CoEnzyme Q10 in Statin Myopathy

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hartford Hospital
• Treatments: Coenzyme Q10; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Ubiquinone

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.