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N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.

Dabigatran versus warfarin in the treatment of acute venous thromboembolism.

Collaborators (249)

Schulman S, Eriksson H, Goldhaber S, Kakkar A, Kearon C, Mismetti P, Schellong S, Minar E, Bergqvist D, Tijssen J, Prins M, Büller H, Otten J, Prins M, Peters R, Mac Gillavry M, Büller H, Pol S, Burroughs A, Gilmore I, Bluguermann J, Carlevaro O, Dipaola L, Gitelman P, Santos D, Schygiel P, Baker R, Blombery P, Gallus A, Gan E, Gibbs H, Salem H, Baghestanian M, Pilger E, Sturm W, Debing E, Gadisseur A, Hainaut P, Verhamme P, Wautrecht JC, Zicot M, Bizzachi JM, Araujo G, De Araujo JD, Panico FM, Nagato Y, Pereira AH, Leao PP, Ramaciotti E, Moreira RC, Timi J, Anderson D, Crowther M, Dolan S, Eikelboom J, Spencer F, Game M, Kahn S, Kassis J, Kearon C, Klinke P, Kovacs M, Milot A, Ritchie B, Rodger M, Solymoss S, Villeneuve J, Yeo E, Cervinka P, Homza M, Hrdy P, Klimsa Z, Lang P, Maly R, Oral I, Reichert P, Spinar J, Varejka P, Vladimir J, Brønnum-Schou J, Jensen S, Jensen SE, Kristensen KS, Nielsen H, Wiemann O, Bost V, Buchmuller A, Guillot K, Laurent P, Lecomte F, Mottier D, Quere I, Wahl D, Beyer J, Dormann A, Hoffmann U, Maier M, Mietaschk A, Schellong S, Katsenis K, Klonaris C, Liappis C, Acsady G, Berhes I, Boda Z, Farkas K, Jakucs J, Kollar L, Matyas L, Riba M, Sereg M, Aggarwal R, Banker D, Bharani A, Gadkari M, Hiremath J, Jain A, Kareem S, Lyengar S, Parakh R, Sekar N, Srinivas A, Suresh K, Vujay T, Brenner B, Efrati S, Elias M, Gavish D, Grossman E, Lahav M, Lishner M, Zeltser D, Agnelli G, Cimminiello C, Palareti G, Prandoni P, Santonastaso M, Silingardi M, Lee EA, Andrade JM, Valles JJ, Biesma D, Dees A, Fijnheer R, Hamulyak K, Kramer MH, Leebeek FW, Lieverse L, Nurmohamed MT, Chunilal S, Jackson S, Ockelford P, Smith M, Njaastad AM, Sandseth PM, Tveit A, Waage A, Barata J, Capitao M, Fernandes FE, Leitão A, Providência L, Alohin DI, Belentsov S, Chernyatina M, Chernyavsky A, Fokin A, Gubenko A, Guz VA, Katelnitsky I, Katelnitsky I, Khamitov AA, Khitaryan A, Khubulava G, Mikhailov I, Shkurin V, Staroverov I, Tchumakov A, Zaporozhsky A, Duris T, Poliacik P, Spisak V, Szentivanyi M, Zubek V, Adler D, Kelbe D, Le Roux D, Pieterse A, Routier R, Siebert R, Sloane B, Smith C, Van Rensburg H, Del Toro J, García-Fuster MJ, Mateo J, Monreal M, Nieto JA, Sánchez-Molini P, Sedano C, Trujillo J, Valle R, Villalta J, Aagesen J, Carlsson A, Eriksson H, Johansson L, Lärfars G, Lindmarker P, Säfvenberg U, Själander A, Bengisun U, Calkavur T, Guney MR, Karahan S, Kurtoglu M, Sakinci U, Gubka A, Mishalov V, Skupyy O, Cohen A, Keeling D, Kesteven P, MacCallum P, Maclean R, Shah P, Watson H, Bartkowiak A, Bolster E, Botnick WC, Burnett B, Chervu A, Comerota AJ, Dy NM, Fulco FA, Gossage JR, Kaatz S, Lahiri B, Lerner RG, Masson JA, Moll S, Morganroth M, Patel K, Paulson R, Powell R, Samson R, Seibert A, Spyropoulos A, Vrooman PS Jr.

Author information

  • 1Department of Medicine, McMaster University and Henderson Research Centre, Hamilton, ON, Canada. schulms@mcmaster.ca

Abstract

BACKGROUND:

The direct oral thrombin inhibitor dabigatran has a predictable anticoagulant effect and may be an alternative therapy to warfarin for patients who have acute venous thromboembolism.

METHODS:

In a randomized, double-blind, noninferiority trial involving patients with acute venous thromboembolism who were initially given parenteral anticoagulation therapy for a median of 9 days (interquartile range, 8 to 11), we compared oral dabigatran, administered at a dose of 150 mg twice daily, with warfarin that was dose-adjusted to achieve an international normalized ratio of 2.0 to 3.0. The primary outcome was the 6-month incidence of recurrent symptomatic, objectively confirmed venous thromboembolism and related deaths. Safety end points included bleeding events, acute coronary syndromes, other adverse events, and results of liver-function tests.

RESULTS:

A total of 30 of the 1274 patients randomly assigned to receive dabigatran (2.4%), as compared with 27 of the 1265 patients randomly assigned to warfarin (2.1%), had recurrent venous thromboembolism; the difference in risk was 0.4 percentage points (95% confidence interval [CI], -0.8 to 1.5; P<0.001 for the prespecified noninferiority margin). The hazard ratio with dabigatran was 1.10 (95% CI, 0.65 to 1.84). Major bleeding episodes occurred in 20 patients assigned to dabigatran (1.6%) and in 24 patients assigned to warfarin (1.9%) (hazard ratio with dabigatran, 0.82; 95% CI, 0.45 to 1.48), and episodes of any bleeding were observed in 205 patients assigned to dabigatran (16.1%) and 277 patients assigned to warfarin (21.9%; hazard ratio with dabigatran, 0.71; 95% CI, 0.59 to 0.85). The numbers of deaths, acute coronary syndromes, and abnormal liver-function tests were similar in the two groups. Adverse events leading to discontinuation of the study drug occurred in 9.0% of patients assigned to dabigatran and in 6.8% of patients assigned to warfarin (P=0.05).

CONCLUSIONS:

For the treatment of acute venous thromboembolism, a fixed dose of dabigatran is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring. (ClinicalTrials.gov number, NCT00291330.)

Copyright 2009 Massachusetts Medical Society.

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PMID:
19966341
[PubMed - indexed for MEDLINE]
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