Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Apolipoprotein B bound to erythrocytes
研究概览
简要总结
Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB.
Objective: to investigate the effect of statins on ery-apoB levels.
Study design: a non-randomized intervention study. Ery-apoB will be measured twice in volunteers who are on statin therapy for medical reasons. After a baseline measurement of ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a second measurement of ery-apoB. Consecutively subjects will start with their original statin therapy again.
Study population: patients on statin therapy aged 18 years or older.
Intervention: temporary discontinuation of statin therapy for a period of six weeks.
Main study endpoints: changes in ery-apoB levels.
Risks, burden and benefits on participation: volunteers will visit the outpatient clinic twice, the second visit will be exactly six weeks after the first visit. The volunteers' general practitioner and medical specialist (internist or cardiologist) will be informed about their participation. Subjects have to fast for 10 hours before every visit and venous blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will discontinue their usual statin therapy for a period of six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.
详细描述
INTRODUCTION:
Previously it has been shown that atherogenic apolipoprotein (apo) B containing lipoproteins bind to erythocytes.1-3 Studies from our laboratory have shown that the binding of apoB on erythrocytes (ery-apoB) may reflect a situation of protection against cardiovascular disease (CVD).4 Mean ery-apoB is significantly lower in subjects with known CVD compared to healthy controls. However, the use of statins could be an important confounding factor, because of its known LDL-C and serum apoB lowering effects.5, 6 In our on-going study population 91% of the patients with CVD were on statin therapy compared to only 19% of the subjects without CVD. Preliminary data showed at least some effect of statin therapy on ery-apoB. A modest, but significant negative correlation was found between ery-apoB and serum apoB and LDL-cholesterol in subjects without statins (Pearson's r -0.172 and -0.185, P < 0.05) but these correlations were lost in subjects using statins. Statins are known for their inhibition of HMG-CoA reductase, which is necessary for the liver to synthesize cholesterol, and increase the expression of hepatic LDL-receptors resulting in lowering of LDL-cholesterol and its related apoB.7, 8 In theory ery-apoB may be lowered by statins as well, which could be an explanation for the differences in ery-apoB between subjects with or without CVD. This interventional study is to explore the effects of statin therapy on ery-apoB.
AIM:
To investigate the effects of statin therapy on plasma levels of erythrocyte-bound apolipoprotein B.
HYPOTHESIS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •use of a statin
排除标准
- •use of other lipid lowering drugs, other than statins
- •a cardiovascular event in the past 6 months
研究组 & 干预措施
Discontinuation of statin therapy
干预措施: Temporary discontinuation of statin therapy (Drug)
结局指标
主要结局
Apolipoprotein B bound to erythrocytes
时间窗: 6 weeks
Change in apollipoprotein B bound to erythrocytes six weeks after cessation of statin therapy
次要结局
- Apolipoprotein B bound to leukocytes(Six weeks)
- Leukocyte activation(six weeks)
研究者
Boudewijn Klop
MD
Sint Franciscus Gasthuis