Treatment of Anemia With Darbepoetin Alfa in Systolic Heart Failure
Does treatment with darbepoetin alfa improve clinical outcomes in patients with chronic systolic heart failure and anemia that is not due to iron deficiency?
The RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial was a randomized, multicenter, international, placebo-controlled, double-blind trial in which patients (n = 2,278) with New York Heart Association (NYHA) functional class II, III, or IV heart failure; a left ventricular ejection fraction of 40% or less; and a hemoglobin of 9.0-12.0 g/dl were assigned to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g/dl) or placebo. The primary outcome was a composite of death from any cause or hospitalization for worsening heart failure.
The primary outcome occurred in 576 of 1,136 patients (50.7%) in the darbepoetin alfa group and 565 of 1,142 patients (49.5%) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0.90-1.13; p = 0.87). Fatal or nonfatal stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the placebo group (p = 0.23). Embolic and thrombotic adverse events were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 (10.0%) in the placebo group (p = 0.01).
The authors concluded that use of darbepoetin alfa for the correction of mild-to-moderate anemia in patients with systolic heart failure and who were iron replete at baseline did not reduce the rate of death or hospitalization.
The results of RED-HF do not support the use of darbepoetin alfa in patients with systolic heart failure and mild-to-moderate anemia. Treatment with darbepoetin alfa did not improve clinical outcomes and also came at the expense of a significant increase in the risk of thromboembolic events.
Keywords: Iron, Heart Diseases, Erythropoietin, Stroke, Hemoglobins, Pyridinolcarbamate, Chronic Disease, Stroke Volume, Confidence Intervals, New York, Heart Failure, Systolic
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