Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Aichi Gakuin University

Status and phase: Completed; Phase 4

Conditions: Inflammation; Oxidative Stress; Metabolic Syndrome

Treatments: Drug: pitavastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00444717

AGU-64

Details and patient eligibility

About

The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

Full description

The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypercholesterolemic patients

Exclusion criteria

• Patients receiving lipid-lowering agents
• Familial hypercholesterolemia
• Renal disease
• Diseases of liver, gallbladder and bile ducts
• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)