Red Yeast Rice Preparations: Are They Suitable Substitutions for Statins?

Abstract

Red yeast rice, a commercially available food supplement known to reduce serum cholesterol, has been repeatedly advocated as alternative therapy for hypercholesterolemic patients that refuse statins, cannot tolerate statin therapy's side effects, or request a "naturopathic" medicine. Red yeast rice contains a fungus (Monascus purpureus), which was utilized in the original production of lovastatin (MEVACOR, Merck & Co, Whitehouse Station, NJ), the first marketed pharmaceutical statin, and is chemically identical to such product. Their identical properties account for the similarity in therapeutic and side effects of red yeast rice and lovastatin. The red yeast rice ingredient that blocks cholesterol production is monacolin K. Because red yeast rice preparations have large variability in monacolin K content, predicting or understanding dose-related efficacy and side-effect risks of red yeast rice is practically impossible. The lipid-regulating potency of red yeast rice in commercial preparations was found to be extensively different according to the number or concentration of monacolin K they possess. Furthermore, more than one type of monacolin was found in different preparations (or batches) of red yeast rice. Other ingredients found in red yeast rice are also known to be potentially toxic. The US Food and Drug Administration issued warnings to consumers in 2007 and in 2013 against taking red yeast rice products due to the lack of assurance about its efficacy, safety, and lack of standardized preparation methods. This article discusses my clinical trial results with red yeast rice, reviews the literature on its therapeutic and side effects, and discusses why red yeast rice is not an acceptable substitution for statins.

Managing hyperlipidaemia in patients with COVID-19 and during its pandemic: An expert panel position statement from HEART UK

“…Red yeast rice (RYR), a nutraceutical that inhibits HMG-CoA reductase and reduces LDL-C [ 52 ], is used by some patients who are intolerant to statins [ 53 ]. It is enzymatically hydrolysed in the small intestine and liver by cytochrome P450.…”

Prevention and Treatment of Atherosclerosis: The Use of Nutraceuticals and Functional Foods

“…Because nutraceuticals are not regulated as drugs, red rice supplements are not always subjected to strict adverse event monitoring programs. Physicians should make patients aware of potential risk factors related to the use of RYR nutraceuticals to ensure safety, lack of allergenic compounds, and potential untoward effects (Dujovne 2017).…”

<p>Evaluating Risk of Incident Diabetes Between Patients Who Used Lovastatin and Red Yeast Rice Prescriptions (LipoCol Forte): A Retrospective Cohort Study Based on a Real-World Database</p>

“…In addition, it is also not easy to predict or understand the side effect risks of RYR because of the high variability in monacolin content in various commercial RYR dietary supplements. [36][37][38] Unlike the dietary supplement, it was suggested that the content of RYR prescriptions with good manufacturing practice were relatively stable and safe, such as Xuezhikang, HypoCol, and LipoCol Forte. [13][14][15]29 A clinical trial suggested that there were no differences between the HypoCol group and the placebo group with regard to glucose tolerance.…”