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).