Should we keep hemoglobin levels as a viable outcome measure?

Area of Science:

• Nephrology
• Hematology
• Pharmacology

Background:

• Anemia management in chronic kidney disease (CKD) often focuses on achieving target hemoglobin (Hb) levels.
• High doses of erythropoiesis-stimulating agents (ESAs) have been associated with increased risks in clinical trials.

Purpose of the Study:

• To advocate for a shift in focus from target Hb levels to ESA dose exposure in anemia management.
• To propose strategies for minimizing high ESA dose exposure in patients with CKD.
• To recommend revising the CMS QIP anemia measure to a target Hb >9 g/dL.

Main Methods:

• Review of evidence from Normal Hematocrit trials, TREAT, and CHOIR studies.
• Modeling the effect of proposed QIP changes on dialysis patient Hb concentrations.
• Identifying potential strategies to reduce high ESA dose exposure.

Main Results:

• Shifting focus to ESA dose exposure is a critical priority.
• Strategies like subcutaneous administration, managing ferritin, blood loss, infections, and using computerized protocols can minimize high ESA doses.
• Adjusting the CMS QIP anemia measure to a target Hb >9 g/dL is supported by existing evidence.

Conclusions:

• Minimizing high ESA dose exposure is essential for improving patient safety.
• Translational studies and clinical trials are needed to confirm the link between high ESA doses and adverse outcomes.
• Revising anemia quality measures is a necessary step in optimizing CKD anemia management.