Plant Sterols Effect on Previous Statin Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ezetimibe

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

Group Type EXPERIMENTAL

Ezetimibe

Intervention Type DRUG

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

Plant sterols

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

Group Type EXPERIMENTAL

Plant sterols

Intervention Type DIETARY_SUPPLEMENT

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

Control group

No additional therapy, statin maintenance

Group Type NO_INTERVENTION

No interventions assigned to this group

Ezetimibe + plant sterols

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

Group Type EXPERIMENTAL

Ezetimibe + plant sterols

Intervention Type OTHER

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

Interventions

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Ezetimibe + plant sterols

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

Intervention Type OTHER

Ezetimibe

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

Intervention Type DRUG

Plant sterols

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No