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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1451713

Safety of combined drug use in patients with cardiovascular and cerebrovascular diseases: an analysis based on the spontaneous reporting database of adverse drug reactions in Hubei Province

Provisionally accepted
Jia Wang Jia Wang 1Yuhang Zhao Yuhang Zhao 2Zherui Chen Zherui Chen 3Rui Huang Rui Huang 2*
  • 1 Traditional Chinese and Western Medicine Hospital of Wuhan, Huazhong University of Science and Technology, Wuhan, China
  • 2 School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China
  • 3 School of Statistics and Mathematics, Zhongnan University of Economics and Law, Wu Han, China

The final, formatted version of the article will be published soon.

    Objective: There is a lack of studies investigating the safety of combination regimens specifically for cardiovascular and cerebrovascular diseases. This study aimed to evaluate the safety of combination drugs for cardiovascular and cerebrovascular diseases using real-world data. Methods: We analyzed adverse drug reaction data received by the Hubei Adverse Drug Reaction Center from the first quarter of 2014 to the fourth quarter of 2022. The safety of combined drugs for cardiovascular and cerebrovascular diseases in different people was assessed using the association rule method and Ω shrinkage measurement. Results: A total of 53,038 reports were included in this study, revealing 9 signals of adverse reactions caused by combination drugs. The strongest signal found in this study was jaundice caused by the combination of amlodipine and atorvastatin (Ω 0.025:3.08, lift: 1116.69, conviction: 1.75). Additionally, the combination of aspirin with other drugs was associated with hemorrhaging in various organs. Female patients showed a cold signal when taking vitamin C and vitamin B6 together compared to male patients (Ω 0.025:0.89, lift: 7.15, conviction: 1.12). Patients under 60 years old had a palpitations signal when combining eritrea bei sha Tanzania and felodipine (Ω 0.025:0.41, lift: 14.65, conviction: 3.8), and an erythema signal when combining nifedipine (Ω 0.025:0.23, lift: 8.17, conviction: 1.077). Conclusion: Among the 9 signals identified in this study, 4 were off-label adverse drug reactions that require further clinical research for exploration and confirmation, in order to provide more scientifically informed drug labeling. Five adverse events associated with aspirin-induced bleeding were identified. Notably, different adverse drug reactions were observed in different populations, suggesting the need for future studies to expedite the development of personalized medicine.

    Keywords: Cardiovascular Diseases, cerebrovascular diseases, Adverse Drug Reaction, Association rule, Ω shrinkage measurement

    Received: 20 Jun 2024; Accepted: 23 Dec 2024.

    Copyright: © 2024 Wang, Zhao, Chen and Huang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Rui Huang, School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430074, Hubei Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.