ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia

• Published in: Nutrition (Burbank, Los Angeles County, Calif.) Vol. 32; no. 7-8; pp. 767 - 776
• Main Authors: Kasliwal, Ravi R., Bansal, Manish, Gupta, Rajeev, Shah, Siddharth, Dani, Sameer, Oomman, Abraham, Pai, Vikas, Prasad, Guru Mallapa, Singhvi, Sunil, Patel, Jitendra, Sivam, Sakthivel, Trehan, Naresh
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.07.2016; Elsevier Limited
• Subjects: Adolescent; Adult; Aged; Anticholesteremic Agents - blood; Anticholesteremic Agents - therapeutic use; Biological Products - blood; Biological Products - therapeutic use; Brand names; Cardiovascular Diseases - blood; Cardiovascular Diseases - prevention & control; Cholesterol; Dietary Supplements; Double-Blind Method; Female; Folic acid; Gastroenterology and Hepatology; health foods; Humans; hyperlipidemia; Hyperlipidemias - blood; Hyperlipidemias - drug therapy; Ingredients; lifestyle; Lipid-lowering; Lipids; Lipids - blood; Low density lipoprotein; low density lipoprotein cholesterol; Male; Manufacturers; Middle Aged; Mortality; nicotinamide; Nutritional intervention; pandemic; Patients; Phosphatase; phytonutrients; placebos; Primary prevention; Proprietary; red yeast rice; Rice; risk reduction; Safety; Seeds; Solvents; Standard deviation; Statins; Treatment Outcome; Vitamin B; Yeast; Yeasts; Young Adult; Primary prevention; Lipid-lowering; Nutritional intervention
• ISSN: 0899-9007; 1873-1244; 1873-1244
• DOI: 10.1016/j.nut.2016.01.012

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. 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. 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. 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. •Prolonged exposure to lower low-density lipoprotein cholesterol (LDL-C) is perhaps the most effective modifiable risk factor in reduction of cardiovascular (CV) events.•Although statins are highly effective, their usage remains poor, especially in low- to low-middle-income countries.•Nutritional supplements, being culturally more acceptable, are a potential solution but have not been systematically tested.•Our study, ESSENS, was the first randomized study evaluating efficacy and safety of a lipid-lowering nutritional supplement in India.•191 statin-free subjects with newly-diagnosed hyperlipidemia and no evidence of CV disease were randomized to one capsule of a proprietary nutritional supplement containing red yeast rice, grape-seed, niacinamide, and folic acid or matched placebo twice daily.•12 wk treatment with the supplement resulted in ∼30% reduction in LDL-C with no apparent safety issues.