Applied Evidence
Statin adverse effects: Sorting out the evidence
Studies have assessed the incidence of everything from myopathy to diabetes and cataracts, but findings have been inconsistent. Here’s help in...
EVIDENCE-BASED ANSWER:
Yes, but perhaps not the red-yeast rice extracts available in the United States.
In patients with known coronary artery disease and dyslipidemia (secondary prevention), therapy with red-yeast rice extract containing naturally-occurring lovastatin is associated with a 30% reduction in coronary heart disease (CHD) mortality and a 60% reduction in myocardial infarction (MI), similar to the effect of statin medications (strength of recommendation [SOR]: B, randomized controlled trials [RCTs] in China).
In patients older than 65 years with hypertension and a previous MI, the rate of adverse effects from lovastatin-containing red-yeast rice is 2.1% (SOR: B, RCT in China).
In patients with previous statin intolerance, the rates of myalgias and treatment discontinuation with lovastatin-containing red-yeast rice therapy are similar to either placebo or another statin (SOR: C, low-powered RCTs).
The US Food and Drug Administration (FDA) doesn’t allow lovastatin-containing red-yeast rice products on the US market; physicians should be aware that products purchased by patients online contain variable amounts of lovastatin.
EVIDENCE SUMMARY
Red-yeast rice is a Chinese dietary and medicinal product of yeast (Monascus purpureus) grown on rice. It contains a wide range of biologically active compounds, including lovastatin (monacolin K). The FDA has banned the sale of red-yeast rice products with more than trace amounts of lovastatin.1
Red-yeast rice beats placebo, similar to statins
A systematic review of 22 RCTs (N=6520), primarily conducted in China using 600 to 2400 mg red-yeast rice extract daily (lovastatin content 5-20 mg), assessed outcomes in patients with known CHD and dyslipidemia.2 In one trial of 4870 patients, users of red-yeast rice had significant reductions in CHD mortality (relative risk [RR]=0.69; 95% confidence interval [CI], 0.54-0.89), incidence of MI (RR=0.39; 95% CI, 0.28-0.55), and revascularization (RR=0.67; 95% CI, 0.50-0.89) compared with placebo users.
However, when compared with statin therapy, red-yeast rice didn’t yield statistically significant differences in CHD mortality (2 trials, N=220; RR=0.26; 95% CI, 0.06-1.21), incidence of MI (1 trial, N=84; RR=0.95; 95% CI, 0.30-3.05) or revascularization (1 trial, N=84; RR=1.14; 95% CI, 0.38-3.46).
Red-yeast rice outperforms placebo in CHD and MI—but not stroke
A secondary analysis of an RCT evaluated the impact of red-yeast rice extract (600 mg twice a day) for 4.5 years on cardiovascular events and mortality in 1530 Chinese patients 60 years of age and older with hypertension and a previous MI.3 The lovastatin content of the red-yeast rice was 5 to 6.4 mg/d.
Compared with placebo, red-yeast rice was associated with a lower incidence of CHD events (RR=0.63; 95% CI, 0.36-0.83), nonfatal MI (RR=0.48; 95% CI, 0.37-0.71), and all-cause mortality (RR=0.65; 95% CI, 0.49-0.83) but not with a statistically significant difference in stroke (RR=0.63; 95% CI, 0.47-1.09) or cardiac revascularization (RR=0.68; 95% CI, 0.52-1.19).
