Hepatotoxicity of the thiazolidinediones

Clinics in Liver Disease

Volumn 7, Issue 2, 2003, Pages 369-379

  Tolman, Keith G ^a   Chandramouli, Jane ^b  

^a UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF UTAH HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACARBOSE; ALANINE AMINOTRANSFERASE; ALPHA GLUCOSIDASE INHIBITOR; ANTIDIABETIC AGENT; BIGUANIDE DERIVATIVE; CARBUTAMIDE; CHLORPROPAMIDE; DIASENSOR; GLIBENCLAMIDE; GLIMEPIRIDE; GLIPIZIDE; LIVER ENZYME; METAHEXAMIDE; METFORMIN; MIGLITOL; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; REPAGLINIDE; ROSIGLITAZONE; SULFONYLUREA DERIVATIVE; TROGLITAZONE;

ANIMAL CELL; ANIMAL MODEL; CHOLESTASIS; CLINICAL TRIAL; DIABETES MELLITUS; DRUG HYPERSENSITIVITY; DRUG INDUCED DISEASE; DRUG METABOLISM; DRUG MONITORING; DRUG STRUCTURE; EOSINOPHILIA; FEVER; FOOD AND DRUG ADMINISTRATION; HUMAN; INSULIN RESISTANCE; JAUNDICE; LIVER BIOPSY; LIVER FAILURE; LIVER FUNCTION; LIVER TOXICITY; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PRESCRIPTION; RASH; RAT; REVIEW; TOXIC HEPATITIS;

EID: 0037709247     PISSN: 10893261     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1089-3261(03)00020-5     Document Type: Review

References (80)

1. Cowie CC, Eberhardt MS. Diabetes - 1996 Vital Statistics. Alexandria, VA: American Diabetes Association; 1996. p. 1-102.
2. Harris MI, Flegal KM, Cowie CC, et al. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in US adults. Diabetes Care 1998;21:518-24.
3. Diabetes Surveillance. 1997. Center for disease control and prevention. Atlanta, GA: US Department of Health and Human Services; 1997.
4. Economic consequences of diabetes mellitus in the US in 1997. American Diabetes Association. Diabetes Care 1998;21:296-309.
5. Morgan CL, Currie CJ, Stott NC, Smithers M, Butler CC, Peters JR. The prevalence of multiple diabetes-related complications. Diabet Med 2000;17:146-51.
6. Kannel WB, D'Agostino RB, Wilson PWF, Belanger AJ, Gagnon DR. Diabetes, fibrinogen, and risk of cardiovascular disease: the Framingham experience. Am Heart J 1990;120:672-6.
7. Fujiwara T, Yoshioka S, Yoshioka T, Ushiyama I, Horikoshi H. Characterization of new oral antidiabetic agent CS-045 - studies in KK and ob/ob mice and Zucker fatty rats. Diabetes 1988;37:1549-58.
8. Ciaraldi TP, Gilmore A, Olefsky JM, Goldberg M, Heidenreich KA. In vitro studies on the action of CS-045, a new antidiabetic agent. Metabolism 1990;39:1056-62.
9. Day C. Thiazolidinediones, a new class of antidiabetic drugs. Diabet Med 1999;16:179-92.
10. Rocehi S, Auwerx J. Peroxisome proliferator-activated receptor- a versatile metabolic regulator. Ann Med 1999;31:342-51.
11. Samraj GPN, Kuritsky L, Quillen DM. Improving management of type 2 diabetes mellitus: Thiazolidinediones. Hosp Pract (Off Ed) 2000;35:123-32.
12. Jha RJ. Thiazolidinediones - the new insulin enhancers. Clin Exp Hypertens 1999;21:157-66.
13. Clementsen P, Hansen CL, Hoegholm A. Glipizide induced toxic hepatitis. Ugeskr Leager 1986;148:771-2.
14. Johnson MD, Campbell LK, Campbell RK. Troglitazone; review and assessment of its role in the treatment of patients with impaired glucose tolerance and diabetes mellitus. Ann Pharmacother 1998;32:337-48.
15. Gillies PS, Dunn CJ. Pioglitazone. Drugs 2000;60:333-43.
16. Balfour JAB, Plosker GL. Rosiglitazone. Drugs 1999;57:921-32.
17. Gitlin N, Julie NL, Spurr CL, Lim KN, Juarbe HM. Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone. Ann Intern Med 1998;129:36-8.
18. Goodman R, Dean PJ, Radparvar A, et al. Glyburide-induced hepatitis. Ann Intern Med 1987;106:837-9.
19. Herrine SK, Choudhary C. Severe hepatotoxicity associated with troglitazone. Ann Inter Med 1999;130:163-4.
20. Neuschwander-Tetri BA, Isley WL, Oki JC, et al. Troglitazone-induced hepatic failure leading to liver transplantation. A case report. Ann Intern Med 1998;129:38-41.
21. Shibuya A, Watanabe M, Fujita Y, et al. An autopsy case of troglitazone-induced fulminant hepatitis. Diabetes Care 1998;21:2140-3.
22. Watkins PB, Whitcomb RW. Hepatic dysfunction associated with troglitazone. N Engl J Med 1998;338:916-7.
23. Misbin RI. Troglitazone-associated hepatic failure. Ann Intern Med 1999;130:330.
24. Vella A, deGroen PC, Dineen SP. Fatal hepatotoxicity associated with troglitazone. Ann Intern Med 1998;129:1080.
25. Murphy EJ, Davern TJ, Shakil AO, et al, Acute Liver Failure Study Group. Troglitazone-induced fulminant hepatic failure. Dig Dis Sci 2000;45:549-53.
26. Chaudhry MU, Simmons DL. Case of the month. Hepatic and renal failure in a patient taking troglitazone and metformin. J Ark Med Soc 2001;98:16-9.
27. Mathai KJ, Reichheld J, Banner BF, Bankovsky HL. Hepatotoxicity due to troglitazone; report of two cases and review of adverse effect reports to the United States Food and Drug Administration. Am J Gastroenterol 2000;95:272-6.
28. Presented at the Endocrinologic and Metabolic Drugs Advisory Board. April 23, 1999. Available from the US Food and Drug Administration (http://www.fda.gov/ohrms/dockets/ac/99/transcpt/ 3507t2.rtf). Accessed February 2, 2001.
29. Yamazaki H, Suzuki M, Tane K, Shimada N, Nakajima M, Yokoi T. In vitro inhibitory effects of troglitazone and its metabolites on drug oxidation activities of human cytochrome P450 enzymes: comparison with pioglitazone and rosiglitazone. Xenobiotica 2000;30:61-70.
30. Babich MM, Pike I, Shiffman ML. Metformin-induced acute hepatitis. Am J Med 1998;104:490-2.
31. Schneider HL, Hombach KD, Kniaz JL, Efrusy ME. Chlorpropamide hepatotoxicity; report of a case and review of its literature. Am J Gastroenterol 1984;79:721.
32. Clarke BF, Campbell IW, Ewing DJ, et al. Generalized hypersensitivity reaction and visual activities with fatal outcome during glibenclamide therapy. Diabetes 1974;23:739.
33. Zimmerman HJ. Hepatotoxicity - The adverse effects of drugs and other chemicals on the liver. Philadelphia: Lippincott Williams and Wilkins; 1999. p. 575-88.
34. Forman LM, Simmons DA, Diamond RH. Hepatic failure in a patient taking rosiglitazone. Ann Intern Med 2000;132:118-21.
35. Ravinuthala RS, Nori U. Rosiglitazone toxicity. Ann Intern Med 2000;133:658.
36. Al-Jalman J, Arjomand H, Kemp DG, Miltal M. Hepatocellular injury in a patient receiving rosiglitazone. Ann Intern Med 2000;132:121-4.
37. Gouda HE, Khan A, Schwartz J, Cohen RI. Liver failure in a patient treated with long-term rosiglitazone therapy. Am J Med 2001;111:584-5.
38. Maeda K. Hepatocelluar injury in a patient receiving pioglitazone. Ann Intern Med 2002;135:306.
39. Chase MP. Pioglitazone-associated fulminant hepatic failure. Am J Gastroenterol 2002;97:502.
40. May LD, Letkowich JH, Kram MT, Rubin DE. Mixed hepatocellular-cholestatic liver injury after pioglitazone therapy. Ann Intern Med 2002;136:449-52.
41. Zawadzki JK, Green L, Graham BJ. Thioglitazone-associated 15-month post-marketing hepatotoxicity. FDA Science Forum. Available at: http://www.cfsan.fda.gov~frf/forum02/a187ab4.htm. Accessed February 5, 2002.
42. Sahi J, Hamilton G, Sinz M, et al. Effect of troglitazone on cytochrome P450 enzymes in primary cultures of human and rat hepatocytes. Xenobiotics 2000;30:273-84.
43. Moore GA, Rossi L, Nicotera P, Orrenius S, O'Brien PJ. Quinone toxicity in hepatocytes: studies on mitochondrial Ca2 + release induced by benzoquinone derivatives. Arch Biochem Biophys 1987;259:283-95.
44. Lee S-M, Cho T-S, Kim D-J, Cha Y-N. Protective effect of ethanol against acetaminophen-induced hepatotoxicity in mice. Biochem Pharmacol 1999;58:1547-55.
45. Chen W, Koenigs LL, Thompson SJ, et al. Oxidation of acetaminophen to its toxic quinone imine and nontoxic catechol metabolities by baculovirus-expressed and purified human cytochromes P450 2E1 and 2A6. Chem Res Toxicol 1998;11:295-301.
46. Mitchell JR, Jollow DJ, Potter WZ, Davis DC, Gillette JR, Brodie BB. Acetaminophen induced necrosis. 1. Role of drug metabolism. J Pharmacol Exp Ther 1973;187:185-94.
47. Ott P, Ranek L, Young MA. Pharmacokinetics of troglitazone, a PPAR-gamma agonist in patients with hepatic insufficiency. Eup J Clin Pharmacol 1998;54:567-71.
48. Sheth SG, Gordon FD, Chopra S. Non-alcoholic steatohepatitis. Ann Intern Med 1997;216:137-45.
49. James OFW, Day CP. Non-alcoholic steatohepatitis (NASH): a disease of emerging identity and importance. J Hepatol 1998;29:495-501.
50. Matteni CA, Younossi ZM, Gramlich T, et al. Non-alcoholic fatty liver disease: a spectrum of clinical and pathological severity. Gastroenterology 1999;116:1413-9.
51. Knobler H, Schihmanter R, Zifroni A, Fenakel G, Schattner A. Increased risk of type 2 diabetes in noncirrhotic patients with chronic hepatitis C virus infection. Mayo Clin Proc 2000;75:355-9.
52. Mason AL, Lau JYN, Hoang N, et al. Association of diabetes mellitus and chronic hepatitis C virus infection. Hepatology 1999;29:328-33.
53. Loi CM, Randinitis EJ, Vassos AB, et al. Lack of effect of type 11 diabetes on the pharmacokinetics of troglitazone in a multiple dose study. J Clin Pharmacol 1997;37:1114-20.
54. Kostrubsky VE, Sinclair JF, Ramachandran V, et al. The role of conjugation in hepatotoxicity of troglitazone in human and porcine hepatocyte cultures. Drug Metab Disp 2000;28:1192-7.
55. Elcock FJ, Lyron JJ, Hitchcock J, Morgan DG, Bertram TA, Bugelski PJ. Toxicity of troglitazone in cultures of rat hepatocytes. Diabetes 1999;48(Suppl 1):A63.
56. Tetly JN, Maggs JL, Rapeport WG, Pirmohamed M, Perk KB. Enzyme-induction dependent bisactivation of troglitazone and troglitazone quinone In vivo. Chem Res Toxicol 2001;14:965-74.
57. Funk C, Pantze M, Jehle L, et al. Troglitazone-induced intrahepatic cholestasis by an interference with the hepatobiliary export of bile acids in male and female rats. Correlation with gender difference in troglitazone sulfate formation and the inhibition of the canalicular bile soft export pump (Bsep) by troglitazone and troglitazone sulfate. Toxicology 2000;167:82-98.
58. Funk C, Ponelle C, Scheuermann G, Pantze M. Cholestatic potential of troglitazone as a possible factor contributing to troglitazone-induced hepatotoxicity: Vivo and vitro interaction at the canalicular bile soft export pump (Bsep) in the rat. Mol Pharmacol 2001;59:627-35.
59. Lenhard MJ, Funk WB. Failure to develop hepatic injury from rosiglitazone in a patient with a history of troglitazone-induced hepatitis. Diabetes Care 2001;24:168-9.
60. Crutzfeldt W, Soling H-O. Oral treatment of diabetes: a clinical and experimental review [Translated by C. Glees]. Berlin: Springer-Verlag; 1961.
61. Nair S, Diehl AM, Perille R. Metformin in non-alcoholic steatohepatitis: efficacy and safety: a preliminary report. Gastroenterology 2002;122(Suppl):abstract #4.
62. Andrades RJ, Lucena MI, Rodriguez-Mendigobial M. Hepatic injury caused by acarbose. [Letter] Ann Intern Med 1996;124:931.
63. Diaz-Gutierrez FL, Ladero JM, Daiz-Rubio M. Acarbose-induced acute hepatitis. [Letter] Am J Gastroenterol 1998;93:481.
64. Carrascosa M, Pascual F, Aresti S. Acarbose-induced acute severe hepatotoxicity. [Letter] Lancet 1998;349:698.
65. Pnnekoek JH. Insulin, glucagon and oral hypoglycemic drugs. In: Dukes MNG, editor. Meyler's side effects of drugs, Vol 8. Amsterdam: Excerpta Medica Foundation; 1975. p. 904-27.
66. Anderson RC, Worth AB, Harris PO. Toxicological studies on carbutamide. Diabetes 1957;6:2.
67. Reichel J, Goldberg SB, Ellenberg M, Schaffner F. Intrahepatic cholestasis following administration of chlorpropamide: report of a case with electron microscopic observations. Am J Med 1960;28:654.
68. Gupta R, Sachar DB. Chlorpropamide-induced cholestatic jaundice and pseudomembranous colitis. Am J Gastroenterol 1985;80:381.
69. Frier BM, Stewart WK. Cholestatic jaundice following chlorpropamide self-poisoning. Clin Toxicol 1977;11:13.
70. Rigberg LA, Robinson MJ, Esperitu C. Chlorpropamide-induced granulomas: a probable hypersensitivity reaction in liver and bone marrow. JAMA 1976;235:409.
71. Davis TW, Kerr RB, Bogoch A. Experience with glipasol (RPRP 2259): antidiabetic sulfonamide drug. Can Med Assoc J 1959;81:101.
72. Wongpaitoon V, Russell RF, Mills PR, Patrick RS. Intrahepatic cholestasis and cutaneous bullae associated with glibenclamide therapy. Postgrad Med J 1981;57:244.
73. Sau D, Pitman E, Mauign M, et al. Granulomatous hepatitis associated with glyburide. Dig Dis Sci 1996;41:322.
74. McMahon TF. Cholestatic jaundice, liver decompensation, and shock resulting from tolbutamide; report of a case. Med Ann DC 1963;32:509.
75. Chan KA, Truman A, Gurwitz J, et al. A cohort study of the incidence of acute liver failure in diabetic patients treated with hypoglycemic agents. Amer Assoc for its Study of Liver Disease Abstract 1186; Dallas, Texas, Nov 9-13, 2001.
76. Graham DJ, Domlard CR, Shatin D, Tsong Y, Burgess MJ. Liver enzyme monitoring in patients treated with troglitazone. JAMA 2001;486:831-3.
77. Tolman KG. Lovastatin and the liver. Am J Cardiol 2002;89:1374-80.
78. Walker AM, Bortinichak CA, Lange L, Yood RA. The infrequency of liver function testing in patients using nonsteroidal anti-inflammatory drugs. Arch Fam Med 1995;4:24-9.
79. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride; impact of Food and Drug Administration regulating action. JAMA 2000;284:3026-39.
80. Preventive Services Task Force. In: Guide to Clinical Preventive Services. 2nd edition. Baltimore: Williams and Williams; 1966.