November - 2 - 2009
New England Journal of Medicine (10/30/09) Pfeffer, Marc A.; Burdmann, Emmanuel A.; Chen, Chao-Yin
The use of darbepoetin alfa in patients with type 2 diabetes, chronic kidney disease, and moderate anemia does not reduce the risk of death or a cardiovascular event or of death or renal event, according to new research, and it may increase the risk of stroke. The study, conducted at 623 sites in 24 countries, involved more than 4,000 patients with type 2 diabetes, chronic kidney disease, and anemia who were not undergoing dialysis. The researchers assigned 2,012 patients to receive darbepoetin alfa to achieve a hemoglobin level of about 13 g per decileter, and 2,026 patients received a placebo. Primary end points of the study were death or a cardiovascular event, and death or end-stage renal disease. Death or a cardiovascular event occurred in 632 patients in the darbepoetin alfa group, and 602 in the placebo group. Death or end-stage renal disease occurred in 652 in the darbepoetin alfa group, and 618 in the placebo group. The authors note that fatal or nonfatal stroke occurred in 101 patients in the treatment group and 53 patients assigned to the placebo group.