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Strive Teleconf Presentation Oct11 2006
1. CVD Critical Pathways Group 2006 Teleconferences This activity is supported by an educational grant from the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. October 11, 2006
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5. Diabetes and Metabolic Syndrome in Patients Hospitalized With CVD Gregg C. Fonarow, MD
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7. Diagnose by presence of 3 or more risk factors Adapted with permission from Grundy SM, et al. Circulation. 2005;112:2735-2752. AHA/NHLBI-Modified ATP III Criteria for the Metabolic Syndrome Risk Factor Defining Level Abdominal obesity Waist circumference* Men >40 in Women >35 in Triglycerides, mg/dL 150 HDL-C, mg/dL Men <40 Women <50 BP, mm Hg 130/≥85 Fasting glucose, mg/dL 100 *Lower cutpoints for Asian Americans.
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9. 1 in 4 Adults Have Diabetes or the Metabolic Syndrome ~ 64 14.6 6.2 Undiagnosed diabetes* Diagnosed diabetes* Metabolic syndrome † Population at risk (millions) 12 8 4 0 35 15 5 0 25 Diagnosed diabetes Metabolic syndrome White Black Hispanic Other White Black Hispanic Other Prevalence, %, age ≥18 yrs Prevalence, %, age ≥20 yrs Mokdad AH, et al. JAMA . 2003;289:76-79. Ford ES, et al. JAMA . 2002;287:356-359. Ford ES, et al. Diabetes Care . 2004;27:2444-2449. 10 6 2 30 20 10 *2005 US data, NIDDK, NIH. † Based on revised NCEP/ATP III definition (NHANES 2000 data).
10. Risk Factors Associated With the Metabolic Syndrome (NHANES 1999-2000) 90.9 73.9 77.0 41.5 73.9 15.1 36.6 14.9 24.9 7.2 26.5 5.6 0 20 40 60 80 100 High Waist Circumference High Triglycerides Low HDL-C High Fasting Glucose High BP CVD History Percentage Metabolic syndrome Without metabolic syndrome Adapted from Ford ES, et al. JAMA. 2002;287:356-359.
11. Metabolic Syndrome Predicts Incidence of Diabetes Independently of Impaired Glucose Tolerance San Antonio Heart Study (N = 1734 ) Lorenzo C, et al. Diabetes Care . 2003;26:3153-3156. *ATP III definition. 60 50 40 30 20 10 0 No Yes Metabolic syndrome* Diabetes, % P = .018 P <.0001 P <.0001 Impaired Glucose Tolerance Yes No
12. Cardiovascular Disease Mortality and the Metabolic Syndrome Follow-up, Years Cumulative Hazard, % RR = 3.55 (95% CI, 1.96-6.43) 866 288 852 279 834 234 292 100 Yes No Metabolic Syndrome?* Metabolic Syndrome Controls *Based on factor analysis; men in highest quarter of distribution of the metabolic syndrome factor were considered to have metabolic syndrome. Reproduced with permission from Lakka HM, et al. JAMA. 2002;288:2709-2716. 12 10 8 6 4 2 0 0 5 10 15
13. Clustering of Risk Factors Increases Mortality in Post-CABG Patients: 8-Year Follow-up Obesity, Diabetes, Hypertension, Hypertriglyceridemia Sprecher DL, Pearce GL. J Am Coll Cardiol. 2000;36:1159-1165. 50 45 40 35 30 25 20 15 10 5 0 0 1 2 3 4 Number of Risk Factors Mortality, % P <.001 for relationship of increasing number of risk factors to mortality Men Women N = 6428; deaths = 860.
14. Overweight and Obesity Increase the Risk of Cardiovascular Disease Mortality Overweight Data are from 1 million men and women (average age, 57 years) followed for 16 years who never smoked and had no history of disease at enrollment. Calle EE, et al. N Engl J Med. 1999;341:1097-1105. Normal weight Obese Relative Risk of Cardiovascular Disease Mortality 0.6 3.0 2.6 2.2 1.8 1.4 1.0 >18 25 30 > 40 BMI, kg/m 2 Women Men
15. The Ticking Clock: CV Risk Before Glucose Nurses’ Health Study; 20-year follow-up of 117,629 women Hu FB, et al. Diabetes Care . 2002;25:1129-1134. Relative risk of MI or stroke No diabetes throughout study Risk of event prior to diabetes diagnosis Risk of event after diabetes diagnosis Diabetes at baseline 5.0 3.7 2.8 1.0 6 4 2 0
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17. Waist Circumference Correlates With BP and Insulin Resistance 768 men with fasting glucose ≤126 mg/dL (≤7 mmol/L) Siani A, et al. Am J Hypertens . 2002;15:780-786. P <.001 for trend in each parameter. 50 40 30 20 10 0 50 40 30 20 10 0 High blood pressure Insulin resistance Quintiles of Waist Circumference % I II III IV V I II III IV V
18. Link Between Hyperglycemia and Poor Hospital Outcomes Clement S et al. Diabetes Care. 2004;27:553-591. Metabolic stress response Stress hormones and peptides Prolonged hospital stay Disability Death Glucose Insulin FFA Ketones Lactate Immune dysfunction Infection dissemination Reactive O 2 species Transcription factors Secondary mediators Cellular injury/apoptosis Inflammation Tissue damage Altered tissue/wound repair Acidosis Infarction/ischemia
19. Increasing Glucose Levels Increase Long-Term Mortality in ACS Bhadriraju S, et al. Am J Cardiol. 2006;97:1573-1577. OPUS-TIMI 16 trial; 10,288 patients with ACS Quartile 1=<101 mg/dL Quartile 2=101–120.6 mg/dL Quartile 3=120.6–157 mg/dL Quartile 4=>157 mg/dL 1 .95 .9 .85 Days of Follow-up Cumulative Survival 0 100 200 300 P for trend across group=0.006 Quartile 1 Quartile 2 Quartile 3 Quartile 4
20. Hyperglycemia Increases In-Hospital Complications and Long-Term Mortality 1. Foo K, et al. Heart . 2003;89:512-516. 2. Kosiborod M, et al. Circulation. 2005;111:3078-3086. N=2,127 patients with AMI or unstable angina 1 Q 1= ≤5.8 mmol/L; Q2= ≤7.2; Q3=≤10.0; Q4=>10.0. Cooperative Cardiovascular Project; N=141,680 elderly patients hospitalized with AMI 2 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 70 120 170 220 270 320 370 Glucose (mg/dl) Mortality Rate Diabetes: No P <.001 for interaction Diabetes: Yes One-Year Mortality <.0001 2.80 (1.74 to 4.50) Q4 1.73 (1.06 to 2.83) Q3 1.10 (0.66 to 1.86) Q2 1.00 Q1 Glucose P Value Odds Ratio Comparison Variable Multivariate Predictors of Left Ventricular Failure
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23. Management of Cardiovascular Risk in Patients With Abdominal Obesity Hypertension Type 2 diabetes Dyslipidemia Risk factors Coronary heart disease Treat the complications? Manage coronary heart disease risk Adapted with permission from Després JP, et al. BMJ . 2001;322:716-720. Treat the cause Abdominally obese patient at increased cardiometabolic risk
24. Effect of Interventions on Weight Change and Risk of Diabetes and Metabolic Syndrome Knowler WM, et al; Diabetes Prevention Program Research Group. N Engl J Med. 2002;346:393-403. Diabetes Prevention Program -8 -0.1 Weight Change, kg -6 -4 -2 0 PB (n = 1082) LS (n = 1079) MET (n = 1073) -5.6* -2.1* *P <.001 vs placebo % Reduction in Incidence of Diabetes -60 -40 -20 MET LS -58* -31 *P <.05 vs metformin -50 -40 -30 -20 -10 0 MET LS Reduction in Risk of Metabolic Syndrome, % -17% † -41%* Risk of developing metabolic syndrome n=1523 LS = lifestyle intervention; MET = metformin; PB = placebo. Orchard TJ, et al; Diabetes Prevention Program Research Group. Ann Intern Med . 2005;142:611-619. * P <.001; † P = .03
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26. Most Widely Prescribed Drugs for Treating Obesity *Approved for OTC use in January 2006. Adapted from Yanovski SZ, Yanovski JA. N Engl J Med. 2002;346:591-602. Phentermine Year Approved Approved Use DEA Schedule 1997 Long term IV 1973 Short term IV 1999 Long term None Generic Name Sibutramine Orlistat*
27. Current Therapies Often Address Individual Risk Factors Waist circumference Blood pressure Blood glucose Triglycerides HDL-cholesterol LDL-cholesterol Insulin resistance Thrombotic risk NCEP ATP III definition of the metabolic syndrome Antiplatelet agents Lipid modifiers Insulin sensitizers Antihypertensives Oral antidiabetic agents
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29. R imonabant I n O verweight/ O besity Trials 1 year 1045 Obese or overweight with type 2 diabetes RIO-Diabetes 1 year 1036 Obese or overweight with untreated dyslipidemia (diabetes excluded) RIO-Lipids 2 years 1507 Obese or overweight with/without comorbidities (except diabetes) RIO-Europe 1+1 year Re-randomized 3045 Obese or overweight with/without comorbidities (except diabetes) RIO-North America Design Population Study N
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31. RIO-North America: Change in Metabolic Syndrome Status Pi-Sunyer FX, et al. JAMA. 2006;295:761-775. Baseline 1-Year Treatment ITT, LOCF Patients, % 31.7% 34.8% 29.2% 21.2% 0 10 20 30 40 Placebo Rimonabant 20 mg P <.001
32. Pooled RIO Studies: Overall Safety Year 1 Year 2 Subjects discontinued due to adverse event Subjects with any serious adverse event* Subjects with any adverse event 4.7% 5.4% 77.0% 4.5% 4.7% 74.4% 4.7% 4.5% 76.7% 86.0% 82.9% 81.8% 13.8% 8.8% 7.2% 5.9% 5.4% 4.2% (n = 466) Placebo (n = 663) Rimonabant 5 mg (n = 688) Rimonabant 20 mg Rimonabant 20 mg (n = 2503) (n = 1602) (n = 2520) Rimonabant 5 mg Placebo Includes all deaths occurring in all four RIO studies: 4 on placebo, 3 on rimonabant 5 mg, 4 on rimonabant 20 mg. RIO- North America RIO- Europe RIO- Lipids RIO- Diabetes RIO- North America RIO- Europe Scheen A, et al. Presented at: American Diabetes Association 65th Annual Scientific Sessions; June 12, 2005; San Diego, Calif.
36. Progress Checklist: Immediate Goals Circulate discharge plan and other tools to all cardiology, ED, and CV nursing staff for comments Circulate pathways to all cardiology, ED, and CV nursing staff for comments Develop draft pathways Assemble team and set up meeting of working group
37. Progress Checklist: Short-term Goals/Activities Grand rounds/conference: Cardiology/IM Grand rounds/conference: Emergency Dept. Grand rounds/conference: Nursing Circulate memo Launch critical pathways Finalize critical pathways
38. Progress Checklist: Long-term Goals/Activities NRMI AHA Get With the Guidelines ACC National Cardiovascular Data Registry CRUSADE GRACE REACH Other Monitor data: Which registry?
40. Concluding Remarks Gregg C. Fonarow, MD Next Program Highlights From the 2006 Transcatheter Cardiovascular Therapeutics (TCT) Conference Christopher P. Cannon, MD Wednesday, November 8, 2006 12:00 Noon Eastern Time (9:00 AM Pacific Time)