XARELTO achieves net clinical benefit in treatment of patients with DVT

BAYER INC.Sep 2 2010

The EINSTEIN-DVT study reinforces that XARELTO is a simple and convenient treatment option for clinicians and patients alike

Bayer HealthCare Pharmaceuticals today announced that XARELTO(R) (rivaroxaban), a novel anti-clotting therapy, achieved improvement in net clinical benefit in a study looking at treatment of patients with deep vein thrombosis (DVT). DVT is the formation of a blood clot in a deep vein, usually in the legs, that partially or totally blocks the flow of blood. It is estimated that DVT affects 45,000 Canadians per year. Around one-third of patients with DVT will progress to having a potentially fatal pulmonary embolism (PE), where the blood clot breaks apart and travels to the lungs, ultimately blocking a blood vessel there. Even in the absence of a PE, DVT alone can have burdensome and costly consequences such as post-thrombotic syndrome and an increased risk of recurring blood clots. Therefore, achieving treatment goals is essential. XARELTO prevents the formation and minimizes the risk of these potentially-deadly blood clots.

"Results from this study could change the way doctors treat deep vein thrombosis," says Dr. Alexander G. G. Turpie, Professor of Medicine at the Michael G. DeGroote School of Medicine at McMaster University, Hamilton, ON. "A single-drug approach such as XARELTO could potentially provide an effective and well-tolerated DVT treatment for clinicians to prescribe, as well as a convenient, fixed-dose regimen for patients to use."

In the study, called EINSTEIN-DVT and presented this week during the European Society of Cardiology (ESC) Congress, net clinical benefit, a pre-specified secondary outcome defined as the composite of the primary efficacy outcome plus major bleeding, was shown as an improvement for oral rivaroxaban compared to standard therapy (2.9% vs. 4.2%, respectively; HR of 0.67, CI: 0.47 - 0.95). The benefit demonstrated by EINSTEIN-DVT means that clinicians and patients could potentially move from two-drug therapy to single-drug therapy, with no need for injections.

Rivaroxaban demonstrated non-inferiority for the primary efficacy outcome, defined as the cumulative incidence of symptomatic recurrent DVT and non-fatal or fatal PE, in patients with acute symptomatic DVT compared with the current standard of care of enoxaparin followed by a vitamin K antagonist, (2.1% vs. 3.0%, respectively (p (less than)0.0001 for non-inferiority)). Rivaroxaban demonstrated similar results compared to the standard of care for the principal safety outcome, a composite of major or non-major clinically relevant bleeding events (8.1% in both treatment groups,>

XARELTO is currently indicated in Canada for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.