Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.

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.

• Authors: Elizabeth A Chrischilles, Joshua J Gagne, Bruce Fireman, Jennifer Nelson, Sengwee Toh, Azadeh Shoaibi, Marsha E Reichman, Shirley Wang, Michael Nguyen, Rongmei Zhang, Rima Izem, Margie R Goulding, Mary Ross Southworth, David J Graham, Candace Fuller, Hannah Katcoff, Tiffany Woodworth, Catherine Rogers, Ryan Saliga, Nancy D Lin, Cheryl N McMahill-Walraven, Vinit P Nair, Kevin Haynes, Ryan M Carnahan
• Journal: Pharmacoepidemiology and drug safety (Pharmacoepidemiol Drug Saf) Vol. 27 Issue 3 Pg. 263-271 (03 2018) ISSN: 1099-1557 [Electronic] England
• PMID: 29318683 (Publication Type: Journal Article, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright © 2018 John Wiley & Sons, Ltd.

Chemical References

• Factor Xa Inhibitors
• Warfarin
• Rivaroxaban

Topics

• Adverse Drug Reaction Reporting Systems (statistics & numerical data)
• Aged
• Aged, 80 and over
• Atrial Fibrillation (complications, drug therapy)
• Brain Infarction (epidemiology, etiology, prevention & control)
• Factor Xa Inhibitors (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Gastrointestinal Hemorrhage (chemically induced, epidemiology)
• Humans
• Intracranial Hemorrhages (chemically induced, epidemiology)
• Male
• Middle Aged
• Pilot Projects
• Prospective Studies
• Rivaroxaban (administration & dosage, adverse effects)
• United States (epidemiology)
• United States Food and Drug Administration (statistics & numerical data)
• Warfarin (administration & dosage, adverse effects)