Department of Cardiology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
NHC Key Laboratory of Assisted Circulation, Sun Yat-sen University, Guangzhou, China.
BMJ Open. 2020 May 17;10(5):e034585. doi: 10.1136/bmjopen-2019-034585.
Reduction in low-density lipoprotein cholesterol (LDL-C) improves clinical outcomes in patients with coronary artery disease. However, rates of lipid-lowering medication adherence are far from ideal. Reducing dosage frequency from multiple dosing to once-daily dosing may improve patients' medication adherence. Xuezhikang (XZK), an extract of Chinese red yeast rice, contains a family of naturally occurring statins and is traditionally prescribed as 600 mg two times per day. A comParative Efficacy study of XZK (APEX study) is designed to test the hypothesis that XZK prescribed 1200 mg once per day (OD group) is non-inferior to 600 mg two times per day (TD group) in patients with hypercholesterolaemia.
The APEX study is a multicentre, prospective randomised controlled, open-label, non-inferiority study. We plan to recruit 316 patients aged ≥18 years with a diagnosis of mild to moderate hypercholesterolaemia for primary prevention. Patients will be randomised (1:1) to OD group and TD group. The OD group take XZK 1200 mg once per day after dinner while TD group take a traditional dose of 600 mg, two times per day after meals. Participants will have an 8-week medication period and be followed up at weeks 0, 4 and 8. The primary end point is the mean percentage change from baseline to week 8 in serum LDL-C. Secondary end points are safety and lipid-lowering effect on other lipoproteins and compliance. Data analyses will be on the intention-to-treat principle using non-inferiority analysis.
The research had been approved by the Clinical Research and Laboratory Animal Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University ((2017)286). The results will be reported through peer-reviewed journals, seminars and conference presentations.
ChiCTR-IIR-17013660.
降低低密度脂蛋白胆固醇（LDL-C）可改善冠心病患者的临床结局。然而，降脂药物的依从率远不理想。将用药频率从每日多次减少到每日一次，可能会提高患者的用药依从性。血脂康（XZK）是从中国红曲中提取的一种药物，含有一组天然他汀类药物，传统上每天服用两次，每次 600 毫克。XZK 比较疗效研究（APEX 研究）旨在检验以下假设：每天服用一次 1200 毫克 XZK（OD 组）与每天服用两次 600 毫克（TD 组）在高胆固醇血症患者中的疗效相当。
APEX 研究是一项多中心、前瞻性、随机对照、开放性、非劣效性研究。我们计划招募 316 名年龄≥18 岁、诊断为轻度至中度高胆固醇血症的患者进行一级预防。患者将被随机（1:1）分配到 OD 组和 TD 组。OD 组在晚餐后服用 XZK 1200 毫克，TD 组则在饭后服用传统剂量的 600 毫克，每日两次。参与者将有 8 周的用药期，并在第 0、4 和 8 周进行随访。主要终点是第 8 周时血清 LDL-C 与基线相比的平均百分比变化。次要终点是安全性和对其他脂蛋白的降脂效果及依从性。数据分析将采用意向治疗原则进行非劣效性分析。
该研究已获得中山大学附属第一医院临床研究与实验室动物伦理委员会的批准[(2017)286]。研究结果将通过同行评议期刊、研讨会和会议报告进行报告。
ChiCTR-IIR-17013660。
