The TREAT Trial was presented at the ASN in San Diego. This much publicized trial examined the role of Aranesp in the management of diabetic patients with CKD. One group was randomized to receive Aranesp with a hemoglobin target of 130 g/l while the control group was given placebo and treated with Aranesp only if their hemoglobin fell below 90 g/l.

There was no advantage to the group given Aranesp and a statistically significant increase in strokes observed in the the treatment group. Below is a link to the article from NEJM and the accompanying editorial written by renowned nephrologist, Dr. Phil Marsden of the University of Toronto.

It is worth noting, that the treatment group was targeted to a higher hemoglobin than we now conventionally use. Furthermore, the dose of Aranesp was more than double the typical dosages used by the majority of my predialysis patients. As has been observed in other studies where high hemoglobin seems harmful, the dose of Aranesp required might explain the observation of harm. Perhaps those patients who respond to lower dosages and those whose hemoglobins remain with target would be perfectly safe to continue.

No Statistically Significant Difference in Cardiovascular and Renal Composite Endpoints Between Aranesp and Placebo

THOUSAND OAKS, Calif., Aug. 25 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type-2 diabetes (the Trial to Reduce CardiovascularEndpoints with Aranesp((R)) Therapy, or TREAT), treatment of anemia with Aranesp((R) )(darbepoetin alfa) to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment. The two primary endpoints were a composite of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia) and a composite of time to all-cause mortality or chronic renal replacement therapy. Among the elements that formed these composite endpoints, an excess of stroke events (a labeled risk of Aranesp therapy) occurred in the Aranesp-treated patients compared to those receiving placebo.