Disproportionality analysis of adverse reaction signals related to Inclisiran based on FDA Adverse Event Reporting System database
Objective The objective of this study is to assess the risk of adverse drug reaction(ADR)associated with Inclisiran from the US Food and Drug Administration Adverse Event Reporting System(FAERS),so as to provide clinical guidance.Methods The OpenVigil 2.1 website was utilized to extract records of reported adverse events associated with Inclisiran from Q1 2021 to Q4 2023.The reporting odds ratio(ROR)method,proportional reporting ratio(PRR)method,and frequency were employed to identify safety warning signals of Inclisiran.Preferred terms(PTs)for risk signals were statistically analyzed and systematically classified.Results A total of 2856 cases of Inclisiran-related adverse drug events(ADEs)were collected.The proportion of females was higher than that of males(51.09%vs 37.18%),and the age range of patients was predominantly between 60 and 80 years old(34.56%%).Among the 1004 ADEs reported,136 effective signals were identified,involving 15 System Organ Classes(SOCs).The primary categories included general disorders and administration site conditions,musculoskeletal and connective tissue disorders,and investigations.The top three PTs by number of reports were injection site pain,arthralgia,and pain in extremity.The PTs with the highest signal strength were lipoprotein increased,Lipoprotein(a)increased,low density lipoprotein increased.This signal mining analysis revealed several signals not mentioned in the instructions such as myalgia,pain in extremity,diarrhoea,fatigue,dyspnoea etc.Analysis of 20 reports from China found that elevated blood glucose and abnormal liver function were frequently reported.Conclusion In addition to the adverse reactions in the instructions,attention should be given to potential adverse reactions associated with Inclisiran in musculoskeletal and connective tissue disorders,investigations,gastrointestinal disorders.For Chinese individuals,close attention should be given to abnormal hepatic function and elevated blood glucose levels.
inclisiranFDA Adverse Event Reporting Systemadverse drug eventdisproportionality analysis
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