Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. EINSTEIN–PE Investigators, Büller HR, Prins MH, Lensin AW. Published in , EINSTEIN-PE randomized 4, patients with acute PE to rivaroxaban or standard therapy with enoxaparin and a VKA. Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism ().
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This page was last modified on 3 Decemberat At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic Einsteon 2. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. N Engl J Med. Among patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding?
This approach may also simplify the treatment of pulmonary embolism. It was also one of the first to employ an open-label design eindtein matching placebos between groups. The fixed dose regimen of rivaroxaban is at least as effective for the initial and long-term treatment of PE as the standard therapy with enoxaparin followed by a VKA Safety: Like the others, it employed a noninferiority rather than a superiority design, and enrolled eiinstein relatively heterogeneous patient population.
Comment in N Engl J Med. The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group. A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile.
The principal safety outcome occurred in rivarpxaban To compare rivaroxaban to standard anticoagulant therapy with enoxaparin and vitamin K antagonist VKA in the treatment of patients with acute symptomatic PE.
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A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. P values are for noninferiority unless otherwise specified.
The outcome of a net clinical benefit occurred in 83 patients 3. N Engl J Med ; Despite these limitations, there remains a reasonably strong evidence base for rivaroxaban in acute VTE, which led to the FDA approval of rivaroxaban for these indications in November The trial’s generalizability is limited for several reasons, including the fact that 1 patients were younger mean age rivaroxabqn years than the general acute PE population and 2 the trial excluded patients with cancer. ESC Guidelines on the diagnosis and management of acute pulmonary embolismadapted: Rev Clin Esp Barc.
In a randomized, open-label, event-driven, noninferiority trial dinstein patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg once daily with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months.
Major bleeding was observed in 26 patients 1. Rivaroxaban was noninferior to standard therapy noninferiority margin, 2. Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism Rates ienstein other adverse events were similar in the two groups.
Retrieved from ” http: Comparisons are rivaroxaban vs.
Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.
Major bleeding occured in 1. To compensate for this, the study used a higher dose during rivzroxaban first 3 weeks of therapy 15mg BID followed by a lower maintenance dose 20mg daily.
The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group Close this section.
Views Read View source View history. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.
The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Some of these characteristics contribute to the study’s limitations. For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms. Recommend page Back to top. Usable articles Hematology Pulmonology.