Hepatotoxicity associated with statins

1. Bjørneboe M, Iversen O, Olsen S. Infective hepatitis and toxic jaundice in a municipal hospital during a five-year period: incidence and prognosis. Acta Med Scand 1967;182:491-501. doi: 10.1111/j.0954-6820.1967.tb10873.xSearch in Google Scholar

2. Malchow-Møller A, Matzen P, Bjerregaard B, Hilden J, Holst-Christensen J, Staehr JT, Altman L, Thomsen C, Juhl E. Causes and characteristics of 500 consecutive causes of jaundice. Scand J Gastroenterol 1981;16:1-6. PMID: 7233075Search in Google Scholar

3. Whitehead MW, Hainsworth I, Kingham JG. The causes of obvious jaundice in South West Wales: perceptions versus reality. Gut 2001;48:409-13. doi: 10.1136/gut.48.3.409Search in Google Scholar

4. Björnsson E, Ismael S, Nejdet S, Kilander A. Severe jaundice in Sweden in the new millennium: causes, investigations, treatment and prognosis. Scand J Gastroenterol 2003;38:86-94. doi: 10.1080/00365520310000492Search in Google Scholar

5. Ostapowicz G, Fontana RJ, Schiodt FV, Larson A, Davern TJ, Han SHB, McCashland TM, Shakil AO, Hay JE, Hynan L, Crippin JS, Blei AT, Samuel G, Reisch J, Lee WM; U.S. Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002;137:947-54. doi: 10.7326/0003-4819-137-12-200212170-00007Search in Google Scholar

6. Williams R. Classification, etiology, and considerations of outcome in acute liver failure. Semin Liver Dis 1996;16:343-8. doi: 10.1055/s-2007-1007247Search in Google Scholar

7. Wei G, Bergqvist A, Broome U, Björnsson E. Acute liver failure in Sweden: etiology and prognosis. Scand J Gastroenterol 2004;39(Suppl 240):48A.Search in Google Scholar

8. O'Grady JG, Alexander GJM, Hayllar KM, Williams R. Early indicators of prognosis in fulminant hepatic failure. Gastroenterology 1989;97:439-45. doi: 10.1016/0016- 5085(89)90081-4Search in Google Scholar

9. Hoofnagle JH, Carithers RL Jr, Shapiro C, Nascher H. Fulminant hepatic failure: summary of a workshop. Hepatology 1995;21:240-52. doi: 10.1016/0270- 9139(95)90434-4Search in Google Scholar

10. Bakke OM, Manocchia M, de Abajo F, Kaitin KI, Lasagna L. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective. Clin Pharm Therap 1995;58:108-17. doi: 10.1016/0009-9236(95)90078-0Search in Google Scholar

11. Zimmerman HJ. Drug-induced liver disease. Clin Liver Dis 2000;4:73-96. PMID: 1123219210.1016/S1089-3261(05)70097-0Search in Google Scholar

12. Black M, Mitchell JR, Zimmerman HJ, Ishak KG, Epler GR. Isoniazid-associated hepatitis in 114 patients. Gastroenterology 1975;69:289-302. PMID: 115003910.1016/S0016-5085(19)32568-5Search in Google Scholar

13. Senior JR. Regulatory perspectives. In: Kaplowitz N, DeLeve D, editors. Drug-induced liver disease. New York: Marcel Dekker; 2003. p. 739-54.Search in Google Scholar

14. Zimmerman HJ. Drug-induced liver disease. In: Sciff ER, Sorrell MF, Maddrey WC, editors. Sciff′s diseases of the liver. 8th edition. Philadelphia: Lippincott-Raven Publishers; 1999. p. 973-1064.Search in Google Scholar

15. Pillans PI. Drug associated hepatic reactions in New Zealand: 21-years’ experience. N Z Med J 1996;109:315-9. PMID: 8816722 Search in Google Scholar

16. Friis H, Andreasen PB. Drug-induced hepatic injury: an analysis of 1100 cases reported to the Danish Committee on Adverse Drug Reactions between 1978 and 1987. J Intern Med 1992;232:133-8. doi: 10.1111/j.1365-2796.1992.tb00562.xSearch in Google Scholar

17. Golomb BA, Evans MA. Statin adverse effects: a review of the literature and evidence for a mitochondrial mechanism. Am J Cardiovasc Drugs 2008;8:373-418. doi: 10.2165/0129784-200808060-0000Search in Google Scholar

18. Björnsson E, Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology 2005;42:481-9. doi: 10.1002/hep.20800 Search in Google Scholar

19. Kshirsagar A, Vetal Y, Ashok P, Bhosle P, Ingawale D. Drug induced hepatotoxicity: a comprehensive review. Internet J Pharmacol 2008 [displayed 18 October 2017]. Available at http://ispub.com/IJPHARM/7/1/372310.5580/2b8Search in Google Scholar

20. Cohen DE, Anania FA, Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006;97(Suppl 1):77C-81C. doi: 10.1016/j.amjcard.2005.12.014Search in Google Scholar

21. Bhardwaj SS, Chalasani N. Lipid lowering agents that cause drug-induced hepatotoxicity. Clin Liver Dis 2007;11:597-613. doi: 10.1016/j.cld.2007.06.010 Search in Google Scholar

22. Kubota T, Fujisaki K, Itoh Y, Yano T, Sendo T, Oishi R. Apoptotic injury in cultured human hepatocytes induced by HMG-CoA reductase inhibitors. Biochem Pharmacol 2004;67:2175-86. doi: 10.1016/j.bcp.2004.02.037Search in Google Scholar

23. Wolters LMM, Van Buuren HR. Rosuvastatin-associated hepatitis with autoimmune features. Eur J Gastroenterol Hepatol 2005;17:589-90. PMID: 1582745310.1097/00042737-200505000-0001915827453Search in Google Scholar

24. Russo MW, Hoofnagle JH, Gu J, Fontana RJ, Barnhart H, Kleiner DE, Chalasani N, Bonkovsky HL. Spectrum of statin hepatotoxicity: experience of the drug-induced liver injury network. Hepat 2014;60:679-86. doi: 10.1002/hep.27157Search in Google Scholar

25. Kubatka P, Kruzliak P, Rotrekl V, Jelinkova S, Mladosievicova B. Statins in oncological research: from experimental studies to clinical practice. Crit Rev Oncol Hematol 2014;92:296-311. doi: 10.1016/j.critrevonc.2014.08.002Search in Google Scholar

26. Cueto R, Valdivielso P, Lucena MI, Garcίa-Arias C, Andrade RJ, Gonzάlez-Santos P. Statins: hepatic disease and hepatotoxicity risk. Open Gastroenterol J 2008;2:18-23. doi: 10.2174/1874259900802010018Search in Google Scholar

27. Chalasani N. Statins and hepatotoxicity: focus on patients with fatty liver. Hepat 2005;41:690-5. doi: 10.1002/hep.20671Search in Google Scholar

28. Thapar M, Russo MW, Bonkovsky HL. Statins and liver injury. Gastroenterol Hepatol 2013;9:605-6. PMCID: PMC3983981Search in Google Scholar

29. Abdoli N, Azarmi Y, Eghbal MA. Protective effects of N-acetylcysteine against the statins cytotoxicity in freshly isolated rat hepatocytes. Adv Pharm Bull 2014;4:249-54. doi: 10.5681/apb.2014.036Search in Google Scholar

30. Tolosa L, Carmona A, Castell JV, Gόmez-Lechόn MJ, Donato MT. High-content screening of drug-induced mitocondrial impairment in hepatic cells: effects of statins. Arch Toxicol 2015;89:1847-60. doi: 10.1007/s00204-014-1334-3Search in Google Scholar

31. Ciba M, Ak M, Karahalil B. Alpha-glutathione-s-transferase can be a biomarker for both drug-related toxicity as well as individual susceptibility. Minerva Psichiatr 2016;57:62-71.Search in Google Scholar

32. Abdoli N, Heidari R, Azarmi Y, Eghbal MA. Mechanism of the statins cytotoicity in freshly isolated rat hepatocytes. J Biochem Molecular Toxicol 2013;27:287-94. doi: 10.1002/ jbt21485Search in Google Scholar

33. Haque T, Sasatomi E, Hayashi PH. Drug-induced liver injury: Pattern recognition and future directions. Gut Liver 2016;10:27-36. doi: 10.5009/gnl15114Search in Google Scholar

34. Fitchett DH, Hegele RA, Verma S. Cardiology patient page. Statin intolerance. Circulation 2015;131:e389-91. doi: 10.1161/CIRCULATIONAHA.114.013189Search in Google Scholar

35. Wang LY, Huang Y, Perng C, Huang B, Lin H. Statin-induced liver injury in an area endemic for hepatitis B virus infection: risk factors and outcome analysis. Br J Clin Pharmacol 2016;82:823-30. doi: 10.1111/bcp.13009Search in Google Scholar

36. de Denus S, Spinler SA, Miller K, Peterson AM. Statins and liver toxicity: a meta-analysis. Pharmacotherapy 2004;24:584-91. doi: 10.1592/phco.24.6.584.34738Search in Google Scholar

37. Bradford RH, Shear CL, Achanassios N, Chremos AN, Dujovne C, Downton M, Franklin FA, Gould AL, Hesney M, Higgins J, Hurley DP, Langendorfer A, Nash DT, Pool JL, Schnaper H. Expanded clinical evaluation of lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Arch Intern Med 1991;151:43-9. doi: 10.1001/archinte.1991.00400010067008Search in Google Scholar

38. Roberts WC. Getting more people on statins. Am J Cardiol 2002;90:683-5. doi: 10.1016/S0002-9149(02)02590-0Search in Google Scholar

39. Tolman KG. The liver and lovastatin. Am J Cardiol 2002;89:1374-80. doi: 10.1016/S0002-9149(02)02355-XSearch in Google Scholar

40. Kirchheiner J, Kudlicz D, Meisel C, Bauer S, Meineke I, Roots I, Brockmöller J. Influence of CYP2C9 polymorphisms on the pharmacokinetics and cholesterollowering activity of (-)-3S,5R-fluvastatin and (+)-3R,5S-fluvastatin in healthy volunteers. Clin Pharmacol Ther 2003;74:186-94. doi: 10.1016/S0009-9236(03)00121-8Search in Google Scholar

41. Flockhart DA, Rae JM. Cytochrome P450 3A pharmacogenetics: the road that needs traveled. Pharmacogenom J 2003;3:3-5. doi: 10.1038/sj.tpj.6500144Search in Google Scholar

42. Chalasani N, Björnsson E. Risk factors for idiosyncratic drug-induced liver injury. Gastroenterology 2010;138:2246-59. doi: 10.1053/j.gastro.2010.04.001Search in Google Scholar

43. Zhong G, Liu Y, Ye Y, Hao F, Wang K, Gong J. Meta-analysis of studies using statins as a reducer for primary liver cancer risk. Sci Rep 2016;26256-65. doi: 10.1038/srep26256Search in Google Scholar

44. Licata A, Minissale MG, Calvaruso V, Craxì A. A focus on epidemiology of drug-induced liver injury: analysis of a prospective cohort. Eur Rev Med Pharmacol Sci 2017;21(Suppl 1):112-21. PMID: 28379588Search in Google Scholar

45. Björnsson E, Jacobsen EI, Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. J Hepatol 2012;56:374-80. doi: 10.1016/j. jhep.2011.07.023Search in Google Scholar

46. Leise MD, Poterucha JJ, Talwalkar JA. Drug-induced liver injury. Mayo Clin Proc 2014;89:95-106. doi: 10.1016/j. mayocp.2013.09.016Search in Google Scholar

47. Raschi E, Poluzzi E, Koci A, Salvo F, Pariente A, Biselli M, Moretti U, Moore N, De Ponti F. Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system. Br J Clin Pharmacol 2015;80:285-93. doi: 10.1111/bcp.12611Search in Google Scholar

48. Björnsson ES. Drug-induced liver injury: an overview over the most critical compounds. Arch Toxicol 2015;89:327-34. doi: 10.1007/s00204-015-1456-2Search in Google Scholar

49. Russo MW, Scobey M, Bonkovsky HL. Drug-induced liver injury associated with statins. Semin Liver Dis 2009;29:412-22. doi: 10.1055/s-0029-1240010Search in Google Scholar

50. Charles EC, Olson KL, Sandhoff BG, McClure DL, Merenich JA. Evaluation of cases of severe statin-related transaminitis within a large health maintenance organization. Am J Med 2005;118:618-24. doi: 10.1016/j.amjmed.2005.02.008Search in Google Scholar

51. Perdices EV, Medina-Cáliz I, Hernando S, Ortega A, Martín- Ocaña F, Navarro JM, Peláez G, Castiella A, Hallal H, Romero-Gómez M, González-Jiménez A, Robles-Díaz M, Lucena MI, Andrade RJ. Hepatotoxicity associated with statin use: analysis of the cases included in the Spanish Hepatotoxicity Registry. Rev Esp Enferm Dig 2014;106:246-54. PMID: 25075655Search in Google Scholar

52. Chang CH, Chang YC, Lee YC, Liu YC, Chuang LM, Lin JW. Severe hepatic injury associated with different statins in patients with chronic liver disease: a nationwide population- based cohort study. J Gastroenterol Hepatol 2015;30:155-62. doi: 10.1111/jgh.12657Search in Google Scholar

53. Younoszai Z, Li Z, Stepanova M, Erario M, Cable R, Younossi ZM. Statin use is not associated with liver related mortality. Ann Hepatol 2014;13:84-90. doi: 10.1007/s11274- 015-1903-5Search in Google Scholar

54. Rangnekar AS, Fontana RJ. An update on drug induced liver injury. Minerva Gastroenterol Dietol 2011;57:213-29. PMID: 21587150Search in Google Scholar

55. Hussaini SH, Farrington EA. Idiosyncratic drug-induced liver injury: an overview. Expert Opin Drug Saf 2007;6:673-84. doi: 10.1517/14740338.6.6.673Search in Google Scholar