Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group

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

  • Lee, Sera (College of Pharmacy, Sookmyung Women's University) ;
  • Ock, Miyoung (College of Pharmacy, Sookmyung Women's University) ;
  • Kim, Hyunah (College of Pharmacy, Sookmyung Women's University)
  • 이세라 (숙명여자대학교 약학대학) ;
  • 옥미영 (숙명여자대학교 약학대학) ;
  • 김현아 (숙명여자대학교 약학대학)
  • Received : 2018.10.16
  • Accepted : 2018.12.16
  • Published : 2018.12.29
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Abstract

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

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References

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