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Clinical question: Does darbepoetin alfa use in patients with diabetes and chronic kidney disease (CKD) who do not require dialysis decrease the risk of death and cardiovascular or renal events?

Background: Anemia is a risk factor for cardiovascular and renal outcomes. The use of erythropoiesis-stimulating agents (ESAs) to increase hemoglobin reduces the need for transfusions and moderately improves quality of life. A placebo-controlled trial to determine if correction of anemia with ESAs improves clinical outcomes has not been conducted.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: 623 sites in 24 countries.

Synopsis: The study team randomized 4,038 patients to receive either dose-adjusted darbepoetin alfa (goal hemoglobin of 13) or placebo, with rescue doses of darbepoetin for hemoglobin below 9g/dL. The primary endpoints were a composite outcome of death, a cardiovascular event and death, or end-stage renal disease.

The median hemoglobin achieved in the darbepoetin and placebo groups were 12.5g/dL and 10.6g/dL, respectively. The primary cardiovascular endpoint occurred in 31.4% of patients receiving darbepoetin and 29.7% of patients receiving placebo (HR 1.05; 95% CI, 0.94-1.17). The primary renal endpoint occurred in 32.4% of patients assigned to darbepoetin and 30.5% of patients assigned to placebo (HR 1.06; 95% CI 0.95-1.19). Significantly more patients assigned to darbepoetin experienced stroke and VTE, and significantly fewer patients required red-cell transfusions.

Bottom line: Darbepoetin use in patients with diabetes and CKD who do not require dialysis for correction of anemia does not improve clinical outcomes, and carries an increased risk of stroke and VTE.

Citation: Pfeffer MA, Burdmann EA, Chen CY, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009;361(21):2019-2032.

Reviewed for TH eWire Charles Baillie, MD, Elizabeth Marandola, MSN, ARNP, Janelle Ocampo, PharmD, BCPS, Craig A. Umscheid, MD, MSCE, Section of Hospital Medicine, Hospital of the University of Pennsylvania, Philadelphia.

For more HM-related research reviews, visit the "In the Literature" section of our Web site.

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