title: ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia.
abstract: OBJECTIVE
  Evidence suggests prolonged exposure to lower levels of low-density lipoprotein cholesterol (LDL-C), starting at a younger age, substantially lowers cardiovascular (CV) risk. Accordingly, the CV pandemic affecting younger population in low- to low-middle-income countries, where statin usage is poor even in secondary prevention, may benefit from lipid-lowering nutritional products, as nutritional intervention is generally preferred in these cultures. However, the safety and efficacy of such preparations have not been systematically tested.
  
  
  METHODS
  In this multicenter, double-blind study, 191 statin-free subjects with newly-diagnosed hyperlipidemia (LDL-C >120 mg/dL, 3.11 mmol/L) and no evidence of CV disease were randomized to one capsule of a proprietary bioactive phytonutrient formulation containing red yeast rice, grape-seed, niacinamide, and folic acid (RYR-NS) or matched placebo twice daily, along with lifestyle modification, for 12 wk.
  
  
  RESULTS
  Mean baseline LDL-C levels were 148.5 ± 24.0 mg/dL (3.85 ± 0.62 mmol/L) and 148.6 ± 21.9 mg/dL (3.85 ± 0.57 mmol/L) in the RYR-NS and placebo groups respectively. Compared with placebo, RYR-NS resulted in a significant reduction in LDL-C (-29.4% versus -3.5%, P < 0.0001) and non-high-density lipoprotein cholesterol (non-HDL-C; -29.8% versus -10.3%, P < 0.0001) at 12 wk. With RYR-NS, 43.4% individuals attained desirable LDL-C levels and 55.4% desirable non-HDL-C levels by week 12, compared to only 0% and 1.1%, respectively, at baseline. No safety issues were observed.
  
  
  CONCLUSIONS
  This study demonstrates the efficacy and safety of RYR-NS in lowering LDL-C and non-HDL-C after 12 wk, with magnitude of LDL-C reduction being comparable to that seen with moderate-intensity statin therapy. Further long-term studies are required to determine the impact of RYR-NS on treatment adherence and clinical outcomes.
authors.affiliation: Medanta - The Medicity, Gurgaon, Delhi NCR, India. Electronic address: rrkasliwal@hotmail.com.
authors.forename: Ravi R
authors.initials: RR
authors.lastname: Kasliwal
authors.affiliation: Medanta - The Medicity, Gurgaon, Delhi NCR, India.
authors.forename: Manish
authors.initials: M
authors.lastname: Bansal
authors.affiliation: Fortis Escorts Hospital, Jaipur, Rajasthan, India.
authors.forename: Rajeev
authors.initials: R
authors.lastname: Gupta
authors.affiliation: Bhatia Hospital, Mumbai, Maharashtra, India.
authors.forename: Siddharth
authors.initials: S
authors.lastname: Shah
authors.affiliation: Lifecare Hospital, Ahmedabad, Gujarat, India.
authors.forename: Sameer
authors.initials: S
authors.lastname: Dani
authors.affiliation: Ramana Maharishi Rangammal Hospital, Tiruvannamalai, Tamil Nadu, India.
authors.forename: Abraham
authors.initials: A
authors.lastname: Oomman
authors.affiliation: Pai Research Center, Pune, Maharashtra, India.
authors.forename: Vikas
authors.initials: V
authors.lastname: Pai
authors.affiliation: Pace Research Center, Bangalore, Karnataka, India.
authors.forename: Guru Mallapa
authors.initials: GM
authors.lastname: Prasad
authors.affiliation: Singhvi Health Center, Chennai, Tamil Nadu, India.
authors.forename: Sunil
authors.initials: S
authors.lastname: Singhvi
authors.affiliation: Pruthvi Heart Center, Ahmedabad, Gujarat, India.
authors.forename: Jitendra
authors.initials: J
authors.lastname: Patel
authors.affiliation: I5 Clinical Research Pvt. Ltd, Chennai, Tamil Nadu, India.
authors.forename: Sakthivel
authors.initials: S
authors.lastname: Sivam
authors.affiliation: Medanta - The Medicity, Gurgaon, Delhi NCR, India.
authors.forename: Naresh
authors.initials: N
authors.lastname: Trehan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000097:blood / Q000627:therapeutic use; D001688:Biological Products / Q000097:blood / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000097:blood / Q000517:prevention & control*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000924:Anticholesteremic Agents; D001688:Biological Products; D008055:Lipids; C117343:red yeast rice
keywords: Lipid-lowering; Nutritional intervention; Primary prevention