Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes. Pharmacotherapy 2012 Nov;32(11):988-97
Date
10/31/2012Pubmed ID
23108695DOI
10.1002/phar.1134Scopus ID
2-s2.0-84871581983 (requires institutional sign-in at Scopus site) 5 CitationsAbstract
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.
Author List
Stroupe KT, Tarlov E, Lee TA, Weichle TW, Zhang QL, Michaelis LC, Ozer H, Durazo-Arvizu R, Browning MM, Hynes DMAuthor
Laura Michaelis MD Chief, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Anemia
Cohort Studies
Drug Labeling
Electronic Health Records
Female
Hematinics
Hemoglobins
Hospitals, Veterans
Humans
Male
Middle Aged
Neoplasms
Practice Patterns, Physicians'
Public Policy
Retrospective Studies
United States
United States Food and Drug Administration
Young Adult
