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N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

Apixaban for extended treatment of venous thromboembolism.

Collaborators (397)

Agnelli G, Buller H, Cohen A, Gallus A, Raskob G, Weitz J, Prins M, Brandjes D, Kolbach D, Limburg M, Mac Gillavry M, Otten JM, Peters R, Roos Y, Segers A, Slagboom T, Bounameaux H, Hirsh J, Samama MM, Wedel H, Curto M, Johnson M, Masiukiewicz U, Pak R, Porcari A, Sanders P, Sisson M, Sullivan B, Thompson J, Auerbach J, Cesario L, Gamero M, Gordon M, Griffiths A, Noble M, Ott J, Pennington A, Peffer A, Reinhold P, Simmons M, Urwin K, Ceresetto J, McRae S, Pabinger I, Pereira AH, Spencer F, Gorican K, Husted SE, Mottier D, Harenberg J, Pinjala R, Zeltser D, Imberti D, Sandset M, Torbicki A, Fijalkowska A, Albino JP, Kirienko A, Shvarts Y, Monreal M, Jacobson B, Dolan G, Gudz I, Ortel T, Spyropoulos A, Torbicki A, Fijalkowska A, Skupyy O, Beryer-Westendorf J, De Pellegrin A, Prasol V, Schellong S, Jacobson B, Falvo N, Abramov I, Cizek V, Husted S, Desai S, Gudz I, Barillari G, Sergeev O, Chetter I, Inbal A, McCollum C, Shvalb P, Torp-Pedersen C, Vasylyuk S, Kraemmer Nielsen H, Pernod G, Schmidt J, Bova C, Gerasymov V, Pabinger-Fasching I, Skalicka L, Zaichuk A, Achkar A, Bremmelgaard A, Chochola J, Gould T, Khalafallah A, Jakobsen T, Rose P, Zhukov B, Dedek V, Mirete Ferrer J, Pesant Y, Repin A, Salem H, Solis Morales L, Spacek R, Cannon K, Grzelakowski P, Jindal R, Pereira A, Zidkova E, Ambrosio G, Cardozo M, Dunaj M, Gallus A, Gavish D, Ghanima W, Harenberg J, Leduc JJ, Mismetti P, Panico M, Porreca E, Riera A, Bareford D, Chong B, Dvoryashina I, Gómez Cerezo J, Kobza I, Nielsen T, Pendleton R, Pullman J, Schiffman G, Stanbro M, Zwettler U, Aquilanti S, Bratsch H, Cohen K, Elias D, Gan E, Holaj R, Klinke W, Liu HS, Sandset PM, van Nieuwenhuizen E, Álvarez-Sala LA, Basson M, Braester A, Bura-Riviere A, Calvo Vargas C, Cohen A, Correa J, Elias M, Frost L, Imberti D, Landolfi R, Marschang P, Moreira R, Mottier D, Natarajan S, Pottier P, Tosetto A, Tuxen C, Vöhringer HF, Alexander A, Barbarash O, Fajardo Campos P, Graham M, Gubka O, Hudcovic M, Hussein O, Imberti D, Jackson D, Katelnitskiy I, Lawall H, Monreal M, Palareti G, Poggio R, Roos J, Simonneau G, Smith SW, Szopinski P, Ortel T, Zimlichman R, Bridgers D, Colan D, Czekalski P, De Jong D, Fortinez JT, Garcia Bragado F, Harrington D, Izbicki G, Kadr H, Koslow A, Loftus I, Marais H, Neumeister A, Oliven A, Palla A, Pop C, Prandoni P, Puskas A, Sanchez Llamas F, Shotan A, Shvarts Y, Singh P, Tveit A, Baker R, Borja V, Brenner B, Brown H, Ceresetto J, Cha TJ, Cohen Y, D'Angelo A, Dhar A, Friis E, Hueur H, Jiménez Rodríguez Madridejos R, Karl J, Karrasch J, Lishner M, Manenti E, McRae S, Meneveau N, Nguyen D, Sanchez-Escalante L, Santoscoy Ibarra J, Sokurenko G, Staroverov I, Stein R, Abdullah I, Agnelli G, Alcocer Gamba M, Balanda J, Bruckner I, Calabuig Alborch J, Caraco Y, Comerota A, Cromer M, de Araujo Filho J, De los Rios Ibarra M, Diaz-Castañon J, Doshi A, Ebrahim I, Fessel WJ, Fletcher E, Fourie N, Fu C, Gutowski P, Haddad G, Hoffman U, Jardula M, Kvasnicka T, Lewczuk J, Leyden M, Livneh A, Lodigiani C, Lovell C, Miekus P, Paloma MJ, Parakh R, Raval M, Schmidt-Lucke J, Shtutin O, Soroka V, Stevens D, Sulik P, Tay JC, Vejby-Christensen H, Vinereanu D, Baghestanian M, Bono J, Cerana S, Freire A, Gibson K, Giumelli C, Iastrebner C, Karpenko A, Kelly A, Lacroix P, LaFata J, Lobo S, Macik BG, Marchena Yglesias P, Nishinari K, Pinjala R, Podczeck-Schweighofer A, Raby K, Sirpal S, Solymoss S, Spencer F, van Zyl L, Vargas Núñez JA, von Bilderling P, Warr T, Wronski J, Wurster M, Albino JA, Albuquerque L, Averill F, Baek SH, Bello F, Bergoeing M, Blanc FX, Bloomberg R, Bolster D, Brockmyre A, Calimano C, Checketts D, Cieplinski W, Chervu A, Collado F, Denaro C, Gaciong Z, Game M, Iskander A, Kaatz S, Kim DI, Koura F, Laguna F, Lanas Zanetti F, Lindhoff-Last E, Melaniuk M, Meade A, Murphy T, Ng HJ, Páramo Fernández JA, Patil C, Piovella F, Prisco D, Pruszczyk P, Reimers G, Rivera E, Rodriguez-Cintron W, Rosenthal S, Salbach P, Salvador D, Schuller D, Siragusa S, Staniszewski R, Torp R, Vora K, Yip G, Alfieri A, Belaji V, Bhagavan N, Carnovali M, Cobos Segarra J, Di Todaro F, Dowell A, Corder C, Crispin P, Cuadrado J, Flippo G, Fraiz J, Guillaumon A, Gvora T, Hakki S, Harris L, Ison R, Htun PT, Jasani R, Kates M, Kaminski L, Kamerkar D, Kirienko A, Kroger K, Laperna L, Leiva J, Luber J, McCann A, McKenzie W, Menna Barreto S, Moran J, Nikulnikov P, Paliwal Y, Patel M, Pilger E, Renwick W, Shevela A, Solymoss S, Starosiliz D, Stringam S, Spyropoulos A, To R, Updegrove J, Van Bellen B, Vöhringer HF, Waintrub M, White J, Yeo E, Zangroniz P, Zeltser D.

Author information

1
Department of Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy. agnellig@unipg.it

Abstract

BACKGROUND:

Apixaban, an oral factor Xa inhibitor that can be administered in a simple, fixed-dose regimen, may be an option for the extended treatment of venous thromboembolism.

METHODS:

In this randomized, double-blind study, we compared two doses of apixaban (2.5 mg and 5 mg, twice daily) with placebo in patients with venous thromboembolism who had completed 6 to 12 months of anticoagulation therapy and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy. The study drugs were administered for 12 months.

RESULTS:

A total of 2486 patients underwent randomization, of whom 2482 were included in the intention-to-treat analyses. Symptomatic recurrent venous thromboembolism or death from venous thromboembolism occurred in 73 of the 829 patients (8.8%) who were receiving placebo, as compared with 14 of the 840 patients (1.7%) who were receiving 2.5 mg of apixaban (a difference of 7.2 percentage points; 95% confidence interval [CI], 5.0 to 9.3) and 14 of the 813 patients (1.7%) who were receiving 5 mg of apixaban (a difference of 7.0 percentage points; 95% CI, 4.9 to 9.1) (P<0.001 for both comparisons). The rates of major bleeding were 0.5% in the placebo group, 0.2% in the 2.5-mg apixaban group, and 0.1% in the 5-mg apixaban group. The rates of clinically relevant nonmajor bleeding were 2.3% in the placebo group, 3.0% in the 2.5-mg apixaban group, and 4.2% in the 5-mg apixaban group. The rate of death from any cause was 1.7% in the placebo group, as compared with 0.8% in the 2.5-mg apixaban group and 0.5% in the 5-mg apixaban group.

CONCLUSIONS:

Extended anticoagulation with apixaban at either a treatment dose (5 mg) or a thromboprophylactic dose (2.5 mg) reduced the risk of recurrent venous thromboembolism without increasing the rate of major bleeding. (Funded by Bristol-Myers Squibb and Pfizer; AMPLIFY-EXT ClinicalTrials.gov number, NCT00633893.).

PMID:
23216615
DOI:
10.1056/NEJMoa1207541
[Indexed for MEDLINE]
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