Benefit of CoQ-10 in Patients on Statins

Specific Aim 1: to demonstrate that supplementation with coQ10 in patients treated with
statins ameliorates symptoms of muscle pain and fatigue and improves energy metabolism and
muscle function.

This objective will be achieved in a randomized, placebo-controlled double blind trial by
assessing the degree of muscle symptoms and interference of pain with daily activities,
aerobic capacity, and muscle function before and after supplementation with either coQ10 or
placebo in groups of statin-treated subjects.

Specific Aim 2: to examine changes at a molecular/cellular level that are associated with
improved pain and muscle function in statin-treated subjects supplemented with coQ10.

This aim will be addressed by analyzing muscle biopsies taken from statin-treated patients
before and after supplementation with coQ10 or placebo.

Inclusion Criteria:

1. Adult men and women 21 years and older taking statin medications for hyperlipidemia
under the current National Cholesterol Education Program guidelines (NCEP III) and
complaining of myopathic symptoms.

Exclusion Criteria:

1. diagnosis of cancer;

2. acute illness of any sort;

3. hemoglobin less than 12,

4. creatinine greater than 1.5 mg/dl;

5. liver dysfunction as evidenced by elevations in transaminases 3-fold higher than
upper limit of normal;

6. use of certain medications or nutritional supplements within the past month;

7. untreated hypertension (diastolic BP> 100 mm HG);

8. diagnosis of diabetes mellitus (fasting blood glucose > 126 mg/dl);

9. untreated hypothyroidism;

10. overt congestive heart failure (by physical exam);

11. active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,

12. bleeding disorders;

13. history of adverse reactions besides myopathy associated with the use of statins;

14. any previous adverse reaction to coQ10 or to multivitamin supplements containing
coQ10;

15. plasma CPK levels > 3 times the upper normal limit; OR

16. congenital myopathies and/or neuromuscular degenerative diseases.