September 15th, 2010

TREAT Analysis: Target Dosing Is Tricky

A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial – and was associated with an increase in the risk for stroke – in people with diabetes, chronic kidney disease, and moderate anemia.)

The new report, appearing in the New England Journal of Medicine, analyzes the responsiveness to treatment and achieved hemoglobin levels and finds that patients with a poor response to initial doses of darbepoetin alfa had higher rates of cardiovascular events and death when compared with good responders. The TREAT investigators write that “it is likely that a poor initial response to ESA treatment in this population represents a marker for severity of illness.”

In their conclusion, the TREAT investigators acknowledge that “we cannot determine whether a poor initial response to an ESA places patients at increased risk for these adverse outcomes or whether the risk was augmented by the higher doses of darbepoetin alfa they received. However, these findings raise the question of whether the degree of hematopoietic responsiveness to ESA treatment, and not just the target hemoglobin level, should be taken into account in ESA therapy.”

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