Journal Article

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

Dani, Sameer, Patel, Jitendra, Sivam, Sakthivel, Kasliwal, Ravi R., Gupta, Rajeev, Oomman, Abraham, Bansal, Manish, Shah, Siddharth, Trehan, Naresh, Pai, Vikas, Prasad, Guru Mallapa, Singhvi, Sunil

2016

Overview

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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: 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