What is the role of betrixaban (Bevyxxa) in the initial anticoagulation therapy for deep venous thrombosis (DVT)?

Updated: Nov 09, 2018
  • Author: Donald Schreiber, MD, CM; Chief Editor: Barry E Brenner, MD, PhD, FACEP  more...
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Answer

Answer

Betrixaban (Bevyxxa), a FXa inhibitor, was approved by the FDA in June 2017. [26] It is indicated for the prophylaxis of VTE in adults hospitalized for acute medical illness who are at risk for thromboembolic complications owing to moderate or severe restricted mobility and other risk factors that may cause VTE. [26]

Approval of betrixaban was based on data from the phase 3 APEX studies. [27, 28] These randomized, double-blind, multinational clinical trials compared extended-duration betrixaban (35-42 days) to short-duration enoxaparin (6-14 days) for VTE in 7,513 acutely medically ill hospitalized patients with VTE risk factors. [26, 27, 28] Patients in the betrixaban group received an initial dose of 160 mg orally on day 1, followed by 80 mg once daily for 35-42 days, and received a placebo injection once daily for 6-14 days. Patients in the enoxaparin group received 40 mg subcutaneously once daily for 6-14 days and took an oral placebo once daily for 35-42 days. [26, 27, 28]

Efficacy was measured in 7,441 patients using a composite outcome score composed of the occurrence of asymptomatic or symptomatic proximal DVT, nonfatal PE, stroke, or VTE-related death. [26, 27, 28]  Those who received betrixaban showed significant decreases in VTE events (4.4%) compared with patients in the enoxaparin group (6%).


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