Signal mining of pneumonia-related adverse events caused by endothelin receptor antagonists based on FAERS database

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Author: ZHANG Congjin QIAN Qing QIAN Huolian XU Rufu  WANG Qiang

Affiliation: Department of Pharmacy, The Second Affiliated Hospital of Army Medical University, Chongqing 400037, China

Keywords: Endothelin receptor antagonists FDA adverse event reporting system Reporting odds ratio Comprehensive standard method Signal mining Adverse drug events

DOI: 10.12173/j.issn.1008-049X.202312132

Reference: ZHANG Congjin, QIAN Qing, QIAN Huolian, XU Rufu, WANG Qiang.Signal mining of pneumonia-related adverse events caused by endothelin receptor antagonists based on FAERS database[J].Zhongguo Yaoshi Zazhi,2024, 27(8):1399-1407.DOI: 10.12173/j.issn.1008-049X.202312132.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To explore and analyze the signals of pneumonia-related adverse events (ADEs) caused by endothelin receptor antagonists (ERAs) and provide reference for clinical safe medication.

Methods Based on the the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS) database, the data from the first quarter of 2015 to the first quarter of 2023 was extracted, and reporting odds ratio, pro-portional reporting ratio, Bayesian confidence propagation neural network and multi-item gamma poisson shrinker were used for mining.

Results 7 279 reports of pneumonia-related ADEs with ERAs as the main suspects were extracted, including 3 705 reports of ambrisentan, 1 028 reports of bosentan and 2 546 reports of macitentan. There were 68 pneumonia ADEs related to ERAs, including 21 ambrisentan, 25 bosentan and 22 macitentan. According to the criteria for judging the signal of ADEs, there were 14 kinds of ADEs that formed signals, and all the systems involved in system organ classification were infections and infectious diseases. Infectious pneumonia accounted for the highest proportion of adverse reactions (93.61%) and caused the most deaths.

Conclusion In the real world, ERAs can lead to pneumonia related ADEs. Female, elderly, and high-dose are important factors in the occurrence of pneumonia-related ADEs, which suggests that medical personnel need to individualized use drugs based on the patient's physiological status and drug characteristics when using ERAs to ensure medication safety.

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