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Analysis of clinical characteristics and automatic monitoring of drug-induced arrhythmias in 167,546 inpatients

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Abstract

Objective

The purpose of this study was to analyze the occurrence characteristics, clinical manifestations, medication distribution, and incidence of drug-induced arrhythmias in a real-world inpatient population.

Methods

According to the inclusion and exclusion criteria as well as the ADR evaluation criteria, we retrospectively evaluated hospitalized patients in 2019 using the arrhythmia module of the Adverse Drug Event Active Surveillance and Assessment System-II (ADE-ASAS-II). A detailed analysis was performed on the demographic data, ADR manifestations, and medication distribution of 2097 patients with drug-induced arrhythmias and QT interval prolongation.

Results

Of the 167,546 hospitalized patients, there were 1809 cases of drug-induced arrhythmias, with an incidence of 1.08%. The ADRs in 45.35% of positive patients occurred within 3 days after medication administration, and 46.73% of the patients were 65 years old or older. The predominant ADRs identified in this study were extrasystole, tachycardia, and QT interval prolongation, of which the incidence was 0.20%. Levofloxacin was the most involved drug, and levofloxacin-associated rates of incidence of arrhythmia and QT interval prolongation were 1.24% and 0.44%, respectively. The risk factors for drug-induced arrhythmias were male sex, advanced age, emaciation, obesity, and underlying illnesses such as cardiovascular diseases, diabetes mellitus, cerebrovascular diseases, and hepatic and renal inadequacy (P < 0.05).

Conclusion

The incidence of drug-induced arrhythmias was in the range of common, while QTc interval prolongation was occasional. It is necessary to pay attention to patients with risk factors.

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Availability of data and materials

The data used to support the findings of this study are available upon reasonable request from the authors.

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Funding

This study was supported by the Key Project of Military Medical Innovation Project in 2017 (No. 17CXZ010) and “the Project of Monitoring and Evaluation of the Use of Key Clinical Drugs” commissioned by the Chinese Association of Research Hospitals (No. Y2021FH-YWPJ01).

Author information

Authors and Affiliations

  1. Department of Pharmacy, Medical Supplies Center, Chinese PLA General Hospital, Beijing, 100853, China

    Haili Guo, Peng Li, Daihong Guo, Ao Gao, Pengzhi Zhao, An Fu, Chao Li & Jingchuang Lu

  2. College of Pharmacy, Chongqing Medical University, Chongqing, 400016, China

    Jingchuang Lu

Authors
  1. Haili Guo
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  2. Peng Li
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  3. Daihong Guo
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  4. Ao Gao
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  5. Pengzhi Zhao
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  6. An Fu
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  7. Chao Li
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  8. Jingchuang Lu
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Contributions

HG: conception, design, data collection, analysis of data, drafting, and revision of manuscript. DG: conception, design, interpretation of results, and critical revision of manuscript. HG and PL: statistics and analysis of data and interpretation of results. AG and PZ review positive cases. All authors reviewed the manuscript.

Corresponding author

Correspondence to Daihong Guo.

Ethics declarations

Ethical approval

This study was approved by the Ethics Committee of Chinese PLA General Hospital (S2018-054–01). All patient data were kept strictly confidential.

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All authors agree to publish in the journal “European Journal of Clinical Pharmacology”.

Competing interests

The authors declare no competing interests.

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Guo, H., Li, P., Guo, D. et al. Analysis of clinical characteristics and automatic monitoring of drug-induced arrhythmias in 167,546 inpatients. Eur J Clin Pharmacol 79, 759–765 (2023). https://doi.org/10.1007/s00228-023-03492-6

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  • DOI: https://doi.org/10.1007/s00228-023-03492-6

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