title: Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes.
abstract: 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.
  
  
  METHODS
  Retrospective analysis.
  
  
  METHODS
  U.S. Department of Veterans Affairs Healthcare System (VA) national databases.
  
  
  METHODS
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Management of Complex Chronic Care, Edward Hines, Jr. VA Hospital, 5000 South 5th Avenue (151H), Hines, IL 60141, USA. Kevin.Stroupe@va.gov
authors.forename: Kevin T
authors.initials: KT
authors.lastname: Stroupe
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tarlov
authors.forename: Todd A
authors.initials: TA
authors.lastname: Lee
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Weichle
authors.forename: Qiuying L
authors.initials: QL
authors.lastname: Zhang
authors.forename: Laura C
authors.initials: LC
authors.lastname: Michaelis
authors.forename: Howard
authors.initials: H
authors.lastname: Ozer
authors.forename: Ramon
authors.initials: R
authors.lastname: Durazo-Arvizu
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Browning
authors.forename: Denise M
authors.initials: DM
authors.lastname: Hynes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000150:complications / Q000188:drug therapy*; D015331:Cohort Studies; D004348:Drug Labeling; D057286:Electronic Health Records; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis*; D006787:Hospitals, Veterans; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000150:complications*; D010818:Practice Patterns, Physicians' / Q000639:trends; D011640:Public Policy / Q000639:trends; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D006397:Hematinics; D006454:Hemoglobins