Plant Sterols Effect on Previous Statin Therapy
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT02089867
- Lead Sponsor
- Jose Rocha Faria Neto
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ezetimibe + plant sterols 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 Plant sterols Plant sterols The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks Ezetimibe Ezetimibe The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
- Primary Outcome Measures
Name Time Method Decrease of LDL cholesterol levels due to plant sterols associated with ezetimibe. 6 weeks The primary end-point was the LDL cholesterol levels change after the plant sterols associated with ezetimibe from baseline up to 6 week treatment.
- Secondary Outcome Measures
Name Time Method 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. 6 weeks 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.
Trial Locations
- Locations (1)
Jose Rocha Faria Neto
🇧🇷Curitiba, Paraná, Brazil