Korean J Clin Pharm.  2018 Dec;28(4):293-299. 10.24304/kjcp.2018.28.4.293.

Comparison of Adverse Events between High-intensity and Moderate- to Low-intensity Statin Group

• Lee S
• Ock M
• Kim H

• KMID: 2437933
• DOI: http://doi.org/10.24304/kjcp.2018.28.4.293

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.

Keyword

Hydroxymethylglutaryl-CoA reductase inhibitors; KAERS; drug-related side effects; adverse reactions

MeSH Terms

Adult
Cardiovascular Diseases
Cholesterol
Coenzyme A
Diabetes Mellitus
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors*
Korea
Lipoproteins
Oxidoreductases
Cholesterol
Coenzyme A
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lipoproteins
Oxidoreductases