A new study published in the 1 October issue of the American Journal of Cardiology confirms that statin and sterol-ester margarine used together produce a positive effect on low-density lipoprotein (LDL) cholesterol reduction in patients.
Unilever Bestfoods, maker of the Take Control spread used in the study, said that it showed that 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 study authors reported that when sterol-ester margarine is added to a statin, the effect on LDL cholesterol remains similar to that observed with use of sterol-ester margarine alone (-6 per cent versus -8 per cent). This positive 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 the Lipid Research Department at St Vincent's Hospital. "The 8 per cent LDL reduction we saw is equivalent to a doubling in the dose of statin."
The multi-centre, randomised, double-blind study was conducted in men and women with primary hypercholesterolemia (high cholesterol). The effect of the sterol-ester margarine, Unilever's Take Control, and cerivastatin together was positive (39 per cent reduction in LDL cholesterol), but there was no significant interactive effect between sterol-ester margarine and cerivastatin (p=0.29). The primary efficacy parametre 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 groups and either received statin plus plant sterol spread, statin plus regular spread, plant sterol spread plus placebo and regular spread plus placebo.
The company pointed to the recent National Cholesterol Education Program (NCEP) guidelines which encourage, after the reduction of saturated fat and cholesterol intake, eating foods with plant sterols and soluble fibre to boost the diet's LDL cholesterol-lowering power.
The NCEP has also advised that dietary and lifestyle changes should be the first line of therapy before prescribing cholesterol-lowering drugs. 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, according to an executive summary of the third report of the NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults published in JAMA last year.
"Using innovative margarine-like spreads containing plant sterols offers the more than 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's 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 per cent, their risk of heart disease would decrease up to 20 per cent," he added.
Unilever claims that Take Control spread, or Becel/Flora pro.activ outside the US, has been proven in more than 30 clinical studies to reduce LDL, or "bad" cholesterol by 10 per cent and that an independent study showed that individuals who consumed Take Control and also changed to a heart-healthy diet lowered their LDL cholesterol by 17 per cent.