Presentation is for healthcare professionals only. Benecol foods and food supplements with plant stanol ester are proven to lower blood cholesterol. Presentation about the scientific background of plant stanol ester and reducing blood cholesterol with it.

1. Benecol products with
plant stanol ester are
proven to lower
cholesterol
Information for healthcare professionals only

2. Cardiovascular diseases (CVDs), including coronary heart
disease (CHD), are the leading cause of mortality globally.
Hypercholesterolemia, especially high LDL cholesterol is one
of the main risk factors for coronary heart disease.

3. Diet and lifestyle changes are the cornerstones
of cholesterol management.

4. Functional foods contain a functional ingredient, either naturally
or by addition, that provides a documented health benefit.
Daily use of functional foods promotes health in long term.

5. Benecol is a family of functional foods and food supplements
which contains a unique cholesterol-lowering ingredient Plant
stanol ester.
Mode of action

6. Benecol products with plant stanol ester provide
fast results and keep cholesterol at a lower level.

7. Back
Plant stanol ester lowers cholesterol by
reducing the absorption of cholesterol in
the small intestine.

8. Benecol with plant stanol ester – efficacy has been
clinically proven in more than 70 published clinical studies.
International cardiovascular guidelines recommend Plant
stanol ester as part of the dietary management of elevated
blood cholesterol.

9. Key guidelines recommending plant stanol ester
Recommending body Guideline
Published/
updated in Key messages regarding the consumption of Plant stanol ester
International Atherosclerosis
Society
An International Atherosclerosis
Society Position Paper: Global
Recommendations for the
Management of Dyslipidemia
2013
• Plan stanols are a useful adjunct to the lowering of LDL-C by dietary means
• Intakes of about 2g/day of plant stanols will reduce serum LDL cholesterol levels by
about 10%
The Sixth Joint Task Force of the
European Society of Cardiology
and Other Societies on
Cardiovascular Disease Prevention
in Clinical Practice
2016 European Guidelines
on Cardiovascular disease
prevention in clinical
practice
2016
• Functional foods containing plant stanols are effective in lowering LDL cholesterol
levels by, on average, 10% when consumed in amounts of 2 g/day
• The cholesterol-lowering effect is achieved in addition to that obtained with a low-fat
diet or use of statins
• Further cholesterol reduction can be obtained with higher daily doses
National Heart, Lung, and Blood
Institute (USA); National Institute
of Health (USA); American
Academy of Pediatrics (USA)
Integrated Guidelines for
Cardiovascular Health and
Risk Reduction in Children and
Adolescents
2011
• Plant stanols are recommended for children with primary elevations in their LDL
cholesterol levels who are not reaching the LDL target values with dietary treatment
alone. With such an approach, the necessity of drug treatment may be avoided
• Plant stanol products can be used after 2 years of age in children with familial
hypercholesterolemia
European Society of Cardiology
(ESC) and the European
Atherosclerosis
Society (EAS)
2016 ESC/EAS Guidelines for
the Management of
Dyslipidemias
2016
• The cholesterol-lowering efficacy of plant stanols has been shown to be 7–10%
• Based on the LDL-C lowering effect and the absence of adverse signals, functional foods
with plant stanols (at least 2 g/day with the main meal) may be considered:
1. in individuals with high cholesterol levels at intermediate or low global CV risk who do
not qualify for pharmacotherapy;
2. as an adjunct to pharmacologic therapy in high- and very high-risk patients who fail to
achieve LDL-C goals on statins or are statin intolerant;
3. in adults and children (.6 years) with FH, in line with current guidance

10. Plant stanol ester (1.5-3 g/d plant stanols) reduces LDL-cholesterol
dose-dependently by 7-12.5%, on average, in 2 to 3 weeks.
The effect is maintained when plant stanol ester is consumed daily
as part of meals.

11. Benecol foods and food supplements with plant stanol ester-
An easy way to lower cholesterol for all.
Patient groups

12. Plant stanol ester in Benecol products has been proven effective
and well-tolerated in different patient groups.
Diabetes
Cardiovascular
disease
Familial
hypercholesterolemia
Bac

13. Plant stanol ester is
recommended for three patient target groups
3. Patients with familial
hypercholesterolemia
1. Low CVD risk
patients who can
manage their
hypercholesterolemia
with diet and lifestyle
2. High risk patients
who need other
effective cholesterol-
lowering methods on
top of their statin
medication or are
statin intolerant

14. • International guidelines1-8 encourage to consider
plant stanol ester as part of the management of
raised cholesterol for the following three patient
groups:
1. Individuals with high LDL-cholesterol at low or inter mediate
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
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. Catapano et al. 2016 ESC/EAS Guidelines for the management of dyslipidaemias. Atherosclerosis
2016; 253: 281-344. 3. Piepoli et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2016; 37:
2315-2381. 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. Standards of Medical Care in Diabetes. Cardiovascular
Disease and Risk Management. Diabetes Care 2017; 40: S75–S87. 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

15. Benecol with plant stanol ester -
Complements other lifestyle changes
and medical treatment.
Plant stanol ester Plant stanol ester
+ healthy diet
Plant stanol ester
+ statin

16. The cholesterol-lowering effect of Plant stanol ester is additive
to other cholesterol-lowering dietary changes and statin
medication.
Back

17. Plant stanol ester – Approved health claim in EU
Based on a scientific evaluation by the European Food Safety Authority EFSA, the
European Commission has authorized an Article 14 health claim (Disease risk reduction
health claim) for Plant stanol ester. Article 14 health claims are the strongest possible
health claims for foods.

18. Key clinical studies on plant stanol ester 1/4
Gylling and
Miettinen 1994
N
11
Subjects
Type II
diabetics
Food
format
margarine
Baseline
diet
normal diet
Plant
stanols
/ day *
3 g
Time of
intervention
6 weeks
Change in LDL
cholesterol
vs. control
-9%
*as plant stanol ester
Main observation about the
effect of plant stanol ester
• Well tolerated
• Reduced cholesterol absorption effectively
• Reduced total and LDL cholesterol levels
Miettinen et al.
1995
153
mildly
hyperholest
erolemic
margarine normal diet
Group 1: 2.6 g
Group 2: 6
months 2.6 g,
after which 6
months 1.8 g
52 weeks
Group 1:
-13%
Group 2:
-9%
• Appr. 2 g/day of plant stanols lowered
effectively total and
• LDL cholesterol, but did not change HDL
cholesterol levels
• The cholesterol-lowering efficacy was
sustained as long as plant stanols were
included in the daily diet
Gylling et al.
1997 22
post-
menopausal
women with
coronary
artery
disease
margarine
low fat, low
cholesterol diet
3 g 7 weeks -15%
• Reduced cholesterol level also in secondary
prevention
• Reduced absorption of both biliary and dietary
cholesterol
• Cholesterol absorption reduced by appr. 45%.
Hallikainen and
Uusitupa 1999 35
mildly
hyperholest
erolemic
margarine
diet low in fat,
low in saturated
fat and low
cholesterol
2.3 g 8 weeks -14%
• Reduced cholesterol levels e effectively also as
part of a strict cholesterol-lowering diet

19. Key clinical studies on plant stanol ester 2/4
Plat et al. 2000
N
39
Subjects
normo- or
mildly
hypercholes
terolemic
Food
format
margarine
shortening,
bisquit or
cookie
Baseline
diet
normal diet
Plant
stanols
/ day *
Group 1: 2.5
g on 1 meal
Group 2: 2.5
g divided
into 3 meals
Time of
intervention
4 weeks
Change in LDL
cholesterol
vs. control
G 1: -9%;
G 2: -10%
*as plant stanol ester
Main observation about the
effect of plant stanol ester
• Effective also when daily intake was
consumed once a day
Back
Blair et al .2000 141 statin users margarine normal diet 2.9 g 8 weeks -10%
• Reduced cholesterol levels e effectively
when combined with statin medication
Tammi et al.
2000
72
Healthy 6-
year-old
children
margarine
diet low in
saturated fat
and cholesterol
1.5 g 12 weeks -8%
• Safe and effective means to lower
cholesterol also in children
Hallikainen et al.
2002
11
mildly
hyperholest
erolemic
margarine normal diet 2 g 2 weeks -10.2%
• Cholesterol levels effectively reduced
already after a week of daily use
Mensink et al.
2002
60
normo-
or mildly
hyper-
cholesterolemi
c
low-fat
yogurt
normal diet 3 g 4 weeks -14%
• Reduced cholesterol levels effectively also
when incorporated in a low-fat food

20. Key clinical studies on plant stanol ester 3/4
Hallikainen et al.
2008
N
19
Subjects
Type I
diabetics
Food
format
vegetable
oil spread
Baseline
diet
normal diet
Plant
stanols
/ day *
2 g
Time of
intervention
12 weeks
Change in LDL
cholesterol
vs. control
-16%
*as plant stanol ester
Main observation about the
effect of plant stanol ester
• Reduced cholesterol levels effectively in
type I diabetics
Back
de Jong et al.
2008
statin users
low-fat
margarine
normal diet 2.5 g 85 weeks -13%
• Cholesterol-lowering efficacy sustained
during long-term use also in statin users
Plat et al. 2009
36
patients
with
metabolic
syndrome
low-fat
yogurt
drink
normal diet 2 g 8 weeks -13%
• In addition to LDL-cholesterol reduction,
triglyseride levels also reduced
significantly (-27.5%).
Gylling et al.
2010
18
mildly
hyperholest
erolemic
vegetable
oil spread
and oat
drink
normal diet 8.8 g 10 weeks -17%
• High dose safely enchanced cholesterol
reduction further
Mensink et al.
2010
49
mildly
hyperholest
erolemic
margarine
and soy
based
yogurt
normal diet
Group 1: 3 g;
Group 2: 6 g;
Group 3: 9 g
4 weeks
G 1: -7%;
G 2: -12%;
G 3: -17%
• Cholesterol was reduced dose
dependently with high daily intakes93

21. Key clinical studies on plant stanol ester 4/4
Athyros et al.
2011
N
150
Subjects
mildly
hyperholest
erolemic
Food
format
margarine
Baseline
diet
normal diet
Plant
stanols
/ day *
2 g
Time of
intervention
17 weeks
Change in LDL
cholesterol
vs. control
-14%
*as plant stanol ester
Main observation about the
effect of plant stanol ester
• The estimated CVD risk reduced by 25-30%
• Plant stanol ester reduced the risk to the
same degree as the Mediterranean diet
• Four out of five mildly hypercholesterolemic
subjects reached their cholesterol target
levels
Hallikainen et al.
2011 24
type I
diabetics
on statin
medication
vegetable
oil spread
normal diet 3 g 4weeks -15%
• Cholesterol was effectively reduced in
statin-treated subjects with type 1
diabetes
Gylling et al.
2013 92
normo- or
mildly
hypercholes
terolemic
vegetable
oil spread
normal diet 3 g 6 months -10.2%
• Cholesterol was effectively reduced in
statin-treated subjects with type 1
diabetes