Phase 2
N=43
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Hypercholesterolemia · Statin-Associated Myopathy
Bottom Line
View on ClinicalTrials.gov: NCT00639223 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500 — 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Red Yeast Rice (Dietary_supplement); Pravastatin (Drug); Lifestyle modification program (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Withdrawal of Therapy Due to Muscle Symptoms That Are Either Intolerable and/or Associated With a Creatine Kinase(CK) >500 |
2; 1 | — |
| SECONDARY Change in LDL-Cholesterol Measured at the Beginning and End of the Study |
-27.0; -30.2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00639223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.