Living With Statins - Interventional Exercise Study

Summary

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:

1. Decreased muscle strength?
2. Skeletal muscle inflammation?
3. Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis?

Re question A \& B: If so, can physical training counteract this effect of statin treatment?

Conditions

• Cardiovascular Disease
• Diabetes Mellitus

Interventions

DRUG

Training+Simvastatin+Q10-placebo

8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin 40 mg/day and Q10-placebo.

DRUG

Training+Simvastatin-placebo+Q10-placebo

8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin-placebo and Q10-placebo.

DRUG

Training+Simvastatin+Q10

8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin 40 mg/day and Q10 400 mg/day.

Sponsors & Collaborators

• University of Copenhagen

  lead OTHER

Principal Investigators

• Flemming Dela, MD, MDSci · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2021-07-31

Completion

2021-12-31

Countries

• Denmark

Study Locations