Abstract 11306: Red Yeast Rice Extract Shows Equivalency to Statins
Background: XueZhiKang (XZK) is a pharmaceutical grade botanical product extracted from red yeast rice that has shown lipid-lowering efficacy and cardiovascular benefits in randomized, double-blind, placebo-controlled studies conducted outside the US. The goal of the present study was to evaluate the lipid lowering efficacy of XZK in patients in both the US and China.
Methods: A double-blind, randomized, placebo-controlled, parallel group study with 116 randomized patients was conducted at 15 sites in the US and China. Inclusion criteria included a fasting low density lipoprotein cholesterol (LDL-C) level ≥ 160 but < 220 mg/dL, total cholesterol level ≥ 240 and triglyceride level < 400. After a 4-week diet run-in period, eligible patients were randomized equally to one of three groups (XZK 1200 mg/day, XZK 2400 mg/day or matching placebo) and treated for 12 weeks in a double-blind manner.
Results: The mean percentage decrease from baseline to week 12 on LDL-C levels (primary efficacy variable) was 26.8% in the 1200 mg/day group (from 177.4±29.8 to 128.6±29.8) and 27.0% in the 2400 mg/day group (from 175.7±25.2 to 125.7±26.7) in the intent-to-treat population with last observation carried forward. The placebo group showed a 0.8% increase in LDL-C level (from 174.3±23.1 to 174.9±26.0), resulting in highly significant (P<0.001) differences between either XZK group vs placebo. Additional beneficial changes were seen in other related lipid parameters. The overall safety profiles were similar between all three groups. There were no reported myopathies or drug-related serious adverse events (AEs).
Conclusions: This study demonstrated that XZK has significant lipid lowering efficacy in dyslipidemic patients and a favorable safety profile with similar results observed in patients enrolled in the US and China. Treatment with XZK appears safe and well tolerated. Future larger and longer studies are indicated to expand the efficacy and safety data of this natural product.
- © 2013 by American Heart Association, Inc.