Istituto di Cardiologia, Azienda Universitario-Ospedaliera S. Orsola-Malpighi, Via Massarenti 9, Bologna 40138, Italy
Servizio di Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria di Udine, Udine, Italy Agenzia Sanitaria Regionale, Regione Emilia Romagna, Bologna, Italy.
Eur Heart J Cardiovasc Pharmacother. 2015 Oct;1(4):254-9. doi: 10.1093/ehjcvp/pvv028. Epub 2015 Jun 15.
In accordance with current guidelines, patients discharged after acute myocardial infarction (AMI) are usually prescribed agents acting on the renin-angiotensin system (ACE-I/ARB). However, adherence to prescribing medications is a recognized problem and most studies demonstrating the value of adherence were limited by their non-randomized design and by 'healthy-adherer' bias. Herein we sought to evaluate the relationship between adherence to ACE-I/ARB and risk of subsequent AMIs, by using the self-controlled case-series design which virtually eliminates interpersonal confounding, being based on intrapersonal comparisons.
We linked data from three longitudinal registries containing information about hospitalizations, drug prescriptions, and vital status of all residents in an Italian region. From 30 089 patients hospitalized for AMI in the years 2009-11, we enrolled the 978 with non-fatal re-AMIs at Days 31-365 after discharge, receiving at least one ACE-I/ARB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to ACE-I/ARB. The relative re-AMI incidence rate ratios (IRRs) of ACE-I/ARB exposure were estimated by conditional Poisson regression. During drug-covered periods, the risk of AMI recurrence was ∼20% lower, i.e. the IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.66-0.96, P = 0.001). The benefit of ACE-I/ARB was confirmed also by sensitivity analyses considering only first recurrences, excluding cases with AMI within previous 3 years, or with long, not AMI, hospital re-admission.
Poor adherence to ACE-I/ARB prescription medication was associated with a 20% increased risk of recurrent AMI. This was consistent with previous research, but the SCSS study design, even if not randomized, eased previous concerns about healthy-adherer bias.
根据现行指南,急性心肌梗死(AMI)后出院的患者通常会开处方使用肾素-血管紧张素系统(ACE-I/ARB)药物。然而,服用药物的依从性是一个公认的问题,大多数证明依从性价值的研究都受到其非随机设计和“健康依从者”偏倚的限制。在此,我们使用自我对照病例系列设计来评估 ACE-I/ARB 依从性与随后发生 AMI 的风险之间的关系,该设计几乎消除了人际混杂,基于个体内比较。
我们将三个纵向登记处的数据进行了关联,这些登记处包含了意大利一个地区所有居民的住院、药物处方和生存状态信息。在 2009-11 年因 AMI 住院的 30089 名患者中,我们纳入了出院后第 31-365 天发生非致命性再 AMI 的 978 名患者,他们至少有一次 ACE-I/ARB 处方是在该地区的任何一家药店开具的。使用处方信息,将每个个体的观察时间分为暴露于 ACE-I/ARB 或未暴露于 ACE-I/ARB 的时期。通过条件泊松回归估计 ACE-I/ARB 暴露的相对再 AMI 发生率比(IRR)。在药物覆盖期间,AMI 复发的风险降低了约 20%,即 IRR(暴露期与未暴露期内再发 AMI 的发生率)为 0.79(95%CI 0.66-0.96,P=0.001)。通过仅考虑首次复发、排除 3 年内有 AMI 病史或因非 AMI 而住院时间较长的病例,或排除 AMI 后住院时间较长的病例的敏感性分析,也证实了 ACE-I/ARB 的获益。
ACE-I/ARB 处方药物的依从性差与再发 AMI 的风险增加 20%相关。这与以前的研究一致,但 SCSS 研究设计,即使是非随机的,也减轻了以前对“健康依从者”偏倚的担忧。