American Journal of Cardiology
Volume 97, Issue 3 , Pages 376-379, 1 February 2006

Effect of Plant Stanol Tablets on Low-Density Lipoprotein Cholesterol Lowering in Patients on Statin Drugs

  • Anne C. Goldberg, MD

      Affiliations

    • Department of Internal Medicine, Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis, Missouri
  • ,
  • Richard E. Ostlund Jr, MD

      Affiliations

    • Department of Internal Medicine, Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis, Missouri
  • ,
  • Joyce H. Bateman, RD

      Affiliations

    • Department of Internal Medicine, Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis, Missouri
  • ,
  • Linda Schimmoeller, RN

      Affiliations

    • Department of Internal Medicine, Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis, Missouri
  • ,
  • Timothy B. McPherson, PhD

      Affiliations

    • Southern Illinois University, Edwardsville, School of Pharmacy, Edwardsville, Illinois
  • ,
  • Curtis A. Spilburg, PhD

      Affiliations

    • Lifeline Technologies, Chesterfield, Missouri.
    • Corresponding Author InformationCorresponding author: Tel: 636-537-1382; fax: 636-537-1981.

Received 12 July 2005; received in revised form 22 August 2005; accepted 22 August 2005. published online 01 December 2005.

The objective of this study was to show that plant sterols in tablet form provide additional low-density lipoprotein (LDL) cholesterol lowering for patients on statin therapy. Dispersible phytosterol tablets were tested in a double-blind, placebo-controlled, parallel clinical trial. Twenty-six patients who were following the American Heart Association Heart Healthy Diet and on long-term statin therapy were studied for 9 weeks. After 3 weeks of placebo treatment, the subjects were randomized to receive either 1.8 g of soy stanols or placebo for 6 weeks in addition to their usual statin regimen. Stanol tablets reduced LDL cholesterol 9.1% (p = 0.007) or 12.2 mg/dl. Total cholesterol was reduced by 12.9 mg/dl (p = 0.03). A strong inverse correlation (rs = −0.82, p = 0.0007) was found between the baseline LDL cholesterol and the percent change in LDL cholesterol observed after stanol treatment. The additional LDL cholesterol lowering with stanol/lecithin tablets provided a potential adjunctive therapy for patients who have not reached their target LDL cholesterol goal during statin therapy.

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 This study was supported by Lifeline Technologies, Chesterfield, Missouri, and a Small Business Innovation Research Grant R43 HL 62780 from the National Institutes of Health, Bethesda, Maryland.

PII: S0002-9149(05)01826-6

doi:10.1016/j.amjcard.2005.08.056

American Journal of Cardiology
Volume 97, Issue 3 , Pages 376-379, 1 February 2006