An Update on Statin Alternatives and Adjuncts

Matthew J Sorrentino


Clin Lipidology. 2012;7(6):721-730. 

In This Article

Red Yeast Rice

Red yeast rice is a traditional Chinese medicinal agent prepared by culturing the yeast Monascus purpureus with rice. This process produces a group of compounds called monacolins. Monacolin K is lovastatin, the first commercially available statin on the market. Some of the other monacolins may have HMG-CoA reductase inhibitory effects also. In addition, some of the red yeast rice preparations contain phytosterols. The red yeast rice preparations that are available may contain different amounts of monacolin K ranging from nearly undetectable levels to the equivalent of approximately 10 mg of lovastatin. A recent survey of 12 commercially available products indicated that the mean dose of lovastatin was approximately 6 mg/day.[39] A randomized controlled trial using one particular formulation of red yeast rice for 12 weeks achieved a 22% reduction in LDL-C.[40]

Red yeast rice has been used as an alternative to statins in statin-intolerant patients. A small survey of 25 patients unable to tolerate statins due to myalgias, gastrointestinal symptoms and liver enzyme abnormalities showed that red yeast rice was well tolerated, and that 92% were able to remain on therapy.[41] The mean reduction in LDL-C in patients unable to tolerate statins was 19%. A randomized trial of 62 patients who discontinued statins due to myalgias compared red yeast rice with placebo over a 24-week period.[42] There was a 21% reduction in LDL-C at 24 weeks. There was no difference in pain severity scores between the placebo or red yeast rice groups. Red yeast rice was compared with pravastatin in 43 patients with a history of statin discontinuation because of myalgias.[43] LCL-C decreased by 30% in the red yeast rice group and 27% in the pravastatin group. Withdrawal from medication due to myalgias occurred in 5% (one patient) of the red yeast rice group and 9% (two patients) in the pravastatin group after 12 weeks. Although red yeast rice has a natural statin as its main lipid-lowering agent, it seems to be tolerated, probably because only low doses of the statin are present. The lipid-lowering effect may be enhanced by phytosterols that are present in many of the products. Because red yeast rice does contain a statin, however, there have been reports of myalgias and one case of rhabdomyolysis attributed to red yeast rice.[42]

There are major concerns about red yeast rice as a long-term medicinal agent. Red yeast rice is considered a food or dietary supplement, but because it contains lovastatin, the US FDA has taken action against several of the products. Some of these products have been reformulated and no longer contain appreciable amounts of lovastatin. In addition, if the red yeast rice is not fermented correctly, the contaminant citrinin can be present. Citrinin is potentially nephrotoxic and may be cancer causing. In a recent survey of 12 commercially available red yeast rice products, one-third contained the potentially toxic citrinin.[39] Because of the lack of standardization and concern about the presence of mycotoxins, caution will need to be used when considering the use of these products.