title: Effects of Xuezhikang in patients with dyslipidemia: a multicenter, randomized, placebo-controlled study.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, University of Kansas, Kansas City, KS, USA.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Moriarty
authors.affiliation: Sterling Research Group, Ltd, Cincinnati, OH, USA.
authors.forename: Eli M
authors.initials: EM
authors.lastname: Roth
authors.affiliation: Karns Medical Corporation, Los Angeles, CA, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Karns
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Ye
authors.affiliation: The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Shui-Ping
authors.initials: SP
authors.lastname: Zhao
authors.affiliation: Wuhan Union Hospital, Wuhan, Hubei, China.
authors.forename: Yuhua
authors.initials: Y
authors.lastname: Liao
authors.affiliation: Thomas Jefferson University, Haverford, PA, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Capuzzi
authors.affiliation: L-MARC Research Center, Louisville, KY, USA.
authors.forename: Harold E
authors.initials: HE
authors.lastname: Bays
authors.affiliation: Jiangsu Province Hospital, Nanjing, Jiangsu, China.
authors.forename: Fumin
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Shanghai First People's Hospital, Shanghai, China.
authors.forename: Shaowen
authors.initials: S
authors.lastname: Liu
authors.affiliation: Clinical Trial Network, Houston, TX, USA.
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Reichman
authors.affiliation: Texas A&M School of Medicine, Corpus Christi, TX, USA.
authors.forename: Osvaldo A
authors.initials: OA
authors.lastname: Brusco
authors.affiliation: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Guoping
authors.initials: G
authors.lastname: Lu
authors.affiliation: Memorial Regional Hospital, Hollywood, FL, USA.
authors.forename: Sam
authors.initials: S
authors.lastname: Lerman
authors.affiliation: Beijing Peking University WBL Biotech Co. Ltd. (WPU), Luye Pharma Group, Beijing, China.
authors.forename: Zhenwen
authors.initials: Z
authors.lastname: Duan
authors.affiliation: Beijing Peking University WBL Biotech Co. Ltd. (WPU), Luye Pharma Group, Beijing, China.
authors.forename: Shuren
authors.initials: S
authors.lastname: Guo
authors.affiliation: Beijing Peking University WBL Biotech Co. Ltd. (WPU), Luye Pharma Group, Beijing, China.
authors.forename: Ping Lan
authors.initials: PL
authors.lastname: Liu
authors.affiliation: Beijing Peking University WBL Biotech Co. Ltd. (WPU), Luye Pharma Group, Beijing, China.
authors.forename: Junxian
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Beijing Peking University WBL Biotech Co. Ltd. (WPU), Luye Pharma Group, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Luye America Pharmaceuticals, Ltd., Luye Pharma Group, Princeton, NJ, USA. Electronic address: simonli@luye.cn.
authors.forename: Simon
authors.initials: S
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D001054:Apolipoproteins A / Q000097:blood; D001055:Apolipoproteins B / Q000097:blood; D001688:Biological Products / Q000276:immunology; D002681:China; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D050171:Dyslipidemias / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008148:Lovastatin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage / Q000009:adverse effects; D014280:Triglycerides / Q000097:blood; D014481:United States
chemical_list: D001054:Apolipoproteins A; D001055:Apolipoproteins B; D001688:Biological Products; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004365:Drugs, Chinese Herbal; D000960:Hypolipidemic Agents; D010919:Placebos; D014280:Triglycerides; C117343:red yeast rice; C496822:xuezhikang; D008148:Lovastatin
keywords: Atherosclerosis; Cholesterol; Lovastatin; Red yeast rice; Xuezhikang