ENGLEWOOD CLIFFS, N.J., Oct. 11 /PRNewswire/ -- A new study published in the American Journal of Cardiology confirms that statin and sterol-ester margarine used together produce a purely additive effect on low-density lipoprotein (LDL) cholesterol reduction in patients. These cholesterol-lowering spreads, which contain plant sterols, may provide doctors with a useful alternative to higher dose statins to reduce their patients LDL or "bad" cholesterol.
The authors reported that when sterol-ester margarine is added to a statin, the additive effect on LDL cholesterol remains similar to that observed with use of sterol-ester margarine alone (-6% vs -8%). This additive effect is equivalent to doubling the dose of statin. No effect was seen on HDL or "good" cholesterol.
"These findings are particularly good news for doctors keen to find a dietary complement to statins in their patients," said Dr. Leon Simons, lead author of the study and professor of Lipid Research Department, St. Vincent's Hospital. "The 8% LDL reduction we saw is equivalent to a doubling in the dose of statin."
This multi-center, randomized, double-blind study was conducted in men and women with primary hypercholesterolemia (high cholesterol). The effect of sterol-ester margarine, Take Control, and cerivastatin together was additive (39% reduction in LDL cholesterol, but there was no significant interactive effect between sterol-ester margarine and cerivastatin (p=0.29). The primary efficacy parameter was the percentage change in LDL cholesterol between baseline and at the end of 4 weeks' treatment. The subjects were divided into four parallel treatment group and either received statin plus plant sterol spread, statin plus regular spread, plant sterol spread plus placebo and regular spread plus placebo.
In May 2001, the National Cholesterol Education Program (NCEP), coordinated by the National Heart, Lung and Blood Institute (NHLBI), issued new cholesterol guidelines that include a more intense and effective eating plan. The first step in the plan is the reduction of saturated fat and cholesterol intake. The NCEP program also encourages, as a further step, eating foods with plant sterols and soluble fiber to boost the diet's LDL cholesterol-lowering power. In fact, the NCEP concludes that dietary and lifestyle changes should be the first line of therapy before prescribing cholesterol-lowering drugs.(1) As a result of these guidelines, it is expected that the number of Americans using dietary treatment to lower their cholesterol will increase from 52 million to 65 million.(1)
"Using innovative margarine-like spreads containing plant sterols offers the over 100 million Americans battling high cholesterol an easy way to lower cholesterol and reduce their risk of heart disease," said Dr. Ernst Schaefer, a physician and professor of Medicine at Tufts University, School of Medicine, Endocrinology and Lipids Division. "These spreads are one of the most significant developments in the dietary management of cholesterol in 30 years. If Americans were to lower cholesterol by 10%, their risk of heart disease would decrease up to 20%," he said.
Take Control spread, which contains plant sterol esters, has been proven in more than 30 clinical studies to reduce LDL, or "bad" cholesterol by 10%.*(2) Moreover, an independent study showed that individuals who consumed Take Control and also changed to a heart-healthy diet lowered their LDL cholesterol by 17%.(3) Take Control is available in supermarkets throughout the U.S. and can be found in the margarine section of the dairy case.
Unilever, the parent company of Unilever Bestfoods, is the world's leading manufacturer of margarines and spreads, with category expertise extending back more than seven decades. Outside the U.S., Take Control(R) is marketed under the brand name, Becel/Flora pro.activ. More information on Take Control products can be found at http://www.takecontrol.com.
Unilever is one of the world's largest consumer product companies with sales in excess of $45 billion. It produces and markets a wide range of foods, home and personal care products.
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* Take Control may reduce the risk of heart disease, as part of a diet low in saturated fat and cholesterol. At least .65g natural soybean extract (plant sterol esters) should be eaten twice a day. Take Control provides 1.7g plant sterol esters per serving. Take Control is not a low fat food.
(1) Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Journal of the American Medical Association 2001; Vol. 285, No. 19, 2486-2497.
(2) Individual results will vary. Hendriks HFJ; Weststrate JA; Van Vliet T; Meijer GW: Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. European Journal of Clinical Nutrition (1999) 53, 319-327; Neil HA; Meijer GW; Roe LS: Randomised controlled trial of use by hypercholesterolaemic patients of a vegetable oil sterol-enriched fat spread. Atherosclerosis (2001) 156: 329-337.
(3) Judd JT, Baer DJ, Chen, SC, Clevidence BA, Muesing RA, Kramer M, Meijer GW (2002). Plant Sterol Esters Lower Plasma Lipids and Most Carotenoids in Mildly Hypercholesterolemic Adults. Lipids 37: 33-42.