title: A randomised single-blind study to improve health-related quality of life by treating anaemia of chronic kidney disease with Aranesp® (darbepoetin alfa) in older people: STIMULATE.
abstract: BACKGROUND
  The prevalence of chronic kidney disease (CKD) increases with age, and the risk of significant anaemia increases as renal function declines. The objectives of this study were to assess the effect of darbepoetin alfa administration on health-related quality of life (HRQOL) through treatment for anaemia in older patients with CKD.
  
  
  METHODS
  In this multicentre, randomised, placebo-controlled trial, older patients (aged ≥ 70 years) with CKD (Stages 3-5, predialysis) and haemoglobin (Hb) < 11.0 g/dL were randomised to darbepoetin alfa (n = 28) or placebo (n = 23). HRQOL was measured using a number of instruments including Short Form-36 (SF-36) and Functional Assessment of Cancer Therapy-Anaemia (FACT-An).
  
  
  RESULTS
  The primary endpoint, mean SF-36 Vitality Score at Week 24, was comparable between the darbepoetin alfa (51.4 [95 % CI 48.0, 54.9]) and placebo (46.7 [40.9, 52.5]) groups. Darbepoetin alfa-treated patients experienced statistically significant improvements in some SF-36 and FACT-An Subscale Scores. Mean Hb was higher with darbepoetin alfa (12.5 [12.1, 12.9] g/dL) than with placebo (10.5 [10.1, 11.0] g/dL). The safety profiles were comparable between the treatment groups. The study was limited by only 20 % of the planned patient recruitment being achieved.
  
  
  CONCLUSIONS
  Darbepoetin alfa increased Hb and, within study limitations, suggested that improvements in some HRQOL domains in older CKD patients with anaemia may be achieved with more physiological haemoglobin.
authors: Renal Research, 1/37 William St, Gosford, NSW, 2250, Australia, sdroger@bigpond.net.au.
authors: Simon D
authors: SD
authors: Roger
authors: Sarbjit V
authors: SV
authors: Jassal
authors: Michael C
authors: MC
authors: Woodward
authors: Steven
authors: S
authors: Soroka
authors: Lawrence P
authors: LP
authors: McMahon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D057239:Early Termination of Clinical Trials; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006304:Health Status; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D018579:Patient Selection; D011788:Quality of Life; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
chemical_list: D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa
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