Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group.
10.24304/kjcp.2018.28.4.293
- Author:
Sera LEE
1
;
Miyoung OCK
;
Hyunah KIM
Author Information
1. College of Pharmacy, Sookmyung Women's University, Seoul 04310, Republic of Korea. hyunah@sookmyung.ac.kr
- Publication Type:Original Article
- Keywords:
Hydroxymethylglutaryl-CoA reductase inhibitors;
KAERS;
drug-related side effects;
adverse reactions
- MeSH:
Adult;
Cardiovascular Diseases;
Cholesterol;
Coenzyme A;
Diabetes Mellitus;
Humans;
Hydroxymethylglutaryl-CoA Reductase Inhibitors*;
Korea;
Lipoproteins;
Oxidoreductases
- From:Korean Journal of Clinical Pharmacy
2018;28(4):293-299
- CountryRepublic of Korea
- Language:Korean
-
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 ≤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 lowintensity 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.
