Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes Journal Article

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Authors: Stroupe, K. T.; Tarlov, E; Lee, T. A.; Weichle, T. W.; Zhang, Q. L.; Michaelis, L. C.; Ozer, H.; Durazo-Arvizu, R; Browning, M. M.; Hynes, D. M.
Article Title: Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes
Abstract: STUDY OBJECTIVE: To determine whether the hemoglobin level at which health care providers prescribed erythropoiesis-stimulating agent (ESA) therapy (trigger hemoglobin level) for their patients receiving chemotherapy was lower after the United States Food and Drug Administration (FDA) mandated a black-box warning in March 2007. DESIGN: Retrospective analysis. DATA SOURCE: U.S. Department of Veterans Affairs Healthcare System (VA) national databases. PATIENTS: A total of 7450 patients who were diagnosed with cancer between 2002 and 2009, were undergoing chemotherapy, and who received an ESA within 12 months after their cancer diagnosis. MEASUREMENTS AND MAIN RESULTS: Data were collected on patients' demographic, clinical, environmental, and treatment-related factors. After controlling for these factors, multivariable regression analyses were used to compare the trigger hemoglobin level before and after the FDA-mandated labeling change. The average trigger hemoglobin level was 0.73 g/dl lower after the labeling change (95% confidence interval [CI] -0.84 to -0.63). Moreover, the decline in trigger hemoglobin levels began in mid-2006, when the average trigger hemoglobin level fell from 10.50 g/dl in early 2006 (95% CI 10.36-10.63) to 9.30 g/dl by late 2009 (95% CI 9.10-9.49). CONCLUSION: Even before the 2007 FDA-mandated changes in ESA product labeling, hemoglobin levels that triggered ESA treatment began declining for patients receiving cancer care within the VA. This highlights the critical importance of dissemination of postmarketing safety data to impact shifts in ESA use for anemia management.
Journal Title: Pharmacotherapy
Volume: 32
Issue: 11
ISSN: 1875-9114; 0277-0008
Publisher: Pharmacotherapy Publications, Inc  
Journal Place: United States
Date Published: 2012
Start Page: 988
End Page: 997
Language: eng
DOI/URL:

10.1002/phar.1134

10.1002/phar.1134
Notes: CI: (c) 2012; JID: 8111305; 0 (Hematinics); 0 (Hemoglobins); 2012/10/26 [aheadofprint]; ppublish