Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle pain. The study will determine whether red yeast is associated with a lower level of muscle related complaints compared to pravastatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Chestnut Hill Health System
• Treatments: Pravastatin; Red yeast rice

Criteria

Inclusion Criteria:

• Subject reports stopping at least one statin drug due to complaints of muscle pain or weakness which his/her physician thinks was attributable to the drug.

• Subject has never taken pravastatin.

• Subject willing to remain off the dietary supplements CoQ10, L-carnitine, fish oil, policosanol, and guggulipid, garlic, and phytosterols in margarines (e.g. Benecol, Promise activ), milk or cereal products, for one month prior to the trial and for the duration of the trial.

Exclusion Criteria:

• A history of muscle damage (CK>1000 IU) on statin therapy.

• A history of generalized chronic pain such as fibromyalgia, or generalized arthritis.

• Any active cardiac problem including chest pain, angina, heart attack, bypass surgery, angioplasty/stent or unstable angina/acute coronary syndrome within the past 6 months.

• Taking other lipid lowering drugs including: ezetimibe, gemfibrozil, niacin, fibrates or bile acid sequestrants.

• Triglyceride level more than 400 mg/dl.

• Taking weight loss medication including orlistat, sibutramine, diethylpropion, phendimetrazine, phentermine.

• Taking pain medication or systemic steroids on a chronic basis.