The regions that did the m diet had lower mortalities from IHD.
Aaagruculture In the m diet, one consumes less red meat and eggs, and Live oil, b legumes are impportant sources of energy.
----- Meeting Notes (3/3/13 14:50) -----
And a week ago, this article was publi.. In the NEJM from spain. Observational cohort studies and a secondary prevention trial have shown an in- verse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary preven- tion of cardiovascular events. ----- Meeting Notes (3/3/13 21:08) ----- which evaluated the primary prevention of cardio d following a medi di.
Was a parallel-group, mul ----- Meeting Notes (3/3/13 21:08) ----- they nameed it the predimed trial,
----- Meeting Notes (3/3/13 23:05) ----- so it is looking only at the diet
They followed the pts for about 4.8 yrs.
They didn’t limit the amount of carbs that they could eat. Interestingly, they actually discouraged ~ Except they didn’t encourage ----- Meeting Notes (3/3/13 14:59) ----- olive oil 20? 확인
To the M d group, they handed out gifts of ol o and nuts, and
The results of multivariate analyses showed a similar protective effect of the two Mediterra- nean diets versus the control diet with respect to the primary end point (Table 3). Regarding com- ponents of the primary end point, only the com- parisons of stroke risk reached statistical signifi- cance Only stroke was significantly lower in M d group compared to The controoooool group, A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, ver- sus the control group (109 events). No diet-related adverse effects were reported. an absolute risk re- duction of approximately 3 major cardiovascular events per 1000 person-years, for a relative risk reduction of approximately 30%, among high- risk persons who were initially free of cardiovas- cular disease
M a showed a lower h r
The Kaplan–Meier curves for the primary end point diverged soon after the trial started, but no effect on all-cause mortality was apparent (Fig. 1) ----- Meeting Notes (3/3/13 21:41) ----- It failed to show a significant difference.
P vls are not very significant, but in general The me di was better for most of the subgorups. par- ticipants assigned to the control diet received personalized advice and were invited to group sessions with the same frequency and intensity as those in the Mediterranean-diet groups
The stopping boundary for the benefit of the Mediterranean diets with respect to the pri- mary end point was crossed at the fourth inter- im evaluation; on July 22, 2011, the data and safety monitoring board recommended stopping the trial on the basis of end points documented through December 1, 2010. but the participants who dropped out had a worse cardiovascular risk pro- file at baseline than those who remained in the study, suggesting a bias toward a benefit in the control group.
They compared the first 3 years of the trials and the rest of the trial ……… we found no significant interaction between the period of trial enrollment (before vs. after the protocol change. After they changed the follow up protocol of the control group, the advantage of the m diet was higher with a hazard ratio much more impressive. Thereafter, participants assigned to the control diet received personalized advice and were invited to group sessions with the same frequency and intensity as those in the Mediterranean-diet groups, with the use of a separate 9-item dietary screener (Table S3 in the Supplementary Appendix). The lower intensity of dietary intervention for the control group during the first few years might have caused a bias toward a benefit in the two Mediterranean-diet groups, since the participants in these two groups received a more intensive intervention during that time. However, we found no significant interaction between the period of trial enrollment (before vs. after the protocol change) and the benefit in the Mediterranean-diet groups. ----- Meeting Notes (3/3/13 21:41) ----- the authors argued that there was no difference before vs after the protocol change. ----- Meeting Notes (3/3/13 21:45) ----- However the authors argue that the advantage of the med diet was higher after the protocol change. So the lack of follow up in the first 3 years of the trial did not affect the trial itself.
Pointed out These aditionals of the predimed trial The authors wrote, “We acknowledge that, even though participants in the control group received advice to reduce fat intake, changes in total fat were small.” This is not surprising since they gave the control group little support in following this diet during the first half of the study. In the “low-fat” group, total fat consumption decreased insignificantly from 39% to 37% (Table S7, appendix). This is much higher than the American Heart Association guidelines of a low-fat diet (<30% fat) or ours for reversing heart disease (<10% fat). ----- Meeting Notes (3/3/13 21:53) ----- I will talk about the ornish diet in more detail lateron
The comcept of the trial was to find the effect .. M diet on metabolic syn. More than 30 pt came out the met syndrome by following the med diet. After 2 years, patients in the intervention group had significant decreases in body weight; body mass index; waist circumference; HOMA score; blood pressure; and levels of glucose, in- sulin, total cholesterol, and triglycer- ides and a significant increase in levels of high-density lipoprotein cholesterol, all of which were greater than those recorded in the control group ( TABLE 3 ). There was no difference for sex. Serum concentrations of IL-6, IL-7, IL-18, and hs-CRP were significantly reduced in pa- tients in the intervention group com- pared with those in the control group. Endothelial function score improved in the intervention group but remained stable in the control group. There was an inverse relation between changes in endothelial function score and changes in hs-CRP levels ( r =−0.36, P =.01) and HOMA scores ( r =−31, P =.01). At 2 years of follow-up, 60 participants in the intervention group had experienced reductions in the number of components of the metabolic syndrome (Table 3), so that only 40 patients could still be classified as having the metabolic syndrome. This was significantly different from the control group, in which 78 patients were still classified as having the metabolic syndrome ( P .001) A Mediterranean-style diet might be effective in reducing the prevalence of the metabolic syndrome and its associated cardiovascular risk.
This is/was another study regarding the me diet.
The Lyon Diet Heart Study is a randomized secondary prevention trial aimed at testing whether a Mediterranean- type diet may reduce the rate of recurrence after a first myocardial infarction. The Lyon Diet Heart Study sought to determine whether a Mediterranean diet could reduce the risk of cardiovascular events following a myocardial infarction. The study randomized 605 patients to a Mediterranean diet high in polyunsaturated fat and fiber or a Western diet high in saturated fat and low in fiber. Three composite outcomes were studied: (a) cardiac death and nonfatal myocardial infarction, (b) cardiac death, nonfatal MI, and major secondary end points (unstable angina, stroke, heart failure, pulmonary or peripheral embolism, and (c) cardiac death, nonfatal MI, major secondary end points, and minor events requiring hospital admission. All three composite outcomes were significantly reduced in the Mediterranean diet group. This slide shows cumulative survival without MI among control and experimental (Mediterranean group) subjects.
----- Meeting Notes (3/3/13 22:14) ----- regarding the low fat diet (in) reducing the risk of cv this.
To test the hypothesis that a dietary intervention, intended to below in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk.
What the most imp thing is the extremly low fat diet. Ornish is known for his lifestyle-driven approach to the control of coronary artery disease (CAD) and other chronic diseases. He has been a physician consultant to former President Bill Clinton since 1993, after the former President's cardiac bypass grafts became clogged, Ornish met with him and encouraged him to follow a mostly plant-based diet, since moderate changes in diet were not sufficient to stop the progression of his heart disease, and he agreed. 
----- Meeting Notes (3/3/13 22:14) ----- The total number was not very high, it is difficult to generalize it to the general population. ----- Meeting Notes (3/3/13 23:20) ----- the pt's with the most ad had the biggest effect.
I went over most of the important diet trials to show the cardiovascular benefit
Before we start our discussion, I wan to mention briefly What other experts have said regarding the predimed trial,
He recommends a personalized approach to each of the pts.
I went over most of the important diet trials to show the cardiovascular benefit
1. Value of the Mediterranean Diet Johns Hopkins Preventive Cardiology Conference Joonseok Kim, MD Department of Internal Medicine Michigan State University 03/04/2013 * No disclosures for this talk
2. Muller-Nordhorn, J. et al. An update on regional variation in cardiovascular mortality within Europe, European Heart Journal, (2007). 29, 1316–1326
3. What is the Mediterranean Diet?• High consumption of fruits, vegetables, bread and other cereals, potatoes, beans, nuts and seeds• Olive oil is an important monounsaturated fat source• Dairy products, fish and poultry are consumed in low to moderate amounts, and little red meat is consumed• Eggs are consumed zero to four times a week• Wine is consumed in low to moderate amounts http://www.heart.org/HEARTORG/GettingHealthy/NutritionCenter/Mediterranean-Diet_UCM_306004_Article.jsp#mainContent
4. USDA vs. Mediterranean Dietary RecommendationsUSDA=United States Department of Agriculture
5. Current AHA Diet Recommendations• Consume a diet rich in vegetables and fruits• Choose whole-grain, high-fiber foods• Consume fish, especially oily fish, at least twice a week• Limit intake of saturated fat to <7% of energy, trans fat to <1% of energy, and cholesterol to <300 mg/day by choosing lean meats and vegetable alternative• Minimize intake of beverages and foods with added sugars• Choose and prepare foods with little or no salt• If you consume alcohol, do so in moderation American Heart Association Nutrition Committee et al. (2006). Circulation, 114, 82–96 http://www.heart.org/HEARTORG/GettingHealthy/Diet-and-Lifestyle-Recommendations_UCM_305855_Article.jsp
6. Current AHA Diet Recommendations• More than half the fat calories in a Mediterranean diet come from monounsaturated fats (mainly from olive oil). Monounsaturated fat doesnt raise blood cholesterol levels the way saturated fat does.• The incidence of heart disease in Mediterranean countries is lower than in the United States. Death rates are lower, too. But this may not be entirely due to the diet.• Before advising people to follow a Mediterranean diet, we need more studies to find out whether the diet itself or other lifestyle factors account for the lower deaths from heart disease. American Heart Association Nutrition Committee et al. (2006). Circulation, 114, 82–96 http://www.heart.org/HEARTORG/GettingHealthy/NutritionCenter/Mediterranean-Diet_UCM_306004_Article.jsp#mainContent
7. Estruch, R. et al. (2013). N Engl J Med,
8. PREDIMED trial• Parallel-group, multicenter, randomized trial• Inclusion criteria– Men (55 to 80 years of age) and women (60 to 80 years of age)– With no cardiovascular disease at enrollment– Who had either type 2 diabetes mellitus or at least three of the following major risk factors • smoking, hypertension, elevated LDL cholesterol levels, low HDL cholesterol levels, overweight or obesity, or a family history of premature coronary heart disease Estruch, R. et al. (2013). N Engl J Med,
9. PREDIMED trial• Participants were randomly assigned, in a 1:1:1 ratio, to one of three dietary intervention groups:• Mediterranean diet supplemented with extra-virgin olive oil – Received extra-virgin olive oil (approximately 1 liter per week)• Mediterranean diet supplemented with nuts – 30 g of mixed nuts per day (15 g of walnuts, 7.5 g of hazelnuts, and 7.5 g of almonds)• Control diet – Received small nonfood gifts• No total calorie restriction was advised, nor was physical activity promoted Estruch, R. et al. (2013). N Engl J Med,
10. PREDIMED trial• Two Mediterranean diet groups – Dietitians ran individual and group dietary-training sessions at the baseline visit and quarterly thereafter – In each session, a 14-item dietary screener was used to assess adherence to the Mediterranean diet and personalized advice was provided – Uinary hydroxytyrosol levels and plasma alpha-linolenic acid levels, were measured in random subsamples of participants at 1, 3, and 5 years• Control group – Dietitians ran dietary-training sessions at the baseline – 14-item dietary screener was used to assess adherence at the baseline – Received a leaflet explaining the low- fat on a yearly basis – After 3 years, they received personalized advice and were invited to group sessions with the same frequency and intensity as those in the Mediterranean-diet groups Estruch, R. et al. (2013). N Engl J Med,
11. PREDIMED trial• A total of 7447 persons were enrolled (age range, 55 to 80 years)• End points – Primary end point • Composite of myocardial infarction, stroke, and death from cardiovascular causes. – Secondary end point • Stroke, myocardial infarction, death from cardiovascular causes, and death from any cause.• A median follow-up of 4.8 years. Estruch, R. et al. (2013). N Engl J Med,
12. Estruch, R. et al. (2013). N Engl J Med,
13. Estruch, R. et al. (2013). N Engl J Med,
14. Estruch, R. et al. (2013). N Engl J Med,
15. Estruch, R. et al. (2013). N Engl J Med,
16. Estruch, R. et al. (2013). N Engl J Med,
17. Estruch, R. et al. (2013). N Engl J Med,
18. Estruch, R. et al. (2013). N Engl J Med,
19. Conclusion• Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra- virgin olive oil or nuts reduced the incidence of major cardiovascular events
20. Weakness• Failed to find significant results for the secondary endpoints except for stroke – There was no significant reduction in myocardial infarction, death from cardiovascular causes, or death from any cause.• The generalizability of the findings is limited because all the study participants lived in a Mediterranean country• Study dropouts were twice as common in the control diet group as in the Mediterranean diet group (11.3% vs 4.9%). Estruch, R. et al. (2013). N Engl J Med,
21. Weakness• The control group didn’t get a fair chance – During the first 3 years of the trial, the control group received a leaflet explaining the low fat diet on a yearly basis
22. Weakness• The control group did not follow a low-fat diet. – In the “low-fat” group, total fat consumption decreased insignificantly from 39% to 37% (Table S7, appendix). This is much higher than the American Heart Association guidelines of a low-fat diet (<30% fat) or ours for reversing heart disease (<10% fat).• The "low-fat" diet group patients were discouraged from eating fatty fish that are rich in omega‑3 fatty acids that are highly protective from cardiovascular disease. Dean Ornish, M.D. Does a Mediterranean Diet Really Beat Low-Fat for Heart Health? http://www.huffingtonpost.com/dr-dean-ornish/mediterranean-diet_b_2755940.html?utm_hp_ref=yahoo&ir=Yahoo
23. Esposito, K. et al. (2004). JAMA, 292, 1440–1446
24. Esposito Mediterranean Diet TrialConcept: Does the Mediterranean Dietreduce features of metabolic syndrome? Changes from baseline to 2 yearsPopulation: 180 patients with the NCEPATPIII metabolic syndromeIntervention: Counseling to adhere toMediterranean Diet vs. standard “prudent” diet(55-60% carbs, 15-20% protein, <30% fat)Follow-up: Mean 2 yearsResults: Mediterranean Diet reduced hsCRP,fasting blood sugar and insulin, insulinresistance, and metabolic syndrome (40 vs.78 cases). Endothelial function improved.Conclusion: The Mediterranean Diet improvesfeatures of the metabolic syndrome, and causes P <0.001 P =0.01reversal of the overall condition. Esposito, K. et al. (2004). JAMA, 292, 1440–1446
26. Lyon Diet Heart Study 605 patients following a MI randomized to a Mediterranean* or Western** diet 100 for 4 years Percent without Cardiac death or myocardial infarction 90 Mediterranean diet Western diet 80 P=0.0001 70 1 2 3 4 5 Year A “Mediterranean” diet reduces CVD event rates*High in polyunsaturated fat and fiber**High in saturated fat and low in fiber de Lorgeril, M. et al. (1999). Circulation, 99, 779–785
27. Howard, B.V. et al. (2006). JAMA, 295, 655–666
28. The Women’s Health Initiative Randomized Controlled Dietary Modification Trial48835 post-menopausal women randomized to a low-fat* diet or usual diet for 8.1 years • A dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains • Low fat diet did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women * Less then 20% of energy intake Howard, B.V. et al. (2006). JAMA, 295, 655–666
29. Ornish Diet • Rich in fruits, vegetables, whole grains, legumes, and soy products in their natural, unrefined forms. • Low in total fat (<10 percent fat), saturated fats, and trans fats. • High in omega‑3 fatty acids (fish oil, flax oil, salmon). • Low in refined carbohydrates such as sugar, white flour (bread, pasta), white rice, and sugar-sweetened beverages. • Low in processed and refined foods.http://www.huffingtonpost.com/dr-dean-ornish/mediterranean-diet_b_2755940.html?utm_hp_ref=yahoo&ir=Yahoo
30. Ornish, D. et al. (1998). JAMA, 280, 2001–2007
31. The Lifestyle Heart Trial48 patients with moderate to severe CAD randomized to an intensive lifestyle change* group or to a usual-care control group for 5 years. 20 (71%) of 28 patients made and maintained comprehensive lifestyle changes for 5 years Intensive lifestyle with low fat diet decreases coronary atherosclerosis * 10%-fat vegetarian diet Exercise 3 hours/week Stress management training 1 hour/day Smoking cessation Group psychosocial support Ornish, D. et al. (1998). JAMA, 280, 2001–2007
32. Discussion• Will the PREDIMED findings have a big effect on practice?• Should we recommend the Mediterranean diet to patients?• Should AHA change dietary recommendations based on PREDIMED findings?
33. Will the PREDIMED findings have a big effect on practice?• I hope this trial will encourage physicians and the general public to embrace the principles of the Mediterranean diet. Prospective diet-intervention trials are naturally difficult to perform in the real world because subjects cannot be blinded to what they eat and confounding variables are common. In the PREDIMED study, the interventions were simple, making compliance practical and limiting the potential effect of confounders. – Arthur Agatston, M.D.
34. Should we recommend the Mediterranean diet to patients?• We should be recommending the Mediterranean diet because of its record of efficacy and excellent compliance, but I vary my particular approach across patient subgroups. For patients with an atherogenic lipid profile (high triglycerides, low HDL, small LDL particles, high insulin levels), I am very aggressive about fairly strict diet recommendations and consultation with a nutritionist. – Arthur Agatston, M.D.
35. Discussion• Will the PREDIMED findings have a big effect on practice?• Should we recommend the Mediterranean diet to patients?• Should AHA change dietary recommendations based on PREDIMED findings?
36. References1. Estruch, R. et al. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med (2013).doi:10.1056/NEJMoa12003032. de Lorgeril, M. et al. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation 99, 779–785 (1999).3. Esposito, K. et al. Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA 292, 1440–1446 (2004).4. Howard, B. V. et al. Low-Fat Dietary Pattern and Risk of Cardiovascular DiseaseThe Womens Health Initiative Randomized Controlled Dietary Modification Trial. JAMA 295, 655–666 (2006).5. Fuentes, F. et al. Mediterranean and Low-Fat Diets Improve Endothelial Function in Hypercholesterolemic Men. Ann. Intern. Med. 134, 1115–1119 (2001).6. Fitó, M. et al. Effect of a traditional Mediterranean diet on lipoprotein oxidation: a randomized controlled trial. Arch Intern Med 167, 1195–1203 (2007). 1. Couto, E. et al. Mediterranean dietary pattern and cancer risk in the EPIC cohort. Br. J. Cancer 104, 1493–1499 (2011).7. MSc, C.-M. K. et al. Adherence to the Mediterranean diet in relation to acute coronary syndrome or stroke nonfatal events: A comparative analysis of a case/case-control study. American Heart Journal 162, 717–724 (2011).8. Trichopoulou, A., Bamia, C. & Trichopoulos, D. Anatomy of health effects of Mediterranean diet: Greek EPIC prospective cohort study. BMJ: British Medical Journal 338, (2009).9. American Heart Association Nutrition Committee et al. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation 114, 82–96 (2006).10. Sofi, F., Abbate, R., Gensini, G. F. & Casini, A. Accruing evidence on benefits of adherence to the Mediterranean diet on health: an updated systematic review and meta-analysis1. American Journal of Clinical Nutrition 92, 1189–1196 (2010).11. Bendinelli, B. et al. Fruit, vegetables, and olive oil and risk of coronary heart disease in Italian women: the EPICOR Study. The American journal of clinical nutrition 93, 275–283 (2011).