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Eisen- und ESA*-Therapie bei renaler Anämie

Iron and erythropoiesis-stimulating agent therapy for renal anemia

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Der Nephrologe Aims and scope

Zusammenfassung

Die Rahmenbedingungen der Behandlung mit Erythropoese-stimulierenden Substanzen (ESA) bei renaler Anämie haben sich innerhalb des letzten Jahres erheblich geändert. Die Ergebnisse der CREATE- und der CHOIR-Studie haben dazu geführt, dass Zulassungsbehörden und Fachgesellschaften den anzustrebenden Ziel-Hämoglobin-Bereich für Patienten mit chronischer Niereninsuffizienz (CKD) auf 11–12 g/dl reduziert haben, von einer Vollkorrektur der Anämie wird ausdrücklich abgeraten. Mit Zulassung der ersten „Biosimilars“ darf man gespannt sein, ob sie hinsichtlich Effektivität und Sicherheit mit Originalpräparaten vergleichbar sind, und ob es durch Zunahme der Anbieter zu einem relevanten Preisrückgang kommen wird. Bei der ESA-Therapie soll zukünftig mehr auf die Konstanz der erreichten Hämoglobinwerte geachtet werden, damit allzu große Hämoglobin-Schwankungen vermieden werden. Hyporesponder sollen nach Maßgabe der „Food and Drug Administration“ (FDA) keine ESA-Hochdosistherapie mehr erhalten, die ESA-Dosis ist in solchen Fällen gerade so hoch zu wählen, dass keine Transfusionen notwendig werden.

Abstract

Recently, the general framework of treatment with erythropoiesis-stimulating agents (ESA) for renal anemia has changed fundamentally. Results from the CREATE and CHOIR trials for chronic kidney disease (CKD) patients prompted the regulatory authorities to reduce target hemoglobin (Hb) levels to the 11–12 g/dl range for all patients with renal anemia and full correction is explicitly discouraged. The first biosimilar ESAs for the treatment of renal anemia have been approved in Europe, but it remains to be seen whether efficacy and safety will be as good as with the original preparations, and whether the cost of treatment will come down by increasing the number of suppliers. A new area of concern in ESA therapy is the stability of Hb levels, as it is feared that excessive fluctuations in Hb levels might be associated with an unfavorable outcome. According to the Food and Drug Administration (FDA), hyporesponsive patients rather than being treated with excessive ESA doses, should receive ESA doses which are just sufficient to avoid the necessity of transfusions.

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Literatur

  1. Hsu CY, McCulloch CE, Curhan GC (2002) 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 13: 504–510

    Article  PubMed  CAS  Google Scholar 

  2. Thomas MC, Tsalamandris C, MacIsaac RJ, Jerums G (2006) The epidemiology of hemoglobin levels in patients with type 2 diabetes. Am J Kidney Dis 48: 537–545

    Article  PubMed  CAS  Google Scholar 

  3. Winkelmayer WC, Kewalramani R, Rutstein M et al. (2004) Pharmacoepidemiology of anemia in kidney transplant recipients. J Am Soc Nephrol 15: 1347–1352

    Article  PubMed  Google Scholar 

  4. Caro J, Brown S, Miller O et al. (1979) Erythropoietin levels in uremic nephric and anephric patients. J Lab Clin Med 93: 449–458

    PubMed  CAS  Google Scholar 

  5. Koury MJ, Bondurant MC (1990) Erythropoietin retards DNA breakdown and prevents programmed death in erythroid progenitor cells. Science 248: 378–381

    Article  PubMed  CAS  Google Scholar 

  6. Eckardt KU, Kurtz A (2005) Regulation of erythropoietin production. Eur J Clin Invest (Suppl 3) 35: 13–19

    Article  Google Scholar 

  7. Oates PS, Ahmed U (2007) Molecular regulation of hepatic expression of iron regulatory hormone hepcidin. J Gastroenterol Hepatol 22: 1378–1387

    Article  PubMed  CAS  Google Scholar 

  8. Weiss G, Goodnough LT (2005) Anemia of chronic disease. N Engl J Med 352: 1011–1023

    Article  PubMed  CAS  Google Scholar 

  9. National Kidney Foundation (2006) K/DOQI clinical practice guidelines for anemia of chronic kidney disease. Am J Kidney Dis (Suppl 3) 47: S17–S130

    Google Scholar 

  10. (2004) Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant (Suppl 2) 19:

  11. Cavill I (2002) Erythropoiesis and iron. Best Pract Res Clin Haematol 15: 399–409

    PubMed  CAS  Google Scholar 

  12. Schaefer RM, Schaefer L (1999) Hypochromic red blood cells and reticulocytes. Kidney Int (Suppl 69) 55: S44–S48

    Google Scholar 

  13. Fishbane S, Shapiro W, Dutka P et al. (2001) A randomized trial of iron deficiency testing strategies in hemodialysis patients. Kidney Int 60: 2406–2411

    Article  PubMed  CAS  Google Scholar 

  14. Hoerl WH (2007) Clinical aspects of iron use in the anemia of kidney disease. J Am Soc Nephrol 18: 382–393

    Article  CAS  Google Scholar 

  15. Macdougall I, Eckardt KU (2006) Novel strategies for stimulating erythropoiesis and potential new treatments for anemia. Lancet 368: 947–953

    Article  PubMed  CAS  Google Scholar 

  16. 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

    Article  PubMed  Google Scholar 

  17. Besarab A, Bolton WK, Browne JK et al. (1998) 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: 584–590

    Article  PubMed  CAS  Google Scholar 

  18. Parfrey PS, Foley RN, Wittreich BH et al. (2005) Double-blind comparison of full and partial anemia correction in incident hemodialysis patients without symptomatic heart disease. J Am Soc Nephrol 16: 2180–2189

    Article  PubMed  Google Scholar 

  19. Drüeke TB, Locatelli F, Clyne N et al. (2006) Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 355: 2071–2084

    Article  PubMed  Google Scholar 

  20. Singh AK, Szczech L, Tang KL et al. (2006) Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 355: 2085–2098

    Article  PubMed  CAS  Google Scholar 

  21. www.kidney.org/news/newsroom/newsitem.cfm: National Kidney Foundation Anemia Guideline Update, New York, 30.08.2007

  22. www.fda.gov/cder/drug/InfoSheets/HCP/RHE200711HCP.htm, 08.11.2007

  23. Fishbane S, Berns JS (2005) Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Int 68: 1337–1343

    Article  PubMed  CAS  Google Scholar 

  24. Collins AJ, Brenner RM, Ofman JJ et al. (2005) Epoetin alfa use in patients with ESRD: an analysis of recent US prescribing patterns and hemoglobin outcomes. Am J Kidney Dis 46: 481–488

    Article  PubMed  CAS  Google Scholar 

  25. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J (2006) Update on adverse events associated with parenteral iron. Nephrol Dial Transplant 21: 378–383

    Article  PubMed  CAS  Google Scholar 

  26. Kosch M, Bahner U, Bettger H et al. (2001) A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer®) vs iron gluconate (Ferrlecit®) in haemodialysis patients treated with rHuEpo. Nephrol Dial Transplant 16: 1239–1244

    Article  PubMed  CAS  Google Scholar 

  27. Seifert A, Herrath D von, Schaefer K (1987) Iron overload, but not treatment with desferrioxamine, favours the development of septicemia in patients on maintenance hemodialysis. Q J Med 65: 1015–1024

    PubMed  CAS  Google Scholar 

  28. Kessler M, Hoen B, Mayeux D et al. (1993) Bacteremia in patients on chronic hemodialysis. Nephron 64: 95–100

    Article  PubMed  CAS  Google Scholar 

  29. Hoen B (1999) Iron and infection: clinical experience. Am J Kidney Dis (Suppl 4) 34: S30–S34

    Article  Google Scholar 

  30. High WA, Ayers RA, Cowper SE (2007) Gadolinium is quantifiable within the tissue of patients with nephrogenic systemic fibrosis. J Am Acad Dermatol 56: 710–712

    Article  PubMed  Google Scholar 

  31. Shellock FG, Kanal E (1999) Safety of magnetic resonance imaging contrast agents. J Magn Reson Imaging 10: 477–484

    Article  PubMed  CAS  Google Scholar 

  32. Mann JS (1993) Stability of gadolinium complexes in vitro and in vivo. J Comput Assist Tomogr (Suppl 1) 17: S19–S23

    Google Scholar 

  33. Swaminathan S, Horn TD, Pellowski D et al. (2007) Nephrogenic systemic fibrosis, gadolinium, and iron mobilization. N Engl J Med 357: 720–722

    Article  PubMed  CAS  Google Scholar 

  34. Marckmann P, Skov L, Rossen K et al. (2006) Nephrogenic systemic fibrosis: Suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol 17: 2359–2362

    Article  PubMed  Google Scholar 

  35. Idee JM, Port M, Raynal I et al. (2006) Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: A review. Fundam Clin Pharmacol 20: 563–576

    Article  PubMed  CAS  Google Scholar 

  36. Joffe P, Thomsen HS, Meusel M (1998) Pharmacokinetics of gadodiamide injection in patients with severe renal insufficiency and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis. Acad Radiol 5: 491–502

    Article  PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Medizinische Klinik und Poliklinik D, Universitätsklinikum Münster, Albert-Schweitzer-Str. 33, 48149, Münster, Deutschland

    R.M. Schaefer

  2. Institut für Allgemeine Pharmakologie und Toxikologie, Universitätsklinikum Frankfurt, Frankfurt, Deutschland

    L. Schaefer

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  1. R.M. Schaefer
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  2. L. Schaefer
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Correspondence to R.M. Schaefer.

Additional information

*ESA Erythopoese-stimulierende Substanzen.

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Schaefer, R., Schaefer, L. Eisen- und ESA*-Therapie bei renaler Anämie. Nephrologe 3, 88–95 (2008). https://doi.org/10.1007/s11560-008-0145-z

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