Methoxy polyethylene glycol-epoetin beta: Worth waiting for or a novelty worn off?

Expert Opinion on Pharmacotherapy

Volumn 10, Issue 9, 2009, Pages 1509-1514

  Schmidt, Rebecca J ^a  

^a WEST VIRGINIA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Anemia; Chronic kidney disease; Erythropoietin stimulating agents

Indexed keywords

CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; METHOXY POLYETHYLENE GLYCOL EPOETIN BETA; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ANEMIA; BLEEDING; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG RECEPTOR BINDING; DRUG SAFETY; GASTROINTESTINAL HEMORRHAGE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; REVIEW; RHINOPHARYNGITIS;

ANEMIA; ANIMALS; ERYTHROPOIETIN; ERYTHROPOIETIN, RECOMBINANT; HUMANS; KIDNEY DISEASES; KIDNEY FAILURE, CHRONIC; POLYETHYLENE GLYCOLS; TIME FACTORS;

EID: 67650685215     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656560902997982     Document Type: Review

References (41)

1. Mcclellan W, Aronoff SL, Bolton WK, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501-1510 (Pubitemid 39361354)
2. Hsu CY, Mcculloch CE, Curhan GC. Epidemiology of anemia associated with chronic renal insufficiency among adults in the United States: results from the Third National Health and Nutrition Examination Survey. J Am Soc Nephrol 2002;13:504-510 (Pubitemid 34106294)
3. Johnson CA, Levey AS, Coresh J, et al. Clinical practice guidelines for chronic kidney disease in adults: Part I. Definition, disease stages, evaluation, treatment, and risk factors. Am Fam Physician 2004;70:869-876
4. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006;47:S11-145
5. Fox CH, Brooks A, Zayas LE, etal. Primary care physicians' knowledge and practice patterns in the treatment of chronic kidney disease: an Upstate New York Practice-based Research Network (UNYNET) study. J Am Board Fam Med 2006;19:54-61 (Pubitemid 44046994)
6. Walker AM, Schneider G, Yeaw J, et al. Anemia as a predictor of cardiovascular events in patients with elevated serum creatinine. J Am Soc Nephrol 2006;17:2293-2298 (Pubitemid 44141920)
7. Levin A, Thompson CR, Ethier J, etal. Left ventricular mass index increase in early renal disease: impact of decline in hemoglobin. Am J Kidney Dis 1999;34:125-134 (Pubitemid 29318806)
8. Khan SS, Kazmi WH, Abichandani R, et al. Health care utilization among patients with chronic kidney disease. Kidney Int 2002;62:229-236 (Pubitemid 34754066)
9. Fink J, Blahut S, Reddy M, Light P. Use of erythropoietin before the initiation of dialysis and its impact on mortality. Am J Kidney Dis 2001;37:348-355 (Pubitemid 32116028)
10. Revicki DA, Brown RE, Feeny DH, et al. Health-related quality of life associated with recombinant human erythropoietin therapy for predialysis chronic renal disease patients. Am J Kidney Dis 1995;25:548-554
11. Clyne N, Jogestrand T. Effect of erythropoietin treatment on physical exercise capacity and on renal function in predialytic uremic patients. Nephron 1992;60:390-396
12. Lim VS, Degowin RL, Zavala D, et al. Recombinant human erythropoietin treatment in pre-dialysis patients. A double-blind placebo-controlled trial. Ann Intern Med 1989;110:108-114
13. Nurko S. Anemia in chronic kidney disease: causes, diagnosis, treatment. Cleve Clin J Med 2006;73:289-297
14. Drueke TB, Eckardt KU, Frei U, et al. Does early anemia correction prevent complications of chronic renal failure? Clin Nephrol;199951:1-11
15. Coresh J, Astor BC, Greene T, et al. Prevalence of chronic kidney disease and decreased kidney function in the adult US population: Third National Health and Nutrition Examination Survey. Am J Kidney Dis 2003;41:1-12 (Pubitemid 36043346)
16. Hsu CY, Vittinghoff E, Lin F, Shlipak MG. The incidence of end-stage renal disease is increasing faster than the prevalence of chronic renal insufficiency. Ann Intern Med 2004;141:95-101 (Pubitemid 38937830)
17. United States Renal Data System: Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,2003
18. United States Renal Data System: Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,2004
19. United States Renal Data System: Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,2006
20. Hunsicker LG. The consequences and costs of chronic kidney disease before ESRD. J Am Soc Nephrol 2004;15:1363-1364 (Pubitemid 38526022)
21. Schoolwerth AC, Engelgau MM, Hostetter TH, etal. Chronic kidney disease: a public health problem that needs a public health action plan. Prev Chronic Dis ;20063:A57
22. Astor BC, Muntner P, Levin A, et al. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med 2002;162:1401-1408
23. Eckardt KU, Mollmann M, Neumann R, et al. Erythropoietin in polycystic kidneys. J Clin Invest 1989;84:1160-1166
24. Pavlovic-Kentera V, Clemons GK, Djukanovic L, Biljanovic-paunovic L. Erythropoietin and anemia in chronic renal failure. Exp Hematol 1987;15:785-789 (Pubitemid 17151452)
25. United States Renal Data System: Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,2007
26. Locatelli F, Aljama P, Bárány P, et al. 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 2004;19(Suppl 2):ii1-47
27. Spinowitz B, Germain M, Benz R, et al. Epoetin Alfa Extended Dosing Study Group. A randomized study of extended dosing regimens for initiation of epoetin alfa treatment for anemia of chronic kidney disease. Clin J Am Soc Nephrol 2008;3(4):1015-1021
28. Jarsch M, Brandt M, Lanzendörfer M, Haselbeck A. Comparative erythropoietin receptor binding kinetics of C.E.R.A. and epoetin-β determined by surface plasmon resonance and competition binding assay. Pharmacology 2008;81:63-69 (Pubitemid 350124538)
29. Macdougall IC, Robson R, Opatrna S, et al. Pharmacokinetics and pharmacodynamics of intravenous and subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) in patients with Chronic Kidney Disease. Clin J Am Soc Nephrol 2006 1:1211-1215
30. Fishbane S, Pannier A, Liogier X, et al. Pharmacokinetic and pharmacodynamic properties of methoxy polyethylene glycol-epoetin beta are unaffected by the site of subcutaneous administration. J Clin Pharmacol 2007;47:1390-1397 (Pubitemid 47624598)
31. Macdougall IC. Novel erythropoiesis-stimulating agents: a new era in anemia management. Clin J Am Soc Nephrol;2008;3:200-207
32. Veng-Pedersen P, Freise KJ, Schmidt RL, Widness JA. Pharmacokinetic differentiation of drug candidates using system analysis and physiological-based modeling. Comparison of C.E.R.A. and erythropoietin. J Pharm Pharmacol 2008;60:1321-1334
33. Besarab A, Salifu MO, Lunde NM, et al. Ba16285 Study Investigators: Efficacy and tolerability of intravenous continuous erythropoietin receptor activator: a 19-week, phase II, multicenter, randomized, open-label, dose-finding study with a 12-month extension phase in patients with chronic renal disease. Clin Ther;200729(4):626-639
34. Klinger M, Arias M, Vargemezis V, et al. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis 2007;50(6):989-1000 (Pubitemid 350122810)
35. Spinowitz B, Coyne DW, Lok CE, et al. RUBRA Study Investigators: C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease on dialysis when administered once every two weeks. Am J Nephrol 2008;28(2):280-289
36. Macdougall IC, Walker R, Provenzano R, et al. ARCTOS Study Investigators: C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol 2008;3(2):337-347
37. Sulowicz W, Locatelli F, Ryckelynck JP, et al. PROTOS Study Investigators. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2007;2(4):637-646
38. Canaud B, Mingardi G, Braun J, et al. STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant 2008;23(11):3654-3661
39. European Medicines Association. Scientific discussion: MIRCERA (methoxy polyethylene glycol-epoetin beta). Available from: http://www.emea.europa.eu/ humandocs/PDFs/EPAR/mircera/H-7 39-en6.pdf [Accessed 14 March 2009]
40. European Medicines Association. Summary of product characteristics: MIRCERA (methoxy polyethylene glycol-epoetin beta). Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/mircera/H-7 39-PI-en.pdf [Accessed 14 March 2009]
41. Provenzano R, Bhaduri S, Singh AK. PROMPT Study Group. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study. Clin Nephrol 2005;64(2):113-123 (Pubitemid 41079007)