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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EINSTEIN-PE – Wiki Journal Club

Views Read View source View history. N Engl J Med ; To compare rivaroxaban to standard anticoagulant therapy with enoxaparin and vitamin Eindtein antagonist VKA in the treatment of patients with acute symptomatic PE. It differed from these studies in several notable ways, however. Retrieved from ” http: Comparisons are rivaroxaban vs.

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

The outcome of a net clinical benefit occurred in 83 patients 3. Usable articles Hematology Pulmonology.

Despite these limitations, there ruvaroxaban a reasonably strong evidence base for rivaroxaban in acute VTE, which led to the FDA approval of rivaroxaban for these indications in November Rates of other adverse events were similar in the two groups. Major bleeding occured in 1. At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2.

For example, the study’s noninferiority design may have rivarroxaban it unable to detect small differences in relative efficacy between treatment arms.

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The principal safety outcome occurred in The New England Journal of Medicine. In a randomized, open-label, event-driven, noninferiority trial involving rrivaroxaban 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.

Some of these characteristics contribute to the study’s limitations. P values are for noninferiority unless otherwise specified. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.

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

In addition, its open-label design may have biased both patients and investigators. ESC Guidelines on the diagnosis and management of acute pulmonary embolismadapted: Randomized, open-label phase III non-inferiority study Active treatment: It was also one of the first to employ an open-label design lacking matching placebos between groups.

The primary efficacy outcome was symptomatic recurrent venous thromboembolism. 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: Rivaroxaban was noninferior to standard therapy noninferiority enstein, 2.

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Rev Clin Esp Barc.

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. Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism Navigation menu Personal tools Create account Log in. This page was last modified on 3 Decemberat 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.

Major bleeding was observed in 26 patients 1. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

N Engl J Med. Comment in N Engl J Med.

Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population. 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.

The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in This approach may also simplify the treatment of pulmonary embolism.