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CoEnzyme Q10 in Statin Myopathy

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: NCT01140308
Recruitment Status : Unknown
Verified September 2012 by Hartford Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 9, 2010
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Hartford Hospital

Brief Summary:

Statins (such as simvastatin or Zocor) are the most effective and widely prescribed medications to lower cholesterol levels and reduce the frequency of heart attacks, cardiac deaths and strokes. Unfortunately, statins can cause muscle discomfort or pain called "myalgia" in patients treated with these drugs. These symptoms often cause patients who need these medications to stop taking the drug. The cause of statin muscle pain is not known, but it is thought that a reduction of a vitamin-like substance called Coenzyme Q10 (CoQ10) during statin treatment may play a role. CoQ10 is a vitamin like substance and is not a drug approved and regulated by the Food and Drug Administration (FDA). This study will look at the effects of CoQ10 supplements on individuals who develop muscle symptoms while on simvastatin.

The investigators hope to test the hypothesis that CoQ10 supplementation compared to placebo in patients with documented statin myalgia reduces the intensity of pain during statin treatment.

Condition or disease Intervention/treatment Phase
Statin Myopathy Drug: CoEnzyme Q10 Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: CoEnzyme Q10 in Statin Myopathy
Study Start Date : September 2009
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Sugar Pill
Simvastatin 20mg + Placebo
Drug: Placebo
Randomization to Treatment: Simvastatin 20mg + Placebo 600mg Load Subjects for 2 weeks on Treatment Eight weeks of treatment
Other Name: Sugar pill

Active Comparator: Co Q10
Simvastatin 20mg + CoQ10
Drug: CoEnzyme Q10
Randomization to Treatment: Simvastatin 20mg + 600 mg CoQ10 (pill) Load Subjects for 2 weeks on Treatment (CoQ10) Eight weeks of Treatment
Other Names:
  • CoQ10
  • Ubiquinone
  • Q10
  • CoQ
  • Q
  • Ubidecarenone

Primary Outcome Measures :
  1. To test the hypothesis that CoQ10 supplementation compared to placebo in patients with documented statin myalgia reduces the intensity of pain during statin treatment. [ Time Frame: We selected 8 weeks of therapy . ]
    Increasing pain tolerability is a key clinical measure. We selected 8 weeks of therapy for the simvastatin vs placebo and CoQ10 vs placebo sections of the study because in the largest clinical study, the median time toonset of mylagia in statin naïve subjects was 1 month (4) and statin rechallenge typically reproduces symptoms more rapidly(3). Consequently, most subjects with true statin myalgia will have clearly developed symptoms at or before 8 weeks, the point at which study procedures are completed, allowing us to accurately assess the impact of CoQ10 on muscle pain intensity.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • We will not exclude patients with diagnosed CAD, peripheral vascular disease or diabetes since these patients warrant aggressive lipid treatment, and would benefit from any intervention that increases their tolerance of statins. We do not consider it inappropriate or unethical to place such patients on placebo during the simvastatin vs placebo phase because these patients will have previously been documented to be intolerant of statins. All patients will be maintained on lipid lowering diets during the study.
  • LDL Cholesterol Levels - LDL levels will not be a criterion for inclusion or exclusion from this study since all patients will have previously been deemed appropriate candidates for statin therapy by their physicians and because recent clinical trial results suggest that statins will be used in high risk individuals regardless of their pretreatment LDL-C values.
  • Race - We will seek to recruit Caucasians, Hispanics and African American in accordance with their distributions in the study communities.
  • CoQ10 Use - Subjects previously using supplemental CoQ10 must discontinue this supplementation for two months prior to entering the study.
  • Diet - All subjects will be instructed in a standard lipid lowering diet and asked to maintain this throughout the 6 months of the study.

Exclusion Criteria:

  • Subjects will be excluded if they have had cancer within 5 years of entry, have hepatic disease (ALT > 2 times normal) or renal disease (creatinine > 2 mg/L) since these patients may require more careful monitoring during the study and would be best managed in a totally clinical setting.
  • Subjects presently treated with other medications known to alter statin metabolism (3)
  • Subjects who cannot discontinue other lipid-lowering medications
  • Subjects with hypo or hyper thyroidism defined as a TSH > 5 or <0.01 IU/L since these conditions are known to be associated with statin intolerance and muscle weakness, respectively
  • Subjects with hepatic dysfunction evidenced by a baseline alanine aminotransferase (ALT) level > 2 UNL
  • Subjects with renal dysfunction defined as a baseline creatinine > 2mg/dl;
  • Subjects with physical disabilities prohibiting the strength and exercise performance measurements
  • Subjects who regularly use corticosteroids or other drugs known to affects skeletal muscle metabolism or regularly have intramuscular injections that will affect CK levels.
  • Women of child-bearing potential who do not use an effective birth-control technique.

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): NCT01140308

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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
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Principal Investigator: Paul D Thompson, MD Hartford Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hartford Hospital Identifier: NCT01140308    
Other Study ID Numbers: 1RC1AT005836-01 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012
Keywords provided by Hartford Hospital:
Statin Myopathy
CoEnzyme Q10
Statin Myalgia
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Coenzyme Q10
Physiological Effects of Drugs