Phytosterols, red yeast rice, and lifestyle changes instead of statins: A randomized, double-blinded, placebo-controlled trial

• Published in: The American heart journal 2013-07, Vol.166 (1), p.187-196.e2
• Main Authors: Becker, David J., MD, French, Benjamin, PhD, Morris, Patti B., RD, Silvent, Erin, BA, Gordon, Ram Y., MD
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Biological Products - therapeutic use; Cardiovascular; Cholesterol; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; Heart attacks; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; Life Style; Lipids - blood; Male; Middle Aged; Phytosterols - therapeutic use; Statins; Treatment Outcome; Yeast; Young Adult
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2013.03.019

Background Many patients who refuse or cannot tolerate statin drugs choose alternative therapies for lipid lowering. Objectives This study aimed to determine the lipid-lowering effects of phytosterol tablets and lifestyle change (LC) on top of red yeast rice (RYR) therapy in patients with a history of statin refusal or statin-associated myalgias. Design A total of 187 participants (mean low-density lipoprotein cholesterol [LDL-C], 154 mg/dL) took RYR 1800 mg twice daily and were randomized to phytosterol tablets 900 mg twice daily or placebo. Participants were also randomized to a 12-week LC program or usual care (UC). Primary end point was change in LDL-C at 12, 24, and 52 weeks. Secondary end points were effect on other lipoproteins, high-sensitivity C-reactive protein, weight, and development of myalgia. Results Phytosterols did not significantly improve LDL-C at weeks 12 ( P = .54), 24 ( P = .67), or 52 ( P = .76) compared with placebo. Compared with the UC group, the LC group had greater reductions in LDL-C at weeks 12 (−51 vs −42 mg/dL, P = .006) and 24 (−48 vs −40 mg/dL, P = .034) and was 2.3 times more likely to achieve an LDL-C