Abstract 11293: Atrial Fibrillation Associated With Ivabradine: An Analysis of FDA Adverse Events Reporting System Database

Abstract

Introduction: Ivabradine has been shown to be associated with atrial fibrillation (AF) in a metanalysis of 11 studies, however, AF has not been routinely reported as an adverse event of ivabradine in clinical trials. The FDA Adverse Event Reporting System (FAERS) is a publicly available database of adverse events (AE) of various drugs. We analyzed the database for real-world AF reporting with Ivabradine. Methods: FAERS was searched for the adverse events reported for ivabradine. All AF cases were individually analyzed. Results: A total of 3550 AE reports of Ivabradine were reported to FAERS from April 2011 to August 2021 out of which 1117 were cardiac adverse events. A total of 78 cases of AF were reported, accounting for 2.1% of the total AE reports and 31% of cardiac AE reports. Sex was reported in 83% of total AF cases, of which 50% were male, and the other 50% were female. 79% of the AF cases were reported by health care professionals, and 21% by consumers. 51% of cases were reported from the United States, 10% from France, and 9% from Germany. In 51% of the cases, no concomitant drug was given with ivabradine, and in 49% a concomitant drug was given; 10% of those was Digoxin/Digitalis that has been associated with AF. When searched using OpenVigilFDA (a web-based user interface to the FAERS for extraction and analysis of adverse events reports), the reporting odds ratio (ROR) of Ivabradine for AF was 3.18 (95% CI: 2.46 - 4.10) and the proportional reporting ratio was 3.15. The comparison of RORs of ivabradine with the drugs traditionally known to cause AF is shown in the figure. Conclusions: Disproportionate reporting of AF with ivabradine indicates that AF is associated with Ivabradine use. Further studies are required to confirm this association