Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Chestnut Hill Health System80 enrolled

Overview

Randomized trial in a primary prevention population * all participants have high LDL cholesterol Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statins(simvastatin) This alternative regimen is over the counter and available at health food stores. The alternative regimen consists of lifestyle changes including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hyperlipidemia

Interventions

simvastatinDRUG

red yeast riceDRUG

pharmaceutical grade fish oilDRUG

therapeutic lifestyle changesBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study Exclusion Criteria: * No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP\>190 or DBP\>100), cannot have known intolerance to one of the study drug

Outcomes

Primary Outcomes

LDL-c cholesterol

Secondary Outcomes

total cholesterol

HDL

Triglycerides

cardiac CRP

Data from ClinicalTrials.gov

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