Li Xiaoyan, Keshishian Allison, Hamilton Melissa, Horblyuk Ruslan, Gupta Kiran, Luo Xuemei, Mardekian Jack, Friend Keith, Nadkarni Anagha, Pan Xianying, Lip Gregory Y H, Deitelzweig Steve
Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb Company, Lawrenceville, NJ, United States of America.
STATinMED Research, Ann Arbor, MI, United States of America.
PLoS One. 2018 Jan 26;13(1):e0191722. doi: 10.1371/journal.pone.0191722. eCollection 2018.
Prior real-world studies have shown that apixaban is associated with a reduced risk of stroke/systemic embolism (stroke/SE) and major bleeding versus warfarin. However, few studies evaluated the effectiveness and safety of apixaban according to its dosage, and most studies contained limited numbers of patients prescribed 2.5 mg twice-daily (BID) apixaban. Using pooled data from 4 American claims database sources, baseline characteristics and outcomes for patients prescribed 5 mg BID and 2.5 mg BID apixaban versus warfarin were compared. After 1:1 propensity-score matching, 31,827 5 mg BID apixaban-matched warfarin patients and 6600 2.5 mg BID apixaban-matched warfarin patients were identified. Patients prescribed 2.5 mg BID apixaban were older, had clinically more severe comorbidities, and were more likely to have a history of stroke and bleeding compared with 5 mg BID apixaban patients. Compared with warfarin, 5 mg BID apixaban was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.60-0.81) and major bleeding (HR: 0.59, 95% CI: 0.53-0.66). Compared with warfarin, 2.5 mg BID apixaban was also associated with a lower risk of stroke/SE (HR: 0.63, 95% CI: 0.49-0.81) and major bleeding (HR: 0.59, 95% CI: 0.49-0.71). In this real-world study, both apixaban doses were assessed in 2 patient groups differing in age and clinical characteristics. Each apixaban dose was associated with a lower risk of stroke/SE and major bleeding compared with warfarin in the distinct population for which it is being prescribed in United States clinical practice.
Clinicaltrials.Gov Identifier: NCT03087487.
先前的真实世界研究表明，与华法林相比，阿哌沙班可降低中风/全身性栓塞（中风/SE）和大出血的风险。然而，很少有研究根据阿哌沙班的剂量评估其有效性和安全性，并且大多数研究中，每日两次服用2.5毫克阿哌沙班的患者数量有限。利用来自4个美国索赔数据库来源的汇总数据，比较了每日两次服用5毫克和2.5毫克阿哌沙班的患者与服用华法林患者的基线特征和结局。经过1:1倾向评分匹配后，确定了31827名每日两次服用5毫克阿哌沙班的匹配华法林患者和6600名每日两次服用2.5毫克阿哌沙班的匹配华法林患者。与每日两次服用5毫克阿哌沙班的患者相比，每日两次服用2.5毫克阿哌沙班的患者年龄更大，临床合并症更严重，并且更有可能有中风和出血史。与华法林相比，每日两次服用5毫克阿哌沙班与较低的中风/SE风险（风险比[HR]：0.70，95%置信区间[CI]：0.60 - 0.81）和大出血风险（HR：0.59，95% CI：0.53 - 0.66）相关。与华法林相比，每日两次服用2.5毫克阿哌沙班也与较低的中风/SE风险（HR：0.63，95% CI：0.49 - 0.81）和大出血风险（HR：0.59，95% CI：0.49 - 0.71）相关。在这项真实世界研究中，对两个年龄和临床特征不同的患者组评估了两种阿哌沙班剂量。在美国临床实践中，对于各自特定的人群，与华法林相比，每种阿哌沙班剂量都与较低的中风/SE和大出血风险相关。
Clinicaltrials.Gov标识符：NCT03087487。
