Phytosterols for Dyslipidemia

Jennifer M. Malinowski; Monica M. Gehret


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

In This Article


Phytosterols are useful for reducing LDL cholesterol in patients who cannot reach their LDL cholesterol goals by diet alone (lower-risk groups) or who are taking maximum tolerated doses of statins (higher-risk groups). These products offer an alternative to statins in patients who cannot take statins (active liver disease) or whose statin dosage must be restricted because of potential drug interactions (concomitant fibrate administration) or diseases (renal disease). Patients with normal cholesterol levels should not be encouraged to take these products based on a lack of efficacy and safety data in this population.

The NCEP ATP III does not differentiate between stanol esters or sterol esters.[1] Therefore, product selection can be based on patient preference and cost. Of course, patients' taste preferences and convenience preferences should also be considered early. Cost is another concern with some of the products. Phytosterol-containing foods are typically more expensive than the same foods without phytosterols. Some patients, in an effort to save money, may ask whether cholesterol lowering is observed with smaller serving sizes than recommended. It is not known if a benefit would be observed, though some products with higher concentrations of phytosterols may offer a benefit at lower doses. FDA allows products to claim that their use reduces patients' risk of heart disease if they contain the following daily amounts: 1.3 g of plant sterol esters, 3.4 g of plant stanol esters, or 800 mg of free phytosterols.[78] One A Day Cholesterol Plus (Bayer Healthcare) does not contain this specified amount and should not be recommended for cholesterol lowering.

Patients should consider the caloric and fat content of available products to avoid excessive intake. The fat content in some food sources such as margarine contributes to increased saturated fat consumption. While the phytosterol-containing spreads may be a good substitute for patients desiring a replacement for regular margarine or butter, they may not be the best way to introduce phytosterols into a diet that does not already incorporate butter spreads. Because of the sugar content and acidity, orange juice formulations should be used with caution in patients with diabetes mellitus and reflux esophagitis. Dairy products containing phytosterols may be useful in patients trying to increase their calcium intake through diet, though these products may not be available in all markets.

Phytosterols supplied as supplements are another alternative but will contribute to the overall "pill burden" for the patient. It is important to clarify to patients that vitamins containing phytosterols must be taken twice daily for the full effect, especially since most vitamins are taken once daily. Whether one product is superior to another is unknown.

A diet rich in fruits and vegetables, concomitant multivitamin administration, or both should be considered to counteract potential reductions in β-carotene absorption. Phytosterols should be avoided in children and in women who are pregnant or lactating until additional safety data become available. More research is needed to evaluate whether the reduced absorption associated with plant stanols versus plant sterols is clinically relevant. Reduced systemic absorption of plant stanols may be a potential advantage, but their adverse-effect profile is similar to that of plant sterols. Most products on the market contain sterol esters, with the exception of Benecol (McNeil). Studies evaluating effectiveness and safety beyond two years are needed.

Definitive studies may never be available for phytosterols. Large trials enrolling 10,000–15,000 people would be needed to provide appropriate power for an anticipated CHD reduction of 12–20%.[18] Surrogate marker (e.g., reduction in intima media thickness) trials may be available in the future. Although the products are helpful in lowering LDL cholesterol, it is unknown whether a morbidity or mortality benefit exists.


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