Official Title: “Red Yeast Rice vs. Pravastatin: A Double-Blind Randomized Comparative Study of Myopathic Symptoms”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

20 million Americans are actively treated with statins at an annual cost of 16 billion dollars. Statins are effective therapeutic agents for reducing LDL cholesterol and have documented effectiveness. However, a significant subset of patients (5-18%), cannot tolerate lipid lowering statin therapy due to intolerable muscle-related symptoms characterized by muscle pain and/or weakness. These symptoms affect quality of life and lead to poor adherence.

Patients may seek alternative therapies to manage hypercholesterolemia if they have been intolerant of statin therapy. One commonly used alternative treatment option is the Chinese herb red yeast rice extract. Several small studies performed in China, have suggested this treatment is efficacious and well tolerated. In the U.S. red yeast rice is sold over the counter a dietary supplement.

The objective of this study is to critically examine the safety and efficacy of the Chinese herb red yeast rice as an alternative lipid lowering therapy, in a statin intolerant population. This objective will be operationalized by a double-blind randomized trial, comparing the effect of red yeast rice extract, to that of pravastatin on the level of myalgia in subjects with a prior history of statin-induced myalgias.

The specific aims include:

1. Determine the relative rates of withdrawal from treatment in subjects receiving red yeast rice compared to pravastatin.

2. Determine if red yeast rice is associated with a lower level of muscle pain (myalgia) symptoms compared to pravastatin as measured by the Brief Pain Inventory, a validated pain questionnaire.

3. Determine if red yeast rice is associated with a lower level of muscle weakness compared to pravastatin as measured by a dynamometry, a validated muscle strength testing method.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Red Yeast Rice
  • Four 600mg capsules twice daily for 12 weeks
• Drug: Pravastatin
  • One 20mg capsule twice daily for 12 weeks
• Behavioral: Lifestyle modification program
  • Weekly sessions each lasting 3 1/2 hours for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
• Experimental: 1

Primary Measures

• Withdrawal of therapy due to muscle symptoms that are either intolerable and/or associated with a creatine kinase(CK) >500
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Change in LDL-Cholesterol measured at the beginning and end of the study
  • Time Frame: 12 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pennsylvania

Overall Clinical Trial Officials and Contacts

Steven C Halbert, MD Study Director University of Pennsylvania  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00639223

Study ID Number: 806827

ClinicalTrials.gov Identifier: NCT00639223

Health Authority: United States: Food and Drug Administration