EINSTEIN DVT Trial Data Presented at ESC

August 31, 2010—Johnson & Johnson Pharmaceutical Research & Development, LLC (Raritan, NJ) announced that the data from the pivotal phase 3 EINSTEIN-DVT clinical trial were presented by lead investigator Harry R. Büller, MD, at the European Society of Cardiology (ESC) Congress in Stockholm, Sweden. This study of the investigational oral anticoagulant rivaroxaban successfully demonstrated noninferiority 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. 

“Results from EINSTEIN-DVT could transform the way physicians treat DVT,” commented Dr. Büller. “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 DVT as a replacement for current standard therapy.”

According to the company, oral rivaroxaban showed noninferiority for the study's primary efficacy outcome, defined as the cumulative incidence of symptomatic recurrent DVT and nonfatal or fatal pulmonary embolism, 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%, respectively [P < .0001 for noninferiority]). Rivaroxaban also demonstrated similar results compared to the standard of care for the principal safety outcome measuring a composite of major and nonmajor clinically relevant bleeding events (8.1% in both treatment groups, [P = .77]). Treatment-emergent, cardiovascular-related outcomes 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.

The company noted that this is the sixth phase 3 trial in the ongoing rivaroxaban global development program that has demonstrated either noninferiority (EINSTEIN-DVT) or superiority (RECORD and EINSTEIN-EXTENSION). EINSTEIN is a global program of three phase 3 clinical trials evaluating the safety and efficacy of rivaroxaban in the treatment and/or prevention of a recurrent, symptomatic VTE in patients with acute symptomatic DVT or pulmonary embolism, with a planned total enrollment of approximately 9,000 patients.