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阿哌沙班在肾功能损害患者中的应用:药代动力学、干预性和观察性研究数据的综述。

Apixaban Use in Patients with Kidney Impairment: A Review of Pharmacokinetic, Interventional, and Observational Study Data.

机构信息

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Pfizer, New York, NY, USA.

出版信息

Am J Cardiovasc Drugs. 2024 Sep;24(5):603-624. doi: 10.1007/s40256-024-00664-2. Epub 2024 Aug 5.

Abstract

Chronic kidney disease (CKD) remains a significant global health issue and is a leading cause of mortality worldwide. Patients with CKD have an increased risk of developing atrial fibrillation (AF) and venous thromboembolism (VTE). While direct oral anticoagulants (DOACs) have become a standard of care for anticoagulation (AC) in patients with AF and VTE, the appropriate use of these agents in comorbid kidney impairment warrants detailed discussion. This scientific narrative review summarizes the effectiveness and safety of apixaban use in patients with renal dysfunction by assessing the current published pharmacokinetic, interventional, observational, and guideline data. Apixaban is a highly selective, orally active, direct inhibitor of factor Xa, with well-established pharmacokinetics and consistent clinical outcomes across a broad range of patient populations, including those with kidney impairment. Overall, the scientific literature has shown that apixaban has a favorable clinical efficacy and safety profile compared with vitamin K antagonists for patients with AF or VTE and comorbid kidney impairment. These data support the approved label dosing strategy of apixaban in reducing the risk of stroke/systemic embolism in patients with nonvalvular AF and in treating VTE across all ranges of kidney function. Both clinician experience and knowledge of patient-specific factors may be required in the management of comorbid patients with advanced CKD or those requiring dialysis, as data on these patients are limited.

摘要

慢性肾脏病(CKD)仍然是一个重大的全球健康问题,也是全球范围内主要的死亡原因。CKD 患者发生心房颤动(AF)和静脉血栓栓塞(VTE)的风险增加。虽然直接口服抗凝剂(DOACs)已成为 AF 和 VTE 患者抗凝治疗(AC)的标准治疗方法,但这些药物在合并肾功能损害患者中的合理使用需要详细讨论。本科学叙事性综述通过评估当前已发表的药代动力学、介入性、观察性和指南数据,总结了阿哌沙班在肾功能障碍患者中的有效性和安全性。阿哌沙班是一种高度选择性、口服活性、直接因子 Xa 抑制剂,具有明确的药代动力学和广泛的患者人群中一致的临床结局,包括肾功能损害患者。总的来说,科学文献表明,与维生素 K 拮抗剂相比,阿哌沙班在 AF 或 VTE 合并肾功能损害的患者中具有良好的临床疗效和安全性。这些数据支持批准的阿哌沙班标签剂量策略,可降低非瓣膜性 AF 患者中风/全身性栓塞的风险,并在所有肾功能范围内治疗 VTE。对于合并晚期 CKD 或需要透析的患者,可能需要临床医生的经验和对患者特定因素的了解,因为这些患者的数据有限。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a84/11344734/14d22fcd5b5b/40256_2024_664_Fig1_HTML.jpg

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