However, researchers found an increased risk of stroke among those assigned to darbepoetin alfa compared to placebo.
The findings will be presented as a Late Breaking Clinical Trial at The Annual Scientific Meeting of The American Society of Nephrology in San Diego, California Friday, October 30, 2009 and will appear concurrently online in The New England Journal of Medicine.
TREAT, (Trial to Reduce cardiovascular Events with Aranesp Therapy) launched in 2004, was a randomized, double-blind placebo-controlled trial of 4038 patients with type 2 diabetes, chronic kidney disease and anemia. It is the largest trial to date to examine the use of erythropoiesis stimulating agents (ESAs), a class of drugs approved to raise hemoglobin levels, and the only study to compare morbidity and mortality outcomes against placebo.
“Chronic kidney disease can be associated with anemia and both of these factors greatly increase the risk of a patient with diabetes having premature adverse cardiovascular events and progressing to dialysis. We tested whether the treatment of anemia with Aranesp would reduce the dreaded complications of diabetes- heart failure, myocardial infarction, stroke, end-stage renal disease (dialysis) and death. Previous trials presumed benefits of ESAs without conducting the most fundamental test against placebo,” said Marc A. Pfeffer M.D., PhD lead investigator of TREAT and Senior Physician in cardiovascular medicine at BWH.
TREAT supplies new data from the most reliable assessment of the risks and benefits of ESA therapy and provides physicians and patients with more accurate information on which to base individual patient care decisions.
Pfeffer, who is also the Dzau Professor of Medicine at Harvard Medical School added,
“Although darbepoetin had some benefits in the patients we studied, it also had important risks. Raising hemoglobin did reduce the need for red cell transfusions and led to a statistically significant but rather modest improvement in a measure of fatigue in our patients with chronic kidney disease (not on dialysis) with moderate anemia. However, in my view, for many patients the increased risk of stroke that was uncovered and possibly deaths in those with prior malignancy outweigh the potential benefits of ESA use. The highest goal of a clinical trial is to provide data that improves clinical practice. TREAT meets this objective.”
The research was supported by and conducted in collaboration with Amgen.