Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial.
BACKGROUND
Red yeast rice is an herbal supplement that decreases low-density lipoprotein (LDL) cholesterol level.


OBJECTIVE
To evaluate the effectiveness and tolerability of red yeast rice and therapeutic lifestyle change to treat dyslipidemia in patients who cannot tolerate statin therapy.


METHODS
Randomized, controlled trial.


METHODS
Community-based cardiology practice.


METHODS
62 patients with dyslipidemia and history of discontinuation of statin therapy due to myalgias.


METHODS
Patients were assigned by random allocation software to receive red yeast rice, 1800 mg (31 patients), or placebo (31 patients) twice daily for 24 weeks. All patients were concomitantly enrolled in a 12-week therapeutic lifestyle change program.


METHODS
Primary outcome was LDL cholesterol level, measured at baseline, week 12, and week 24. Secondary outcomes included total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride, liver enzyme, and creatinine phosphokinase (CPK) levels; weight; and Brief Pain Inventory score.


RESULTS
In the red yeast rice group, LDL cholesterol decreased by 1.11 mmol/L (43 mg/dL) from baseline at week 12 and by 0.90 mmol/L (35 mg/dL) at week 24. In the placebo group, LDL cholesterol decreased by 0.28 mmol/L (11 mg/dL) at week 12 and by 0.39 mmol/L (15 mg/dL) at week 24. Low-density lipoprotein cholesterol level was significantly lower in the red yeast rice group than in the placebo group at both weeks 12 (P < 0.001) and 24 (P = 0.011). Significant treatment effects were also observed for total cholesterol level at weeks 12 (P < 0.001) and 24 (P = 0.016). Levels of HDL cholesterol, triglyceride, liver enzyme, or CPK; weight loss; and pain severity scores did not significantly differ between groups at either week 12 or week 24.


CONCLUSIONS
The study was small, was single-site, was of short duration, and focused on laboratory measures.


CONCLUSIONS
Red yeast rice and therapeutic lifestyle change decrease LDL cholesterol level without increasing CPK or pain levels and may be a treatment option for dyslipidemic patients who cannot tolerate statin therapy.
Becker
David J
DJ
Chestnut Hill Hospital, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. dbeckerchcardiology@hotmail.com
Gordon
Ram Y
RY
Halbert
Steven C
SC
French
Benjamin
B
Morris
Patti B
PB
Rader
Daniel J
DJ
D000368:Aged; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D002784:Cholesterol / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003402:Creatine Kinase / Q000097:blood; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy* / Q000188:drug therapy*; D008019:Life Style; D008099:Liver / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000139:chemically induced; D010146:Pain / Q000139:chemically induced; D028761:Withholding Treatment
D001688:Biological Products; D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C117343:red yeast rice; D002784:Cholesterol; D003402:Creatine Kinase