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To Monitor Dabigatran Or Not: A Matter Of Patient Safety.

Hemamalini Ketha, J. Mills
Published 2015 · Medicine

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In October 2010, the US Food and Drug Administration (FDA)2 approved dabigatran etexilate (Pradaxa), a new oral, direct thrombin inhibitor, for prevention of stroke and thrombosis in patients with nonvalvular atrial fibrillation (AF). This marked a new era in the development of fixed-dose novel oral anticoagulants (NOACs) with the hope of achieving improved safety and clinical outcomes compared with warfarin. The concept of a fixed-dose anticoagulant that requires no monitoring quickly made the transition from concept to practice, helped partially by the FDA's new approach to innovative therapies. This new approach gave the manufacturer, Boehringer Ingelheim, access to priority reviews and a shorter approval process for its blockbuster drug, dabigatran. Rather than the conventional requirement of at least 2 pivotal trials, only a single large clinical trial was necessary for approval. Fixed-dose dabigatran demonstrated noninferior performance compared with dose-optimized warfarin therapy in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial for prevention of stroke and thrombosis in patients with nonvalvular AF, thus providing the bulk of support for FDA approval. After approval by the FDA in 2010 and the European Medicines Agency (EMA) a year later, dabigatran's popularity grew quickly, and by the end of 2013 sales approached $2 billion. However, amid litigation in US courts that centered on claims that dabigatran caused severe and fatal bleeding in patients, an investigation by the British Medical Journal revealed that as far back as 2010 Boehringer Ingelheim had knowledge that adjusting the dose of dabigatran might provide patients with superior efficacy and safety compared with a fixed dose (1, 2). This raised serious concerns about what the manufacturer chose not to disclose as it sought regulatory approval. The clinical impetus to explore novel anticoagulants originated from the difficulty in managing anticoagulation in patients receiving the standard-of-care treatment, warfarin. Anticoagulation …
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