Title
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
Phase
Phase 2/Phase 3Lead Sponsor
Pontifícia Universidade Católica do ParanáStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Coronary Artery DiseaseIntervention/Treatment
ezetimibe phytosterol ...Study Participants
47The 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.
The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks
The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
No additional therapy, statin maintenance
The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks
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
