Plant Sterols Effect on Previous Statin Therapy

Jose Rocha Faria Neto

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: Plant sterols; Drug: Ezetimibe; Other: Ezetimibe + plant sterols

Study type: Interventional

Funder types: Other

Identifiers

NCT02089867

CEP 632

Details and patient eligibility

About

The purpose of this study is to determine the effect of plant sterols associated with ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy

Full description

Background: Consumption of food products enriched with plant sterols and treatment with ezetimibe both reduce cholesterol absorption in the intestine by different mechanisms and effectively reduce LDL cholesterol (LDL-c) plasma levels. Although, the associated usage of ezetimibe to plants sterols in coronary patients not reaching recommended lipid levels despite the use of statins has not yet been demonstrated. Objectives: Evaluate if ezetimibe 10mg associated to plant sterols spread enriched with 2g of plant sterols in coronary patients not reaching recommended lipid levels despite the use of statins is able to reduce cholesterol levels after 6 week treatment. Methods: Prospective, open-label study with both male and female patients with stable coronary disease and LDL > 70mg/dL. Patients will be randomized for the following 6 week treatment: control group (CT) no additional statin therapy, ezetimibe group (EZ) 10 mg/day ezetimibe, plant sterol group (PS) spread enriched with 2g of plant sterols or ezetimibe+plant sterols group (EZ+PS) 10mg/day EZ + 2g PS. Anthropometric evaluations and laboratory exams (blood glucose test, total cholesterol, LDL-c, HDL-c, triglycerides, and C-Reactive Protein) will be performed in all groups at baseline and after the sixth week intervention.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with previous myocardial infarction, stroke or coronary angiography demonstrating significant coronary disease.
• Subjects under statin treatment with a fixed dosage for the previous three months before randomization, and did not reached LDL less than 70mg/dl.

Exclusion criteria

• Subjects already taking ezetimibe and/or plant sterols
• Younger than 18 years
• Presence of any contraindication to statin
• Pregnant women or breast-feeding women or
• Patients with previous history of statin hypersensibility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 4 patient groups

Ezetimibe

Experimental group

Description:

The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.

Treatment:

Drug: Ezetimibe

Plant sterols

Experimental group

Description:

The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks

Treatment:

Dietary Supplement: Plant sterols

Control group

No Intervention group

Description:

No additional therapy, statin maintenance

Ezetimibe + plant sterols

Experimental group

Description:

The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks

Treatment:

Other: Ezetimibe + plant sterols