LOWERS FAST C O KEEPS LOW O C O. Benecol provides fast results and. dietary way to lower cholesterol. For healthcare professionals

Transcription

1 C O O LOWERS FAST O C O KEEPS LOW Benecol provides fast results and keeps Benecol cholesterol - Effective at lower and level, easy naturally dietary way to lower cholesterol For healthcare professionals

2 Dear Reader and Healthcare professional Cardiovascular diseases (CVDs) are the leading cause of mortality globally and 10% of the global disease burden (DALYs) is attributed to CVD. Elevated blood cholesterol levels, especially LDL cholesterol level, are significant risk factors for cardiovascular diseases. Lowering cholesterol is one of the most important means of preventing cardiovascular diseases. The lower the blood LDL cholesterol level is, and the earlier the reduction in cholesterol is achieved, the better. Benecol foods with added Plant stanol ester effectively lower LDL cholesterol and keep it at the reached lower level. Based on strong scientific evidence, Plant stanol ester is included in key international guidelines for the management of dyslipidemias. This brochure outlines the key scientific studies that have shown the efficacy of Benecol in different subject and patient groups and in different usage situations. If you have hypercholesterolemic patients who need an extra boost for cholesterol reduction, please consider recommending the daily use of Benecol to them. Benecol provides fast results and keeps cholesterol at a lower level, naturally! The Benecol Team International Atherosclerosis Society, 2013 European Society of Cardiology and European Atherosclerosis Society, 2011 Fifth Joint Task Force of European Society of Cardiology, 2012 WHO, 2012 WHO, World Heart Federation, and World Stroke Organization, 2011 The cholesterol-lowering effect of plant stanols has been known since the 1950s. However, it was not until 1989 when the method of producing plant stanol ester by esterifying plant stanols with vegetable oil fatty acids was invented, thus making it possible to incorporate plant stanols into foods. Benecol foods with Plant stanol ester were first introduced in Finland in 1995 as an entirely new category of great tasting foods that actively lower cholesterol. In Hong Kong, two flavours of Benecol minidrinks, Strawberry and Blueberry, are available in grocery stores.

3 Benecol Proven efficacy in lowering cholesterol The efficacy of Benecol and its cholesterol-lowering ingredient, Plant stanol ester, has been proven in more than 70 published clinical studies*. These studies show that a daily intake of 2 g plant stanols (as Plant stanol ester) reduces serum total and LDL cholesterol levels by an average of 10% (Fig 1). 2 g of plant stanols per day reduces LDL cholesterol on average by 10% Week 0 Week 2 Week 4 The cholesterol-lowering effect has been shown: in healthy individuals with normal orelevated cholesterol levels in women, men and children of different ages in patients with familial hypercholesterolemia coronary heart disease type 1 or type 2 diabetes or a metabolic syndrome as part of a typical diet as well as a strict cholesterol-lowering diet in combination with cholesterol-lowering statin therapy in populations from Asia, Europe, North America and Australia when Plant stanol ester has been incorporated into different types of foods, such as yoghurt mini-drinks, s and spreads, cereal products, instant coffee, spoonable yoghurts and soy-based products HDL cholesterol and triglyceride levels have remained unchanged in most studies. However, recent evidence strongly indicates that the regular use of Plant stanol ester as part of the diet also reduces elevated triglyceride levels. The substantial reduction in serum cholesterol concentration predicts a significant reduction in the risk of cardiovascular disease: the use of Benecol products reduces the estimated risk of coronary heart disease by 25-30%. -10% Figure 1. More than 70 clinical studies show that a daily use of Benecol lowers cholesterol fast and keeps it at the lower level. The reduction in cholesterol achieved with Benecol is sustained as long as the products are used daily in sufficient amounts. Optimal cholesterol-lowering efficacy is achieved when Benecol is used regularly as part of a meal. Gylling and Miettinen 1994 Miettinen et al Gylling et al Andersson et al Hallikainen and Uusitupa 1999 Blair et al Tammi et al Vuorio et al Plat et al Mensink et al Hallikainen et al Naumann et al Plat et al Theuwissen et al Athyros et al Chaiyodsilp et al * Complete list of clinical studies is available at professionals.benecol.com.hk Safety and health claims of Benecol The consumption of Benecol foods is safe and well tolerated. This has been shown in specific safety and toxicology tests, in more than 70 published clinical studies and through the history of safe use of Benecol products globally for 20 years. Safety assessments have been conducted by food safety authorities in several different countries. Benecol is allowed to use health claims requiring strong scientific evidence, e.g. in the US and Europe: In the US, Plant stanol ester has had the Generally Recognized as Safe (GRAS) status since Also, products with Plant stanol ester are allowed to use an FDA-approved health claim: Diets low in saturated fat and cholesterol that include 2 g per day of plant stanols eaten with meals or snacks may reduce the risk of heart disease. Within the European Union, Benecol products have received a permission to use the strongest possible health claim assessed by the European Food Safety Authority (EFSA) and approved by the EU Commission: Plant stanol ester has been shown to lower blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease. Official Journal of the European Union L 277/3-12,

4 Plant Stanol Ester The active ingredient of Benecol Plant stanols are plant-based compounds, naturally found in foods. Structurally they resemble cholesterol (Fig 2). Plant stanols are primarily present in cereal products and vegetable oils. Plant stanols reduce cholesterol absorption in the small intestine. However, the amount of plant stanols in a is insufficient to lower serum cholesterol levels. CHOLESTEROL PLANT STANOL sitostanol PLANT STANOL ESTER plant stanol and vegetable oil fatty acid bound with an ester bond Figure 2. Molecular structures of cholesterol, a plant stanol and Plant stanol ester In Benecol products, plant stanols are added as Plant stanol ester. Esterification with vegetable oil fatty acids is essential because free plant stanols may not lower cholesterol optimally, and when added to foods, they can form crystals that feel granular in the mouth. Plant stanol ester does not affect the taste or mouthfeel of the product. And most importantly, esterified plant stanols lower cholesterol effectively. The characteristics of Plant stanol ester are listed in Table 1. Table 1: Characteristics of Plant stanol ester Main components Plant stanols (sitostanol, campestanol) and vegetable oil fatty acids Main natural sources in diet Cereals Natural daily intake from diet* mg/d Absorption rate* % *as free plant stanols Plant stanols are recommended by international experts According to all key international treatment guidelines, dietary intervention is the cornerstone of dyslipidemia management and CVD prevention. Diet also plays an important role when cholesterol medication has already been initiated, since the effects of diet and medication are additive. Diet also has other beneficial effects beyond its effects on serum lipid concentrations. Several international and national organizations recommend consuming foods that contain Plant stanol ester as part of a cholesterol-lowering diet (Table 2).

5 How Benecol works? The Mechanism of action Plant stanol ester reduces serum total and LDL cholesterol levels by partly blocking the absorption of cholesterol from the digestive tract. The absorption of both dietary and biliary cholesterol is reduced by Plant stanol ester consumption. The reduced cholesterol absorption accomplished by Plant stanol ester consumption results in a significant reduction in serum total and LDL cholesterol concentrations with no effect on HDL cholesterol. Plant stanol ester is first hydrolysed to plant stanols and fatty acids in the small intestine. Due to structural similarity, plant stanols can partly supersede cholesterol from mixed micelles, which carry cholesterol and other fat-soluble substances to the intestinal wall to be absorbed (Fig 3). Additionally, plant stanols may activate certain transport proteins within the enterocytes, which carry cholesterol from the enterocyte back to the intestinal lumen to be excreted out of the body. WITHOUT PLANT STANOL - 50 % of cholesterol is absorbed Cholesterol WITH PLANT STANOL - 20 % of cholesterol is absorbed Plant Stanol In a normal situation, approximately 50% of cholesterol is absorbed from the digestive tract, but when Benecol foods are included in the diet, only about 20% of cholesterol is absorbed. The fatty acid part of Plant stanol ester is absorbed into the body like any other fatty acid in foods. It is noteworthy that plant stanols, unlike cholesterol, are virtually unabsorbable. Figure 3. Plant stanols reduce cholesterol absorption in the intestine. Ikeda et al Miettinen and Kesäniemi 1989 Heinemann et al Gylling et al Phillips et al Piironen et al Ostlund et al Piironen et al Plat and Mensink 2002 Katan et al Valsta et al Plat and Mensink 2009 de Smet et al Table 2. Key treatment and prevention guidelines recommending the use of Plant stanol ester Recommending body European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) National Heart, Lung, and Blood Institute (USA); National Institute of Health (USA); American Academy of Pediatrics (USA) The Fifth Joint Task Force of the European Society of Cardiology (ESC) and Other Societies on Cardiovascular Disease Prevention in Clinical Practice International Atherosclerosis Society MIMS Hong Kong Guideline ESC/EAS Guidelines for the management of dyslipidemias Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents European Guidelines on cardiovascular disease prevention in clinical practice (version 2012) An International Atherosclerosis Society Position Paper: Global Recommendations for the Management of Dyslipidemia Cardiology: Cardiovascular disease prevention Published/ updated in Key messages regarding the consumption of Plant stanol ester Functional foods enriched with plant stanols are recommended as part of a lifestyle intervention aiming at lowering LDL cholesterol levels Plant stanols have a strong scientific evidence base and their efficacy is significant Plant stanols should be considered for individuals with elevated cholesterol values for whom the total CV risk assessment does not justify the use of cholesterol lowering drugs Functional foods containing plant stanols additionally reduce LDL cholesterol levels by up to 5-10% when combined with statin medication Plant stanols are recommended for children with primary elevations in their LDL cholesterol levels who do not reach 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 Functional foods containing plant stanols are effective in lowering LDL cholesterol levels by, on average, 10% when consumed in amounts of 2 g/day Further cholesterol reduction can be obtained with higher daily doses of plant stanols The cholesterol-lowering effect is in addition to that obtained with a low-fat diet or by using statins Plant stanols are a useful adjunct to lowering of LDL-C by dietary means Intakes of about 2g/day of plant stanols will reduce serum LDL cholesterol levels by about 10% Therapeutic lifestyle changes should be advised for all patients above the goal range of lipid values. Dietary options like plant stanols can be added for lipid management.

6 Combining Benecol with statin treatment Lifestyle changes are always the cornerstone of cholesterol management, but in certain situations, medication, most often statins, is also needed. However, even patients on statin medication benefit from using Benecol as part of a healthy lifestyle. Statins inhibit the synthesis of cholesterol in the liver, while plant stanols in Benecol block the absorption of cholesterol in the digestive tract. Because of the different mechanisms of action, the cholesterol-lowering effects of statins and Benecol are additive. Adding Benecol to the diet of patients on statin medication reduces LDL cholesterol further by on average 10%. This reduction is significantly greater than the effect of doubling the statin dose, which generally produces an additional 6% reduction in LDL cholesterol (Fig 4). Moreover, Benecol usage does not cause any unwanted side effects. Blair et al de Jong et al Hallikainen et al The Key clinical studies with Plant stanol es Clinical study N Subjects Food format Baseline diet Gylling and Miettinen Type II diabetics Miettinen et al Gylling et al post-menopausal women with coronary artery disease low fat, low cholesterol diet Hallikainen and Uusitupa mildly to moderately hypercholesterolemic diet low in fat, low in saturated fat and low cholesterol Plat et al normo- or shortening, bisquit or cookie Blair et al statin users Tammi et al Hallikainen et al healthy 6-year-old children diet low in saturated fat and cholesterol Mensink et al Hallikainen et al de Jong et al normo- or mildly hypercholesterolemic Type I diabetics statin users low-fat yogurt vegetable oil spread low-fat Plat et al patients with metabolic syndrome low-fat yogurt drink Gylling et al vegetable oil spread and oat drink Mensink et al and soy based yogurt Athyros et al hypolipidemic diet Hallikainen et al type I diabetics on statin medication vegetable oil spread Gylling et al normo- or mildly hypercholesterolemic vegetable oil spread

7 Combining Plant stanols with statins is more effective than doubling the statin dose Change in LDL cholesterol (%) Statin medication Double statin dose Plant stanol ester Figure 4. The cholesterol lowering effects of statins and Benecol are additive. ter Plant stanols / day (as plant stanol ester) Time of intervention 6 weeks Change in LDL cholesterol vs. control -9% Main observation about the effect of plant stanol ester Well tolerated Reduced cholesterol absorption effectively Reduced total and LDL cholesterol levels 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 7 weeks -15% Reduced cholesterol level also in secondary prevention Reduced absorption of both biliary and dietary cholesterol Cholesterol absorption reduced by appr. 45% weeks -14% Reduced cholesterol levels effectively also as part of a strict cholesterol-lowering diet Group 1: 2.5 g on 1 meal Group 2: 2.5 g divided into 3 meals 4 weeks Group 1: -9%; Group 2: -10% Effective also when daily intake was consumed once a day 2.9 g 8 weeks -10% Reduced cholesterol levels effectively when combined with statin medication 1.5 g 12 weeks -8% Safe and effective means to lower cholesterol also in children 2 g 2 weeks -10.2% Cholesterol levels effectively reduced already after a week of daily use 4 weeks -14% Reduced cholesterol levels effectively also when incorporated in a low-fat food 2 g 12 weeks -16% Reduced cholesterol levels effectively in type I diabetics 2.5 g 85 weeks -13% Cholesterol-lowering efficacy sustained during long-term use also in statin users 2 g 8 weeks -13% In addition to LDL-cholesterol reduction, triglyseride levels also reduced significantly (-27.5%). 8.8 g 10 weeks -17% High dose safely enchanced cholesterol reduction further Group 1: ; Group 2: 6 g; Group 3: 9 g 4 weeks Group 1: -7%; Group 2: -12%; Group 3: -17% Cholesterol was reduced dose dependently with high daily intakes 2 g 16 weeks -14% 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 subjects reached their cholesterol target levels 4 weeks -15 % Cholesterol was effectively reduced in statin-treated subjects with type 1 diabetes 6 months -10.2% Long-term consumption of Plant stanol ester reduced arterial stiffness in small arteries

8 Please visit professionals.benecol.com.hk to find more information about Benecol. References: Andersson A et al. Eur Heart J Suppl 1999; 1: S80-S90. Athyros VG et al. Nutr Metab Cardiovasc Dis 2011; 21: Blair SN et al. Am J Cardiol 2000; 86: Cardiovascular Disease Prevention. In MIMS Cardiology, Hong Kong ; 5th edition: A1-A7. Chaiyodsilp S et al. The Bangkok Medical Journal 2013; 5: Commission Regulation (EC) No 983/2009, Official Journal of the European Union L 277: European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). ESC/EAS Guidelines for the management of dyslipidaemias. European Heart Journal 2011; 32: Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). European Heart Journal 2012: 33; Gylling H et al. Circulation 1997; 96: Gylling H et al. Clin Nutr 2010; 29: Gylling H et al. Atherosclerosis 2014; 232: Gylling H and Miettinen T. Diabetologia. 1994;37: Hallikainen M and Uusitupa. Am J Clin Nutr 1999; 69: Hallikainen M et al. BMC Cardiovasc Disorders 2002; 2: 14. Hallikainen M et al. Atherosclerosis 2008; 199: Hallikainen M et al. Atherosclerosis 2011; 217: Heinemann T et al. Eur J Clin Pharmacol 1991; 40 (Suppl 1): S59-S63. Ikeda I et al. J Nutr Sci Vitaminol 1989; 35: International Atherosclerosis Society. IAS Position Paper: Global Recommendations for the Management of Dyslipidemia, de Jong A et al. Br J Nutr 2008; 100: Katan MB et al. Mayo Clinic Proc 2003; 78: Mensink RP et al. Atherosclerosis 2002; 160: Mensink RP et al.am J Clin Nutr 2010; 92: Miettinen TA et al. N Engl J Med 1995; 333: Miettinen TA and Kesäniemi YA. Am J Clin Nutr 1989; 49: National Heart, Lung, and Blood Institute& National Institute of Health & American Academy of Pediatrics. Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents: Summary Report. Pediatrics 2011; 128 (Supplement 5): S213 -S256. Naumann E et al. J Am Coll Nutr 2008; 27: Ostlund RE Jr et al. Am J Physiol Endocrinol Metab 2002; 282: E911-E916. Phillips KM et al. Food Chem 1999; 64: Piironen V et al. J Food Compos Anal 2000; 13: Piironen V et al. Cereal Chem 2002; 79: Plat J et al. Eur J Clin Nutr 2000; 54: Plat J et al. J Nutr 2009; 139: Plat J and Mensink RP. FASEB J 2002; 16: Plat J and Mensink RP. Lipids 2009; 44: de Smet E et al. Mol Nutr Food Res 2012; 56: Tammi A et al. J Pediatr 2000; 136: Theuwissen E et al. Lipids 2009; 44: Valsta LM et al. Br J Nutr 2004; 92: WHO Fact Sheet 317, 2012, en/index.html WHO, World Heart Federation, and World Stroke Organization. Global atlas on cardiovascular disease prevention and control, Vuorio AF et al. Arterioscler Thromb Vasc Biol 2000; 20: / / BRIIFFI