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Primary prevention of cardiovascular


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Primary prevention of cardiovascular

  1. 1. PUBLISHED ON 25 FEB, 2013 IN NEJM
  2. 2. MEDITERRANEAN DIET The Mediterranean diet is a modern nutritional recommendation inspired by the traditional dietary patterns of southern ITALY, GREECE, and SPAIN . On November 17, 2010, UNESCO recognized this diet pattern as an Intangible Cultural Heritage of Italy, Greece, Spain and Morocco
  4. 4. MEDITERRANEAN DIET Its major characteristics are:  a high consumption of non-refined grains, legumes, nuts, fruits and vegetables;  a relatively HIGH FAT INTAKE(>40% greater thanA RELATIVELY high-fat consumption (even OF TOTAL 40 percent of total energy intake) mostly from MUFA, whichCALORIE INTAKE) IN FORM OF OLIVE OIL AND NUTS accounts for 20 percent or more of the total energy intake;( MUFA ) IS THE HALLMARK OF MEDITERRANEAN  olive oil used to cook and for dressing salads is theDIET , principal source of fat;  fish consumption is moderate to high;  poultry and dairy products (usually as yogurt or cheese) are consumed in moderate to small amounts;  a low consumption of red meats, processed meats or meat products;  a moderate alcohol intake, usually in the form of red wine consumed with meals
  5. 5. MEDITERRANEAN DIET  Trials have shown that increasing adherence to the Mediterranean diet has been consistently beneficial with respect to the cardiovascular risk.  A systematic review ranked the Mediterranean diet as the most likely dietary model to provide protection against coronary heart disease.With this background, a randomized trial wasdesigned to test the efficacy of Mediterranean dieton primary cardiovascular prevention.
  7. 7. STUDY DESIGN… The PREDIMED study (Prevención con Dieta Mediterránea) was a parallel-group, multicenter, randomized trial examining the potential benefits of a Mediterranean-style diet for primary prevention of cardiovascular disease (CVD). A total of 7,447 subjects aged 55 to 80 years were enrolled. 57% were female.
  8. 8. STUDY DESIGN…inclusion criteria Patient should not have any cardiovascular disease at baseline. Patient should either have type 2 diabetes or three or more of the following major CVD risk factors:  smoking,  hypertension,  elevated LDL-C,  low HDL-C,  overweight or obesity, or  family history of premature coronary heart disease.
  9. 9. Subjects were randomized in a 1:1:1 fashion to 3 groups: 1) Mediterranean diet + extra-virgin olive oil (≥4 tbsp/day; n=2,543) 2) Mediterranean diet + nuts (30 g mixed nuts/day, including walnuts, almonds, and hazelnuts; n=2,454) 3) Low-fat diet (control; n=2,450)No total calorie restriction was advised and no physical activity was promoted.
  10. 10.  The primary endpoint = composite of myocardial infarction (MI), stroke, or CV mortality. Secondary endpoints included stroke, MI, CV mortality, and all-cause mortality. The trial was stopped after a median of 4.8 years based on an interim analysis showing benefits seen with Mediterranean diets.
  13. 13. RESULTS
  14. 14. PRIMARY ENDPOINT EVENTSThe primary endpoint, a composite of MI, stroke, or CV mortality,occurred as follows: Mediterranean diet + extra-virgin olive oil:96 events (3.8%)hazard ratio (HR), 0.70P=0.009 vs the control diet Mediterranean diet + nuts:83 events (3.4%)HR, 0.70P=0.02 vs the control diet Control group: 109 events (4.4%)
  15. 15. PRIMARY ENDPOINT PER 1000 PERSON YEARSThe rate of the primary endpoint per 1,000 person-years was as follows: Mediterranean diet + extra-virgin olive oil: 8.1 (95% CI, 6.6-9.9); P=0.009 vs the control diet Mediterranean diet + nuts: 8.0 (95% CI, 6.4- 9.9); P=0.02 vs the control diet Control group: 11.2 (95% CI, 9.2-13.5)
  16. 16. SECONDARY END POINTSStroke  Mediterranean diet + extra-virgin olive oil: 49 events; HR vs control, 0.67 P=0.04 vs the control diet  Mediterranean diet + nuts: 32 events HR vs control, 0.54 P=0.006 vs the control diet  Control group: 58 events
  17. 17. SECONDARY END POINTSMYOCARDIAL INFARCTION  Mediterranean diet + extra-virgin olive oil: 37 events; HR vs control, 0.80 P=0.34 vs the control diet  Mediterranean diet + nuts: 31 events; HR vs control, 0.74 P=0.22 vs the control diet  Control group: 38 events
  18. 18. SECONDARY END POINTSCV MORTALITY  Mediterranean diet + extra-virgin olive oil: 26 events; HR vs control, 0.69 P=0.17 vs the control diet  Mediterranean diet + nuts: 31 events; HR vs control, 1.01 P=0.98 vs the control diet  Control group: 30 events
  19. 19. SECONDARY END POINTSALL-CAUSE MORTALITY  Mediterranean diet + extra-virgin olive oil: 118 events; HR vs control, 0.82 (95% CI, 0.64-1.07); P=0.15 vs the control diet  Mediterranean diet + nuts: 116 events; HR vs control, 0.97 (95% CI, 0.74-1.26); P=0.82 vs the control diet  Control group: 114 events
  20. 20. Groups assigned to Mediterranean diets didbetter than the low fat diet group in terms ofboth primary and secondary end-points
  21. 21.  In this trial, an energy-unrestricted Mediterranean diet supplemented with either extra-virgin olive oil or nuts resulted in risk reduction of major cardiovascular events among high-risk persons who were initially free of cardiovascular disease. These results support the benefits of the Mediterranean diet for cardiovascular risk reduction. The results of our trial might explain, in part, the lower cardiovascular mortality in Mediterranean countries than in northern European countries or the United States.
  22. 22. PAST STUDIES Multiple trials in the past have demonstrated beneficial effects of mediterranian diet in Metabolic syndrome Diabetes mellitus Reducing markers of oxidation/inflammation and endothelial dysfunction Thus a causal role of mediterranian diet in cardiovascular prevention has high biological plausibility
  23. 23. ARCH INTERN MEDICINE 2009 Apr 13;169(7):659-69.In applying a predefined algorithm, we identified strong evidence of a causalrelationship for protective factors, including intake of vegetables, nuts,and monounsaturated fatty acids and Mediterranean, prudent, and highqualitydietary patterns, and harmful factors, including intake of trans– fatty acids andfoods with a high glycemic index or load and a western dietary pattern. Amongthese dietary exposures, however, only a Mediterranean dietarypattern has been studied in RCTs and significantlyassociated with CHD.
  24. 24. lyon diet heart study (2001)showed a large reduction inrates of coronary heart disease events with amodified mediterranean diet enriched with alpha-linolenic acid (a key constituent of walnuts).
  25. 25. CONCLUSION: The adherence tothe Mediterranean Diet seems to reducethe incidence of metabolic syndrome
  26. 26. HOW DOES MEDITERRANEAN DIET HELP? IMPROVES THE LIPID PROFILE Replacing saturated fat with MUFA from olive oil produces a decline in total and LDL cholesterol, and maintains HDL cholesterol at higher levels, thus obtaining a net advantage on the overall lipid profile.
  27. 27. HOW DOES MEDITERRANEAN DIET HELP? DECREASES THE OXIDATIVE STRESS olive oil is resistant to oxidative modification, thus it does not lead to formation of oxidation products like peroxides, hydroxyperoxides etc , which have a causal implication in heart diseases.
  28. 28. HOW DOES MEDITERRANEAN DIET HELP? NEGATIVE EFFECT ON THROMBOGENECITY AND ATHEROMA PLAQUE FORMATION  incorporation of oleic acid into cultured endothelial cells has shown to decrease the expression of endothelial leukocyte adhesion molecules with reductions in VCAM- 1 and inhibition of nuclear factor-kappa B activation.  Postprandial factor VII is significantly lower after a MUFA-rich diet.  Olive oil is also associated with a reduced DNA synthesis in human coronary smooth muscle cells.
  30. 30. CONCLUSION This primary prevention trial showed that an energy- unrestricted Mediterranean diet, supplemented with extra-virgin olive oil or nuts, resulted in a substantial reduction in the risk of major cardiovascular events among high-risk persons. The results support the benefits of the Mediterranean diet for the primary prevention of cardiovascular disease
  32. 32. Salient components of the Mediterranean diet reportedly associated with better survival include  moderate consumption of ethanol (mostly from wine),  low consumption of meat and meat products, and  high consumption of vegetables, fruits, nuts,  legumes, fish, and olive oil Perhaps there is a synergy among the nutrient-rich foods included in the Mediterranean diet that fosters favourable changes in intermediate pathways of cardio-metabolic risk, such as blood lipids, insulin sensitivity, resistance to oxidation, inflammation, and vaso-reactivity.
  33. 33. MEDITERRANEAN DIET The principal aspects of this diet include proportionally high consumption of OLIVE OIL, LEGUMES, UNREFINED CEREALS, FRUITS, and VEGETABLES, moderate to high consumption of fish, moderate consumption of dairy products (mostly as cheese and yogurt), moderate wine consumption, and low consumption of meat and meat products. there are discrepancies among nutrition experts because of the high-fat content of Mediterranean Diets (up to >40% of total energy intake), which is in conflict with the usual recommendation to follow a low-fat diet in order to avoid overweight/obesity and to prevent coronary heart disease (CHD)
  34. 34.  In its simplest form the hazard ratio can be interpreted as the chance of an event occurring in the treatment arm divided by the chance of the event occurring in the control arm, or vice versa, of a study.
  35. 35. Our results compare favourably with those ofthe Women’s Health Initiative DietaryModification Trial, wherein a low-fat dietaryapproach resulted in no cardiovascular benefit.
  36. 36. Participants with hypertension, dyslipidemia andhigher BMI responded better to Mediterranean Diets
  37. 37. Exclusion criteria Documented history of previous cardiovascular disease, including CHD (angina, myocardial infarction, coronary revascularization procedures or existence of abnormal Q waves in the electrocardiogram (EKG)), stroke (either ischemic or hemorrhagic, including transient ischemic attacks), and clinical peripheral artery disease with symptoms of intermittent claudication. Severe medical condition that may impair the ability of the person to participate in a nutrition intervention study (e.g. digestive disease with fat intolerance, advanced malignancy, or major neurological, psychiatric or endocrine disease) Any other medical condition thought to limit survival to less than 1 year. Immunodeficiency or HIV-positive status. Illegal drug use or chronic alcoholism or total daily alcohol intake >80 g/d. Body mass index > 40 kg/m2. Difficulties or major inconvenience to change dietary habits
  38. 38. Exclusion criteria Impossibility to follow a Mediterranean-type diet, for religious reasons or due to the presence of disorders of chewing or swallowing (e.g., difficulties to consume nuts) History of food allergy with hypersensitivity to any of the components of olive oil or nuts. Participation in any drug trial or use of any investigational drug within the last year. Institutionalized patients for chronic care, those who lack autonomy, are unable to walk, lack a stable address, or are unable to attend visits in the PCC every 3 months. Illiteracy. Patients with an acute infection or inflammation (e.g., pneumonia) are allowed to participate in the study 3 months after the resolution of their condition.