CoEnzyme Q10 in Statin Myopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hartford Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01140308
First received: June 8, 2010
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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 Intervention
Statin Myopathy
Drug: CoEnzyme Q10
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: CoEnzyme Q10 in Statin Myopathy

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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 . ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 135
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Placebo
  • 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:
  • CoEnzyme Q10
  • CoQ10
  • Ubiquinone
  • Q10
  • CoQ
  • Q
  • Ubidecarenone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140308

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Paul D Thompson, MD Hartford Hospital
  More Information

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01140308     History of Changes
Other Study ID Numbers: 1RC1AT005836-01
Study First Received: June 8, 2010
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Hartford Hospital:
Statin Myopathy
CoEnzyme Q10
CoQ10
Statin Myalgia

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Coenzyme Q10
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Simvastatin
Ubiquinone
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014