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American Journal of Medicine
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American Journal of Medicine
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Of dabigatran‘s 4 large clinical trials, 2 were designed to test dabigatran for the initial treatment of VTE and 2 were designed to test dabigatran for the long-term treatment. This is useful because clinicians think of the treatment of VTE as including both an early phase, which is acute treatment lasting 3 to 6 months, and a long- term phase, beyond 3 to 6 months, for prevention of recurrence.
RE-COVER I and RE-COVER II are for the initial treatment of VTE. The second one, RE-COVER II, is not yet published, but has been presented[8] RE-COVER I [7] included patients with objectively confirmed VTE, some of whom received LMWH or heparin before they were entered into the trial (Figure 11). Having determined eligibility and obtained consent, patients were randomized to receive either warfarin or warfarin placebo on a background of continued parenteral treatment. In other words, the new oral anticoagulant dabigatran was not started upfront, but the treatment was delayed. The duration of the delay was determined by the INR for the initial warfarin. Once the INR reached 2.0 on two occasions, 24 hours apart, the patient was transitioned to dabigatran or dabigatran placebo.
RE-COVER II on the other hand was a trial comparing dabigatran versus warfarin after an initial period of treatment with heparin, or in this case, LMWH. The primary outcome was VTE or VTE-related death at 6 months. The dose of dabigatran 150 mg twice daily and the intensity of warfarin therapy was the standard INR range 2 to 3. Eikelboom J. Am J Med 2013; published on-line at http://education.amjmed.com/00000.
[7] Schulman S, Kearon C, Kakkar AK, et al; for the RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361:2342-2352. Eikelboom - figure 11, figure 12, figure 13
[8] Schulman S, Kakkar AK, Schellong SM, et al. A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II). Blood (ASH Annual Meeting Abstracts). 2011;118:Abstract 205.Eikelboom - figure 11.