The story behind widely prescribed statin heart-health drugs should provoke outrage.
For starters, cholesterol-lowering per se is probably not the safest or best way to reduce the risk of cardiovascular disease and its adverse outcomes.
(Note: Do not stop taking a prescribed statin drug without consulting your physician … that sudden change could be harmful.)
The story of statin drugs is a David vs. Goliath tale, featuring harm to the public's freedom, health, and pocketbook.
Red yeast rice (RYR) is a traditional Chinese food, dye, and medicine, whose use dates back to about 300 BCE.
Two different molds – Aspergillus or Monascus purpureus – can be used to make red yeast rice.
Prompted by evidence that RYR could lower cholesterol levels, researchers isolated a highly effective constituent from Aspergillus and Monascus, called lovastatin or monacolin K.
Purified lovastatin became Merck & Co.'s patented prescription drug Mevacor, while extracts of red yeast rice were sold as supplements, which contained varying amounts of monacolin K (lovastatin).
That situation didn't last long, because drug companies soon filed lawsuits to protect their profits from various patented “statin” drugs.
Since 2001 court ruling, it's been illegal to sell RYR supplements containing lovastatin in the U.S.
Many people manage to get red yeast rice extracts from other countries or via the Internet … which may contain contaminants and little or no lovastatin. (See “Natural Statins Come Under Fire
The medical rationale for making lovastatin a prescription-only drug is that statins can cause muscle and liver damage and can lead to kidney damage or failure, so their use requires regular medical supervision and tests.
Anyone who consumes statins from any source (RYR or a prescription statin drug) should do that only under medical supervision, to avoid potentially serious adverse effects.
However, it's clear from clinical trials that – despite having less lovastatin than prescription statin drugs – high-quality RYR supplements reduce cholesterol and heart attacks equally well while causing fewer side effects. (This does not make them risk-free.)
Earlier this year, the famously tough European Food Safety Authority (EFSA) concluded that monacolin K from red yeast rice could lower LDL cholesterol levels to healthy levels (EFSA 2013).
Its expert panel also approved use of RYR for cholesterol-lowering, and found that people needed to take 10 mg of monacolin K from RYR daily in order in order to gain this benefit.
The advantages of RYR probably stem from the presence of various anti-inflammatory agents, and cholesterol-lowering compounds aside from monacolin K (lovastatin) … including sterols and various other monacolins.
How do statins and RYR work, and how do they compare?
Like RYR, Mevacor and other statin drugs (e.g., Lipitor, Zocor, and Crestor) lower cholesterol by blocking the enzyme HMG-CoA reductase, which the body uses to make it.
By blocking HMG-CoA reductase, statin drugs – and RYR – lower blood levels of total cholesterol and LDL cholesterol.
Statins lower LDL cholesterol, but don't perform substantially better than RYR containing smaller concentrations of lovastatin (monacolins, including monacolin K).
Seven years ago, Chinese doctors published a meta-analysis (review) of 93 published, controlled clinical trials testing RYR in 9625 participants (Liu J et al. 2006).
Although the studies were of lower quality, they concluded that RYR lowered total cholesterol by 5 mg/dl, LDL cholesterol by 28 mg/dl, and triglycerides by 35 mg/dl, while raising HDL (“good”) cholesterol by 6 mg/dl.
(The American Heart Association considers an LDL cholesterol level of 130 mg/dL “borderline high”, and RYR lowered that level by 22 percent.)
As the Chinese doctors wrote, “The lipid [cholesterol and triglycerides] modification effects appeared to be similar to pravastatin, simvastatin, lovastatin, atorvastatin, or fluvastatin.”
A more recent meta-analysis of 22 trials found that RYR “remarkably lowered total cholesterol, triglycerides, and LDL cholesterol compared with placebo and produced results similar to statins (Shang Q et al. 2012).
Later, Chinese researchers conducted a large, placebo-controlled trial testing a RYR supplement (Lipascor), which followed 4,870 post-heart attack patients for an average of 4.5 years (Lu Z et al. 2008).
The risk of subsequent heart attacks dropped by 45 percent in the RYR group, while their risk of cardiac death dropped by 31 percent, their risk of death from any cause fell by 33 percent.
In fact, this RYR supplement worked better than any of the prescription statin drugs tested up to then.
Now, a clinical trial from Italy adds evidence that RYR works as well or better than prescription statin drugs.
Italian trial adds positive evidence for red yeast rice
The results of a small clinical trial from Italy echo those of prior studies, and further support the safety and efficacy of high-quality RYR supplements.
A daily RYR dose providing 10mg of monacolins safely lowered elevated cholesterol levels and key marker of inflammation linked to adverse changes to arteries (vascular remodeling).
Researchers from Italy's Universities of Bologna and Pavia recruited 25 people with mildly elevated cholesterol levels to participate in a double-blind, placebo-controlled randomized clinical trial (Cicero AF et al. 2013).
The volunteers were assigned to consume a “stabilization” diet for four weeks, and were then randomly assigned to take a red yeast rice supplements or placebo for an additional four weeks.
(The RYR supplement also contained CoQ10, which may reduce the muscle/joint aches or muscle damage that occur in a small percent of people taking natural or prescription statins.)
Compared to the placebo group, the RYR group enjoyed significant reductions in total cholesterol, LDL cholesterol, and non-HDL cholesterol … which is the most reliable cholesterol-related risk factor.
In addition, levels of two key inflammatory compounds called matrix metalloproteinases (MMP2 and MMP9) dropped by 28 and 27 percent respectively, while another, called hs-CRP dropped by 24 percent.
(High MMP and CRP levels are considered risk factors for artery damage leading to cardiovascular disease and heart attacks.)
No significant differences were seen in the two groups' levels of triglycerides or HDL cholesterol, and no safety differences were noted.
In addition to RYR, other approaches to cholesterol-lowering and inflammation control appear promising.
- Becker DJ, Gordon RY, Morris PB, Yorko J, Gordon YJ, Li M, Iqbal N. Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial. Mayo Clin Proc. 2008 Jul;83(7):758-64.
- Cicero AF, Derosa G, Parini A, Maffioli P, D'Addato S, Reggi A, Giovannini M, Borghi C. Red yeast rice improves lipid pattern, high-sensitivity C-reactive protein, and vascular remodeling parameters in moderately hypercholesterolemic Italian subjects. Nutr Res. 2013 Aug;33(8):622-8. doi: 10.1016/j.nutres.2013.05.015. Epub 2013 Jul 12.
- European Food Safety Authority (EFSA). Response to comments on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of health claims related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/20061 Accessed at http://www.efsa.europa.eu/en/supporting/doc/423e.pdf
- European Food Safety Authority (EFSA). Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2013;11(2):3084 [13 pp.]. doi:10.2903/j.efsa.2013.3084. Accessed at http://www.efsa.europa.eu/en/efsajournal/pub/3084.htm
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- Shang Q, Liu Z, Chen K, Xu H, Liu J. A systematic review of xuezhikang, an extract from red yeast rice, for coronary heart disease complicated by dyslipidemia. Evid Based Complement Alternat Med. 2012;2012:636547. doi: 10.1155/2012/636547. Epub 2012 Apr 12.
- Zhao SP, Lu ZL, Du BM, Chen Z, Wu YF, Yu XH, Zhao YC, Liu L, Ye HJ, Wu ZH; China Coronary Secondary Prevention Study (CCSPS). Xuezhikang, an extract of cholestin, reduces cardiovascular events in type 2 diabetes patients with coronary heart disease: subgroup analysis of patients with type 2 diabetes from China coronary secondary prevention study (CCSPS). J Cardiovasc Pharmacol. 2007 Feb;49(2):81-4.