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

CHICAGO -- A novel oral anti-coagulant outperformed the injected standard therapy on important safety measures for initial and long-term treatment of pulmonary embolism a blockage of lung blood vessels usually caused by a clot and showed comparable efficacy, according to data from the EINSTEIN-PE trial presented today at the American College of Cardiology's 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.

Pulmonary embolism (PE) and deep vein thrombosis (DVT), a blot clot generally occurring in the legs, constitute the two categories of a condition called venous thromboembolism (VTE). VTE is the third most common cardiovascular disease, and PE is the third most common cause of hospital-related death. EINSTEIN-PE is one of a series of large international phase III clinical trials of the anti-coagulant rivaroxaban to treat VTE or prevent a recurrence in patients with acute PE or DVT. The Food and Drug Administration has approved rivaroxaban as the only oral anti-coagulant for prevention of VTE in patients who have knee or hip replacement, procedures that carry clotting risks.

The trial compared rivaroxaban with standard therapy injection of the anti-coagulant enoxaparin, followed by a vitamin K antagonist (VKA; either warfarin or acenocoumarol) chosen by each participating site to demonstrate that the oral drug as a single agent is equivalent to the complicated two-drug standard therapy. In the standard regimen, enoxaparin must be given as an injection, and the VKA must be monitored with blood tests to make sure the dose is adequate and safe, because common drugs such as antibiotics, alcohol and some foods interact with VKAs. The monitoring measure is INR, an expression of the time it takes blood to clot: the higher the INR number, the higher the risk of bleeding.

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Contact: Beth Casteel
bcasteel@acc.org
240-328-4549
American College of Cardiology
Source:Eurekalert

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