logo
Share SHARE
FONT-SIZE Plus   Neg

XARELTO Found As Effective As Standard Treatment In VTE Trial - Quick Facts

Janssen Research & Development LLC reported results of the EINSTEIN-PE study, demonstrating that the oral anticoagulant XARELTO or rivaroxaban was comparable to today's standard of care in treating patients with acute symptomatic pulmonary embolism or PE and in preventing secondary venous blood clot development, also called as venous thromboembolism or VTE. Further, the study discovered that rivaroxaban had a similar safety profile and significantly lower risk of major bleeding versus the current standard regimen.

The EINSTEIN-PE study compared rivaroxaban to enoxaparin followed by vitamin K antagonist in the treatment of 4,833 patients with acute symptomatic PE for the prevention of recurrent VTE. Patients received treatment for three, six or 12 months. As a result of the study, rivaroxaban showed non-inferiority to standard therapy for the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis or DVT and non-fatal or fatal PE. In addition, Rivaroxaban demonstrated similar results compared to standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events.

Rivaroxaban treatment also resulted in a significant reduction in major bleeding events versus standard therapy. VTE is the collective term for both deep vein thrombosis or DVT and PE. The company intends to file the EINSTEIN studies in a supplemental New Drug Application with the FDA during the second quarter of this year. Janssen Research & Development LLC and Janssen Pharmaceuticals Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ).

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Shares of social network company Twitter Inc. (TWTR), jumped over 5 percent on Wednesday, after one of its cofounders Ev Williams dropped a hint during a television interview about the company's sale. Ev Williams, a Twitter cofounder and board member, was asked by Bloomberg TV about the company's... Mazda Motor Corp. (MZDAF.PK) is recalling over 190,000 CX-7 sport utility vehicles to fix a issue that could lead to loss of steering control. The recall involves CX-7 models from 2007 through 2012 manufactured between February 14, 2006 to May 9, 2012. The company said there have been no reports of... Over 68 million email address and passwords of Dropbox users were stolen by hackers, according to a report from Motherboard. Although, the account details were stolen during a previously disclosed breach that took place in 2012, the magnitude of the attack has come to light only now. Following...
comments powered by Disqus
Follow RTT