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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Major bleeding occured in 1.
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 Close this section. The bleeding rates were similar in the two study groups, with fewer major bleeding events in the rivaroxaban group. The outcome of a net clinical benefit occurred in 83 patients 3.
The New England Journal of Medicine.
The primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Randomized, open-label phase III non-inferiority study Active treatment: Einstdin 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. N Engl J Med.
Comment in N Engl J Med. Some of these characteristics contribute to the study’s limitations. At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2.
Rates of other adverse events were similar in the two groups. Retrieved from ” http: This page was last modified on 3 Decemberat Views Read View source View history. Major bleeding was observed in 26 patients 1. In addition, its open-label design may have biased both patients and investigators.
It differed from these studies in several notable ways, however. Usable articles Hematology Pulmonology. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. Despite these limitations, there remains a reasonably strong evidence base for rivaroxaban rivaroxabwn acute VTE, which led to the FDA approval of rivaroxaban for these indications in November The fixed dose regimen of rivaroxaban is at least rivaroxabqn effective for the initial and long-term treatment of PE as the standard therapy with enoxaparin followed by a VKA Safety: Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism ESC Guidelines on the diagnosis and management of acute pulmonary embolismadapted: Navigation menu Personal tools Create account Log in.
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.
The principal safety outcome was major or clinically relevant nonmajor bleeding. A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has rivaroxabn shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring.
Rev Clin Esp Barc. In a randomized, open-label, event-driven, noninferiority trial involving patients who had acute riivaroxaban 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. Comparisons are rivaroxaban vs.
Rivaroxaban was noninferior to standard therapy noninferiority margin, 2.
To compare rivaroxaban to standard anticoagulant therapy with enoxaparin and vitamin K antagonist VKA in the treatment of patients with acute symptomatic PE. Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.
The principal safety outcome occurred in This approach may also simplify the treatment of pulmonary embolism. It was also one of the first to employ an open-label design lacking matching placebos between groups. Like the others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population.
Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.
The trial’s generalizability is limited einatein 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 otherwise specified. Recommend page Back to top. The primary efficacy outcome was symptomatic recurrent venous thromboembolism.
For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms.