Are there implications from the Trial to Reduce Cardiovascular Events with Aranesp Therapy study for anemia management in dialysis patients?
OBJECTIVE
Publication of the first large randomized placebo-controlled study of erythropoiesis-stimulating agent (ESA) treatment of anemia in patients with chronic kidney disease (CKD) not on dialysis, the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) along with recent changes in the regulatory environment and reimbursement policies related to ESA treatment have prompted reexamination of clinical ESA use in patients with CKD, including those on dialysis. This review addresses this and other recent studies of ESA treatment for renal anemia to higher hemoglobin (Hgb) targets above the range of 10-12 g/dl.


RESULTS
TREAT and other recent large randomized, controlled trials of ESA treatment in patients with CKD have not demonstrated a clinical benefit in terms of mortality, morbidity, or quality of life improvement of targeting Hgb levels greater than 12-13 g/dl. Some of these studies have demonstrated increased risk of stroke, vascular access thrombosis, hypertension, and other events. These findings are generally consistent with those of an earlier study of patients with end-stage renal disease (ESRD) on hemodialysis.


CONCLUSIONS
ESA treatment for renal anemia should be aimed at reducing transfusion risk, with a treatment target in most patients of 10-12 g/dl; therapy should be individualized, rapid increases in Hgb level should probably be avoided, and lowest appropriate ESA doses should be used. Temptation to increase ESA doses to very high levels in an attempt to overcome ESA hypo responsiveness should be resisted.
Berns
Jeffrey S
JS
University of Pennsylvania School of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. bernsj@uphs.upenn.edu
D000740:Anemia / Q000097:blood / Q000188:drug therapy / Q000209:etiology; D001803:Blood Transfusion; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019317:Evidence-Based Medicine; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000628:therapy*; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa