Red Yeast Rice Extract Lowers M.I. Incidence and Mortality from Coronary Disease
Author: Steve Austin, N.D.
Reference: Li J-J, Lu Z-L, Kou W-R, et al. Beneficial impact of Xuezhikang on cardiovascular events and mortality in elderly hypertensive patients with previous myocardial infarction from the China Coronary Secondary Prevention Study (CCSPS). J Clin Pharmacol 2009;49:947-56.
Design: Randomized double-blind intervention trial
Participants: 1530 elderly (≥65 years of age) hypertensive subjects with a history of myocardial infarction (MI)
Study Medication and Dosage: Subjects received either Xuezhikang, a red yeast rice (RYR) extract, administered as 600 mg b.i.d., or placebo for an average of 4.5 years. Each 600 mg capsule of RYR contained 2.5-3.2 mg of monacolin K plus “a small quantity of lovastatin hydroxyl acid as well as ergosterol and some other components.”
Primary Outcome Measures: Recurrent coronary events
Key Findings: Compared with the placebo group, there was a 38% reduced risk of suffering a coronary event (primarily MIs) (P=0.0009). Similarly there was a 29% reduced risk of dying from coronary disease during the course of the trial (P=0.05). Secondary endpoints revealed a 21% decline in LDL levels in the RYR group (P=0.0001) and a 12% decline in triglyceride levels (P=0.003) compared with trivial declines in the placebo group. Total mortality also declined by 36% in the group receiving RYR (P=0.003).
Practice Implications: RYR extracts are known to reduce cholesterol levels in humans and have been traditionally used in China to treat people with cardiovascular disease. RYR naturally contains the same molecule found in the prescription drug lovastatin. Previous RYR research has focused primarily on cholesterol reduction, though some evidenc
e for reduction in inflammatory markers has also surfaced.
The current trial goes several steps further, showing clinically (and statistically) significant reductions in coronary disease incidence and mortality. Hidden in the data is a near-statistically significant (P=0.06) 37% reduction in the risk of stroke and a statistically significant (P<0.04) reduction in total cancer incidence when compared with the placebo group. No current understanding of the effects of RYR clearly explains these additional positive findings.
One caveat requires mentioning: a previous report studying the pharmacokinetics of a related statin drug found that area-under-the-curve response was twice as great in Chinese subjects compared with white subjects (Clin Pharmacol Ther 2005;78:330-41). Should further investigations confirm these findings in regard to monacolins found in RYR, white (and potentially black) patients might require significantly higher doses of RYR to achieve the same clinical outcomes that occurred in the new report, which studied Chinese subjects.
