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

Sponsored by:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00590408

Purpose

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	Intervention	Phase
Statin-Associated Myalgia	Dietary Supplement: coenzyme Q10 Dietary Supplement: matching placebo	Phase IV

MedlinePlus related topics: Dietary Supplements Diets Statins

Drug Information available for: Coenzyme Q10

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Further study details as provided by Creighton University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2006
Study Completion Date:	July 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Dietary Supplement: coenzyme Q10 60mg capsule twice daily for 12 weeks
2: Placebo Comparator	Dietary Supplement: matching placebo matching placebo capsule twice daily for 12 weeks

Eligibility

Ages Eligible for Study:	19 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590408

Locations

United States, Nebraska
The Cardiac Center of Creighton University Medical Center
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Investigators

Principal Investigator:

Robyn Kondrack, PharmD

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University ( Robyn Kondrack, PharmD )
Study ID Numbers:	05-13642, 05-13642
Study First Received:	December 28, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00590408 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

coenzyme Q10
statin
myalgia

Study placed in the following topic categories:

Vitamins
Ubiquinone
Trace Elements

Micronutrients
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coenzyme Q10

Additional relevant MeSH terms:

Vitamins
Growth Substances
Physiological Effects of Drugs
Ubiquinone

Micronutrients
Pharmacologic Actions
Coenzyme Q10

ClinicalTrials.gov processed this record on May 07, 2009