Critical appraisal of randomized controlled trials of anemia correction in patients with renal failure.

Purpose of Review: Recent randomized controlled trials (RCTs) have reported risks and benefits in the correction of anemia using erythropoietin-stimulating agents (ESAs) in patients with predialysis chronic kidney disease (CKD) or end-stage renal disease. The purpose of this review is to critically appraise the RCTs most relevant to clinical decision-making.
Recent Findings: The Trial to Reduce cardiovascular Events with Aransep Therapy (TREAT) is the biggest and best designed RCT performed so far, enrolling 4038 diabetic patients with CKD in a double-blind, placebo-controlled trial. Comparing the high hemoglobin (Hb) darbopoietin group with placebo, it reported no difference in cardiac and renal outcomes, a significantly increased risk of stroke, and modest improvement in fatigue and transfusion rate. Meta-analysis demonstrated that correction of anemia with ESA was associated with a significantly increased risk of hypertension and vascular access clotting and an increased risk of death that approached statistical significance. Quality-of-life improvements appeared to maximize in the target Hb range of 10-12 g/dl.
Summary: Treatment of renal anemia using ESAs to target Hb higher than 13 g/dl is harmful. Treatment of Hb below 9 g/dl provides substantial transfusion and quality-of-life benefits, but safety is unknown. Target Hb levels of 10-12 g/dl seem reasonable, but increasing ESA doses in hyporesponsive patients to achieve a specific target is not.