On August 9, 2007, the US FDA issued a warning to consumers against the use of red yeast rice products in the treatment of high blood cholesterol. These products which are sold as nutritional supplements (and therefore bought over-the-counter (OTC)) contain lovastatin, the active ingredient of anti-cholesterol prescription drugs such as Mevacor.
According to the FDA:
These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.
In addition, FDA has disapproved applications by pharmaceutical companies for OTC marketing of lovastatin.
XZK is an extract from the red yeast rice Monascus purpureus and has been used in traditional Chinese medicine for centuries. Monascus purpureus is not a rice plant but actually a species of mold with reddish color commonly found growing on grains like rice and maize, hence the name.
In a recent study known as the Chinese Coronary Secondary Prevention Study, researchers investigated the long-term efficacy of XZK on the reduction of recurrent cardiovascular events. The multicenter study included4870 Chinese patients aged 18 to 70 years old with average LDL-cholesterol levels. The participants were followed up for an average of 4.5 years.
The study results show the following:
- XZK treatment showed a 45% risk reduction for myocardial infarction and coronary heart disease,
- cardiovascular events significantly decreased by 39%
- Total mortality was decreased by 33%
- The need for coronary revascularization decreased by 1/3
- Total and LDL cholesterol and triglycerides decreased
- HDL cholesterol levels increased.
- Cancer risk was also significantly reduced.
The XZK capsules used in the study contained many components, including lovastatin, lovastatin hydroxyl acid, and ergosterol. Although lovastatin is indicated for the treatment of high cholesterol levels, the authors believe that this component alone is not responsible for the all the health benefits of red yeast rice extract. More in-depth analysis of the chemical components is necessary to identify all the beneficial ingredients.
The authors conclude that
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