Statin-intolerance in individuals is becoming a more prevalent issue, considering the rise in the number of patients undergoing lipid-lowering treatment. This has necessitated the need for a shift in the medication regime from statins to alternative medicines or other classes of lipid-lowering drugs such as cholesterol absorption inhibitors and bile acid sequestrants. Now, a randomized controlled trial published in the recent issue of the Annals of Internal Medicine further substantiates that the Chinese herbal dietary supplement, red yeast rice, and therapeutic lifestyle changes could significantly lower the levels of total cholesterol and low-density lipoprotein (LDL) in statin-intolerant individuals.
David J Becker, Physician at the Chestnut Hill Hospital, Philadelphia, and colleagues conducted the study to assess the tolerability and efficacy of red yeast rice and therapeutic lifestyle change in treating statin-intolerant dyslipidemia patients. Sixty-two patients with statin therapy withdrawal due to myalgias, were randomly divided into two equal groups to receive either 1,800 mg red yeast rice or placebo, twice daily for 24 weeks, and undergo a 12-week therapeutic lifestyle change program.
A significant decrease in the levels of LDL cholesterol by 27.3% (43 mg/dL) was observed at week 12 (P<0.001) and 21.3% (35 mg/dL) at week 24 (P=0.011) from baseline in the red yeast rice group as compared to 5.7% and 8.7% with placebo in the corresponding weeks. A significant difference in the mean total cholesterol level measured at week 12 (P<0.001) and 24 (P=0.016) was also observed between the two groups. However, weight loss, pain severity scores, and the levels of high-density lipoprotein (HDL) cholesterol, hepatic enzyme, creatinine phosphokinase (CPK) or triglyceride did not vary substantially between the groups during the treatment period. Based on the study findings, the investigators concluded on the efficacy of red yeast rice and therapeutic lifestyle changes in lowering LDL cholesterol levels with no elevation of CPK or pain levels, thereby suggesting it as a potent therapeutic strategy for dyslipidemia in statin-intolerant patients.
Earlier, Liu et al (Chinese Medicine, 2006) conducted a meta-analysis to evaluate the safety and efficacy of red yeast rice preparations as lipid-modifying agents in subjects with primary hyperlipidemia. The researchers considered 93 randomized studies comprising of 9,625 subjects and three preparations of red yeast rice: Cholestin, Xuezhikang and Zhibituo.
The serum total cholesterol, triglycerides, and LDL cholesterol levels were found to be considerably reduced, while the HDL cholesterol levels were increased in the red yeast rice group, in contrast to the placebo. It was also observed that the lipid-modifying activity was similar to that of statins like atorvastatin, fluvastatin, lovastatin, pravastatin, or simvastatin. Red yeast rice preparations were found to be superior to non-statin lipid lowering agents like nicotinate and fish oils; however, lower or equivalent activity was observed when compared to fenofibrate and gemfibrozil. Mild adverse events like gastrointestinal discomfort and dizziness were noted to be associated with red yeast rice preparations. The study demonstrated the short-term benefits of red yeast rice preparations in lowering lipid levels, suggesting further studies to recommend red yeast rice preparations as an alternative treatment of hyperlipidemia.
Statin intolerance is associated with major adverse events like gastrointestinal symptoms, increase in the levels of hepatic enzymes, and statin-associated myalgias. Some rare complications include rhabdomyolysis and myositis (increased CPK level).
Red yeast rice, usually prepared through fermentation with Monascus purpureus fungal strain, contains certain metabolites known as monacolins, including lovastatin, that are presumed to impart the cholesterol-reducing activity to red yeast rice preparation. Despite its proposed medicinal properties, red yeast rice is not approved by the US FDA as it contains lovastatin, a regulated drug (available as a prescription drug called Mevacor®), and is sold over-the-counter as a food supplement. However, there persists legal and industrial debate if red yeast rice should be classified as a prescription drug or a dietary supplement.
The current study highlights the safety and efficacy of red yeast rice preparations in reducing total and LDL cholesterol in statin-intolerant individuals. However, further large-scale multi-center prospective studies are required to evaluate the dosage and long-term efficiency of red yeast rice preparations before recommending it as an effective alternative for statin drugs, especially in the context of it containing lovastatin, a regulated drug, and FDA not yet approving it as a safe dietary supplement.
References
1. Becker DJ, Gordon RY, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice for dyslipidemia in statin-intolerant patients: a randomized trial. Ann Intern Med. 2009 Jun 16;150(12):830-9, W147-9.
2. Liu J, Zhang J, Shi Y, Grimsgaard S, Alraek T, Fønnebø V. Chinese red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-analysis of randomized controlled trials. Chin Med. 2006 Nov 23;1:4.
