Clinical trial NCT00639223: Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Official title: Red Yeast Rice vs. Pravastatin: A Double-Blind Randomized Comparative Study of Myopathic Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Statin-Associated Myopathy
Keywords: Statin related myalgia
Hyperlipidemia
Red yeast rice
Cardiovascular Diseases
Nutritional and Metabolic Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Chestnut Hill Health System
First posted: 2008-03-20
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in LDL-Cholesterol Measured at the Beginning and End of the Study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Chestnut Hill Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Steven C Halbert, MD
role: STUDY_DIRECTOR
References: