Secondary Prevention of Venous Thromboembolism with the Oral Direct Thrombin Inhibitor Ximelagatran

New England Journal of Medicine

Volumn 349, Issue 18, 2003, Pages 1713-1721

  Schulman, Sam ^a   Wåhlander, Karin ^b,c   Lundström, Torbjörn ^b   Clason, Solveig Billing ^b   Eriksson, Henry ^c  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b ASTRAZENECA R AND D   (Sweden)

^c SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; PLACEBO; THROMBIN INHIBITOR; XIMELAGATRAN;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DRUG EFFICACY; DRUG SAFETY; ECHOGRAPHY; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEMATURIA; HUMAN; LIVER DYSFUNCTION; LUNG SCINTISCANNING; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; SECONDARY PREVENTION; STATISTICAL ANALYSIS; THROMBOEMBOLISM; VAGINA BLEEDING;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTICOAGULANTS; AZETIDINES; BENZYLAMINES; DOUBLE-BLIND METHOD; FEMALE; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PRODRUGS; PULMONARY EMBOLISM; RECURRENCE; RISK; THROMBIN; THROMBOEMBOLISM; VENOUS THROMBOSIS;

EID: 0142182558     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa030104     Document Type: Article

References (23)

1. Heit JA, Silverstein MD, Mohr DN, et al. The epidemiology of venous thromboembolism in the community. Thromb Haemost 2001;86:452-63.
2. Schulman S, Khedin A-S, Lindmarker P, et al. A comparison of six weeks with six months of oral anticoagulant therapy after a first episode of venous thromboembolism. N Engl J Med 1995;332:1661-5.
3. Pinede L, Ninet J, Duhaut P, et al. Comparison of 3 and 6 months of oral anticoagulant therapy after a first episode of proximal deep vein thrombosis or pulmonary embolism and comparison of 6 and 12 weeks of therapy after isolated calfdeep vein thrombosis. Circulation 2001;103:2453-60.
4. Schulman S, Granqvist S, Holmström M, et al. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. N Engl J Med 1997;336:393-8.
5. S. Kearon C, Gent M, Hirsh J, et al. A comparison of three months of anticoagulation with extended anticoaguladon for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999;340:901-7. [Erratum, N Engl J Med 1999;341:298.]
6. S. Kearon C, Gent M, Hirsh J, et al. A comparison of three months of anticoagulation with extended anticoaguladon for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999;340:901-7. [Erratum, N Engl J Med 1999;341:298.]
7. Agnelli G, Prandoni P, Santamaria MG, et al. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. N Engl J Med 2001;345:165-9.
8. Ridker PM, Goldhaber SZ, Danielson E, et al. Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med 2003;348:1425-34.
9. Kearon C, Ginsberg JS, Kovacs MJ, et al. Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med 2003;349:631-9.
10. Hyers TM, Agnelli G, Hull RD, et al. Antithrombotic therapy for venous thromboembolic disease. Chest 2001;119:Suppl:176S-193S.
11. Gustafsson D, Nyström J-E, Carlsson S, et al. The direct thrombin inhibitor melagatran and its oral prodrug H 376195: intestinal absorption properties, biochemical and pharmacodynamic effects. Thromb Res 2001;101:171-81.
12. 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.
13. Eriksson UG, Bredberg U, Hoffmann K-J, 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.
14. Elg M, Gustafsson D, Carlsson S. Anti-thrombotic effects and bleeding time of thrombin inhibitors and warfarin in the rat. Thromb Res 1999;94:187-97.
15. Eriksson H, Wählander K, Gustafsson D, Welin LT, Frison L, Schulman S. A randomized, controlled, dose-guiding study of the oral direct thrombin inhibitor ximelagatran compared with standard therapy for the treatment of acute deep vein thrombosis: THRIVE I. J Thromb Haemost 2003;1:41-7.
16. Heit JA, Colwell CW, Francis CW, et al. Comparison of the oral direct thrombin inhibitor ximelagatran with enoxaparin as prophylaxis against venous thromboembolism after total knee replacement: a phase 2 dose-finding study. Arch Intern Med 2001;161:2215-21.
17. Francis CW, Davidson BL, Berkowitz SD, et al. Ximelagatran versus waffarin for the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind trial. Ann Intern Med 2002;137:648-55.
18. Eriksson BI, Bergqvist D, Kälebo 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.
19. Sostman HD, Coleman RE, DeLong DM, Newman GE, Paine S. Evaluation of revised criteria for ventilation-perfusion scintigraphy in patients with suspected pulmonary embolism. Radiology 1994;193:103-7.
20. Nordström M, Lindblad B, Bergqvist D, Kjellström T. A prospective study of the incidence of deep-vein thrombosis within a defined urban population. J Intern Med 1992;232:155-60.
21. Levine M, Gent M, Hirsh J, et al. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med 1996;334:677-81.
22. Petersen P, Grind M, Adler J. Ximelagatran versus warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. SPORTIF II: a dose-guiding, tolerability, and safety study. J Am Coll Cardiol 2003;41:1445-51.
23. Eriksson-Lepkowska M, Thuresson A, Johansson S, et al. The effect of the oral direct thrombin inhibitor ximelagatran on the pharmacokinetics of P450-metabolized drugs, in healthy male volunteers. Blood 2001;98:89b. abstract.