Tufts University School of Medicine, Boston, MA, USA.
Tufts University School of Medicine, Boston, MA, USA.
Clin Ther. 2018 Dec;40(12):2140-2167. doi: 10.1016/j.clinthera.2018.10.009. Epub 2018 Nov 5.
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.
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.
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.
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.
本研究旨在回顾有关新型口服抗凝剂（NOAC）在治疗和预防静脉血栓栓塞症（VTE）中的应用的已发表文献，并通过比较 III 期和 IV 期临床试验中的行为，确定每种 NOAC 的适当定位。
使用 ClinicalTrials.gov 数据库确定涉及口服 NOAC（阿哌沙班、达比加群酯、依度沙班和利伐沙班）治疗或预防 VTE 的疗效和安全性的 III 期和上市后（IV 期）随机对照试验。特别感兴趣的研究包括比较 NOAC 给药与低分子量肝素和/或维生素 K 拮抗剂的标准抗凝治疗的研究。
总体而言，NOAC 提供了一种简化的抗凝方案，与标准治疗相比，在多项研究中具有非劣效性和相似的出血率。这一发现适用于需要抗凝的多种 VTE 情况，如急性 VTE 的治疗和预防，包括深静脉血栓形成和肺栓塞。没有饮食限制和无需监测的固定口服剂量使 NOAC 成为门诊治疗的理想选择。详细讨论了每种单独的 NOAC 的明显定位；然而，比较特定临床环境中 NOAC 性能的试验很少，使得这些定位的精确定义成为问题。
现在对于临床医生来说，考虑将 NOAC 作为 VTE 治疗和预防的一线药物似乎是合理的，并尝试根据每个患者的情况调整其特定药物的选择。比较特定临床环境中 NOAC 性能的更多试验对于确保这些药物得到充分利用至关重要。
