Jarboe Lindsey, Dadlani Apaar, Bandikatla Sudeepthi, Wade Regan, Barve Ashutosh
Pharmacy, University of Louisville Hospital, Louisville, USA.
Internal Medicine, University of Louisville, Louisville, USA.
Cureus. 2022 Apr 11;14(4):e24029. doi: 10.7759/cureus.24029. eCollection 2022 Apr.
Low molecular weight heparin and vitamin K antagonists are commonly used in cirrhotic patients requiring anticoagulation. However, their monitoring with anti-factor Xa and international normalized ratio (INR) may not be reliable in cirrhosis. Direct oral anticoagulants (DOACs) do not need laboratory monitoring, making these agents a favorable alternative. However, apixaban and rivaroxaban have been avoided in advanced liver disease due to their metabolism in the liver. The purpose of this medication use evaluation was to assess the use of DOACs, specifically apixaban and rivaroxaban, in patients with cirrhosis.
We performed a retrospective, single-center study. Inpatients who had a diagnosis of cirrhosis and received at least one dose of a DOAC (apixaban or rivaroxaban) from April 2016 through June 2020 at our hospital were included in the analysis. Data collected included the reason for admission, Child-Pugh classification, renal function, if this was a home medication or newly started as an inpatient medication, indication, and dosing. The clinical efficacy outcome (new venous thromboembolic event (VTE) or progression of old VTE), and clinical safety outcome (bleeding event) were analyzed.
41 patients with cirrhosis were treated with apixaban or rivaroxaban. Based on the Child-Pugh classification, 29.3% (n=12/41) were placed on a DOAC outside of the FDA prescribing recommendations. In this subpopulation, 8.3% (n=1/12) patients had venous thromboembolism (VTE) and 16.6% (n=2/12) had bleeding events. Overall, 7.3% patients (n=3/41) had VTE and 4.8% (n=2/41) had bleeding events. In the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) trial comparing the efficacy and safety profile of apixaban with enoxaparin/warfarin therapy in acute VTE, 2.3% of patients had VTE and 15% had bleeding events.
Our study demonstrated that it may be possible to safely use DOACs in patients with advanced cirrhosis. Further studies are needed to evaluate the safety and efficacy of DOACs in this patient population, as our study was limited by the small sample size and its retrospective design.
低分子量肝素和维生素K拮抗剂常用于需要抗凝治疗的肝硬化患者。然而，在肝硬化患者中，使用抗Xa因子和国际标准化比值（INR）对其进行监测可能并不可靠。直接口服抗凝剂（DOACs）无需实验室监测，使其成为一种有利的替代药物。然而，由于阿哌沙班和利伐沙班在肝脏中代谢，晚期肝病患者一直避免使用。本药物使用评估的目的是评估DOACs，特别是阿哌沙班和利伐沙班在肝硬化患者中的使用情况。
我们进行了一项回顾性单中心研究。分析纳入了2016年4月至2020年6月期间在我院诊断为肝硬化并接受至少一剂DOAC（阿哌沙班或利伐沙班）的住院患者。收集的数据包括入院原因、Child-Pugh分级、肾功能、这是家庭用药还是住院时新开始使用的药物、用药指征和剂量。分析临床疗效结果（新的静脉血栓栓塞事件（VTE）或旧VTE的进展）和临床安全性结果（出血事件）。
41例肝硬化患者接受了阿哌沙班或利伐沙班治疗。根据Child-Pugh分级，29.3%（n = 12/41）的患者在FDA处方建议之外使用DOAC。在这一亚组中，8.3%（n = 1/12）的患者发生静脉血栓栓塞（VTE），16.6%（n = 2/12）的患者发生出血事件。总体而言，7.3%的患者（n = 3/41）发生VTE, 4.8%（n = 2/41）的患者发生出血事件。在阿哌沙班用于肺栓塞和深静脉血栓形成初始治疗作为一线治疗（AMPLIFY）试验中，比较了阿哌沙班与依诺肝素/华法林治疗急性VTE的疗效和安全性，2.3%的患者发生VTE，15%的患者发生出血事件。
我们的研究表明，晚期肝硬化患者可能可以安全使用DOACs。由于我们的研究受样本量小及其回顾性设计的限制，需要进一步研究来评估DOACs在该患者群体中的安全性和有效性。
