Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia

Study Overview
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Brief Summary
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Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.

Conditions
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Statin-associated Myalgia

Intervention / Treatment
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* Dietary Supplement: coenzyme Q10
* Dietary Supplement: matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level Exclusion Criteria: Women of childbearing potential Patients currently taking coenzyme Q10 (or have taken in the previous 30 days) Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins Patients with a history of alcoholism or malnutrition Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Dietary Supplement: coenzyme Q10<br>* 60mg capsule twice daily for 12 weeks<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: matching placebo<br>* matching placebo capsule twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy |  | every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy |  | every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statin, coenzyme Q10, myalgia