Safety assessment of tenecteplase for the treatment of acute myocardial infarction and ischemic stroke, and identification of key genes.

Tenecteplase (TNK) is used for the treatment of acute myocardial infarction (AMI) and ischemic stroke (IS). This study provided a reference for clinical safety by analyzing adverse drug events (ADEs) with TNK from the Food and Drug Administration Adverse Drug Event Spontaneous Reporting System (FAERS) database. ADE reports of TNK in the treatment of IS and AMI from January 2004 to the third quarter of 2024 (Q3 2024) were collected from the FAERS database. Reporting odds ratio (ROR) was used to mine the ADE signals of TNK. Candidate genes associated with TNK were retrieved and subjected to functional enrichment analyses. Key genes shared among TNK, AMI and IS were further identified. This study included 323 adverse event reports of TNK for IS and 191 reports for AMI. Baseline analyses showed males made up 48.7% of AMI patients, with balanced sex distribution among IS patients. Four system organ class (SOC)-level positive signals were detected in the AMI group versus one in the IS group, with CEREBROVASCULAR ACCIDENT and HAEMOGLOBIN DECREASED as the two shared preferred term (PT)-level adverse events across both cohorts. Two key genes, PLAT and PLG, linked to TNK therapy for both conditions were further screened, and Gene Ontology (GO) plus Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses revealed their involvement in biological processes including fibrinolysis regulation, complement cascades and coagulation cascades. This study identified ADEs of TNK in the treatment of IS and AMI, and also identified two key genes related to TNK. These results provide vital support for the clinical monitoring and molecular basis of TNK.