1. Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.
- Author
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Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, and Carnahan RM
- Subjects
- Aged, Aged, 80 and over, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Brain Infarction epidemiology, Brain Infarction etiology, Brain Infarction prevention & control, Factor Xa Inhibitors administration & dosage, Female, Follow-Up Studies, Gastrointestinal Hemorrhage chemically induced, Gastrointestinal Hemorrhage epidemiology, Humans, Intracranial Hemorrhages chemically induced, Intracranial Hemorrhages epidemiology, Male, Middle Aged, Pilot Projects, Prospective Studies, Rivaroxaban administration & dosage, United States epidemiology, Warfarin administration & dosage, Warfarin adverse effects, Adverse Drug Reaction Reporting Systems statistics & numerical data, Factor Xa Inhibitors adverse effects, Rivaroxaban adverse effects, United States Food and Drug Administration statistics & numerical data
- Abstract
Purpose: The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance., Methods: 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., Results: 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)., Conclusions: This study demonstrates the capability of Sentinel to conduct prospective safety monitoring and raises no new concerns about rivaroxaban safety., (Copyright © 2018 John Wiley & Sons, Ltd.)
- Published
- 2018
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