Analysis of Inclisiran in the US FDA Adverse Event Reporting System (FAERS): a focus on overall patient population and sex-specific subgroups

ABSTRACT

Background

Our study aimed to identify inclisiran-related adverse events(AEs) for primary hypercholesterolemia and arteriosclerotic cardiovascular disease(ASCVD) from the US FDA Adverse Event Reporting System (FAERS) database, analyzing its links to AEs in the overall patient population and sex-specific subgroups to improve medication safety.

Methods

We analyzed inclisiran-related AEs signals by using statistical methods like Reporting Odds Ratio (ROR), Proportional Reporting Ratios (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma-Poisson Shrinker (MGPS).

Results

Analyzing 2,400 AE reports with inclisiran as the primary suspected drug in the FAERS database, we identified 70 AE signals over 13 organ systems using the above four methods. Notable findings were strong signals for systemic diseases and various reactions at the site of administration (ROR 1.49, 95% CI 1.41–1.57), and various musculoskeletal and connective tissue diseases (ROR 4.07, 95% CI 3.83–4.03) in overall and gender-specific populations. Myalgia, a new ADE signal not in the drug insert, was a top signal by intensity and frequency (ROR 14.76, 95% CI 12.84–16.98).

Conclusion

Our study revealed the strongest AE signals associated with inclisiran in both the overall population and gender subgroups, highlighting potential risks in clinical medication use and guiding balanced clinical decision-making.

KEYWORDS:

• Inclisiran
• real-world data analysis
• adverse event
• overall patient population
• sex-specific subgroups

Declaration of interest

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 contributions

Yubin He and Xin Guan designed the study, analyzed the data, and wrote the manuscript. YaYun Zhang, ZiXiong Zhu assisted in data collection and analysis. YanHui Zhang and Yue Feng conducted a literature review. Professor XueWen Li revised the manuscript.

Acknowledgments

We thank all data contributors to the FAERS database.

Supplementary Material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2348562

Additional information

Funding

This manuscript was funded by the National Natural Science Foundation of China [Granted No.82170398].