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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Rivaroxaban was noninferior to standard therapy noninferiority margin, 2.
In addition, its open-label design may have biased both patients and investigators. The principal safety outcome was major or clinically relevant nonmajor bleeding.
The primary efficacy outcome was symptomatic recurrent venous thromboembolism. Recommend page Back to top. The outcome of a net clinical benefit occurred in 83 finstein 3.
Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.
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.
Among patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding? The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group. Randomized, open-label phase III non-inferiority study Active treatment: The fixed dose regimen of rivaroxaban is at least as effective for the initial and long-term treatment einztein PE rivaroxxaban the standard therapy with enoxaparin followed by a VKA Safety: It differed from these rifaroxaban in several notable ways, however.
Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population.
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. This approach may also simplify the treatment of pulmonary embolism. Navigation menu Einstien tools Create account Log in. ESC Guidelines on the diagnosis and management of acute pulmonary embolismadapted: Comment in Einstekn Engl J Med.
P values are for noninferiority unless otherwise specified. To compensate rivaroxaaban this, the study used a higher dose during the first 3 weeks of therapy 15mg BID followed by a lower maintenance dose 20mg daily.
Some of these characteristics contribute to the study’s limitations.
The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. 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 Retrieved from ” http: N Engl J Med.
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. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates. The New England Journal of Medicine.
Usable articles Hematology Pulmonology. Major bleeding occured in 1. For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms. Comparisons are rivaroxaban vs.