Red Yeast Rice Reduces LDL-Cholesterol Levels in Statin-Intolerant Patients

According to the results of a new study, the use of red yeast rice and a therapeutic lifestyle change significantly reduced LDL-cholesterol levels in statin-intolerant patients with dyslipidemia and may provide a future treatment alternative for these difficult-to-treat patients. The results of the study are published in the June 16, 2009 issue of the Annals of Internal Medicine. "If properly regulated, I would say it's time that we began using red yeast rice in these statin-intolerant patients," said lead investigator Dr David Becker (Chestnut Hill Hospital, Flourtown, PA).

Extracts of red yeast rice have been widely used in China for therapy in patients with circulatory and digestive disorders for centuries, and preparations of red yeast rice have been shown to lower plasma LDL levels. Lovastatin occurs naturally in certain forms of red yeast rice that are made when the rice is cultivated with the mold Monascus purpureus. Red yeast rice is readily available in health food stores and over the internet, with US sales of $17 million in 2006.
In this study, 62 patients with dyslipidemia and a history of stopping statin therapy due to myalgias were randomized to receive 1800 mg of red yeast rice or placebo twice daily for 24 weeks. All patients were concomitantly enrolled in a 12-week therapeutic lifestyle-change program that included eating a Mediterranean-based diet, an exercise program, and relaxation techniques. The mean number of statins tried before the intervention was two.

After 12 weeks of treatment, LDL- and total-cholesterol levels were significantly lower in the red-yeast-rice group when compared with the placebo-treated patients. HDL-cholesterol levels were unchanged with treatment, and triglyceride levels were not significantly different between treatment arms. LDL- and HDL-cholesterol levels increased slightly from weeks 12 to 24, likely because the lifestyle intervention program ended and adherence to therapy declined, note investigators.

"The traditional approach among cardiologists is to patiently, or not so patiently, try one statin after another until they find a drug they can tolerate, because we know that they have to take this medication." said Becker. In the study, just two patients developed persistent intolerable myalgias. Becker noted that when patients develop myalgias with one statin, 40% to 60% typically end up stopping a second or third statin. Pain scores, derived from a self-administered questionnaire, were similar in both treatment arms at 12 and 24 weeks.

Becker noted that the dose of red yeast rice used in the study is equivalent to a daily lovastatin dose of just 6 mg, much less than established therapeutic doses of 20 mg to 40 mg, and that the amount of LDL lowering observed in the trial is disproportionate to such a low dose. Asked why red yeast rice was so well tolerated and yet so effective, Becker said that red yeast rice contains monacolin K, which is the naturally occurring lovastatin, but also numerous other monacolins that might work to lower LDL-cholesterol levels without causing recurrent muscle pain.

Investigators urged caution about moving these results into clinical practice, however, specifically pointing out that while the chemical composition of red yeast rice was known and controlled in this study, there is a lack of consistency between different manufacturers and an ongoing need for the Food and Drug Administration to better regulate this popular dietary supplement.