Janssen Pharmaceuticals, Inc., Janssen Scientific Affairs, Titusville, New Jersey, USA.
Janssen Pharmaceuticals, Inc., Janssen Medical Affairs, Titusville, New Jersey, USA.
J Clin Pharmacol. 2021 Aug;61(8):1010-1026. doi: 10.1002/jcph.1838. Epub 2021 Mar 13.
Rivaroxaban is a factor Xa inhibitor oral anticoagulant first approved for use in the United States in 2011. Under the drug class commonly termed direct oral anticoagulants, rivaroxaban is approved for the most indications within its class, 7 indications, which are: (1) reduction of risk of stroke and systemic embolism (SE) in nonvalvular atrial fibrillation, (2) treatment of deep vein thrombosis (DVT), (3) treatment of pulmonary embolism (PE), (4) reduction in the risk of recurrence of DVT and/or PE, (5) prophylaxis of DVT following hip or knee replacement surgery, (6) prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding, and (7) reduction of risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Considering the relationship between cardiovascular disease, renal impairment, and the use of oral anticoagulants, the following targeted review was created. This review reports the results of the primary pharmacology, pharmacokinetic modeling, clinical safety and efficacy, and real-world postmarketing effectiveness and safety of rivaroxaban in patients with various degrees of renal impairment. Based on these data, rivaroxaban is a viable option for when anticoagulation is needed in patients who have both cardiovascular disease and renal impairment. However, as with any therapy, the benefits and risks of intervention should be carefully assessed and balanced. Patients treated with rivaroxaban for several of its approved indications should have their kidney function assessed prior to and during continued therapy to ensure consistency with the drug label.
利伐沙班是一种 Xa 因子抑制剂口服抗凝剂，于 2011 年首次在美国获准使用。在通常被称为直接口服抗凝剂的药物类别中，利伐沙班在其类别中获得了最多的适应证批准，共有 7 个适应证，分别是：（1）降低非瓣膜性心房颤动患者中风和全身性栓塞（SE）的风险，（2）治疗深静脉血栓形成（DVT），（3）治疗肺栓塞（PE），（4）降低 DVT 和/或 PE 复发的风险，（5）髋关节或膝关节置换术后 DVT 的预防，（6）急性疾病患者静脉血栓栓塞的预防，这些患者存在血栓栓塞并发症的风险，但出血风险不高，（7）降低慢性冠状动脉疾病或外周动脉疾病患者主要心血管事件的风险。鉴于心血管疾病、肾功能损害和口服抗凝剂的使用之间的关系，创建了以下有针对性的综述。该综述报告了利伐沙班在不同程度肾功能损害患者中的主要药理学、药代动力学建模、临床安全性和疗效以及真实世界的上市后有效性和安全性的结果。基于这些数据，当心血管疾病和肾功能损害的患者需要抗凝治疗时，利伐沙班是一种可行的选择。然而，与任何治疗方法一样，干预的益处和风险应仔细评估并权衡。接受利伐沙班治疗其几种适应证的患者在开始治疗前和治疗期间应评估肾功能，以确保与药物标签一致。
