Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Aug 31 2010

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), announced today that the investigational, oral anticoagulant rivaroxaban successfully demonstrated non-inferiority compared to the standard of care for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT), with a comparable safety profile. Data from the pivotal Phase 3 EINSTEIN-DVT clinical trial were presented today during a Hot Line session at the European Society of Cardiology (ESC) Congress in Stockholm, Sweden.

“Results from EINSTEIN-DVT could transform the way physicians treat deep vein thrombosis”

"Results from EINSTEIN-DVT could transform the way physicians treat deep vein thrombosis," said lead investigator Harry R. Büller, M.D., Academic Medical Center in Amsterdam, Netherlands, who presented the results. "While the current standard of care is effective when well-controlled, it is often associated with significant drawbacks for patients and physicians. A novel single-drug approach such as oral rivaroxaban could potentially provide an effective and well-tolerated, simple, fixed-dose regimen for the treatment of deep vein thrombosis as a replacement for current standard therapy."

In the study, oral 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 (VKA), [2.1% vs. 3.0%, respectively (p <0.0001 for non-inferiority)]. Rivaroxaban also demonstrated similar results compared to the standard of care for the principal safety outcome measuring a composite of major and non-major clinically relevant bleeding events [8.1% in both treatment groups,>4 were low in both treatment groups (0.7% vs. 0.8% in the rivaroxaban and enoxaparin/VKA arms, respectively), and there was no signal of serious liver injury observed in either group. Rivaroxaban was well tolerated in the study, and discontinuation rates related to adverse events were low and similar in both treatment groups.

This is the sixth Phase 3 trial in the ongoing rivaroxaban global development program that has demonstrated either non-inferiority (EINSTEIN-DVT) or superiority (RECORD 1-4 and EINSTEIN-EXTENSION).

According to research reported in the journal Circulation, approximately two million Americans have a DVT episode each year. DVT may have burdensome and costly consequences such as pulmonary embolism, venous hypertension, ulceration, an increased risk of recurring clots and post-thrombotic syndrome.

Source : Johnson & Johnson Pharmaceutical