Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Condition: Hypercholesterolemia; Statin-Associated Myopathy
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Red Yeast Rice; Pravastatin; Lifestyle modification program
Intervention type(s): Dietary Supplement; Drug; Behavioral
Intervention description(s): Four 600mg capsules twice daily for 12 weeks; One 20mg capsule twice daily for 12 weeks; Weekly sessions each lasting 3 1/2 hours for 12 weeks
Other intervention name(s): Pravachol
Intervention MeSH terms: Pravastatin; Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Statin related myalgia; Hyperlipidemia; Red yeast rice; Cardiovascular Diseases; Nutritional and Metabolic Diseases