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The use, misuse and abuse of dabigatran

A number of issues need to be considered before using dabigatran routinely in clinical practice

There has been much publicity and controversy about the role of dabigatran in the prevention of embolic stroke in those with atrial fibrillation since the landmark RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial was published in September 2009.1 In this perspective, we provide a critical appraisal of the original trial and highlight some concerns (“use”), review some of the issues about bleeding and inappropriate selection of patients (“misuse”), and detail some of the heated and unique politics around its attempted listing on the Pharmaceutical Benefits Scheme (PBS) in Australia (“abuse”).

Use of dabigatran

A rigorous critical appraisal of the RE-LY trial reveals a few concerns.

Selection bias: Just under a third of participants enrolled in the trial had a CHADS2 (congestive heart failure, hypertension, age ≥ 75 years, diabetes, 1 point each; prior stroke or transient…