Hemoglobin levels triggering erythropoiesis-stimulating agent therapy in patients with cancer: the shift after United States Food and Drug Administration policy changes.
Pharmacotherapy
; 32(11): 988-97, 2012 Nov.
Article
in En
| MEDLINE
| ID: mdl-23108695
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 MAINRESULTS:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Public Policy
/
Practice Patterns, Physicians'
/
Hemoglobins
/
Hematinics
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Anemia
/
Neoplasms
Type of study:
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Aspects:
Determinantes_sociais_saude
Limits:
Adolescent
/
Adult
/
Aged
/
Aged80
/
Female
/
Humans
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Male
/
Middle aged
Country/Region as subject:
America do norte
Language:
En
Journal:
Pharmacotherapy
Year:
2012
Document type:
Article
Affiliation country:
United States