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Diabetes . . .

Diabetes . . . Common and underdiagnosed Causes macro- and microvascular events Reduces duration and quality of life. Estimated Prevalence of Diabetes in the US Adult Men and Women. 30. Men. Women. 21.1. 20.2. 20. 17.8. 17.5. Percent of Population. 12.9. 12.4. 10. 6.8. 6.1. 1.6.

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Diabetes . . .

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  1. Diabetes . . . • Common and underdiagnosed • Causes macro- and microvascular events • Reduces duration and quality of life

  2. Estimated Prevalence of Diabetes in the USAdult Men and Women 30 Men Women 21.1 20.2 20 17.8 17.5 Percent of Population 12.9 12.4 10 6.8 6.1 1.6 1.7 0 20-39 40-49 50-59 60-74 75+ Age (y) Harris, et al. Diabetes Care. 1998;21:518-24.

  3. Diagnosed and Undiagnosed Diabetes in the USEstimated Cases Among Adults, 1997 12 10.2 10 8 Millions of Cases 6 5.4 4 2 0 Diagnosed Undiagnosed Harris, et al. Diabetes Care. 1998;21:518-24.

  4. Retinopathy in Adults not Known to Have Diabetes Rationale for Diagnostic Criteria for DiabetesGlycemic Values in Deciles of Populations US (NHANES III) 15 FPG 2hPG HbA1c 10 Retinopathy (%) 5 0 FPG (mg/dL) 2hPG (mg/dL) HbA1c (%) 42- 87- 90- 93- 96- 98- 101- 104- 109- 120- 34- 75- 86- 94- 102- 112- 120- 133- 154- 195- 3.3- 4.9- 5.1- 5.2- 5.4- 5.5- 5.6- 5.7- 5.9- 6.2- Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1999;22(Supp 1):S5-S19.

  5. Retinopathy in Adults not Known to Have Diabetes Rationale for Diagnostic Criteria for DiabetesGlycemic Values in Deciles of Populations Egypt 50 40 FPG 2hPG HbA1c 30 Retinopathy (%) 20 10 0 FPG (mg/dL) 2hPG (mg/dL) HbA1c (%) 57- 79- 84- 89- 93- 99- 108- 130- 178- 258- 39- 80- 90- 99- 110- 125- 155- 218- 304- 386- 2.2- 4.7- 4.9- 5.1- 5.4- 5.6- 6.0- 6.9- 8.5- 10.3- Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1999;22(Supp 1):S5-S19.

  6. Glucose Tolerance Categories FPG 2-Hour PG on OGTT Diabetes Mellitus Diabetes Mellitus 126 mg/dL 7.0 mmol/L 200 mg/dL 11.1 mmol/L Impaired Fasting Impaired Glucose Glucose Tolerance 110 mg/dL 6.1 mmol/L 140 mg/dL 7.8 mmol/L Normal Normal Adapted from The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997;20:1183-97.

  7. Diagnosis of DiabetesThree Methods 1. Random plasma glucose >200 mg/dL on 2 separate occasions + symptoms (polyuria, polydipsia, unexplained weight loss) 2. FPG >126 mg/dL on 2 separate occasions 3. 2-hour plasma glucose >200 mg/dL during OGTTon 2 separate occasions Adapted from The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997;20:1183-97.

  8. THE FUNAGATA DIABETES STUDYImpaired Glucose Tolerance is a CV Risk Factor Cumulative Cardiovascular Survival 1.00 1.00 0.99 0.98 0.98 0.96 0.97 0.96 0.94 Normal IGT (2 hr PG 140-200) DM (2 hr PG >200) Normal IFG (FPG 110-126) DM (FPG >126) 0.95 0.92 0.94 0 0 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 Year Year Tominaga M, et al. Impaired glucose tolerance is a risk factor for cardiovascular disease, but not impaired fasting glucose. Diabetes Care 1999;22:920-4.

  9. FRAMINGHAM STUDY AND JOSLIN PATIENTS Diabetes is a CV Risk Factor Women Men 60 60 Diabetes No Diabetes 50 50 2x 40 40 4-5x Mortality Rate Per 1000 Mortality Rate Per 1000 30 30 20 20 10 10 0 0 0-3 4-7 8-11 12-15 16-19 20-23 0-3 4-7 8-11 12-15 16-19 20-23 Duration of Follow-up (Years) Duration of Follow-up (Years) Krolewski AS, et al. Evolving natural history of coronary disease in diabetes mellitus. Am J Med 1991;90(Supp 2A):56S-61S.

  10. MRFITType 2 Diabetes is a CV Risk FactorAdditive Effects of Hypertension, Hypercholesterolemia, and Smoking 140 No Diabetes 120 Diabetes 100 80 Age Adjusted CV Death RatePer 10,000 Person Years 60 40 20 0 None One Two All Three Number of Risk Factors Stamler J, et al. Diabetes, other risk factors, and 12-year cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care 1993;16:434-44.

  11. Type 2 Diabetes is a CV Risk FactorDiabetes and Prior MI Predict Mortality Equally No Diabetes or MI 100 Diabetes without MI MI without Diabetes 80 60 Survival (%) Diabetes + MI 40 20 0 0 1 2 3 4 5 6 7 8 Year Haffner SM, et al. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med 1998;339:229-34.

  12. Reduced Life-expectance with DiabetesUS Adults Aged 55 to 64 in 1971 to 1975 Median Life Expectance 30 No Diabetes 25 Diabetes 18 20 17 Years 10 10 0 Women Men Gu K, et al. Mortality in adults with and without diabetes in a national cohort of the US population, 1971-1993.Diabetes Care 1998;21:1138-45.

  13. Lifetime Microvascular Events in Type 2 Diabetes Predictions from a Statistical Model Standard Care Comprehensive Care Percentage HbA1c 10% HbA1c 7.2% Change Blindness 19% 5% -72 Renal failure 17% 2% -87 Symptomaticneuropathy 31% 10% -68 Amputation 15% 5% -67 Eastman RC, et al. Model of complications of non-insulin dependent diabetes mellitus. II analysis of the health benefits and cost-effectiveness of treating NIDDM with the goal of normoglycemia. Diabetes Care 1997;20:735-44.

  14. Treatment Improves Outcomes

  15. KUMAMOTO STUDYEffect of Treatment on HbA1c Conventional Intensive 12 11 10 HbA1c (%) 2.3% HbA1c 9 8 7 6 5 0 1 2 3 4 5 6 Years Ohkubo Y, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus. A randomized prospective 6-year study. Diab Res Clin Pract 1995;28:103-17.

  16. KUMAMOTO STUDYRisk Reduction of Microvascular Complications 50 RetinopathyPrimary Prevention NephropathyPrimary Prevention 40 40 30 30 -70% P=0.039 -62% P=0.032 20 20 10 10 0 0 Cumulative Percent Progressing RetinopathySecondary Intervention NephropathySecondary Intervention Conventional Intensive 50 40 40 -52% P=0.049 -52% P=0.044 30 30 20 20 10 10 0 0 0 1 2 3 4 5 6 0 1 2 3 4 5 6 Years Years Ohkubo Y, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus. A randomized prospective 6-year study. Diab Res Clin Pract 1995;28:103-17.

  17. UKPDS MAIN STUDYEffect of Treatment on HbA1c 9 Conventional (10-y cohort) Intensive (10-y cohort) 8 Conventional ADA action (all patients) Median HbA1c (%) Intensive (all patients) 7 ADA goal 6.2% upper limit of normal range 6 0 0 3 6 9 12 15 Time From Randomization (y) Adapted from UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837-53.

  18. UKPDS MAIN STUDYRisk Reduction of Microvascular Complications 30 Conventional Intensive Risk Reduction 25% P=0.0099 20 % of Patients With an Event 10 Time From Randomization (y) 0 0 3 6 9 12 15 UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837-53.

  19. UKPDS MAIN STUDYRisk Reduction of Various Endpoints P=0.0099 25% Microvascular 21% Retinopathy P=0.015 Albuminuria 33% P=0.000054 Myocardial infarction 16% P=0.052 Diabetes-related end points 12% P=0.029 0 5 10 15 20 25 30 35 Risk Reduction (%) UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837-853.

  20. UKPDS METFORMIN SUBSTUDYEffect of Treatment on HbA1c Conventional (200) 9 Insulin (199) Chlorpropamide (129) Glyburide (148) 8 Metformin (181) ADA action Median HbA1c (%) 7 ADA goal 6 Upper limit of normal range (6.2%) 0 0 2 4 6 8 10 Time From Randomization (y) Adapted from UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-65.

  21. UKPDS METFORMIN SUBSTUDYGain of Weight During Treatment Conventional (200) 10 Insulin (199) Chlorpropamide (129) Glyburide (148) Metformin (181) 5 Mean Change (kg) 0 Baseline = 85 kg -5 0 2 4 6 8 10 Time From Randomization (y) Adapted from UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-65.

  22. UKPDS METFORMIN SUBSTUDYRisk-Reduction of Microvascular Complications 30 Conventional (411) Intensive (951) Metformin (342) M vs. C 20 P=0.19 % of Patients With Event 10 M vs. I P=0.39 0 0 3 6 9 12 15 Time From Randomization (y) Adapted from UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-65.

  23. UKPDS METFORMIN SUBSTUDYDiabetes-Related Deaths 30 Conventional (411) Intensive (951) Metformin (342) 20 Mvs.C P=.017 Proportion With Event (%) 10 Mvs. I P=.11 0 0 3 6 9 12 16 Time From Randomization (y) Patients at Risk 404 378 304 132 23 Conventional 339 321 267 123 28 Metformin 930 870 701 319 61 Intensive Adapted from UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-865.

  24. UKPDS HYPERTENSION SUBSTUDYEffect of Atenolol or Captopril on Blood Pressure Systolic 160 140 Less Tight Control Tight Control withAtenolol or Captopril 120 Mean Blood Pressure (mm Hg) 100 Diastolic 80 0 0 1 2 3 4 5 6 7 8 9 Years from Randomization UK Prospective Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703-13.

  25. UKPDS HYPERTENSION SUBSTUDYRisk-Reduction of Microvascular Endpoints 20 Risk-Reduction 37% P=0.0092 Less Tight Control Tight Control Patients With Events (%) 10 0 0 1 2 3 4 5 6 7 8 9 Years from Randomization UK Prospective Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703-13.

  26. UKPDS HYPERTENSION SUBSTUDYRisk-Reduction of Stroke 20 Risk-Reduction 44% P=0.013 Less Tight Control Tight Control Patients With Events (%) 10 0 0 1 2 3 4 5 6 7 8 9 Years from Randomization UK Prospective Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703-13.

  27. UKPDS HYPERTENSION SUBSTUDYDiabetes-Related Deaths 40 Risk-Reduction 32% P=0.019 Less Tight Control Tight Control 30 Mortality (%) 20 10 0 0 1 2 3 4 5 6 7 8 9 Years from Randomization UK Prospective Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703-13.

  28. UKPDS HYPERTENSION SUBSTUDYDiabetes-Related Deaths: Atenolol vs. Captopril 20 Less Tight Control Captopril Atenolol 15 P=0.28 Mortality (%) 10 5 0 0 1 2 3 4 5 6 7 8 9 Years from Randomization UK Prospective Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascualr complications in type 2 diabetes.: UKPDS 39. BMJ 1998;317:713-720.

  29. SYSTOLIC HYPERTENSION IN THE ELDERLY PROGRAM (SHEP)Diabetes Subgroup AnalysisEffect of Thiazide-Based Treatment on Blood Pressure Diabetes No Diabetes Placebo Treatment 180 180 160 160 140 140 Systolic 120 120 Systolic 100 100 Blood Pressure (mm Hg) Blood Pressure (mm Hg) 80 80 60 60 40 40 Diastolic Diastolic 20 20 0 0 0 1 2 3 4 5 0 1 2 3 4 5 Years Years Curb JD, et al. Effect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. JAMA 1996;276:1886-92.

  30. SYSTOLIC HYPERTENSION IN THE ELDERLY PROGRAM (SHEP)Diabetes Subgroup AnalysisEffect of Thiazide-Based Treatment on CV Events 40 Risk Reduction 34% Risk Reduction 34% 31.5 Placebo 30 Treatment 21.4 Percent With Events at 5 Years 18.4 20 13.3 10 0 No Diabetes (n=4736) Diabetes (n=583) Curb JD et al. Effect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. JAMA 1996;276:1886-92.

  31. No Diabetes Diabetes n 4242 202 Baseline mmol/L 4.88 4.80 mg/dL 189 186 Reduction 34% 36% SCANDINAVIAN SIMVASTATIN SURVIVAL STUDY (4S)Diabetes Subgroup AnalysisReduction of LDL-Cholesterol Pyorala K et al. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. Diabetes Care 1997;20:614-20.

  32. SCANDINAVIAN SIMVASTATIN SURVIVAL STUDY (4S)Diabetes Subgroup AnalysisReduction of Major Recurrent CV Events Diabetes No Diabetes 0.60 0.60 Placebo Simvastatin Placebo Simvastatin 0.50 0.50 0.40 0.40 Risk Reduction 55% P=0.002 Risk Reduction 32% P=0.0001 Proportion With Major CHD Event 0.30 0.30 Proportion With Major CHD Event 0.20 0.20 0.10 0.10 0.00 0.00 0 1 2 3 4 5 6 0 1 2 3 4 5 6 Years Since Randomization Years Since Randomization Pyorala K et al. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. Diabetes Care 1997;20:614-20.

  33. CARE TRIALDiabetes Subgroup AnalysisReduction of LDL-Cholesterol by Pravastatin No Diabetes Diabetes n 3573 586 Baseline mmol/L 3.59 3.52 mg/dL 139 136 On Pravastatin 40 mg mmol/L 2.56 2.48 mg/dL 99 96 Reduction 29% 29% Goldberg RB, et al. Cardiovascular events and their reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction survivors with average cholesterol levels. Subgroup analysis in the Cholesterol And Recurrent Events (CARE) Trial. Circulation 1998;98:2513-19.

  34. CARE TRIALDiabetes Subgroup AnalysisReduction of Recurrent CV Events Diabetes No Diabetes 45 45 Risk Reduction 23% P<0.001 40 Risk Reduction 25% P<0.05 40 35 35 30 30 Placebo Pravastatin 25 25 Percent With Event Percent With Event 20 20 15 15 Placebo Pravastatin 10 10 5 5 0 0 0 1 2 3 4 5 0 1 2 3 4 5 Years of Follow-up Goldberg RB et al. Cardiovascular events and their reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction survivors with average cholesterol levels. Subgroup analysis in the Cholesterol And Recurrent Events (CARE) Trial. Circulation 1998;98:2513-19.

  35. CV Risk-Reduction With Antiplatelet TherapyHigh-Risk PatientsDiabetes Subgroup Meta-analysis No Diabetes Diabetes n 21,197 21,136 Vascular events Control 16.4% 22.3% Antiplatelet Rx (usually ASA) 12.8% 18.5% Risk Reduction 28% 21% Antiplatelet Trialists Collaboration. Collaborative overview of randomized trials of antiplatelet therapy I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patient. BMJ 1994;308:71-2.

  36. Targets and TacticsforTypical Patients

  37. Women Men N 1574 2139 Age years 53 52 BMI kg/m2 30.8 28.3 FPG mmol/L 12.4 11.6mg/dL 223 209 HbA1c % 9.3 9.0 BP mm/Hg 140/84 134/82 LDL-cholesterol mmol/L 3.90 3.35 mg/dL 151 139 UKPDSMetabolic Profile at Diagnosis of Type 2 Diabetes UK Prospective Diabetes Study Group. UK Prospective Diabetes Study 27. Plasma lipids and lipoproteins at diagnosis of NIDDM by age and sex. Diabetes Care 1997;20:1683-7.

  38. ADA Glycemic Targets NormalGoal Action Level HbA1c (%) <6 <7 >8 Fasting and preprandialblood glucose mmol/L <6.1 4.4 to 6.7 >7.8 mg/dL<110 80 to 120 >140 American Diabetes Association. Standards of Medical Care for Patients with Diabetes Mellitus. Diabetes Care 1999;22(Suppl):S32-S41.

  39. Goal mm Hg Usual patient <130/85 Isolated systolic hypertension If ≥180 <160 If 160 to 179 Reduce by 20 ADA Blood Pressure Targets American Diabetes Association. Standards of Medical Care for Patients with Diabetes Mellitus. Diabetes Care 1999;22(Suppl):S32-S41.

  40. Medical Nutrition Therapy Drug Therapy Begin Rx Goal Begin Rx Goal With CV disease >100 ≤100 >100 ≤100 No CV disease >100 ≤100 >130 ≤100 ADA LDL-Cholesterol Targets American Diabetes Association. Standards of Medical Care for Patients with Diabetes Mellitus. Diabetes Care 1999;22(Suppl):S32-S41 & S56-S59.

  41. Tactics for Reaching Glycemic Targets • Lifestyle intervention • Oral monotherapy • Oral combination • Oral-insulin combinations • Multiple insulin injections Medical Management of Type 2 Diabetes, Fourth Edition, Zimmerman BR ed, American Diabetes Association, Alexandria, VA, 1998.

  42. Lifestyle Intervention Control weight Limit sodium and alcohol Optimize activity Initial Drug Choices ACE-inhibitor orb-blocker or Low-dose diuretic Combinations Two or three of the above Other options•a-blockers • Calcium antagonists• Hydralazine Tactics for Reaching Blood Pressure Targets Kaplan NM. Hypertension in patients with diabetes. In Current Management of Diabetes Mellitus, ed. De Fronzo RA, Mosby, 1998. American Diabetes Association. Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care 1999;22(Suppl):S56-S59.

  43. Trial ComparisonCalcium Risk Drug Antagonist Ratio ABCD Enalapril Nisoldipine 1/5.5 FACET Fosinopril Amilodipine 1/2.4 MIDAS Hydrochlorothiazide Isradipine 1/2.7 Calcium Antagonists vs. Other AntihypertensivesControversy Over Use in Diabetes Pahor M et al. Treatment of hypertensive patients with diabetes. Lancet 1998;351:690-1.

  44. Lifestyle Intervention Control weight Limit fat Optimize activity Initial Drug Choices Usual patient• Statin Triglyceride >400 mg/dL• Fibric acid derivative Combinations Statin + fibric acid derivative Other options• Bile acid binding resins• Nicotinic acid Tactics for Reaching Lipid Targets American Diabetes Association. Management of Dyslipidemia in Adults with Diabetes. Diabetes Care 1999;22(Suppl):S56-S59.

  45. THE CURVES STUDYLDL Reduction With Various Statins -10 Fluvastatin Pravastatin Lovastatin Simvastatin Atorvastatin -20 -30 Mean % Change in LDL-C -40 -50 -60 10 mg 20 mg 40 mg 80 mg Total Daily Dose (mg) Jones P et al. Comparative dose efficacy of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia. Am J Cardiol 1998;81:582-7.

  46. Summary • Epidemiologic and interventional evidence defines these targets • HbA1c 7% • Blood Pressure 130/85 mm Hg • LDL-cholesterol 100 mg/dL • Basic treatment tactics include • For glycemic control • Oral and oral-insulin combinations • For blood pressure control • ACE-inhibitor, b-blocker, and diuretic combinations • For LDL-cholesterol control • Statins • For vascular protection • ASA 81-325 mg daily

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