Plant Sterols Effect on Previous Statin Therapy

Phase 3CompletedNCT02089867

Jose Rocha Faria Neto47 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Ezetimibe + plant sterolsOTHER

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

EzetimibeDRUG

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

Plant sterolsDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Jose Rocha Faria Neto

Curitiba, Paraná, Brazil

Outcomes

Primary Outcomes

Decrease of LDL cholesterol levels due to plant sterols associated with ezetimibe.

The primary end-point was the LDL cholesterol levels change after the plant sterols associated with ezetimibe from baseline up to 6 week treatment.

Time frame: 6 weeks

Secondary Outcomes

Any change of non-LDL-cholesterol, total cholesterol, high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), triglycerides levels, and changes in high sensitive C reactive protein (CRP) levels.

Secondary end points included any change of non-LDL-cholesterol, total cholesterol, high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), triglycerides levels, and changes in high sensitive C reactive protein (CRP) levels from baseline up to 6 week treatment.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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