Internal Medicine Service, Hospital Carlos III, Madrid, Spain.
Internal Medicine Department Hospital de la Princesa, Madrid, Spain.
BMC Cardiovasc Disord. 2022 Dec 22;22(1):560. doi: 10.1186/s12872-022-03013-w.
Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event.
The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups.
The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm.
The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).
心血管（CV）复方药是一种有用的基础治疗方法，它将不同类别的药物组合在一个药丸中，以同时针对一个以上的风险因素，从而预防 CV 疾病。本试验的目的是确定在没有先前 CV 事件的高危或极高危人群中，与常规治疗相比，CNIC-复方药在降低低密度脂蛋白胆固醇（LDL-c）和收缩压（SBP）方面是否至少非劣效。
VULCANO 是一项国际性、多中心、开放性试验，共纳入 492 名来自医院诊所或初级保健中心的患者。患者被随机分配到含有阿司匹林、阿托伐他汀和雷米普利的 CNIC-复方药或常规治疗组。主要结局是治疗 16 周后两组间 LDL-c 和 SBP 值的平均变化比较。
治疗间 LDL-c 平均变化的上限置信区间低于预设的界值（10mg/dL）且大于零，CNIC-复方药达到了非劣效性和优越性（p=0.0001）。两组间 SBP 无显著差异。然而，上限置信区间超过了预设的 3mmHg 非劣效界值。CNIC-复方药在降低总胆固醇（p=0.0004）和非高密度脂蛋白胆固醇水平方面具有显著优势（p=0.0017）。无重大出血事件报告。CNIC-复方药组非严重胃肠道疾病的频率更高。
从常规治疗转换为 CNIC-复方药治疗是安全的，似乎是控制风险因素和预防 CVD 的合理策略。试验注册 该试验于 2017 年 2 月 20 日在欧盟临床试验注册中心（EudraCT）注册（注册号 2016-004015-13；https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13）。
