Mining and evaluation of relugolix-related cardiovascular safety signals
OBJECTIVE To mine the cardiovascular safety signal of relugolix,and provide a reference for the listing of this drug in China and future clinical safety drug evaluation.METHODS The adverse event(AE)report data of relugolix,as the primary or secondary suspected drug,was collected from the FDA Adverse Event Reporting System(FAERS)from the first quarter of 2021 to the third quarter of 2023.The reporting odds ratio(ROR)method was used for data mining.The AEs in the FAERS database were identified and coded using preferred terms(PT)stated in version 24.0 of the Medical Dictionary for Drug Regulatory Activities(MedDRA).The AEs of the target drug were identified by the narrow standardized MedDRA query(SMQ)terms and high-level term(HLT).Sensitivity analysis was conducted using AEs suspected to be primarily or secondarily related to relugolix or related to drug interaction and concomitant drug,and broad SMQ terms.RESULTS A total of 4 354 relugolix-related AE reports were extracted.In the primary analysis,nine SMQ terms were analyzed,involving 2 positive signals such as dyslipidemia and hyperglycemia/new onset diabetes mellitus.Eleven HLTs were analyzed,and three positive signals were detected for three terms including cholesterol analyses,triglyceride analyses and hyperglycemia conditions(non-alternative analysis).Sensitivity analysis results indicated the reliability of the study findings.CONCLUSIONS Relugolix may induce risk signals related to high blood lipids and high blood glucose,but no moderate risk signals such as hypertension,heart disease,and stroke are found.During relugolix treatment in clinical practice,attention must be paid to hyperlipidemia and hyperglycemia-related AE.
万方数据
维普
