PMID- 36669842 OWN - NLM STAT- MEDLINE DCOM- 20230124 LR - 20231120 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 13 IP - 1 DP - 2023 Jan 20 TI - Data mining techniques for detecting signals of adverse drug reaction of cardiac therapy drugs based on Jinan adverse event reporting system database: a retrospective study. PG - e068127 LID - 10.1136/bmjopen-2022-068127 [doi] LID - e068127 AB - OBJECTIVE: Cardiac therapy drugs are widely used in the treatment of heart disease. However, the concern regarding adverse events (AEs) of cardiac therapy drugs have been rising. This study aimed to analyse cardiac therapy drug-related AEs using the Jinan adverse event reporting system (JAERS) database mining and conduct a comprehensive evaluation to provide safe medication information for patients. DESIGN: Retrospective observational study. SETTING: In this study, cardiac therapy drug-related AEs were detected using the JAERS database from January 2000 to March 2022. METHODS: Reports of cardiac therapy drug-related AEs were extracted from JAERS database, and the basic information of patients, reports and common AEs were analysed. Four disproportionality analysis methods, proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), Medicines and Healthcare products Regulatory Agency (MHRA), were used to detect cardiac therapy drug-related signals. We further checked whether the detected signals exist on drug labels in China and two developed countries, the USA and Japan. RESULTS: In total, 168 314 AEs were reported, of which 4788 were associated with cardiac therapy drugs. Using the PRR, ROR, MHRA and BCPNN method, we detected 52 signals, 52 signals, 33 signals and 43 signals, respectively. Among the 52 signals, 14 were not included on the drug labels of China. One (isosorbide mononitrate-head bilges) was not included on the drug labels of the three countries. CONCLUSION: We identified 14 new cardiac therapy drug signals that did not appear on drug labels in China and 1 new signal that did not appear on drug labels in 3 counties. A causal link between cardiac therapy drugs and AEs should be evaluated in further studies. CI - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Guan, Yuyao AU - Guan Y AD - Department of Pharmacy, Shandong University Affiliated Shandong Provincial Third Hospital, Jinan, Shandong, China jilei2022022022@163.com zhangqiuhong2222@163.com guanxiaoyao0815@163.com. FAU - Qi, Yingmei AU - Qi Y AD - Jinan Adverse Drug Reactions and Medical Device Adverse Event Monitoring Center, Jinan, Shandong, China. FAU - Zheng, Lei AU - Zheng L AD - Department of Pharmacy, Shandong University Affiliated Shandong Provincial Third Hospital, Jinan, Shandong, China. FAU - Yang, Jing AU - Yang J AD - Department of Pharmacy, Shandong University Affiliated Shandong Provincial Third Hospital, Jinan, Shandong, China. FAU - Zhang, Mingzhu AU - Zhang M AD - Department of Pharmacy, Shandong University Affiliated Shandong Provincial Third Hospital, Jinan, Shandong, China. FAU - Zhang, Qiuhong AU - Zhang Q AD - Jinan Adverse Drug Reactions and Medical Device Adverse Event Monitoring Center, Jinan, Shandong, China jilei2022022022@163.com zhangqiuhong2222@163.com guanxiaoyao0815@163.com. FAU - Ji, Lei AU - Ji L AUID- ORCID: 0000-0001-9828-0140 AD - Shandong Provincial Key Laboratory of Applied Microbiology, Ecology Institute, Qilu University of Technology, Jinan, Shandong, China jilei2022022022@163.com zhangqiuhong2222@163.com guanxiaoyao0815@163.com. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20230120 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Humans MH - United States MH - Retrospective Studies MH - Bayes Theorem MH - *Adverse Drug Reaction Reporting Systems MH - *Drug-Related Side Effects and Adverse Reactions/diagnosis/epidemiology MH - Data Mining MH - Databases, Factual MH - United States Food and Drug Administration PMC - PMC9872458 OTO - NOTNLM OT - Adult cardiology OT - Cardiac Epidemiology OT - Health & safety OT - Risk management COIS- Competing interests: None declared. EDAT- 2023/01/21 06:00 MHDA- 2023/01/25 06:00 PMCR- 2023/01/20 CRDT- 2023/01/20 21:03 PHST- 2023/01/20 21:03 [entrez] PHST- 2023/01/21 06:00 [pubmed] PHST- 2023/01/25 06:00 [medline] PHST- 2023/01/20 00:00 [pmc-release] AID - bmjopen-2022-068127 [pii] AID - 10.1136/bmjopen-2022-068127 [doi] PST - epublish SO - BMJ Open. 2023 Jan 20;13(1):e068127. doi: 10.1136/bmjopen-2022-068127.