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Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE

Darbepoetin alfa einmal alle 2 Wochen hielt den Hämoglobin-Wert bei Dialysepatienten in einer Beobachtungsstudie stabil – die Österreichauswertung von ALTERNATE

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Summary

ALTERNATE is an international observational study evaluating biweekly darbepoetin alfa (DA) in adult dialysis patients in clinical practice. Austrian ALTERNATE results are presented here (n = 505). The follow-up study ALTERNATE follow-up (AFU) followed Austrian ALTERNATE patients for an additional 12 months (n = 135). Data were collected 6 months before and 12 months after conversion to biweekly dosing and during 12 months of follow-up. The primary measures were hemoglobin concentration 12 months after conversion and at the end of AFU, respectively. Mean (95 % CI) hemoglobin (g/dL) was 11.87 (11.75–11.99) at conversion, 11.71 (11.58–11.83) at month 12, and 11.66 (11.45–11.86) at end of AFU. Geometric mean (95 % CI) weekly dose (μg/wk) was 32.97 (30.80–35.30) at conversion, 29.90 (26.71–33.46) 12 months after conversion, and 24.38 (18.40–30.35) at end of AFU. The studies show that hemoglobin and dose could be effectively maintained over an extended period of time after conversion from higher frequency erythropoiesis-stimulating agents to biweekly DA.

Zusammenfassung

ALTERNATE ist eine internationale Beobachtungsstudie, welche die zweiwöchentliche Gabe von Darbepoetin alfa (DA) bei erwachsenen Dialysepatienten in der klinischen Praxis untersuchte. Die österreichische Auswertung wird hier vorgestellt (n = 505). Die Nachbeobachtungsstudie AFU, dokumentierte österreichische ALTERNATE Patienten über weitere 12 Monate (n = 135). Daten wurden sechs Monate vor und 12 Monate nach Umstellung auf das zweiwöchentliche Verabreichungsintervall, sowie innerhalb einer 12-monatigen Nachbeobachtung gesammelt. Die primären Messparameter waren die Hämoglobinwerte 12 Monate nach Umstellung und am Ende von AFU. Der mittlere Hämoglobinwert (95 % CI; g/dl) war 11,87 (11,75–11,99) bei Umstellung, 11,71 (11,58–11,83) zu Monat 12 und 11,66 (11,45–11,86) am Ende von AFU. Die geometrisch mittlere Wochendosis (95 % CI; µg/Woche) war 32,97 (30,80–35,30) bei Umstellung, 29,90 (26,71–33,46) 12 Monate nach Umstellung und 24,38 (18,40–30,35) am Ende von AFU. Die Studien zeigen, dass der Hämoglobinspiegel und die Dosis nach Umstellung von einem höherfrequenten erythropoese-stimulierenden Faktor auf zweiwöchentliches DA über eine längeren Zeitraum stabil gehalten werden konnten.

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References

  1. Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355(20):2085–98.

    Article  PubMed  CAS  Google Scholar 

  2. Drueke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006;355(20):2071–84.

    Article  PubMed  CAS  Google Scholar 

  3. Pfeffer MA, Burdmann EA, Chen CY, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009;361(21):2019–32.

    Article  PubMed  Google Scholar 

  4. Phrommintikul A, Haas SJ, 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):381–8.

    Article  PubMed  CAS  Google Scholar 

  5. Besarab A, Bolton WK, Browne JK, et al. 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. 1998;339(9):584–90.

    Article  PubMed  CAS  Google Scholar 

  6. Locatelli F, Covic A, Eckardt KU, Wiecek A, Vanholder R. Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transplant. 2009;24(2):348–54.

    Article  PubMed  Google Scholar 

  7. Burnier M, Douchamps JA, Tanghe A, et al. Less frequent dosing of erythropoiesis stimulating agents in patients undergoing dialysis: a European multicentre cost study. J Med Econ. 2009;12(2):77–86.

    Article  PubMed  Google Scholar 

  8. Wish JB. Anemia management under a bundled payment policy for dialysis: a preview for the United States from Japan. Kidney Int. 2011;79(3):265–7.

    Article  PubMed  Google Scholar 

  9. Hasegawa T, Bragg-Gresham JL, Pisoni RL, et al. Changes in anemia management and hemoglobin levels following revision of a bundling policy to incorporate recombinant human erythropoietin. Kidney Int. 2011;79(3):340–6.

    Article  PubMed  CAS  Google Scholar 

  10. Collins AJ, Brenner RM, Ofman JJ, et al. Epoetin alfa use in patients with ESRD: an analysis of recent US prescribing patterns and hemoglobin outcomes. Am J Kidney Dis. 2005;46(3):481–8.

    Article  PubMed  CAS  Google Scholar 

  11. Carrera F, Burnier M. Use of darbepoetin alfa in the treatment of anaemia of chronic kidney disease: clinical and pharmacoeconomic considerations. NDT Plus. 2009;2(Suppl 1):i9–17.

    Google Scholar 

  12. Ardèvol M, Fontseré N, Casals M, Bonal J. A feasibility cost-analysis study of recombinant human erythropoietin and darbepoetin alfa in ambulatory haemodialysis patients during current clinical practice. Eur J Hosp Pharm Sci. 2006;12(3):47–51.

    Google Scholar 

  13. Roger SD, Cooper B. What is the practical conversion dose when changing from epoetin alfa to darbepoetin outside of clinical trials? Nephrology (Carlton). 2004;9(4):223–8.

  14. Rottembourg JB, Bridges I, Pronai W, et al. An observational study of the effectiveness of darbepoetin alpha administered in dialysis patients once every 2 weeks for 12 months. Clin Nephrol. 2011;75(3):242–50.

    Article  PubMed  CAS  Google Scholar 

  15. European Medicines Agency. Aranesp (Darbepoetin alfa) Summary of Product Characteristics. Updated February 3, 2011. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000332/WC500026149.pdf. Accessed March 3 2011.

  16. Locatelli F, Aljama P, Barany P, et al. 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.

    Google Scholar 

  17. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. 2008. http://www.strobe-statement.org/index.php?id=strobe-home. Accessed . Accessed 8 April 2011.

  18. Bock HA, Hirt-Minkowski P, Brunisholz M, et al. Darbepoetin alpha in lower-than-equimolar doses maintains haemoglobin levels in stable haemodialysis patients converting from epoetin alpha/beta. Nephrol Dial Transplant. 2008;23(1):301–8.

    Article  PubMed  CAS  Google Scholar 

  19. Mann J, Kessler M, Villa G, et al. Darbepoetin alfa once every 2 weeks for treatment of anemia in dialysis patients: a combined analysis of eight multicenter trials. Clin Nephrol. 2007;67(3):140–8.

    Article  PubMed  CAS  Google Scholar 

  20. European MA. Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease. 2007. London. http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/11/WC500015604.pdf. Accessed February 25 2011.

  21. Watschinger B, Salmhofer H, Horn S, et al. The MAINTAIN study-managing hemoglobin variability with darbepoetin alfa in dialysis patients experiencing a severe drop in hemoglobin. Wien Klin Wochenschr. 2013;125(3–4):71–82.

    Google Scholar 

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Acknowledgements

The authors take final and full responsibility for the article and acknowledge that Iain Bridges of Amgen Ltd., Cambridge, UK, assisted in the statistical analysis of the ALTERNATE data and Helmut Erb of Clinical Trials Management GmbH, Vienna, Austria, assisted in the statistical analysis of AFU. The authors also thank the patients and center staff at each participating center.

Conflict of interest

Clemens Wieser declares that he received speaker’s honoraria from Amgen, Roche, Ratiopharm, and Fresenius medical group. Christine Jaeger declares that she is an employee of Amgen and holds Amgen stock. Margit Hemetsberger declares that she receives consulting fees from Amgen and holds Amgen stock. Wolfgang Pronai, Ulrich Neyer, Ursula Barnas, Daniel Dekic, and Alexander Rosenkranz declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Internal Medicine, Section of Nephrology, Dialysis Unit, Krankenhaus der Barmherzigen Brüder, Johannes von Gott Platz 1, 7001, Eisenstadt, Austria

    Wolfgang Pronai

  2. Department of Nephrology and Dialysis, Feldkirch Academic Teaching Hospital, Feldkirch, Austria

    Ulrich Neyer

  3. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria

    Ulrich Neyer

  4. 3. Med. Abteilung, SMZ-Ost Donauspital, Vienna, Austria

    Ursula Barnas

  5. First Medical Division, Landeskrankenhaus Klagenfurt, Klagenfurt, Austria

    Clemens Wieser

  6. Amgen Austria GmbH, Vienna, Austria

    Christine Jaeger

  7. Clinical Trials Management GmbH, Vienna, Austria

    Daniel Dekic

  8. Hemetsberger Medical Services, Vienna, Austria

    Margit Hemetsberger

  9. Department of Internal Medicine IV, Nephrology and Hypertension, Innsbruck Medical University, Innsbruck, Austria

    Alexander R. Rosenkranz

  10. Department of Internal Medicine, Clinical Division of Nephrology, Medical University of Graz, Graz, Austria

    Alexander R. Rosenkranz

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  1. Wolfgang Pronai
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  2. Ulrich Neyer
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  4. Clemens Wieser
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  5. Christine Jaeger
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Correspondence to Wolfgang Pronai.

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Pronai, W., Neyer, U., Barnas, U. et al. Darbepoetin alfa once every 2 weeks effectively maintained hemoglobin in dialysis patients in an observational study: Austrian cohort of ALTERNATE. Wien Med Wochenschr 164, 109–119 (2014). https://doi.org/10.1007/s10354-013-0256-7

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  • DOI: https://doi.org/10.1007/s10354-013-0256-7

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