Statins and the risk of liver injury: A population-based case-control study

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 7, 2014, Pages 719-725

  Chen, Guan Lin ^a   Hsiao, Fei Yuan ^a,b   Dong, Yaa Hui ^c   Shen, Li Jiuan ^a,b   Wu, Fe Lin Lin ^a,b  

^a NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^c NATIONAL TAIWAN UNIVERSITY   (Taiwan)

Author keywords

Case control study; Liver injury; National Health Insurance Research Database (NHIRD); Pharmacoepidemiology; Statin

Indexed keywords

ATORVASTATIN; BILIRUBIN; FLUINDOSTATIN; MEVINOLIN; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; FLUOROBENZENE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PYRIMIDINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ARTICLE; BILIRUBIN BLOOD LEVEL; CHOLELITHIASIS; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG USE; FEMALE; HOSPITAL ADMISSION; HUMAN; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; POPULATION BASED CASE CONTROL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; CASE CONTROL STUDY; DOSE RESPONSE; DRUG-INDUCED LIVER INJURY; FACTUAL DATABASE; MIDDLE AGED; MULTIVARIATE ANALYSIS; REGRESSION ANALYSIS; RISK; TAIWAN; YOUNG ADULT;

ADULT; AGED; CASE-CONTROL STUDIES; DATABASES, FACTUAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG-INDUCED LIVER INJURY; FEMALE; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PYRIMIDINES; REGRESSION ANALYSIS; RISK; SULFONAMIDES; TAIWAN; YOUNG ADULT;

EID: 84903820325     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3646     Document Type: Article

References (43)

1. Spencer FA, Allegrone J, Goldberg RJ, et al. Association of statin therapy with outcomes of acute coronary syndromes: the GRACE study. Ann Intern Med 2004; 140: 857-866.
2. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90, 056 participants in 14 randomised trials of statins. Lancet 2005; 366: 1267-1278.
3. Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170, 000 participants in 26 randomised trials. Lancet 2010; 376: 1670-1681.
4. MacDonald JS, Gerson RJ, Kornbrust DJ, et al. Preclinical evaluation of lovastatin. Am J Cardiol 1988; 62: 16J-27J.
5. Horsmans Y, Desager JP, Harvengt C. Biochemical changes and morphological alterations of the liver in guinea-pigs after administration of simvastatin (HMG CoA reductase-inhibitor). Pharmacol Toxicol 1990; 67: 336-339.
6. Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation 2006; 114: 2788-2797.
7. Tolman KG. Defining patient risks from expanded preventive therapies. Am J Cardiol 2000; 85: 15E-19E.
8. Russo MW, Scobey M, Bonkovsky HL. Drug-induced liver injury associated with statins. Semin Liver Dis 2009; 29: 412-422.
9. Chao P-H, Chen W-W, On A. Drug induced liver injury: analysis of taiwan national adverse drug reaction reporting system. Formos J Med 2013; 17: 457-467.
10. Tzefos M, Olin JL. 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor use in chronic liver disease: a therapeutic controversy. J Clin Lipidol 2011; 5: 450-459.
11. Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol 2007; 47: 135-141.
12. Athyros VG, Tziomalos K, Gossios TD, et al. Safety and efficacy of long-term statin treatment for cardiovascular events in patients with coronary heart disease and abnormal liver tests in the Greek Atorvastatin and Coronary Heart Disease Evaluation (GREACE) Study: a post-hoc analysis. Lancet 2010; 376: 1916-1922.
13. Khorashadi S, Hasson NK, Cheung RC. Incidence of statin hepatotoxicity in patients with hepatitis C. Clin Gastroenterol Hepatol 2006;4:902-907; quiz 806.
14. Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy 2007; 27: 845-851.
15. Abraldes JG, Albillos A, Banares R, et al. Simvastatin lowers portal pressure in patients with cirrhosis and portal hypertension: a randomized controlled trial. Gastroenterology 2009; 136: 1651-1658.
16. Abu Rajab M, Kaplan MM. Statins in primary biliary cirrhosis: are they safe? Dig Dis Sci 2010; 55: 2086-2088.
17. Hsiao F, Yang C, Huang Y, Huang W. Using Taiwan's national health insurance research databases for pharmacoepidemiology research. J Food Drug Anal 2007; 15: 99.
18. Petrovic M, Reiter M, Zipko H, Pohl W, Wanke T. Effects of inspiratory muscle training on dynamic hyperinflation in patients with COPD. Int J Chron Obstruct Pulmon Dis 2012; 7: 797-805.
19. Jinjuvadia K, Kwan W, Fontana RJ. Searching for a needle in a haystack: use of ICD-9-CM codes in drug-induced liver injury. Am J Gastroenterol 2007; 102: 2437-2443.
20. Romans SE, Kreindler D, Asllani E, et al. Mood and the menstrual cycle. Psychother Psychosom 2013; 82: 53-60.
21. Petrovic MA, Kretzer R, Simon BA, Berkow LC. Mechanical airway obstruction due to dislodged spinal hardware. J Clin Anesth 2012; 24: 578-581.
22. Group TLS. Long-term effectiveness and safety of pravastatin in 9014 patients with coronary heart disease and average cholesterol concentrations: the LIPID trial follow-up. Lancet 2002; 359: 1379-1387.
23. Hippisley-Cox J, Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ 2010;340:c2197.
24. Alsheikh-Ali AA, Ambrose MS, Kuvin JT, Karas RH. The safety of rosuvastatin as used in common clinical practice: a postmarketing analysis. Circulation 2005; 111: 3051-3057.
25. Famularo G, Miele L, Minisola G, Grieco A. Liver toxicity of rosuvastatin therapy. World J Gastroenterol 2007; 13: 1286-1288.
26. Wolters LM, Van Buuren HR. Rosuvastatin-associated hepatitis with autoimmune features. Eur J Gastroenterol Hepatol 2005; 17: 589-590.
27. Kato JD, Wang CT. Cardiac rehabilitation participant with sickle cell trait and statin-related hepatotoxicity: a case report. J Cardiopulm Rehabil Prev 2012; 32: 182-186.
28. Nezasa K, Higaki K, Hasegawa H, et al. Uptake of HMG-CoA reductase inhibitor ZD4522 into hepatocytes and distribution into liver and other tissues of the rat. Atherosclerosis 2000; 151: 39.
29. Nezasa K, Higaki K, Matsumura T, et al. Liver-specific distribution of rosuvastatin in rats: comparison with pravastatin and simvastatin. Drug Metab Dispos 2002; 30: 1158-1163.
30. Kitamura S, Maeda K, Wang Y, Sugiyama Y. Involvement of multiple transporters in the hepatobiliary transport of rosuvastatin. Drug Metab Dispos 2008; 36: 2014-2023.
31. Niemi M. Role of OATP transporters in the disposition of drugs. Pharmacogenomics 2007; 8: 787-802.
32. Kalliokoski A, Niemi M. Impact of OATP transporters on pharmacokinetics. Br J Pharmacol 2009; 158: 693-705.
33. Pasanen MK, Fredrikson H, Neuvonen PJ, Niemi M. Different effects of SLCO1B1 polymorphism on the pharmacokinetics of atorvastatin and rosuvastatin. Clin Pharmacol Ther 2007; 82: 726-733.
34. Iusuf D, van Esch A, Hobbs M, et al. Murine Oatp1a/1b uptake transporters control rosuvastatin systemic exposure without affecting its apparent liver exposure. Mol Pharmacol 2013; 83: 919-929.
35. Zhang W, Yu BN, He YJ, et al. Role of BCRP 421C>A polymorphism on rosuvastatin pharmacokinetics in healthy Chinese males. Clin Chim Acta 2006; 373: 99-103.
36. Zamber CP, Lamba JK, Yasuda K, et al. Natural allelic variants of breast cancer resistance protein (BCRP) and their relationship to BCRP expression in human intestine. Pharmacogenetics 2003; 13: 19-28.
37. Tomita Y, Maeda K, Sugiyama Y. Ethnic variability in the plasma exposures of OATP1B1 substrates such as HMG-CoA reductase inhibitors: a kinetic consideration of its mechanism. Clin Pharmacol Ther 2013; 94: 37-51.
38. Lee E, Ryan S, Birmingham B, et al. Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin Pharmacol Ther 2005; 78: 330-341.
39. Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 2004; 292: 2585-2590.
40. Ucar M, Mjorndal T, Dahlqvist R. HMG-CoA reductase inhibitors and myotoxicity. Drug Saf 2000; 22: 441-457.
41. Rosenson RS. Current overview of statin-induced myopathy. Am J Med 2004; 116: 408-416.
42. Neuvonen PJ, Niemi M, Backman JT. Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance. Clin Pharmacol Ther 2006; 80: 565-581.
43. Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology 1997; 26: 664-669.