First single-drug approach anticoagulation therapy shown to be effective in treatment of DVT, and in the prevention of recurring blood clots
Online publication of significant Phase III EINSTEIN-DVT and EINSTEIN-Extension studies in The New England Journal of Medicine
Full publication of the Phase III EINSTEIN-DVT study confirmed that, for the first time since the introduction of warfarin 55 years ago1 we have taken a step towards being able to potentially offer an oral single-drug approach – rivaroxaban – as an alternative to traditional standard treatment [a combination of low molecular weight heparin (LMWH) and warfarin] to patients with deep vein thrombosis (DVT).2
When compared to current standard treatment, rivaroxaban demonstrated:2
• Non-inferiority in terms of the primary efficacy outcome [defined as the cumulative incidence of symptomatic recurrent DVT and non-fatal or fatal pulmonary embolism (PE)]: 2.1% vs. 3.0% (p
The multinational Phase III EINSTEIN-DVT study investigated a new single-drug approach with rivaroxaban compared with standard therapy in a randomised, open-label non-inferiority study involving more than 3,400 patients with acute symptomatic DVT, but without any symptoms of PE. Standard therapy for DVT currently includes two compounds: LMWH administered by subcutaneous injection, followed by a VKA, which requires regular monitoring of the prothrombin time, reported as the INR, to optimise efficacy and safety.
EINSTEIN-Extension compared the efficacy and safety of rivaroxaban to placebo in the secondary prevention of recurrent symptomatic venous blood clots in patients who had previously suffered a symptomatic DVT or PE, by extending preventative treatment by 6 or 12 months beyond a previously completed regimen of 6 to 12 months of therapy. 1,196 patients from 28 countries around the world were enrolled.
About rivaroxaban
Rivaroxaban is licensed in adult patients for VTE prevention after elective knee and hip replacement.
Rivaroxaban was invented in Bayer’s Wuppertal laboratories in Germany and is marketed in Europe by Bayer Schering Pharma. It is approved in the European Union for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery. Additional approvals have been granted in other countries, including Australia, Canada, China, Mexico and Singapore. To date, rivaroxaban has been launched in more than 75 countries around the world by Bayer Schering Pharma. More than 65,000 patients are expected to be enrolled into the rivaroxaban clinical development programme, which will evaluate the product in a broad range of acute and chronic blood clotting conditions.
References
1. Scully, M. Warfarin therapy – Rat poison and the prevention of thrombosis. The Biochemist. February 2002; 15-17
2. The EINSTEIN Investigators, Oral Rivaroxaban for Symptomatic Venous Thromboembolism. Published online NEJM, NEJM, 4 December 2010; 1-12
3. Buller. HR. lba-2 Once-Daily Oral Rivaroxaban Versus Placebo in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism. The Einstein-Extension Study. Late-breaking Abstact Session; LBA–2. 51st Annual Meeting of the American Society of Haematology. 8 December 2009. Available here. Last Accessed: 30 November 2009
4. Winter, M. et al. Procedures for the outpatient management of patients with deep venous thrombosis. Clin. Lab. Haem. 2005; 27: 61-66
5. Office for National Statistics. Available at: statistics/cci/nugget.asp?id=6 Last accessed 26.08.10
6. Hansson PO, Sorbo J, Eriksson H. Recurrent Venous Thromboembolism After Deep Vein Thrombosis. Archive of International Medicine. 2000;160:769-774
7. NHS Clinical Knowledge Summaries. Available here. Last accessed 26.08.10
8. Turpie AG. Oral, direct factor Xa inhibitors in development for the prevention and treatment of thromboembolic diseases. Arterioscler Thromb Vasc Biol. 2007;27:1238-1247
Source:
Athena
View drug information on Warfarin Sodium tablets.