Red Yeast Rice and Phytosterols In Statin Intolerance

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins.

The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid lowering benefits when compared to red yeast rice alone.

These supplements will be given to all participants. Up to one-half will enroll in a lifestyle intervention program called Change of Heart and will be compared to patients who do not participate in the program. The study will last one year.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chestnut Hill Health System
• Treatments: Red yeast rice

Criteria

Inclusion Criteria:

• Men and women age > 21

• LDL > 100 and physician suggestion to take statin

• Subject complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy

• Having stopped a statin drug for personal reasons and not willing to restart this medication

• Refusal to take a statin as prescribed by personal physician

• CPK < 400

• Not taking any cholesterol lowering medication, red yeast rice extract or a phytosterol product for at least 1 month prior to initiation of trial

• Ability to exercise without physical restrictions

• Ability to attend 12 week consecutive Change of Heart lifestyle education sessions

• Liver function studies normal at baseline

• Subject willing to remain off the dietary supplement CoQ10 for duration of trial

• TSH must be normal

Exclusion Criteria:

• A history of muscle damage (CPK > 400 IU) on statin therapy

• Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year

• Known intolerance to one of the study drugs

• Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease

• Uncontrolled hypertension (defined as SBP > 180 mmHg or DBP > 100 mmHg

• Heart attack, bypass surgery, or angioplasty/stent within 1 year of study

• Triglyceride level more than 400 mg/dl

• Underlying musculoskeletal disorder preventing muscle testing

• Taking other medicines including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily