의약품부작용보고시스템 데이터베이스를 이용한 고강도 statin과 중·저강도 statin 관련 이상사례 비교 분석

Abstract

Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-densitylipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ≤75 with clinical atheroscleroticcardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ≥7.5% estimated 10-year ASCVD risk and LDL-C ≥190 mg/dL. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. Theaim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea AdverseEvent Reporting System (KAERS) database. Methods: Adults (≥18 years) with statin-associated AEs from July 2009-June 2014were included. Only AEs classified as “certain”, “probable” and “possible” based on the WHO-Uppsala Monitoring Center criteriawere analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to lowintensitystatin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG (67 ± 14 vs 62 ± 12). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormalwas reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliarysystem disorders were more frequently reported in HG compared to MLG.