Exposure and effectiveness of phytosterol/-stanol-enriched margarines

Studies on effectiveness of phytosterol/-stanol-enriched margarines in the community have received low priority. For postlaunch monitoring purposes including risk-benefit analyses, it is needed to investigate both exposure and effectiveness of these margarines.

To study the use and effectiveness of phytosterol/-stanol-enriched margarine.

The study population consisted of 2379 subjects that participated in a community intervention study ('Hartslag Limburg') aged 28-76 years. In 1998 and 2003, blood samples for total and high-density lipoprotein (HDL) cholesterol were obtained. A general questionnaire and food frequency questionnaire (FFQ) were administered. From 1999 onwards, phytosterol/-stanol-enriched margarines were introduced on the Dutch market. On the basis of 2003 data, subjects were classified in users of (a) phytosterol/-stanol-enriched margarine, (b) cholesterol-lowering drugs, (c) the combination (both enriched margarine and drugs) and (d) neither enriched margarines nor cholesterol-lowering drugs.

Mean (+/-s.d.) daily intake of phytosterol-enriched margarine (n=99) and phytostanol-enriched margarine (n=16) was 14+/-9 g. From 1998 to 2003, total serum cholesterol concentration changed significantly different among the four groups: in the combination users -2.04+/-1.50 mmol/l (-29%), in cholesterol-lowering drug users -1.09+/-1.17 mmol/l (-17%), in the enriched margarine users -0.24+/-0.75 mmol/l (-4%) and in non-users +0.10+/-0.72 mmol/l (+2%)(P<0.05).

Recommended doses are not consumed, but phytosterol/-stanol-enriched margarines can modestly reduce serum total cholesterol in the community. These margarines cannot equal the effect of cholesterol-lowering drugs, but may act additively. Further investigation of the health effects that may occur during simultaneous cholesterol lowering drugs and phytosterol-or -stanol-enriched margarines usage is important, as well as community education about the cholesterol lowering foods and drugs.

Netherlands Organization for Health Research and Development (ZonMW) (data collection of Hartslag Limburg and further data- analyses).