Real-world safety of icosapent ethyl: analysis based on spontaneous reports in FAERS database

ABSTRACT

Background

The triglyceride-lowering drug, icosapent ethyl (IPE), was granted a new indication for the reduction of atherosclerotic cardiovascular disease risk in 2019. This study aimed to investigate the safety profile of IPE by mining the FDA Adverse Event Reporting System (FAERS) database.

Methods

The reporting odds ratio was used to analyze IPE’s adverse events (AEs) based on the FAERS data from July 2012 to December 2022. We described the characteristics of AE reports and evaluated the clinical prioritization of AEs. Then we defined and analyzed nine interested adverse drug reactions (ADRs) in both overall and subgroups, and investigated the times to onset.

Results

The findings of our study strengthen the evidence for an increased risk of atrial fibrillation using IPE. IPE alone may not increase the risk of bleeding unless combined with antithrombotic drugs. Similar to statins, IPE alone can increase the risk of musculoskeletal pain, drug-related hepatic disorders, and hyperglycemia, but the risk could not double when IPE was combined with statins. Most ADRs occur in the early stage of treatment.

Conclusions

This study provides a comprehensive real-world safety profile of IPE, which indicates that IPE is well-tolerated.

KEYWORDS:

• Icosapent ethyl
• adverse event
• data mining
• FAERS
• pharmacovigilance

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Haixia Cai and Shujuan Zhao conceived and designed the study. Haixia Cai, Beixi Jia, and Shujuan Zhao performed the literature search, data processing, and analysis. Haixia Cai wrote the main manuscript. Zhonghua Fu, Boya Chen, and Yinping Liu reviewed and revised the manuscript. All the authors contributed to the interpretation of data and approved the final version of the manuscript.

Acknowledgments

This research received no specific grant from any funding agencies in the public, commercial, or non-profit sectors.

Data availability statement

The original datasets are available from the FAERS database at https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2274946

Additional information

Funding

This paper was not funded.