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

NCT ID: NCT00639223

Last Updated: 2010-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-10-31

Brief 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.

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.

Conditions

Hypercholesterolemia; Statin-Associated Myopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pravastatin

Group Type: ACTIVE_COMPARATOR

Pravastatin

Intervention Type: DRUG

One 20mg capsule twice daily for 12 weeks

Lifestyle modification program

Intervention Type: BEHAVIORAL

Weekly sessions each lasting 3 1/2 hours for 12 weeks

Red yeast Rice

Group Type: EXPERIMENTAL

Red Yeast Rice

Intervention Type: DIETARY_SUPPLEMENT

Four 600mg capsules twice daily for 12 weeks

Lifestyle modification program

Intervention Type: BEHAVIORAL

Weekly sessions each lasting 3 1/2 hours for 12 weeks

Interventions

Red Yeast Rice

Four 600mg capsules twice daily for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Pravastatin

One 20mg capsule twice daily for 12 weeks

Intervention Type: DRUG

Lifestyle modification program

Weekly sessions each lasting 3 1/2 hours for 12 weeks

Intervention Type: BEHAVIORAL

Other Intervention Names

Pravachol

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chestnut Hill Health System

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Chestnut Hill Health System

Principal Investigators

Steven C Halbert, MD

Role: STUDY_DIRECTOR

University of Pennsylvania

Locations

Chestnut Hill Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

806827

Identifier Type: -

Identifier Source: org_study_id