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J Clin Lipidol. 2014 Nov-Dec;8(6):568-75. doi: 10.1016/j.jacl.2014.09.002. Epub 2014 Sep 16.

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

Author information

1
Department of Medicine, University of Kansas, Kansas City, KS, USA.
2
Sterling Research Group, Ltd, Cincinnati, OH, USA.
3
Karns Medical Corporation, Los Angeles, CA, USA.
4
Chinese PLA General Hospital, Beijing, China.
5
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
6
Wuhan Union Hospital, Wuhan, Hubei, China.
7
Thomas Jefferson University, Haverford, PA, USA.
8
L-MARC Research Center, Louisville, KY, USA.
9
Jiangsu Province Hospital, Nanjing, Jiangsu, China.
10
Shanghai First People's Hospital, Shanghai, China.
11
Clinical Trial Network, Houston, TX, USA.
12
Texas A&M School of Medicine, Corpus Christi, TX, USA.
13
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
14
Memorial Regional Hospital, Hollywood, FL, USA.
15
Beijing Peking University WBL Biotech Co. Ltd. (WPU), Luye Pharma Group, Beijing, China.
16
Luye America Pharmaceuticals, Ltd., Luye Pharma Group, Princeton, NJ, USA. Electronic address: simonli@luye.cn.

Abstract

BACKGROUND:

Xuezhikang (XZK) is an extract of fermented red yeast rice that has lipid-lowering properties.

OBJECTIVE:

To evaluate the effects of XZK on lipids in subjects with dyslipidemia but no coronary heart disease.

METHODS:

A total of 116 adults with baseline non-high-density lipoprotein cholesterol (non-HDL-C) levels of approximately 208 mg/dL and low-density lipoprotein cholesterol (LDL-C) levels of approximately 175 mg/dL were randomized to either placebo or XZK 1200 or 2400 mg daily and treated for 12 weeks.

RESULTS:

A majority of the patients were white (53.4%) or Asian (37.1%). Daily XZK 1200 mg and 2400 mg for 4 to 12 weeks 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 2400 mg 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.

CONCLUSION:

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.

KEYWORDS:

Atherosclerosis; Cholesterol; Lovastatin; Red yeast rice; Xuezhikang

PMID:
25499939
DOI:
10.1016/j.jacl.2014.09.002
[Indexed for MEDLINE]

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