What is the efficacy of betrixaban (Bevyxxa) in the treatment of deep venous thrombosis (DVT)?

Updated: Jun 05, 2019
  • Author: Kaushal (Kevin) Patel, MD; Chief Editor: Barry E Brenner, MD, PhD, FACEP  more...
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Answer

Approval of betrixaban was based on data from the phase 3 APEX studies. [134, 135] 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. [133, 134, 135] 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. [133, 134, 135]

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. [133, 134, 135]  Those who received betrixaban showed significant decreases in VTE events (4.4%) compared with patients in the enoxaparin group (6%).


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