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Volumn 8, Issue 5, 2013, Pages 389-399

A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: Background and methodology of the MONITOR-CKD5 study

Author keywords

Biosimilar; Erythropoietin; Haemodialysis; Pharmacoepidemiology; Renal anaemia

Indexed keywords

ANTIANEMIC AGENT; ERYTHROPOIETIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN;

EID: 84880421358     PISSN: 18280447     EISSN: 19709366     Source Type: Journal    
DOI: 10.1007/s11739-011-0622-7     Document Type: Article
Times cited : (8)

References (32)
  • 1
    • 28944451243 scopus 로고    scopus 로고
    • The epidemiology and control of anemia among pre-ESRD patients with chronic kidney disease
    • McClellan WM, Jurkovitz C, Abramson J (2005) The epidemiology and control of anemia among pre-ESRD patients with chronic kidney disease. Eur J Clin Invest 35(Suppl 3): 58-65.
    • (2005) Eur J Clin Invest , vol.35 , Issue.SUPPL. 3 , pp. 58-65
    • McClellan, W.M.1    Jurkovitz, C.2    Abramson, J.3
  • 2
    • 0034108227 scopus 로고    scopus 로고
    • Pathophysiology of renal anemia
    • Eckardt KU (2000) Pathophysiology of renal anemia. Clin Nephrol 53(Suppl): S2-S8.
    • (2000) Clin Nephrol , vol.53 , Issue.SUPPL.
    • Eckardt, K.U.1
  • 3
    • 0036176161 scopus 로고    scopus 로고
    • K/DOQI clinical practice guidelines for chronic kidney disease: Evaluation, classification, and stratification
    • (2002) K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis 39 (Suppl 1): S1-266.
    • (2002) Am J Kidney Dis , vol.39 , Issue.SUPPL. 1
  • 4
    • 0037166636 scopus 로고    scopus 로고
    • Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994)
    • Astor BC, Muntner P, Levin A, Eustace JA, Coresh J (2002) Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med 162: 1401-1408.
    • (2002) Arch Intern Med , vol.162 , pp. 1401-1408
    • Astor, B.C.1    Muntner, P.2    Levin, A.3    Eustace, J.A.4    Coresh, J.5
  • 5
    • 9144264827 scopus 로고    scopus 로고
    • Anemia in hemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS)
    • Locatelli F, Pisoni RL, Combe C et al (2004) Anemia in hemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 19: 121-132.
    • (2004) Nephrol Dial Transplant , vol.19 , pp. 121-132
    • Locatelli, F.1    Pisoni, R.L.2    Combe, C.3
  • 6
    • 31644443928 scopus 로고    scopus 로고
    • Optimal anemia management reduces cardiovascular morbidity, mortality, and costs in chronic kidney disease
    • Rao M, Pereira BJ (2005) Optimal anemia management reduces cardiovascular morbidity, mortality, and costs in chronic kidney disease. Kidney Int 68: 1432-1438.
    • (2005) Kidney Int , vol.68 , pp. 1432-1438
    • Rao, M.1    Pereira, B.J.2
  • 7
    • 34548046760 scopus 로고    scopus 로고
    • K/DOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of haemoglobin target
    • (2007) K/DOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of haemoglobin target. Am J Kidney Dis 50: 471-530.
    • (2007) Am J Kidney Dis , vol.50 , pp. 471-530
  • 8
    • 4344581912 scopus 로고    scopus 로고
    • Revised European best practice guidelines for the management of anemia in patients with chronic renal failure
    • Locatelli F, Aljama P, Barany P et al (2004) Revised European best practice guidelines for the management of anemia in patients with chronic renal failure. Nephrol Dial Transplant 19(Suppl 2): ii1-ii47.
    • (2004) Nephrol Dial Transplant , vol.19 , Issue.SUPPL. 2
    • Locatelli, F.1    Aljama, P.2    Barany, P.3
  • 9
    • 58649094413 scopus 로고    scopus 로고
    • Anemia management in patients with chronic kidney disease: a position statement by the Anemia Working Group of European Renal Best Practice (ERBP)
    • Locatelli F, Covic A, Eckardt KU, Wiecek A, Vanholder R (2009) Anemia management in patients with chronic kidney disease: a position statement by the Anemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transplant 24: 348-354.
    • (2009) Nephrol Dial Transplant , vol.24 , pp. 348-354
    • Locatelli, F.1    Covic, A.2    Eckardt, K.U.3    Wiecek, A.4    Vanholder, R.5
  • 10
    • 0033810113 scopus 로고    scopus 로고
    • European Best Practice Guidelines 5: target haemoglobin
    • Jacobs C, Hörl WH, Macdougall IC et al (2000) European Best Practice Guidelines 5: target haemoglobin. Nephrol Dial Transplant 15(Suppl 4): 15-19.
    • (2000) Nephrol Dial Transplant , vol.15 , Issue.SUPPL. 4 , pp. 15-19
    • Jacobs, C.1    Hörl, W.H.2    Macdougall, I.C.3
  • 11
    • 19044397278 scopus 로고    scopus 로고
    • Results of the European Survey on Anemia Management 2003 (ESAM 2003): current status of anemia management in dialysis patients, factors affecting epoetin dosage and changes in anemia management over the last 5 years
    • Jacobs C, Frei D, Perkins AC (2005) Results of the European Survey on Anemia Management 2003 (ESAM 2003): current status of anemia management in dialysis patients, factors affecting epoetin dosage and changes in anemia management over the last 5 years. Nephrol Dial Transplant 20(Suppl 3): iii3-iii24.
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 3
    • Jacobs, C.1    Frei, D.2    Perkins, A.C.3
  • 12
    • 3042772186 scopus 로고    scopus 로고
    • Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS)
    • Pisoni RL, Bragg-Gresham JL, Young EW et al (2004) Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis 44: 94-111.
    • (2004) Am J Kidney Dis , vol.44 , pp. 94-111
    • Pisoni, R.L.1    Bragg-Gresham, J.L.2    Young, E.W.3
  • 13
    • 19044370225 scopus 로고    scopus 로고
    • Optimal treatment of renal anemia (OPTA): improving the efficacy and efficiency of renal anemia therapy in hemodialysis patients receiving intravenous epoetin
    • Hörl WH, Vanrenterghem Y, Canaud B et al (2005) Optimal treatment of renal anemia (OPTA): improving the efficacy and efficiency of renal anemia therapy in hemodialysis patients receiving intravenous epoetin. Nephrol Dial Transplant 20(Suppl 3): iii25-iii32.
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 3
    • Hörl, W.H.1    Vanrenterghem, Y.2    Canaud, B.3
  • 14
    • 34548402981 scopus 로고    scopus 로고
    • Improving outcomes for dialysis patients in the international Dialysis Outcomes and Practice Patterns Study
    • Port FK, Pisoni RL, Bommer J et al (2006) Improving outcomes for dialysis patients in the international Dialysis Outcomes and Practice Patterns Study. Clin J Am Soc Nephrol 1: 246-255.
    • (2006) Clin J Am Soc Nephrol , vol.1 , pp. 246-255
    • Port, F.K.1    Pisoni, R.L.2    Bommer, J.3
  • 15
    • 0942268185 scopus 로고    scopus 로고
    • DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States
    • Port FK, Pisoni RL, Bragg-Gresham JL et al (2004) DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif 22: 175-180.
    • (2004) Blood Purif , vol.22 , pp. 175-180
    • Port, F.K.1    Pisoni, R.L.2    Bragg-Gresham, J.L.3
  • 17
    • 21044442354 scopus 로고    scopus 로고
    • Mineral metabolism and hemoglobin concentration among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS)
    • Kimata N, Akiba T, Pisoni RL et al (2005) Mineral metabolism and hemoglobin concentration among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 20: 927-935.
    • (2005) Nephrol Dial Transplant , vol.20 , pp. 927-935
    • Kimata, N.1    Akiba, T.2    Pisoni, R.L.3
  • 18
    • 9144256041 scopus 로고    scopus 로고
    • Mortality and hospitalization in hemodialysis patients in five European countries: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS)
    • Rayner HC, Pisoni RL, Bommer J et al (2004) Mortality and hospitalization in hemodialysis patients in five European countries: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 19: 108-120.
    • (2004) Nephrol Dial Transplant , vol.19 , pp. 108-120
    • Rayner, H.C.1    Pisoni, R.L.2    Bommer, J.3
  • 19
    • 29244456140 scopus 로고    scopus 로고
    • Evidence-based systematic literature review of hemoglobin/hematocrit and all-cause mortality in dialysis patients
    • Volkova N, Arab L (2006) Evidence-based systematic literature review of hemoglobin/hematocrit and all-cause mortality in dialysis patients. Am J Kidney Dis 47: 24-36.
    • (2006) Am J Kidney Dis , vol.47 , pp. 24-36
    • Volkova, N.1    Arab, L.2
  • 20
    • 51149089765 scopus 로고    scopus 로고
    • Analyzing change: a primer on multilevel models with applications to nephrology
    • Holden JE, Kelley K, Agarwal R (2008) Analyzing change: a primer on multilevel models with applications to nephrology. Am J Nephrol 28: 792-801.
    • (2008) Am J Nephrol , vol.28 , pp. 792-801
    • Holden, J.E.1    Kelley, K.2    Agarwal, R.3
  • 22
    • 55249120005 scopus 로고    scopus 로고
    • Clinical practice guidelines for anemia in chronic kidney disease: problems and solutions. A position statement from kidney disease: improving global outcomes (KDIGO)
    • Locatelli F, Nissenson AR, Barrett BJ et al (2008) Clinical practice guidelines for anemia in chronic kidney disease: problems and solutions. A position statement from kidney disease: improving global outcomes (KDIGO). Kidney Int 74: 1237-1240.
    • (2008) Kidney Int , vol.74 , pp. 1237-1240
    • Locatelli, F.1    Nissenson, A.R.2    Barrett, B.J.3
  • 23
    • 70949108082 scopus 로고    scopus 로고
    • A trial of darbepoetin-alfa in type 2 diabetes and chronic kidney disease
    • Pfeffer M, Burdmann EA, Cooper DE et al (2009) A trial of darbepoetin-alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 361: 1-14.
    • (2009) N Engl J Med , vol.361 , pp. 1-14
    • Pfeffer, M.1    Burdmann, E.A.2    Cooper, D.E.3
  • 24
    • 75149198323 scopus 로고    scopus 로고
    • Does TREAT give the boot to ESAs in the treatment of CKD anemia
    • Singh AK (2009) Does TREAT give the boot to ESAs in the treatment of CKD anemia. J Am Soc Nephrol 21: 2-6.
    • (2009) J Am Soc Nephrol , vol.21 , pp. 2-6
    • Singh, A.K.1
  • 25
    • 77952305393 scopus 로고    scopus 로고
    • Time to reconsider evidence for anaemia treatment (TREAT) = essential safety arguments (ESA)
    • Goldsmith D, Covic A (2010) Time to reconsider evidence for anaemia treatment (TREAT) = essential safety arguments (ESA). Nephrol Dial Transplant 25: 1734-1737.
    • (2010) Nephrol Dial Transplant , vol.25 , pp. 1734-1737
    • Goldsmith, D.1    Covic, A.2
  • 26
    • 12844279975 scopus 로고    scopus 로고
    • The promises and pitfalls of evidence-based medicine
    • Timmermans S, Mauck A (2005) The promises and pitfalls of evidence-based medicine. Health Aff 24: 18-28.
    • (2005) Health Aff , vol.24 , pp. 18-28
    • Timmermans, S.1    Mauck, A.2
  • 27
    • 67650067226 scopus 로고    scopus 로고
    • Bioequivalence of HX575 (IV) (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple subcutaneous administrations: an open-label randomised controlled trial
    • Sörgel F, Thyroff-Friesinger U, Vetter A et al (2009) Bioequivalence of HX575 (IV) (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple subcutaneous administrations: an open-label randomised controlled trial. BMC Clin Pharmacol 9: 10.
    • (2009) BMC Clin Pharmacol , vol.9 , pp. 10
    • Sörgel, F.1    Thyroff-Friesinger, U.2    Vetter, A.3
  • 28
    • 67649967626 scopus 로고    scopus 로고
    • Bioequivalence of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administration
    • Sörgel F, Thyroff-Friesinger U, Vetter A et al (2009) Bioequivalence of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administration. Int J Clin Pharmacol Ther 6: 391-401.
    • (2009) Int J Clin Pharmacol Ther , vol.6 , pp. 391-401
    • Sörgel, F.1    Thyroff-Friesinger, U.2    Vetter, A.3
  • 29
    • 70049109465 scopus 로고    scopus 로고
    • Binocrit: assessment of quality, safety, and efficacy of biopharmaceuticals
    • Brockmeyer C, Seidl A (2009) Binocrit: assessment of quality, safety, and efficacy of biopharmaceuticals. Eur J Hosp Pharm Pract 15: 34-40.
    • (2009) Eur J Hosp Pharm Pract , vol.15 , pp. 34-40
    • Brockmeyer, C.1    Seidl, A.2
  • 30
    • 70350776252 scopus 로고    scopus 로고
    • Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
    • Haag-Weber M, Vetter A, Thyroff-Friesinger U et al (2009) Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 72: 380-390.
    • (2009) Clin Nephrol , vol.72 , pp. 380-390
    • Haag-Weber, M.1    Vetter, A.2    Thyroff-Friesinger, U.3
  • 31
    • 0023186839 scopus 로고
    • Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners
    • Geller NL, Pocock SJ (1987) Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners. Biometrics 43: 213-223.
    • (1987) Biometrics , vol.43 , pp. 213-223
    • Geller, N.L.1    Pocock, S.J.2
  • 32
    • 18744406319 scopus 로고    scopus 로고
    • Multiplicity in randomised trials II: subgroup and interim analyses
    • Schulz KF, Grimes DA (2005) Multiplicity in randomised trials II: subgroup and interim analyses. Lancet 365: 1657-1661.
    • (2005) Lancet , vol.365 , pp. 1657-1661
    • Schulz, K.F.1    Grimes, D.A.2


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