Use in those with chronic kidney disease and anemia did not reduce mortality or renal disease
MONDAY, Nov. 2 (HealthDay News) -- In patients with diabetes, chronic kidney disease and anemia, darbepoetin alfa does not reduce death, cardiovascular or renal events, and may be linked to an increased risk of stroke, according to a study published online Oct. 30 in the New England Journal of Medicine.
Marc A. Pfeffer, M.D., of Brigham and Women's Hospital in Boston, and colleagues randomly assigned 2,012 patients with diabetes, chronic kidney disease and anemia to darbepoetin alfa to achieve a 13 g per deciliter hemoglobin level and 2,026 patients to placebo, with rescue darbepoetin alfa administered for hemoglobin levels below 9 g per deciliter.
The researchers found that death or a cardiovascular event occurred in 632 patients administered darbepoetin alfa and 602 patients on placebo (hazard ratio, 1.05), while death or end-stage renal disease occurred in 652 patients on darbepoetin alfa and 618 on placebo (hazard ratio, 1.06). Stroke occurred in 101 patients on darbepoetin alfa and 53 on placebo (hazard ratio, 1.92). In addition, the researchers observed only a modest improvement in patient-reported fatigue in the darbepoetin alfa group.
"It is our view that, in many patients with diabetes, chronic kidney disease, and moderate anemia who are not undergoing dialysis, the increased risk of stroke and possibly death among patients with a history of a malignant condition will outweigh any potential benefit of an erythropoiesis-stimulating agent," the authors conclude.
The study was supported by Amgen; several authors reported financial and consulting relationships with Amgen and other pharmaceutical companies.