Abstract
Abstract 11293: Atrial Fibrillation Associated With Ivabradine: An Analysis of FDA Adverse Events Reporting System Database
Circulation (New York, N.Y.), Vol.146(S_1), p.A11293
11/08/2022
DOI: 10.1161/circ.146.suppl_1.11293
Abstract
Byline: Javaria Ahmad, Internal Medicine, Louisiana State Univ, Shreveport, LA; Hassaan Ali A Ahmad, Internal Medicine, Faisalabad Med Univ, Pakistan; Paari Dominic, Louisiana State Univ, Shreveport, LA 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
Details
- Title: Subtitle
- Abstract 11293: Atrial Fibrillation Associated With Ivabradine: An Analysis of FDA Adverse Events Reporting System Database
- Creators
- Javaria AhmadHassaan Ali A AhmadPaari Dominic
- Resource Type
- Abstract
- Publication Details
- Circulation (New York, N.Y.), Vol.146(S_1), p.A11293
- Publisher
- Lippincott Williams & Wilkins, WK Health
- DOI
- 10.1161/circ.146.suppl_1.11293
- ISSN
- 0009-7322
- eISSN
- 1524-4539
- Language
- English
- Date published
- 11/08/2022
- Description audience
- Professional
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984367143402771
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