Journal article
Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System
Pharmacoepidemiology and drug safety, Vol.27(3), pp.263-271
03/2018
DOI: 10.1002/pds.4375
PMID: 29318683
Abstract
The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance.
In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods.
Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin. In follow-up analyses using primary position diagnoses from inpatient encounters for increased definition specificity, the hazard ratios (HR) for rivaroxaban vs warfarin new users were 0.61 (0.47, 0.79) for IS, 1.47 (1.29, 1.67) for GIB, and 0.71 (0.50, 1.01) for ICH. For GIB, the HR varied by age: <66 HR = 0.88 (0.60, 1.30) and 66+ HR = 1.49 (1.30, 1.71).
This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety.
Details
- Title: Subtitle
- Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System
- Creators
- Elizabeth A Chrischilles - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USAJoshua J Gagne - Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USABruce Fireman - Kaiser Permanente Northern California, Oakland, CA, USAJennifer Nelson - Biostatistics Unit, Group Health Research Institute and Department of Biostatistics, University of Washington, Seattle, WA, USASengwee Toh - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USAAzadeh Shoaibi - Center for Biologics Evaluation and Research, US Food and Drug, Rockville, MD, USAMarsha E Reichman - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USAShirley Wang - Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USAMichael Nguyen - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USARongmei Zhang - Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, US Food and Drug Administration, Silver Spring, MD, USARima Izem - Division of Biometric VII, Office of Biostatistics, Office of Translation Sciences, US Food and Drug Administration, Silver Spring, MD, USAMargie R Goulding - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USAMary Ross Southworth - Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USADavid J Graham - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USACandace Fuller - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USAHannah Katcoff - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USATiffany Woodworth - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USACatherine Rogers - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USARyan Saliga - Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USANancy D Lin - Optum Epidemiology, Waltham, MA, USACheryl N McMahill-Walraven - Aetna, Blue Bell, PA, USAVinit P Nair - Humana Inc. Louisville, KY, USAKevin Haynes - HealthCore Inc. Alexandria, VA, USARyan M Carnahan - Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA
- Resource Type
- Journal article
- Publication Details
- Pharmacoepidemiology and drug safety, Vol.27(3), pp.263-271
- DOI
- 10.1002/pds.4375
- PMID
- 29318683
- NLM abbreviation
- Pharmacoepidemiol Drug Saf
- ISSN
- 1053-8569
- eISSN
- 1099-1557
- Publisher
- England
- Grant note
- DOI: 10.13039/100000038, name: U.S. Food and Drug Administration, award: HHSF223200910006I
- Language
- English
- Date published
- 03/2018
- Academic Unit
- Pharmacy; Epidemiology; Injury Prevention Research Center
- Record Identifier
- 9983995057402771
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