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Darbepoetin Alfa Associated with Heightened Stroke Risk
Darbepoetin alfa (Aranesp) is associated with increased risk for stroke in patients with diabetes and chronic kidney disease, according to an industry-sponsored study published online in the New England Journal of Medicine.
Researchers randomized some 4000 patients with type 2 diabetes, chronic kidney disease, and moderate anemia to darbepoetin alfa (hemoglobin goal of 13 g/dL) or placebo (rescue therapy initiated if hemoglobin fell below 9 g/dL). After a median follow-up of roughly 2.5 years, the groups did not differ in rates of the two primary composite outcomes (death or end-stage renal disease; death or a cardiovascular event). However, darbepoetin alfa recipients were more likely to experience a stroke (5.0%, vs. 2.6% with placebo).
The treatment group saw "a humble improvement at best" in fatigue scores, notes an editorialist.
The authors conclude that for many patients, the heightened risk for stroke "will outweigh any potential benefit" of an erythropoiesis-stimulating agent.
LINK(S):
NEJM article (Free)
NEJM editorial (Free)
Published in Physician's First Watch November 2, 2009
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