Darbepoetin alfa: a novel erythropoiesis-stimulating protein.
OBJECTIVE
To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of darbepoetin alfa.


METHODS
Pertinent references were identified by a MEDLINE search (1995-January 2001) of the medical literature, review of English-language literature and references of these articles, product information, and abstracts from professional meetings.


METHODS
Clinical efficacy data were gathered from all available trial data citing darbepoetin alfa. Additional information concerning pharmacology, pharmacokinetics, and safety was also reviewed.


RESULTS
Darbepoetin alfa is a new erythropoiesis-stimulating protein with a threefold longer half-life than recombinant human erythropoietin (r-HuEPO). Darbepoetin alfa is approved for intravenous and subcutaneous administration in patients requiring and not requiring dialysis. Clinical studies in patients with chronic kidney disease (CKD) have shown darbepoetin alfa to be equivalent to r-HuEPO in terms of increases in hemoglobin concentration, percentage of patients obtaining target hemoglobin, and average time to reach target hemoglobin concentration. Trials are currently ongoing in patients receiving cancer chemotherapy. The adverse event profile appears to be similar between the 2 agents.


CONCLUSIONS
The equivalent efficacy and safety profile, as well as the longer half-life, may make darbepoetin alfa an attractive alternative to r-HuEPO in patients with CKD. Since these patients need to receive r-HuEPO 1-3 times weekly at the expense of increased healthcare utilization to improve their hemoglobin, agents such as darbepoetin alfa, with longer durations of action, may reduce healthcare expenses. In addition, enhanced patient compliance may be realized with once-weekly or once every-other-week administration.
Joy
Melanie S
MS
School of Medicine, Division of Nephrology and Hypertension, University of North Carolina, CB #7155, 348 MacNider Bldg., Chapel Hill, NC 27599-7155, USA. Melanie_ Joy@med.unc.edu
D000328:Adult; D000740:Anemia / Q000188:drug therapy; D000818:Animals; D019540:Area Under Curve; D002648:Child; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006207:Half-Life; D006801:Humans; D007676:Kidney Failure, Chronic / Q000188:drug therapy / Q000378:metabolism*; D008297:Male; D008657:Metabolic Clearance Rate; D051379:Mice; D016032:Randomized Controlled Trials as Topic
D004921:Erythropoietin; D000068256:Darbepoetin alfa