Clinical InvestigationPrevention and RehabilitationPhytosterols, red yeast rice, and lifestyle changes instead of statins: A randomized, double-blinded, placebo-controlled trial
Section snippets
Design overview
We designed a randomized, double-blinded, placebo-controlled trial to evaluate the combined lipid-lowering effects of RYR, phytosterols, and lifestyle change. We selected a 2 × 2 factorial design to simultaneously evaluate the impact of the 2 interventions (phytosterols vs placebo and lifestyle change vs usual care). All participants took RYR. Participants were recruited from July to October 2009 from 2 study centers: Abington Memorial Hospital, Abington, PA, and Chestnut Hill Hospital,
Results
Two hundred twenty participants were randomized; 33 were subsequently identified as ineligible or withdrew consent (Figure 1). Among the remaining 187 participants, mean age was 62 years, 75% were female, and 28% were African American; 68% were low risk (≤5%), 30% were intermediate risk (>5%-<20%), and 2% were high risk (≥20%) according to the Framingham risk score. Eight subjects with a history of coronary artery disease were enrolled on a compassionate basis having refused recommended
Discussion
Our study compared the lipid-lowering efficacy of phytosterol tablets vs placebo and lifestyle changes vs usual care in patients taking RYR who were statin intolerant or refused statin therapy. Phytosterol tablets did not significantly improve lipoprotein levels at any period compared with placebo. Participants in the LCG were 2.3 times more likely to achieve an LDL-C <100 mg/dL and had significantly more weight loss than the UCG. All participants were treated with RYR and LDL-C, TC, TG, and
Conclusion
Phytosterol tablets did not improve lipoprotein levels when added to RYR in participants who either were intolerant of statins or had refused a physician's recommendation to take statin therapy. Subjects randomized to a lifestyle change program had significantly lower TC and LDL-C through week 24 and lost significantly more weight than participants in the UCG. All regimens were well tolerated and safe throughout the yearlong trial. In conclusion, a combination of RYR and lifestyle change may
Disclosures
Drs Becker and Gordon have served as consultants for Lupin Pharmaceuticals, Baltimore, MD. Dr French, Ms. Morris, and Ms. Silvent have no financial disclosures to report.
References (33)
- et al.
Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled tria
Lancet
(2003) - et al.
Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance
Am J Cardiol
(2010) - et al.
Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement
Am J Clin Nutr
(1999) - et al.
Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels
Mayo Clin Proc
(2003) Lowering LDL, cholesterol with margarine containing plant stanol/sterol esters: is it still relevant in 2011?
Complement Ther Med
(2011)- et al.
Integrating complementary medicine into cardiovascular medicine. A report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (writing committee to develop an expert consensus document on complementary and integrative medicine)
J Am Coll Cardiol
(2005) - et al.
Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study
JAMA
(1998) - et al.
Persistence of use of lipid-lowering medications: a cross-national study
JAMA
(1998) - et al.
Apparent discontinuation rates in patients prescribed lipid-lowering drugs
Med J Aust
(1996) - et al.
Plant sterols/stanols as cholesterol lowering agents: a meta-analysis of randomized controlled trials
Food Nutr Res
(2008)
Comparison of efficacy of plant stanol ester and sterol ester: short-term and longer-term studies
Am J Cardiol
Effects of diet and exercise in men and postmenopausal women with low levels of HDL cholesterol and high levels of LDL cholesterol
N Engl J Med
Additive effects of plant sterol and stanol esters to statin therapy
Am J Cardiol
Risks associated with statin therapy: a systematic overview of randomized clinical trials
Circulation
Cited by (26)
The current trend and challenges of developing red yeast rice-based food supplements for hypercholesterolemia
2023, Journal of Future FoodsRed Yeast Rice for Hypercholesterolemia: JACC Focus Seminar
2021, Journal of the American College of CardiologyCitation Excerpt :Of some interest is also the combination of RYR with plant sterols or artichoke extracts. In a double-blind, placebo-controlled, RCT evaluating the effect of phytosterols 800 mg, RYR (monacolin K 5 mg) and their association in 90 hypercholesterolemic subjects, the group treated with the nutraceutical association experienced an LDL-C reduction by 27% and apoB decrease by 19% (both, p < 0.001) (22), in line with what was reported in previous smaller trials (23,24). The association of RYR (200 mg, containing monacolin K 10 mg) and artichoke extract (500 mg) has also been recently evaluated in a double-bind, placebo-controlled, crossover clinical trial involving 30 adults in primary prevention of CVD with suboptimal LDL-C levels.
The Role of Nutraceuticals in Statin Intolerant Patients
2018, Journal of the American College of CardiologyCitation Excerpt :The increased accumulation of plant sterols and stanols in the blood and tissues leads to moderate to high plasma cholesterol levels, and increased risk of premature atherosclerosis (133). Becker et al. (134) determined the lipid-lowering effects of phytosterol tablets (900 mg twice daily) and lifestyle change in addition to RYR therapy (RYR 1,800 mg twice daily) in patients with a history of statin refusal or statin-associated myalgias (187 participants; mean LDL-C 154 mg/dl [4 mmol/l]) for 12, 24, and 52 weeks (134). The addition of phytosterol tablets to RYR did not result in further significant lowering of LDL-C levels at weeks 12, 24, or 52 compared with placebo.
Dyslipidemia
2018, Integrative Medicine: Fourth EditionRed Yeast Rice Preparations: Are They Suitable Substitutions for Statins?
2017, American Journal of MedicineCitation Excerpt :There are many publications attesting to the low-density lipoprotein-lowering properties of red yeast rice preparations. Epidemiological data of areas in China where red rice consumption is prevalent indicate lower incidence of atherosclerotic cardiovascular disease.3,11,13-16 These observations seem to justify using red yeast rice as a substitution for statins.