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 ().
|Published (Last):||3 February 2004|
|PDF File Size:||19.54 Mb|
|ePub File Size:||9.67 Mb|
|Price:||Free* [*Free Regsitration Required]|
Rates of other adverse events were similar in the two groups. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. It differed from these studies in several notable ways, however. Oral, direct Factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep vein thrombosis or pulmonary embolism N Engl J Med ; Navigation menu Personal tools Create account Log in.
Einstekn compare rivaroxaban to standard anticoagulant therapy with enoxaparin and vitamin K antagonist VKA in the treatment of patients with acute symptomatic PE.
The outcome of a net clinical benefit occurred in 83 patients 3. Major bleeding occured in 1.
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 primary safety endpoint, a first major and clinically relevant non-major bleeding episode, was observed in Major bleeding was observed in 26 patients 1.
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.
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.
The bleeding rates were similar in sinstein two study groups, with fewer major bleeding events in the rivaroxaban group Close this section.
Retrieved from ” http: This page was last modified on 3 Decemberat Among patients with acute PE, rivaroxaban is noninferior to warfarin in preventing recurrent VTE, and is associated with similar bleeding rates.
Rev Clin Esp Barc. Recommend page Back to top. Rivaroxahan Engl J Med. The principal safety outcome was major or clinically relevant nonmajor bleeding. P values are for noninferiority rivarozaban otherwise specified. 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: The New England Journal of Medicine.
Rivaroxaban was noninferior to standard therapy noninferiority margin, 2.
Like rivaorxaban others, it employed a noninferiority rather than a superiority design, and enrolled a relatively heterogeneous patient population.
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. The principal safety outcome occurred in Comparisons are rivaroxaban vs.
At a mean follow-up of 7 months, rivaroxaban was noninferior to standard therapy in terms of the rate of recurrent symptomatic VTE 2. Some of these characteristics contribute to the study’s limitations.
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 In addition, its open-label design may have biased both patients and investigators. The bleeding rates were similar in the two study groups, with fewer major bleeding events in the ps group. Usable articles Hematology Pulmonology.
ESC Guidelines on the diagnosis and management of acute pulmonary embolismrivaroxzban Views Read View source View history.
This approach may also simplify the treatment of pulmonary embolism. Among patients with acute PE, is rivaroxaban noninferior to warfarin in preventing recurrent VTE or bleeding? It was also one of the first to employ an open-label design lacking matching placebos between groups.
EINSTEIN-PE – Wiki Journal Club
Randomized, einstekn phase III non-inferiority study Active treatment: Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. 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 rivaroxqban. Comment in N Engl J Med. For example, the study’s noninferiority design may have rendered it unable to detect small differences in relative efficacy between treatment arms.