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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The outcome of a net clinical benefit occurred in 83 patients 3. Rates of other adverse events were similar in the two groups. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates. To compare rivaroxaban to standard anticoagulant rviaroxaban with enoxaparin and vitamin K antagonist VKA in the treatment of patients with acute symptomatic PE.
Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population.
It differed from these studies in several notable ways, however. Comment in N Engl J Med. 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.
It was also one of the first to employ an open-label design lacking matching placebos between groups. Rivaroxaban was noninferior to standard therapy noninferiority margin, 2. The primary efficacy outcome was symptomatic recurrent venous thromboembolism.
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To compensate for this, the study used a higher dose during the first 3 weeks of therapy 15mg BID followed by a lower maintenance dose 20mg daily. P values are for noninferiority unless otherwise specified. Views Read View source View history.
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 principal safety outcome was major or clinically relevant nonmajor bleeding.
Rev Clin Esp Barc. N Engl J Med.
The fixed dose regimen of rivaroxaban le at least as effective for the initial and long-term treatment of PE as the standard therapy with enoxaparin einsein by a VKA Safety: Ienstein Guidelines on the diagnosis and management of acute pulmonary embolismadapted: For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms.
Major bleeding was observed in 26 patients 1. In a randomized, open-label, event-driven, noninferiority trial involving 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, ribaroxaban 12 months.
Navigation menu Personal tools Create account Log in. At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2. Usable articles Hematology Pulmonology. The New England Journal of Medicine.
This page was last modified on 3 Decemberat The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group.
The principal safety outcome occurred in This approach may also simplify ;e treatment of pulmonary embolism. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. Among patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding?
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The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group Close this section. 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. Retrieved from ” http: N Engl J Med ; Comparisons are rivaroxaban vs. The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Oral, direct Factor Xa inhibitor eknstein in patients with acute symptomatic deep vein thrombosis or pulmonary embolism Some of these characteristics contribute to the study’s limitations.
Major bleeding occured in 1. Randomized, open-label phase III non-inferiority study Active treatment: In addition, its open-label design may have biased both patients and rivaroxabam. The trial’s generalizability is limited for several reasons, including the fact that 1 patients were younger mean age 58 years than the general acute PE population and 2 the trial excluded patients with cancer.