每日一次血脂康与每日两次血脂康治疗轻、中度高胆固醇血症患者的疗效和安全性（APEX 研究）：一项多中心、前瞻性、随机对照、开放标签、非劣效性研究方案。

Efficacy and safety of xuezhikang once per day versus two times per day in patients with mild to moderate hypercholesterolaemia (APEX study): a protocol for a multicentre, prospective randomised controlled, open-label, non-inferiority study.

机构信息

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.

出版信息

BMJ Open. 2020 May 17;10(5):e034585. doi: 10.1136/bmjopen-2019-034585.

DOI:10.1136/bmjopen-2019-034585

PMID:32423930

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7239523/

Abstract

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

ChiCTR-IIR-17013660.

摘要

简介

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。

方法与分析

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。