Amirfar Elaheh, Shirvani Ehsan, Ghaffari Hoseini Shervin, Mansourian Marjan, Aminzadeh Shima, Jamalian Marjan, Nateghi Alireza, Amirpour Afshin, Kermani-Alghoreaishi Mohammad, Teimouri-Jervekani Zahra, Najafian Jamshid, Sanei Hamid, Khosravi-Farsani Alireza, Heshmt-Ghahdarijani Kiyan, Askari Mozhdeh, Sahebzadeh Mohammadsadegh, Sarrafzadegan Nizal, Roohafza Hamidreza, Sadeghi Masoumeh
Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
These authors contributed equally as First author.
ARYA Atheroscler. 2024;20(6):43-53. doi: 10.48305/arya.2025.43212.3007.
Polypill or fixed-dose combination has been recognized as an effective secondary prevention strategy for patients with cardiovascular disease (CVD). This study aimed to evaluate the effectiveness of the polypill on one-year medication adherence, patient satisfaction, and lipid profile control in patients with ST-elevation myocardial infarction (STEMI).
This was an open-label, multicentric, randomized clinical trial study of STEMI patients who were prescribed a polypill (Aspirin 81 mg, Atorvastatin 40 mg, Metoprolol Succinate 47.5 mg, and Valsartan 40 mg) versus usual care (continued with separate medications) for secondary prevention. The primary outcome was to compare one-year medication adherence between groups. Other outcomes included comparing patient satisfaction and lipid profile after 12 months of follow-up, as well as identifying predictor factors of medication adherence.
Of 624 STEMI participants, 289 patients were treated with the polypill (79.2% male; mean age 61.67 ± 8.54 years), and 335 patients received usual care (82.7% male; mean age 62.10 ± 9.63 years). After one-year follow-up, no significant differences were detected between groups regarding medication adherence (p-value = 0.351) and cholesterol levels (p-value = 0.808). The polypill strategy was associated with increased patient satisfaction and better control of LDL-C (p-value = 0.043) and HDL-C (p-value < 0.001). Patients with a history of chronic kidney disease (OR: 13.392; p-value = 0.001), cerebrovascular disease (OR: 4.577; p-value = 0.011), and higher waist circumference (OR: 1.01; p-value = 0.002) demonstrated a lower probability of medication adherence. In contrast, in-hospital complications such as arrhythmia (OR: 0.039; p-value = 0.010), bleeding (OR: 0.034; p-value = 0.007), and higher ejection fraction (OR: 0.965; p-value = 0.002) were associated with a higher probability of medication adherence.
In STEMI patients, participants treated with polypills were more satisfied and showed better lipid profile control. However, a longer follow-up duration is needed to examine the effectiveness of the polypill on medication adherence in this subgroup.
复方制剂或固定剂量组合已被公认为心血管疾病（CVD）患者的有效二级预防策略。本研究旨在评估复方制剂对ST段抬高型心肌梗死（STEMI）患者一年药物依从性、患者满意度和血脂控制的有效性。
这是一项针对STEMI患者的开放标签、多中心、随机临床试验研究，这些患者被处方了一种复方制剂（阿司匹林81毫克、阿托伐他汀40毫克、琥珀酸美托洛尔47.5毫克和缬沙坦40毫克）与常规治疗（继续使用单独的药物）进行二级预防。主要结局是比较两组之间的一年药物依从性。其他结局包括比较随访12个月后的患者满意度和血脂情况，以及确定药物依从性的预测因素。
在624名STEMI参与者中，289名患者接受了复方制剂治疗（男性占79.2%；平均年龄61.67±8.54岁），335名患者接受了常规治疗（男性占82.7%；平均年龄62.10±9.63岁）。经过一年的随访，两组在药物依从性（p值=0.351）和胆固醇水平（p值=0.808）方面未发现显著差异。复方制剂策略与患者满意度提高以及低密度脂蛋白胆固醇（LDL-C）（p值=0.043）和高密度脂蛋白胆固醇（HDL-C）（p值<0.001）的更好控制相关。有慢性肾病病史（比值比：13.392；p值=0.001）、脑血管疾病病史（比值比：4.577；p值=0.011）和腰围较大（比值比：1.01；p值=0.002）的患者药物依从性概率较低。相比之下，院内并发症如心律失常（比值比：0.039；p值=0.010）、出血（比值比：0.034；p值=0.007）和射血分数较高（比值比：0.965；p值=0.002）与药物依从性概率较高相关。
在STEMI患者中，接受复方制剂治疗的参与者更满意，并且血脂控制更好。然而，需要更长的随访时间来检验复方制剂对该亚组患者药物依从性的有效性。
