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
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
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
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
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
- 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.
- 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,
- Taking pain medication or systemic steroids on a chronic basis.