title: Once-weekly epoetin alfa for treating the anemia of chronic kidney disease.
abstract: OBJECTIVE
  Anemia occurs in approximately 47% of patients with chronic kidney disease (CKD) not on dialysis. Recombinant human erythropoietin (r-HuEPO, epoetin alfa) has been proven safe and effective for anemia treatment in patients with CKD using a three times-weekly regimen. The current study was conducted to evaluate the clinical safety and efficacy of a less frequent dosing regimen (once weekly) in this population.
  
  
  METHODS
  This prospective, multicenter, open-label, non-randomized study enrolled 1,557 adult anemic (hemoglobin (Hb) < or = 10 g/dl) CKD patients not on dialysis. Epoetin alfa 10,000 U was administered subcutaneously once weekly for 16 weeks. Titration to 20,000 U once weekly at week 5 was permitted if patients had an increase in Hb < 1 g/dl. Safety and efficacy were assessed by changes in health-related quality of life (Linear Analog Scale Assessment (LASA) and Kidney Disease Questionnaire (KDQ)), changes in hematologic parameters and transfusion utilization, and incidence and severity of adverse events.
  
  
  RESULTS
  1,338 patients were evaluable for efficacy. Mean Hb level increased from 9.1 g/dl at baseline to 11.6 g/dl at study completion (last observed value after baseline) (p < 0.0001). Overall, 89.8% of patients responded to once-weekly dosing, exhibiting an increase in Hb level of > or = 1 g/dl from baseline. The percentage of patients that required transfusion decreased from 11.1% (baseline) to 3.7% (during the study) (p < 0.0001). All quality-of-life parameters improved significantly from baseline (p < 0.0001). Mean LASA scores for energy, activity and overall quality of life increased from baseline to study completion by 27.9 mm (70.5%), 24.5 mm (57.0%) and 22.6 mm (47.4%), respectively. All 5 KDQ domains showed statistically significant improvements (p < 0.0001). Hb change was a strong predictor for all 5 KDQ domains and the overall score (p < 0.0001). Treatment with once-weekly epoetin alfa was well tolerated, similar to that reported with three times-weekly dosing.
  
  
  CONCLUSIONS
  Once-weekly epoetin alfa therapy is safe and effective for treating anemia in patients with CKD not on dialysis, and is associated with significant improvements in functional status and quality of life.
authors.affiliation: Department of Nephrology, St. John Hospital and Medical Center, Detroit, Michigan 48236, USA. provenzano@earthlink.net
authors.forename: R
authors.initials: R
authors.lastname: Provenzano
authors.forename: L
authors.initials: L
authors.lastname: Garcia-Mayol
authors.forename: P
authors.initials: P
authors.lastname: Suchinda
authors.forename: B
authors.initials: B
authors.lastname: Von Hartitzsch
authors.forename: S B
authors.initials: SB
authors.lastname: Woollen
authors.forename: R
authors.initials: R
authors.lastname: Zabaneh
authors.forename: J C
authors.initials: JC
authors.lastname: Fink
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D001803:Blood Transfusion / Q000706:statistics & numerical data; D002908:Chronic Disease; D015897:Comorbidity; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006454:Hemoglobins / Q000187:drug effects; D006801:Humans; D007674:Kidney Diseases / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa