title: Update on anemia management in nephrology, including current guidelines on the use of erythropoiesis-stimulating agents and implications of the introduction of "biosimilars".
abstract: Several million patients with chronic kidney disease (CKD) have benefited from the use of erythropoiesis-stimulating agents (ESAs) to correct severe anemia. However, mortality data now suggest that treating CKD patients to achieve a hemoglobin (Hb) level >13 g/dl can be harmful. For levels of 11.5-13 g/dl, there is no evidence of either harm or benefit compared with a lower Hb level. Quality of life studies are variable in quality but do suggest superior outcomes and functional status. In the 9 years following 1997, the target Hb level recommended by international guidelines tended to increase, especially for patients without accompanying cardiovascular disease. However, strangely enough, the most recent target level of the Kidney Disease Outcomes Quality Initiative is 11-12 g/dl, which is exactly the range advocated by the same group a decade earlier. The relative importance of quality of life compared with other outcomes, the use of iron, and the impact of venous thrombotic events continue to be debated. In addition, new issues have arisen from the introduction of "biosimilar" erythropoietins, biopharmaceuticals that refer to the existing agents and are submitted for marketing authorization after the existing agents' protection expires. Biosimilars can resemble the agents on which they are modeled but cannot fully copy their properties. The complexity in molecular structure, the possible presence of impurities (which may include bacterial endotoxins), and the inherent immunogenicity of such agents have required authorities to develop a sophisticated regulatory framework.
authors.affiliation: Department of Nephrology, Dialysis and Renal Transplantation, A. Manzoni Hospital, Lecco, Italy. f.locatelli@ospedale.lecco.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
authors.forename: Harald
authors.initials: H
authors.lastname: Becker
mesh_terms: D000740:Anemia / Q000188:drug therapy*; D004921:Erythropoietin / Q000627:therapeutic use*; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood* / Q000188:drug therapy / Q000628:therapy
chemical_list: D006397:Hematinics; D004921:Erythropoietin