Nguyen Elaine, Egri Florence, Mearns Elizabeth S, White Charles M, Coleman Craig I
University of Connecticut, School of Pharmacy, Storrs, Connecticut.
Hartford Hospital Evidence-Based Practice Center, Hartford, Connecticut.
Pharmacotherapy. 2016 May;36(5):488-95. doi: 10.1002/phar.1746. Epub 2016 Apr 27.
To estimate the quality-adjusted life-years (QALYs), costs, and cost-effectiveness of high-dose edoxaban compared with adjusted-dose warfarin in patients at risk for stroke who have nonvalvular atrial fibrillation (NVAF) and a creatinine clearance (Clcr ) of 15-95 ml/minute.
A Markov model was created to compare the cost-effectiveness of high-dose edoxaban and adjusted-dose warfarin in patients with a Clcr of 15-95 ml/minute. The model was performed from a U.S. societal perspective and assumed patients initiated therapy at 70 years of age, had a mean CHADS2 (congestive heart failure, hypertension, age 75 or older, diabetes, stroke) score of 3, and no contraindications to anticoagulation. The model assumed a cycle length of 1 month and a lifetime horizon (maximum of 30 years/360 cycles). Data sources included renal subgroup analysis of the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation (ENGAGE-AF) trial and other published studies. Outcomes included lifetime costs (2014 US$), QALYs, and incremental cost-effectiveness ratios. The robustness of the model's conclusions was tested using one-way and 10,000-iteration probabilistic sensitivity analysis (PSA).
Patients treated with high-dose edoxaban lived an average of 10.50 QALYs at a lifetime treatment cost of $99,833 compared with 10.11 QALYs and $123,516 for those treated with adjusted-dose warfarin. The model's conclusions were found to be robust upon one-way sensitivity analyses. PSA suggested high-dose edoxaban was economically dominant compared with adjusted-dose warfarin in more than 99% of the 10,000 iterations run.
High-dose edoxaban appears to be an economically dominant strategy when compared with adjusted-dose warfarin for the prevention of stroke in NVAF patients with a Clcr of 15-95 ml/minute and an appreciable risk of stroke.
评估在肌酐清除率（Clcr）为15 - 95毫升/分钟、有非瓣膜性心房颤动（NVAF）且有卒中风险的患者中，与调整剂量华法林相比，高剂量依度沙班的质量调整生命年（QALYs）、成本及成本效益。
建立一个马尔可夫模型，以比较Clcr为15 - 95毫升/分钟的患者使用高剂量依度沙班和调整剂量华法林的成本效益。该模型从美国社会角度进行分析，假设患者70岁开始治疗，平均CHADS2（充血性心力衰竭、高血压、75岁及以上、糖尿病、卒中）评分为3，且无抗凝治疗禁忌证。模型假设周期长度为1个月，终身期限（最长30年/360个周期）。数据来源包括心房颤动中新一代Xa因子有效抗凝（ENGAGE - AF）试验的肾脏亚组分析及其他已发表研究。结果包括终身成本（2014年美元）、QALYs及增量成本效益比。使用单因素和10000次迭代概率敏感性分析（PSA）来检验模型结论的稳健性。
接受高剂量依度沙班治疗的患者平均获得10.50个QALYs，终身治疗成本为99,833美元；而接受调整剂量华法林治疗的患者平均获得10.11个QALYs，成本为123,516美元。单因素敏感性分析表明模型结论具有稳健性。PSA显示，在10000次迭代中，超过99%的情况下，高剂量依度沙班与调整剂量华法林相比具有经济优势。
对于Clcr为15 - 95毫升/分钟且有明显卒中风险的NVAF患者，在预防卒中方面，与调整剂量华法林相比，高剂量依度沙班似乎是一种具有经济优势的策略。
