We have read with attention and interest the report of Halbert et al recently published in The American Journal of Cardiology , as well as a previous report of the same research group published in the Annals of Internal Medicine concerning the tolerability of red yeast rice in statin-intolerant patients. The reported results are very similar to those already observed by our group in 48 patients intolerant to >1 statin, the last of which was prescribed in our lipid clinic, and followed for ≥12 months: only 4 patients (8.3%) dropped out of the study because of side effects (2 with asymptomatic increases in creatine phosphokinase >5 times the upper limit of normal, 1 with myalgia, and 1 with dyspepsia). After 3 months, total cholesterol decreased by 22.3 ± 5.8%, low-density lipoprotein cholesterol by 31.3 ± 8.3%, and triglycerides by 16.11 ± 10.7% (all p values <0.01). These reduction were confirmed every 3 months for 1 year. High-density lipoprotein cholesterol significantly improved only in patients affected by metabolic syndrome.

However, without agreeing with the anxiety of some colleagues about the safety of red yeast rice, we think that the message of this evidence should be clarified for the lay reader. In fact, the causes of statin-associated myopathy are yet not definitively explained, and in some cases, statins resulted in only subclinical muscular or systemic disorders, such as fibromyalgia or other rheumatologic diseases. In contrast, statin-associated myopathy could be the result of a pharmacologic interaction that can also occur with red yeast rice. Finally, it is noteworthy that the claim of red yeast rice tolerability could lead some patients to take this drug a priori, even when their estimated cardiovascular disease would suggest statin therapy. In fact, in an ongoing study we are carrying out in the setting of our lipid clinics, we are observing that ≥20% of patients with high cardiovascular risk are taking red yeast rice–based nutraceuticals despite statin therapy (unpublished data). The same study reveals, however, that most nutraceuticals taken by our patients are a priori inefficacious in terms of their ability to reduce cholesterolemia, mainly because of the lack of a standardized component. Thus, it is also necessary to clearly evaluate the quality of the products and the competence of the prescribers.

In conclusion, we suggest that an expert committee draw some specific guidelines that could help physicians, pharmacists, and patients identify when the use of red yeast rice supplements could be efficacious and safe and which products are reliable.