Effects of Xuezhikang in patients with dyslipidemia: a multicenter, randomized, placebo-controlled study.

Abstract

Xuezhikang (XZK) is an extract of fermented red yeast rice that has lipid-lowering properties. To evaluate the effects of XZK on lipids in subjects with dyslipidemia but no coronary heart disease. A total of 116 adults with baseline non-high-density lipoprotein cholesterol (non-HDL-C) levels of approximately 208mg/dL and low-density lipoprotein cholesterol (LDL-C) levels of approximately 175mg/dL were randomized to either placebo or XZK 1200 or 2400mg daily and treated for 12weeks. A majority of the patients were white (53.4%) or Asian (37.1%). Daily XZK 1200mg and 2400mg for 4 to 12weeks resulted in statistically significant (P<.001) and clinically meaningful decreases in non-HDL-C (∼24% reduction) and LDL-C (∼27% reduction) compared with placebo. XZK treatment at either dose enabled approximately 50% of subjects to reduce their LDL-C levels by≥30%. Doubling the XZK daily dose from 1200 to 2400mg at treatment week 8 caused an additional 4.6% reduction in LDL-C. Significant benefits were also observed across secondary efficacy variables, including total cholesterol (TC), apolipoprotein B (Apo B), triglycerides, HDL-C, the TC/HDL-C ratio, and the Apo B/Apo A-I ratio, at treatment week 8 or 12. XZK was safe and well tolerated. Safety and tolerability profiles were similar across treatment groups. Most adverse events were gastrointestinal. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase. Xuezhikang significantly reduced non-HDL-C and LDL-C, and was well tolerated. Further, longer-term studies in more diverse patient populations are needed to corroborate these findings.