4.6 Article

Darbepoetin Alfa Impact on Health Status in Diabetes Patients with Kidney Disease: A Randomized Trial

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AMER SOC NEPHROLOGY
DOI: 10.2215/CJN.06450710

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资金

  1. Amgen
  2. Robert Wood Johnson Foundation
  3. Abbott
  4. AstraZeneca
  5. Biogen
  6. Boehringer Ingelheim
  7. Boston Scientific
  8. Bristol-Myers Squibb
  9. Centocor
  10. CVRx
  11. Genentech
  12. Cytokinetics
  13. Daiichi Sankyo
  14. Genzyme
  15. Medtronic
  16. Novartis
  17. Roche
  18. Sanofi-Aventis
  19. Servier
  20. VIA Pharmaceutics
  21. Baxter
  22. Celladon
  23. Menarini
  24. Novocardia
  25. BioMerieux
  26. Solvay
  27. Takeda
  28. BMS Sanofi
  29. Vox Media
  30. BMS
  31. Hoffmann-La Roche
  32. Pfizer
  33. Scios
  34. GlaxoSmithKline
  35. Ortho biotech
  36. Affymax
  37. Hospira
  38. Sandoz

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Background and objectives Quality of life (QOL) is markedly impaired in patients with anemia, diabetes mellitus, and chronic kidney disease. Limited data exist regarding the effect of anemia treatment on patient perceptions. The objectives were to determine the longitudinal impact of anemia treatment on quality of life in patients with diabetes and chronic kidney disease and to determine the predictors of baseline and change in QOL. Design, setting, participants, & measurements In a large, double blind study, patients with type 2 diabetes mellitus, nondialysis chronic kidney disease (estimated CFR, 20 to 60 ml/min per 1.73 m(2)), and anemia (hemoglobin 10.4 g/dl) were randomized to darbepoetin alfa or placebo. QOL was measured with Functional Assessment of Cancer Therapy-Fatigue, Short Form-36, and EuroQol scores over 97 weeks. Results Patients randomized to darbepoetin alfa reported significant improvements compared with placebo patients in Functional Assessment of Cancer Therapy-Fatigue, and EuroQol scores visual analog scores, persisting through 97 weeks. No consistent differences in Short Form-36 were noted. Consistent predictors of worse change scores include lower activity level, older age, pulmonary disease, and duration of diabetes. Interim stroke had a substantial negative impact on fatigue and physical function. Conclusion Darbepoetin alfa confers a consistent, but small, improvement in fatigue and overall quality of life but not in other domains. These modest QOL benefits must be considered in the context of neutral overall effect and increased risk of stroke in a small proportion of patients. Patient's QOL and potential treatment risk should be considered in any treatment decision. Clin J Am Soc Nephrol 6: 845-855, 2011. doi: 10.2215/CJN.06450710

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