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Lower your cholesterol – naturally! Psyllium The informed patient Product presentations, compositions and indications as referenced herein may differ from those in your country. Therefore, please contact Dr. Falk Pharma GmbH, Freiburg (Germany) or the local Falk partner. Publisher DR. FALK PHARMA GmbH Leinenweberstr. 5 Postfach 6529 79041 Freiburg Germany © 2006 Dr. Falk Pharma GmbH All rights reserved. 2nd revised edition 2006 The informed patient Lower your cholesterol – naturally! Psyllium The informed patient Contents Foreword 4 What is cholesterol? 6 Why do we need cholesterol? 6 How much cholesterol do our bodies need? 7 How does the body take in cholesterol? 8 Cholesterol – a time bomb 10 What can happen when cholesterol levels are too high? 11 What can you do about it? 11 LDL and HDL – the mixture is important! 13 How do you reach the goal of “lowering LDL while raising HDL“? 14 Lowering LDL cholesterol using natural dietary fiber derived from psyllium 17 – How does psyllium, the active ingredient in Mucofalk®, reduce the cholesterol level in the blood? – When is psyllium recommended for lowering LDL cholesterol? – How is psyllium (Mucofalk®) taken? – Psyllium – a multifaceted natural remedy 3 Foreword Do you know the role of cholesterol in your body? Do you know how high your cholesterol level is? The purpose of this brochure is to provide you with everything you need to know about this subject, such as the essential functions of cholesterol in your body, the negative effects that may occur when your cholesterol level is too high and, of course, your options for preventing or lowering elevated cholesterol levels in order to prevent any complications from occurring. Diseases of the cardiovascular system (heart and circulation) claim nearly 400,000 lives every year in Germany and lead the list of causes of death. Many of these deaths are due to arteriosclerosis (“hardening” or calcification of the arteries). Arteriosclerosis can also exert a negative effect on other diseases. Arteriosclerosis, however, is not a disease that happens overnight. Instead, it develops silently over many years and is too often the payback for a lessthan-healthy lifestyle. It is crucial to prevent the development of arteriosclerosis or at least avoid its complications. Current research shows that hardening of the arteries can to a certain extent be slowed or even reduced as a result of adopting a healthy lifestyle. The treatment of disorders of lipid metabolism has shown extraordinary success over the past few years. This is the case not only in patients with markedly elevated cholesterol levels (hypercholes- 4 The informed patient terolemia) but even in those with moderately increased levels who at the same time have other risk factors such as smoking, high blood pressure (hypertension), overweight, inadequate exercise, diabetes mellitus or hereditary predisposition for diseases of the heart and circulation. Besides increasing physical activity and adopting healthy dietary practices, elevated cholesterol levels can be reduced with any of a number of effective agents. An especially well-tolerated alternative is the use of natural, water-soluble dietary fiber, such as that derived from psyllium (Mucofalk®). 5 What is cholesterol? Cholesterol (Greek cholé = bile and sterós = hard, solid) is a substance similar to fat that is found in foods of animal origin such as meat, poultry, giblets, sausage, whole milk and dairy products, butter and eggs. Of these foods, giblets and eggs have the highest amounts of cholesterol. One egg yolk or 120 grams of butter are enough to supply practically the entire recommended daily allowance of 300 mg. Cholesterol is essential for life. Thus, the body does not depend on dietary intake of cholesterol but is also able to produce it. Cholesterol is a component of cell membranes and the basic building block in the production of certain hormones and bile acids, the latter of which are necessary for digestion. The main site of production and, at the same time, the primary storehouse of cholesterol is the liver. Why do we need cholesterol? The body uses cholesterol As a building block for all the body’s cells ● To produce bile acids essential for the digestion of fats ● To produce vitamin D, which is required for building strong bones ● To produce steroid and sex hormones ● 6 The informed patient How much cholesterol do our bodies need? In adults ingesting a diet moderately rich in cholesterol, daily cholesterol production stands at about 11–13 mg per kilogram of body weight. This means that our body does not require dietary cholesterol intake, since the liver produces cholesterol and is able to cover the body’s requirements even when we consume a diet that is practically cholesterol free. In the Western industrial nations, the average daily intake of cholesterol ranges from 500 to 750 mg per person. Because the small bowel can absorb no more than 300–500 mg of dietary cholesterol per day, it is necessary to reduce dietary cholesterol intake to less than 300 mg per day in order to exert any significant effect on a person’s cholesterol levels. 7 How does the body take in cholesterol? Because of its fat-like chemical structure, cholesterol is not soluble in water. In order for it to be absorbed into the blood, it must be surrounded by special proteins known as apoproteins. This combination of apoproteins and lipids (fats) results in the formation of lipoproteins. Based on their physical characteristics, these molecules are classified according to their respective densities. The inclusion of cholesterol into different kinds of lipoproteins is the basis for the distinction between the so-called “good” HDL cholesterol (High Density Lipoprotein) and “bad” LDL cholesterol (Low Density Lipoprotein). Thus, cholesterol itself is always the same; its transport form is actually responsible for whether it is primarily useful or dangerous for the body. When the cholesterol level in your blood is checked, testing includes the proportions of HDL and LDL cholesterol. 8 The informed patient The pathways of cholesterol in the human organism Blood stream Blood stream HDL HDL Body cells Deposits LDL Deposits LDL Cholesterol biosynthesis VLDL Liver Bile acids Gallbladder Portal vein Feces Cholesterol Bile acids Dietary cholesterol is partially absorbed in the small bowel. It is transported into the body as chylomicrons and as HDL and LDL. LDL transports cholesterol to the target organs while HDL transports unused cholesterol from the target organs back to the liver, where it is used for the production of bile acids or excreted with the bile into the gut. HDL = High density lipoprotein LDL = Low density lipoprotein VLDL = Very low density lipoprotein 9 Cholesterol – a time bomb High concentrations of cholesterol in the blood are sneaky. You do not see them or feel them. Only by testing the level of cholesterol in the blood and an evaluation of other risk factors can quantify the urgency of taking action. “Too much” in terms of cholesterol usually means too much LDL - the “bad” cholesterol. Reasons include heredity, environmental and dietary factors, as well as metabolic diseases. However, women may show very high levels of HDL - the so-called “good” cholesterol. Thus, an elevated total cholesterol level does not automatically point to excessive LDL. Other causes of high cholesterol levels include unbalanced diet, smoking, overweight, diabetes mellitus and inadequate exercise. 10 The informed patient What can happen when cholesterol levels are too high? As the concentration of LDL in the blood increases, due, for example, to a high-fat or high-cholesterol diet, a point comes where the normal capacity of the body to metabolize and dispose of excess LDL cholesterol is exceeded. As a result, LDL cholesterol may be deposited on the inner walls of arteries, forming a so-called atherosclerotic plaque. This process, especially in connection with other risk factors such as smoking, high blood pressure (over 140/90 mmHg), overweight or diabetes, can ultimately lead to changes in the lumen (the interior channel) of the blood vessels. The growth of plaques by itself rarely blocks a vessel; more commonly, the plaque ruptures, followed by formation of a blood clot, which may partially or completely occlude the vessel. Serious complications include coronary heart disease, stroke or severely reduced circulation to a limb or organ. What can you do about it? Because the amount of cholesterol in the body is determined by both the amount of cholesterol in the diet and the body’s own production, simply reducing dietary intake of cholesterol is inadequate to produce a meaningful change. Reducing cholesterol intake simply causes the body to produce more cholesterol in the liver and vice-versa. 11 Much more important are measures that influence the factors responsible for the absorption of cholesterol from the blood. First and foremost are saturated fats, which occur almost exclusively in foods derived from animal sources, including meat, sausage, cheese, cream, butter, lard, milk, creamfilled pastries and milk chocolate. The consumption of these foods should be reduced. Soluble dietary fiber promotes the excretion of bile acids. An increased intake of soluble fiber results in reduction in LDL cholesterol and an increase in the HDL level. Your goal should be: Reduce LDL and Increase its “opponent” — HDL! 12 The informed patient LDL and HDL – the mixture is important! LDL transports cholesterol to the various organs of our body. It “docks” at the cell membrane and “hands over” the cholesterol to the cells. If there is too much LDL in the blood and the cells are adequately supplied with cholesterol, LDL may deposit on the inner walls of the blood vessels. The result: The vessel becomes increasingly narrow and circulation gets progressively poorer. This is known as arteriosclerosis, or “hardening of the arteries”. Thus, to a certain degree: The less LDL, the better! HDL, on the other hand, possesses the useful ability to remove cholesterol deposited on vessel walls and transport it back to the liver. HDL can to some degree protect against the formation of atherosclerotic deposits in the blood vessels. Thus: The more HDL, the better! 13 How do you reach the goal of “lowering LDL while raising HDL“? Reducing overweight Calculating the so-called body-mass index (BMI) or measuring your waistline (over 88 cm for women and over 102 cm for men) are simple ways of determining whether you are overweight. The BMI is calculated using the following formula: Body weight in kg BMI = __________________ (Height in m)2 Normal: 19–25 Overweight: 25–30 Obesity: over 30 In many cases simply normalizing body weight can return cholesterol levels to normal. Regular exercise is also very effective because it increases the HDL concentration. Best results are obtained from endurance sports such as hiking, walking, jogging, dancing, cycling or swimming one-half hour three to four times a week. 14 The informed patient Adjusting your diet Changing one’s habits is quite difficult for many people. However, “changing your diet” does not necessarily require many changes. Especially effective is the so-called “Mediterranean” diet, consisting of little meat, fish twice a week, a lot of high fiber vegetables and fruit. The amount of fat is also low and consists primarily of high-quality vegetable fats, such as olive oil, with a high proportion of monounsaturated fatty acids. Finally, don’t forget the fresh herbs and spices! Moderate fat intake Although our diet contains an average 130 grams of fat per day, the recommended daily fat intake should not exceed 60–80 grams. Of this, no more than one to two tablespoons of high-quality margarine (such as diet margarine) and one to two tablespoons of high-quality vegetable oil such as olive or rape-seed oil should be taken. Dietary intake of high-quality mono- and polyunsaturated fatty acids You should limit as far as possible your intake of animal fats (e.g. meat, sausage, milk, eggs, butter) and substitute unsaturated vegetable fats (e.g. mono-unsaturated fatty acids such as olive and rape-seed oil). Especially favorable for your health are polyunsaturated fatty acids, especially the eicosanoids or omega-3 fatty acids found in linseed oil, rape-seed oil, soy products and nuts as well as in fish high in fat such as salmon, herring and mackerel. 15 Low-cholesterol foods For many patients, a transition to low-cholesterol foods will not have much of an effect because their body answers the change with an increase in the liver’s own production of cholesterol. Nevertheless, it is advisable to limit daily cholesterol intake to 300 mg or less. Nearly all high-cholesterol foods are also high in saturated fats; hence, low-fat foods are usually also low in cholesterol. Increase your intake of dietary fiber Dietary intake of fiber has decreased significantly over the past 50 years. In earlier times, daily fiber intake stood at about 100 grams, compared to only about 20 grams today. Remember that a high-fiber diet can reduce the LDL level and increase HDL levels. What are the benefits of weight reduction and changes in your diet? The above-described measure often suffice to reduce serum LDL cholesterol levels by as much as 15%. If this is not adequate to normalize cholesterol levels, there are safe and effective medications that may help. 16 The informed patient Lowering LDL cholesterol using natural dietary fiber derived from psyllium (Plantago ovata seed shells) The seed shells of Plantago ovata, also known as psyllium, contain large amounts of natural bulking substances and dietary fiber. Plantago ovata is native to Iran and India and is also cultivated in those countries. This plant has been used for centuries to regulate bowel function. More recently, the cholesterol-lowering properties of psyllium have received increasing attention. Plantago ovata 17 How does psyllium, the active ingredient in Mucofalk®, reduce the cholesterol level in the blood? Soluble bulking agents bind a portion of the bile acids in the small intestine and prevent their re-absorption into the portal circulation. As a result, the liver is forced to continuously absorb cholesterol from the circulating blood as the basic building block for the production of new bile acids, thus reducing the serum concentration of cholesterol. Fiber directly binds lipids (fats) and dietary cholesterol in the gut, prevents its absorption into the blood, and promotes its excretion with the stool. Psyllium reaches the colon unchanged. Soluble bulking agents are metabolized by the intestinal flora to short-chain fatty acids. These substances are absorbed into the blood and transported to the liver, where they may reduce cholesterol synthesis. The intake of Plantago ovata seed shells (psyllium) can reduce the serum cholesterol level by about 10–15%. The efficacy of psyllium in reducing LDL cholesterol has been investigated in over 30 studies. 18 The informed patient When is psyllium recommended for lowering LDL cholesterol? The first step is to attempt to reduce LDL cholesterol by means of adjusting the patient’s lifestyle and dietary habits. Depending on the individual patient’s risk profile, a typical “target” level for LDL cholesterol lies in the range of 100–130 mg/dl. In certain high-risk patients (e.g. those with coronary heart disease or diabetes) levels under 100 mg/dl may be advisable. Anyone can estimate their individual risk of heart attack using a simple computer program, such as the Procam risk calculator available on the Internet at www.chd-taskforce.de. Your personal risk is calculated using data such as gender, age, serum lipids, blood pressure and factors such as number of cigarettes smoked, diabetes and a family history of cardiovascular disease. The higher your risk, the more urgent the need to do something about it! 19 Generally recommended levels for serum lipids: Parameter Value in mg/dl (mmol/l) Commentary Total cholesterol < 200 (< 5.16) 200–239 (5.16–6.16) _> 240 (>_ 6.19) Recommended Borderline elevated High LDL cholesterol < 100 (< 2.58) HDL cholesterol < 40 (< 1.03) _> 40 (>_ 1.55) In CHD or a ten year-risk > 20%* and/or diabetes mellitus With two or more risk factors No or only one risk factor Low Normal Triglycerides < 150 (< 1.69) 150–199 (1.69–2.25) Normal Borderline elevated _> 200 (>_ 2.26) High < 130 (< 3.35) < 160 (< 4.13) *Procam Risk Calculator (www.chd-taskforce.de) Risk factors with elevated cholesterol levels: ● Cigarette smoking ● Hypertension (high blood pressure) over 140/90 mmHg ● Diabetes mellitus ● Overweight ● Positive family history for coronary heart disease (Men under 60 years, women under 70 years) ● Low HDL cholesterol < 40 mg/dl (< 1.1 mmol/l) ● Sex and age: Men > 45 years, Women > 55 years or early menopause 20 The informed patient Psyllium, the active substance in Mucofalk®, is especially suitable in persons with mild to moderately elevated LDL cholesterol levels (about 130–160 mg/dl) for prophylaxis of arteriosclerosis. With significantly increased cholesterol levels and additional risk factors a combination therapy is often a final step toward exhausting all options. Although this has not yet been proven in studies, the addition of psyllium in these cases may be useful, especially when one considers the high tolerability of this natural remedy. How is psyllium (Mucofalk®) taken? The daily ingestion of 10–20 grams of Plantago ovata seed shells (psyllium) with meals is recommended as a suitable dose for reducing cholesterol. This corresponds to 1–2 pouches of Mucofalk® three times daily. Psyllium – a multifaceted natural remedy Psyllium is helpful not only in patients with elevated levels of cholesterol in their blood. The seed shells of Plantago ovata are a highly effective bulking agent: In the gut, they absorb water and their soluble bulking substances increase the volume of the stool. The stool increases in amount, becoming soft and pliable, which facilitates bowel movement. In addition, as a “pre-biotic”, psyllium, by serving as a nutrient, promotes the growth of the normal intestinal bacterial flora. The bacteria, in turn, provide important nutrients for the intestinal mucosal membrane. This process also increases the stool volume and the bowel returns to regular activity. 21 These special properties make Mucofalk® an especially effective and well-tolerated remedy for chronic constipation and irritable bowel syndrome, as well as at times when easier bowel movements with soft stool are required, such as in patients with anal fissures (tears of the mucous membrane of the anus), hemorrhoids or surgical procedures involving the rectum. Finally, psyllium serves to absorb excess fluid in the bowel and is a successful supportive therapy in patients with diarrhea. 22 Lower your cholesterol – naturally ® Mucofalk Psyllium Lowering of cholesterol -5% -10% 4 8 12 16 20 24 Weeks -15% Mucofalk ® Mucofalk®. Active ingredient: Indian isphagula husk, ground (Plantago ovata seed shells). Composition: 5 g of granules (1 sachet) contains: active ingredients: 3.25 g of Indian isphagula husk, ground. Excipients: dextrin, sodium alginate, sodium chloride, saccharin sodium, sucrose (saccharose), citric acid, sodium citrate 2 H2O, orange flavouring. Indications: chronic constipation; diseases in which easier bowel movements with soft stools are desirable, e.g. anal fissures, haemorrhoids, following surgery in the rectum area. As supportive treatment in diarrhoea of various causes. Diseases in which an increase in daily dietary fiber intake is recommended, e.g. in patients with irritable bowel syndrome, and those with mild to moderately increased serum cholesterol levels in addition to diet. Contraindications: hypersensitivity to Isphagula or any of the excipients; excessively hard stools; abdominal complaints and pain, nausea and vomiting prior to assessment by a physician; sudden changes in bowel habits (persisting over two weeks); after use of a laxative without subsequent bowel movement; unassessed rectal bleeding; difficulty swallowing and nausea; stenoses of the esophagus, the gastroesophageal junction or elsewhere in the gastrointestinal tract; threatened or existing intestinal obstruction or megacolon syndrome, disturbances of water and electrolyte metabolism, disorders associated with a decreased fluid intake; poorly controlled diabetes mellitus. Children under the age of 12 years. Side effects: during the first few days of treatment, possible increase in bloating and feelings of fullness; these decrease in the course of treatment. DR. FALK PHARMA GmbH Very rarely, hypersensitivity reactions ranging in severity up to Leinenweberstr. 5 anaphylactoid reactions. Bronchospasm was reported in one Postfach 6529 79041 Freiburg patient. In these cases, the patient should stop taking the mediGermany cine and consult a doctor. Interactions: See patient information leaflet. Dosage information: See patient information leaflet. Date of information: 9/2005. Leinenweberstr. 5 Postfach 6529 79041 Freiburg Germany M82e 2-3/2006/3.000 Bu DR. FALK PHARMA GmbH