A Real-world Study on Adverse Events Related to Mirogabalin Based on the VigiAccess Database

Abstract

Objective: To utilize the VigiAccess database for data mining to analyze the characteristics of adverse reactions induced by mirogabalin, providing critical information for clinical medication use. Method: This study analyzed data from the VigiAccess database, filtering out adverse reaction reports where mirogabalin was identified as the Primary Suspect Drug (PS). Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM) methods were employed as data mining algorithms for pharmacovigilance and adverse event monitoring. These methods identify potential drug-adverse event association signals by analyzing the relationship between drug use and adverse event reporting. ROR and PRR focus on calculating reporting ratios, while BCPNN and EBGM use neural networks and empirical Bayes models, respectively, to enhance the accuracy and reliability of signal detection. Results: A total of 734 adverse reaction reports associated with mirogabalin were obtained. The results showed that females reported the highest number of adverse reactions, accounting for 59.67%, while males accounted for 38.83%. In terms of age distribution, the highest number of reports came from individuals over 75 years old, accounting for 33.79%. Adverse reactions mainly involved the nervous system (33.45%), general diseases and reactions at the site of administration (11.62%), and gastrointestinal disorders (10.74%). The most common adverse reactions included dizziness (11.62%), somnolence (8.27%), renal dysfunction (2.90%), and edema (2.82%). Signal intensity analysis revealed that certain adverse reactions (such as renal dysfunction, rhabdomyolysis, and drug-induced liver injury) had significant signal strength, suggesting a strong association with mirogabalin. Conclusion: This study, through signal mining of the VigiAccess database, reveals the characteristics of mirogabalin’s adverse reactions in the real world, particularly in the nervous system and renal function. These findings provide important reference information for clinicians, aiding in the optimization of the safe use of mirogabalin. Future research should further validate the causal relationships of these signals and explore individualized treatment strategies to reduce the incidence of adverse reactions and improve patient outcomes.