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

This study has been terminated.
(Lack of recruitment)
Sponsor:
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00590408
First received: December 28, 2007
Last updated: November 27, 2009
Last verified: November 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Statins
U.S. FDA Resources

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 ]

Enrollment: 10
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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: Robyn Kondrack, PharmD, Creighton University
ClinicalTrials.gov Identifier: NCT00590408     History of Changes
Other Study ID Numbers: 05-13642, 05-13642
Study First Received: December 28, 2007
Last Updated: November 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
coenzyme Q10
statin
myalgia

Additional relevant MeSH terms:
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on May 16, 2013