Excavation and analysis of hyperglycemia risk of 4 immunosuppressive agents based on FAERS
AIM To excavate and evaluate tacrolimus,cyclosporine,sirolimus,and everolimus associated with hyperglycemia/new-onset diabetes based on American FDA Event Reporting System(FAERS),and to provide reference for rational drug use in clinical practice.METHODS The preferred term(PT)within the narrow sense of"hyperglycemia/new onset diabetes mellitus"in the SMQ term set was queried using the ICH International Dictionary of Medical Terms(MedDRA),and cases related to the above drugs were extracted in FAERS from the first quarter of 2013 to the fourth quarter of 2022.After data deduplication,hyperglycemia/new-onset diabetes signal detection and analysis were performed using the reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method.RESULTS A total of 736 ADE reports were extracted,of which renal transplantation accounted for 38.99%,male accounted for 54.30%,the age of patients was mainly 45-64 years old,and severe ADE accounted for 57.06%.The results of signal retrieval showed that 24 suspicious signals were detected by the PRR and ROR method at the same time,of which 14 suspicious signals were detected by tacrolimus,5 suspicious signals were detected by everolimus,3 suspicious signals were detected by sirolimus,and 2 suspicious signals were detected by cyclosporine.The types and intensities of signals differed among 4 immunosuppressive agents.CONCLUSION All 4 immunosuppressive agents commonly used in clinical practice carry the risk of hyperglycemia.Compared with other drugs,tacrolimus has shown a strong statistical correlation with hyperglycemia.It is suggested that attention should be paid to the hyperglycemia-related adverse reactions in clinical application.