How effective is betrixaban in the treatment of pulmonary embolism (PE)?

Updated: Jun 06, 2019
  • Author: Daniel R Ouellette, MD, FCCP; Chief Editor: Zab Mosenifar, MD, FACP, FCCP  more...
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Answer

Betrixaban, a factor Xa inhibitor, was approved by the FDA in June 2017. It is indicated for 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.

Approval of betrixaban was based on data from the phase 3 APEX studies. These randomized, double-blind, multinational clinical trials compared extended-duration betrixaban (35-42 days) to short-duration enoxaparin (6-14 days) for VTE in 7513 acutely medically ill hospitalized patients with VTE risk factors.

Patients in the betrixaban group took 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 6-4 days and took an oral placebo once daily for 35-42 days.

Efficacy was measured in 7441 patients using a composite outcome score composed of the occurrence of asymptomatic or symptomatic proximal deep vein thrombosis, nonfatal pulmonary embolism, stroke, or VTE-related death. Betrixaban showed significant decreases in VTE events compared with enoxaparin. [99, 100]


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