Simvastatin vs Therapeutic Lifestyle Changes and Supplements

Becker DJ, Gordon RY, Morris PB, et al. Simvastatin vs Therapeutic Lifestyle Changes and Supplements: Randomized Primary Prevention Trial. Mayo Clin Proc 2008 Jul;83:758-764.

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MAYO CLIN PROC. 2008;83:758-764 © 2008 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH

Simvastatin vs Therapeutic Lifestyle Changes and Supplements: Randomized Primary Prevention Trial
DAVID J. BECKER, MD; RAM Y. GORDON, MD; PATTI B. MORRIS, RD; JACQUELINE YORKO, MED; Y. JEROLD GORDON, MD; MINGYAO LI, PHD; NAYYAR IQBAL, MD, MSCE 

Address reprint requests and correspondence to David J. Becker, MD, 1722 Bethlehem Pike, Flourtown, PA 19095 (dbeckerchcardiology@hotmail.com).

OBJECTIVE: To compare the lipid-lowering effects of an alternative regimen (lifestyle changes, red yeast rice, and fish oil) with a standard dose of a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin).
PATIENTS AND METHODS: This randomized trial enrolled 74 patients with hypercholesterolemia who met Adult Treatment Panel III criteria for primary prevention using statin therapy. All participants were randomized to an alternative treatment group (AG) or to receive simvastatin (40 mg/d) in this open-label trial conducted between April 1, 2006, and June 30, 2006. The alternative treatment included therapeutic lifestyle changes, ingestion of red yeast rice, and fish oil supplements for 12 weeks. The simvastatin group received medication and traditional counseling. The primary outcome measure was the percentage change in low-density lipoprotein cholesterol (LDL-C). Secondary measures were changes in other lipoproteins and weight loss.
RESULTS: There was a statistically significant reduction in LDL-C levels in both the AG (–42.4%±15%) (P<.001 and="" the="" simvastatin="" group="" no="" significant="" differences="" were="" noted="" between="" groups.="" ag="" also="" demonstrated="" reductions="" in="" triglycerides="" vs="" confidence="" interval="" to="" p=".003)" weight="" compared="" with="" group.=""> CONCLUSION: Lifestyle changes combined with ingestion of red yeast rice and fish oil reduced LDL-C in proportions similar to standard therapy with simvastatin. Pending confirmation in larger trials, this multifactorial, alternative approach to lipid lowering has promise for a subset of patients unwilling or unable to take statins.

Trial Registration:clinicaltrials.gov identifier: NCT0042

Mayo Clin Proc. 2008;83(7):758-764