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

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 Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Statin-Associated Myopathy
• Intervention / Treatment: Drug: Pravastatin; Behavioral: Lifestyle modification program; Dietary supplement: Red Yeast Rice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19118
      • Chestnut Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pravastatin	Drug: Pravastatin; One 20mg capsule twice daily for 12 weeks; Other Names: Pravachol; Behavioral: Lifestyle modification program; Weekly sessions each lasting 3 1/2 hours for 12 weeks
Experimental: Red yeast Rice	Behavioral: Lifestyle modification program; Weekly sessions each lasting 3 1/2 hours for 12 weeks; Dietary supplement: Red Yeast Rice; Four 600mg capsules twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in LDL-Cholesterol Measured at the Beginning and End of the Study	12 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Chestnut Hill Health System
• Investigators: Study Director: Steven C Halbert, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 14, 2008
• First Submitted That Met QC Criteria: March 19, 2008
• First Posted (Estimate): March 20, 2008

Study Record Updates

• Last Update Posted (Estimate): January 18, 2010
• Last Update Submitted That Met QC Criteria: December 9, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Hyperlipidemia; Red yeast rice; Statin related myalgia; Nutritional and Metabolic Diseases
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin; Red yeast rice
• Other Study ID Numbers: 806827