Browse > Article
http://dx.doi.org/10.24304/kjcp.2018.28.4.293

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

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)
Publication Information
Korean Journal of Clinical Pharmacy / v.28, no.4, 2018 , pp. 293-299 More about this Journal
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.
Keywords
Hydroxymethylglutaryl-CoA reductase inhibitors; KAERS; drug-related side effects; adverse reactions;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Ramkumar S, Raghunath A, Raghunath S. Statin therapy: review of safety and potential side effects. Acta Cardiol Sin 2016;32(6):631-9.
2 Mihaylova B, Emberson J, Blackwell L, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012;380:581-90.   DOI
3 Thompson PD, Panza G, Zaleski A, et al. Statin-associated side effects. J Am Coll Cardiol 2016;67(20):2395-410.   DOI
4 Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63(25):2889-934.   DOI
5 Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350(15):1495-504.   DOI
6 de Lemos JA, Blazing MA, Wiviott SD, et al. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA 2004;292(11):1307-16.   DOI
7 Afilalo J, Majdan AA, Eisenberg MJ. Intensive statin therapy in acute coronary syndromes and stable coronary heart disease: a comparative meta-analysis of randomised controlled trials. Heart 2007;93(8):914-21.   DOI
8 Cannon CP, Steinberg BA, Murphy SA, Mega JL, et al. Metaanalysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. J Am Coll Cardiol 2006;48(3):438-45.   DOI
9 Silva M, Matthews ML, Jarvis C, et al. Meta-analysis of druginduced adverse events associated with intensive-dose statin therapy. Clin Ther 2007;29(2):253-60.   DOI
10 Korea Institute of Drug Safety & Risk Management. KIDS-KD manual ver 3.0 [Internet]. Korea Institute of Drug Safety & Risk Management;2016. Available from https://www.drugsafe.or.kr/iwt/ds/ko/bbs/EgovBbs.do?bbsId=BBSMS TR_000000000291&nttId=1749&pageIndex=1&searchCnd=&searchWrd=. Accessed July, 23 2018.
11 WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2013 [Internet]. Oslo:WHO Collaborating Centre for Drug Statistics Methodology;2012. Available from https://www.whocc.no/filearchive/publications/1_2013guidelines.pdf. Accessed July 23, 2018.
12 World Health Organization. The WHO Adverse Reaction Terminology (WHO-ART) 2005 [Internet]. World Health Organization;2017 Available from https://www.who-umc.org/whodrug/whodrug-portfolio. Accessed July 23, 2018.
13 Statistics Korea. Korean Standard Classification of Diseases and Causes of Death (KCD-6) [Internet]. Daejeon: Statistics Korea; 2011. Available from http://www.kcdcode.co.kr/browse/main/Accessed 23 July, 2018.
14 The use of the WHO-UMC system for standardized case causality assessment. World Health Organization (WHO)-Uppsala Monitoring Centre. Available from http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf. Accessed July 23, 2018.
15 Yu YM, Shin WG, Lee JY, et al. Patterns of adverse drug reactions in different age groups: analysis of spontaneous reports by community pharmacists. PLoS One 2015;10(7):e0132916.   DOI
16 Dweik RA, Yaya S, Stacey D, Kohen D. Spontaneous adverse drug reaction reporting by patients in Canada: a multi-method studystudy protocol. Springerplus 2016;5:213.   DOI
17 Lee MW, Lee JS, Han OY, et al. Study for association between adverse drug reactions and causative drugs in the elderly using datamining analysis. Korean J Clin Pharm 2014;24(1):39-44.
18 Lee J, Noh Y, Shin S, et al. Impact of statins on risk of new onset diabetes mellitus: a population-based cohort study using the Korean National Health Insurance claimsdatabase. Ther Clin Risk Manag 2016;12:1533-43.   DOI
19 Akimoto H, Negishi A, Oshima S, et al. Onset timing of statininduced musculoskeletal adverse events and concomitant drugassociated shift in onset timing of MAEs. Pharmacol Res Perspect 2018;6(6):1-9.
20 Lexicomp Online, Atoravstatin adverse reactions, Hudson, Ohio: Wolters Kluwer Clinical Drug Information, Inc.; 2013; Available from http://www.lexicomponline.com/lco/action/doc/retrieve/docid/multinat_f/4668926#f_adverse-reactions. Accessed July 23, 2018).
21 Cohen DE, Anania FA, Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006;97(8A):77C-81C.
22 Escobar C, Echarri R, Barrios V. Relative safety profiles of high dose statin regimens. Vasc health risk manag 2008;4(3):525-33.   DOI
23 Jose J. Statins and its hepatic effects: Newer data, implications, and changing recommendations. J Pharm Bioallied Sci 2016;8(1):23-8.   DOI
24 Davidson MH, Clark JA, Glass LM, et al. Statin safety: an appraisal from the adverse event reporting system. Am J Cardiol 2006;97(8A):32C-43C.   DOI
25 Dobritoiu AM, Forsea DG. Statins and the skin. Ther Pharmacol Clin Toxicol 2011;15:98-104.
26 Salna MP, Singer HM, Dana AN. Pravastatin-induced eczematous eruption mimicking psoriasis. Case Rep Dermatol Med 2017;2017:3418204.
27 Bruckert E, Hayem G, Dejager S, et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther 2005;19(6):403-14.   DOI
28 Escobar C, Echarri R, Barrios V. Relative safety profiles of high dose statin regimens. Vasc health risk manag 2008;4(3):525-33.   DOI
29 Collins GS, Altman DG. Predicting the adverse risk of statin treatment: an independent and external validation of Qstatinrisk scores in the UK. Heart 2012;98(14):1091-7.   DOI
30 Nguyen KA, Li L, Lu D, et al. A comprehensive review and metaanalysis of risk factors for statin-induced myopathy. Eur J Clin Pharmacol 2018;74(9):1099-109.   DOI
31 James K. Liao. Safety and Efficacy of Statins in Asians. Am J Cardiol 2007;99(3):410-4.   DOI
32 Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med 2005;165(12):1363-9.   DOI
33 Lee SW, Lee J, Kim NH, et al. Pruritus induced by multiple statins: a case report. JPERM 2017;9:41-4.