Format

Send to

Choose Destination
N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.

Oral apixaban for the treatment of acute venous thromboembolism.

Collaborators (441)

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, Crawford J, Gordon M, Noble M, Pennington A, Reinhold P, Simmons M, Urwin K, Ceresetto J, McRae S, Pabinger I, Pereira AH, Spencer F, Wang C, Zhang J, Gorican K, Husted SE, Mottier D, Harenberg J, Vértes A, Pinjala R, Zeltser D, Prandoni P, Sandset M, Torbicki A, Fijalkowska A, Alvares JP, Kirienko A, Shvarts Y, Sala LA, Jacobson B, Gudz I, Ortel T, Spyropoulos A, Beyer-Westendorf J, Sipos G, Bredikhin R, Della Siega A, Klinke W, Lawall H, Zwettler U, Prasol V, Cannon K, Vasylyuk S, Jin B, Prandoni P, Desai S, Zaichuk A, Katelnitskiy I, De Pellegrin A, Santonastaso M, Skupyy O, Pesant Y, Shvalb P, Spacek R, Visonà A, Alvarez Sala L, Borja V, Gudz I, Noori E, Sereg M, Ortel T, Braester A, Falvo N, Mottier D, Jacobson B, Vöhringer H, Laperna L, Oliven A, Skalicka L, Bolster D, Haidar A, Schellong S, Vértes A, Smith S, Sergeev O, Pullman J, Torp-Pedersen C, Zimlichman R, Elias M, Fourie N, Pernod G, Panchenko E, Pendleton R, van Nieuwenhuizen E, Vinereanu D, Agnelli G, Becattini C, Manina G, Leduc J, Dunaj M, Frost L, Gavish D, Jakobsen T, Lishner M, Morales L, Chochola J, Gubka O, Holaj R, Hussein O, Katona A, Sergeeva E, Bova C, Cepeda J, Cohen K, Sobkowicz B, Grzelakowski P, Husted S, Lupkovics G, Spencer F, Dedek V, Liu C, Puskas A, Ritchie B, Ambrosio G, Parisi R, Heuer H, Livneh A, Podpera I, Stanbro M, Caraco Y, Fulmer J, Ghirarduzzi A, Schmidt-Lucke J, Bergmann J, Cizek V, Leyden M, Stein R, Abramov I, Chong B, Colan D, Jindal R, Liu S, Pereira A, Porreca E, Salem H, Welker J, Yusen R, Dhar A, Gallus A, Podczeck-Schweighofer A, Shtutin O, Vital Durand D, Zeltser D, Zhang J, Balaji V, Correa J, Harenberg J, Kline J, Runyon M, Laszlo Z, Martelet M, Parakh R, Sandset PM, Schmidt J, Yeo E, Bhagavan N, Bura-Riviere A, Cepeda J, Ferrer J, Lacroix P, Lewczuk J, Pilger E, Sokurenko G, Yu H, Nikulnikov P, Pabinger-Fasching I, Sanchez-Diaz C, Schuller D, Shvarts Y, Suresh K, Wang C, Lobo S, Lyons R, Marschang P, Palla A, Schulman S, Spyropoulous A, Fraiz J, Gerasymov V, Lerner R, Llamas Esperón G, Manenti E, Masson J, Moreira R, Poy C, Rodoman G, Bruckner I, Gurghean A, Carrier M, Freire A, Gan E, Gibson K, Herold M, Hudcovic M, Kamath G, Koslow A, Meneveau N, Roos J, Zahn R, Balanda J, Bratsch H, Dolan S, Gould T, Hirschl M, Hoffmann U, Kaatz S, Shah V, Kadapatti K, Kræmmer Nielsen H, Lahav M, Natarajan S, Tuxen C, Tveit A, Alves C, Formiga A, Brudevold R, Cardozo M, Gorican K, Lorch D, Marais H, Mismetti P, Panico M, Pop C, Quist-Paulsen P, Stevens D, Tarleton G, Yoshida W, Cox M, Crispin P, Czekalski P, Ebrahim I, Game M, Ghanima W, Harrington D, Jackson D, Lawall H, Lee A, Matoska P, Meade A, Camargo AC, Nishinari K, Sanchez Llamas F, Tosetto A, Vejby-Christensen H, Basson M, Blombery P, Fu G, Jha V, Keltai K, Le Jeunne C, Lodigiani C, Ma Y, Nagy A, Neumeister A, Pinjala R, Shotan A, Wong T, Ying K, Anderson S, Brenner B, Carnovali M, Cerana S, Cunha C, Diaz-Castañon J, Graham M, Kirenko A, Palareti G, Rodriguez-Cintron W, Nathanson A, Rosenthal S, Sanders D, Scheinberg P, Schjesvold F, Torp R, van Zyl L, Venher I, Xia G, Brockmyre A, Chen Z, Hakki S, Hanefield C, Mügge A, Janczak D, Karpovych D, Lancaster G, Lavigne C, Lugassy G, Melaniuk M, Moran J, Oliver M, Schattner A, Staroverov I, Timi J, Vöhringer F, von Bilderling P, Warr T, White R, Wronski J, Wu C, Almeida C, Blum A, Bono J, Durán M, Erzinger F, Fu W, Jagadesan R, Jurecka W, Korban E, Nguyen D, Raval M, Willms D, Zevin S, Zhu H, Abdullah I, Achkar A, Albuquerque L, Ali M, Bai C, Bloomfield D, Chen J, Fajardo Campos P, Garcia Bragado F, Kobza I, Lindhoff-Last E, Lourenço A, Marchena Yglesias P, Marshall P, Siegel M, Mikhailova O, Oliva M, Pottier P, Pruszczyk P, Sauer M, Baloira A, Cromer M, D'Angelo A, Faucher J, Gutowski P, Hong S, Lissauer M, Lopes A, Lopes R, Maholtz M, Mesquita E, Miekus P, Mohan B, Ng H, Peterson M, Piovella F, Siragusa S, Srinivas R, Tiberio G, Van Bellen B, Arutyunov G, Assi N, Baker R, Blanc F, Curnow J, Fu C, Gonzalez-Porras J, Guijarro Merino R, Gunasingam S, Gupta P, Laule M, Liu Z, Luber J, Masson J, Serifilippi G, Paulson R, Shevela A, Simonneau G, Siu D, Sosa Liprandi M, Takács J, Tay J, Vora K, Witkiewicz W, Zhao L, Aquilanti S, Dabbagh O, Dellas C, Denaro C, Doshi A, Fijalkowska A, Flippo G, Giumelli C, Gomez Cerezo J, Han D, Harris L, Hofmann L Jr, Kamerkar D, Kaminski L, Kazimir M, Kloczko J, Ko Y, Koura F, Lavender R, Maly J, Margolis B, McRae S, Mos L, Sanchez-Escalante L, Solvang A, Soroka V, Szopinski P, Thawani H, Vickars L, Welker J, Yip G, Zangroniz P.

Author information

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

Abstract

BACKGROUND:

Apixaban, an oral factor Xa inhibitor administered in fixed doses, may simplify the treatment of venous thromboembolism.

METHODS:

In this randomized, double-blind study, we compared apixaban (at a dose of 10 mg twice daily for 7 days, followed by 5 mg twice daily for 6 months) with conventional therapy (subcutaneous enoxaparin, followed by warfarin) in 5395 patients with acute venous thromboembolism. The primary efficacy outcome was recurrent symptomatic venous thromboembolism or death related to venous thromboembolism. The principal safety outcomes were major bleeding alone and major bleeding plus clinically relevant nonmajor bleeding.

RESULTS:

The primary efficacy outcome occurred in 59 of 2609 patients (2.3%) in the apixaban group, as compared with 71 of 2635 (2.7%) in the conventional-therapy group (relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; difference in risk [apixaban minus conventional therapy], -0.4 percentage points; 95% CI, -1.3 to 0.4). Apixaban was noninferior to conventional therapy (P<0.001) for predefined upper limits of the 95% confidence intervals for both relative risk (<1.80) and difference in risk (<3.5 percentage points). Major bleeding occurred in 0.6% of patients who received apixaban and in 1.8% of those who received conventional therapy (relative risk, 0.31; 95% CI, 0.17 to 0.55; P<0.001 for superiority). The composite outcome of major bleeding and clinically relevant nonmajor bleeding occurred in 4.3% of the patients in the apixaban group, as compared with 9.7% of those in the conventional-therapy group (relative risk, 0.44; 95% CI, 0.36 to 0.55; P<0.001). Rates of other adverse events were similar in the two groups.

CONCLUSIONS:

A fixed-dose regimen of apixaban alone was noninferior to conventional therapy for the treatment of acute venous thromboembolism and was associated with significantly less bleeding (Funded by Pfizer and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00643201).

PMID:
23808982
DOI:
10.1056/NEJMoa1302507
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center