Pharmerit Ltd, York, UK.
Curr Med Res Opin. 2010 Mar;26(3):641-51. doi: 10.1185/03007990903529267.
This study assesses the costs and effects of combination treatment with clopidogrel and aspirin in comparison to aspirin alone in patients with an ST-segment elevation myocardial infarction (STEMI) in a Dutch setting.
A decision tree model is used to combine data from different sources about efficacy, epidemiology and costs. In the short-run, cost-effectiveness is based on efficacy data derived from the CLARITY trial. The cost-effectiveness of continued treatment is addressed by analysing which conditions need to be fulfilled to deem the strategy 'cost-effective', and discussing whether it is likely that it is. Estimates concerning the benefits of preventing events are derived from Swedish registries. Approximations of both direct and indirect costs are derived from the literature. Effects are expressed as life years gained and Quality Adjust Life Years (QALYs). Uncertainties are addressed by uni- and multivariate sensitivity analyses with and without taking account of the dependency between the separate ischaemic events.
A treatment regimen similar to that of the CLARITY trial, including patients similar to those in the trial, is estimated to result in 0.05 additional life years and 0.062 additional quality adjusted life years for a cost that is euro1929 lower than aspirin therapy. Continuation of treatment outside the trial period is expected to result in ICERs of below euro20,000 per QALY as long as the real risk reduction of combination treatment is greater than 0.487% per year.
The results indicate that clopidogrel therapy combined with aspirin, according to the regimen seen in CLARITY, and using data from Swedish registries to inform the model, is cost-effective. Sensitivity analyses suggest that the model is robust to a wide range of parameter estimates, including those based on data from Swedish registries. Continued treatment is very likely to be cost effective in light of all the indirect evidence.
本研究评估了在荷兰 ST 段抬高型心肌梗死（STEMI）患者中，与单独使用阿司匹林相比，氯吡格雷联合阿司匹林治疗的成本和效果。
采用决策树模型，结合不同来源的疗效、流行病学和成本数据。在短期内，成本效益基于 CLARITY 试验得出的疗效数据。通过分析需要满足哪些条件才能认为该策略“具有成本效益”，并讨论是否有可能认为该策略具有成本效益，来解决继续治疗的成本效益问题。预防事件的效益估计来自瑞典登记处。直接和间接成本的近似值来自文献。效果以增加的寿命年和质量调整生命年（QALYs）表示。通过单变量和多变量敏感性分析来解决不确定性，包括考虑和不考虑单独缺血事件之间的依赖性。
类似于 CLARITY 试验的治疗方案，包括与试验中相似的患者，预计将额外增加 0.05 个生命年和 0.062 个质量调整生命年，而成本比阿司匹林治疗低 1929 欧元。只要联合治疗的实际风险降低大于每年 0.487%，那么在试验期外继续治疗的增量成本效益比预计将低于每 QALY 20,000 欧元。
结果表明，根据 CLARITY 试验所见的方案，使用来自瑞典登记处的数据为模型提供信息，联合使用氯吡格雷和阿司匹林治疗是具有成本效益的。敏感性分析表明，该模型对广泛的参数估计具有稳健性，包括基于瑞典登记处数据的估计。鉴于所有间接证据，继续治疗很可能具有成本效益。
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