The association of darbepoetin alfa with hemoglobin and health-related quality of life in patients with chronic kidney disease not receiving dialysis.
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.
Abu-Alfa
Ali K
AK
Yale School of Medicine, New Haven, CT 06520-8029, USA. ali.abu-alfa@yale.edu <ali.abu-alfa@yale.edu>
Sloan
Lance
L
Charytan
Chaim
C
Sekkarie
Mohamed
M
Scarlata
Debra
D
Globe
Denise
D
Audhya
Paul
P
D000368:Aged; D000740:Anemia / Q000097:blood* / Q000209:etiology; D003404:Creatinine / Q000097:blood; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000494:pharmacology; D005260:Female; D005919:Glomerular Filtration Rate; D006397:Hematinics / Q000494:pharmacology*; D006454:Hemoglobins / Q000187:drug effects*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood* / Q000150:complications / Q000503:physiopathology; D008297:Male; D011788:Quality of Life; D006435:Renal Dialysis
D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D003404:Creatinine