Biomarkers for drug-induced liver injury

References

• Chong CR, Sullivan DJ Jr. New uses for old drugs. Nature448, 645–646 (2007).
   PubMed Web of Science ®Google Scholar
• Hussaini SH, Farrington EA. Idiosyncratic drug-induced liver injury: an overview. Expert Opin. Drug Saf.6, 673–684 (2007).
   PubMed Web of Science ®Google Scholar
• Tarantino G, Pezzullo MG, Dario di Minno MN et al. Drug-induced liver injury due to ‘natural products’ used for weight loss: a case report. World J. Gastroenterol.15, 2414–2417 (2009).
   PubMed Web of Science ®Google Scholar
• Assis DN, Navarro VJ. Human drug hepatotoxicity: a contemporary clinical perspective. Expert Opin. Drug Metab. Toxicol.5, 463–473 (2009).
   PubMed Web of Science ®Google Scholar
• Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat. Rev. Drug Discov.4, 489–499 (2005).
   PubMed Web of Science ®Google Scholar
• Lee WM. Etiologies of acute liver failure. Semin. Liver Dis.28, 142–152 (2008).
   PubMed Web of Science ®Google Scholar
• Teschke R, Schwarzenboeck A, Hennermann KH. Causality assessment in hepatotoxicity by drugs and dietary supplements. Br. J. Clin. Pharmacol.66, 758–766 (2008).
   PubMed Web of Science ®Google Scholar
• Peters TS. Do preclinical testing strategies help predict human hepatotoxic potentials? Toxicol. Pathol.33, 146–154 (2005).
   PubMed Web of Science ®Google Scholar
• Dykens JA, Jamieson JD, Marroquin LD et al.In vitro assessment of mitochondrial dysfunction and cytotoxicity of nefazodone, trazodone, and buspirone. Toxicol. Sci.103, 335–345 (2008).
   PubMed Web of Science ®Google Scholar
• Tarantino G, Conca P, Basile V et al. A prospective study of acute drug-induced liver injury in patients suffering from non-alcoholic fatty liver disease. Hepatol. Res.37, 410–415 (2007).
   PubMed Web of Science ®Google Scholar
• Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints. preferred definitions and conceptual framework. Clin. Pharmacol. Ther.69, 89–95 (2001).
   PubMed Web of Science ®Google Scholar
• Senior JR. How can ‘Hy’s law’ help the clinician? Pharmacoepidemiol. Drug Saf.15, 235–239 (2006).
   PubMed Web of Science ®Google Scholar
• Ozer J, Ratner M, Shaw M et al. The current state of serum biomarkers of hepatotoxicity. Toxicology245, 194–205 (2008).
   PubMed Web of Science ®Google Scholar
• Yang RZ, Park S, Reagan WJ et al. Alanine aminotransferase isoenzymes. molecular cloning and quantitative analysis of tissue expression in rats and serum elevation in liver toxicity. Hepatology49, 598–607 (2009).
   PubMed Web of Science ®Google Scholar
• Edgar AD, Tomkiewicz C, Costet P et al. Fenofibrate modifies transaminase gene expression via a peroxisome proliferator activated receptor α-dependent pathway. Toxicol. Lett.98, 13–23 (1998).
   PubMed Web of Science ®Google Scholar
• Thulin P, Rafter I, Stockling K et al. PPARa regulates the hepatotoxic biomarker alanine aminotransferase (ALT1) gene expression in human hepatocytes. Toxicol. Appl. Pharmacol.231, 1–9 (2008).
   PubMed Web of Science ®Google Scholar
• Liu R, Pan X, Whitington PF. Increased hepatic expression is a major determinant of serum alanine aminotransferase elevation in mice with nonalcoholic steatohepatitis. Liver Int.29, 337–343 (2009).
   PubMedGoogle Scholar
• Solter PF, Wollenberg GK, Huang X et al. Prolonged sublethal exposure to the protein phosphatase inhibitor microcystin-LR results in multiple dose-dependent hepatotoxic effects. Toxicol. Sci.44, 87–96 (1998).
   PubMedGoogle Scholar
• Solter P, Liu Z, Guzman R. Decreased hepatic ALT synthesis is an outcome of subchronic microcystin-LR toxicity. Toxicol. Appl. Pharmacol.164, 216–220 (2000).
   PubMed Web of Science ®Google Scholar
• Miyazaki M, Rosenblum J, Kasahara Y et al. Determination of enzymatic source of alanine aminotransferase activity in serum from dogs with liver injury. J. Pharmacol. Toxicol. Methods60(3), 307–315 (2009).
   PubMedGoogle Scholar
• Macchia T, Mancinelli R, Gentili S et al. Mitochondrial aspartate aminotransferase isoenzyme: a biochemical marker for the clinical management of alcoholics? Clin. Chim. Acta263, 79–96 (1997).
   PubMedGoogle Scholar
• Musana KA, Yale SH, Abdulkarim AS. Tests of liver injury. Clin. Med. Res.2, 129–131 (2004).
   PubMedGoogle Scholar
• Ramachandran R, Kakar S. Histological patterns in drug-induced liver disease. J. Clin. Pathol.62, 481–492 (2009).
   PubMed Web of Science ®Google Scholar
• Reust CE, Hall L. Clinical inquiries. What is the differential diagnosis of an elevated alkaline phosphatase (AP) level in an otherwise asymptomatic patient? J. Fam. Pract.50, 496–497 (2001).
   PubMedGoogle Scholar
• Ohmori S, Shiraki K, Inoue H et al. Clinical characteristics and prognostic indicators of drug-induced fulminant hepatic failure. Hepatogastroenterology50, 1531–1534 (2003).
   PubMedGoogle Scholar
• Senior JR. Monitoring for hepatotoxicity. What is the predictive value of liver ‘function’ tests? Clin. Pharmacol. Ther.85, 331–334 (2009).
   PubMed Web of Science ®Google Scholar
• Fabris L, Cadamuro M, Okolicsanyi L. The patient presenting with isolated hyperbilirubinemia. Dig. Liver Dis.41, 375–381 (2009).
   PubMedGoogle Scholar
• Tarantino G. Could quantitative liver function tests gain wide acceptance among hepatologists? World J. Gastroenterol.15, 3457–3461 (2009).
   PubMed Web of Science ®Google Scholar
• Young TH, Tang HS, Chao YC et al. Quantitative rat liver function test by galactose single point method. Lab. Anim.42, 495–504 (2008).
   PubMedGoogle Scholar
• Schmidt LE, Ott P, Tygstrup N. Galactose elimination capacity as a prognostic marker in patients with severe acetaminophen-induced hepatotoxicity: 10 years’ experience. Clin. Gastroenterol. Hepatol.2, 418–424 (2004).
   PubMed Web of Science ®Google Scholar
• Fontana RJ, Turgeon DK, Woolf TF et al. The caffeine breath test does not identify patients susceptible to tacrine hepatotoxicity. Hepatology23, 1429–1435 (1996).
   PubMed Web of Science ®Google Scholar
• Bopp SK, Lettieri T. Comparison of four different colorimetric and fluorometric cytotoxicity assays in a zebrafish liver cell line. BMC Pharmacol.8, 8 (2008).
   PubMedGoogle Scholar
• Vinken M, Decrock E, De Vuyst E et al. Biochemical characterisation of an in vitro model of hepatocellular apoptotic cell death. Altern. Lab. Anim.37, 209–218 (2009).
   PubMedGoogle Scholar
• O’Brien PJ, Slaughter MR, Polley SR et al. Advantages of glutamate dehydrogenase as a blood biomarker of acute hepatic injury in rats. Lab. Anim.36, 313–321 (2002).
   PubMed Web of Science ®Google Scholar
• Halmes NC, Hinson JA, Martin BM et al. Glutamate dehydrogenase covalently binds to a reactive metabolite of acetaminophen. Chem. Res. Toxicol.9, 541–546 (1996).
   PubMed Web of Science ®Google Scholar
• Smith EL, Landon M, Piszkiewicz D et al. Bovine liver glutamate dehydrogenase. tentative amino acid sequence; identification of a reactive lysine; nitration of a specific tyrosine and loss of allosteric inhibition by guanosine triphosphate. Proc. Natl Acad. Sci. USA67, 724–730 (1970).
   PubMed Web of Science ®Google Scholar
• Zhang Y, Lu N, Gao Z. Hemin-H2O2-NO2- induced protein oxidation and tyrosine nitration are different from those of SIN-1: a study on glutamate dehydrogenase nitrative/oxidative modification. Int. J. Biochem. Cell. Biol.41, 907–915 (2009).
   PubMed Web of Science ®Google Scholar
• Banerjee S, Schmidt T, Fang J et al. Structural studies on ADP activation of mammalian glutamate dehydrogenase and the evolution of regulation. Biochemistry42, 3446–3456 (2003).
   PubMedGoogle Scholar
• Lee WK, Shin S, Cho SS et al. Purification and characterization of glutamate dehydrogenase as another isoprotein binding to the membrane of rough endoplasmic reticulum. J. Cell. Biochem.76, 244–253 (1999).
   PubMedGoogle Scholar
• James LP, Capparelli EV, Simpson PM et al. Acetaminophen-associated hepatic injury: evaluation of acetaminophen protein adducts in children and adolescents with acetaminophen overdose. Clin. Pharmacol. Ther.84, 684–690 (2008).
   PubMed Web of Science ®Google Scholar
• James LP, Letzig L, Simpson PM et al. Pharmacokinetics of acetaminophen–protein adducts in adults with acetaminophen overdose and acute liver failure. Drug Metab. Dispos.37, 1779–1784 (2009).
   PubMed Web of Science ®Google Scholar
• Wade LT, Kenna JG, Caldwell J. Immunochemical identification of mouse hepatic protein adducts derived from the nonsteroidal anti-inflammatory drugs diclofenac, sulindac and ibuprofen. Chem. Res. Toxicol.10, 546–555 (1997).
   PubMed Web of Science ®Google Scholar
• Heijne WH, Stierum RH, Leeman WR et al. The introduction of toxicogenomics; potential new markers of hepatotoxicity. Cancer Biomark.1, 41–57 (2005).
   PubMedGoogle Scholar
• Saha B, Nandi D. Farnesyltransferase inhibitors reduce ras activation and ameliorate acetaminophen-induced liver injury in mice. Hepatology50(5), 1547–1557 (2009).
   PubMedGoogle Scholar
• Rutherford AE, Hynan LS, Borges CB et al. Serum apoptosis markers in acute liver failure. a pilot study. Clin. Gastroenterol. Hepatol.5, 1477–1483 (2007).
   PubMed Web of Science ®Google Scholar
• Tagami A, Ohnishi H, Hughes RD. Increased serum soluble Fas in patients with acute liver failure due to paracetamol overdose. Hepatogastroenterology50, 742–745 (2003).
   PubMedGoogle Scholar
• Singhal S, Chakravarty A, Das BC et al. Tumour necrosis factor-a and soluble Fas ligand as biomarkers in non-acetaminophen-induced acute liver failure. Biomarkers14, 347–353 (2009).
   PubMed Web of Science ®Google Scholar
• Carr DF, Alfirevic A, Tugwood JD et al. Molecular and genetic association of interleukin-6 in tacrine-induced hepatotoxicity. Pharmacogenet. Genomics17, 961–972 (2007).
   PubMed Web of Science ®Google Scholar
• Aithal GP, Ramsay L, Daly AK et al. Hepatic adducts, circulating antibodies, and cytokine polymorphisms in patients with diclofenac hepatotoxicity. Hepatology39, 1430–1440 (2004).
   PubMed Web of Science ®Google Scholar
• Pachkoria K, Lucena MI, Crespo E et al. Analysis of IL-10, IL-4 and TNF-α polymorphisms in drug-induced liver injury (DILI) and its outcome. J. Hepatol.49, 107–114 (2008).
   PubMed Web of Science ®Google Scholar
• Pham BN, Bemuau J, Durand F et al. Eotaxin expression and eosinophil infiltrate in the liver of patients with drug-induced liver disease. J. Hepatol.34, 537–547 (2001).
   PubMed Web of Science ®Google Scholar
• Tarantino G, Di Minno MN, Capone D. Drug-induced liver injury. Is it somehow foreseeable? World J. Gastroenterol.15, 2817–2833 (2009).
   PubMed Web of Science ®Google Scholar
• Grismer LE, Gill SA, Harris MD. Liver biopsy in psoriatic arthritis to detect methotrexate hepatotoxicity. J. Clin. Rheumatol.7, 224–227 (2001).
   PubMedGoogle Scholar
• Blomme EA, Yang Y, Waring JF. Use of toxicogenomics to understand mechanisms of drug-induced hepatotoxicity during drug discovery and development. Toxicol. Lett.186, 22–31 (2009).
   PubMed Web of Science ®Google Scholar
• Liguori MJ, Anderson MG, Bukofzer S et al. Microarray analysis in human hepatocytes suggests a mechanism for hepatotoxicity induced by trovafloxacin. Hepatology41, 177–186 (2005).
   PubMed Web of Science ®Google Scholar
• Natsoulis G, Pearson CI, Gollub J et al. The liver pharmacological and xenobiotic gene response repertoire. Mol. Syst. Biol.4, 175 (2008).
   PubMed Web of Science ®Google Scholar
• McMillian M, Nie AY, Parker JB et al. A gene expression signature for oxidant stress/reactive metabolites in rat liver. Biochem. Pharmacol.68, 2249–2261 (2004).
   PubMed Web of Science ®Google Scholar
• McMillian M, Nie AY, Parker JB et al. Inverse gene expression patterns for macrophage activating hepatotoxicants and peroxisome proliferators in rat liver. Biochem. Pharmacol.67, 2141–2165 (2004).
   PubMed Web of Science ®Google Scholar
• McMillian M, Nie A, Parker JB et al. Drug-induced oxidative stress in rat liver from a toxicogenomics perspective. Toxicol. Appl. Pharmacol.207, 171–178 (2005).
   PubMedGoogle Scholar
• Yuan L, Kaplowitz N. Glutathione in liver diseases and hepatotoxicity. Mol. Aspects Med.30, 29–41 (2009).
   PubMed Web of Science ®Google Scholar
• Kiyosawa N, Ito K, Sakuma K et al. Evaluation of glutathione deficiency in rat livers by microarray analysis. Biochem. Pharmacol.68, 1465–1475 (2004).
   PubMedGoogle Scholar
• Kiyosawa N, Uehara T, Gao W et al. Identification of glutathione depletion-responsive genes using phorone-treated rat liver. J. Toxicol. Sci.32, 469–486 (2007).
   PubMedGoogle Scholar
• Reasor MJ, Kacew S. Drug-induced phospholipidosis: are there functional consequences? Exp. Biol. Med. (Maywood)226, 825–830 (2001).
   PubMed Web of Science ®Google Scholar
• Anderson N, Borlak J. Drug-induced phospholipidosis. FEBS Lett.580, 5533–5540 (2006).
   PubMed Web of Science ®Google Scholar
• Hirode M, Ono A, Miyagishima T et al. Gene expression profiling in rat liver treated with compounds inducing phospholipidosis. Toxicol. Appl. Pharmacol.229, 290–299 (2008).
   PubMed Web of Science ®Google Scholar
• Sawada H, Takami K, Asahi S. A toxicogenomic approach to drug-induced phospholipidosis: analysis of its induction mechanism and establishment of a novel in vitro screening system. Toxicol. Sci.83, 282–292 (2005).
   PubMed Web of Science ®Google Scholar
• Atienzar F, Gerets H, Dufrane S et al. Determination of phospholipidosis potential based on gene expression analysis in HepG2 cells. Toxicol. Sci.96, 101–114 (2007).
   PubMed Web of Science ®Google Scholar
• Ganey PE, Luyendyk JP, Newport SW et al. Role of the coagulation system in acetaminophen-induced hepatotoxicity in mice. Hepatology46, 1177–1186 (2007).
   PubMedGoogle Scholar
• Hirode M, Omura K, Kiyosawa N et al. Gene expression profiling in rat liver treated with various hepatotoxic-compounds inducing coagulopathy. J. Toxicol. Sci.34, 281–293 (2009).
   PubMedGoogle Scholar
• Bushel PR, Heinloth AN, Li J et al. Blood gene expression signatures predict exposure levels. Proc. Natl Acad. Sci. USA104, 18211–18216 (2007).
   PubMed Web of Science ®Google Scholar
• Umbright C, Sellamuthu R, Li S et al. Blood gene expression markers to detect and distinguish target organ toxicity. Mol. Cell. Biochem.335(1–2), 223–234 (2009).
   PubMedGoogle Scholar
• Boelsterli UA, Lim PL. Mitochondrial abnormalities – a link to idiosyncratic drug hepatotoxicity? Toxicol. Appl. Pharmacol.220, 92–107 (2007).
   PubMed Web of Science ®Google Scholar
• Lammert C, Einarsson S, Saha C et al. Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: search for signals. Hepatology47, 2003–2009 (2008).
   PubMed Web of Science ®Google Scholar
• Senior JR. What is idiosyncratic hepatotoxicity? What is it not? Hepatology47, 1813–1815 (2008).
   PubMed Web of Science ®Google Scholar
• Uetrecht J. Idiosyncratic drug reactions. current understanding. Annu. Rev. Pharmacol. Toxicol.47, 513–539 (2007).
   PubMed Web of Science ®Google Scholar
• Zou W, Beggs KM, Sparkenbaugh EM et al. Sulindac metabolism and synergy with TNF in a drug-inflammation interaction model of idiosyncratic liver injury. J. Pharmacol. Exp. Ther.331(1), 114–121 (2009).
   PubMed Web of Science ®Google Scholar
• Kashimshetty R, Desai VG, Kale VM et al. Underlying mitochondrial dysfunction triggers flutamide-induced oxidative liver injury in a mouse model of idiosyncratic drug toxicity. Toxicol. Appl. Pharmacol.238, 150–159 (2009).
   PubMed Web of Science ®Google Scholar
• Gao J, Ann Garulacan L, Storm SM et al. Identification of in vitro protein biomarkers of idiosyncratic liver toxicity. Toxicol. In Vitro18, 533–541 (2004).
   PubMed Web of Science ®Google Scholar
• Mendrick DL. Toxicogenomics and classic toxicology. How to improve prediction and mechanistic understanding of human toxicity. Methods Mol. Biol.460, 1–22 (2008).
   PubMedGoogle Scholar
• Mendrick DL. Genomic and genetic biomarkers of toxicity. Toxicology245, 175–181 (2008).
   PubMed Web of Science ®Google Scholar
• Andrade RJ, Robles M, Ulzurrun E et al. Drug-induced liver injury: insights from genetic studies. Pharmacogenomics10, 1467–1487 (2009).
   PubMed Web of Science ®Google Scholar
• Russmann S, Kullak-Ublick GA, Grattagliano I. Current concepts of mechanisms in drug-induced hepatotoxicity. Curr. Med. Chem.16, 3041–3053 (2009).
   PubMed Web of Science ®Google Scholar
• Daly AK, Donaldson PT, Bhatnagar P et al.HLA-B*5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin. Nat. Genet.41, 816–819 (2009).
   PubMed Web of Science ®Google Scholar
• Bartels CL, Tsongalis GJ. MicroRNAs: novel biomarkers for human cancer. Clin. Chem.55, 623–631 (2009).
   PubMed Web of Science ®Google Scholar
• Cortez MA, Calin GA. MicroRNA identification in plasma and serum: a new tool to diagnose and monitor diseases. Expert Opin. Biol. Ther.9, 703–711 (2009).
   PubMed Web of Science ®Google Scholar
• Miyamoto M, Yanai M, Ookubo S et al. Detection of cell-free, liver-specific mRNAs in peripheral blood from rats with hepatotoxicity: a potential toxicological biomarker for safety evaluation. Toxicol. Sci.106, 538–545 (2008).
   PubMed Web of Science ®Google Scholar
• Wang K, Zhang S, Marzolf B et al. Circulating microRNAs, potential biomarkers for drug-induced liver injury. Proc. Natl Acad. Sci. USA106, 4402–4407 (2009).
   PubMed Web of Science ®Google Scholar
• Kudo Y, Ochi T, Shimada H et al. Utility of plasma circulating mRNA as a marker to detect hepatic injury. J. Vet. Med. Sci.70, 993–995 (2008).
   PubMed Web of Science ®Google Scholar
• Laterza OF, Lim L, Garrett-Engele PW et al. Plasma microRNAs as diagnostically sensitive and specific biomarkers of tissue injury. Clin. Chem.55(11), 1977–1983 (2009).
   PubMed Web of Science ®Google Scholar
• Soga T, Baran R, Suematsu M et al. Differential metabolomics reveals ophthalmic acid as an oxidative stress biomarker indicating hepatic glutathione consumption. J. Biol. Chem.281, 16768–16776 (2006).
   PubMed Web of Science ®Google Scholar
• Lee MS, Jung BH, Chung BC et al. Metabolomics study with gas chromatography-mass spectrometry for predicting valproic acid-induced hepatotoxicity and discovery of novel biomarkers in rat urine. Int. J. Toxicol.28(5), 392–404 (2009).
   PubMed Web of Science ®Google Scholar
• Amacher DE, Adler R, Herath A et al. Use of proteomic methods to identify serum biomarkers associated with rat liver toxicity or hypertrophy. Clin. Chem.51, 1796–1803 (2005).
   PubMed Web of Science ®Google Scholar
• Goodsaid F, Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J.9, E105–E108 (2007).
   PubMed Web of Science ®Google Scholar