Plant Sterols Effect on Previous Statin Therapy

A Randomized Open Label Trial to Assess the Effect of Plant Sterols Associated With Ezetimibe in LDL-cholesterol Levels in Coronary Patients Previously on Statin Therapy

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Ezetimibe; Dietary supplement: Plant sterols; Other: Ezetimibe + plant sterols

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 80215-901
      • Jose Rocha Faria Neto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ezetimibe; The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.	Drug: Ezetimibe; The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
Experimental: Plant sterols; The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks	Dietary supplement: Plant sterols; The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
No Intervention: Control group; No additional therapy, statin maintenance
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: Jose Rocha Faria Neto
• Investigators: Study Chair: Jose R Faria Neto, PhD, Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: March 15, 2014
• First Submitted That Met QC Criteria: March 15, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 17, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Coronary artery disease; Ezetimibe; LDL-cholesterol; Plant sterol; Hydroxymethylglutaryl coenzyme A Reductase Inhibitors
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Ezetimibe
• Other Study ID Numbers: CEP 632