Gaziano Thomas, Castellano José María, Dymond Amy, Looby Alissa, Mealing Stuart, Owen Ruth, Pocock Stuart, González-Juanatey José Ramón, Cordero Alberto, Fernández-Ortiz Antonio, Linhart Aleš, Schiele François, Doehner Wolfram, Fernández Luisa Ojeda, Fuster Valentín
Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain.
Lancet Reg Health Eur. 2025 Jun 27;55:101348. doi: 10.1016/j.lanepe.2025.101348. eCollection 2025 Aug.
The SECURE trial (NCT02596126) demonstrated the efficacy of the cardiovascular polypill ("CV-Polypill"-acetyl salicylic acid, atorvastatin and ramipril) in reducing the risk of recurrent major cardiovascular events compared with standard care when initiated within six months of a myocardial infarction. This analysis aimed to estimate the cost-effectiveness of the CV-Polypill from the Spanish healthcare perspective using SECURE trial data.
A decision analytic Markov modelling approach was conducted to compare the CV-Polypill with standard care over a lifetime time horizon. Six parametric distributions were fitted to SECURE trial data on time to reinfarction, stroke or death (cardiovascular or non-cardiovascular). Cost and utility data were sourced from literature. Respective model outputs were discounted at 3%. The model captured direct medical costs associated with treatment acquisition and acute/ongoing cardiovascular events. Probabilistic sensitivity analyses (PSA) and scenario analyses were conducted.
The CV-Polypill is dominant (improves health outcomes and reduces costs) in 84·8% of PSA iterations (848/1000 iterations), and cost effective in 89·3% of PSA iterations (893/1000 iterations) at a €30,000 threshold. Secondary prevention with the CV-Polypill reduces the recurrence of cardiovascular events and costs over the time horizon, from the Spanish healthcare perspective. A range of scenario analyses were conducted, demonstrating the robustness of the results when different inputs and assumptions were varied.
The CV-Polypill is a dominant strategy in secondary cardiovascular prevention, compared with standard care, from the Spanish healthcare perspective. The CV-Polypill should be considered as a secondary prevention for Spanish patients, like those enrolled in SECURE, at hospital discharge.
By Ferrer International.
SECURE试验（NCT02596126）表明，在心肌梗死后六个月内开始使用心血管复方制剂（“CV - 复方制剂”——乙酰水杨酸、阿托伐他汀和雷米普利）与标准治疗相比，可降低复发性重大心血管事件的风险。本分析旨在利用SECURE试验数据，从西班牙医疗保健的角度评估CV - 复方制剂的成本效益。
采用决策分析马尔可夫建模方法，在终身时间范围内比较CV - 复方制剂与标准治疗。对SECURE试验中再梗死、中风或死亡（心血管或非心血管）时间的数据拟合了六种参数分布。成本和效用数据来自文献。各模型输出按3%进行贴现。该模型涵盖了与治疗获取以及急性/持续性心血管事件相关的直接医疗成本。进行了概率敏感性分析（PSA）和情景分析。
在30000欧元的阈值下，CV - 复方制剂在84.8%的PSA迭代（848/1000次迭代）中占主导地位（改善健康结果并降低成本），在89.3%的PSA迭代（893/1000次迭代）中具有成本效益。从西班牙医疗保健的角度来看，使用CV - 复方制剂进行二级预防可在该时间范围内降低心血管事件的复发率和成本。进行了一系列情景分析，表明当不同的输入和假设发生变化时，结果具有稳健性。
从西班牙医疗保健的角度来看，与标准治疗相比，CV - 复方制剂在心血管二级预防中是一种占主导地位的策略。对于西班牙患者，如参加SECURE试验的患者，出院时应考虑将CV - 复方制剂作为二级预防措施。
由费雷尔国际公司提供。
