Joel Michels Topf1. 1. St. John Hospital and Medical Center, Chronic Kidney Disease Clinics, 22201 Moross Road, Suite 150, Detroit, Michigan 48236, USA. joel.topf@gmail.com
Abstract
BACKGROUND: For 20 years, anemia has been treated with erythropoietin-stimulating agents (ESA). Until recently there have been only two ESA: recombinant erythropoietin and darbepoetin. In 2007 a third agent was approved for clinical use, CERA. METHODS: This review covers all of the peer-reviewed literature regarding ESA. The review also covers unique aspects of the regulatory publications with the FDA and European Agency for the Evaluation of Medicinal Products. RESULTS: CERA is effective at correcting renal anemia. Compared to previous ESA, CERA has a dramatically lengthened half-life, making it the only ESA licensed for once-a-month dosing. However, like the previous ESA, CERA has not been shown to reduce morbidity or mortality and has only been shown to correct anemia and improve quality of life.
BACKGROUND: For 20 years, anemia has been treated with erythropoietin-stimulating agents (ESA). Until recently there have been only two ESA: recombinant erythropoietin and darbepoetin. In 2007 a third agent was approved for clinical use, CERA. METHODS: This review covers all of the peer-reviewed literature regarding ESA. The review also covers unique aspects of the regulatory publications with the FDA and European Agency for the Evaluation of Medicinal Products. RESULTS: CERA is effective at correcting renal anemia. Compared to previous ESA, CERA has a dramatically lengthened half-life, making it the only ESA licensed for once-a-month dosing. However, like the previous ESA, CERA has not been shown to reduce morbidity or mortality and has only been shown to correct anemia and improve quality of life.
Authors: Mauricette Michallet; Elisabeth Luporsi; Pierre Soubeyran; Nadia Ali Amar; Vincent Boulanger; Miguel Carreiro; Louis-Marie Dourthe; Jean-Luc Labourey; Daniel Lepille; Frédéric Maloisel; Jean-Loup Mouysset; Sophie Nahon; Bérengère Narciso; Pierre Nouyrigat; Raouf Radji; Nacéra Sakek; Hélène Albrand Journal: BMC Cancer Date: 2014-07-10 Impact factor: 4.430