Parapharmaceuticals Dr Eman A. Ha H mmad
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1 Parapharmaceuticals DrEmanA. Hammad 1
2
3 What do you think? 3
4 Introduction Vitamins are defined as organiccompounds that are intended to supplement the diet and cannot be synthesized by humans Multivitamin /mineral supplements for prophylactic or disease-mitigating purposes 4
5 Introduction Cost from USA In 2005, $20.3 billion were spent In 2011,one-third of Americans take a daily multivitamin $5 billion per year Cost from UK In 2012, costsfor vitamin prescription increased by 11.2 per cent ( 10.6m). Within UK population use of vitamins continues to rise, by 12.0 per cent (2.3m items). Most of the increased use is of vitamin D preparations, including colecalciferol with costs increasing by 9.0m. 5
6 Definitions Upper intake levels (ULs) the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population Recommended daily allowance is the amount of a nutrient needed to meet the daily basic needs of healthy people. The RDA is one of the factors used to determine daily values. 6
7 Definitions Daily value (DV) is the amount recommended to help prevent against disease - -amounts often higher than the RDA. The DVis what's presented on food labels, and the RDAis mainly used by health professionals. 7
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9 However, DV listed on supplement labels to often do not reflect the latest intake recommendations 9
10 Definitions The newest standard for nutrient requirements is Dietary Reference Intake (DRI) The DRI recommendations are made up of three components: The estimated average requirements (EAR), a level nutritionists say should meet the needs of 50 percent of the people in a defined age and gender group The RDA or, where no RDA has been established, the adequate intake (AI) The upper limit (UL), meaning the highest level that experts consider to be safe. 10
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12 Nutrient Daily Value (DV) Dietary Reference Intake (DRI) for Adult Men* Dietary Reference Intake (DRI) for Adult Women* Vitamin A 5,000 IU 3,000 IU 2,300 IU Vitamin C 60 mg 90 mg 75 mg Vitamin D 400 IU IU (AI) IU (AI) Vitamin E 30 IU IU** IU** Vitamin K 80 mcg 120 mcg (AI) 90 mcg (AI) Thiamin 1.5 mg 1.2 mg 1.1 mg Riboflavin 1.7 mg 1.3 mg 1.1 mg Niacin 20 mg 16 mg 14 mg Vitamin B6 2 mg mg mg Folic acid 400 mcg 400 mcg 400 mcg Vitamin B12 6 mcg 2.4 mcg 2.4 mcg Biotin 300 mcg 30 mcg (AI) 30 mcg (AI) Pantothenic acid 10 mg 5 mg (AI) 5 mg (AI) Choline None est. 550 mg (AI) 425 mg (AI) Calcium 1,000 mg 1,000-1,200 mg 1,000-1,200 mg Iron 18 mg 8 mg 8-18 mg Phosphorus 1,000 mg 700 mg 700 mg Iodine 150 mcg 150 mcg 150 mcg Magnesium 400 mg mg mg Zinc 15 mg 11 mg 8 mg Selenium 70 mcg 55 mcg 55 mcg Copper 2 mg 0.9 mg 0.9 mg Manganese 2 mg 2.3 mg (AI) 1.8 mg (AI) Chromium 120 mcg mcg (AI) mcg (AI) Molybdenum 75 mcg 45 mcg 45 mcg Potassium 4,000 mg 4,700 mg (AI) 4,700 mg (AI) *The RDA is given unless no RDA has been established, in which case the Adequate Intake (AI) is indicated. **22 IU natural or d-alpha-tocopherol; 33 IU synthetic d,l-alpha-tocopherol. More than 350 mg/day from supplements may cause diarrhea. 12
13 L2-3: Rational for the use of multivitamins a minerals
14 Learning outcomes By the end of this lecture you will be able to: Understand the rational for the use of multivitamins and minerals in specific patient population Understand the rational for the use of multivitamins and minerals for patients in use of specific medicines Assess the evidence base for recommending multivitamins and minerals for the use in common chronic diseases 14
15 What is the rationale for the use of a multivitamin? Healthy individuals Healthy individuals do not require a daily multivitamin. "There is no scientific basis for recommending vitamin-mineral supplements to the healthy population," "No supplement trial has ever been able to reproduce the health benefits of eating adequate amounts of fresh fruits and vegetables," 15
16 What vitamins we need? We need 13 vitamins to maintain health vitamins A, C, D, E, K and the eight B vitamins Vitamin C: helps to keep cells healthy Vitamin A is good for eyesight and healthy skin Vitamin D helps to regulate calcium and is essential for strong bones and teeth Vitamin E is needed to maintain cell structure. 16
17 Who needs vitamin supplements? Pregnant and breastfeeding women should take vitamin D supplements Women trying to conceive and women in the first 12 weeks of pregnancy should take folic acid People aged 65 and over should take vitamin D supplements People who are not exposed to much sun should take vitamin D supplements All children aged six months to five years should be given a supplement containing vitamins A, C and D 17
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21 Multivitamins and minerals in specific populations 21
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24 Multivitamins and minerals for patients on selected medicines 24
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27 potential as chemopreventive agents for the prevention of chronic disease. 27
28 Factors that affect the efficacy and safety of multivitamins and minerals in chronic disease prevention Can you suggest one? 28
29 Patient related factors Age Sex Race Genetic susceptibility Geographic location Smoking Diet and physical activity Obesity Sunlight exposure 29
30 Summary of clinical evidence for the use of multivitamins and minerals in chronic disease 30
31 31
32 Cardiovascular Diseases Vitamin E One study in dialysis patients showed decreased cardiovascular deaths. Newer trials, however, revealed that about 9000 men and women at high risk for heart disease who took 400 IU of vitamin E for 4 to 5 years experienced no cardiovascular benefit. The Women s Health Study showed that 600 IU vitamin E every other day showed a non-significant trend to reduce the risk of venous thromboembolism. Randomized controlled trials are needed to support both findings. 32
33 Folic acid, B6, and B12 Many studies have reported increased risk of CHD or ischemic stroke associated with low folateintake or low blood folatelevels. The recent Women s Antioxidant and Folic Acid Cardiovascular study, with 5442 high-risk women, did not show any reduction in cardiovascular events, taking a combination folic acid, B6, and B12 supplement over 7 years. 33
34 Vitamin C The American Heart Association does not recommend supplementing with antioxidants including C, E, and beta-carotenefor the general public or for those with heart disease. They do, however, recommend diets rich in fruits, vegetables, and whole grains. A higher quintile of vitamin C supplement intake in diabeticwomen was directly related to increased cardiovascular mortality. 34
35 Magnesium For magnesium, a Cochrane review of studies did not find evidence that supplementation reduces high blood pressure in adults. 35
36 36
37 Fish oil Omega-3 fatty acids in tuna, herring Help prevent heart problems, cancer, dementia, asthma, joint problems and psychosis A 2006 meta-analysis showed reduction in cardiac death and all cause of mortality 37
38 Cancer Antioxidants, vitamins A, C, or E and folic acid Can mop up these free radicals and fight oxidative damage Insufficient evidence for the prevention of cancer with antioxidants, vitamins A, C, or E; folic acid; or multivitamins. Studies found an increased risk of lung cancer with beta carotene in smokers 38
39 Zinc supplementation > 2 risk of prostate cancer if taken in doses greater than 100 mg daily or for 10 or more years. A meta-analysis of cohort studies has shown a decreased risk of prostate cancer with selenium intake. 39
40 Respiratory Diseases Vitamin C In populations with a high likelihood of vitamin C deficiency,or low plasma vitamin C levels, supplementation has preventive and therapeutic effects on reducing the incidence and duration of pneumonia. In a systematic review from the Cochrane Library 2007; there is little evidence that vitamin C supplementation (0.2g per day or more) is beneficial for preventing infection. Even higher doses of 1g per day or more did not prevent colds in the general population. 40
41 In the same review, regular high doses of vitamin C (1g per day or more) seem to reduce the duration of colds a little, by 8% in adults and 13% in children. Vitamin C supplements seemed to have a greater effect for people who were undergoing extreme physical stress, such as marathon runners. In conclusions, no evidence that the vitamin could treat early cold symptoms, more studies are warranted 41
42 Zinc Can inhibit the replication of the rhinovirus, which is the most frequent cause of cold symptoms In a 2011 Cochrane review; taking zinc lozenges or syrup within 24 hours of symptoms starting may reduce the length of cold symptoms by about a day. T he severity of the symptoms may also be reduced. Regular zinc supplements (taken for at least five months) appear to protect people against catching colds The review was of 15 trials involving more than 1,300 people, and so is likely to be reliable. However, whether these small benefits are worth the expense is an individual decision. Oral Zinc is safe in amounts that do not exceed 40 mg orally a day. 42
43 Diabetes 43
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45 Take home message Healthy diet is an adequate source of all vitamins and mineral needed It is not appropriate to recommend vitamins/ minerals to all patients/customers Vitamins/mineral supplement should be individualise considering the patient needs/ medical or drug history The growing evidence suggesting that over use of vitamins/mineral may lead to potential harm Further studies are needed to establish more reliable evidence for the use/ disuse of vitamins/minerals 45
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