Controversial Role of Plant Sterol Esters in the Management of Hypercholesterolaemia

Oliver Weingärtner; Michael Böhm; Ulrich Laufs


Eur Heart J. 2009;30(4):404-409. 

In This Article

Do Current Guidelines for Therapeutic Lifestyle Changes have to be Reconsidered?

Since the introduction on the market of the first phytosterol enriched margarine, no cases with negative health effects have been reported. However, controlled studies are only available for an observational period of up to 1 year, for which the number of participants was low and the special effects of plant sterols were not studied separately, so that the possible pro-atherosclerotic effects due to long-term consumption could not be detected in these studies.[19,20,23,24,49] In contrast to functional foods enriched with saturated, less absorbable plant stanol esters (which reduce not only serum cholesterol, but also plant sterol levels), a diet supplementation with plant sterol esters has proven to lead to a significant increase in plant sterol levels.[20,50] Functional foods are marketed directly to consumers. In comparison to drugs, food supplements are subject to much 'weaker' authorization and control requirements, but this does not exclude the possibility that they might be hazardous.

Due to the lack of evidence regarding clinical events and the potential for negative side-effects, the 'health claim' of the US Food and Drug Administration, the NCEP ATP III guidelines, and the current diet and lifestyle recommendations of the American Heart Association should be re-evaluated. The German Drug Commission (Arzneimittelkommission der Deutschen Ärzteschaft) has stated in January 2004 that because of unclear safety data and lacking evidence of effectiveness, the general use of such products was not to be recommended.[10] Similarly, the recently revised guidelines for primary and secondary prevention of cardiovascular diseases of the National Health System (NHS) call for randomized controlled trials testing relevant clinical endpoints.[11] As long as results of such trials are pending, recommendation of functional foods or drugs supplemented with plant sterol esters to reduce serum cholesterol concentrations will be a matter of controversial debate.


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