EINSTEIN PE RIVAROXABAN PDF

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 New England Journal of Medicine. In a randomized, open-label, event-driven, noninferiority trial involving patients who had acute symptomatic pulmonary embolism with or without deep-vein ps, 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.

ESC Guidelines on the diagnosis and management of acute pulmonary embolismadapted: Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism It was also one of the first to employ an open-label design lacking matching placebos between groups. For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms.

EINSTEIN-PE – Wiki Journal Club

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 Comment in N Engl J Med. In addition, its open-label design may have biased both patients and investigators.

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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. This page was last modified on 3 Decemberat This approach may also simplify the treatment of pulmonary embolism. 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.

Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.

N Engl J Med ; At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2. Retrieved from ” http: Some of these characteristics contribute to the study’s limitations. The principal safety outcome occurred in 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.

Randomized, open-label phase III non-inferiority study Active treatment: The primary efficacy outcome was symptomatic recurrent venous thromboembolism.

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Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

The outcome of a net clinical benefit occurred in 83 patients 3. Major bleeding occured in 1. Rates of other adverse events were similar in the two groups. Recommend page Back to top. rivagoxaban

A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, riivaroxaban been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. Rivaroxaban was noninferior to standard therapy noninferiority margin, 2. Major bleeding was observed in 26 patients 1.

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Comparisons are rivaroxaban vs.

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. P values are for noninferiority unless ps specified.

Rev Clin Esp Barc.