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首页> 外文期刊>Journal of atherosclerosis and thrombosis. >Rationale and Design of the Standard Versus Intensive Statin Therapy for Hypercholesterolemic Patients with Diabetic Retinopathy (EMPATHY) Study: a Randomized Controlled Trial
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Rationale and Design of the Standard Versus Intensive Statin Therapy for Hypercholesterolemic Patients with Diabetic Retinopathy (EMPATHY) Study: a Randomized Controlled Trial

机译：糖尿病性视网膜病变（EMPATHY）研究的高胆固醇血症患者标准与强化他汀类药物疗法的基本原理和设计：一项随机对照试验

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Aim : Hyperlipidemia and diabetic retinopathy increase the risk of cardiovascular disease (CVD). The standard versus intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study examines whether intensive lipid-lowering therapy is superior to standard therapy in reducing the incidence of cardiovascular events in patients with hyperlipidemia and diabetic retinopathy, but without a history of coronary artery disease. Methods : Patients who had elevated low-density lipoprotein cholesterol (LDL-C) and diabetic retinopathy without a history of coronary artery disease were eligible for the study. Patients were randomly assigned in a 1:1 ratio to receive intensive or standard therapy. Patients are being treated with monotherapy with 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (statin) for a maximum of 5.5 years to achieve the following LDL-C target: ＜70 mg/dL for the intensive therapy group or ≥100 and ＜120 mg/dL for the standard therapy group. The primary endpoint is a composite of incidence of CVD and death from CVD. Results : Between May 2010 and October 2013, 5,995 patients were assessed for eligibility, and 5,144 were assigned to the study treatment (2,571 and 2,573 in the intensive and standard therapy groups, respectively), and baseline data were analyzed from 5,107 (2,550 in the intensive therapy group and 2,557 in the standard therapy group). Conclusions : This is the first study assessing the benefits of intensive statin therapy in patients with hypercholesterolemia and diabetic retinopathy in a primary prevention setting. Furthermore, this study evaluates the appropriateness of the treat-to-target approach because all patients are treated to achieve specific LDL-C targets by titrating statin therapy.Clinical Trial Registration Number: UMIN000003486.
机译：目的：高脂血症和糖尿病性视网膜病会增加患心血管疾病（CVD）的风险。高胆固醇血症的标准他汀类药物与强效他汀类药物治疗之间的关系（EMPATHY）研究检查在降低高脂血症和糖尿病性视网膜病但无冠状动脉病史的患者中，强化降脂治疗是否优于标准治疗疾病。方法：具有低密度脂蛋白胆固醇（LDL-C）升高和糖尿病性视网膜病且无冠心病史的患者符合研究条件。患者按1：1比例随机分配以接受强化或标准治疗。患者接受3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂（他汀类药物）的单药治疗最多5.5年，以达到以下LDL-C目标：强化治疗组＜70 mg / dL或≥100标准治疗组＜120 mg / dL。主要终点是CVD发病率与CVD死亡的综合因素。结果：2010年5月至2013年10月之间，对5995例患者进行了资格评估，并将5144例患者分配为研究治疗药物（强化治疗组和标准治疗组分别为2571例和2573例），并分析了5107例患者的基线数据（其中2550例患者为2550例）。强化治疗组和标准治疗组中的2557）。结论：这是第一项评估他汀类药物强化治疗对高胆固醇血症和糖尿病性视网膜病患者的一级预防效果的研究。此外，这项研究评估了按目标治疗方法的适当性，因为通过滴定他汀类药物治疗所有患者均达到了特定的LDL-C目标。临床试验注册号：UMIN000003486。

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