Comparable pharmacokinetics and pharmacodynamics of melagatran in Japanese and Caucasian volunteers after oral administration of the direct thrombin inhibitor ximelagatran

Clinical Pharmacokinetics

Volumn 45, Issue 1, 2006, Pages 85-94

  Wernevik, Linda C ^a   Nyström, Per ^a   Andersson, Magnus ^a   Johnsson, Gillis ^a   Bylock, Anders ^a   Nakanishi, Takashi ^b   Eriksson, Ulf G ^a  

^a ASTRAZENECA R AND D   (Sweden)

^b ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

MELAGATRAN; THROMBIN INHIBITOR; XIMELAGATRAN;

AREA UNDER THE CURVE; ARTICLE; BLOOD CLOTTING TIME; CAUCASIAN; CONTROLLED STUDY; CORRELATION ANALYSIS; DRUG ABSORPTION; DRUG ELIMINATION; ETHNIC GROUP; ETHNOLOGY; EX VIVO STUDY; HEADACHE; HUMAN; JAPAN; KIDNEY FUNCTION; MALE; METABOLITE; NAUSEA AND VOMITING; NORMAL HUMAN; PRIORITY JOURNAL; UPPER RESPIRATORY TRACT INFECTION;

ADMINISTRATION, ORAL; ADULT; AGED; AGING; ANTICOAGULANTS; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; AZETIDINES; BENZYLAMINES; DOSE-RESPONSE RELATIONSHIP, DRUG; EUROPEAN CONTINENTAL ANCESTRY GROUP; HUMANS; MALE; METABOLIC CLEARANCE RATE; PRODRUGS; SINGLE-BLIND METHOD; THROMBIN;

EID: 31344458792     PISSN: 03125963     EISSN: 03125963     Source Type: Journal    
DOI: 10.2165/00003088-200645010-00006     Document Type: Article

References (20)

1. Eriksson UG, Bredberg U, Hoffmann KJ, et al. Absorption, distribution, metabolism, and excretion of ximelagatran, an oral direct thrombin inhibitor, in rats, dogs, and humans. Drug Metab Dispos 2003; 31: 294-305
2. Eriksson UG, Bredberg U, Gislén K, et al. Pharmacokinetics and pharmacodynamics of ximelagatran, a novel oral direct thrombin inhibitor, in young healthy male subjects. Eur J Clin Pharmacol 2003; 59: 35-43
3. Johansson LC, Frison L, Logren U, et al. Influence of age on the pharmacokinetics and pharmacodynamics of ximelagatran, an oral direct thrombin inhibitor. Clin Pharmacokinet 2003; 42: 381-92
4. Bredberg E, Andersson TB, Frison L, et al. Ximelagatran, an oral direct thrombin inhibitor, has a low potential for cyto-chrome P450-mediated drug-drug interactions. Clin Pharmacokinet 2003; 42: 765-77
5. Wählander K, Lapidus L, Olsson CG, et al. Pharmacokinetics, pharmacodynamics and clinical effects of the oral direct thrombin inhibitor ximelagatran in acute treatment of patients with pulmonary embolism and deep vein thrombosis. Thromb Res 2002; 107: 93-9
6. Eriksson BI, Agnelli G, Cohen AT, et al. on behalf of the EXPRESS Study Group. The direct thrombin inhibitor melagatran followed by oral ximelagatran compared with enox-aparin for the prevention of venous thromboembolism after total hip or knee replacement: the EXPRESS study. J Thromb Haemost 2003; 1: 2490-6
7. Francis CW, Berkowitz SD, Comp PC, et al. Comparison of ximelagatran with warfarin for the prevention of venous thromboembolism after total knee replacement. N Engl J Med 2003; 349: 1703-12
8. Eriksson BI, Bergqvist D, Kalebo P, et al. Ximelagatran and melagatran compared with dalteparin for prevention of venous thromboembolism after total hip or knee replacement: the METHRO II randomised trial. Lancet 2002; 360: 1441-7
9. Schulman S, Wahlander K, Lundstrom T, et al. Secondary prevention of venous thromboembolism with the oral direct thrombin inhibitor ximelagatran. N Engl J Med 2003; 349: 1713-21
10. Petersen P, on behalf of the SPORTIF II investigators. Long-term treatment of patients using the new oral direct thrombin inhibitor ximelagatran (formerly H 376/95) versus warfarin in moderate to high stroke risk patients with atrial fibrillation. J Neurol Sci 2001; 187 Suppl. 1: S124-5
11. Olsson SB, on behalf of the SPORTIF III investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation: randomised controlled trial. Lancet 2003; 362: 1691-8
12. Ginsberg JS. Management of venous thromboembolism. N Engl J Med 1996; 335: 1816-28
13. Wells PS, Holbrook AM, Crowther NR, et al. Interactions of warfarin with drugs and food. Ann Intern Med 1994; 121: 676-83
14. Takahashi H, Echizen H. Pharmacogenetics of warfarin elimination and its clinical implications. Clin Pharmacokinet 2001; 40: 587-603
15. Takahashi H, Wilkinson GR, Caraco Y, et al. Population differences in S-warfarin metabolism between CYP2C9 genotype-matched Caucasian and Japanese patients. Clin Pharmacol Ther 2003; 73: 253-63
16. Johnson JA. Predictability of the effects of race or ethnicity on pharmacokinetics of drugs. Int J Clin Pharmacol Ther 2000; 38: 53-60
17. Johansson LC, Andersson M, Fager G, et al. No influence of ethnic origin on the pharmacokinetics and pharmacodynamics of melagatran following oral administration of ximelagatran, a novel oral direct thrombin inhibitor, to healthy male volunteers. Clin Pharmacokinet 2003; 42: 475-84
18. Larsson M, Logren U, Ahnoff M, et al. Determination of melagatran, a novel, direct thrombin inhibitor, in human plasma and urine by liquid chromatography: mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2002; 766: 47-55
19. Uchida E, Naito C. Ethnic difference: how the data from randomized controlled trials can be utilized between different ethnic groups. Clin Eval 1999; 26: 487-503
20. Naito C. Necessity and requirements of bridging studies and their present status in Japan. Int J Clin Pharmacol Ther 2000; 38: 80-6