Phytosterols for Dyslipidemia

Jennifer M. Malinowski; Monica M. Gehret


Am J Health Syst Pharm. 2010;67(14):1165-1173. 

In This Article

Abstract and Introduction


Purpose. The efficacy and safety of phytosterols for the management of dyslipidemia are reviewed.
Summary. Phytosterols have been evaluated in over 40 clinical trials. The incorporation of 2 g of phytosterols daily into margarine, mayonnaise, orange juice, olive oil, low-fat milk, yogurt, and tablets is associated with significant reductions in low-density-lipoprotein (LDL) cholesterol from baseline over 1–12 months in adults with normal or high cholesterol, in children, and in patients with type 2 diabetes mellitus. Phytosterol dosages of 1.6–3 g daily have been shown to reduce LDL cholesterol by 4.1–15% versus placebo within the first month of therapy. One meta-analysis found mean reductions of 10–11%, but results vary. Several placebo-controlled trials found that the addition of phytosterols to statin therapy was associated with reductions of 7–20% in LDL cholesterol for up to 1.5 years. Overall, phytosterols are useful for reducing LDL cholesterol in patients who cannot reach their treatment goal by diet alone or who are taking maximum tolerated doses of statins. These products offer an alternative to statins in patients who cannot take statins or whose statin dosage is restricted because of potential drug interactions or concomitant diseases. Commonly reported adverse effects are primarily gastrointestinal in nature.
Conclusion. Phytosterol therapy produces an average 10–11% reduction in LDL cholesterol concentration, but it is unknown whether this effect persists beyond two years. Phytosterol products are well tolerated and have few drug interactions, but their long-term safety has not been established. Current evidence is sufficient to recommend phytosterols for lowering LDL cholesterol in adults.


Elevated total cholesterol and low-density-lipoprotein (LDL) cholesterol concentrations are well-established risk factors for coronary heart disease (CHD).[1] Outcomes from large clinical trials suggest that lowering total and LDL cholesterol levels with hydroxymethylglutaryl–coenzyme A reductase inhibitors (statins) reduces the morbidity and mortality associated with heart disease. Statins are also the preferred agents for decreasing LDL cholesterol levels.[1]

Unfortunately, not all patients attain their lipid goals with statin therapy alone.[1] The 2004 National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) guideline update supports aggressive LDL cholesterol reductions to as low as 70 mg/dL for additional benefit in certain patient populations.[2] This poses a potential therapeutic problem if the degree of reduction required from baseline exceeds the LDL-cholesterol-lowering capacity of available statins.

Another example of such a problem is the patient on maximal doses of statins who has reached his or her treatment goal but experiences dosage-related adverse effects, such as myalgias or elevations in liver transaminases. Although statin discontinuation is not always warranted in this situation, a dosage reduction resulting in less-effective LDL cholesterol management may be considered if statins are deemed the causative agent.[3] Combination therapies may be warranted in this case to boost the LDL-cholesterol-lowering effectiveness of the lower-dose statin.

Further, not all patients with hypercholesterolemia will need a statin. For patients with no or one risk factor for heart disease (LDL cholesterol goal of <160 mg/dL), therapeutic lifestyle changes that include a diet low in saturated fat, low in cholesterol, and high in fiber and daily physical activity may be enough to satisfy lipid goals. Patients with moderate risk (LDL cholesterol goal of <130 mg/dL) may not necessarily require statin therapy, depending on the severity of risk factors.[1] Patients with active acute liver disease or unexplained liver enzyme elevations should not take statins.[3,4]

For over 50 years, plant sterols and stanols have been known to reduce total and LDL cholesterol.[1,5] The NCEP[1] and the American Heart Association[4] recognize the benefits of plant sterols and stanols— collectively known as phytosterols—as an adjunct to therapeutic lifestyle changes in adults with elevated cholesterol levels. Two grams of esterified phytosterols daily achieves an approximate 9–20% reduction in LDL cholesterol in dyslipidemic patients, including those already taking statins.[1,4]

This article reviews the efficacy and safety of phytosterols in the management of dyslipidemia.


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