Lamotte Mark, Annemans Lieven, Evers Thomas, Kubin Maria
Health Economics and Disease Management, Brussels, Belgium.
Pharmacoeconomics. 2006;24(2):155-69. doi: 10.2165/00019053-200624020-00005.
Low-dose aspirin (acetylsalicylic acid) is standard care in patients with a history of cardiovascular disease (CVD). The use of low-dose aspirin in primary prevention is not yet fully established, although meta-analyses and US and European guidelines support its use in people at increased risk of CVD. The primary objective of this study was to assess the economic consequences of the use of low-dose aspirin in the primary prevention of CVD in four European countries (UK, Germany, Spain and Italy).
Based on results (benefits and harms) reported in meta-analyses, a state-transition model was developed to predict the cost effectiveness of low-dose aspirin in the primary prevention of CVD. The model consists of five health states: no history of CVD, history of stroke, history of myocardial infarction (MI), history of stroke and MI, and death. A 10-year time horizon and 1-year cycles were used. Secondary prevention data were derived from the aspirin arm of the CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events) study. Direct costs from the public healthcare payer's perspective were used (euro, 2003 values). Effects were expressed in life-years (LY) and QALYs gained. Quality weights were obtained from published data.Country-specific discounting was applied on effects and costs (3.5% for the UK, 5% for Germany and 3% for Spain and Italy). Univariate sensitivity analysis and Monte Carlo simulation were performed to assess uncertainty in the results.
For patients with an annual risk of coronary heart disease (CHD) of 1.5%, the model resulted in 10-year savings with low-dose aspirin of on average euro 201 (95% CI 81, 331), euro 281 (95% CI 141, 422), euro 797 (95% CI 301, 1331) and euro 427 (95% CI 122, 731) per patient in the UK, Germany, Spain and Italy, respectively. Average total cost was almost 3- to 4-fold higher in Spain and Italy than in the UK and Germany. Savings (non-significant) start in the first year of treatment in all countries. Sensitivity analyses on cost of complications, utility, discounting, stroke rate and gastrointestinal bleeding rate showed the robustness of the results. From an annual risk of CHD of 0.236% for the UK, 0.324% for Germany, 0.244% for Spain and 0.560% for Italy, low-dose aspirin was cost saving compared with placebo. Monte Carlo analysis showed aspirin dominance in about 97% of cases for the three studied annual risks of CHD (0.6%, 1.0% and 1.5%) in the UK, Germany and Spain. In Italy, aspirin dominance in > 95% of cases was seen at annual risks of 1% and 1.5%.
Administering low-dose aspirin to patients with an annual risk of CHD of > or = 1% appears to be significantly cost saving from the healthcare payer's perspective in all countries analysed. Sensitivity analyses (CHD risk and bleedings) suggested the results were robust.
低剂量阿司匹林（乙酰水杨酸）是有心血管疾病（CVD）病史患者的标准治疗方法。尽管荟萃分析以及美国和欧洲指南支持在CVD风险增加的人群中使用低剂量阿司匹林，但在一级预防中的应用尚未完全确立。本研究的主要目的是评估在四个欧洲国家（英国、德国、西班牙和意大利）使用低剂量阿司匹林进行CVD一级预防的经济后果。
基于荟萃分析报告的结果（益处和危害），开发了一个状态转换模型来预测低剂量阿司匹林在CVD一级预防中的成本效益。该模型由五个健康状态组成：无CVD病史、中风病史、心肌梗死（MI）病史、中风和MI病史以及死亡。采用10年时间范围和1年周期。二级预防数据来自CAPRIE（氯吡格雷与阿司匹林治疗缺血性事件高危患者）研究的阿司匹林组。从公共医疗支付者的角度使用直接成本（欧元，2003年价值）。效果以获得的生命年（LY）和质量调整生命年（QALY）表示。质量权重从已发表的数据中获得。对效果和成本应用特定国家的贴现率（英国为3.5%，德国为5%，西班牙和意大利为3%）。进行单因素敏感性分析和蒙特卡罗模拟以评估结果的不确定性。
对于冠心病（CHD）年风险为1.5%的患者，该模型显示在英国、德国、西班牙和意大利，低剂量阿司匹林分别使每位患者在10年内平均节省201欧元（95%CI 81, 331）、281欧元（95%CI 141, 422）、797欧元（95%CI 301, 1331）和427欧元（95%CI 122, 731）。西班牙和意大利的平均总成本几乎比英国和德国高3至4倍。所有国家在治疗的第一年就开始节省费用（无统计学意义）。对并发症成本、效用、贴现率、中风率和胃肠道出血率的敏感性分析表明结果具有稳健性。从英国CHD年风险为0.236%、德国为0.324%、西班牙为0.244%、意大利为0.560%开始，与安慰剂相比，低剂量阿司匹林具有成本效益。蒙特卡罗分析表明，在英国、德国和西班牙，对于研究的三种CHD年风险（0.6%、1.0%和1.5%），阿司匹林在约97%的病例中占优势。在意大利，当CHD年风险为1%和1.5%时，阿司匹林在>95%的病例中占优势。
从医疗支付者的角度来看，在所有分析的国家中，对CHD年风险≥1%的患者使用低剂量阿司匹林似乎能显著节省成本。敏感性分析（CHD风险和出血）表明结果具有稳健性。
