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The Evidence for Current Cardiovascular Disease Prevention Guidelines: Lifestyle Management Evidence and Guidelines American The Evidence for Current Cardiovascular Disease Prevention Guidelines: Lifestyle Management Evidence and Guidelines American College of Cardiology Best Practice Quality Initiative Subcommittee and Prevention Committee

Classification of Recommendations and Levels of Evidence *Data available from clinical trials or registries Classification of Recommendations and Levels of Evidence *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. †In 2003, the ACC/AHA Task Force on Practice Guidelines developed a list of suggested phrases to use when writing recommendations. All guideline recommendations have been written in full sentences that express a complete thought, such that a recommendation, even if separated and presented apart from the rest of the document (including headings above sets of recommendations), would still convey the full intent of the recommendation. It is hoped that this will increase readers’ comprehension of the guidelines and will allow queries at the individual recommendation level.

Icons Representing the Classification and Evidence Levels for Recommendations I IIa IIb III I Icons Representing the Classification and Evidence Levels for Recommendations I IIa IIb III I IIa IIb III I IIa IIb III

Evidence for Current Cardiovascular Disease Prevention Guidelines Cigarette Smoking Cessation Evidence and Guidelines Evidence for Current Cardiovascular Disease Prevention Guidelines Cigarette Smoking Cessation Evidence and Guidelines

Smoking Prevalence in the United States National Health Interview Survey Estimated percentage of current Smoking Prevalence in the United States National Health Interview Survey Estimated percentage of current smokers in the United States by sex There has been a decrease in the prevalence of cigarette smoking in men and women over time Source: CDC, Morbidity and Mortality Weekly Report 2007; 56: 1157 -1161

Tobacco Use: Most Preventable Cause of Death Most preventable causes of death in the Tobacco Use: Most Preventable Cause of Death Most preventable causes of death in the U. S. in 1990 and 2000 Causes # (%) in 1990 # (%) in 2000 Tobacco 400, 000 (19) 435, 000 (18) Poor diet and physical activity (obesity) 300, 000 (14) 400, 000 (17) Alcohol consumption 100, 000 (5) 85, 000 (4) Microbial agents 90, 000 (4) 75, 000 (3) Toxic agents 60, 000 (3) 55, 000 (2) Motor vehicle accidents 25, 000 (1) 43, 000 (2) Firearms 35, 000 (2) 29, 000 (1) Sexual behavior 30, 000 (1) 20, 000 (<1) Illicit drug use 20, 000 (<1) 17, 000 (<1) 1, 060, 000 (50*) 1, 159, 000 (48%*) Total *Reflects percent total of 9 most preventable causes of death Source: Mokdad AH et al. JAMA 2004; 291: 1238 -1245

Cigarette Smoking Cessation Evidence: Risk of Non-fatal Myocardial Infarction* RR (95% Cl) Study Aberg, Cigarette Smoking Cessation Evidence: Risk of Non-fatal Myocardial Infarction* RR (95% Cl) Study Aberg, et al. 1983 0. 67 (0. 53 -0. 84) Herlitz, et al. 1995 0. 99 (0. 42 -2. 33) Johansson, et al. 1985 0. 79 (0. 46 -1. 37) Perkins, et al. 1985 3. 87 (0. 81 -18. 37) Sato, et al. 1992 0. 10 (0. 00 -1. 95) Sparrow, et al. 1978 0. 76 (0. 37 -1. 58) Vlietstra, et al. 1986 0. 63 (0. 51 -0. 78) Voors, et al. 1996 0. 54 (0. 29 -1. 01) 0. 1 Ceased smoking 1. 0 Continued smoking 10 *Includes those with known coronary heart disease Source: Critchley JA et al. JAMA 2003; 290: 86 -97

Cigarette Smoking Cessation Evidence: Tailored Materials 1058 current and recent ex-smokers randomized to a Cigarette Smoking Cessation Evidence: Tailored Materials 1058 current and recent ex-smokers randomized to a smoking cessation strategy of usual care* vs. computed-generated tailored advice** Abstinence rates (%) 35 30 25 20 p=0. 015 20. 9 Usual care Tailored care p=0. 004 18. 9 15. 4 15 p=0. 013 16. 4 12. 7 p=0. 080 11. 3 10 12. 2 9. 0 5 0 24 hour 7 day 1 month Duration of abstinence 3 month Self-help materials tailored for the needs of individual smokers are more effective than usual materials *Usual care consists of telephone counselling and a mailed information packet **Tailored care consists of usual care + a computer-generated individually tailored advice letter Source: Sutton S et al. Addiction 2007; 102: 994 -1000.

Cigarette Smoking Cessation: Effect of Counseling Intervention Meta-analysis of 33 clinical trials assessing the Cigarette Smoking Cessation: Effect of Counseling Intervention Meta-analysis of 33 clinical trials assessing the benefit of smoking cessation counseling interventions with or without pharmacotherapy Intensity 1: Contact in hospital of <15 minutes only Intensity 2: Contact in hospital of >15 minutes only Intensity 3: Any hospital contact plus postdischarge support of <1 month Intensity 4: Any hospital contact plus postdischarge support of >1 month Inpatient counseling with contact >1 month after discharge is associated with the greatest rate of smoking cessation Source: Rigotti NA et al. Arch Intern Med 2008; 168: 1950 -1960

Cigarette Smoking Cessation: Frequency of Nicotine Dependence Percent Reporting >1 Indicators of Nicotine Dependence, Cigarette Smoking Cessation: Frequency of Nicotine Dependence Percent Reporting >1 Indicators of Nicotine Dependence, by Age and Intensity of Smoking 12 -24 Years Old Less than 6* 25+ Years Old 6 -15* 16 -25* 26+* *Cigarettes per day Source: Substance Abuse and Mental Health Services Administration; United States, 2010 National Survey.

Cigarette Smoking Cessation: Types of Nicotine Replacement Increase in nicotine concentration (ng/ml) Plasma nicotine Cigarette Smoking Cessation: Types of Nicotine Replacement Increase in nicotine concentration (ng/ml) Plasma nicotine concentrations 14 12 10 8 Cigarette Gum 4 mg 6 Gum 2 mg 4 Inhaler 2 Nasal spray Patch 0 5 10 15 20 25 30 Minutes Source: Balfour DJ et al. Pharmacol Ther 1996; 72: 51 -81

Cigarette Smoking Cessation Evidence: Effect of Combination Therapy Limited Behavioral Support Intervention Effect Size Cigarette Smoking Cessation Evidence: Effect of Combination Therapy Limited Behavioral Support Intervention Effect Size 95% CI Nicotine gum 5% 4 -6% Nicotine transdermal patch 5% 4 -7% Intensive Behavioral Support Intervention Effect Size 95% CI Nicotine gum 8% 6 -10% Nicotine transdermal patch 6% 5 -8% Nicotine nasal spray 12% 7 -17% Nicotine inhaler 8% 4 -12% Nicotine sublingual tablet 8% 1 -14% CI=Confidence interval Sources: West R et al. Thorax 2000; 55: 987 -999 Silagy C et al. Cochrane Database Syst Rev 2002; CD 000146

Cigarette Smoking Cessation Evidence: Primary Prevention 893 smokers randomized to 9 weeks of bupropion Cigarette Smoking Cessation Evidence: Primary Prevention 893 smokers randomized to 9 weeks of bupropion (150 mg daily for 3 days and then 150 mg bid), NRT (21 mg patch weeks 2 -7, 14 mg patch week 8, and 7 mg patch week 9), bupropion and NRT, or placebo Placebo (n=160) NRT (n=244) Bupropion (n=244) Nicotine patch and Bupropion (n=245) Abstinence rate at 6 months 18. 8% 21. 3% 34. 8%a, b 38. 8%a, c, d Abstinence rate at 12 months 15. 6% 16. 4% 30. 3%a, c 35. 5%a, c, e Bupropion with or without NRT provides the greatest benefit ap<0. 001 when compared to placebo when compared to NRT cp<0. 001 when compared to NRT dp=0. 37 when compared to bupropion ep=0. 22 when compared to bupropion bp=0. 001 NRT=Nicotine replacement therapy Source: Jorenby DE et al. NEJM 1999; 340: 685 -691

Cigarette Smoking Cessation Evidence: Primary Prevention 1, 027 smokers randomized to 12 weeks of Cigarette Smoking Cessation Evidence: Primary Prevention 1, 027 smokers randomized to 12 weeks of varenicline (titrated to 1 mg bid), bupropion (titrated to 150 mg bid), or placebo Varenicline vs. Bupropion P<0. 001 (weeks 9 -12), P=0. 004 (weeks 9 -52) Varenicline provides greater rates of abstinence than bupropion Source: Jorenby DE et al. JAMA 2006; 296: 56 -63

Cigarette Smoking Cessation: Pharmacotherapy* Agent Caution Side Effects Dosage Duration Instructions Bupropion SR (Zyban®)** Cigarette Smoking Cessation: Pharmacotherapy* Agent Caution Side Effects Dosage Duration Instructions Bupropion SR (Zyban®)** Seizure disorder Eating disorder Taking MAO inhibitor Pregnancy Insomnia Dry mouth 150 mg QAM then 150 mg BID 3 days Start 1 -2 weeks before quit date. Take 2 nd dose in early afternoon or decrease to 150 mg QAM for insomnia. Transdermal Nicotine Patch*** Varenicline (Chantix®)** Depression/ Suicide Within 2 weeks of a MI Unstable angina Arrhythmias Heart failure Skin reaction Insomnia Pregnancy Nausea Sleep disorder Depression/ Suicide CV risk 8 weeks, but up to 6 months 21 mg QAM 14 mg QAM 7 mg QAM or 15 mg QAM 4 weeks 2 weeks 0. 5 mg QD then 0. 5 mg BID then 1 mg BID 3 days 8 weeks Apply to different hairless site daily. Remove before bed for insomnia. Start at <15 mg for <10 cigs/day Start 1 week before the quit date 4 days 12 weeks *Pharmacotherapy combined with behavioral support provides the best success rate **The FDA has placed a black box warning on varenicline and buproprion SR due to the risk of depression and/or suicidal thoughts ***Other nicotine replacement therapy options include: nicotine gum, lozenge, inhaler, nasal spray

Cigarette Smoking Cessation: Effect of Pharmacotherapy Meta-analysis of 33 clinical trials assessing the benefit Cigarette Smoking Cessation: Effect of Pharmacotherapy Meta-analysis of 33 clinical trials assessing the benefit of smoking cessation counseling interventions with or without pharmacotherapy Adding pharmacotherapy (nicotine replacement or bupropion) to counseling intervention does not improve rates of smoking cessation NRT=Nicotine replacement therapy Source: Rigotti NA et al. Arch Intern Med 2008; 168: 1950 -1960

Cigarette Smoking Cessation: Benefit of Community Smoking Ban Prospective assessment of smoking status and Cigarette Smoking Cessation: Benefit of Community Smoking Ban Prospective assessment of smoking status and exposure to second-hand smoke among patients admitted with an ACS to 9 Scottish hospitals before and after legislation prohibiting smoking in enclosed public places Smoke-free legislation results in reduced ACS admissions ACS=Acute coronary syndrome Source: Pell JP et al. NEJM 2008; 359: 482 -491

Cigarette Smoking Cessation: Benefit of Community Smoking Ban Meta-analysis evaluating the ratio of community Cigarette Smoking Cessation: Benefit of Community Smoking Ban Meta-analysis evaluating the ratio of community rates of acute MI before and after implementation of a smoking restriction law Smoke-free legislation results in a rapid and substantial reduction in MI MI=Myocardial infarction Source: Lightwood JM et al. Circulation 2009; 120: 1373 -1379

Cigarette Smoking Cessation: Benefit of Financial Incentives 878 smokers working for a U. S. Cigarette Smoking Cessation: Benefit of Financial Incentives 878 smokers working for a U. S. company randomized to receive information about smoking-cessation programs or information plus financial incentives Financial incentives for smokers increase the cessation rate Source: Volpp KG et al. NEJM 2009; 360: 699 -709

Tobacco Cessation Algorithm Ask and document tobacco use status Current User Recent Quitter (<6 Tobacco Cessation Algorithm Ask and document tobacco use status Current User Recent Quitter (<6 months) Advise Provide a strong, personalized message Assess Readiness to quit in next 30 days Ready Not Ready Assist: Negotiate plan • STAR** • Discuss pharmacotherapy • Social support • Provide educational materials Prevent Relapse • Congratulate successes • Encourage • Discuss benefits experienced by patient • Address weight gain, negative mood, and lack of support Increase Motivation • Relevance to personal situation • Risks: short and long-term, environmental • Rewards: potential benefits of quitting • Roadblocks: identify barriers and solutions • Repetition: repeat motivational intervention • Reassess readiness to quit **STAR Arrange Follow-up to check plan or adjust meds • Call right before and after quit date • Weekly follow-up x 2 weeks, then monthly x 6 months • Ask about difficulties (withdrawal, depressed mood) • Build upon successes • Seek commitment to stay tobacco-free Set quit date Tell family, friends, and coworkers Anticipate challenges: withdrawal, breaks Remove tobacco from the house, car, etc. Source: Fiore MC et al. Treating tobacco use and dependence: an evidence based clinical practice guideline for tobacco cessation. U. S. Department of Health and Human Services, 2000

AHA Primary Prevention of CV Disease in DM Tobacco Recommendations Primary Prevention • All AHA Primary Prevention of CV Disease in DM Tobacco Recommendations Primary Prevention • All patients should be asked about tobacco use status at every visit. • Every tobacco user should be advised to quit. • The tobacco user’s willingness to quit should be assessed. • The patient can be assisted by counseling and by developing a plan to quit. • Follow-up, referral to special programs, or pharmacotherapy (e. g. , NRT and buproprion) should be incorporated as needed. AHA=American Heart Association, CV=Cardiovascular, DM=Diabetes mellitus, NRT=Nicotine replacement therapy Source: Buse JB et al. Circulation 2007; 115: 114 -126

ADA Smoking Cessation Recommendations for Patients with Diabetes Mellitus Primary Prevention • All patients ADA Smoking Cessation Recommendations for Patients with Diabetes Mellitus Primary Prevention • All patients should be advised not to smoke. • Smoking cessation counseling and other forms of treatment should be included as a routine component of diabetes care. ADA=American Diabetes Association Source: American Diabetes Association. Diabetes Care 2010; 33: S 11 -61

Tobacco Cessation Recommendations Secondary Prevention Goals: Complete tobacco cessation and no environmental tobacco smoke Tobacco Cessation Recommendations Secondary Prevention Goals: Complete tobacco cessation and no environmental tobacco smoke exposure I IIa IIb III Patients should be asked about tobacco use status at every office visit I IIa IIb III Every tobacco user should be advised at every visit to quit I IIa IIb III The tobacco user’s willingness to quit should be assessed at every visit. Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Tobacco Cessation Recommendations (Continued) Secondary Prevention I IIa IIb III Patients should be assisted Tobacco Cessation Recommendations (Continued) Secondary Prevention I IIa IIb III Patients should be assisted by counseling and by development of a plan for quitting that may include pharmacotherapy and/or referral to a smoking cessation program I IIa IIb III Arrangement for follow up is recommended. I IIa IIb III All patients should be advised at every office visit to avoid exposure to environmental tobacco smoke at work, home, and public places Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Evidence for Current Cardiovascular Disease Prevention Guidelines Diet and Weight Management Evidence and Guidelines Evidence for Current Cardiovascular Disease Prevention Guidelines Diet and Weight Management Evidence and Guidelines

Overweight and Obese States: Definition Using the Body Mass Index (BMI) Defined by Body Overweight and Obese States: Definition Using the Body Mass Index (BMI) Defined by Body Mass Index = (703. 1)* Wt (lbs)/ Ht 2 (in) Weight Category BMI (kg/m 2) Normal 18. 5 -24. 9 Overweight* 25. 0 -29. 9 Obesity (Class I) 30. 0 -34. 9 Obesity (Class II) 35. 0 -39. 9 Obesity (Class III) >40. 0 *Measurement of waist circumference is most helpful in this category Source: The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. NIH/NHLBI/NAASO. October, 2000. NIH publication No. 00 -4084

Prevalence of Obesity in U. S. Adults 1996 1991 2006 2008 Percentage of State Prevalence of Obesity in U. S. Adults 1996 1991 2006 2008 Percentage of State Obese (BMI > 30) No Data <10% 10– 14% 15– 19% 20– 24% 25 -29% >30% Source: CDC Overweight and Obesity

Change in Body Mass Index Distribution in the United States Over Time National Health Change in Body Mass Index Distribution in the United States Over Time National Health and Nutrition Examination Survey (NHANES) 100% Body mass index (kg/m 2) age-adjusted percentage 90% 80% 70% 60% 50% 40% 30% >35 30 -35 25 -30 >25 20% 10% 0% Source: Ford ES et al. Circulation 2009; 120: 1181 -1188

Adult obesity At age 21 -29 years (%) Body Mass Index: Risk of Developing Adult obesity At age 21 -29 years (%) Body Mass Index: Risk of Developing Obesity in Adulthood Age of child (years) BMI=Body mass index Source: Whitaker RC et al. NEJM 1997; 337: 869 -873

Body Mass Index: Relationship with Waist Circumference Source: Despres JP et al. Arterioscler Thromb Body Mass Index: Relationship with Waist Circumference Source: Despres JP et al. Arterioscler Thromb Vasc Biol 2008; 48: 1039 -1049

Body Mass Index: Risk of Hypertension Study to Help Improve Early Evaluation and Management Body Mass Index: Risk of Hypertension Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) and National Health and Nutrition Examination Survey (NHANES) Source: Bays HE et al. Int J Clin Pract 2007; 61: 737 -747

Body Mass Index: Risk of Diabetes Mellitus Study to Help Improve Early Evaluation and Body Mass Index: Risk of Diabetes Mellitus Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD) and National Health and Nutrition Examination Survey (NHANES) Source: Bays HE et al. Int J Clin Pract 2007; 61: 737 -747

Body Mass Index: Risk of Cardiovascular Disease Hazard Ratio 4. 0 Hemorrhagic CVA 4. Body Mass Index: Risk of Cardiovascular Disease Hazard Ratio 4. 0 Hemorrhagic CVA 4. 0 Ischemic CVA 4. 0 2. 0 1. 0 0. 5 Ischemic Heart Disease 0. 5 16 20 24 28 32 36 Body Mass Index (kg/m 2)* *BMI is calculated as the weight in kg divided by the BSA in meters 2 CVA=Cerebrovascular accident Source: Mhurchu N et al. Int J Epidemiol 2004; 33: 751 -758

Diet Evidence: Types of Treatment Programs Very low fat – Ornish (Reversal diet and Diet Evidence: Types of Treatment Programs Very low fat – Ornish (Reversal diet and Prevention diet) • Vegetarian with 10% calories from fat. No cooking oils, avocados, nuts, and seeds. High fiber. No caloric restriction. – Pritikin • Very low-fat (primarily vegetarian) diet based on whole grains, fruits, and vegetables Intermediate – Sugar Busters • 30% protein, 40% fat, 30% carbohydrates (low glycemic index) – Zone • 30% protein, 30% fat, 40% carbohydrates

Diet Evidence: Types of Treatment Programs (Continued) Very low carbohydrate – Atkins (Induction and Diet Evidence: Types of Treatment Programs (Continued) Very low carbohydrate – Atkins (Induction and Maintenance) • 1 st 2 weeks (<20 grams of carbohydrates/day with no high glycemic foods). • Then can add 5 grams of carbohydrates/day each week to maximum of 90 grams of carbohydrates/day long term. – South Beach (3 Phases) • 1 st phase (2 weeks) significantly restricts carbohydrates • 2 nd phase reintroduces low glycemic carbohydrates • 3 rd phase attempts to maintain weight Caloric restriction – Weight watchers • Assigns foods a point value and restricts the number of points that can be consumed/day

Diet Evidence: Primary Prevention 160 overweight and obese patients randomized to the Atkins, Zone, Diet Evidence: Primary Prevention 160 overweight and obese patients randomized to the Atkins, Zone, Weight Watchers, or Ornish diets for 1 year Ornish 20/40* Weight Watchers 26/40* Zone 26/40* Atkins 21/40* 0 3 Wt loss (lbs) 6 9 Weight loss is similar among diet programs, but hard to sustain because of poor long-term compliance *Ratio of individuals completing the study to those enrolled Source: Dansinger, ML et al. JAMA 2005; 293: 43 -53

AHA Primary Prevention of CV Disease in DM Weight Management Recommendations Primary Prevention • AHA Primary Prevention of CV Disease in DM Weight Management Recommendations Primary Prevention • Structured programs that emphasize lifestyle changes such as reduced fat (<30% of daily energy) and total energy intake and increased regular physical activity, alone with regular participant contact, can produce long-term weight loss on the order of 5 -7% of starting weight, with improvement in blood pressure. • For individuals with elevated plasma triglycerides and reduced HDLC, improved glycemic control, moderate weight loss (5 -7% of starting weight), increased physical activity, dietary saturated fat restriction, and modest replacement of dietary carbohydrates (5 -7%) by either monounsaturated or polyunsaturated fats may be beneficial. AHA=American Heart Association, CV=Cardiovascular, DM=Diabetes mellitus, HDL-C=High density lipoprotein cholesterol Source: Buse JB et al. Circulation 2007; 115: 114 -126

Weight Management Recommendations Secondary Prevention Goals: I IIa IIb III BMI 18. 5 -24. Weight Management Recommendations Secondary Prevention Goals: I IIa IIb III BMI 18. 5 -24. 9 kg/m 2, Waist circumference for women: <35 inches, men: <40 inches* Body mass index and/or waist circumference should be assessed at every visit, and the clinician should consistently encourage weight maintenance/reduction through an appropriate balance of lifestyle physical activity, structured exercise, caloric intake, and formal behavioral programs when indicated to maintain/achieve a body mass index between 18. 5 and 24. 9 kg/m 2 Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Weight Management Recommendations (Continued) Secondary Prevention I IIa IIb III If waist circumference (measured Weight Management Recommendations (Continued) Secondary Prevention I IIa IIb III If waist circumference (measured horizontally at the iliac crest) is >35 inches (>89 cm) in women and >40 inches (>102 cm) in men, therapeutic lifestyle interventions should be intensified and focused on weight management I IIa IIb III The initial goal of weight loss therapy should be to reduce body weight by approximately 5% to 10% from baseline. With success, further weight loss can be attempted if indicated. Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Evidence for Current Cardiovascular Disease Prevention Guidelines Diet Evidence, Cardiovascular Events, and Guidelines Evidence for Current Cardiovascular Disease Prevention Guidelines Diet Evidence, Cardiovascular Events, and Guidelines

Relationship Between Diet and CV Disease Diet Intermediary Biological Mechanisms* Risk of Coronary Heart Relationship Between Diet and CV Disease Diet Intermediary Biological Mechanisms* Risk of Coronary Heart Disease *Includes lipid levels [LDL-C, HDL-C, triglycerides, Lp(a), blood pressure, thrombotic tendency, cardiac rhythm, endothelial function, systemic inflammation, insulin sensitivity, oxidative stress, homocysteine level CV=Cardiovascular Source: Hu FB et al. JAMA. 2002; 288: 2569 -2578

Diet Evidence: Effect on Lipid Parameters and CRP 46 dyslipidemic patients randomized to a Diet Evidence: Effect on Lipid Parameters and CRP 46 dyslipidemic patients randomized to a low fat diet, a low fat diet and lovastatin (20 mg), or a dietary portfolio* for 4 weeks Change from Baseline (%) 30 LDL-C 20 LDL-C: HDL-C CRP 10 Low fat diet 0 Statin -10 Dietary portfolio* -20 -30 -40 -50 0 2 Weeks 4 0 2 4 Weeks A diversified diet improves lipid parameters and CRP levels *Enriched in plant sterols, soy protein, viscous fiber, and almonds CRP=C-reactive protein, HDl-C=High density lipoprotein cholesterol, LDL-C=Low density lipoprotein cholesterol Source: Jenkins DJ et al. JAMA 2003; 290: 502 -510

Diet Evidence: Effect on Blood Pressure Dietary Approaches to Stop Hypertension (DASH) Group 459 Diet Evidence: Effect on Blood Pressure Dietary Approaches to Stop Hypertension (DASH) Group 459 hypertensive patients randomized to 1 of 3 diets for 8 weeks 132 Systolic blood pressure 130 (mm Hg) 126 128 Diet low in fruits, vegetables, and dairy products 124 Diet enriched in fruits, vegetables, and fiber 86 Diastolic blood pressure 84 (mm Hg) 80 Diet enriched in fruits and vegetables and low in fat and cholesterol 82 78 0 1 2 3 4 5 6 7/8 Weeks A diversified diet improves blood pressure Source: Appel LJ et al. NEJM 1997; 336: 1117 -1124

Diet Evidence: Benefits of Fruits and Vegetables Nurses’ Health Study and Health Professional’s Follow-up Diet Evidence: Benefits of Fruits and Vegetables Nurses’ Health Study and Health Professional’s Follow-up Study 126, 399 persons followed for 8 -14 years to assess the relationship between fruit and vegetable intake and adverse CV outcomes* Increased fruit and vegetable intake reduces CV risk *Includes nonfatal MI and fatal coronary heart disease CV=Cardiovascular Joshipura KJ et al. Ann Intern Med 2001; 134: 1106 -1114

Diet Evidence: Benefits of Whole Grains and Fiber 336, 244 persons followed for 6 Diet Evidence: Benefits of Whole Grains and Fiber 336, 244 persons followed for 6 -10 years to assess the relationship between dietary fiber intake and adverse CV outcomes RR=0. 73, P<0. 001 Increased dietary fiber intake reduces CV risk CV=Cardiovascular, CHD=Coronary heart disease Source: Pereira MA et al. Arch Int Med 2004; 164: 370 -376

Diet Evidence: Making Smart Food Choices • Helps consumers make better food choices • Diet Evidence: Making Smart Food Choices • Helps consumers make better food choices • Reminds individuals to eat healthfully • Illustrates the 5 food groups using a mealtime visual • Selected messages include: • Balancing calories • Foods to increase • Foods to reduce Source: United States Department of Agriculture, http: //www. choosemyplate. gov/index. html

Diet Evidence: Primary Prevention 22, 043 adults evaluated for adherence to a Mediterranean diet, Diet Evidence: Primary Prevention 22, 043 adults evaluated for adherence to a Mediterranean diet, with points given for high consumption of vegetables, legumes, fruits, nuts, cereal, and fish and points subtracted for high consumption of meat, poultry, and dairy Variable # of Deaths/ # of Participants Fully Adjusted Hazard Ratio (95% CI) Death from any cause 275/22, 043 0. 75 (0. 64 -0. 87) 54/22, 043 0. 67 (0. 47 -0. 94) 97/22, 043 0. 76 (0. 59 -0. 98) Death from CHD Death from cancer High adherence to a Mediterranean diet is associated with a reduction in death CHD=Coronary heart disease Source: Trichopoulou A et al. NEJM 2003; 348: 2599 -2608

Diet Evidence: Secondary Prevention Lyon Diet Heart Study 605 patients following a myocardial infarction Diet Evidence: Secondary Prevention Lyon Diet Heart Study 605 patients following a myocardial infarction randomized to a Mediterranean* or Western** diet for 4 years Freedom from cardiac death or myocardial infarction (%) 100 90 Mediterranean diet Western diet 80 70 P=0. 0001 1 2 3 Year 4 5 A Mediterranean diet reduces cardiovascular events *High in polyunsaturated fat and fiber, **High in saturated fat and low in fiber Source: De Lorgeril M et al. Circulation 1999; 99: 779 -785

Adult Treatment Panel (ATP) III Dietary Recommendations Nutrient Saturated fat* Recommended Intake <7% of Adult Treatment Panel (ATP) III Dietary Recommendations Nutrient Saturated fat* Recommended Intake <7% of total calories Polyunsaturated fat Up to 10% of total calories Monounsaturated fat Up to 20% of total calories Total fat 25%– 35% of total calories Carbohydrate (esp. complex carbs) Fiber 50%– 60% of total calories 20– 30 g/d Protein Cholesterol ~15% of total calories <200 mg/d *Trans fatty acids also raise LDL-C and should be kept at a low intake Note: Regarding total calories, balance energy intake and expenditure to maintain desirable body weight LDL-C=Low density lipoprotein cholesterol Source: Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. JAMA 2001; 285: 2486 -2497

American Heart Association Nutrition Committee Dietary Recommendations for Cardiovascular Disease Risk Reduction • Balance American Heart Association Nutrition Committee Dietary Recommendations for Cardiovascular Disease Risk Reduction • Balance calorie intake and physical activity to achieve or maintain a healthy body weight • Consume a diet rich in fruits and vegetables • Consume whole-grain, high-fiber foods • Consume fish, especially oily fish, at least twice a week • Limit intake of saturated fat to <7%, trans fat to <1% of energy, and cholesterol <300 mg/day by: – Choosing lean mean and vegetable alternatives – Choosing fat free (skim), 1% fat, and low-fat dairy products, – Minimizing intake of partially hydrogenated fats • Minimize intake of beverages and foods with added sugar • Choose and prepare foods with little or no salt • If alcohol is consumed, do so in moderation AHA=American Heart Association Source: AHA Nutrition Committee. Circulation 2006; 114: 82 -96

Dietary Recommendations Primary Prevention I IIa IIb III Women should consume a diet rich Dietary Recommendations Primary Prevention I IIa IIb III Women should consume a diet rich in fruits and vegetables; choose whole-grain, high-fiber foods; consume fish, especially oily fish, * at least twice a week; limit intake of saturated fat to <10% of energy, and if possible to <7%, cholesterol to <300 mg/d, alcohol intake to no more than 1 drink per day, and sodium intake to <2. 3 g/d (approximately 1 tsp salt). Consumption of trans-fatty acids should be as low as possible (eg, <1% of energy) *Pregnant and lactating women should avoid eating fish potentially high in ethylmercury m Source: Mosca L et al. Circulation 2007; 115: 1481 -1501

AHA Primary Prevention of CV Disease in DM Dietary Recommendations Primary Prevention • To AHA Primary Prevention of CV Disease in DM Dietary Recommendations Primary Prevention • To achieve reductions in LDL-C levels: o Saturated fats should be <7% of energy intake. o Dietary cholesterol intake should be <200 mg/day. o Intake of trans-unsaturated fatty acids should be <1% of energy intake. • Total energy intake should be adjusted to achieve body-weight goals. • Total dietary fat intake should be moderated (25 -35% of total calories) and should consist mainly of monounsaturated or polyunsaturated fat. AHA=American Heart Association, CV=Cardiovascular, DM=Diabetes mellitus, LDL -C=Low density lipoprotein cholesterol Source: Buse JB et al. Circulation 2007; 115: 114 -126

AHA Primary Prevention of CV Disease in DM Dietary Recommendations Primary Prevention • Ample AHA Primary Prevention of CV Disease in DM Dietary Recommendations Primary Prevention • Ample intake of dietary fiber (>14 grams/1000 calories consumed) may be of benefit. • If individuals choose to drink alcohol, daily intake should be limited to 1 drink* for adult women and 2 drinks* for adult men. Alcohol ingestion increase caloric intake and should be minimized when weight loss is the goal. Individuals with elevated plasma triglyceride levels should limit alcohol intake, because intake may exacerbate hypertriglyceridemia. • In both normotensive and hypertensive individuals, a reduction in sodium intake may lower blood pressure. The goal should be to reduce sodium intake to 1200 -2300 mg/day. ** * Defined as a 12 ounce beer, a 4 ounce glass of wine, or a 1. 5 ounce glass of distilled spirits ** Equivalent to 3000 -6000 mg/day of sodium chloride AHA=American Heart Association, CV=Cardiovascular, DM=Diabetes mellitus Source: Buse JB et al. Circulation 2007; 115: 114 -126

ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus Primary Prevention • Weight ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus Primary Prevention • Weight loss is recommended for all overweight or obese individuals who are at risk for DM. • For weight loss, either low-carbohydrate or low-fat calorie-restricted diets may be effective in the short-term (up to 1 year). • Among individuals at high risk for developing type II DM, structured programs emphasizing lifestyle changes that include moderate weight loss (7% body weight) and regular physical activity (150 minutes/week) with dietary strategies include reduced intake of dietary fat and can reduce the risk of developing DM and are therefore recommended. ADA=American Diabetes Association, DM=Diabetes mellitus Source: American Diabetes Association. Diabetes Care 2010; 33: S 11 -61

ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus (Continued) Primary Prevention • ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus (Continued) Primary Prevention • Individuals at high risk for type II DM should be encouraged to achieve USDA recommendation for dietary fiber (14 grams fiber/1000 kcal) and foods containing whole grains (one-half of gram intake). • Saturated fat intake should be <7% of total calories. • Reducing intake of trans-fat lowers LDL-C and increase HDL-C. Therefore, intake of trans-fat should be minimized. • Monitoring carbohydrate intake, whether by carbohydrate counting, exchanges, or experience-based estimation remains a key strategy in achieving glycemic control. ADA=American Diabetes Association, DM=Diabetes mellitus, HDL-C=High density lipoprotein cholesterol, LDL-C=Low density lipoprotein cholesterol Source: American Diabetes Association. Diabetes Care 2010; 33: S 11 -61

ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus (Continued) Primary Prevention • ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus (Continued) Primary Prevention • For individuals with DM, use of the glycemic index and glycemic load may provide a modest additional benefit for glycemic control over that observed when total carbohydrate is considered alone. • Sugar alcohols and nonnutritive sweeteners are safe when consumed within the acceptable daily intake levels established by the FDA. • If adults with DM choose to use alcohol, daily intake should be limited to a moderate amount (<1 drink per day for adult women and <2 drinks per day for adult men). AHA=American Heart Association, DM=Diabetes mellitus, FDA=Food and Drug Administration Source: American Diabetes Association. Diabetes Care 2010; 33: S 11 -61

ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus (Continued) Primary Prevention • ADA Medical Nutrition Therapy Recommendations for Patients with Diabetes Mellitus (Continued) Primary Prevention • Routine supplementation with antioxidants, such as Vitamin E and C, and carotene, is not advised because of lack of evidence of efficacy and concerns related to long-term safety. • Benefit from chromium supplementation in patients with DM or obesity has not been conclusively demonstrated and therefore cannot be recommended. • Individualized meal planning should include optimization of food choices to meet recommended dietary allowances (RDAs)/dietary reference intakes (DRIs) for all micronutrients. ADA=American Diabetes Association, DM=Diabetes mellitus Source: American Diabetes Association. Diabetes Care 2010; 33: S 11 -61

Dietary Recommendations Secondary Prevention I IIa IIb III Dietary therapy for all patients should Dietary Recommendations Secondary Prevention I IIa IIb III Dietary therapy for all patients should include reduced intake of saturated fats (to <7% of total calories), trans fatty acids (to <1% of total calories), and cholesterol (to <200 mg/d) For all patients, it may be reasonable to recommend omega 3 fatty acids from fish or fish oil capsules (1 gram/day) for cardiovascular disease risk reduction Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Evidence for Current Cardiovascular Disease Prevention Guidelines Physical Activity Evidence and Guidelines Evidence for Current Cardiovascular Disease Prevention Guidelines Physical Activity Evidence and Guidelines

Adverse Effects of Physical Inactivity Inflammation Dyslipidemia Age Hypertension Diabetes Mellitus Smoking Obesity Hypercoagulability Adverse Effects of Physical Inactivity Inflammation Dyslipidemia Age Hypertension Diabetes Mellitus Smoking Obesity Hypercoagulability Genetics Atherosclerosis Novel Risk Factors

Prevalence of Physical Activity Prevalence of physical activity among individuals >18 years of age Prevalence of Physical Activity Prevalence of physical activity among individuals >18 years of age Over half the U. S. adult population is physically inactive NH=Non-Hispanic Source: Lloyd-Jones D et al. Circulation 2010; 121: 46 -215

Exercise Evidence: Effect on Body Composition 173 sedentary, overweight (body mass index >24 kg/m Exercise Evidence: Effect on Body Composition 173 sedentary, overweight (body mass index >24 kg/m 2) post-menopausal women randomized to moderate intensity exercise vs. stretching for 1 year Total Body Fat Intra-abdominal Fat Moderate exercise reduces total and intra-abdominal fat Note: Minutes per week spent in moderate-intensity sports activity (low-active, 135 min/wk; intermediately active, 136 -195 min/wk; and highly active, >195 min/wk) Source: Irwin ML et al. JAMA 2003; 289: 323 -330

Exercise Evidence: Effect on Lipid Parameters Assessment of lipid profiles in 719 patients undergoing Exercise Evidence: Effect on Lipid Parameters Assessment of lipid profiles in 719 patients undergoing cardiac rehab Year and Lipid Level (mg/d. L) Baseline 1 3 5 Change from Baseline Men Women 214 239 213 223 210 209 196 193 8% 20%* LDL-C Men Women 138 155 134 135 131 120 118 102 15% 34%* HDL-C Men Women 37 47 40 50 41 55 39 56 5% 20%† TG Men Women 200 188 197 190 199 174 202 171 NS Lipids TC *P=0. 0001 for change in women vs men †P=0. 03 for change in women vs men HDL-C=High density lipoprotein cholesterol, LDL-C=Low density lipoprotein cholesterol, TG=Triglyceride Source: Warner JG et al. Circulation 1995; 92: 773 -777

Exercise Evidence: Effect on Lipid Parameters Look AHEAD Trial 5, 145 patients aged 45 Exercise Evidence: Effect on Lipid Parameters Look AHEAD Trial 5, 145 patients aged 45 -74 years with type 2 DM and BMI of 25 kg/m 2 (27 kg/m 2 if taking insulin) randomized to an intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity versus diabetes support and education (DSE) ILI DSE P value LDL (mg/d. L) -5. 2 ± 0. 6 -5. 7 ± 0. 6 0. 49 HDL (mg/d. L) 3. 4 ± 0. 2 1. 4 ± 0. 1 <0. 001 Triglycerides (mg/d. L) -30. 3 ± 2. 0 -14. 6 ± 1. 8 <0. 001 % Metabolic Syndrome -14. 7 ± 0. 8 -7. 1 ± 0. 7 <0. 001 Intensive lifestyle intervention results in greater improvement in lipid parameters BMI=Body mass index, DM=Diabetes mellitus, DSE=Diabetes support and education, ILI=Intensive lifestyle intervention Source: Look AHEAD investigators. Diabetes Care 2007; 30: 1374 -1383

Exercise Evidence: Effect on Obesity and Diabetes Mellitus (DM) Nurse’s Health Study 35% 30% Exercise Evidence: Effect on Obesity and Diabetes Mellitus (DM) Nurse’s Health Study 35% 30% Risk of obesity Risk of DM 25% 20% 15% 10% 5% 0% Reduction: Each hour a day spent walking briskly Increase: Each two hours a day spent watching TV Increase: Each two hours a day spent sitting at work Exercise reduces the incidence of obesity and DM Source: Hu FB et al. JAMA 2003; 289: 1785 -1791

Exercise Evidence: Effect on Coronary Heart Disease Risk Women’s Health Initiative Observational Study P=0. Exercise Evidence: Effect on Coronary Heart Disease Risk Women’s Health Initiative Observational Study P=0. 008 P=0. 004 Relative Risk of CHD Walking Relative Risk of CHD Vigorous exercise* 1 2 3 4 5 Quintiles of activity (MET-hour/week**) *Includes aerobics, aerobic dancing, jogging, tennis, and swimming laps **Average active hours per week energy expenditure per activity CHD=Coronary heart disease Source: Manson JE et al. NEJM 2002; 347: 716 -725

Physical Activity: Effect on Mortality Death Rate (per 10, 000) 13, 344 healthy men Physical Activity: Effect on Mortality Death Rate (per 10, 000) 13, 344 healthy men and women followed for 8 years Men Women Fitness Level to High) Fitness Level (Low to High) Low physical fitness is associated with increased mortality Source: Blair SN et al. JAMA 1998; 262: 2395 -2401

Physical Activity: Secondary Prevention Age-adjusted mortality rate/1000 person-years Observational study of self-reported physical activity Physical Activity: Secondary Prevention Age-adjusted mortality rate/1000 person-years Observational study of self-reported physical activity in 772 men with CHD Physical activity Moderate exercise is associated with reduced mortality CHD=Coronary heart disease, CVD=Cardiovascular disease Source: Wannamethee SG et al. Circulation 2000; 102: 1358 -1363

Cardiac Rehabilitation: Benefits Following a Myocardial Infarction Effect of cardiac rehabilitation in randomized controlled Cardiac Rehabilitation: Benefits Following a Myocardial Infarction Effect of cardiac rehabilitation in randomized controlled trials following a MI * * Cardiac rehabilitation reduces CV events after a MI *p<0. 0125 CV=Cardiovascular, MI=Myocardial infarction Source: Oldridge NB et al. JAMA 1988; 260: 945 -950

Cardiac Rehabilitation: Prevalence of Incomplete Attendance Sessions attended (%) Observational study of 30, 161 Cardiac Rehabilitation: Prevalence of Incomplete Attendance Sessions attended (%) Observational study of 30, 161 Medicare patients attending at least 1 phase II cardiac rehabilitation session Number of Sessions Attended A large number of patients fail to complete 36 sessions of cardiac rehabilitation Source: Hammill BG et al. Circulation 2010; 121: 63 -70

Cardiac Rehabilitation: Greater Benefit with Greater Attendance Death (%) Myocardial infarction (%) Observational study Cardiac Rehabilitation: Greater Benefit with Greater Attendance Death (%) Myocardial infarction (%) Observational study of 30, 161 Medicare patients attending at least 1 phase II cardiac rehabilitation session Years after Index Date There is a strong dose-response relationship between the number of cardiac rehabilitation sessions attended and long-term CV outcomes CV=Cardiovascular Source: Hammill BG et al. Circulation 2010; 121: 63 -70

Cardiac Rehabilitation: Benefit of Secondary Prevention Programs Meta-analysis of 63 randomized clinical trials evaluating Cardiac Rehabilitation: Benefit of Secondary Prevention Programs Meta-analysis of 63 randomized clinical trials evaluating cardiac secondary prevention programs with or without exercise programs All cause mortality Recurrent myocardial infarction Secondary prevention programs provide CV benefit CV=Cardiovascular Source: Clark AM et al. Ann of Intern Med 2005; 143: 659 -72

AHA Primary Prevention of CV Disease in DM Physical Activity Recommendations Primary Prevention • AHA Primary Prevention of CV Disease in DM Physical Activity Recommendations Primary Prevention • To improve glycemic control, assist with weight loss or maintenance, and reduce the risk of CVD, at least 150 minutes of moderate-intensity aerobic physical activity or at least 90 minutes of vigorous aerobic exercise per week is recommended. The physical activity should be distributed over at least 3 days per week, with no more than 2 consecutive days without physical activity. • For long-term maintenance of major weight loss, a larger amount of exercise (7 hours of moderate or vigorous aerobic physical activity per week) may be helpful. AHA=American Heart Association, CV=Cardiovascular, CVD=Cardiovascular disease, DM=Diabetes mellitus Source: Buse JB et al. Circulation 2007; 115: 114 -126

ADA Physical Activity Recommendations for Patients with Diabetes Mellitus Primary Prevention • People with ADA Physical Activity Recommendations for Patients with Diabetes Mellitus Primary Prevention • People with DM should be advised to perform at least 150 minutes/week of moderate-intensity aerobic physical activity (50 -70% of maximum heart rate). • In the absence of contraindications, people with type II DM should be encouraged to perform resistance training three times per week. ADA=American Diabetes Association, DM=Diabetes mellitus Source: American Diabetes Association. Diabetes Care 2010; 33: S 11 -61

Physical Activity Recommendations Secondary Prevention Goal: I IIa IIb III At least 30 minutes, Physical Activity Recommendations Secondary Prevention Goal: I IIa IIb III At least 30 minutes, 7 days per week (minimum 5 days per week) of physical activity For all patients, the clinician should encourage 30 to 60 minutes of moderate-intensity aerobic activity, such as brisk walking, at least 5 days and preferably 7 days per week, supplemented by an increase in daily lifestyle activities (e. g. , walking breaks at work, gardening, household work) to improve cardiorespiratory fitness and move patients out of the least fit, least active high-risk cohort Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Physical Activity Recommendations (Continued) Secondary Prevention I IIa IIb III For all patients, risk Physical Activity Recommendations (Continued) Secondary Prevention I IIa IIb III For all patients, risk assessment with a physical activity history and/or an exercise test is recommended to guide prognosis and prescription I IIa IIb III The clinician should counsel patients to report and be evaluated for symptoms related to exercise. I IIa IIb III It is reasonable for the clinician to recommend complementary resistance training at least 2 days per week Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Cardiac Rehabilitation Recommendations Secondary Prevention I IIa IIb III All eligible patients with ACS Cardiac Rehabilitation Recommendations Secondary Prevention I IIa IIb III All eligible patients with ACS or whose status is immediately post coronary artery bypass surgery or post. PCI should be referred to a comprehensive outpatient cardiovascular rehabilitation program either prior to hospital discharge or during the first follow-up office visit I IIa IIb III All eligible outpatients with the diagnosis of ACS, coronary artery bypass surgery or PCI (Level of Evidence: A), chronic angina (Level of Evidence: B), and/or peripheral artery disease (Level of Evidence: A) within the past year should be referred to a comprehensive outpatient cardiovascular rehabilitation program. Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446

Cardiac Rehabilitation Recommendations (Continued) Secondary Prevention I IIa IIb III A home-based cardiac rehabilitation Cardiac Rehabilitation Recommendations (Continued) Secondary Prevention I IIa IIb III A home-based cardiac rehabilitation program can be substituted for a supervised, center-based program for lowrisk patients A comprehensive exercise-based outpatient cardiac rehabilitation program can be safe and beneficial for clinically stable outpatients with a history of heart failure Source: Smith SC Jr. et al. JACC 2011; 58: 2432 -2446