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American Journal of Medicine
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American Journal of Medicine
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For RE-SONATE, the primary outcome at 6 months was again VTE or VTE-related mortality. The expectation would be that compared with placebo, the NOAC would be more effective and would cause bleeding, and that is exactly what was found: any VTE and VTE-related or unexplained deaths were significantly reduced with dabigatran compared with placebo. This effect was evident already in the first 6 months, and once treatment was discontinued, the event curves remained more or less parallel out to 18 months. The latter finding is important and encouraging because in previous trials of long-term warfarin, once the treatment was stopped, there was a rapid increase in events in the patients who had stopped warfarin so that by 18 months, the two event curves were superimposed.[9]
Thus it would seem that giving dabigatran long-term attenuates or eliminates that rapid increase in events in patients who stopped warfarin after a prolonged period of treatment. Eikelboom J. Am J Med 2013; published on-line at http://education.amjmed.com/00000.
[9] Schulman S, Kearon C, Kakkar AK, et al; for the RE-MEDY and the RE-SONATE Trials Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013;368:709-718.