Lipid-lowering agents and hepatotoxicity

Clinics in Liver Disease

Volumn 17, Issue 4, 2013, Pages 699-714

  Demyen, Michael ^a   Alkhalloufi, Kawtar ^b   Pyrsopoulos, Nikolaos T ^a  

^a RUTGERS NEW JERSEY MEDICAL SCHOOL   (United States)

^b HOWARD UNIVERSITY COLLEGE OF MEDICINE   (United States)

Author keywords

Drug induced liver injury; Hepatotoxicity; Lipid lowering agents; Statins

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; ATORVASTATIN; CERIVASTATIN; CHOLESTEROL; CLARITHROMYCIN; COLESEVELAM; COLESTIPOL; COLESTYRAMINE; CYCLOSPORIN; CYTOCHROME P450 3A4; DICLOFENAC; DIGOXIN; EZETIMIBE; FENOFIBRATE; FENOFIBRIC ACID; FLUINDOSTATIN; GEMFIBROZIL; ITRACONAZOLE; MEVINOLIN; NEFAZODONE; NICOTINAMIDE; NICOTINIC ACID; PITAVASTATIN; PLACEBO; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TACROLIMUS; UNINDEXED DRUG;

ACUTE LIVER FAILURE; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL ACTIVITY; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BODY MASS; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CHOLESTEROL SYNTHESIS; CHRONIC LIVER DISEASE; CLINICAL EVALUATION; COMPARATIVE STUDY; DECOMPENSATED LIVER CIRRHOSIS; DRUG EFFECT; DRUG SAFETY; DYSLIPIDEMIA; FLUSHING; FOOD AND DRUG ADMINISTRATION; GRANULOMATOSIS; HEART PROTECTION; HEPATITIS C; HUMAN; HYDROPHILICITY; KIDNEY GRAFT; LIVER FUNCTION; LIVER FUNCTION TEST; LIVER INJURY; LIVER TOXICITY; LOW DRUG DOSE; META ANALYSIS; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONALCOHOLIC FATTY LIVER; OBSTRUCTIVE JAUNDICE; OPEN STUDY; PATIENT SELECTION; POSTMARKETING SURVEILLANCE; PRIMARY BILIARY CIRRHOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; REVIEW; RISK REDUCTION; SECONDARY PREVENTION; SIDE EFFECT; TREATMENT FAILURE;

DRUG-INDUCED LIVER INJURY; HEPATOTOXICITY; LIPID-LOWERING AGENTS; STATINS;

CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DRUG-INDUCED LIVER INJURY; HUMANS; HYPOLIPIDEMIC AGENTS;

EID: 84884939001     PISSN: 10893261     EISSN: 15578224     Source Type: Journal    
DOI: 10.1016/j.cld.2013.07.016     Document Type: Review

References (55)

1. Jellinger P.S., Smith D.A., Mehta A.E., et al. American Association of Clinical Endocrinologists' guidelines for management of dyslipidemia and prevention of atherosclerosis. Endocr Pract 2012, 18(Suppl 1):1-78.
2. Smith S.C., Benjamin E.J., Bonow R.O., et al. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association. JAm Coll Cardiol 2011, 58(23):2432-2446.
3. Bader T. The myth of statin-induced hepatotoxicity. Am J Gastroenterol 2010, 105:978-980. 10.1038/ajg.2010.102.
4. Hunninghake D.B. HMG-CoA reductase inhibitors. Curr Opin Lipidol 1992, 3:22-28.
5. Law M.R., Wald N.J., Rudnicka A.R. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 2003, 326:1423.
6. Rzouq F.S., Volk M.L., Hatoum H.H., et al. Hepatotoxicity fears contribute to underutilization of statin medications by primary care physicians. Am J Med Sci 2010, 340:89-93.
7. De Denus S., Spinler S.A., Miller K., et al. Statins and liver toxicity: a meta-analysis. Pharmacotherapy 2004, 24:584-591.
8. Law M., Rudnicka A.R. Statin safety: a systematic review. Am J Cardiol 2006, 97(8A):52C-60C.
9. Bradford R.H., Shear C.L., Chremos A.N., et al. 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(1):43-49.
10. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994, 344(8934):1383-1389.
11. MRC/BHF Heart Protection Study Collaborative Group, Armitage J., Bowman L., Collins R., et al. Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people. BMC Clin Pharmacol 2009, 9:6.
12. Shepherd J., Cobbe S.M., Ford I., for the West of Scotland Coronary Prevention Study Group (WOS), et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. NEngl J Med 1995, 333:1301-1307.
13. The Long-term Intervention with Pravastatin in Ischemic Disease Group (LIPID). Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. NEngl J Med 1998, 339:1349-1357.
14. Sacks F.M., Pfeffer M.A., Moye L.A., for the Cholesterol and Recurrent Events Trial Investigators (CARE), et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. NEngl J Med 1996, 335:1001-1009.
15. Garcia-Rodriguez L.A., Masso-Gonzalez E.L., Wallander M.A., et al. The safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care. Pharmacoepidemiol Drug Saf 2008, 17:943-952.
16. Arca M. Atorvastatin: a safety and tolerability profile. Drugs 2007, 67(Suppl 1):63-69.
17. Dale K.M., White C.M., Henyan N.N., et al. Impact of statin dosing intensity on transaminase and creatine kinase. Am J Med 2007, 120(8):706-712.
18. Newman C., Tsai J., Szarek M., et al. Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients. Am J Cardiol 2006, 97(1):61-67.
19. Alsheikh-Ali A.A., Maddukuri P.V., Han H., et al. Effect of the magnitude of lipid lowering on risk of elevated liver enzymes, rhabdomyolysis, and cancer: insights from large randomized statin trials. JAm Coll Cardiol 2007, 50:409-418.
20. Jacobson T.A. Statin safety: lessons from new drug applications for marketed statins. Am J Cardiol 2006, 97(8A):44C-51C.
21. Tolman K.G. Defining patient risks from expanded preventive therapies. Am J Cardiol 2000, 85:15E-19E.
22. Björnsson E., Jacobsen E.I., Kalaitzakis E. Hepatotoxicity associated with statins: reports of idiosyncratic liver injury post-marketing. JHepatol 2012, 56(2):374-380. 10.1016/j.jhep.2011.07.023.
23. Bellosta S., Paoletti R., Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation 2004, 109(23 Suppl 1):III50-III57.
24. Jacobson T.A. Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when coadministered with cytochrome P450 inhibitors. Am J Cardiol 2004, 94(9):1140-1146.
25. Holdaas H., Fellström B., Jardine A.G., et al. Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet 2003, 361(9374):2024-2031.
26. Madhoun M.F., Bader T. Statins improve ALT values in chronic hepatitis C patients with abnormal values. Dig Dis Sci 2010, 55:870-871.
27. Khorashadi S., Hasson N.K., Cheung R.C. Incidence of statin hepatotoxicity in patients with hepatitis C. Clin Gastroenterol Hepatol 2006, 4(7):902-907. [quiz: 806].
28. Bader T., Fazili J., Madhoun M., et al. Fluvastatin inhibits hepatitis C replication in humans. Am J Gastroenterol 2008, 103:1383-1389.
29. Matalka M.S., Ravnan M.C., Deedwania P.C. Is alternate daily dose of atorvastatin effective in treating patients with hyperlipidemia? The Alternate Day versus Daily Dosing of Atorvastatin Study (ADDAS). Am Heart J 2002, 144:674-677.
30. Athyros V.G., Tziomalos K., Gossios T.D., 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.
31. Bader T. Liver tests are irrelevant when prescribing statins. Lancet 2010, 376:1882-1883.
32. Lewis J.H., Mortensen M.E., Zweig S., et al. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatology 2007, 46(5):1453-1463.
33. Cohen D., Anania F., Chalasani N. An assessment of statin safety by hepatologists. Am J Cardiol 2006, 97:C77-C81.
34. Simonson S.G., Martin P.D., Mitchell P., et al. Pharmacokinetics and pharmacodynamics of rosuvastatin in subjects with hepatic impairment. Eur J Clin Pharmacol 2003, 58(10):669-675.
35. Onofrei M.D., Butler K.L., Fuke D.C., et al. Safety of statin therapy in patients with preexisting liver disease. Pharmacotherapy 2008, 28(4):522-529.
36. Abraldes J.G., Albillos A., Bañares R., et al. Simvastatin lowers portal pressure in patients with cirrhosis and portal hypertension: a randomized controlled trial. Gastroenterology 2009, 136:1651-1658.
37. Garcia-Calvo M., Lisnock J., Bull H.G., et al. The target of ezetimibe is Niemann-Pick C1-Like 1 (NPC1L1). Proc Natl Acad Sci USA 2005, 102:8132-8137.
38. Gagné C., Bays H.E., Weiss S.R., et al. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol 2002, 90:1084-1091.
39. Knopp R.H., Dujovne C.A., Le Beaut A., et al. Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: a pooled analysis from two controlled phase III clinical studies. Int J Clin Pract 2003, 57:363-368.
40. Dujovne C.A., Suresh R., McCrary Sisk C., et al. Safety and efficacy of ezetimibe monotherapy in 1624 primary hypercholesterolaemic patients for up to 2 years. Int J Clin Pract 2008, 62:1332-1336.
41. Castellote J., Ariza J., Rota R., et al. Xavier Xiol Serious drug-induced liver disease secondary to ezetimibe. World J Gastroenterol 2008, 14(32):5098-5099.
42. Goldman-Levine J.D., Bohlman L.G. Ezetimibe/simvastatin (Vytorin) for hypercholesterolemia. Am Fam Physician 2005, 72:2081-2082.
43. Conard S., Bays H., Leiter L.A., et al. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab 2010, 12:210-218.
44. Zimmerman H.J. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver 1999, 660. Lippincott, Philadelphia, 662. 2nd edition.
45. The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA 1984, 251(3):351-364.
46. The Lovastatin Study Group III. A multicenter comparison of lovastatin and cholestyramine therapy for severe primary hypercholesterolemia. JAMA 1988, 260:359-366.
47. Sirmans S.M., Beck J.K., Banh H.L., et al. Colestipol-induced hepatotoxicity. Pharmacotherapy 2001, 21(4):513-516.
48. Goldfine A.B., Fonseca V.A., Jones M.R., et al. Long-term safety and tolerability of colesevelam HCl in subjects with type 2 diabetes. Horm Metab Res 2010, 42:23-30.
49. Backes J.M., Padley R.J., Moriarty P.M. Important considerations for treatment with dietary supplement versus prescription niacin products. Postgrad Med 2011, 123:70-83.
50. Mckenney J.M., Proctor J.D., Harris S., et al. Acomparison of the efficacy and toxic effects of sustained versus immediate release niacin in hypercholesterolemic patients. JAMA 1994, 271:672-677.
51. Mohiuddin S.M., Pepine C.J., Kelly M.T., et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J 2009, 157(1):195-203.
52. Backes J.M., Howard P.A., Ruisinger J.F., et al. Does simvastatin cause more myotoxicity compared with other statins?. Ann Pharmacother 2009, 43:2012-2020.
53. Murdock D.K., Murdock A.K., Murdock R.W., et al. Long-term safety and efficacy of combination gemfibrozil and HMG-CoA reductase inhibitors for the treatment of mixed lipid disorders. Am Heart J 1999, 138:151-155.
54. Athyros V.G., Papageorgiou A.A., Hatzikonstandinou H.A., et al. Safety and efficacy of long-term statin-fibrate combinations in patients with refractory familial combined hyperlipidemia. Am J Cardiol 1997, 80:608-613.
55. Riegger G., Abletshauser C., Ludwig M., et al. The effect of fluvastatin on cardiac events in patients with symptomatic coronary artery disease during one year of treatment. Atherosclerosis 1999, 144(1):263-270.