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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590408
Recruitment Status : Terminated (Lack of recruitment)
First Posted : January 10, 2008
Last Update Posted : December 1, 2009
Information provided by:
Creighton University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Statin-associated Myalgia Dietary Supplement: coenzyme Q10 Dietary Supplement: matching placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Dietary Supplement: coenzyme Q10
60mg capsule twice daily for 12 weeks

Placebo Comparator: 2 Dietary Supplement: matching placebo
matching placebo capsule twice daily for 12 weeks

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590408

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United States, Nebraska
The Cardiac Center of Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
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Principal Investigator: Robyn Kondrack, PharmD Creighton University

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Responsible Party: Robyn Kondrack, PharmD, Creighton University Identifier: NCT00590408     History of Changes
Other Study ID Numbers: 05-13642
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Keywords provided by Creighton University:
coenzyme Q10

Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Signs and Symptoms
Coenzyme Q10
Growth Substances
Physiological Effects of Drugs