一项多中心、开放标签、双臂平行组非劣效性随机对照临床试验，评估匹伐他汀与阿托伐他汀相比在高血压伴血脂异常的糖尿病前期患者中对糖代谢的影响：中国糖化血红蛋白代谢保护联盟研究（CAMPUS）的原理和设计。

A Multi-Center, Open-Label, Two-Arm Parallel Group Non-inferiority Randomized Controlled Trial Evaluating the Effect of Pitavastatin, Compared to Atorvastatin, on Glucose Metabolism in Prediabetics with Hypertension and Dyslipidemia: Rationale and Design for the China Hemoglobin A1c Metabolism Protection Union Study (CAMPUS).

机构信息

Department of Hypertension and Cardiovascular Disease, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.

School of Public Health, Sun Yat-sen University, Guangzhou, China.

出版信息

Cardiovasc Drugs Ther. 2018 Dec;32(6):581-589. doi: 10.1007/s10557-018-6826-6.

DOI:10.1007/s10557-018-6826-6

PMID:30187345

Abstract

BACKGROUND

Hypertension and dyslipidemia are major risk factors for cardiovascular disease (CVD). In 2012, over 270 million patients (25.2%) in China were hypertensive and 40.4% was dyslipidemic. The majority of these patients rely on statins for the prevention of cardiovascular disease. However, certain types of statins (e.g., atorvastatin), compared to others (e.g., pitavastatin), may be associated with unfavorable effects on glucose metabolism. This leads to concerns when prescribing statins to patients who also have a predisposition to glucose metabolic disorders (i.e., prediabetes). Thus, this study aims to investigate the effect of pitavastatin, compared to atorvastatin, on glucose metabolism, as measured by hemoglobin A1c (HbA1c), in Chinese prediabetics with hypertension and dyslipidemias.

METHODS

The China hemoglobin A1c Metabolism Protection Union Study (CAMPUS) is a multi-center, prospective, open-label, 12-month, two-arm parallel group, and non-inferiority randomized controlled trial (RCT). A total of 396 prediabetics with hypertension and dyslipidemias will be randomly assigned 1:1 to either pitavastatin 2 mg/day or atorvastatin 20 mg/day, and followed for 12 months (follow-up visits at 1, 3, 6, and 12 months) for HbA1c levels, as well as other measures of glucose metabolism, serum lipid levels, blood pressure control, measures of inflammation, vascular endothelial function, carotid atherosclerosis, and hypertension-related left ventricular hypertrophy. If the results of low-density lipoprotein cholesterol (LDL-C) levels in month 3 after treatment initiation do not meet individual target, drug dose for the participant would be doubled.

DISCUSSION

CAMPUS will be the first RCT to investigate the effect of pitavastatin, compared to atorvastatin, on glucose metabolism in Chinese prediabetics with hypertension and dyslipidemias. Further, this study might eventually provide information to design a clinical strategy, and facilitate the improvement of primary prevention in patients at risk for diabetes and CVD.

TRIAL REGISTRATION

ClinicalTrials.gov number: NCT03532620. Registered 22 May 2018.

摘要

背景

高血压和血脂异常是心血管疾病（CVD）的主要危险因素。2012 年，中国有超过 2.7 亿患者（25.2%）患有高血压，其中 40.4%血脂异常。这些患者中的大多数依赖他汀类药物预防心血管疾病。然而，某些类型的他汀类药物（如阿托伐他汀）与其他类型的他汀类药物（如匹伐他汀）相比，可能对葡萄糖代谢产生不利影响。这使得在给有葡萄糖代谢紊乱倾向（即糖尿病前期）的患者开他汀类药物时产生了顾虑。因此，本研究旨在探讨与阿托伐他汀相比，匹伐他汀对中国高血压合并血脂异常的糖尿病前期患者的血糖代谢（糖化血红蛋白（HbA1c））的影响。

方法

中国糖化血红蛋白代谢保护联盟研究（CAMPUS）是一项多中心、前瞻性、开放性、12 个月、双臂平行组、非劣效性随机对照试验（RCT）。共有 396 名高血压合并血脂异常的糖尿病前期患者将被随机分为 1:1 组，分别接受匹伐他汀 2mg/天或阿托伐他汀 20mg/天治疗，并随访 12 个月（随访时间为 1、3、6 和 12 个月），以评估 HbA1c 水平以及其他血糖代谢指标、血脂水平、血压控制情况、炎症指标、血管内皮功能、颈动脉粥样硬化和高血压相关的左心室肥厚情况。如果治疗开始后 3 个月的低密度脂蛋白胆固醇（LDL-C）水平未达到个体目标，则将参与者的药物剂量加倍。