Al Yami Majed S, Qudayr Asma H, Alhushan Lina M, Hakami Fatemah M, Korayem Ghazwa B, Alshaya Omar A, Almohammed Omar A
Department of Pharmacy Practice, College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences.
Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
Saudi Pharm J. 2023 Aug;31(8):101673. doi: 10.1016/j.jsps.2023.06.006. Epub 2023 Jun 17.
Since the risk of recurrence of venous thromboembolism (VTE) increases with duration or inadequate anticoagulation dosage, a proper regimen of apixaban and rivaroxaban is essential in patients with VTE, especially during the acute phase. This study aims to describe the clinical characteristics and dosing of anticoagulants for patients who received apixaban or rivaroxaban for VTE treatment.
The multi-center retrospective observational study included patients diagnosed with VTE who had received apixaban or rivaroxaban between January 1, 2016, and December 31, 2021. The study's description of real-world practices includes patients' characteristics, along with anticoagulant dose and duration used for lead-in or maintenance therapy to manage VTE.
The study involved 695 patients with VTE; 342 of whom were treated with apixaban (49.2%), while 353 were treated with rivaroxaban (50.8%). During the acute phase, 30.1% and 19.3% of patients did not receive lead-in therapy with apixaban and rivaroxaban, respectively, and 1.2% received reduced doses of either medication. Among the patients who received apixaban alone for lead-in, the majority (79.5%) received the recommended duration, while 17.1% received a shorter lead-in duration (≤5 days), with an overall mean duration of 6.5 days. Most patients who received rivaroxaban alone for lead-in (93.0%) received the drug for the recommended duration, with an overall mean duration of 20.2 days. Most of the patients who did not receive apixaban or rivaroxaban for lead-in used parenteral anticoagulants for varying durations; however, around 25.0% of these patients did not receive any lead-in anticoagulant and started on maintenance therapy. Overall, patients who did not receive apixaban or rivaroxaban lead-in therapy were commonly associated with a higher risk of bleeding according to their clinical characteristics.
A notable proportion of patients with VTE who were mostly at low to intermediate risk of bleeding received non-recommended doses or durations of apixaban or rivaroxaban for lead-in therapy. Large studies are needed to establish evidence about the outcomes associated with these practices.
由于静脉血栓栓塞症（VTE）复发风险会随着抗凝持续时间延长或剂量不足而增加，因此对于VTE患者，尤其是急性期患者，恰当的阿哌沙班和利伐沙班治疗方案至关重要。本研究旨在描述接受阿哌沙班或利伐沙班治疗VTE患者的临床特征及抗凝药物剂量。
这项多中心回顾性观察性研究纳入了2016年1月1日至2021年12月31日期间被诊断为VTE且接受阿哌沙班或利伐沙班治疗的患者。该研究对实际临床实践的描述包括患者特征，以及用于导入期或维持期治疗VTE的抗凝药物剂量和持续时间。
该研究纳入了695例VTE患者；其中342例接受阿哌沙班治疗（49.2%），353例接受利伐沙班治疗（50.8%）。在急性期，分别有30.1%和19.3%的阿哌沙班和利伐沙班患者未接受导入期治疗，1.2%的患者接受了减量药物治疗。在仅接受阿哌沙班导入期治疗的患者中，大多数（79.5%）接受了推荐的持续时间，而17.1%的患者导入期持续时间较短（≤5天），总体平均持续时间为6.5天。大多数仅接受利伐沙班导入期治疗的患者（93.0%）接受了推荐的持续时间，总体平均持续时间为20.2天。大多数未接受阿哌沙班或利伐沙班导入期治疗的患者使用了不同持续时间的肠外抗凝药物；然而，这些患者中约25.0%未接受任何导入期抗凝治疗，而是直接开始维持期治疗。总体而言，根据临床特征，未接受阿哌沙班或利伐沙班导入期治疗的患者通常出血风险较高。
相当一部分VTE患者（大多为低至中度出血风险）在导入期治疗时接受了非推荐剂量或持续时间的阿哌沙班或利伐沙班治疗。需要开展大型研究以证实这些治疗方式的相关结局。
