Hepatotoxicity of thiazolidinediones

Expert Opinion on Drug Safety

Volumn 2, Issue 6, 2003, Pages 581-586

  Isley, William L ^a  

^a MAYO CLINIC   (United States)

Author keywords

drug reaction; fatty liver; glitazone(s); hepatotoxicity; liver; side effects; thiazolidinedione(s)

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT;

CLINICAL TRIAL; HUMAN; REVIEW; TOXIC HEPATITIS;

CLINICAL TRIALS; HEPATITIS, TOXIC; HUMANS; HYPOGLYCEMIC AGENTS; THIAZOLIDINEDIONES;

EID: 1842576485     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2.6.581     Document Type: Review

References (52)

1. FRANCIS GA, FAYARD E, PICARD F, AUWERX J: Nuclear receptors and the control of metabolism. Annu. Rev. Physiol. (2003) 65:261-311. (Pubitemid 38249155)
2. NO AUTHORS LISTED: From the Food and Drug Administration. JAMA (2000) 283:2228.
3. WISE J: Diabetes drug withdrawn after reports of hepatic events. Br. Med. J. (1997) 315:1564.
4. O'KEEFE JH Jr, MILES JM, HARRIS WH, MOE RM, MCCALLISTER BD: Improving the adverse cardiovascular prognosis of Type 2 diabetes. Mayo Clin. Proc. (1999) 74:171-180. (Pubitemid 29085215)
5. BERKOWITZ K, PETERS R, KJOS SL et al.: Effect of troglitazone on insulin sensitivity and pancreatic β-cell function in women at high risk for NIDDM. Diabetes (1996) 45:1572-1579. (Pubitemid 26357551)
6. SCHWARTZ S, RASKIN P, FONSECA V, GRAVELINE JF: Effect of troglitazone in insulin-treated patients with Type II diabetes mellitus: Troglitazone Exogenous Insulin Study Group. N. Engl. J. Med. (1998) 338:861-866. (Pubitemid 28135962)
7. BUCHANAN TA, XIANG AH, PETERS RK et al.: Preservation of pancreatic β-cell function and prevention of Type 2 diabetes by pharmacological treatment of insulin resistance in high-risk hispanic women. Diabetes (2002) 51:2796-2803. (Pubitemid 34970933)
8. NEUSCHWANDER-TETRI BA, ISLEY WI, OKI JC et al.: Troglitazone-induced hepatic failure leading to liver transplantation. Ann. Intern. Med. (1998) 129:38-41. (Pubitemid 28304651)
9. 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) 129:36-38. (Pubitemid 28304650)
10. VELLA A, DE GROEN PC, DINNEEN SF: Fatal hepatotoxicity associated with troglitazone. Ann. Intern. Med. (1998) 129:1080. Letter.
11. HERRINE SK, CHOUDHARY C: Severe hepatotoxicity associated with troglitazone. Ann. Intern. Med. (1999) 130:163-164. Letter.
12. SHIBUYA A, WATANABE M, FUJITA Y et al.: An autopsy case of troglitazone-induced fulminant hepatitis. Diabetes Care (1998) 21:2140-2143. (Pubitemid 28549164)
13. IWASE M, YAMAGUCHI M, YOSHINARI M et al.: A Japanese case of liver dysfunction after 19 months of troglitazone treatment. Diabetes Care (1999) 22:1382-1384. (Pubitemid 29350261)
14. PRENDERGAST KA, BERG CL,WISNIEWSKI R: Troglitazone-associated hepatotoxicity treated successfully with steroids. Ann. Intern. Med. (2000) 133:751.
15. KOHLROSER J, MATHIA J, REICHHELD H, BANNER BF, BONKOVSKY HL: Hepatotoxicity due to troglitazone: report of two cases and review of adverse events reported to the United States Food and Drug Administration. Am. J. Gastroenterol. (2000) 95:272-276. (Pubitemid 30041572)
16. FUKANO M, AMANO S, SATO J et al.: Subacute hepatic failure associated with a new antidiabetic agent, troglitazone: a case report with autopsy examination. Hum. Pathol. (2000) 31:250-253. (Pubitemid 30090658)
17. BOOTH AM, CALDWELL SH, IEZZONI JC: Troglitazone associated hepatic failure. Am. J. Gastroenterol. (2000) 95:557-558.
18. MALIK AH, PRASAD P, SABOORIAN MH, THIELE DL, MALET PF: Hepatic injury due to troglitazone. Dig. Dis. Sci. (2000) 45:210-214. (Pubitemid 30111711)
19. MURPHY EJ, DAVERN TJ, SHAKIL AO et al.: Troglitazone induced fulminant hepatic failure. Acute Liver Failure Study Group. Dig. Dis. Sci. (2000) 45:549-553.
20. JAGANNATH S, RAI R: Rapid-onset subfulminant liver failure associated with troglitazone. Ann. Intern. Med. (2000) 18:677. (Pubitemid 30217567)
21. SCHIANO T, DOLEHIDE K, HART J, BAKER AL: Severe but reversible hepatitis induced by troglitazone. Dig. Dis. Sci. (2000) 45:1039-1042. (Pubitemid 30238272)
22. BELL DS, OVALLE F: Late-onset troglitazone-induced hepatic dysfunction. Diabetes Care (2000) 23:128-129.
23. ISLEY WL, OKI JC: Hepatotoxicity of thiazolidinediones. Diabetes Obes. Metab. (2001) 3:389-392. (Pubitemid 34030856)
24. SCHEEN AJ: Hepatotoxicity with thiazolidinediones. Drug Saf. (2001) 24:873-888.
25. GRAHAM D: Presentation at Endocrinologic and Metabolic Drugs Advisory Committee, United States Food and Drug Administration. Bethesda, USA. 26 March (1999).
26. PRESCRIBING INFORMATION FOR AVANDIA: SmithKline Beecham. April 2000.
27. PRESCRIBING INFORMATION FOR ACTOS: Takeda Pharmaceuticals America, Inc./Eli Lilly. November 1999.
28. WATKINS PB, WHITCOMB RW: Hepatic dysfunction associated with troglitazone. N. Engl. J. Med. (1998) 338:916-917. Letter.
29. PRESCRIBING INFORMATION FOR REZULIN: Parke-Davis. March 1997.
30. PRESCRIBING INFORMATION FOR REZULIN: Parke-Davis. November 1997.
31. PRESCRIBING INFORMATION FOR REZULIN: Parke-Davis. July 1998.
32. FORMAN LM, SIMMONS DA, DIAMOND RH: Hepatic failure in a patient taking rosiglitazone. Ann. Intern. Med. (2000) 132:118-121. (Pubitemid 30044178)
33. AL-SALMAN J, ARJOMAND H, KEMP DG, MITTAL M: Hepatocellular injury in a patient receiving rosiglitazone: a case report. Ann. Intern. Med. (2000) 132:121-124. (Pubitemid 30044179)
34. FREID J, EVERITT D, BOSCIA J: Rosiglitazone and liver failure. Ann. Intern. Med. (2000) 132:164. Letter.
35. ISLEY WL, OKI JC: Rosiglitazone and liver failure. Ann. Intern. Med. (2000) 133:393. Letter.
36. RAVINUTHALA RS, NORI U: Rosiglitazone toxicity. Ann. Intern. Med. (2000) 133:658. Letter.
37. BONKOVSKY HL, ASAR R, BIRD S, SZABO G, BANNER B: Severe cholestatic hepatitis caused by thiazolidinediones: risks associated with substituting rosiglitazone for troglitazone. Dig. Dis. Sci. (2002) 47:1632-1637. (Pubitemid 34753947)
38. LEBOVITZ HE, KREIDER M, FREED MI: Evaluation of liver function in Type 2 diabetic patients during clinical trials: evidence that rosiglitazone does not cause hepatic dysfunction. Diabetes Care (2002) 25:815-821. (Pubitemid 41094276)
39. MAEDA K: Hepatocellular injury in a patient receiving pioglitazone. Ann. Intern. Med. (2001) 135:306. Letter. (Pubitemid 32799355)
40. MAY LD, LEFKOWITCH JH, KRAMMT, RUBIN DE: Mixed hepatocellular-cholestatic liver injury after pioglitazone therapy. Ann. Intern. Med. (2002) 136:449-452. (Pubitemid 34233175)
41. PINTO AG, CUMMINGS OW, CHALASANI N: Severe but reversible cholestatic liver injury after pioglitazone therapy. Ann. Intern. Med. (2002) 137:857. Letter. (Pubitemid 35334459)
42. LEE WM: Drug-induced hepatotoxicity. N. Engl. J. Med. (2003) 349:474-485. (Pubitemid 36910027)
43. YAMAMOTO Y, NAKAJIMA M, YAMAZAKI H, YOKOI T: Cytotoxicity and apoptosis produced by troglitazone in human hepatoma cells. Life Sci. (2001) 70:471-482. (Pubitemid 34017540)
44. LLOYD S, HAYDEN MJ, SAKAI Y et al.: Differential in vitro hepatotoxicity of troglitazone and rosiglitazone among cryopreserved human hepatocytes from 37 donors. Chem. Biol. Interact. (2002) 142:57-71. (Pubitemid 35232553)
45. EVERETT L, GALLI A, CRABB D: The role of hepatic peroxisome proliferator-activated receptors (PPARs) in health and disease. Liver (2000) 20:191-199. (Pubitemid 30342716)
46. JIA DM, TABARU A, AKIYAMA T, ABE S, OTSUKI M: Troglitazone prevents fatty changes of the liver in obese diabetic rats. J. Gastroenterol. Hepatol. (2000) 15:1183-1191.
47. CALDWELL SH, HESPENHEIDE EE, REDICK JA et al.: A pilot study of a thiazolidinedione, troglitazone, in nonalcoholic steatohepatitis. Am. J. Gastroenterol. (2001) 96:519-525.
48. NEUSCHWANDER-TETRI BA, BRUNT EM, WEHMEIER KR et al.: Interim results of a pilot study demonstrating the early effects of the PPAR-γligand rosiglitazone on insulin sensitivity, aminotransferases, hepatic steatosis and body weight in patients with non-alcoholic steatohepatitis. J. Hepatol. (2003) 38:434-440. (Pubitemid 36399245)
49. FREEDMAN R, UWAIFO G, LUTCHMAN G et al.: Changes in insulin sensitivity and improvements in liver histology in patients with nonalcoholic steatohepatitis (NASH) treated with pioglitazone (PIO). Diabetes (2003) 52(Suppl. 1):A76. Abstract 324-OR.
50. BOELSTERLI UA, BEDOUCHA M: Toxicological consequences of altered peroxisome proliferator-activated receptor gamma (PPARγ) expression in the liver: insights from models of obesity and Type 2 diabetes. Biochem. Pharmacol. (2002) 63:1-10. (Pubitemid 34075287)
51. ISLEY WL: Glitazones: good for glycemia. Good for the liver? Diabetes Technol. Ther. (2003) 5:43-44. (Pubitemid 36506089)
52. MOFRAD P, CONTOS MJ, HAQUE M et al.: Clinical and histologic spectrum of nonalcoholic fatty liver disease associated with normal ALT values. Hepatology (2003) 37:1286-1292. (Pubitemid 36667307)