If You Can’t Take a Statin . . .

Regular visitors to this blog must feel I’ve gone overboard on the use of statin drugs. They were originally approved for treating raised low-density-lipoprotein cholesterol (LDL-C), but in recent years a large number of uses have been reported that have little to do with raised cholesterol levels, at least in the first instance. But statins have occasionally severe side effects, affecting the muscles; initially there is pain and inflammation of the muscles that can lead to a breakdown of muscle cells called rhabdomyolysis, which may cause kidney failure and even death. (Statins have other side effects, but they are even rarer and not so serious).

Red yeast rice has been touted as a supplement that does what statins do, but without their side effects. In support of this, a study was reported in the Annals of Internal Medicine. The subjects were 62 patients with high cholesterol levels who had stopped statin therapy because of muscle pain. They were assigned randomly to take three 600-mg red yeast rice capsules or three placebo capsules, twice a day for 24 weeks. All patients were also enrolled in a 12-week diet and nutrition program.

Over the course of the study, LDL cholesterol levels decreased more in the red yeast rice patients (on average, -35 mg/dL) than in patients taking the placebo (on average, -15 mg/dL). Total cholesterol levels also decreased more with red yeast rice than with placebo (-26 mg/dL vs. -14 mg/dL). Muscle pain scores, HDL cholesterol levels, weight loss, and liver or muscle enzyme levels showed no significant differences between the two groups.

The study shows that, in people who can’t tolerate statins, red yeast rice is well-tolerated and has a similar effect on cholesterol levels as statins. It should be noted that red yeast rice contains monocolin K, which is the naturally-occurring lovastatin (marketed as Mevacor®). The dose of red yeast rice used in the study was equivalent to a daily dose of 6 mg lovastatin, which is much lower than the therapeutically effective dose of 20 – 40 mg daily. Red yeast rice is probably effective because it contains numerous other monacolins that might lower LDL-cholesterol without causing recurrent muscle pain.

The problem with more widespread use of red yeast rice is that the study was too small and too short to detect any serious but rare side effects, such as those seen with statin medications. More extensive studies will be needed if it is to become an established treatment for patients, with FDA approval. Moreover, there is no evidence (yet) that it can provide any of the ‘non-cholesterol’ benefits of approved statins.