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Volumn 38, Issue 8, 2012, Pages 783-796

A review of safety, efficacy, and utilization of erythropoietin, darbepoetin, and peginesatide for patients with cancer or chronic kidney disease: A report from the southern network on adverse reactions (SONAR)

(14)  Bennett, Charles L a,b,c,d   Spiegel, David M e   MacDougall, Iain C f   Norris, Le Ann a,c   Qureshi, Zaina P a,b,c   Sartor, Oliver g   Lai, Stephen Y h   Tallman, Martin S i   Raisch, Dennis W j   Smith, Sheila Weiss k   Silver, Samuel l   Murday, Alanna S a,c   Armitage, James O m   Goldsmith, David n  


Author keywords

darbepoetin; epoetin; erythropoiesis stimulating agents; peginesatide

Indexed keywords

ANTINEOPLASTIC AGENT; ERYTHROPOIETIN; HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PEGINESATIDE; PLACEBO; RECOMBINANT ERYTHROPOIETIN;

EID: 84868567135     PISSN: 00946176     EISSN: 10989064     Source Type: Journal    
DOI: 10.1055/s-0032-1328884     Document Type: Review
Times cited : (33)

References (52)
  • 2
    • 70949108082 scopus 로고    scopus 로고
    • A trial of darbepoetin-alfa in type 2 diabetes and chronic kidney disease
    • Pfeffer M., Burdmann E. A., Cooper D. E., et al. A trial of darbepoetin-alfa in type 2 diabetes and chronic kidney disease. N Engl J Med: 2009; 361 1 14
    • (2009) N Engl J Med , vol.361 , pp. 1-14
    • Pfeffer, M.1    Burdmann, E.A.2    Cooper, D.E.3
  • 4
    • 0041976976 scopus 로고    scopus 로고
    • Breast cancer trial with erythropoietin terminated unexpectedly
    • DOI 10.1016/S1470-2045(03)01163-X
    • Leyland-Jones B. BEST Investigators and Study Group Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol: 2003; 4 8 459 460 (Pubitemid 37009952)
    • (2003) Lancet Oncology , vol.4 , Issue.8 , pp. 459-460
    • Leyland-Jones, B.1
  • 7
    • 84891931168 scopus 로고    scopus 로고
    • A systematic review and economic evaluation of epoetin alpha, epoetin beta and darbepoetin alpha in anaemia associated with cancer, especially that attributable to cancer treatment
    • iii-iv
    • Wilson J., Yao G. L., Raftery J., et al. A systematic review and economic evaluation of epoetin alpha, epoetin beta and darbepoetin alpha in anaemia associated with cancer, especially that attributable to cancer treatment. Health Technol Assess: 2007; 11 13 1 202, iii-iv
    • (2007) Health Technol Assess , vol.11 , Issue.13 , pp. 1-202
    • Wilson, J.1    Yao, G.L.2    Raftery, J.3
  • 8
    • 65449117261 scopus 로고    scopus 로고
    • Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: A meta-analysis of randomised trials
    • Bohlius J., Schmidlin K., Brillant C., et al. Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. Lancet: 2009; 373 9674 1532 1542
    • (2009) Lancet , vol.373 , Issue.9674 , pp. 1532-1542
    • Bohlius, J.1    Schmidlin, K.2    Brillant, C.3
  • 9
    • 75549086280 scopus 로고    scopus 로고
    • Erythropoiesis-stimulating agents in oncology: A study-level meta-analysis of survival and other safety outcomes
    • Glaspy J., Crawford J., Vansteenkiste J., et al. Erythropoiesis- stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. Br J Cancer: 2010; 102 2 301 315
    • (2010) Br J Cancer , vol.102 , Issue.2 , pp. 301-315
    • Glaspy, J.1    Crawford, J.2    Vansteenkiste, J.3
  • 10
    • 67049114157 scopus 로고    scopus 로고
    • Benefits and harms of erythropoiesis-stimulating agents for anemia related to cancer: A meta-analysis
    • Tonelli M., Hemmelgarn B., Reiman T., et al. Benefits and harms of erythropoiesis-stimulating agents for anemia related to cancer: a meta-analysis. CMAJ: 2009; 180 11 E62 -E71
    • (2009) CMAJ , vol.180 , Issue.11
    • Tonelli, M.1    Hemmelgarn, B.2    Reiman, T.3
  • 11
    • 84879995459 scopus 로고    scopus 로고
    • Amgen, Inc. Accessed May 2,: 2012
    • Epogen package insert. Amgen, Inc. 2007. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/label/2007/103234s5158ppi.pdf. Accessed May 2,: 2012
    • (2007) Epogen Package Insert
  • 12
    • 84879995570 scopus 로고    scopus 로고
    • Reassessment of the risks of erythropoiesis-stimulating agents (ESAs) administered for the treatment of anemia associated with chronic renal failure
    • September 11 FDA Advisory Committee Briefing Document Accessed May 2, 2012
    • FDA Advisory Committee Briefing Document Reassessment of the risks of erythropoiesis-stimulating agents (ESAs) administered for the treatment of anemia associated with chronic renal failure. Joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee. September 11, 2007. Available at: http://www.fda.gov/ ohrms/dockets/ac/07/briefing/2007-4315b1-01-FDA.pdf. Accessed May 2, 2012
    • (2007) Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee
  • 13
    • 37849003198 scopus 로고    scopus 로고
    • Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update
    • American Society of Clinical Oncology; American Society of Hematology
    • Rizzo J. D., Somerfield M. R., Hagerty K. L., et al. American Society of Clinical Oncology; American Society of Hematology Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. J Clin Oncol: 2008; 26 1 132 149
    • (2008) J Clin Oncol , vol.26 , Issue.1 , pp. 132-149
    • Rizzo, J.D.1    Somerfield, M.R.2    Hagerty, K.L.3
  • 14
    • 84879995545 scopus 로고    scopus 로고
    • Epoetin alfa and darbepoetin
    • Accessed May 2, 2012
    • Meeting Briefing Document ODAC Epoetin alfa and darbepoetin. 2008. Available at: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4345b2-05- amgen.pdf. Accessed May 2, 2012
    • (2008) Meeting Briefing Document ODAC
  • 15
    • 58249138127 scopus 로고    scopus 로고
    • Epogen F.D.A. Accessed May 2,: 2012
    • Epogen F. DA. (Epoetin alfa) For injection package insert. 2008. Available at: http://www.fda.gov/cder/foi/label/2008/103234s5195sPI.pdf. Accessed May 2,: 2012
    • (2008) (Epoetin Alfa) for Injection Package Insert
  • 16
    • 60349103553 scopus 로고    scopus 로고
    • Patient Medication Guide F. DA Accessed May 2, 2012
    • Patient Medication Guide F. DA. Epogen (Epoetin alfa). 2008. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/label/2008/ 103234s5195Medguide.pdf. Accessed May 2, 2012
    • (2008) Epogen (Epoetin Alfa)
  • 19
    • 78651434523 scopus 로고    scopus 로고
    • American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer
    • American Society of Clinical Oncology; American Society of Hematology
    • Rizzo J. D., Brouwers M., Hurley P., et al. American Society of Clinical Oncology; American Society of Hematology American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol: 2010; 28 33 4996 5010
    • (2010) J Clin Oncol , vol.28 , Issue.33 , pp. 4996-5010
    • Rizzo, J.D.1    Brouwers, M.2    Hurley, P.3
  • 21
    • 73349116562 scopus 로고    scopus 로고
    • Update on erythropoiesis-stimulating agents and clinical trials in oncology
    • Aapro M., Spivak J. L. Update on erythropoiesis-stimulating agents and clinical trials in oncology. Oncologist: 2009; 14 01 6 15
    • (2009) Oncologist , vol.14 , Issue.1 , pp. 6-15
    • Aapro, M.1    Spivak, J.L.2
  • 23
    • 84879995827 scopus 로고    scopus 로고
    • National Institute for Health and Clinical Excellence (NICE) London, UK National Institute for Health and Clinical Excellence (NICE) Accessed
    • National Institute for Health and Clinical Excellence (NICE) Technology Appraisal Guidance-Epoetin Alfa, Epoetin Beta, and Darboepoetin Alfa for Cancer Treatment Induced Anaemia. London, UK National Institute for Health and Clinical Excellence (NICE): 2008;. Available at: http://www.nice.org.uk/nicemedia/pdf/ TA142Guidance.pdf. Accessed
    • (2008) Technology Appraisal Guidance-Epoetin Alfa, Epoetin Beta, and Darboepoetin Alfa for Cancer Treatment Induced Anaemia
  • 28
    • 7444268479 scopus 로고    scopus 로고
    • Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients
    • DOI 10.1016/j.jclinepi.2004.05.002, PII S0895435604001398
    • Cotter D. J., Stefanik K., Zhang Y., Thamer M., Scharfstein D., Kaufman J. Hematocrit was not validated as a surrogate end point for survival among epoetin-treated hemodialysis patients. J Clin Epidemiol: 2004; 57 10 1086 1095 (Pubitemid 39446648)
    • (2004) Journal of Clinical Epidemiology , vol.57 , Issue.10 , pp. 1086-1095
    • Cotter, D.J.1    Stefanik, K.2    Zhang, Y.3    Thamer, M.4    Scharfstein, D.5    Kaufman, J.6
  • 29
    • 34548046760 scopus 로고    scopus 로고
    • KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 Update of Hemoglobin Target
    • KDOQI
    • KDOQI 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 3 471 530
    • (2007) Am J Kidney Dis , vol.50 , Issue.3 , pp. 471-530
  • 30
    • 33846669860 scopus 로고    scopus 로고
    • Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: A meta-analysis
    • DOI 10.1016/S0140-6736(07)60194-9, PII S0140673607601949
    • Phrommintikul A., Haas S. J., Elsik M., Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Lancet: 2007; 369 9559 381 388 (Pubitemid 46188479)
    • (2007) Lancet , vol.369 , Issue.9559 , pp. 381-388
    • Phrommintikul, A.1    Haas, S.J.2    Elsik, M.3    Krum, H.4
  • 31
    • 80052262012 scopus 로고    scopus 로고
    • High doses of epoetin do not lower mortality and cardiovascular risk among elderly hemodialysis patients with diabetes
    • Zhang Y., Thamer M., Kaufman J. S., Cotter D. J., Hernán M. A. High doses of epoetin do not lower mortality and cardiovascular risk among elderly hemodialysis patients with diabetes. Kidney Int: 2011; 80 6 663 669
    • (2011) Kidney Int , vol.80 , Issue.6 , pp. 663-669
    • Zhang, Y.1    Thamer, M.2    Kaufman, J.S.3    Cotter, D.J.4    Hernán, M.A.5
  • 32
    • 34548046760 scopus 로고    scopus 로고
    • KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target
    • KDOQI
    • KDOQI 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 3 471 530
    • (2007) Am J Kidney Dis , vol.50 , Issue.3 , pp. 471-530
  • 33
    • 84879995683 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research US FDA
    • US FDA Center for Drug Evaluation and Research. Cardiovascular and Renal Drugs Advisory Committee meeting. 2008. Available at: http://www.fda.gov/ohrms/ dockets/ac/08/transcripts/2008-4390t1-part1.PDF. Accessed May 2, 2012
    • (2008) Cardiovascular and Renal Drugs Advisory Committee Meeting
  • 34
    • 58249138127 scopus 로고    scopus 로고
    • Epogen F.D.A. November 19 Accessed May 2, 2012
    • Epogen F. DA. (Epoetin alfa) For injection package insert. November 19, 2008. Available at: http://www.fda.gov/cder/foi/label/2008/103234s5195sPI.pdf. Accessed May 2, 2012
    • (2008) (Epoetin Alfa) for Injection Package Insert
  • 35
    • 79751528864 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research US FDA Accessed May 2, 2012
    • US FDA Center for Drug Evaluation and Research. Cardiovascular and Renal Drugs Advisory Committee meeting. 2010. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/UCM238530.pdf. Accessed May 2, 2012
    • (2010) Cardiovascular and Renal Drugs Advisory Committee Meeting
  • 36
    • 84879995925 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research US FDA Accessed May 2, 2012
    • US FDA Center for Drug Evaluation and Research. Cardiovascular and Renal Drugs Advisory Committee meeting. 2011. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/UCM256586.pdf. Accessed May 2, 2012
    • (2011) Cardiovascular and Renal Drugs Advisory Committee Meeting
  • 37
    • 84879995840 scopus 로고    scopus 로고
    • Accessed May 2, 2012
    • Epogen package insert FDA. 2010. Available at: http://www.accessdata.fda. gov/drugsatfda-docs/label/2010/103234s5199lbl.pdf. Accessed May 2, 2012
    • (2010) Epogen Package Insert FDA
  • 38
    • 84879995678 scopus 로고    scopus 로고
    • June 24 Accessed May 2, 2012
    • Epogen/Procrit label. June 24, 2011. Available at: http://www.accessdata. fda.gov/drugsatfda-docs/label/2011/103234Orig1s5166-103234Orig1s5266lbl.pdf. Accessed May 2, 2012
    • (2011) Epogen/Procrit Label
  • 39
    • 77952118055 scopus 로고    scopus 로고
    • Abseamed (Epoetin alfa). October 12 Accessed April 4, 2012
    • EMA summary of product characteristics Abseamed (Epoetin alfa). October 12, 2009. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR-Procedural-steps-taken-and-scientific-information-after-authorisation/ human/000726/WC500028289.pdf. Accessed April 4, 2012
    • (2009) EMA Summary of Product Characteristics
  • 40
    • 77956255701 scopus 로고    scopus 로고
    • Target haemoglobin to aim for with erythropoiesis-stimulating agents: A position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study
    • Locatelli F., Aljama P., Canaud B., et al. Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study. Nephrol Dial Transplant: 2010; 25 9 2846 2850
    • (2010) Nephrol Dial Transplant , vol.25 , Issue.9 , pp. 2846-2850
    • Locatelli, F.1    Aljama, P.2    Canaud, B.3
  • 41
  • 42
    • 48649096158 scopus 로고    scopus 로고
    • Introduction to the Canadian Society of Nephrology clinical practice guidelines for the management of anemia associated with chronic kidney disease
    • Manns B. J., White C. T., Madore F., et al. Introduction to the Canadian Society of Nephrology clinical practice guidelines for the management of anemia associated with chronic kidney disease. Kidney Int Suppl: 2008; 110 S1 S3
    • (2008) Kidney Int Suppl , Issue.110
    • Manns, B.J.1    White, C.T.2    Madore, F.3
  • 44
    • 77950788570 scopus 로고    scopus 로고
    • Reassessments of ESAs for cancer treatment in the US and Europe
    • Bennett C. L., McKoy J. M., Henke M., et al. Reassessments of ESAs for cancer treatment in the US and Europe. Oncology (Williston Park): 2010; 24 3 260 268
    • (2010) Oncology (Williston Park) , vol.24 , Issue.3 , pp. 260-268
    • Bennett, C.L.1    McKoy, J.M.2    Henke, M.3
  • 45
    • 77954243266 scopus 로고    scopus 로고
    • International trends in erythropoietin use and hemoglobin levels in hemodialysis patients
    • McFarlane P. A., Pisoni R. L., Eichleay M. A., Wald R., Port F. K., Mendelssohn D. International trends in erythropoietin use and hemoglobin levels in hemodialysis patients. Kidney Int: 2010; 78 2 215 223
    • (2010) Kidney Int , vol.78 , Issue.2 , pp. 215-223
    • McFarlane, P.A.1    Pisoni, R.L.2    Eichleay, M.A.3    Wald, R.4    Port, F.K.5    Mendelssohn, D.6
  • 46
    • 79951647537 scopus 로고    scopus 로고
    • Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009
    • Regidor D., McClellan W. M., Kewalramani R., Sharma A., Bradbury B. D. Changes in erythropoiesis-stimulating agent (ESA) dosing and haemoglobin levels in US non-dialysis chronic kidney disease patients between 2005 and 2009. Nephrol Dial Transplant: 2011; 26 5 1583 1591
    • (2011) Nephrol Dial Transplant , vol.26 , Issue.5 , pp. 1583-1591
    • Regidor, D.1    McClellan, W.M.2    Kewalramani, R.3    Sharma, A.4    Bradbury, B.D.5
  • 47
    • 79960387136 scopus 로고    scopus 로고
    • Significant further evidence to bolster the link between epoetin and strokes in chronic kidney disease and cancer
    • Goldsmith D. J., Covic A. C. Significant further evidence to bolster the link between epoetin and strokes in chronic kidney disease and cancer. Kidney Int: 2011; 80 3 237 239
    • (2011) Kidney Int , vol.80 , Issue.3 , pp. 237-239
    • Goldsmith, D.J.1    Covic, A.C.2
  • 48
    • 77955722809 scopus 로고    scopus 로고
    • Meta-analysis: Erythropoiesis-stimulating agents in patients with chronic kidney disease
    • Palmer S. C., Navaneethan S. D., Craig J. C., et al. Meta-analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med: 2010; 153 1 23 33
    • (2010) Ann Intern Med , vol.153 , Issue.1 , pp. 23-33
    • Palmer, S.C.1    Navaneethan, S.D.2    Craig, J.C.3
  • 49
    • 84879995623 scopus 로고    scopus 로고
    • Medical Technology and Practice Patterns Institute (MTPPI) Accessed May 2, 2012
    • Medical Technology and Practice Patterns Institute (MTPPI) Citizen's petition. 2009. Available at: http://www.mtppi.org/new/FDA-2009-P-0426-0001.pdf. Accessed May 2, 2012
    • (2009) Citizen's Petition
  • 50
    • 84879995721 scopus 로고    scopus 로고
    • Cancer Care Ontario Accessed May 2, 2012
    • Cancer Care Ontario Epoetin alfa (Eprex) Janseen Ortho Formulary. Available at: http://www.cancercare.on.ca/search/default.aspx?q= formulary%20erythropoietin&type=0,6-76,6-40484|-1,1377-78. Accessed May 2, 2012
    • Epoetin Alfa (Eprex) Janseen Ortho Formulary
  • 51
    • 84879995784 scopus 로고    scopus 로고
    • EMA Accessed May 2, 2012
    • EMA Manufacturer's label. Annex II. 2007. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/ human/000726/WC500028282.pdf. Accessed May 2, 2012
    • (2007) Manufacturer's Label. Annex II
  • 52
    • 84879995623 scopus 로고    scopus 로고
    • Medical Technology and Practice Patterns Institute (MTPPI) Accessed May 2, 2012
    • Medical Technology and Practice Patterns Institute (MTPPI) Citizen's petition. 2009. Available at: http://www.mtppi.org/new/FDA-2009-P-0426-0001.pdf. Accessed May 2, 2012
    • (2009) Citizen's Petition


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