To explore the security alert signals of evolocumab after marketing using data mining technology in order to provide the basis for safe drug use in clinical.

FDA Adverse Event Reporting System (FAERS) were searched for 19 quarters since the drug was approved for marketing (3rd quarter of 2015) by the FDA to the 1st quarter of 2020. The measure of disproportionality included the reporting odds ratio and the proportional reporting ratio, the correlation degree of the adverse drug event (ADE) signals was simultaneously calculated.

After multiple screenings, the signals obtained by ROR and PRR completely overlapped in a total of 46 cases, of which 28 adverse event specifications were not appear in the specification. The strong signals of evolocumab were mainly concentrated in myalgia, injection site reaction, and back pain, etc. The largest number of system organ classification (SOC) signals were mainly concentrated in musculoskeletal and connective tissue disorders, infection and infectious diseases, and perception dysfunction, etc. At the same time, it has been discovered that the drug may cause nerve perception dysfunction and increased blood glucose, etc. Through further analysis of the adverse events related to gender and age differences, a total of 14 high-risk signals with gender differences were found. Male patients should be alert to increased blood creatine phosphokinase, and hypoacusis, etc; female patients should be alert to nervousness and swelling face, etc. There were 15 high risk signals with age differences. Non-elderly patients should be alert to increased blood creatine phosphokinase, and increased hepatic enzyme, etc; elderly patients should be alert to hypoacusis, and arthritis, etc.

The signal mining of adverse events through FAERS can deeply analyze the safety of evolocumab after it enters marketed, and then effectively reduce the risk of clinical medication.