Analysis on the risk of muscle adverse events of PCSK9 inhibitors based on the FAERS database
Objective To explore the occurrence of muscle adverse events(MAEs)of proprotein convertase subtilisin/kex-in type 9(PCSK9)inhibitors for clinical drug safety.Methods MAE reports of PCSK9 inhibitors and statins were retrieved from the US Food and Drug Administration adverse event reporting system(FAERS)database.The search period spanned from Janu-ary 1,2015 to December 31,2022.The reporting odds ratio(ROR)method was used to compare the occurrence of muscle adverse events between two types of drugs.Results A total of 233 343 adverse event reports with PCSK9 inhibitors or statins as the primary suspected drug were included in the analysis.Specifically,reports primarily suspecting alirocumab,evolocumab,and inclisiran numbered 17 729,92 577,and 852,respectively,while those suspecting statins totaled 122 185.There were 21 402 reports of MAEs,with 8509 involving PCSK9 inhibitors monotherapy,12 365 involving statins monotherapy,and 528 involving the combined use of PCSK9 inhibitors and statins.The ROR for MAEs with PCSK9 inhibitors monotherapy versus statins monotherapy was 0.75(95%CI:0.72 to 0.77).The ROR for MAEs with the combined use of PCSK9 inhibitors and statins compared to statins monotherapy was 3.07(95%CI:2.77 to 3.39).Conclusion The risk of MAEs associated with PCSK9 inhibitors was lower compared to statins.However,the combination of PCSK9 inhibitors and statins may increase the risk of MAEs.
PCSK9 inhibitorsstatinsmuscle adverse eventsadverse events reporting system database
NETL
NSTL
万方数据
