A Review of the Efficacy and Safety Profiles of the Novel Oral Anticoagulants in the Treatment and Prevention of Venous Thromboembolism.

PURPOSE: This study aims to review the published literature concerning the use of novel oral anticoagulants (NOACs) in the treatment and prevention of venous thromboembolism (VTE) and to identify the appropriate niche for each NOAC by comparing their behaviors in Phase III and Phase IV clinical trial settings.

METHODS: The ClinicalTrials.gov database was used to identify Phase III and postmarketing (Phase IV) randomized controlled trials concerning the efficacy and safety profiles of the oral NOACs (apixaban, dabigatran etexilate, exodaban, and rivaroxaban) for the treatment or prevention of VTE. Studies of special interest included those that compared the administration of a NOAC versus standard anticoagulation therapy with low-molecular-weight heparin and/or a vitamin K antagonist.

FINDINGS: Overall, the NOACs offer a simplified anticoagulation regimen that has noninferiority and similar rates of bleeding when compared with standard therapy throughout multiple studies. This finding held true across several VTE conditions that required anticoagulation, such as the treatment and prophylaxis of acute VTE, including both deep vein thrombosis and pulmonary embolism. Absence of dietary restrictions and fixed oral dosing that does not require monitoring makes NOACs ideal for the outpatient setting. Apparent niches for each individual NOAC are discussed in detail; however, the paucity of trials comparing NOAC performance in specific clinical settings makes precise definition of these niches problematic.

IMPLICATIONS: It now seems reasonable for clinicians to consider NOACs as first-line agents for both the treatment and prophylaxis of VTE and to attempt to tailor their particular medication choices for each patient scenario. More trials comparing NOAC performance in specific clinical settings are essential to ensure these medications are being used to their full potential.