Supplementation of Omega-3 Fatty Acid Complex to Routine Statin Treatment Decreases Patients' Day-time Blood Pressure, Improves Inflammatory Status and Prohibits Platelet Aggregation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- augmentation index
研究概览
简要总结
Recent evidences showed beneficial effects of omega-3 fatty acids on cardiovascular morbidity and mortality.
Regular Omega-3 fatty acid consumption reduces cardiovascular mortality, ischemic heart disease and stroke mortality. There is probably no single mechanism of action that explains this beneficial effect; but possible mechanisms include reduce susceptibility of the heart to ventricular arrhythmia, antithrombogenic effect, reduce triglyceride level, promotion of nitric oxide-induced endothelial relaxation, and retard growth of atherosclerotic plaque.
The combination of satins and omega3 was proved to be better the any of the drugs alone in several studies.
The purpose of the study is to investigate several possible mechanisms that may explain the add on beneficial effect of omega-3 in hypercholesterolemic patients already treated with satins.
详细描述
Cardiovascular disease is a leading cause of death in the western world. HMG-co A Reductase (statins) stands in the first line of treatment of cardiovascular disease because of their direct effect on LDL and their pleotrophic effect (mainly anti-inflammatory).
Recent evidences showed beneficial effects of omega-3 fatty acids on cardiovascular morbidity and mortality
Regular Omega-3 fatty acid consumption reduces cardiovascular mortality , , ischemic heart disease and stroke mortality. There is probably no single mechanism of action that explains this beneficial effect; but possible mechanisms include reduce susceptibility of the heart to ventricular arrhythmia, antithrombogenic effect , reduce triglyceride level , promotion of nitric oxide-induced endothelial relaxation , , and retard growth of atherosclerotic plaque.
Statins have a proven survival benefit in patients with hypercholesterolemia by preventing both primary and secondary cardiovascular events . Statins also has beneficial effect on lipid profile (mainly LDL and less triglycerides), they reduce plaque growth and improves endothelial function.
Many studies have demonstrated the additive effect of the combination of statins and omega-3 fatty acids on lipid profile, as well as additive effect on inflammatory markers (IL-6 and CRP).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •dyslipidemia controlled (LDL < 130)
- •statin treatment
- •triglycerides < 200
- •informed consent
排除标准
- •thrombocytopenia or bleeding tendency
- •uncontrolled diabetes mellitus
- •uncontrolled hypertension (systolic > 160 or diastolic > 100)
- •omega 3 pretreatment
- •recent acute coronary syndrome or cerebrovascular event (less than 3 months)
研究组 & 干预措施
omega-3
omega-3: 2 pills of Omega"950"®, Solgar, New Jersey, USA. Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA
干预措施: omega-3 (Drug)
placebo
hard gelatin capsule of Capsugel®, France, filled with 1ml of soya oil
干预措施: placebo (Drug)
结局指标
主要结局
augmentation index
时间窗: 0, 3 weeks, 6 weeks, 20 weeks
Each patient was seated in a quiet room, blood pressure was measured. Radial artery pressure waveform was sampled with a Millar tonometer (SPC-301, Millar Instruments) and calibrated to the average blood pressure. Waveforms were then processed using the specific software (SphygmoCor, version 7, AtCor). Integral system software was used for calculation of the averaged radial artery waveform and derivation of the corresponding central aortic pressure waveform, using a previously validated generalized transfer function.
次要结局
- blood pressure (24 hours monitor)(0, or 3 weeks, 6 weeks, 20 weeks)
- platelet function(0, 3 weeks, 6 weeks, 20 weeks)
- Isoprostane(0, 3 weeks, 6 weeks, 20 weeks)
- PAI-1, TNF-alpha, IL6(0, 3,6 and 20 weeks)