Horm Metab Res 2024; 56(06): 419-423
DOI: 10.1055/a-2210-3395
Original Article: Endocrine Care

Risk Factors Analysis of Severe Liver Injury Induced by Statins

Feng-yun Su
1   Department of Pharmacy, The Second Affiliated Hospital of Shandong First Medical University, Tai’an, China
Wen-hua Li
2   Department of Orthopedics, The Second Affiliated Hospital of Shandong First Medical University, Tai’an, China
Xu-dong Zhao
3   Department of Obstetrics and Gynecology, The Affiliated Tai’an City Central Hospital of Qingdao University, Qingdao, China
Qian Han
4   Department of Respiratory, The Second Affiliated Hospital of Shandong First Medical University, Tai’an, China
Xin Xu
5   Department of Oncology, The Second Affiliated Hospital of Shandong First Medical University, Tai’an, China
Tao Geng
1   Department of Pharmacy, The Second Affiliated Hospital of Shandong First Medical University, Tai’an, China
› Author Affiliations
Funding Information Shandong Adverse Drug Reaction Monitoring Center Project — 2017SDADRKY05


The aim of this study is to report the risk factors of severe statin induced liver injury (SILI). From the database of Shandong ADR Monitoring Center and Outpatients and inpatients in our hospital, SILI cases reported from 2013 to 2021 were extracted and screened. The diagnostic criteria of SILI, the inclusion and exclusion criteria of severe and general SILI were established separately. After the SILI cases were selected and confirmed, the socio-demographic and clinical characteristics were collected. Single factor chi-square test and multi-factor unconditional logistic regression analysis were used to analyze the influencing factors of severe SILI. From 1391 reported cases, 1211 met SILI diagnostic criteria, of which 157 were severe SILI and 964 were general SILI. Univariate analysis showed that age, drug combination, statin category were the influencing factors of severe SILI (p<0.1). Multivariate logistic analysis showed that drug combination and statin category were the influencing factors of severe SILI (p<0.05). Atorvastatin caused the most serious SILI, and its risk is 1.77 times higher than rosuvastatin. The serious SILI risk of drug combination was 2.08 times higher than statin alone. The patient with these factors should be monitored intensively during clinical treatment, to ensure their medication safety.

Publication History

Received: 04 August 2023

Accepted after revision: 13 November 2023

Accepted Manuscript online:
13 November 2023

Article published online:
03 January 2024

© 2023. Thieme. All rights reserved.

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  • References

  • 1 Opoku S, Gan Y, Yobo EA. et al. Awareness, treatment, control, and determinants of dyslipidemia among adults in China. Sci Rep 2021; 11: 10056
  • 2 Huang Y, Gao L, Xie X. et al Epidemiology of dyslipidemia in Chinese adults: meta-analysis of prevalence, awareness, treatment, and control. Popul Health Metr 2014; 12 Article No. 28
  • 3 Collins R, Reith C, Emberson J. et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; 388: 2532-2561
  • 4 Working Group of the Evaluation on the Safety of S. [Experts consensus of the evaluation on the statin drugs safty]. Zhonghua Xin Xue Guan Bing Za Zhi 2014; 42: 890-894
  • 5 Bays H, Cohen DE, Chalasani N. et al. An assessment by the Statin Liver Safety Task Force: 2014 update. J Clin Lipidol 2014; 8: S47-S57
  • 6 Yu Y-C, Mao Y-M, Chen C-W. et al. CSH guidelines for the diagnosis and treatment of drug-induced liver injury. Hepatol Int 2017; 11: 221-241
  • 7 Shen T, Liu Y, Shang J. et al. Incidence and etiology of drug-induced liver injury in mainland China. Gastroenterology 2019; 156: 2230-2241 e11
  • 8 Li C-P, Song Y-X, Lin Z-J. et al Essential trace elements in patients with dyslipidemia: A meta-analysis. Curr Med Chem 2023; DOI: 10.2174/0929867330666230428161653. Online ahead of print
  • 9 Wang YR, Pan R, He L. Taking medication for diabetes may modify the link between serum zinc concentrations and prediabetes and diabetes in the general population. Biol Trace Elem Res 2023; 201: 1118-1119
  • 10 Song YX, He LP, Li CP. The relationship between serum calcium level and risk factor of pregnancy-induced hypertension: a meta-analysis. Clin Exp Obstet Gynecol 2023; 50: 66
  • 11 Li XY, Zhong W, Mao Ym. [Statin-related drug-induced liver injury]. Zhonghua Gan Zang Bing Za Zhi 2023; 31: 659-663
  • 12 Averbukh LD, Turshudzhyab A, Wu DC. et al. Statin-induced liver injury patterns: a clinical review. J Clin Transl Hepatol 2022; 10: 543-552
  • 13 Yu J-M, Chen W-M, Shia B-C. et al. Protective effects of different classes, intensity, cumulative dose-dependent of statins against primary ischemic stroke in patients with type 2 diabetes mellitus. Curr Atheroscler Rep 2023; 25: 619-628
  • 14 Huang P-H, Lu Y-A, Tsai Y-L. et al. 2022 Taiwan lipid guidelines for primary prevention. J Formos Med Assoc 2022; 121: 2393-2407
  • 15 Sniderman AD. Is there value in liver function test and creatine phosphokinase monitoring with statin use?. Am J Cardiol 2004; 94: 30F-34F
  • 16 Tsui L, Chen L, Ye P. et al. Adverse drug reactions of non-statin antihyperlipidaemic drugs in China from 1989 to 2019: a national database analysis. BMJ Open 2023; 13: e068915
  • 17 Charles EC, Olson KL, Sandhoff BG. et al. Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization. Am J Med 2005; 118: 618-624
  • 18 Bjornsson E, Jacobsen EI, Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. J Hepatol 2012; 56: 374-380
  • 19 He LP, Zhou ZX, Li CP. Narrative review of ferroptosis in obesity. J Cell Mol Med 2023; 27: 920-926
  • 20 Li CP, Su HQ, He LP. Vitamin D may alleviate pre-eclampsia by modulating the ferroptosis signalling pathway: a hypothesis based on recent literature. J Cell Mol Med 2023; 27: 1923-1927
  • 21 Yu XL, Li CP, He LP. Vitamin D may alleviate irritable bowel syndrome by modulating serotonin synthesis: a hypothesis based on recent literature. Front Physiol 2023; 14: 1152958
  • 22 Yu X-L, Wu Q-Q, He LP. et al. Role of in vitamin D in irritable bowel syndrome. World J Clin Cases 2023; 11: 2677-2683