Mining and analysis of risk signal mining of adverse events of inclisiran based on FAERS database
Objective To explore the risk signals of the adverse events of inclisiran to provide reference for the safe clinical use of this drug.Methods To mine and analyze inclisiran's reported adverse events in the FAERS database from the fourth quarter of 2020 through the fourth quarter of 2023 by ROR and PRR methods.Results A total of 164 positive PT signals were obtained,and 4 831 related reports were reported,involving 19 SOC categories,mainly focusing on various musculoskeletal and connective tissue diseases,systemic diseases and reactions at the administration site,respiratory,thoracic and mediastinal diseases and gastrointestinal diseases.Maculopathy,induration,decreased international standardized ratio,bladder discomfort,facial discomfort,and myalgia were the new adverse event signals and also the top 20 adverse event signals with signal intensity.Conclusion The occurrence of common adverse events(injection site reaction,arthralgia,bronchitis)of inclisiran is basically consistent with the instructions of the drug.In clinical application,attention should be paid to adverse events not mentioned in the instructions,such as dyspnea,hard spot,induration,myalgia,facial discomfort,diarrhea,etc.,and indicators such as the international standardized ratio should be closely monitored to make timely intervention.
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