Journal of Hebei Medical University ›› 2024, Vol. 45 ›› Issue (12): 1380-1386.doi: 10.3969/j.issn.1007-3205.2024.12.004

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Mining and analysis of adverse drug event signals of proton pump inhibitors in elderly patients based on openFDA database

  

  1. 1.College of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China; 2.Department of 
    Pharmacy, the First Hospital of Qinhuangdao City, Hebei Province, Qinhuangdao 066000, China

  • Online:2024-12-25 Published:2025-01-03

Abstract: Objective To mine adverse drug event(ADE) signals for the use of proton pump inhibitors (PPIs) in elderly patients, and to provide a reference for the safe and rational clinical use of PPIs in elderly patients. 
Methods Adverse event reports collected in the openFDA database from January 1, 2017 to September 30, 2022 were analyzed using both the reporting odds ratio (ROR) method and Medicines and Healthcare products Regulatory Agency (MHRA) to mine adverse event signals of five PPIs. 
Results A total of 177 ADE signals were detected, involving 15 commonly used systems. Of these, there were a total of 68 signals for rabeprazole, 35 for lansoprazole, 33 for pantoprazole, 22 for omeprazole and 19 for esomeprazole. There were mainly 31 signals (36.64%) for renal and urinary disorders,25 signals (13.04%) for gastrointestinal disorders, and 19 signals (9.28%) for metabolic and nutritional disorders.Rabeprazole produced the highest variety and number of signals, mainly involving respiratory, thoracic and mediastinal disorders. 
Conclusion For PPIs used in the elderly, in addition to the ADE already mentioned in the specification, the risks associated with renal function, electrolyte levels, and respiratory infections should be monitored, and certain preventive and therapeutic measures should be taken, or the application of PPIs should be avoided in high-risk populations and replaced by relatively safe PPIs, in order to ensure patientsafety. 


Key words: proton pump inhibitors, openFDA, elderly patients, adverse drug event signal mining