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

Completed · Phase 2

Conditions studied: Hypercholesterolemia, Statin-Associated Myopathy

In brief

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.

Key facts

Study ID

NCT00639223

Run by

University of Pennsylvania

People needed

43

Starts

2008-01-01

Expected to finish

2008-10-01

Last updated by the study team

2010-01-18

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chestnut Hill Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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