In 2006, two large, international, randomized trials comparing high-intensity to low-intensity treatment with epoetin alfa were published. Both trials demonstrated that low-intensity treatment—with goal serum hemoglobin values of 11.3 or 10.5 to 11.5 g/dL, respectively—was associated with improved outcomes in patients with anemia and nondialysis-dependent chronic kidney disease. Over the following 6 to 12 months, regulatory agencies, insurers, and hospital systems would react, sometimes dramatically, as further literature became available that caused a rethinking of the appropriate use of these valuable agents. This article will summarize the response to recent literature regarding the administration of erythropoietic stimulating agents.
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Wright JR, Ung YC, Julian JA, et al. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-related anemia. J Clin Oncol. 2007;25:1027-1032.
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US Department of Health & Human Services, Centers for Medicare & Medicaid Services.Proposed Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N). http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=203.
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US Department of Health & Human Services, Centers for Medicare & Medicaid Services.Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications (CAG-00383N). http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=203 .
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