西班牙心血管二级预防的CV-polypill策略与标准治疗的成本效益：基于SECURE试验的分析

IF 13 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2025-06-27 DOI:10.1016/j.lanepe.2025.101348

Thomas Gaziano , José María Castellano , Amy Dymond , Alissa Looby , Stuart Mealing , Ruth Owen , Stuart Pocock , José Ramón González-Juanatey , Alberto Cordero , Antonio Fernández-Ortiz , Aleš Linhart , François Schiele , Wolfram Doehner , Luisa Ojeda Fernández , Valentín Fuster

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引用次数: 0

摘要

SECURE试验（NCT02596126）表明，与标准治疗相比，在心肌梗死后6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）在降低主要心血管事件复发风险方面的疗效。本分析旨在使用SECURE试验数据从西班牙医疗保健角度估计CV-Polypill的成本效益。方法采用决策分析马尔可夫模型方法，比较CV-Polypill与标准护理在一生时间范围内的差异。SECURE试验数据在再梗死、卒中或死亡（心血管或非心血管）的时间上拟合了6个参数分布。成本和效用数据来源于文献。各自的模型输出按3%折现。该模型捕获了与获得治疗和急性/持续心血管事件相关的直接医疗费用。进行了概率敏感性分析（PSA）和情景分析。研究结果：在84.8%的PSA迭代（848/1000次迭代）中，CV-Polypill占主导地位（改善健康结果并降低成本），在30,000欧元的阈值下，89.3%的PSA迭代（893/1000次迭代）具有成本效益。从西班牙医疗保健的角度来看，CV-Polypill的二级预防减少了心血管事件的复发和成本。进行了一系列情景分析，证明了不同输入和假设变化时结果的稳健性。从西班牙医疗保健的角度来看，与标准治疗相比，CV-Polypill是二级心血管预防的主要策略。CV-Polypill应该被认为是西班牙患者出院时的二级预防措施，就像那些参加SECURE的患者一样。资助：Ferrer International。

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Cost-effectiveness of the CV-polypill strategy versus standard care for secondary cardiovascular prevention in Spain: an analysis based on the SECURE trial

Background

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.

Methods

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.

Findings

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.

Interpretation

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.

Funding

By Ferrer International.

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.