J Cardiovasc Pharmacol. 2023 Sep 20. doi: 10.1097/FJC.0000000000001485. Online ahead of print.
Venous thromboembolism (VTE) is a prevalent yet preventable cause of death, particularly among hospitalized patients. Studies have shown that the risk of VTE remains high for up to 6 months after discharge, highlighting the need for extended thromboprophylaxis as a viable treatment approach. Despite the availability of several anticoagulant drugs like vitamin K antagonists, heparinoids, rivaroxaban, apixaban, edoxaban, and dabigatran, none of them has received approval from the US Food and Drug Administration (FDA) for long-term thromboprophylaxis. However, an emerging factor Xa inhibitor called Betrixaban has shown promising results in Phase II and III trials, positioning itself as the first and only FDA-approved anticoagulant for extended thromboprophylaxis in hospitalized patients after discharge. Betrixaban offers distinct pharmacological characteristics, including a long half-life, low renal excretion, and unique hepatic metabolism, making it an attractive option for various theoretical uses. Numerous articles have been published discussing the safety and efficacy of betrixaban, all of which have emphasized its usefulness and practicality. However, there has been limited discussion regarding its weaknesses and areas of ambiguity. Therefore, this article aims to explore the challenges faced during the approval process of betrixaban and provide a comprehensive review of the literature on its advantages and disadvantages as a long-term prophylaxis approach for VTE. Furthermore, we aim to identify the ambiguous points that require further investigation in future studies.