Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being (LIFESTAT)
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|ClinicalTrials.gov Identifier: NCT02255682|
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : January 4, 2017
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.
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?
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Diabetes Mellitus||Drug: Simvastatin Dietary Supplement: Q10||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Placebo Comparator: Simvastatin and Q10-placebo
Simvastatin 40 mg orally administered daily and Q10-placebo for 8 weeks
Active Comparator: Simvastatin and Q10
Simvastatin 40 mg orally administered daily for 8 weeks in combination with Q10 supplementation of 400 mg/daily
Dietary Supplement: Q10
Other Name: Bioquinon Q10
- Difference in myalgia [ Time Frame: 8 weeks ]Difference in myalgia, measured by visual analog scale (VAS) between Simvastatin treated patients receiving Q10 or Q10-placebo.
- Difference in VO2-max [ Time Frame: 8 weeks ]Difference in VO2-max in Simvastatin treated patients receiving Q10 or Q10-placebo.
- Difference in muscle strength [ Time Frame: 8 weeks ]Difference in muscle strength in Simvastatin treated patients receiving Q10 or Q10-placebo.
- Difference in glucose metabolism [ Time Frame: 8 weeks ]Difference in glucose metabolism in Simvastatin treated patients receiving Q10 or Q10-placebo.
- Difference in mitochondrial function [ Time Frame: 8 weeks ]Difference in mitochondrial function in Simvastatin treated patients receiving Q10 or Q10-placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255682
|University of Copenhagen|
|Copenhagen, Denmark, 2200|
|Principal Investigator:||Flemming Dela, MD, MDSci||University of Copenhagen|