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Novel drug in pill form safer than standard approach to treat blocked lung blood vessels
Date:3/26/2012

ight way, it's a perfectly effective drug with almost 90 percent reduction in recurrent thrombosis, but it has to be well controlled," said Harry R. Buller, MD, PhD, professor of vascular medicine at the Academic Medical Center, Amsterdam, The Netherlands, who chairs the program for the three EINSTEIN studies. "The reason people look for alternatives is that it's a nightmare to give. Rivaroxaban makes things easier for everybody patients and physicians. Our major aim was to show that it's at least as good as standard care."

The study, conducted at 263 sites in 38 countries, randomly assigned 2,419 patients to the rivaroxaban arm and 2,414 to standard treatment. All enrolled patients had a primary diagnosis of PE, and 25 percent in both groups also had DVT. Patients were treated for three, six or 12 months (average, seven) as deemed appropriate by each clinician before randomization. The rivaroxaban group received 15 mg twice a day for three weeks followed by 20 mg once a day. In the standard-therapy arm, the regimen was enoxaparin at 1.0 mg per kg of body weight twice daily, continued at least five days and stopped when the INR was 2.0 or more for two consecutive days, plus a VKA started within 48 hours after randomization with dose adjustment to maintain an INR of 2.0 to 3.0.

Rivaroxaban's efficacy was highly significant for non-inferiority with 2.1 percent recurrences (50 events) vs. 1.8 percent (44 events) in the standard-therapy arm. On safety measures of bleeding, rivaroxaban did much better: principal safety measure of major or clinically relevant bleeding, 10.3 percent vs. 11.4 percent for standard treatment; for major bleeding alone, 1.1 percent vs. 2.2 percent for standard therapy. Rates for primary endpoints were similar in both study arms regardless of patient characteristics.

"Physicians want to know about major bleeding, the most important safety outcome, and rivaroxaban was highly significantly superior. This was our most a
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Contact: Beth Casteel
bcasteel@acc.org
240-328-4549
American College of Cardiology
Source:Eurekalert

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