Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Difference in myalgia
研究概览
简要总结
Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of cardio-vascular diseases. The use of statins has increased markedly and it is now one of the most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a daily basis, 40 % of these are taking the medication without having any other risk factors for cardio-vascular diseases than elevated blood-cholesterol i.e. they are in primary prevention.
Statins are not without side effects and studies have shown that there is an elevated risk of developing diabetes when taking statins. This has led to an increased debate about the use of statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent one event of cardio-vascular disease, it is necessary to treat 200 people for 3-5 years. These data suggest that more conservative use of statins to prevent CVD in otherwise healthy individuals at low risk for future CVD may be warranted.
Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially can prevent a physically active lifestyle. The biomedical background of these side effects is not fully elucidated but it has been shown that there is a link to decreasing levels of an important enzyme, Q10, which plays a role in muscle energy metabolism.
Hypothesis
The overarching research question is: why does statin treatment cause muscle pain? Does statin treatment impair (or even prevent) physical exercise training? Furthermore we would like to answer the following questions:
- Does statin treatment impair (or even prohibit) physical exercise training?
- Does statin treatment cause:
- Decreased muscle strength?
- Skeletal muscle inflammation?
- Decreased mitochondrial respiratory function?
- Abnormal glucose homeostasis?
详细描述
Background
HYPERCHOLESTEROLEMIA AND STATIN USE IN DENMARK
Simvastatin is the most commonly prescribed statin, a class of drugs that inhibit hydroxyl-methyl-glutaryl (HMG) coenzyme A reductase, and thereby blocking biosynthesis of cholesterol in the liver. Simvastatin is prescribed for individuals with elevated low-density lipoprotein cholesterol (LDL-C) and/or total cholesterol, because these clinical parameters are viewed as a risk factor for cardiovascular-disease (CVD), even in the absence of other health problems or risk factors, such as previous myocardial infarction, diabetes or hypertension.
Approximately 40% of the prescriptions for statins are issued for primary prevention of elevated cholesterol by general practitioners to patients without bodily symptoms or signs. Only the "cholesterol number" makes the risk of heart attack and stroke visible. The lack of symptoms is likely to be of importance for patients' adherence to treatment as is adverse effects. A number of factors, such as information in mass media and changes in daily life, may affect the decision to take the treatment
TREATMENT GUIDELINES FOR HYPERCHOLESTEROLEMIA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-70 years.
- •prescribed Simvastatin 40 mg/daily by their general practitioner.
排除标准
- •Diabetes Mellitus.
- •Cardiovascular disease such as arrythmia, ischaemic heart disease.
- •Musculoskeletal disorders preventing the subject to perform physical.
- •Mental disorders preventing the subject to understand the project description.
研究组 & 干预措施
Simvastatin and Q10
Simvastatin 40 mg orally administered daily for 8 weeks in combination with Q10 supplementation of 400 mg/daily
干预措施: Q10 (Dietary Supplement)
Simvastatin and Q10-placebo
Simvastatin 40 mg orally administered daily and Q10-placebo for 8 weeks
干预措施: Simvastatin (Drug)
Simvastatin and Q10
Simvastatin 40 mg orally administered daily for 8 weeks in combination with Q10 supplementation of 400 mg/daily
干预措施: Simvastatin (Drug)
结局指标
主要结局
Difference in myalgia
时间窗: 8 weeks
Difference in myalgia, measured by visual analog scale (VAS) between Simvastatin treated patients receiving Q10 or Q10-placebo.
次要结局
- Difference in VO2-max(8 weeks)
- Difference in muscle strength(8 weeks)
- Difference in glucose metabolism(8 weeks)
- Difference in mitochondrial function(8 weeks)
研究者
Flemming Dela
Associate Professor
University of Copenhagen