Observations of alanine aminotransferase and aspartate aminotransferase in THRIVE studies treated orally with Ximelagatran

International Journal of Toxicology

Volumn 25, Issue 3, 2006, Pages 165-169

  Harenberg, Job ^a   Jörg, Ingrid ^a   Weiss, Christel ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Alanine Aminotransferase; Aspartate Aminotransferase; Blood; Liver; Venous Thromboembolism; Ximelagatran

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; ENOXAPARIN; PLACEBO; THROMBIN INHIBITOR; WARFARIN; XIMELAGATRAN;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANALYSIS OF VARIANCE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD ANALYSIS; CLINICAL ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; HUMAN; RECURRENT DISEASE; STUDENT T TEST; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; ALANINE TRANSAMINASE; ANTICOAGULANTS; ASPARTATE AMINOTRANSFERASES; AZETIDINES; BENZYLAMINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HUMANS; THROMBIN; THROMBOEMBOLISM; VENOUS THROMBOSIS;

EID: 33746287448     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1080/10915810600683143     Document Type: Article

References (29)

1. Australian Institute of Health and Welfare. Australian hospital statistics 2002-03. Available at: www.aihw.gov.au/publications/index.cfm/title/ 10015 (accessed Dec. 2004).
2. Brighton, T. A. 2004. The direct thrombin inhibitor melagatran/ ximelagatran. M.J.A. 181:432-437.
3. Büller, H. R., G. Agnelli, R. D. Hull, T. M. Hyers, M. H. Prins, and G. E. Raskob. 2004. Antithrombotic therapy for venous thromboembolic disease: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126(suppl):401S-428S.
4. Cooper, A. J., S. A. Bruschi, A. Iriatre, and M. Martinez-Carrion. 2002. Mitochondrial aspartate aminotransferase catalyses cysteine S-conjugate β-lyase reactions. Biochem. J. 386:253-261.
5. Cox, D., R. O'Kennedy, and R. D. Thornes. 1989. The rarity of liver toxicity in patients treated with coumarin (1,2-benzopyrone). Human Toxicol. 8:501-506.
6. Darling, J. R., P. C. Sharpe, E. K. Stiby, J. A, McAteer, G. P. R. Archbold, and K. R. Milligan. 2000. Serum mitochondrial aspartate transaminase activity after isoflurance or halothane anaesthesia. Br. J. Anaesth. 85:195-198.
7. De Man, R. A. 1993. Phenprocoumon-induced liver failure. Neth. J. Med. 43:91.
8. Dorn-Beinecke, A. 2003. Phenprocoumon-induced hepatitis as an immunologically mediated drug allergic complication of antithrombotic therapy. Thromb. Haemost. 90:1210-1213.
9. Ehrenforth, S., I. Scharrer, and G. Herrmann, 1995. Phenprocoumon- induzierte nekrotisierende Hepatitis. Dtsch. Med. Wschr. 120:1529-1530.
10. Eriksson, B. I., G. Agnelli, A. T. Cohen, O. E. Dahl, P. Mouret N. Rosencher, C. Eskilson, I. Nylander, L. Frison, and M. Ogren for the METHRO III Study Group. 2003. Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement. Thromb. Haemost. 89:288-296.
11. Executive Steering Committee on behalf of the SPORTIF III Investigators. 2003. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): Randomised controlled trial. Lancet 362:1691-1698.
12. Fiessinger, J.-N., M. V. Huisman, B. L. Davidson, H. Bounameaux, C. W. Francis, and H. Eriksson. 2005. Ximelagatran vs low-molecular-weight heparin and warfarin for the treatment of deep vein thrombosis. JAMA 293:681-689.
13. Francis, C. W., S. D. Berkowitz, P. C. Comp, J. R. Liberman, J. S. Ginsberg, G. and G. Paiement. 2003. For the EXULT A Study Group. Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. N. Engl. J. Med. 349:1703-1712.
14. Freedman, M. D., P. Leese, R. Prasad, and D. Hayden. 1990. An evaluation of the biological response to Fraxiparin (a low molecular weight heparin) in the healthy individual. J. Clin. Pharmacol. 30:720-727.
15. Guevara, A., J. Labarca, and G. Gonzalez-Martin 1993. Heparin-induced transaminase elevations. A prospective study. Int. J. Clin. Pharmacol. 31:137-141.
16. Gustafsson, D., J. E. Nystrom, S. Carlsson, U. Bredberg, U. Eriksson, E. Gyzander, M. Elg, T. Antonsson, K. Hoffmann, A. Ungell, H. Sorensen, S. Nagard, A. Abrahamsson, and R. Bylund. 2001. The direct thrombin inhibitor melagatran and its oral prodrug H376/95: Intestinal absorption properties, biochemical and pharmacodynamic effects. Thromb. Res. 101:171-181.
17. Harenberg, J., Ch. Giese, C.-E. Dempfle, and D. L. Heene. 1988. Biological activity and safety of the subcutaneous administration of high doses of low molecular weight heparin for 8 days in human volunteers. Thromb. Haemost. 61:357-362.
18. Höhler, T., M. Schnütgen, I. Helmreich-Becker, W. J. Mayet, and F. H. Mayer zum Buschenfelde. 1994. Drug-induced hepatitis: A rare complication of oral anticoagulants. J. Hepatol. 21:447-449.
19. International Federation of Clinical Chemistry (IFCC). 1986. Approved recommendation (1985) on IFCC methods for the measurement of catalytic concentration of enzymes. Part 2. IFCC method for alanine aminotransferase. J. Clin. Chem. Clin. Biochem. 24:481-495.
20. Lee, W. M., D. Larrey, R. Olsson, J. H. Lewis, M. Keisu, L. Auclert, and S. Sheth. 2005. Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf. 28:351-370.
21. Lumen, L. 1986. New diagnostic markers of alcohol abuse. Hepatology 6:742-745.
22. Minar, E., H. Ehringer, and M. Hirschl. 1980. Transaminase increase: A largely unknown side effect of heparin treatment. Dtsch. Med. Wschr. 105:1713-1717.
23. Mix, H., S. Wagner, K. Böker, S. Gloger, K. J. Oldhafer, and M. Behrend. 1999. Subacute liver failure induced by phenprocoumon treatment. Digestion 60:579-582.
24. Monreal, M., E. Lafoz, R. Salvador, J. Roncales, and A. Navarro. 1989. Adverse effects of three different forms of heparin therapy: thrombocytopenia, increased transaminases, and hyperkalaemia. Eur. J. Clin. Pharmacol. 37:415-418.
25. Reiter, M., R. A. Bucek, N. Koca, J. Heger, and E. Minar for the PERSIST Group. 2003. Idraparinux and liver enzymes: Observations from the PERSIST trial. Blood Coagul. Fibrinol. 14:61-65.
26. Schulman, S., K. Wahlander, T. Lundstrom, S. B. Clason, and H. Eriksson: THRIVE III Investigators. 2003. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N. Engl. J. Med. 349:1713-1721.
27. Sharpe, P. C., R. McBride, and G. P. R. Archbold. 1996. Biochemical markers of alcohol abuse. Q. J. Med. 89:137-144.
28. US Food and Drug Administration: Statistical review and evaluation-clinical studies (Exanta 36 mg bid oral formulation). Available at: www.fda.gov/ohrms/dockers/ac/04/briefing/2004-4069b1.htm (accessed Dec. 2004).
29. Wallentin, L., R. G. Wilcox, W.D. Weaver, H. Emanuelsson, A. Goodvin, A. Nystrom, and P. Bylock for the ESTEEM Investigators. 2003. Oral ximelagatran for secondary prophylaxis after myocardial infarction: the ESTEEM randomised controlled trial. Lancet 362:789-797.