Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance - Full Text View

Sponsors and Collaborators:	University of Pennsylvania Chestnut Hill Health System
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00639223

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia Statin-Associated Myopathy	Dietary Supplement: Red Yeast Rice Drug: Pravastatin Behavioral: Lifestyle modification program	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Red Yeast Rice vs. Pravastatin: A Double-Blind Randomized Comparative Study of Myopathic Symptoms

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Metabolic Disorders Muscle Disorders Statins

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in LDL-Cholesterol measured at the beginning and end of the study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	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
1: Experimental	Dietary Supplement: Red Yeast Rice Four 600mg capsules twice daily for 12 weeks Behavioral: Lifestyle modification program Weekly sessions each lasting 3 1/2 hours for 12 weeks

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:

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

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639223

Locations

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

Sponsors and Collaborators

University of Pennsylvania

Chestnut Hill Health System

Investigators

Study Director:

Steven C Halbert, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Chestnut Hill Health System ( David Becker MD Principal Investigator )
Study ID Numbers:	806827
Study First Received:	March 14, 2008
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00639223 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:

Statin related myalgia
Hyperlipidemia
Red yeast rice
Cardiovascular Diseases
Nutritional and Metabolic Diseases

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Red Yeast
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pravastatin

Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Hypercholesterolemia
Metabolic Disorder
Red yeast rice
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

Pravastatin
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Hypercholesterolemia
Red yeast rice
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009