Exercise for Statin Toxicity

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Overseen ByDaniel J Parente, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
Must be taking: Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how genetic differences might affect the response of individuals taking statins (a medication for heart health) to exercise. Statins effectively prevent heart attacks and strokes, but they can sometimes interfere with exercise benefits. Participants will engage in supervised exercise for six weeks to observe changes in fitness. The trial seeks English-speaking adults who are overweight, currently taking high-dose atorvastatin, and exercise less than 30 minutes weekly. As an unphased trial, this study offers a unique opportunity to contribute to understanding the interaction between genetics, medication, and exercise.

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 prior data suggests that exercise is safe for statin users?

Research has shown that moderate exercise is usually safe for people, regardless of statin use. Exercise can enhance muscle performance for those on statins, even without symptoms. However, some studies found a slight increase in muscle-related side effects when people on statins exercise. These side effects can occur in various parts of the body but are uncommon. Overall, exercise is generally well-tolerated and can even strengthen muscles in people taking statins.12345

Why are researchers excited about this trial?

Most treatments for statin toxicity focus on adjusting the statin dosage or switching to a different statin. However, this approach doesn't address the root of the issue for everyone. Exercise is unique because it doesn't involve medication and may help improve muscle health and reduce pain associated with statin use. Researchers are excited about this trial because exercise could provide a non-pharmaceutical option to manage statin side effects, potentially enhancing patients' quality of life without altering their cholesterol-lowering regimen. This approach could empower patients to take a more active role in their own treatment journey.

What evidence suggests that exercise might be an effective treatment for statin toxicity?

Research has shown that while statins can lower heart risks, they might also reduce the benefits of exercise. Some studies have found that people taking statins may experience more muscle pain after exercising compared to those not taking them. However, walking long distances did not worsen muscle pain for those on statins. Statins might also increase the risk of muscle problems during exercise. This trial investigates whether genetic differences affect the interaction between statins and exercise. Participants will engage in exercise within a single-arm study to examine these effects.15678

Who Is on the Research Team?

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Daniel J Parente, MD PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

Citations

The Role of Exercise in Statin-Associated Muscle ...Self-reported SAMs tended to be 5% greater after short-term exercise in statin users compared with placebo, although this difference did not achieve ...
The Interaction Between Statins and Exercise: Mechanisms ...Statin-associated musculoskeletal side effects, exacerbated by recommended physical activity, could lead to reduced statin use in individuals who would benefit ...
I Am an Athlete: Will This Statin Affect My Performance?After walking 30-50 km per day for 4 days, statin therapy did not worsen exercise-induced muscle symptoms, CK levels increased in all groups, ...
Combined Effects of Statins and Exercise on Training ...In summary, although statins effectively diminish ASCVD risk by lowering LDL-C, emerging data suggest statins can reduce the beneficial effects of exercise ...
The effects of statins on exercise and physical activityStatins may increase the incidence of exercise-related muscle complaints and in some studies augment the exercise-induced rise in muscle enzymes.
Statin Toxicity | Circulation ResearchIn this article, we review the mechanisms and clinical importance of statin toxicity and focus on the evaluation and management of statin-associated muscle ...
Statin-induced muscular side effects at rest and exercisePhysical activity seems to be a key trigger for onset of statin-induced muscular side effects. The appearance of symptoms can be symmetrical, asymmetrical, ...
Exercise Training Improves Muscle Performance and ...Moderate intensity exercise training improves skeletal muscle performance in symptomatic and asymptomatic statin users.
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