Epoetin alfa was approved in 1989 by the Food and Drug Administration (FDA) for the treatment of anemia associated with chronic kidney disease “to elevate or maintain the red blood cell level and to decrease the need for transfusions.” Although epoetin alfa and darbepoetin alfa, a related erythropoiesis-stimulating agent (ESA) approved in 2001, have been widely accepted for this indication, optimal hemoglobin targets have never been established. A number of small studies conducted in the late 1980s supported the concept that higher hemoglobin concentrations are beneficial; the use of ESAs for anemia in patients with chronic kidney disease was purported to improve patients’ quality of life, cognitive function, energy, and well-being and to ameliorate left ventricular hypertrophy. Subsequently, randomized trials have endeavored to show that using ESAs to raise hemoglobin concentrations to higher targets improves clinical outcomes. Unfortunately and unexpectedly, all results have suggested the opposite.
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