Examination of lower targets for low-density lipoprotein cholesterol and blood pressure in diabetes - the Stop Atherosclerosis in Native Diabetics Study (SANDS)
Examination of lower targets for low-density lipoprotein cholesterol and blood pressure in diabetes - the Stop Atherosclerosis in Native Diabetics Study (SANDS)
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DOI：
10.1016/j.ahj.2006.05.021
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发表时间：
2006-11-01
影响因子：
4.8
通讯作者：
Howard, Barbara V.
中科院分区：
文献类型：
--
作者：
Russell, Marie;Fleg, Jerome L.;Howard, Barbara V.
美国的糖尿病发病率正在迅速上升。糖尿病增加了患心血管疾病的风险，心血管疾病是糖尿病患者死亡的主要原因。传统的心血管危险因素高脂血症和高血压加重糖尿病血管疾病。糖尿病患者低密度脂蛋白胆固醇（LDL-C）和血压的治疗目标一直存在争议。SANDS是一项随机、开放标签、为期3年的试验，旨在研究与LDL-C < 100 mg/dL和BP < 130/85 mm Hg的标准目标相比，积极LDL-C（目标< 70 mg/dL）和血压（目标< 115/75 mm Hg）降低的效果。549名40岁以上患有2型糖尿病的美国印第安人男性和女性被随机分为两组。血脂和血压的管理使用食品和药物管理局批准的药物在一个算法的方法。通过颈动脉超声检查评估动脉粥样硬化的存在和进展；超声心动图评估心功能。主要终点是颈动脉内膜内侧厚度变化和致死性/非致死性心血管事件的复合结局。这些结果通过对颈动脉厚度的分级分析和对心血管事件的“最差等级”进行组合。次要终点包括颈动脉斑块评分、左心室、几何和功能、血清c反应蛋白和安全措施。研究设计和分析计划的独特之处在于，由于护理标准的改变，使用了复合结果，并在试验期间改变了常规组中基线或突发心血管疾病参与者的LDL-C治疗目标。研究结果将进一步了解积极降低危险因素对美国糖尿病患者动脉粥样硬化负担和心功能的影响，并将有助于确定糖尿病患者的最佳LDL-C和BP治疗目标。
Diabetes incidence is increasing rapidly in the United States. Diabetes increases the risk for cardiovascular disease, the major cause of death in diabetic individuals. The conventional cardiovascular risk factors of hyperlipidemia and hypertension worsen diabetic vascular disease. Treatment targets for low-density lipoprotein cholesterol (LDL-C) and blood pressure in diabetic individuals are being debated. The SANDS is a randomized, open-label, 3-year trial to examine the effects of aggressive LDL-C (goal < 70 mg/dL) and blood pressure (BP) (goal < 115/75 mm Hg) reduction versus the standard goal's of < 100 mg/dL for LDL-C and < 130/85 mm Hg for BP. Five hundred forty-nine American-Indian men and women > 40 years old with type 2 diabetes were randomized to I of 2 groups. Lipids and BP are managed using Food and Drug Administration-approved medications in an algorithmic approach. The presence and progression of atherosclerosis are evaluated by carotid ultrasonography; echocardiography assesses cardiac function. The primary end point is the composite outcome of change in carotid artery intimal medial thickness and fatal/nonfatal cardiovascular events. These outcomes are combined by using a ranked analysis for carotid thickness and assigning a "worst rank" for a cardiovascular event. Secondary end points include carotid plaque score, left ventricular, geometry and function, serum C-reactive protein, and safety measures. Unique aspects of the study design and analysis plan involve the use of a composite outcome and changes during the trial of LDL-C treatment goals for participants with baseline or incident cardiovascular disease in the conventional group because of changes in the standard of care. Study results will further understanding of the effects of aggressive risk factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in US populations and will help determine optimal LDL-C and BP treatment goals for diabetic patients.