A Study Comparing CoQ10 Levels While Taking 3 Different Statins

University of Kansas Medical Center134 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

Hypercholesterolemia

Interventions

Pitavastin 4mgDRUG

Atorvastatin 20mgDRUG

Rosuvastatin 5mgDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Changes in Plasma CoQ10 Levels

Change in levels will be measured by taking difference between Baseline and Week 12 measures.

Time frame: Change from Baseline to 12 Weeks

Secondary Outcomes

Changes in Major Lipid Parameters - VLDL Size

Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.

Time frame: Change from Baseline to 12 Weeks

Changes to Glucose Metabolism - HbA1c and Insulin

Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.

Time frame: Change from Baseline to 12 weeks

Changes in HDL and LDL Size

Change in levels will be measured by difference in levels at 12 weeks

Time frame: Change from Baseline to 12 Weeks

Changes to Glucose Metabolism - Fructosamine

Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.

Time frame: Change from Baseline to 12 weeks

Changes HDL Particle Number and LDL Particle Number

Change in levels will be measured by difference in levels at 12 weeks.

Time frame: Change from Baseline to 12 Weeks

Data from ClinicalTrials.gov

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