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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2008

Interventions

  • Dietary Supplement: coenzyme Q10
    • 60mg capsule twice daily for 12 weeks
  • Dietary Supplement: matching placebo
    • matching placebo capsule twice daily for 12 weeks

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Creighton University
  • Provider of Information About this Clinical Study
    • Robyn Kondrack, PharmD, Creighton University
  • Overall Official(s)
    • Robyn Kondrack, PharmD, Principal Investigator, Creighton University

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