Disproportionality Analysis of Frequently Reported Adverse Events of Lipid-Modifying Agents Using a Community Pharmacy Database

Objective: This study characterized the safety profile of lipid-modifying agents through a disproportionality analysis of frequently reported adverse events (AEs) using a nationwide community pharmacy database in Korea.Methods: AE reports submitted to the Korean Pharmaceutical Association Regional Pharmacovigilance Center from April 2013 to December 2024 were analyzed.Reports in which the drug was classified as either a suspected or concomitant drug were included.Only reports assessed as Possible or higher according to World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality criteria were eligible for analysis.Disproportionality results were presented as reporting odds ratios (RORs) with 95% confidence intervals (CIs).Results: Among reports related to lipid-modifying agents, statins accounted for the largest proportion (59.91%).In the disproportionality analysis of frequently reported AEs, gastrointestinal disorders were the most commonly reported at System Organ Class (SOC) level but showed the lowest ROR (0.54, 95% CI 0.52-0.55).At Preferred Term (PT) level, myalgia was the most frequently reported AE and showed the highest ROR (14.56, 95% CI 13.83-15.33).High RORs for myalgia were observed across statins, fibrates, and combination agents.In some combination agents, hepatic enzyme elevation, peripheral edema, and hypotension were infrequently reported but were associated with relatively high RORs.Conclusion: This nationwide community pharmacy-based pharmacovigilance study highlights the importance of community pharmacy data in routine drug safety monitoring of lipid-modifying agents.(PeRM