Date: 2012-03-26
Type of
information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in The New English Journal of Medicine
Company: Bayer (Germany)
Product: Xarelto® (rivaroxaban)
Action
mechanism: anticoagulant agent/oral direct Factor Xa inhibitor
Disease: prevention of venous thromboembolism (VTE) in patients with acute symptomatic pulmonary embolism (PE)
Therapeutic
area: Cardiovascular diseases
Country: Andorra, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel,Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, The Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Singapore,South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, UK, USA
Trial
details:
- The EINSTEIN-PE study compared the oral single-drug approach with rivaroxaban 15 mg twice daily for three weeks followed by 20 mg once daily with the current standard of care of subcutaneous enoxaparin followed by a VKA 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.
- EINSTEIN-PE is one of three Phase III studies in the global EINSTEIN program that evaluated the safety and efficacy of rivaroxaban in the treatment of venous thromboembolism in almost 10,000 patients. This multinational, randomized, event-driven study with blinded outcome assessment was sponsored by Bayer HealthCare and Janssen Research & Development. (NCT00439777)
Latest
news:
- • On March 26, 2012, Bayer has announced that the oral anticoagulant Xarelto® (rivaroxaban), used as a single drug intervention, was as effective and safe as the current dual drug approach of subcutaneous enoxaparin followed by Vitamin K antagonist (VKA), in treating patients with acute symptomatic pulmonary embolism (PE) and preventing them from developing a secondary venous blood clot (known as venous thromboembolism or VTE). Rivaroxaban demonstrated similar overall bleeding rates, but was associated with significantly lower rates of major bleeding versus the current standard regimen. These data were presented as a late-breaker at the American College of Cardiology Annual Scientific Sessions, and published in the New England Journal of Medicine.
- Patients received treatment for three, six or 12 months. In the study, rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE [2.1% vs. 1.8%, respectively (p=0.003 for non-inferiority)]. Rivaroxaban also demonstrated similar safety results compared to current standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events [10.3% vs. 11.4% (p=0.23), respectively]. Importantly, rivaroxaban treatment resulted in a significant reduction in major bleeding events [1.1% vs. 2.2% (p=0.003), respectively] compared to the current standard therapy.
- On December 9, 2011, Xarelto® (rivaroxaban) received European Commission approval for the treatment of DVT and the prevention of recurrent DVT and PE following an acute DVT in adults.
Is
general: Yes
