Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Physical performance measured by VO2-max
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. More than 600,000 people in Denmark are taking statins on a daily basis, approximately 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 prohibit) physical exercise training? Furthermore the following questions will be investigated:
A. Does statin treatment cause:
- Decreased muscle strength?
- Skeletal muscle inflammation?
- Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis?
Re question A & B: If so, can physical training counteract this effect of statin treatment?
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Elevated blood-cholesterol
排除标准
- •Cholesterol-lowering drugs
- •Diabetes Mellitus
- •Cardiovascular disease such as arrythmia, ischaemic heart disease.
- •Musculoskeletal disorders preventing the subject to perform physical training
- •Mental disorders preventing the subject to understand the project description.
研究组 & 干预措施
Training+Simvastatin+Q10-placebo
Training+Simvastatin+Q10-placebo. 8 Weeks of exercise training on a bicycle ergometer three times a week and 40 mg of Simvastatin pr day and Q10-placebo.
干预措施: Training+Simvastatin+Q10-placebo (Drug)
Training+Simvastatin-placebo+Q10-placebo
Training+Simvastatin-placebo+Q10-placebo. 8 Weeks of exercise training on a bicycle ergometer three times a week, Simvastatin-placebo and Q10-placebo.
干预措施: Training+Simvastatin-placebo+Q10-placebo (Drug)
Training+Simvastatin+Q10
Training+Simvastatin+Q10. 8 Weeks of exercise training on a bicycle ergometer three times a week and 40 mg of Simvastatin pr day in combination with 400 mg of oral supplementation with Q10.
干预措施: Training+Simvastatin+Q10 (Drug)
结局指标
主要结局
Physical performance measured by VO2-max
时间窗: 8 weeks
Difference in physical performance measured by VO2-max (mlO2/min/kgBW) in the three different intervention groups.
次要结局
- Myalgia measured by VAS(8 weeks)
- Difference in muscle strength measured by KinCom dynamometer and PowerRig(8 weeks)
- Difference in glucose metabolism measured by hyperinsulinemic euglycemic clamp(8 weeks)
- Difference in mitochondrial function measured by respirometry(8 weeks)
研究者
Flemming Dela
Professor
University of Copenhagen