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Plant stanol ester: Evidence based dietary management of hypercholesterolemia Food Matters Live London, November 23rd, 2016 Susanna Rosin, MSc, MA, Authorized Nutritionist Marketing Manager, Healthcare Professional Communication, Raisio Group, Finland
Content
2
Why is cholesterol-lowering important?
The role of diet in the management of hypercholesterolemia
Clinical evidence behind plant stanol ester
Optimal implementation of a cholesterol-lowering diet
11.10.2012 3 3
Why is cholesterol lowering important?
Reduction in LDL-C results in reduced rate of vascular events
4
Cannon et al. N Engl J Med 2015; 372: 2387-2397.
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7
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11.10.2012 9 9 CONFIDENTIAL – Copyright®Raisio
The role of diet in the management of hypercholesterolemia
”A healthy diet is recommended as a cornerstone of CVD
prevention in all individuals.”
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12
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Lipid management
through
healthy dietary choices
can be safely
implemented
from early age
”Preventing heart attacks by lowering LDL:
It’s not how low but how long”
Professor, Nobel Prize Winner Michael S Brown
Evidence-based cholesterol-lowering diet • Replace saturated fat with unsaturated fat
• LIMIT animal fat (dairy fat, fatty meats etc.) and tropical oils
• PREFER vegetable oils and soft margarines, fish, nuts Approximate reduction in LDL-C: 8-10%
• Eat more soluble fiber • EAT MORE fiber-rich whole grains, vegetables, fruits
and berries Approximate reduction in LDL-C: 3-5%
• Include products with added plant stanols • REPLACE currently used products with Benecol
products Approximate reduction in LDL-C: 7-12%
1. International Atherosclerosis Society, 2013 2. American Diabetes Association, 2013 3. European Atherosclerosis Society and
European Society of Cardiology, 2016
11.10.2012 17 17
Clinical evidence behind Plant stanol ester
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Plant stanol ester
Plant stanol ester significantly reduces LDL-cholesterol concentration
Plant stanol ester • Reduces total and LDL- cholesterol dose-dependently in the magnitude of 10%
• Does not affect HDL-cholesterol
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CONSUMPTION OF 1.5-3.0 G/D OF PLANT STANOLS REDUCES LDL-CHOLESTEROL DOSE-DEPENDENTLY BY 7-12.5% IN 2 TO 3 WEEKS
Mechanism of action
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WITH PLANT STANOLS ~20% of cholesterol is absorbed
WITHOUT PLANT STANOLS ~50% of cholesterol is absorbed
Cholesterol Plant stanol ester
Plant stanol ester reduces cholesterol absorption in the small intestine.
Proven efficacy The cholesterol lowering efficacy of plant stanol ester has been shown in over 70 clinical studies:
• In women, men and children • In normocholesterolemic subjects • In subjects with modestly elevated or high cholesterol levels • In individuals with type 1 or type 2 diabetes • In individuals with the metabolic syndrome • In patients with CAD • In individuals with familial hypercholesterolemia • As a part of habitual diet • As a part of strict cholesterol lowering diet • In conjunction with statin medication • In different populations all over the world
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Plant stanol ester
(1.5-3 g/d plant stanols) reduces LDL-C
by 7-12.5%, on average
22 Athyros et al. Nutr Metab Cardiovasc Dis 2011; 21(3): 213-221.
Control spread
Mediterranean diet
Plant stanol ester spread (2 g plant stanol/d)
CHANGE IN LDL-CHOLESTEROL SURING THE INTERVENTION IN CONTROL GROUP AND THE TWO STUDY GROUPS
*
* Red
uct
ion
in L
DL-
C (
%)
Months
* * *
*p <0.01 vs. control
Plant stanol ester lowers LDL-cholesterol fast
Miettinen et al. New Engl J Med 1995; 333: 1308-1312. 23
The efficacy of plant stanol ester is sustained with continuous consumption
Plant stanol ester spread (1.8 g plant stanols/d)
Control spread
Plant stanol ester spread (2.6 g plant stanols/d)
CHANGE IN SERUM TOTAL CHOLESTEROL CIONCENTRATION IN STUDY AND CONTROL GROUPS
* *
Ch
ole
ster
ol (
mg/
dl)
Months
*p<0.05 vs. control
* * *
*
Hallikainen and Uusitupa. Am J Clin Nutr 1999; 69: 403-410.
Additive effect to other healthy dietary changes
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Cholesterol-lowering diet
Cholesterol-lowering diet + plant stanol ester (2.3 g plant stanol/d)
Ch
ange
% in
LD
L-ch
ole
ster
ol
PLANT STANOL ESTER GIVES A SPECIFIC EFFECT ON TOP OF THE EFFECT OF A STRICT CHOLESTEROL-LOWERING DIET
*Plant stanol ester specific effect a= p<0.01 vs. baseline
b= p<0.001 vs. baseline and p<0.01 vs. control
LDL-cholesterol
a
b
Blair et al. Am J Cardiol 2000; 86: 46-52.
Control spread
* * *
INCREMENTAL LDL-CHOLESTEROL LOWERING WITH PLANT STANOL ESTER IN STATIN USERS
Plant stanol ester spread (3 g plant stanol/d)
Ch
ange
in L
DL-
cho
lest
ero
l (%
)
Weeks
10 % plant stanol ester specific effect
Additive effect to statins
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*p<0.001 vs. control
Recognized effect
• Plant stanol ester has been granted strong health claims by the
• EU Commission
• US FDA
• Several international cardiovascular guidelines recommend consumption of functional foods with plant stanols as part of the cholesterol-lowering diet
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Plant stanol ester has been shown to
lower blood cholesterol.
High cholesterol is a risk factor in the
development of coronary heart
disease.
• European Society of Cardiology & European Atherosclerosis Society, 2016 • European Society of Cardiology, 2016 • American College of Cardiology, 2016 • American Diabetes Association, 2016 • National Lipid Association, 2015 • European Atherosclerosis Society, 2014 • Joint British Societies, 2014 • International Atherosclerosis Society, 2013 • European Atherosclerosis Society, 2013 • National Heart, Lung, and Blood Institute & National Institutes of Health & American Academy of Pediatrics, 2011 • The Australian Heart Foundation, 2009 • American Diabetes Association & American College of Cardiology, 2008 • Joint WHO/FAO Expert Consultation, 2003
Cardiovascular guidelines encourage the use of plant stanols for cholesterol reduction
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11.10.2012 28 28 CONFIDENTIAL – Copyright®Raisio
Optimal implementation of a cholesterol-lowering diet
Cholesterol reduction in primary prevention according to guidelines1-3
.. including plant stanol ester..
.. if not enough, start pharmaceuticals
Usually statins
Healthy lifestyle and diet..
1. International Atherosclerosis Society, 2013 2. American Diabetes Association, 2013 3. European Atherosclerosis Society, and
European Society of Cardiology, 2016 29
Plant stanols are recommended for1-8
1. Individuals with high LDL cholesterol at low or intermediate cardiovascular risk who do not qualify for statin therapy
2. High and very high risk patients, such as patients with diabetes, who fail to reach their LDL-cholesterol targets on statins alone, or are statin intolerant
3. Adults and children with familial hypercholesterolemia (FH)
1) Gylling et al. EAS Consensus Paper. Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Atherosclerosis 2014; 232: 346-360. 2)
Reiner et al. ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J 2011; 32: 1769–1818. 3)Piepoli et al. 2016 European Guidelines on cardiovascular disease prevention in
clinical practice. Eur Heart J 2016. doi:10.1093/eurheartj/ehw106. 4) International Atherosclerosis Society. IAS Position Paper: Global Recommendations for the Management of Dyslipidemia,
2013. 5) American Diabetes Association. Cardiovascular disease and risk management. Sec. 8. In Standards of Medical Care in Diabetes 2016. Diabetes Care 2016; 39: S60–S71. 6) Expert
Panel on Integrated Guidelines for Cardio vascular Health and Risk Reduction in Children and Adolescents: Summary Report. Pediatrics 2011; 128: S213 -S256. 7) Nordestgaard et al. EAS
Consensus Paper. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease Eur Heart J 2013;
34 (45): 3478-3490. 8) Stroes et al. EAS Consensus Paper. Statin- associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on
Assessment, Aetiology and Management. Eur Heart J 2015; 36 (17): 1012-1022.
For full cholesterol-lowering benefit use foods with added plant stanols
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Daily
In recommended amounts
As part of meals
Together with other heart-healthy dietary choices
