McClain Conner, Buckallew Amanda R, Armbruster Anastasia L
Missouri Baptist Medical Center, St. Louis, MO, USA.
University of Health Sciences & Pharmacy, St. Louis, MO, USA.
J Pharm Technol. 2024 Aug;40(4):171-177. doi: 10.1177/87551225241247691. Epub 2024 Apr 27.
Current guidelines and literature suggest apixaban may be used in patients with severe kidney disease and atrial fibrillation (AF) for stroke and systemic embolism risk reduction (SSE) or patients with acute venous thromboembolism (VTE). Limited data is available for long-term safety and efficacy outcomes in this patient population. Evaluate the use of apixaban for AF or VTE in patients with advanced kidney disease. This single-center, retrospective, Investigational Review Board approved study evaluated patients ≥18 years of age with severe kidney disease on apixaban therapy for VTE or AF from March 1, 2018, to December 31, 2020. The primary outcome was major bleeding from apixaban initiation/continuation until 12 months after discharge. The secondary outcomes included a composite bleed (major bleeding, clinically relevant non-major bleeding, and minor bleeding), the occurrence of VTE or SSE, and death during hospitalization from any cause other than bleeding. Overall, 156 patients met inclusion criteria. Six patients experienced major bleeding (3.8%). Composite bleeding occurred in 16 patients (10.3%); no patients had SSE or VTE, and 4 patients died from causes other than bleeding (2.6%). Limitations included the small sample size and retrospective nature of the study. This study demonstrated that patients with advanced chronic kidney disease on apixaban for AF or VTE had low major bleeding and similar overall bleeding rates compared with previously published literature. When considering the use of apixaban in this population, risks and benefits should be weighed in addition to the consideration of FDA-label dosing guidance.
当前指南和文献表明,阿哌沙班可用于患有严重肾病和心房颤动(AF)的患者,以降低中风和全身性栓塞风险(SSE),或用于患有急性静脉血栓栓塞(VTE)的患者。关于该患者群体长期安全性和疗效结果的数据有限。评估阿哌沙班在晚期肾病患者中用于AF或VTE的情况。这项经调查审查委员会批准的单中心回顾性研究,评估了2018年3月1日至2020年12月31日期间,年龄≥18岁、因VTE或AF接受阿哌沙班治疗的严重肾病患者。主要结局是从开始/继续使用阿哌沙班至出院后12个月的大出血情况。次要结局包括复合性出血(大出血、临床相关非大出血和小出血)、VTE或SSE的发生情况,以及因出血以外的任何原因导致的住院期间死亡。总体而言,156名患者符合纳入标准。6名患者发生大出血(3.8%)。16名患者发生复合性出血(10.3%);无患者发生SSE或VTE,4名患者死于出血以外的原因(2.6%)。局限性包括样本量小和研究的回顾性性质。这项研究表明,与先前发表的文献相比,接受阿哌沙班治疗AF或VTE的晚期慢性肾病患者大出血发生率低,总体出血率相似。在考虑对该人群使用阿哌沙班时,除了考虑美国食品药品监督管理局(FDA)标签上的给药指导外,还应权衡风险和益处。