camp M, Kuzur M, et al. Epoetin alfa 60,000 U once weekly followed by 120,000 U every 3 weeks maintains hemoglobin levels in anemic cancer patients undergoing chemotherapy [abstract 3516]. Blood. 2002;100(11 pt 2):16b-17b.
47. Petroff S, Germain M, O'Shea M, Braden G, Sweet S, Mulhern J. Prolonged erythropoietin (EPO) dosing intervals in pre-ESRD patients [abstract A2098]. J Am Soc Nephrol. 2001;12:407a.
48. Crawford J, Cella D, Cleeland CS, et al. Relationship between changes in hemoglobin level and quality of life during chemotherapy in anemic cancer patients receiving epoetin alfa therapy. Cancer. 2002;95:888-895.
49. Littlewood TJ, Bajetta E, Rapoport B, Nortier J. Early administration of epoetin alfa optimizes anemia management with respect to hematologic and quality of life (QOL) outcomes in anemic cancer patients (pts) undergoing chemotherapy [abstract 3524]. Blood. 2002;100(11 pt 2):18b-19b.
50. Cavill I, Macdougall I, Gokal R, et al. Iron management in patients on rHuEPO. Br J Renal Med. 1997;2:6-8.
51. Henry DH. Supplemental iron: a key to optimizing the response to cancer-related anemia to rHuEPO? Oncologist 1998;3:275-278.
52. Auerbach M, Barker L, Bahrain H, Trout R, McIlwain M, Ballard H. Intravenous iron (IV Fe) optimizes the response to erythropoietin (EPO) in patients with anemia of cancer and cancer chemotherapy: results of a multicenter, open-label, randomized trial [abstract 3323]. Blood. 2001;98(11 suppl, pt 1):799a.
53. National Kidney Foundation. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: update 2000. Am J Kidney Dis. 2001;37(suppl 1):S182-S238.
54. Macdougall IC, Tucker B, Thompson J, et al. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int. 1996;50:1694-1699.
55. National Kidney Foundation. NKF-K/DOQI clinical practice guidelines for anemia of chronic kidney disease, update 2002. Am J Kidney Dis. 2002;39(suppl 1):S1-S266.
56. Bárány P, Pettersson E, Konarski-Svensson JK. Long-term effects on quality of life in haemodialysis patients of correction of anaemia with erythropoietin. Nephrol Dial Transplant. 1993;8:426-432.
57. Levin NW, Lazarus JM, Nissenson AR, for the National Cooperative rHu Erythropoietin Study Group. Maximizing patient benefits with epoetin alfa therapy: National Cooperative rHu Erythropoietin Study in patients with chronic renal failure - an interim report. Am J Kidney Dis. 1993;22(suppl 1):3-12.
58. Frankenfield D, Johnson CA, Wish JB, Rocco MV, Madore F, Owen WF Jr, for the ESRD Core Indicators Project. Anemia management of adult hemodialysis patients in the US: results from the 1997 ESRD Core Indicators Project. Kidney Int. 2000;57:578-589.
59. Bianchetti MG, Hämmerli I, Roduit C, Neuhaus TJ, Leumann EP, Oetliker OH. Epoetin alfa in anaemic children or adolescents on regular dialysis. Eur J Pediatr. 1991;150:509-512.
60. Ongkingco JRC, Ruley EJ, Turner ME, Fragale MR. Efficacy of once- versus thrice-weekly subcutaneous recombinant human erythropoietin in children receiving continuous cycling peritoneal dialysis. Am J Nephrol. 1994;14:14-18.
61. Ma JZ, Ebben J, Xia H, Collins AJ. Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol. 1999;10:610-619.
62. Collins A, St Peter WI, Li SY, Ebben J, Chen S, Ma JZ. Hematocrit (hct) levels 36-<39% are associated with lower hospitalization risk in Medicare hemodialysis (HD) patients [abstract A1374]. J Am Soc Nephrol. 2000;11:262A.
63. Foley RN, Parfrey PS, Harnett JD, Kent GM, Murray OC, Barre PE. The impact of anemia on cardiomyopathy, morbidity, and mortality in end-stage renal disease. Am J Kidney Dis. 1996;28:53-61.
64. Kuriyama S, Tomonari H, Yoshida H, Hashimoto T, Kawaguchi Y, Sakai O. Reversal of anemia by erythropoietin therapy retards the progression of chronic renal failure, especially in nondiabetic patients. Nephron. 1997;77:176-185.
65. Jungers P, Choukroun G, Oualim Z, Robino C, Nguyen AT, Man NK. Beneficial influence of recombinant human erythropoietin therapy on the rate of progression of chronic renal failure in predialysis patients. Nephrol Dial Transplant 2001;16:307-312.
66. The US Recombinant Human Erythropoietin Predialysis Study Group. Double-blind, placebo-controlled study of the therapeutic use of recombinant human erythropoietin for anemia associated with chronic renal failure in predialysis patients. Am J Kidney Dis. 1991;18:50-59.
67. Pickett JL, Theberge DC, Brown WS, Schweitzer SU, Nissenson AR. Normalizing hematocrit in dialysis patients improves brain function. Am J Kidney Dis. 1999;33:1122-1130.
68. Marsh JT, Brown WS, Wolcott D, et al. rHuEPO treatment improves brain and cognitive function of anemic dialysis patients. Kidney Int. 1991;39:155-163.
69. Robertson HT, Haley NR, Guthrie M, Cardenas D, Eschbach JW, Adamson JW. Recombinant erythropoietin improves exercise capacity in anemic hemodialysis patients. Am J Kidney Dis. 1990;15:325-332.
70. Levin A, Singer J, Thompson C, Ross H, Lewis M. Prevalent left ventricular hypertrophy in the predialysis population: identifying opportunities for intervention. Am J Kidney Dis. 1996;27:347-354.
71. Hayashi T, Suzuki A, Shoji T, et al. Cardiovascular effect of normalizing the hematocrit level during erythropoietin therapy in predialysis patients with chronic renal failure. Am J Kidney Dis. 2000;35:250-256.
72. Macdougall IC. How to improve survival in predialysis patients. Nephron. 2000;85(suppl 1):15-22.
73. Silverberg D, Blum M, Peer G, Iaina A. Anemia during the predialysis period: a key to cardiac damage in renal failure. Nephron. 1998;80:1-5.
74. Tsakiris D. Morbidity and mortality reduction associated with the use of erythropoietin. Nephron. 2000;85:2-8.
75. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993;329:1456-1462.
76. McClellan W, Owen WF Jr. Preliminary results of the prevalence of anemia in patients with early renal insufficiency (PAERI) study [abstract A1173]. J Am Soc Nephrol. 2001;12:227a.
77. Obrador GT, Pereira BJG. Early referral to the nephrologist and timely initiation of renal replacement therapy: a paradigm shift in the management of patients with chronic renal failure. Am J Kidney Dis. 1998;31:398-417.
78. Hambleton J. Hematologic complications of HIV infection. Oncology. 1996;10:671-680.
79. Sullivan PS, Hanson DL, Chu SY, Jones JL, Ward JW, and The Adult/Adolescent Spectrum of Disease Group. Epidemiology of anemia in human immunodeficiency virus (HIV)-infected persons: results from the Multistate Adult and Adolescent Spectrum of HIV Disease Surveillance Project. Blood. 1998;91:301-308.
80. Bain BJ. Pathogenesis and pathophysiology of anemia in HIV infection. Curr Opin Hematol. 1999;6:89-93.
81. Henry DH. Experience with epoetin alfa and acquired immunodeficiency syndrome anemia. Semin Oncol. 1998;25(suppl 7):64-68.
82. Phair JP, Abels RI, McNeill MV, Sullivan DJ. Recombinant human erythropoietin treatment: investigational new drug protocol for the anemia of the acquired immunodeficiency syndrome. Arch Intern Med. 1993;153:2669-2675.
83. Balfour HH Jr. Recombinant human erythropoietin for treatment of anemia in persons with AIDS not receiving zidovudine. Int J Antimicrob Agents. 1997;8:189-192.
84. Volberding P, for The Anemia in HIV Working Group. Consensus statement: anemia in HIV infection - current trends, treatment options, and practice strategies. Clin Ther. 2000;22:1004-1020.
85. Sharp V, Paredes J, Steinbock C. Anemia in HIV disease in the HAART era: is it common [abstract 3179]? Blood. 1999;94(suppl 1, pt2):8b.
86. Moore R. Human immunodeficiency virus infection, anemia, and survival. Clin Infect Dis. 1999;29:44-49.
87. Mocroft A, Kirk O, Barton SE, et al, for the EuroSIDA Study Group. Anaemia is an independent predictive marker for clinical prognosis in HIV-infected patients from across Europe. AIDS. 1999;13:943-950.
88. Moore RD, Forney D. Anemia in HIV-infected patients receiving highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2002;29:54-57.
89. Levine AM, Berhane K, Masri-Lavine L, et al. Prevalence and correlates of anemia in a large cohort of HIV-infected women: Women's Inter-agency HIV Study. J Acquir Immune Oefic Syndr. 2001;26:28-35.
90. Lewden C, Leport C, Cuzin L, et al, for the A APROCO Study Group. Prognostic factors of mortality in the APROCO-ANRS EP11 cohort of HIV-1 infected adults started on a protease inhibitor-containing therapy [abstract]. In: Proceedings of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2000; Toronto, Ontario. Abstract 1909.
91. Creagh T, Mildvan D, Moore R, Bohn H, Yarrish R, Ray L. A case-control study examining the association of disease prognosis with the development and treatment of anemia in patients infected with HIV-1: interim results [abstract]. In: 12th National HIV/AIDS Update Conference: HIV/AIDS at the crossroads: confronting critical issues; March 14-17, 2000; San Francisco, Calif. Abstract 304.
92. Lundgren JD, Mocroft A, Gatell JM, et al. A clinically prognostic scoring system for patients receiving highly active antiretroviral therapy: results from the EuroSIDA study. J Infect Dis. 2002;185:178-187.
93. Moore RD. Anemia and human immunodeficiency virus disease in the era of highly active antiretroviral therapy. Semin Hematol 2000;37 (suppl 6):18-23.
94. Vogelzang NJ, Breitbart W, Cella D, et al, for the Fatigue Coalition. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. Semin Hematol. 1997;34(suppl 2):4-12.
95. Curt GA, Breitbart W, Cella DF, et al. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5:353-360.
96. Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst. 1999;91:1616-1634.
97. Caro JJ, Salas M, Ward A, Goss G. Anemia as an independent prognostic factor for survival in patients with cancer: a systematic, quantitative review. Cancer. 2001;91:2214-2221.
98. Miller CB, Jones RJ, Piantadosi S, Abeloff MD, Spivak JL. Decreased erythropoietin response in patients with the anemia of cancer. N Engl J Med. 1990;322:1689-1692.
99. Means RT Jr, Krantz SB. Progress in understanding the pathogenesis of the anemia of chronic disease. Blood. 1992;80:1639-1647.
100. Case DC Jr, Bukowski RM, Carey RW, et al. Recombinant human erythropoietin therapy for anemic cancer patients on combination chemotherapy. J Natl Cancer Inst. 1993;85:801-806.
101. Henry DH, Brooks BJ Jr, Case DC Jr, et al. Recombinant human erythropoietin therapy for anemic cancer patients receiving cisplatin chemotherapy. Cancer J Sci Am. 1995;1:252-260.
102. Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S, for the Procrit Study Group. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. J Clin Oncol. 1997;15:1218-1234.
103. Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumortype: results from a prospective community oncology study. J Clin Oncol. 1998;16:3412-3425.
104. Garton JP, Gertz MA, Witzig TE, et al. Epoetin alfa for the treatment of the anemia of multiple myeloma: a prospective, randomized, placebo-controlled, double-blind trial. Arch Intern Med. 1995;155:2069-2074.
105. Österborg A, Boogaerts MA, Cimino R, et al, for the European Study Group of the Erythropoietin (Epoetin Beta) Treatment in Multiple Myeloma and Non-Hodgkin's Lymphoma. Recombinant human erythropoietin in transfusion-dependent anemic patients with multiple myeloma and non-Hodgkin's lymphoma - a randomized multicenter study. Blood. 1996;87:2675-2682.
106. Dammacco F, Castoldi G, Rödjer S. Efficacy of epoetin alfa in the treatment of anaemia of multiple myeloma. Br J Haematol. 2001;113:172-179.
107. Siakantaris MP, Angelopoulou MK, Vassilakopoulos TP, Dimopoulou MN, Kontopidou FN, Pangalis GA. Correction of disease related anaemia of B-chronic lymphoproliferative disorders by recombinant human erythropoietin: maintenance is necessary to sustain response. Leuk Lymphoma. 2000;40:141-147.
108. Mittelman M, Neumann D, Peled A, Kanter P, Haran-Ghera N. Erythropoietin induces tumor regression and antitumor immune responses in murine myeloma models. Proc Natl Acad Sci U S A. 2001;98:5181-5186.
109. Lavey RS, Dempsey WH. Erythropoietin increases hemoglobin in cancer patients during radiation therapy. Int J Radiat Oncol Biol Phys. 1993;27:1147-1152.
110. Dusenbery KE, McGuire WA, Holt PJ, et al. Erythropoietin increases hemoglobin during radiation therapy for cervical cancer. Int J Radiat Oncol Biol Phys. 1994;29:1079-1084.
111. Sweeney PJ, Nicolae D, Ignacio L, et al. Effect of subcutaneous recombinant human erythropoietin in cancer patients receiving radiotherapy: final report of a randomized, open-labelled, phase II trial. Br J Cancer. 1998;77:1996-2002.
112. Blohmer JU, Petry K, Kolben M, et al. Adjuvant sequential chemo-radiotherapy with vs without erythropoietin in high-risk patients with carcinoma of the cervix-first results of a phase III study [abstract 823]. Proc Am Soc Clin Oncol. 2001;20(pt 1):206a.
113. Glaser C, Millesi W, Gössweiner S, Leitha T, Dobrowsky W, Kornek GV. r-HuErythropoietin supply increases efficacy of neoadjuvant radio-chemotherapy in patients with oral squamous cell carcinoma [abstract 1532]. Proc Am Soc Clin Oncol. 1998;17:397a.
114. Glaser CM, Millesi W, Kornek GV, et al. Impact of hemoglobin (Hgb) level and use of recombinant human erythropoietin (r-HuEPO) on response to neoadjuvant chemoradiation therapy, tumor control, and survival in patients with oral or oropharyngeal squamous cell carcinoma (SCCA) [abstract 10]. Int J Radiat Oncol Biol Phys. 1999;45(suppl 1):149-150.
115. Ludwig H, Fritz E, Kotzmann H, Höcker P, Gisslinger H, Barnas U. Erythropoietin treatment of anemia associated with multiple myeloma. N Engl J Med. 1990;322:1693-1699.
116. Oster W, Herrmann F, Gamm H, et al. Erythropoietin for the treatment of anemia of malignancy associated with neoplastic bone marrow infiltration. J Clin Oncol. 1990;8:956-962.
117. Henry DH, Abels RI. Recombinant human erythropoietin in the treatment of cancer and chemotherapy-induced anemia: results of double-blind and open-label follow-up studies. Semin Oncol. 1994;21 (suppl 3):21-28.
118. Abels R. Erythropoietin for anaemia in cancer patients. Eur J Cancer. 1993;29Ä(suppl):S2-S8.
119. Quirt I, Robeson C, Lau CY, et al, for the Canadian Eprex Oncology Study Group. Epoetin alfa therapy increases hemoglobin levels and improves quality of life in patients with cancer-related anemia who are not receiving chemotherapy and patients with anemia who are receiving chemotherapy. J Clin Oncol. 2001;19:4126-4134.
120. Canadian Orthopedic Perioperative Erythropoietin Study Group. Effectiveness of perioperative recombinant human erythropoietin in elective hip replacement. Lancet. 1993;341:1227-1232.
121. de Andrade JR, Jove M, Landon G, Frei D, Guilfoyle M, Young DC. Baseline hemoglobin as a predictor of risk of transfusion and response to epoetin alfa in orthopedic surgery patients. Am J Orthop. 1996;25:533-542.
122. Faris PM, Ritter MA, Abels RI, for the American Erythropoietin Study Group. The effects of recombinant human erythropoietin on perioperative transfusion requirements in patients having a major orthopaedic operation. J Bone Joint Surg. 1996;78:62-72.
123. Stowell CP, Chandler H, Jové M, Guilfoyle M, Wacholtz MC. An open-label, randomized study to compare the safety and efficacy of perioperative epoetin alfa with preoperative autologous blood donation in total joint arthroplasty. Orthopedics. 1999;22(suppl):S105-S112.
124. Faris PM, Ritter MA. Epoetin alfa: a bloodless approach for the treatment of perioperative anemia. Clin Orthop. 1998;357:60-67.
125. Nieder AM, Rosenblum N, Lepor H. Comparison of two different doses of preoperative recombinant erythropoietin in men undergoing radical retropubic prostatectomy. Urology. 2001;57:737-741.
126. Monk TG, Goodnough LT, Brecher ME, Colberg JW, Andriole GL, Catalona WJ. A prospective randomized comparison of three blood conservation strategies for radical prostatectomy. Anesthesiology. 1999;91:24-33.
127. Chun TY, Martin S, Lepor H. Preoperative recombinant human erythropoietin injection versus preoperative autologous blood donation in patients undergoing radical retropubic prostatectomy. Urology. 1997;50:727-732.
128. Gilbert WB, Smith JA Jr. Blood use strategies in urologic surgery. Urology. 2000;55:461-467.
129. Revicki DA, Brown RE, Henry DH, McNeill MV, Rios A, Watson T. Recombinant human erythropoietin and health-related quality of life of AIDS patients with anemia. J Acquir Immune Defic Syndr. 1994;7:474-484.
130. Abrams DI, Steinhart C, Frascino R. Epoetin alfa therapy for anaemia in HIV-infected patients: impact on quality of life. Int J STD AIDS. 2000;11:659-665.
131. Haber HL, Leavy JA, Kessler PD; Kukin ML, Gottlieb SS, Packer M. The erythrocyte sedimentation rate in congestive heart failure. N Engl J Med. 1991;324:353-358.
132. Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med. 1995;333:1190-1195.
133. Rich MW, Shah AS, Vinson JM, Freedland KE, Kuru T, Sperry JC. Iatrogenic congestive heart failure in older adults: clinical course and prognosis. J Am Geriatr Soc. 1996;44:638-643.
134. Maeda K, Tanaka Y, Tsukano Y, et al. Multivariate analysis using a linear discriminant function for predicting the prognosis of congestive heart failure. Jpn Circ J. 1982;46:137-142.
135. Volpe M, Tritto C, Testa U, et al. Blood levels of erythropoietin in congestive heart failure and correlation with clinical, hemodynamic, and hormonal profiles. Am J Cardiol. 1994;74:468-473.
136. Carson JL. Morbidity risk assessment in the surgically anemic patient. Am J Surg. 1995;170 (suppl):32S-36S.
137. Carson JL, Duff A, Poses RM, et al. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996;348:1055-1060.
138. Anand IS, Chandrashekhar Y, Ferrari R, Poole-Wilson PA, Harris PC. Pathogenesis of oedema in chronic severe anemia: studies of body water and sodium, renal function, haemodynamic variables, and plasma hormones. Br Heart J. 1993;70:357-362.
139. Löw I, Grutzmacher P, Bergmann M, Schoeppe W. Echocardiographic findings in patients on maintenance hemodialysis substituted with recombinant human erythropoietin. Clin Nephrol. 1989;31:26-30.
140. Löw-Friedrich I, Grutzmacher P, Marz W, Bergmann M, Schoeppe W. Therapy with recombinant human erythropoietin reduces cardiac size and improves heart function in chronic hemodialysis patients. Am J Nephrol. 1991;11:54-60.
141. Goldberg N, Lundin AP, Delano B, Friedman EA, Stein RA. Changes in left ventricular size, wall thickness, and function in anemic patients treated with recombinant human erythropoietin. Am Heart J. 1992;124:424-427.
142. Foley RN, Parfrey PS, Morgan J, et al. A randomized controlled trial of complete vs partial correction of anemia in hemodialysis patients with asymptomatic concentric LV hypertrophy or LV dilatation [abstract]. J Am Soc Nephrol. 1998;9:208.
143. Linde T, Wikstrom B, Andersson LG, Danielson BG. Renal anaemia treatment with recombinant human erythropoietin increases cardiac output in patients with ischaemic heart disease. Scand J Urol Nephrol. 1996;30:115-120.
144. Silverberg DS, Wexler D, Blum M, et al. The use of subcutaneous erythropoietin and intravenous iron for the treatment of the anemia of severe, resistant congestive heart failure improves cardiac and renal function and functional cardiac class, and markedly reduces hospitalizations. J Am Coll Cardiol. 2000;35:1737-1744.
145. Sakanaka M, Wen T-C, Matsuda S, et al. In vivo evidence that erythropoietin protects neurons from ischemic damage. Proc Natl Acad Sci USA. 1998;95:4635-4640.
146. Brines ML, Ghezzi P, Keenan S, et al. Erythropoietin crosses the blood-brain barrier to protect against experimental brain injury. Proc Natl Acad Sci U S A. 2000;97:10526-10531.
147. Morishita E, Masuda S, Nagao M, et al. Erythropoietin receptor is expressed in rat hippocampal and cerebral cortical neurons, and erythropoietin prevents in vitro glutamate-induced neuronal death. Neuroscience. 1997;76:105-116.
148. Bernaudin M, Bellail A, Marti HH, et al. Neurons and astrocytes express EPO mRNA: oxygen-sensing mechanisms that involve the redox-state of the brain. Glia. 2000;30:271-278.
149. Digicaylioglu M, Bichet S, Marti HH, et al. Localization of specific erythropoietin binding sites in defined areas of the mouse brain. Proc Natl Acad Sci U S A. 1995;92:3717-3720.
150. Juul SE, Anderson DK, Li Y, et al. Erythropoietin and erythropoietin receptor in the developing human central nervous system. Pediatr Res. 1998;43:40-49.
151. Juul SE, Stallings SA, Christensen RD. Erythropoietin in the cerebrospinal fluid of neonates who sustained CNS injury. Pediatr Res. 1999;46:543-547.
152. Marti HH, Wenger RH, Rivas LA, et al. Erythropoietin gene expression in human, monkey and murine brain. Eur J Neurosci. 1996;8:666-676.
153. Marti HH, Gassmann M, Wenger RH, et al. Detection of erythropoietin in human liquor: Intrinsic erythropoietin production in the brain. Kidney Int. 1997;51:416-418.
154. Golden PL, Maccagnan TJ, Pardridge WM. Human blood brain barrier leptin receptor: binding and endocytosis in isolated human brain microvessels. J Clin Invest. 1997;99:14-18.
155. Pardridge WM. Drug delivery to the brain. J Cereb Blood Flow Metab. 1997;17:713-731.
156. Newman MF, Kirchner JL, Phillips-Bute B, et al. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001;344:395-402.
157. van Dam FSAM, Schagen SB, Muller MJ, et al. Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: high-dose versus standard-dose chemotherapy. J Natl Cancer Inst. 1998;90:210-218.
158. Schagen SB, van Dam FSAM, Muller MJ, Boogerd W, Lindeboom J, Bruning PF. Cognitive deficits after postoperative adjuvant chemotherapy for breast carcinoma. Cancer. 1999;85:640-650.
159. Brezden CB, Phillips K-A, Abdolell M, Bunston T, Tannock IF. Cognitive function in breast cancer patients receiving adjuvant chemotherapy. J Clin Oncol. 2000;18:2695-2701.
160. Jacobsen PB, Thors CL, Cawley M, Ax E, Grendys EC. Relation of decline in hemoglobin to cognitive functioning and fatigue during chemotherapy treatment [abstract 1542]. Proc Am Soc Clin Oncol 2002;21:381a.
161. O'Shaughnessy J, Vukelja S, Savin M, et al. Effects of epoetin alfa on cognitive function, asthenia, and quality of life in women with breast cancer receiving adjuvant or neoadjuvant chemotherapy: analysis of 6-month follow-up data [abstract 550]. Breast Cancer Res Treat. 2002;76(suppl 1):S138.
162. Rodriguez RM, Corwin HL, Gettinger A, et al. Nutritional deficiencies and blunted erythropoietin response as causes of the anemia of critical illness. J Crit Care. 2001;16:36-41.
163. Corwin HL, Parsonnet KC, Gettinger A. RBC transfusion in the ICU: is there a reason? Chest. 1995;108:167-771.
164. Groeger JS, Guntupalli KK, Strosberg M, et al. Descriptive analysis of critical care units in the United States: patient characteristics and intensive care unit utilization. Crit Care Med. 1993;21:279-291.
165. Vincent JL. Anemia and blood transfusion in critically ill patients. JAMA, 2002;288:1499-1507.
166. Corwin HL, Abraham E, Fink MP, et al. Anemia and blood transfusion in the critically ill: current clinical practice in the US - the CRIT Study [abstract 5]. Crit Care Med. 2001;29(12, suppl):A2.
167. Hébert PC, Wells G, Tweeddale M, et al. Does transfusion practice affect mortality in critically ill patients? Am J Respir Crit Care Med. 1997;155:1618-1623.
168. Hébert PC, Wells G, Blajchman MA, et al, for The Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med. 1999;340:409-417.
169. Krafte-Jacobs B, Levetown ML, Bray GL, Ruttimann E, Pollack MM. Erythropoietin response to critical illness. Crit Care Med. 1994;22:821-826.
170. van Iperen CE, Gaillard CAJM, Kraaijenhagen RJ, et al. Response of erythropoiesis and iron metabolism to recombinant human erythropoietin in intensive care unit patients. Crit Care Med. 2000;28:2773-2778.
171. Corwin HL, Krantz SB. Anemia of the critically ill: "acute" anemia of chronic disease [editorial]. Crit Care Med. 2000;28:3098-3099.
172. Nelson AH, Fleisher LA, Rosenbaum SH. Relationship between postoperative anemia and cardiac morbidity in high-risk vascular patients in the intensive care unit. Crit Care Med. 1993;21:860-866.
173. Corwin HL, Gettinger A, Rodriguez RM, et al. Efficacy of recombinant human erythropoietin in the critically ill patient: a randomized, double-blind, placebo-controlled trial. Crit Care Med. 1999;27:2346-2350.
174. Corwin HL, Gettinger A, Pearl RG, et al, for the EPO Critical Care Trials Group. Efficacy of recombinant human erythropoietin in critically ill patients: a randomized controlled trial. JAMA. 2002;288:2827-2835.
175. Centers for Disease Control and Prevention. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR Recomm Rep. 1998;47(RR-19):1-39.
176. Bodenheimer HC Jr, Lindsay KL, Davis GL, Lewis JH, Thung SN, Seeff LB. Tolerance and efficacy of oral ribavirin treatment of chronic hepatitis C: a multicenter trial. Hepatology. 1997;26:473-477.
177. Davis GL, Esteban-Mur R, Rustgi V, et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. N Engl J Med. 1998;339:1493-1499.
178. McHutchison JG, Gordon SC, Schiff ER, et al, for the Hepatitis Interventional Therapy Group. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med. 1998;339:1485-1492.
179. Rebetron prescribing information. Kenilworth, NJ: Schering Corp; May 1999.
180. Rendo P, Rosso A, Gómez F, et al. Anemia in patients with chronic hepatitis C treated with ribavirin and interferon [abstract C181]. Antivir Ther. 2000;5(suppl 1):C96.
181. De Franchesci L, Fattovich G, Turrini F, et al. Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection: role of membrane oxidative damage. Hepatology. 2000;31:997-1004.
182. Weisz KB, Braun JF, Dieterich DT, et al, and the Hepatitis Resource Network. Erythropoietin use for ribavirin/interferon-induced anemia in hepatitis C patients [abstract]. In: Proceedings of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 24-27, 1998; San Diego, Calif. Abstract H-156
183. Dieterich D, Weisz K, Goldman D, Talal A, Malicdem L, Markatou M. Interferon (IFN) and ribavirin (RBV) therapy for hepatitis C (HCV) in HIV-coinfected patients [abstract]. In: Proceedings of the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 26-29, 1999; San Francisco, Calif. Abstract H-105.
184. Chen J-Y, Wu T-X, Chanlai S-P. Recombinant human erythropoietin in the treatment of anemia of prematurity. Am J Perinatol. 1995;12:314-318.
185. Meyer MP, Meyer JH, Commerford A, et al. Recombinant human erythropoietin in the treatment of the anemia of prematurity: results of a double-blind, placebo-controlled study. Pediatrics. 1994;93:918-923.
186. Shannon KM, Keith JF III, Mentzer WC, et al. Recombinant human erythropoietin stimulates erythropoiesis and reduces erythrocyte transfusions in very low birth weight preterm infants. Pediatrics. 1995;95:1-8.
187. Soubasi V, Kremenopoulos G, Diamanti E, Tsantall C, Sarafidis K, Tsakiris D. Follow-up of very low birth weight infants after erythropoietin treatment to prevent anemia of prematurity. J Pediatr. 1995;127:291-297.
188. Campos A, Garin EH. Therapy of renal anemia in children and adolescents with recombinant human erythropoietin (rHuEPO). Clin Pediatr (Phila). 1992;31:94-99.
189. Montini G, Zacchello G, Baraldi E, et al. Benefits and risks of anemia correction with recombinant human erythropoietin in children maintained by hemodialysis. J Pediatr. 1990;117:556-560.
190. Offner G, Hoyer PF, Latta K, Winkler L, Brodehl J, Scigalla P. One year's experience with recombinant erythropoietin in children undergoing continuous ambulatory or cycling peritoneal dialysis. Pediatr Nephrol. 1990;4:498-500.
191. Müller-Wiefel DE, Scigalla P. Specific problems of renal anemia in childhood. Contrib Nephrol. 1988;66:71-84.
192. Procrit prescribing information [package insert]. Raritan, NJ: Ortho Biotech Products LP; December 2000.
193. Schärer K, Klare B, Braun A, Dressel P, Gretz N. Treatment of renal anemia by subcutaneous eryth-ropoietin in children with preterminal chronic renal failure. Acta Paediatr. 1993;82:953-958.
194. Mueller BU, Jacobsen F, Jarosinski P, Lewis LL, Pizzo PA. Erythropoietin for zidovudine-associated anemia in children with HIV infection. Pediatr AIDS HIV Infect Fetus Adolesc. 1994;5:169-173.
195. Zuccotti GV, Plebani A, Biasucci G, et al. Granulocyte-colony stimulating factor and erythropoietin therapy in children with human immunddeficiency virus infection. J Int Med Res. 1996;24:115-121.
196. Beck MN, Beck D. Recombinant erythropoietin in acute chemotherapy-induced anemia of children with cancer. Med Pediatr Oncol. 1995;25:17-21.
197. Bennetts G, Bertolone S, Bray G, Dinndorf P, Feusner J, Cairo M. Erythropoietin reduces volume of red cell transfusions required in some subsets of children with acute lymphocytic leukemia [abstract 3401]. Blood. 1995;86(10 suppl 1):853a.
198. Henze G, Michon J, Morland B, et al. Phase III randomized study: efficacy of epoetin alfa in reducing blood transfusions in newly diagnosed pediatric cancer patients receiving chemotherapy [abstract 1547]. Proc Am Soc Clin Oncol. 2002;21:387a.
199. Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002;346:469-475.
200. Casadevall N. Antibodies against rHuEPO: native and recombinant. Nephrol Dial Transplant. 2002;17(suppl 5):42-47.
201. Bunn HF. Drug-induced autoimmune red-cell aplasia. N Engl J Med. 2002;346:522-523.
202. Crémieux P-Y, Barrett B, Anderson K, Slavin MB. Cost of outpatient blood transfusion in cancer patients. J Clin Oncol. 2000;18:2755-2761.
203. Cantor SB, Hudson DV Jr, Lichtiger B, Rubenstein EB. Costs of blood transfusion: a process-flow analysis. J Clin Oncol. 1998;16:2364-2370.
204. Crémieux P-Y, Finkelstein SN, Berndt ER, Crawford J, Slavin MB. Cost effectiveness, quality-adjusted life-years and supportive care: recombinant human erythropoietin as a treatment of cancer-associated anaemia. Pharmacoeconomics. 1999;16(5 pt 1):459-472.
205. 2002 Red Book-Update. Vol 21. No. 2. Montvale, NJ: Thomson Healthcare; 2003.