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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ERivaroxaban, a direct, specific, competitive factor Xa inhibitor that inhibits thrombin generation, is an effective treatment for venous thromboembolism. The Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism trial [EINSTEIN PE; Buller HR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012] reported data that showed that rivaroxaban was noninferior to standard therapy but had a superior bleeding profile in patients with pulmonary embolism.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EThrombotic Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ERivaroxaban, a direct, specific, competitive factor Xa inhibitor that inhibits thrombin generation, is an effective treatment for venous thromboembolism (VTE). The Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep\u2013Vein Thrombosis or Pulmonary Embolism trial [EINSTEIN PE; Buller HR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012] reported data that showed that rivaroxaban was noninferior to standard therapy but had a superior bleeding profile in patients with pulmonary embolism (PE). Results were presented by Harry Roger Buller, MD, Academic Medical Center, Amsterdam, The Netherlands.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThis was a multicenter, randomized, open\u2013label, assessor\u2013blind, event\u2013driven, noninferiority trial that comprised patients with acute symptomatic PE with or without deep\u2013vein thrombosis (DVT). Patients (n=4832) were randomized to receive open\u2013label oral rivaroxaban 15 mg twice daily for 3 weeks, then 20 mg once daily, versus subcutaneous enoxaparin (1 mg\/kg) twice daily for 5 days plus a vitamin K antagonist (VKA; acenocoumarol or warfarin), initiated within 48 hours of randomization. Enoxaparin was discontinued when the patient\u0027s international normalized ratio (INR) was \u22652.0 for 2 consecutive days after at least 5 days of enoxaparin treatment. INR was measured at least once a month and the dose of the VKA was adjusted to maintain an INR of 2.0 to 3.0. The study treatment duration was 3, 6, or 12 months, and patients were followed for 30 days post\u2013treatment. The primary efficacy outcome was first recurrent VTE (defined as fatal or nonfatal PE or DVT). The principal safety outcome was the first major or nonmajor clinically relevant bleeding.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn this population of patients with acute symptomatic PE with or without DVT, rivaroxaban was noninferior to enoxaparin, followed by VKA for efficacy (2.1% vs 1.8%; HR, 1.12; 95% CI, 0.75 to 1.68; p=0.003 for a noninferiority margin of 2.0). Significantly fewer patients who were randomized to rivaroxaban had major bleeding compared with those who were treated with enoxaparin\/VKA (1.1% vs 2.2%; HR, 0.49; 95% CI, 0.31 to 0.79; p=0.003). Major or nonmajor clinically relevant bleeding occurred in 10.3% of the rivaroxaban\u2013 versus 11.4% of enoxaparin\/VKA\u2013treated patients (HR, 0.90; 95% CI, 0.76 to 1.07; p=0.23). Primary efficacy and safety outcomes were similar between the two treatments, irrespective of age, body weight, gender, kidney function, and cancer. There was no difference in liver toxicity.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe investigators concluded that oral rivaroxaban, 15 mg twice daily for 3 weeks, followed by 20 mg once daily, provides patients and clinicians with a simple, single\u2013drug approach for the acute and continued treatment of both DVT and PE, with a potential improvement in the benefit\/risk profile.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/4\/21.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznhip\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}