Exercise for Statin Toxicity

Overseen By Daniel J Parente, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must be taking: Statins

Must not be taking: Fibric acid, Fish oil

Disqualifiers: Smoking, Cancer, HIV/AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) have beneficial effects (prevent stroke, heart attack) but also some bad ones (block some good effects of exercise). Individuals have genetic variations in proteins that metabolize/transport statins. The investigators hypothesize that these variations modulate the relationship between statin use and lack of benefit from exercise. The investigators will test this by having statin-users do supervised exercise for 6 weeks, measuring the cardiorespiratory fitness before/after and correlating this to genetic variations present in the participant.

Will I have to stop taking my current medications?

The trial requires participants to continue taking high-dose atorvastatin (a type of statin) as part of the study. However, you cannot use other medications that affect lipid metabolism, like fibric acid or fish oil.

What data supports the effectiveness of exercise as a treatment for statin toxicity?

Moderate intensity exercise training can improve muscle performance in people taking statins, which may help reduce some of the negative effects of these drugs. Additionally, combining exercise with statin therapy can lower heart disease risk more effectively than either approach alone. ^{1 2 3 4 5}

Is exercise safe for people taking statins?

Exercise is generally safe for most people, but when combined with statins, it can increase the risk of muscle problems like myopathy (muscle weakness) and rhabdomyolysis (a serious condition where muscle tissue breaks down). It's important to talk to your doctor about any exercise plans if you're taking statins. ^{1 2 6 7 8}

How does exercise as a treatment for statin toxicity differ from other treatments?

Exercise as a treatment for statin toxicity is unique because it focuses on improving physical fitness and cardiovascular health through physical activity, rather than using medications. While statins can interfere with exercise benefits, combining exercise with statin use may enhance insulin sensitivity and improve glucose metabolism, offering a different approach to managing side effects compared to traditional drug treatments. ^{1 2 4 9 10}

Research Team

Daniel J Parente, MD PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for English-speaking adults aged 35-65 who are overweight or obese, currently taking high-dose atorvastatin for preventing heart disease/stroke, and do less than 30 minutes of exercise weekly. They must be willing to exercise three times a week without changing their diet during the study.

Inclusion Criteria

I am between 35 and 65 years old.

English-speaking

My BMI is between 25 and 43.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in supervised exercise for 6 weeks while using statins, with cardiorespiratory fitness measured before and after

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exercise

Trial Overview The study examines how genetic differences affect the way statin users respond to exercise. Participants will undergo supervised exercise for six weeks, with fitness levels measured before and after to see how it correlates with their genetic makeup.

Participant Groups

Group I: Single arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

The effects of statin medications on aerobic exercise capacity and training adaptations. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Moderate Intensity Exercise Training Improves Skeletal Muscle Performance in Symptomatic and Asymptomatic Statin Users. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Short-term cessation of statin therapy does not alter aerobic exercise performance in physically active middle-aged adults. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Statins on Fat Oxidation Improvements After Aerobic Exercise Training. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of fluvastatin in combination with moderate endurance training on parameters of lipid metabolism. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Statin-induced myopathy: the two faces of Janus. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Changes in ubiquitin proteasome pathway gene expression in skeletal muscle with exercise and statins. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Statins, cardiovascular disease, and drug safety. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise Training Adaptations in Metabolic Syndrome Individuals on Chronic Statin Treatment. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The use of statins potentiates the insulin-sensitizing effect of exercise training in obese males with and without Type 2 diabetes. [2022]