CoEnzyme Q10 in Statin Myopathy

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.