A Study Comparing CoQ10 Levels While Taking 3 Different Statins

Phase 4

Completed

Interventions: Drug: Atorvastatin 20mg
Drug: Pitavastin 4mg
Drug: Rosuvastatin 5mg

Brief Summary: The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.

Detailed Description: Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.

Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.

In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.

Recruitment & Eligibility

Inclusion Criteria

LDL-C levels of 100-200mg/dl; triglycerides </=200mg/dl at screening visit
Willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study

Exclusion Criteria

LDL-C <100mg/dl or >200mg/dl, Triglycerides >200mg/dl
History of diabetes mellitus or documented fasting blood glucose >125mg/dl or HbA1c >6.4%
History of coronary artery disease
history of chronic renal or hepatic disease
known sensitivity of intolerance to a statin
persistent elevated liver enzymes or CPK (>3 x upper normal limit)
currently taking CoQ10 supplements and unable discontinue for duration of study

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4mg	Atorvastatin 20mg	Pitavastatin 4mg tablet by mouth once daily for 12 weeks
Pitavastatin 4mg	Rosuvastatin 5mg	Pitavastatin 4mg tablet by mouth once daily for 12 weeks
Atorvastatin 20mg	Rosuvastatin 5mg	Atorvastatin 20mg tablet by mouth once daily for 12 weeks
Atorvastatin 20mg	Pitavastin 4mg	Atorvastatin 20mg tablet by mouth once daily for 12 weeks
rosuvastatin 5 mg	Pitavastin 4mg	rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
rosuvastatin 5 mg	Atorvastatin 20mg	rosuvastatin 5 mg tablet by mouth once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in Plasma CoQ10 Levels	Change from Baseline to 12 Weeks	Change in levels will be measured by taking difference between Baseline and Week 12 measures.

Secondary Outcome Measures

Name	Time	Method
Changes in Major Lipid Parameters - VLDL Size	Change from Baseline to 12 Weeks	Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.
Changes to Glucose Metabolism - HbA1c and Insulin	Change from Baseline to 12 weeks	Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
Changes in HDL and LDL Size	Change from Baseline to 12 Weeks	Change in levels will be measured by difference in levels at 12 weeks
Changes to Glucose Metabolism - Fructosamine	Change from Baseline to 12 weeks	Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.
Changes HDL Particle Number and LDL Particle Number	Change from Baseline to 12 Weeks	Change in levels will be measured by difference in levels at 12 weeks.