Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells: Comparison of Atorvastatin With Pravastatin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels
研究概览
简要总结
Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances [TBARS], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.
详细描述
Individuals with a high cholesterol level, diabetes or metabolic syndrome (collection of abnormalities such as high blood pressure, high triglyceride levels [fat], obesity, high blood glucose level) have an increased risk of developing a hardening of the arteries and heart disease.
A group of medications called statins, commonly used worldwide to lower cholesterol levels, are known to reduce the risk of heart disease through their effects on reducing cholesterol levels. These medications also have effects beyond the lowering of cholesterol that may help mediate their beneficial effects on the heart and blood vessels.
These include a reduced production of molecules that harm the arteries such as reactive oxygen species (ROS) and increasing the number of stem cells that help repair vessels, called endothelial progenitor cells (EPCs).
Recent studies have shown that different statins might have different effects on protecting people from developing heart disease. These differences may be due to differences in these non-cholesterol lowering processes, and are the subject of this study.
Standard of Care:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females without child bearing potential aged 21-80 years
- •Fasting low-density lipoprotein (LDL) level > 120mg/dL.
- •Either known to be diabetic or have at least 3 components of metabolic syndrome that are defined below:
- •Hypertension defined as blood pressure (BP) > 140 systolic or > 90 mmHg diastolic, or stable medical therapy for documented hypertension;
- •Fasting glucose > 110 mg/dL;
- •Waist > 40 inches in males, and > 35 inches in females;
- •Triglycerides > 150mg/dL; or
- •High-density lipoprotein (HDL) cholesterol < 40 mg/dL in males and < 50 mg/dL in females.
- •Able to provide written informed consent
- •Non-smoker
排除标准
- •On any oral antioxidants or lipid lowering medications in the previous 8 weeks
- •Age < 21 or > 80 years
- •Premenopausal females with potential for pregnancy
- •LDL cholesterol level < 120 mg/dl
- •Initiation or change in dose of any concomitant medical therapy within 2 months before the study
- •Uncontrolled hypertension with BP > 180 mmHg systolic and > 120 mmHg diastolic
- •Current smoker
- •Previous intolerance or allergy to statins
- •Acute infection in previous 4 weeks
- •History of substance abuse
- •Uninterpretable Brachial Artery Reactivity Study
- •Current neoplasm
- •Chronic renal failure (creatinine > 2.5 mg/dL) or liver failure (liver enzymes > 2X normal)
- •Acute coronary syndrome, heart failure, cerebrovascular accident (CVA), or coronary intervention within 3 months
- •Known aortic stenosis, hypertrophic cardiomyopathy, or symptomatic heart failure.
- •Inability to give informed consent
- •Inability to return to Emory for follow-up
研究组 & 干预措施
Atorvastatin 10MG
干预措施: Atorvastatin (Drug)
Pravastatin 80mg
干预措施: Pravastatin (Drug)
结局指标
主要结局
Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels
时间窗: Baseline &12 Weeks
Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.
次要结局
- Change in Flow-mediated Dilatation (FMD)(Baseline & 12 Weeks)
研究者
Arshed A. Quyyumi
Professor
Emory University