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Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group
Korean J Clin Pharm 2018;28(4):293-299
Published online December 31, 2018
© 2018 Korean College of Clinical Pharmacy.

Sera Lee#, Miyoung Ock#, and Hyunah Kim*

College of Pharmacy, Sookmyung Women’s University, Seoul 04310, Republic of Korea
Correspondence to: Hyunah Kim, College of Pharmacy, Sookmyung Women's University, Cheongpa-ro 47-gil 100, Yongsan-gu, Seoul, 04310, Republic of Korea Tel: +82-2-2077-7961, Fax: +82-2-2077-7629 E-mail:
#Sera Lee and Miyoung Ock are co-first authors, with each contributing equally to this manuscript.
Received October 16, 2018; Revised December 12, 2018; Accepted December 16, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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 ≤75 with clinical atherosclerotic cardiovascular 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. 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 (≥18 years) 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 ± 14 vs 62 ± 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.
Keywords : Hydroxymethylglutaryl-CoA reductase inhibitors, KAERS, drug-related side effects, adverse reactions

December 2018, 28 (4)
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