OBJECTIVE: Anemia of chronic kidney disease (CKD) decreases patients' health-related quality of life (HRQoL). The objective of this subanalysis was to determine the effect of every-other-week (Q2W) darbepoetin alfa on hemoglobin (Hb) levels and HRQoL measures in subjects with CKD who are naïve to erythropoiesis-stimulating agents (ESAs). METHODS: STAAR was a 52-week, multicenter, single-arm study. Subject inclusion criteria included: > or = 18 years of age and creatinine clearance < or = 70 mL/min or estimated glomerular filtration rate < or = 60 mL/min/1.73 m(2) but not receiving dialysis. Subjects included in this subanalysis were previously naïve to ESAs, had Hb < 11 g/dL, were initiated on subcutaneous Q2W darbepoetin alfa to achieve a Hb level not to exceed 12 g/dL, and had responses to at least one question on the KDQOL-CRI forms administered at baseline, week 12, and week 52. RESULTS: Of 911 ESA-naïve subjects enrolled in the study, 277 (30.4%) were included in this subanalysis. The majority of subanalysis subjects were Caucasian (63.2%) and/or women (54.5%). Mean Hb concentrations and all KDQOL-CRI scores improved significantly between baseline and week 12 (p < 0.0001), and were maintained until week 52. Darbepoetin alfa was well tolerated. CONCLUSIONS: Darbepoetin alfa initiated Q2W achieved and maintained Hb targets, and significantly improved and maintained HRQoL in study subjects with CKD. Limitations of the study must be considered when extrapolating these results to assess the benefits of treatment on HRQoL in the general CKD population.
OBJECTIVE:Anemia of chronic kidney disease (CKD) decreases patients' health-related quality of life (HRQoL). The objective of this subanalysis was to determine the effect of every-other-week (Q2W) darbepoetin alfa on hemoglobin (Hb) levels and HRQoL measures in subjects with CKD who are naïve to erythropoiesis-stimulating agents (ESAs). METHODS: STAAR was a 52-week, multicenter, single-arm study. Subject inclusion criteria included: > or = 18 years of age and creatinine clearance < or = 70 mL/min or estimated glomerular filtration rate < or = 60 mL/min/1.73 m(2) but not receiving dialysis. Subjects included in this subanalysis were previously naïve to ESAs, had Hb < 11 g/dL, were initiated on subcutaneous Q2W darbepoetin alfa to achieve a Hb level not to exceed 12 g/dL, and had responses to at least one question on the KDQOL-CRI forms administered at baseline, week 12, and week 52. RESULTS: Of 911 ESA-naïve subjects enrolled in the study, 277 (30.4%) were included in this subanalysis. The majority of subanalysis subjects were Caucasian (63.2%) and/or women (54.5%). Mean Hb concentrations and all KDQOL-CRI scores improved significantly between baseline and week 12 (p < 0.0001), and were maintained until week 52. Darbepoetin alfa was well tolerated. CONCLUSIONS: Darbepoetin alfa initiated Q2W achieved and maintained Hb targets, and significantly improved and maintained HRQoL in study subjects with CKD. Limitations of the study must be considered when extrapolating these results to assess the benefits of treatment on HRQoL in the general CKD population.
Authors: Eldrin F Lewis; Marc A Pfeffer; Amy Feng; Hajime Uno; John J V McMurray; Robert Toto; Shravanthi R Gandra; Scott D Solomon; Moustafa Moustafa; Iain C Macdougall; Francesco Locatelli; Patrick S Parfrey Journal: Clin J Am Soc Nephrol Date: 2011-01-06 Impact factor: 8.237