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EINSTEIN PE RIVAROXABAN PDF

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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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Navigation menu Personal tools Create account Log in. The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Comment in N Engl J Med. It was also one of the first to employ an open-label design lacking matching placebos between groups. The principal safety outcome occurred in Rivaroxaban was noninferior to standard therapy noninferiority margin, 2.

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, or 12 months.

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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The principal safety outcome was major or clinically relevant nonmajor bleeding.

Anticoagulation-trials: EINSTEIN-PE

The bleeding rates were similar in the two study groups, with ricaroxaban major bleeding events in the rivaroxaban group Close this section. Major bleeding occured in 1.

Retrieved from ” http: It differed from these studies in several notable ways, however. A fixed-dose regimen of rivaroxaban, givaroxaban 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.

Some of these characteristics contribute to the study’s limitations.

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism 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 rivaroxabann excluded patients with cancer. 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.

Rivaaroxaban patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding? Rates of other adverse events were similar in the two groups.

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Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

The fixed dose regimen of rivaroxaban is at least as effective for the initial and long-term treatment of PE as the standard therapy eisntein enoxaparin followed by a VKA Safety: Recommend page Back to top.

This approach may also simplify the treatment of pulmonary embolism. Rev Clin Esp Barc.

The primary efficacy outcome was symptomatic recurrent venous thromboembolism. 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.

Views Read View source View history. P values are for noninferiority unless otherwise specified.

EINSTEIN-PE

Usable articles Hematology Pulmonology. The New England Journal of Medicine. In addition, its open-label design may have biased both patients and investigators.

The outcome of a net clinical benefit occurred in 83 patients 3.

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 This page was last modified on 3 Decemberat