Cholesterol lowering margarine launched in United Kingdom
BMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7189.960a (Published 10 April 1999) Cite this as: BMJ 1999;318:960All rapid responses
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Six years ago I (1) and others (2) questioned the benefits of using
cholesterol-lowering margarines for the primary prevention of coronary
heart disease (CHD). Now a review article (3) describes further findings
on using such functional foods. The review compares plant stanol-ester
spreads with plant sterol-ester spreads.
Significant reductions in serum beta-carotene are not considered
relevant because vitamin A was unaffected and because these reductions can
be prevented by eating fruit and vegetables. Increases in serum plant
sterols during plant sterol consumption are a subject of debate because
high sterol levels have been associated with atherogenesis and CHD.
Only two longer-term studies, over one year, have been reported on
the use of these plant esters. Total and low density lipoprotein (LDL)
cholesterol concentrations were reduced significantly in women and men by
about 10% and 14% respectively during plant stanol ester consumption. Such
modest cholesterol reductions may not be sufficient to reduce CHD event
rates as demonstrated with Pravastatin in over 10,000 moderately hyper-
cholesterolaemic subjects(4).
In a second longer-term study consumption of plant sterol esters for
one year did not change total and LDL cholesterol levels in women(5). In
men only LDL cholesterol, but not total cholesterol, was significantly
reduced by only 5 to 7%. It is suggested that increased cholesterol
synthesis in response to reduced cholesterol absorption and decreased
cholesterol elimination during plant sterol consumption are factors that
may ultimately prevent consistent cholesterol reductions.
The review concludes that further studies are needed on efficacy and
safety of plant sterol ester margarine consumption. It is considered that
stanol esters may be successful for CHD prevention, but outcome data on
clinical events is not presented.
Ten years after these functional foods were first marketed, we still
do not have convincing evidence that they are effective as monotherapy in
the prevention of cardiovascular disease.
References:
1) van Heyningen C.
Cholesterol lowering margarine may not be useful in healthy fat modified
diet. BMJ 1999, 319, 186.
2) Larkin M. Functional foods nibble away at serum cholesterol
concentrations
Lancet, 2000, 355, 555
3) Gylling H, Miettinen TA.
The effect of plant stanol - and sterol – enriched foods on lipid
metabolism, serum lipids and coronary heart disease.
Ann Clin Biochem 2005, 42, 254 – 263
4) ALLHAT Officers and Coordinators for the ALLHAT Collaborative
Research Group. The Antihypertensive and Lipid-Lowering Treatment to
Prevent Heart Attack Trial.
Major outcomes in moderately hypercholesterolaemic, hypertensive patients
randomised to Pravastatin vs usual care: The Antihypertensive and Lipid-
Lowering Treatment to Prevent Heart Attack Trial.
(ALLHAT-LLT).
JAMA 2002, 288 (23), 2998-3007
5) Hendricks HFJ, Brink EJ, Meijer GW, et. al.
Safety of long-term consumption of plant sterol esters – enriched spread.
Eur. J Clin Nutr 2003, 57, 681-92
Competing interests:
None declared
Competing interests: No competing interests
A cholestrol lowering margarine - Benecol - which reduces intestinal
cholesterol absorption, was launched in the UK in April (1). National
press advertisements indicate that it reduces serum LDL cholesterol by an
average 14% when taken as three servings daily with a healthy diet. The
reference given relates to a study on mildly hypercholesterolaemic
subjects in North Karelia, Finland (2). During this study dietary fat
intake was about 35% of total energy intake with a cholesterol intake
above 300mg pr day. A mean reduction in total cholesterol of 7.4% was
achieved after 6 months, and of 10.2% after 12 months. Such a 10%
cholesterol reduction translates into a 13% reduction in coronary
disease risk over 10 years using the computer program for risk estimation
provided with the new British guidelines (3).
A review of clinical trials with phytosterols found that the serum
lipid response varies widely (LDL cholesterol reductions between 2 and
33%) depending on study design, amount of phytostrol intake and initial
cholesterol levels (4). When used with a low fat and cholesterol (less
than 200mg cholesterol/day) intake, sitostanol, at the same dose as used
in the North Karelia study, failed to show a significant cholesterol
lowering effect (5).
Hence the evidence suggests to me that those consuming an average
British diet may well show a cholesterol lowering response with this
margarine, but on a healthy fat-modified diet this costly product is
unlikely to further reduce lipid levels.
Dr Charles van Heyningen
Consultant Chemical Pathologist
Clinical Laboratories
University Hospital Aintree
Longmoor Lane
Liverpool L9 7AL
References
1 Mayer. S. Cholesterol lowering margarine launched in United
Kingdom (News) BMJ 1999, 318, 960.
2 Miettinen, T.A., Puska, P., Gylling, H., Vanhanen, H., and Vartiainen
E. Reduction of serum cholesterol with
sitostanol-ester margarine in a mildly hypercholesterolemic
population. N. Engl. J. Med. 1995. 333: 1308-1312.
3 Joint British recommendations on prevention of coronary heart disease
in clinical practice. Heart 1998, 80 (supplement 2) S1 - S29.
4 Jones, P.J., MacDougall, D.E., Ntanios, F., and Vansone, C.A. Dietary
phytosterols as cholesterol-lowering agents in humans. Can. J. Physiol.
Pharmacol 1997. 75:217-227.
5 Denke, M.A. Lack of efficacy of low-dose sitostanol therapy as an
adjunct to cholesterol-lowering diet in men with moderate
hypercholesterolaemia. Am.J.Clin.Nutri. 1995. 61:392-396.
Competing interests: No competing interests
Editor,
The British Medical Journal house style seems to demand universal
abolition
of hyphens in compound adjectives. Thus, your editors are, apparently,
required to write 'cholesterol lowering drug prices' (i.e. cholesterol is
reducing drug prices) when what is really meant is 'cholesterol-lowering
drug prices' (i.e. the prices of cholesterol-lowering drugs).
A recent heading in the BMJ immediately suggests that cholesterol is
lowering margarine, whatever that may mean. This oddly perverse editorial
policy must have annoyed many literally-minded readers other than myself.
Why not conform, like most other articulate publications, including
The
Lancet, to the long-established and sensible practice of using hyphens for
the simple purpose of avoiding ambiguity?
Yours faithfully,
Robert Youngson
Blandford Forum
Dorset DT11 7NY
Competing interests: No competing interests
It was my predecessor, a first class grammarian, who abolished
hyphens.
He had, as I remember, four main reasons. Firstly, authors (and editors)
regularly put the hyphens in the wrong place. Secondly, most sentences
can be recast to avoid ambiguity. Thirdly, hyphens are old fashioned.
Fourthly, many authors had a tendency to overuse them. We have continued
his policy with some relaxation. Careful readers will spot hyphens in
the BMJ.
Dr Youngson's example of misuse is a poor one. I suggest that he
tries
asking a hundred people what the title "Cholesterol lowering margarine
launched in United Kingdom" might mean. I don't think that any will
misinterpret the meaning.
Richard Smith
Editor
Competing interests: No competing interests
Benecol may possibly lower serum cholesterol, but a high cholesterol
is not a disease. It is highly unlikely that Benecol prevents coronary
heart disease just because it lowers the cholesterol concentration as the
combined results from eight ecological, four dynamic population, 41 cross-
sectional, 25 cohort, and six case-control studies as well as a meta-
analysis of nine, controlled, randomised trials strongly contradict an
influence of dietary saturated and polyunsaturated fats on atherosclerosis
or coronary heart disease (1).
That the serum cholesterol concentration was unchanged at follow-up in the
only successful dietary trial (2) is in accord with the observation from
the statin-trials (3), as well as from the previous cholesterol lowering
trials (4), that any treatment effect is independent on the degree of
cholesterol lowering. Lack of dose-response is a strong argument against
causality indicating that a high serum cholesterol is only a risk marker
which is secondary to other, more important factors; it therefore seems
without meaning to exchange nutritious and palatable natural fats with a
chemical product with unknown long-term effects.
Besides, the decrease of coronary mortality seen in North Karelia was not
due to the Karelia project because mortality decreased also in the rest of
Finland, where no health education was given (5).
Uffe Ravnskov
1. Ravnskov U. The questionable role of saturated and polyunsaturated
fatty acids in cardiovascular disease. J Clin Epidemiol. 1998;51:443-60
2. de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, et
al. Mediterranean alpha-linolenic acid-rich diet in secondary prevention
of coronary heart disease. Lancet 1994;343:1454-9
3. Sacks FM, Moyé LA, Davis BR, Cole TG, Rouleau JL, Nash DT et al.
Relationship between plasma LDL concentrations during treatment with
pravastatin and recurrent coronary events in the cholesterol and recurrent
events trial. Circulation 1998;97:1446-52.
4. Ravnskov U. Cholesterol lowering trials in coronary heart disease:
frequency of citation and outcome. BMJ 1992;305:15-9
5. Oliver MF. North Karelia project. Lancet 1987;2:517-8.
Competing interests: No competing interests
Re: Long-Term Benefit of Cholesterol Lowering Foods
of evidence, after 10 years, of actual heart disease reduction, leave alone
mortality benefit, from cholesterol absorption reducing margarines.
Let me make 3 points:
1. The only margarine with an all-cause mortality benefit is
a high omega-3 canola (colza/rape) product used in the Lyon
Study (1); it took a post infarct patient group of 600 and only
2.25 years before the ethics people halted the trial for demonstrated benefit
despite no difference in cholesterol.
2. Two other anti-cholesterol absorption drugs, ezetimibe and resin sequestrant are both without mortality benefit with the most telling evidence being for the sequestrant LRC
trial where 1900 mean 49 year old U.S. males in the top 0.8% for cholesterol experienced an insignificant 3 fewer deaths after 7.4 years than the same sized placebo group (2).
3. Finally, in 41,801 hypercholesterolemic Japanese [baseline ~270 mg/dL] on cholesterol lowering simvastatin, the J-LIT
study ended with significantly greater mortality in the lowest cholesterol groups (3):
[figure: http://www.health-heart.org/J-LIT_BMJ.gif ]
Based on the foregoing, spending £2.49 for 250 grams of cholesterol lowering margarine is arguably the very least cost effective way of trying to extend one's healthy life. vos{at}health-heart.org
1. Leaf A. Dietary
Prevention of Coronary Heart Disease The Lyon Diet Heart Study
Dietary Prevention of Coronary Heart Disease The Lyon Diet Heart Study.
Circ. 1999;99:733-5. Medline 9989956.
2. No authors listed. The
Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction
in incidence of coronary heart disease. JAMA. 1984 Jan 20;251(3):351-64.
Medline 6361299.
3. Matsuzaki M, Kita T, Mabuchi H, Matsuzawa Y, Nakaya N et al.
Large
scale cohort study of the relationship between serum cholesterol concentration
and coronary events with low-dose. Circ J. 2002 Dec;66(12):1087-95.
Medline 12499611
Competing interests:
None declared
Competing interests: No competing interests