1 Ochsner Clinic Foundation, Department of Hospital Medicine, New Orleans, Louisiana, and The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, Louisiana.
2 Pfizer, New York, New York.
J Manag Care Spec Pharm. 2017 Nov;23(11):1191-1201. doi: 10.18553/jmcp.2017.17060. Epub 2017 Aug 11.
The clinical trial ARISTOTLE showed that apixaban was superior to warfarin in reducing the risks of stroke and bleeding among patients with nonvalvular atrial fibrillation (NVAF). Further study of the effect of apixaban versus warfarin use on health care resource utilization (HCRU) and associated costs in the real-world setting is warranted, especially among elderly patients who are at higher risk of stroke and bleeding.
To compare HCRU and costs among elderly NVAF patients treated with apixaban versus warfarin in the United States.
Elderly patients (aged ≥ 65 years) with Medicare coverage who initiated apixaban or warfarin were identified from the Humana research database during January 1, 2013-September 30, 2015. Patients were required to have 12 months of continuous insurance coverage before drug initiation (baseline period) and an atrial fibrillation diagnosis during the baseline period or on the date of drug initiation. NVAF patients were grouped into cohorts depending on the drug initiated. Propensity score matching (PSM) was conducted to control for differences in demographics and clinical characteristics of study cohorts. Patients were followed after the index date for a variable length of follow-up. All-cause and disease-specific HCRU and costs during the follow-up were evaluated before and after PSM and reported as per patient per year.
Of the overall (unmatched) population, 8,250 patients (mean age: 78.0 years) initiated apixaban and 14,051 patients (mean age: 78.2 years) initiated warfarin. Among NVAF patients who initiated apixaban versus those who initiated warfarin, mean Charlson Comorbidity Index (CCI) scores (3.0 vs. 3.4, P < 0.001); stroke risk scores, including CHADS (2.7 vs. 2.9, P < 0.001) and CHADS-VASc (4.6 vs. 4.7, P < 0.001); and bleeding risk scores, including HAS-BLED (3.1 vs. 3.2, P < 0.001), were lower. Additionally, total annual all-cause health care costs were lower during the baseline period for patients treated with apixaban versus warfarin ($17,077 vs. $20,236, P < 0.001). After PSM, 14,214 patients were matched, with 7,107 in each cohort. Mean age, CCI score, and stroke and bleeding risks were similar between matched cohorts, as were total all-cause health care costs during the baseline period. During the follow-up among matched cohorts, apixaban versus warfarin treatment was associated with higher annual pharmacy costs ($5,159 vs. $2,867, P < 0.001) but lower annual inpatient ($8,327 vs. $14,296, P < 0.001), outpatient ($9,655 vs. $11,469, P < 0.001), and total all-cause health care costs ($23,141 vs. $28,633, P < 0.001), which were reflective of lower inpatient, outpatient, and all-cause HCRU among apixaban-treated patients. Furthermore, bleeding-related ($2,101 vs. $3,963, P < 0.001) and stroke-related ($652 vs. $1,178, P = 0.001) annual medical costs were lower for patients treated with apixaban versus warfarin.
After controlling for differences in patient characteristics, in the real-world setting apixaban versus warfarin use was associated with less HCRU and lower total all-cause health care costs and costs for bleeding- and stroke-related medical services, but greater pharmacy costs, among elderly NVAF patients.
This study was sponsored by Pfizer and Bristol-Myers Squibb. Deitelzweig is a consultant for Pfizer and Bristol-Myers Squibb and has served on their advisory boards and received speaker fees. Deitelzweig also serves as consultant and advisory board member to Portola and Janssen. Luo, Trocio, and Mardekian are employees of Pfizer and own stock in the company. Gupta and Curtice are employees of Bristol-Myers Squibb and own stock in the company. Lingohr-Smith, Menges, and Lin are employees of Novosys Health, which received research funds from Pfizer and Bristol-Myers Squibb to conduct this study and develop the manuscript. Study concept and design were primarily contributed by Deitelzweig, Luo, and Gupta, along with Trocio, Mardekian, Curtice, and Lin. Lin, Menges, and Lingohr-Smith took the lead in data collection, with assistance from the other authors. Data interpretation was performed by Deitelzweig, Menges, and Lin, with assistance from the other authors. The manuscript was written by Lingohr-Smith and Menges, along with the other authors, and revised by all the authors. Some aspects of this study were presented at the American Heart Association Scientific Sessions in New Orleans, Louisiana, November 12-16, 2016.
临床试验 ARISTOTLE 表明，与华法林相比，阿哌沙班可降低非瓣膜性心房颤动（NVAF）患者的中风和出血风险。在真实世界环境中，进一步研究阿哌沙班与华法林对卫生保健资源利用（HCRU）和相关成本的影响是必要的，特别是在中风和出血风险较高的老年患者中。
比较美国老年 NVAF 患者使用阿哌沙班与华法林的 HCRU 和成本。
从 Humana 研究数据库中确定了在 2013 年 1 月 1 日至 2015 年 9 月 30 日期间有医疗保险覆盖的年龄≥65 岁的老年患者（≥65 岁），开始使用阿哌沙班或华法林。患者在药物起始前（基线期）必须有 12 个月的连续保险覆盖期，并且在基线期或药物起始日期患有心房颤动。根据起始药物将 NVAF 患者分为队列。采用倾向评分匹配（PSM）来控制研究队列的人口统计学和临床特征差异。在索引日期后，患者将被随访一段时间。在 PSM 前后，评估了随访期间的所有原因和疾病特异性 HCRU 和成本，并按每位患者每年报告。
在总（未匹配）人群中，8250 名患者（平均年龄：78.0 岁）开始使用阿哌沙班，14051 名患者（平均年龄：78.2 岁）开始使用华法林。与开始使用阿哌沙班的 NVAF 患者相比，开始使用华法林的患者平均 Charlson 合并症指数（CCI）评分（3.0 与 3.4，P<0.001）；中风风险评分，包括 CHADS（2.7 与 2.9，P<0.001）和 CHADS-VASc（4.6 与 4.7，P<0.001）；和出血风险评分，包括 HAS-BLED（3.1 与 3.2，P<0.001）均较低。此外，与华法林相比，阿哌沙班治疗的患者在基线期的总年度全因医疗保健费用较低（17077 美元与 20236 美元，P<0.001）。在 PSM 后，匹配了 14214 名患者，每个队列有 7107 名患者。匹配队列的平均年龄、CCI 评分以及中风和出血风险相似，基线期的总全因医疗保健费用也相似。在匹配队列的随访中，与华法林相比，阿哌沙班治疗与较高的年度药房费用相关（5159 美元与 2867 美元，P<0.001），但较低的年度住院（8327 美元与 14296 美元，P<0.001）、门诊（9655 美元与 11469 美元，P<0.001）和全因医疗保健费用（23141 美元与 28633 美元，P<0.001），这反映了阿哌沙班治疗患者较低的住院、门诊和全因 HCRU。此外，阿哌沙班治疗患者的出血相关（2101 美元与 3963 美元，P<0.001）和中风相关（652 美元与 1178 美元，P=0.001）年度医疗费用也较低。
在控制患者特征差异后，在真实世界环境中，与华法林相比，阿哌沙班的使用与较低的 HCRU 以及较低的全因医疗保健总成本和出血及中风相关医疗服务成本相关，但与华法林相比，阿哌沙班治疗的患者的药房费用较高。
这项研究由辉瑞和百时美施贵宝赞助。Deitelzweig 是辉瑞和百时美施贵宝的顾问，曾在他们的咨询委员会任职，并获得演讲费。Deitelzweig 还担任 Portola 和 Janssen 的顾问和咨询委员会成员。Luo、Trocio 和 Mardekian 是辉瑞公司的员工，拥有该公司的股票。Gupta 和 Curtice 是百时美施贵宝公司的员工，拥有该公司的股票。Lingohr-Smith、Menges 和 Lin 是 Novosys Health 的员工，该公司从辉瑞和百时美施贵宝获得研究资金来进行这项研究并撰写这份手稿。概念和设计主要由 Deitelzweig、Luo 和 Gupta 以及 Trocio、Mardekian、Curtice 和 Lin 贡献。Lin、Menges 和 Lingohr-Smith 主要负责数据收集，并得到了其他作者的协助。数据解释由 Deitelzweig、Menges 和 Lingohr-Smith 完成，其他作者提供了协助。手稿由 Lingohr-Smith 和 Menges 共同撰写，并由所有作者修订。本研究的某些方面在 2016 年 11 月 12 日至 16 日于路易斯安那州新奥尔良举行的美国心脏协会科学会议上进行了介绍。
