Why the study?
To provide a comprehensive, updated summary of dabigatran pharmacological characteristics, pivotal randomized controlled trials, and real-world efficacy and safety data over the decade since its introduction.
This review summarizes a decade of clinical evidence and real-world data on the efficacy and safety of dabigatran etexilate and its reversal agent idarucizumab.
Idarucizumab may enhance dabigatran safety in bleeding; extends reversal evidence for thrombin inhibition in AF/VTE.
During the last decade, non-vitamin K antagonist oral anticoagulants (NOACs) revolutionized the thromboprophylaxis management of several medical conditions, including atrial fibrillation and venous thromboembolism. Dabigatran etexilate was the first NOAC widely available worldwide, and it is currently the only one that directly inhibits thrombin. More recently, the availability of idarucizumab, a specific reversal agent, has increased the safety of dabigatran use in clinical practice, especially for those patients with severe and life-threatening bleeding. This review aims to summarize current evidence on dabigatran, starting from its pharmacological characteristics, and providing an updated overview of pivotal randomized controlled trials and real-world data on its efficacy and safety.
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Romiti et al. (2020) studied this question.
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