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Oral Anticoagulant Dabigatran Etexilate Approved in Canada TORONTO -- June 16, 2008 -- Health Canada has approved dabigatran etexilate (Pradax), an oral direct thrombin inhibitor for the prevention of venous thromboembolism in adult patients who have undergone elective total hip or total knee replacement surgery. Dabigatran etexilate is an oral, once-daily anticoagulant that does not require extensive anticoagulation monitoring. Dabigatran etexilate does not interact with food and has a low potential for drug-drug interactions. The Canadian approval of dabigatran etexilate is based on data from the RE-NOVATE, RE-MOBILIZE, and RE-MODEL trials. In these 3 pivotal trials, a low incidence and severity of major bleeding were reported in patients treated with dabigatran etexilate, which were similar to those treated with enoxaparin. Rates of liver enzyme alanine aminotransferase elevations greater than 3 times the upper limit of normal were also low and comparable to enoxaparin at any time postbaseline with dabigatran etexilate, supporting liver safety. "Because patients are spending less time in [the] hospital, there is a greater need for safe and convenient treatment options like [dabigatran etexilate] as patients are discharged," says Michael Tanzer, MD, Montreal General Hospital, Montreal, Quebec. "The average hospital stay following hip and knee replacement surgery has been substantially shortened, which means that the care and management of patients has shifted from in-hospital to at-home. Because there is little to no blood monitoring required with [dabigatran etexilate] and no food interactions, patients are now able to conveniently and safely continue therapy in an out-of-hospital setting." SOURCE: Environics Communications E-mail this page to a friend or colleague! To print, use this version