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Treatment of Anemia With Darbepoetin Alfa in Systolic Heart Failure
Study Questions:
Does treatment with darbepoetin alfa improve clinical outcomes in patients with chronic systolic heart failure and anemia that is not due to iron deficiency?
Methods:
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.
Results:
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).
Conclusions:
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.
Perspective:
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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