MASIRA Research Institute, Universidad de Santander (UDES), Bucaramanga, Santander, Colombia.
Department of Internal Medicine. Cardiology Unit, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogotá, Colombia.
Vasc Health Risk Manag. 2023 Sep 12;19:605-615. doi: 10.2147/VHRM.S421024. eCollection 2023.
BACKGROUND: Higher medication adherence reduces the risk of new cardiovascular events. However, there are individual and health system barriers that lead to lower adherence. The polypill has demonstrated benefits in cardiovascular morbidity and mortality mainly driven by an increase in adherence. We aim to evaluate the impact of the polypill on adherence to cardiovascular medication, its efficacy and safety in cardiovascular disease (CVD) prevention. METHODS: A systematic review following PRISMA guidelines was conducted. Databases were searched from January 2003 to December 2022. We included randomized, pragmatic, or real-world clinical trials and observational studies. The primary outcome was medication adherence, secondary outcomes were efficacy in cardiovascular disease in primary and secondary prevention and safety. RESULTS: From the 490 publications screened, 13 met the inclusion criteria and were incorporated into a comparative table Of those included, 70% were randomized controlled trials (RCTs) and 53.8% focused on secondary prevention. Most of the studies received a high and moderate quality rating. Self-report, pill counting and, the Morisky scale were the most frequent methods to evaluate adherence (84.6%). Compared with standard medication, the polypill improved overall medication adherence by 13%, with percentages ranging from 7.6% to 34.9%. Moreover, a potential benefit was also observed in reducing Major Adverse Cardiovascular Events (MACE), particularly in secondary prevention studies, with hazard ratios ranged between 0.43 to 0.76. Compared to standard care, the profile of side effects was similar. CONCLUSION: The polypill is an effective, safe, and practical strategy to improve adherence in people at risk of CVD. Although there is a demonstrated benefit in reducing MACE, predominantly in secondary prevention, there are still gaps in its efficacy in primary prevention and reducing total mortality. Therefore, the importance of obtaining long-term results of the polypill effect and how this strategy can be implemented in real practice.
背景：更高的药物依从性降低了新发心血管事件的风险。然而，个人和医疗体系存在障碍，导致依从性降低。复方药已被证明在心血管发病率和死亡率方面具有益处，主要是通过提高依从性实现的。我们旨在评估复方药对心血管药物依从性的影响，以及其在心血管疾病（CVD）预防中的疗效和安全性。
方法：按照 PRISMA 指南进行系统评价。从 2003 年 1 月至 2022 年 12 月，我们检索了数据库。我们纳入了随机、实用或真实世界的临床试验和观察性研究。主要结局是药物依从性，次要结局是一级和二级预防中的心血管疾病疗效和安全性。
结果：从筛选出的 490 篇文献中，有 13 篇符合纳入标准，并被纳入一个比较表中。其中 70%为随机对照试验（RCT），53.8%的研究重点是二级预防。大多数研究的质量评分较高或为中等。自我报告、药片计数和 Morisky 量表是评估依从性最常用的方法（84.6%）。与标准药物治疗相比，复方药使整体药物依从性提高了 13%，百分比范围为 7.6%至 34.9%。此外，还观察到在减少主要不良心血管事件（MACE）方面存在潜在获益，特别是在二级预防研究中，风险比范围为 0.43 至 0.76。与标准护理相比，副作用谱相似。
结论：复方药是一种提高 CVD 风险人群药物依从性的有效、安全且实用的策略。虽然在降低 MACE 方面已经显示出获益，主要是在二级预防中，但在一级预防和降低总死亡率方面，其疗效仍存在差距。因此，获得复方药效果的长期结果以及该策略如何在实际中实施非常重要。
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