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What is the target HB for patients with CKD receiving ESA therapy?
After considering the results of several RCTs of higher versus lower Hb targets in patients with Chronic kidney disease receiving ESA therapy, the Food and Drug Administration (FDA) changed the product information for epoetin and darbepoetin in 2011.
In these RCTs patients experienced greater risks for death, major adverse cardiovascular events, and stroke when administered ESAs to target Hb level >11 g/dL (per the FDA; see the next section).
No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks.
Therefore it is recommended that the lowest ESA dose be used that is sufficient to reduce the need for RBC transfusions.
What is the evidence on which the FDA based its recommendations regarding target HB level?
The Normal Hematocrit Cardiovascular Trial, published in 1998, demonstrated a tendency toward more cardiovascular events among patients undergoing HD and receiving epoetin who were randomized to a target hematocrit to 42% versus 30%.
Retrospective analyses of these studies suggest that the risk of adverse outcomes is correlated with the ESA dose received, rather than the Hb level achieved. A patient who achieves an Hb of 13 g/dL using a low dose of ESA is at lower risk than a patient who requires a large dose of ESA to increase the Hb level from 9 to 11 g/dL.
It should be noted that the target Hb level in the high Hb arm of all the principal trials was at least 13 g/dL, and the FDA’s statement that the risk for adverse outcomes occurred when ESAs were administered to a target Hb >11 g/dL is a very cautious, non-evidence-based interpretation of the studies’ results.
