A Study Comparing CoQ10 Levels While Taking 3 Different Statins (SPARQ)

University of Kansas

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin 20mg; Drug: Pitavastin 4mg; Drug: Rosuvastatin 5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01660191

12943

Details and patient eligibility

About

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

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 3 patient groups

Pitavastatin 4mg

Active Comparator group

Description:

Pitavastatin 4mg tablet by mouth once daily for 12 weeks

Treatment:

Drug: Rosuvastatin 5mg

Drug: Atorvastatin 20mg

Atorvastatin 20mg

Active Comparator group

Description:

Atorvastatin 20mg tablet by mouth once daily for 12 weeks

Treatment:

Drug: Rosuvastatin 5mg

Drug: Pitavastin 4mg

rosuvastatin 5 mg

Active Comparator group

Description:

rosuvastatin 5 mg tablet by mouth once daily for 12 weeks

Treatment:

Drug: Pitavastin 4mg

Drug: Atorvastatin 20mg