Choi JungMin, Lee So-Ryoung, Kwon Soonil, Ahn Hyo-Jeong, Lee Kyung-Yeon, Park Jong-Sung, Choi Jong-Il, Lee Sung Ho, Heo Jung Ho, Oh Il-Young, On Young Keun, Yu Hee Tae, Lee Kwang-No, Kim Nam-Ho, Park Hyung Wook, Lee Ki Hong, Shin Seung Yong, Oh Seil, Lip Gregory Y H, Han Seongwook, Choi Eue-Keun
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Front Cardiovasc Med. 2024 Jun 10;11:1367623. doi: 10.3389/fcvm.2024.1367623. eCollection 2024.
Data on off-label reduced dose risk among patients with atrial fibrillation (AF) who qualify for a single-dose reduction of apixaban is scarce.
We prospectively assessed apixaban dosing and clinical characteristics in AF patients meeting a dose reduction criterion.
The multicentre, prospective cohort study, the efficAcy and Safety of aPixaban In REal-world practice in Korean frail patients with AF (ASPIRE), encompasses patients with AF who met the criteria for a single-dose reduction of apixaban and were given varying doses of apixaban, either the on-label standard dose or the off-label reduced dose.
Of 2,000 patients (mean age 74.3 ± 7.9 years, 55.8% women), 29.7% were ≥80 years, 62.6% weighed ≤60 kg, and 7.8% had serum creatinine ≥1.5 mg/dL. Of these, 51.3% were prescribed an off-label reduced dose of apixaban. The off-label group was characterized with older age, more comorbidities, and antiplatelet agents, while the on-label group had more prior strokes. Physicians preferred off-label reduced dose in the "marginal zone," defined as age 75-80 years, weight 60-65 kg, and creatinine levels 1.2-1.5 mg/dL.
In real-world clinical setting of the Korean population, off-label reduced dose apixaban was administered to nearly half of the patients who qualified for a single dose reduction. This reduced dosage was more commonly prescribed to patients with frail characteristics, while patients with a history of stroke were more often given the standard dose as per the label. A future study is planned to contrast the safety and effectiveness of the standard dose against the reduced dose of apixaban in this population.
对于符合阿哌沙班单剂量减量条件的心房颤动（AF）患者，关于超说明书减量风险的数据很少。
我们前瞻性评估了符合减量标准的AF患者的阿哌沙班剂量及临床特征。
多中心前瞻性队列研究“阿哌沙班在韩国老年AF患者真实世界实践中的疗效和安全性（ASPIRE）”纳入了符合阿哌沙班单剂量减量标准且接受不同剂量阿哌沙班治疗的AF患者，这些剂量包括说明书标注的标准剂量或超说明书减量剂量。
在2000例患者（平均年龄74.3±7.9岁，55.8%为女性）中，29.7%年龄≥80岁，62.6%体重≤60 kg，7.8%血清肌酐≥1.5 mg/dL。其中，51.3%的患者接受了超说明书减量剂量的阿哌沙班治疗。超说明书组患者的特点是年龄较大、合并症较多且使用抗血小板药物，而说明书标注组患者既往卒中史较多。医生在“临界范围”（定义为年龄75 - 80岁、体重60 - 65 kg、肌酐水平1.2 - 1.5 mg/dL）的患者中更倾向于使用超说明书减量剂量。
在韩国人群的真实临床环境中，近一半符合单剂量减量条件的患者接受了超说明书减量剂量的阿哌沙班治疗。这种减量剂量更常用于具有虚弱特征的患者，而有卒中史的患者更常按照说明书使用标准剂量。计划开展一项未来研究，对比该人群中阿哌沙班标准剂量与减量剂量的安全性和有效性。
