Anemia in the News
ESAs Increased Stroke Risk for Patients with Diabetes and Kidney Disease
A recent article published in The New England Journal of Medicine concluded that the use of erythropoiesis-stimulating agents (ESAs) to treat patients with type 2 diabetes and chronic kidney disease did not reduce the risk of mortality, cardiovascular events or end stage renal disease, but did however result in an increased risk of stroke compared with placebo.
The TREAT study of 4,038 patients by Pfeffer et al was designed to compare the effect of darbepoetin alfa on death, cardiac events and end stage renal disease in patients with type 2 diabetes, chronic kidney disease (CKD) and moderate anemia who were not on dialysis. Data demonstrated that death or cardiac events occurred in 632 treatment patients versus 602 patients receiving placebo and death or end stage renal disease occurred in 652 and 618 patients, respectively.
Also revealed was a nearly two-fold increase in risk of stroke, a secondary outcome with fatal and non-fatal strokes being reported in 5.0% of patients receiving darbepoetin alfa and 2.6% of patients receiving placebo.
Conversely, patients on darbepoetin alfa received fewer red blood cell transfusions (297 versus 496) and exhibited modest improvement in patient-reported fatigue compared to patients on placebo.
In their discussion of these risks and benefits, the authors concluded 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 ESA.”
Patients receiving darbepoetin alfa in this study targeted a hemoglobin level of approximately 13.0 g/dL and achieved a median Hb level of 12.5 g/dL from 3 months to the end of the study. “Rescue” doses of darbepoetin alfa were also given to patients in the control group if their Hb level fell below 9.0 g/dL. Forty-six percent of the 2026 patients on placebo received at least one dose of darbepoetin alfa over the duration of the study. The starting median Hb level for all participants was 10.4 g/dL.
The study results were presented by the authors at the 2009 American Society of Nephrology meeting in San Diego and the study was funded by Amgen, the manufacturer of the darbepoetin alfa drug Aranesp. For more information about this study, view the original article on The New England Journal of Medicine’s website.