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Original Research

Hemorrhage induced by antithrombotic agents: new insights from a real-world pharmacovigilance study

ORCID Icon, , , , , , , & show all
Pages 487-495 | Received 04 Apr 2023, Accepted 15 Sep 2023, Published online: 18 Mar 2024
 

ABSTRACT

Background

Hemorrhage represents the most common and serious side effect of antithrombotic agents. Many studies have compared the risk of bleeding between different antithrombotic agents, but analysis of time-to-onset for hemorrhage induced by these drugs is yet sparse.

Methods

We conducted a retrospective study based on the adverse drug reaction reports on antithrombotic agents collected by the Henan Adverse Drug Reaction Monitoring Center. We assessed the reporting odds ratio to determine the disproportionate reporting signals for bleeding and the Weibull shape parameter was used to evaluate the time-to-onset data.

Results

In the signal detection, crude low molecular weight heparin-hemorrhage was found as a positive signal. The hemorrhage for most antithrombotic agents was random failure profiles. In particular, the hazard of hemorrhage decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.

Conclusion

We found that the risk of bleeding in patients taking Crude low molecular weight heparins was significantly higher compared to other antithrombotic agents, but with a small magnificence, which may be attributed to the severely irrational use of this medication under improper management. Statistics in days, results showed that the risk of bleeding decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.

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.

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.

Acknowledgments

The authors thank Yuanxuan Cai, Xin Ding, Qijun Hu and Chi Zhang for their support.

Author contributions

Conceptualization, Kangyuan Guo, Ganyi Wang, Li Zhang, Zhanchun Feng, Xiaobo Sun and Da Feng; Data curation, Ganyi Wang, Ziqi Yan and Zhiming Jiao; Formal analysis, Kangyuan Guo, Xudong Xia and Zhiming Jiao; Funding acquisition, Da Feng; Investigation, Ganyi Wang, Ziqi Yan and Zhiming Jiao; Methodology, Kangyuan Guo, Zhanchun Feng and Xiaobo Sun; Project administration, Da Feng; Resources, Ganyi Wang, Xudong Xia; Software, Kangyuan Guo, Li Zhang, Xiaobo Sun, Ziqi Yan and Zhiming Jiao; Supervision, Ganyi Wang, Zhanchun Feng, Xudong Xia and Da Feng; Validation, Kangyuan Guo, Li Zhang, Zhanchun Feng, Xudong Xia, Xiaobo Sun, Ziqi Yan, Zhiming Jiao and Da Feng; Visualization, Kangyuan Guo and Li Zhang; Writing – original draft, Kangyuan Guo, Ganyi Wang and Li Zhang; Writing – review & editing, Kangyuan Guo, Ganyi Wang, Li Zhang, Zhanchun Feng, Xudong Xia, Xiaobo Sun, Ziqi Yan and Da Feng.

Informed consent statement

Not applicable. The Adverse Drug Reaction Monitoring Center of Henan Province ensures the preservation of the anonymity of both patients and notifiers.

Institutional review board statement

The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (2020A282).

Additional information

Funding

This manuscript was funded by the National Natural Science Foundation of China [No. 72274071], the Science and Technology Research Program of Henan Province [No. 212102311047], Natural Science Foundation of Hubei Province [No. 2023AFB1067], Wuhan Aurora Program [No. 2022020801020094] and the Health Commission of Hubei Province scientific research project [Grant Number: WJ2021Q022].

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