Abstract
Venous thromboembolism (VTE) is a common, potentially preventable cause of morbidity and mortality among acute medically ill patients. More than half of VTE events in this population occur after hospital discharge. Thus, providing extended-duration VTE prophylaxis from in-hospital through the post-discharge continuum may improve the quality of care in patients at risk of VTE. Betrixaban is a new oral, once-daily factor Xa inhibitor approved by the United States (US) Food and Drug Administration (FDA) for extended-duration prophylaxis of VTE in acute medically ill patients. The clinical efficacy and safety of betrixaban in acute medically ill patients perceived to be at high risk for VTE were evaluated in a large, randomized, double-blind, active-controlled, multinational clinical trial [Acute Medically Ill VTE Prevention With Extended Duration Betrixaban (APEX)]. Patients were randomized to receive subcutaneous enoxaparin (10 ± 4 days) or oral betrixaban (35-42 days) plus matching placebos. The primary efficacy outcome was a composite of asymptomatic proximal deep vein thrombosis and symptomatic VTE; the primary safety measure was major bleeding. Extended-duration betrixaban reduced VTE events without an increase in major bleeding in the modified intent-to-treat analysis. Post hoc analyses of the APEX trial provided further evidence to support the efficacy and safety of betrixaban in reducing all-cause ischaemic stroke, fatal or irreversible ischaemic or bleeding events, as well as reducing VTE-related rehospitalization. In summary, analyses of the APEX study demonstrated a positive benefit-risk profile for extended prophylaxis of VTE with betrixaban in acute medically ill patients. This is likely to have important public health and health economic implications.