Slide 1. Slide 2. Slide 3. A Fork in the Road: Navigating Through New Terrain. Diabetes Standards of Care Then and Now

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1 Slide 1 A Fork in the Road: Navigating Through New Terrain Carol Hatch Wysham, MD Clinical Associate Professor of Medicine University of Washington School of Medicine Section Head, Rockwood Center for Diabetes and Endocrinology Spokane, Washington Chairperson, Professional Practice Committee American Diabetes Association Slide 2 Diabetes Standards of Care Then and Now May pages, 10 references January pages 395 references Slide 3 American Diabetes Assocation Standards of Medical Care in Diabetes 2011 New diagnostic criteria for gestational diabetes (GDM) 75 gram OGTT Diagnostic thresholds (fasting 92 mg/dl, 1 hr 180 mg/dl, 2 hr 153 mg/dl) GDM diagnosed when one value at or above one threshold Hyperglycemia/Hypertension Emphasizes importance of individualization of glucose & BP Goals Nephropathy Added recommendations for monitoring for complications of CKD Care delivery Transitions of care from pediatric to adult clinics Updated systems of care American Diabetes Association. Diabetes Care 34 (Suppl 1), 2011

2 Relative Risk of Complications Slide 4 Complications Risk in Diabetes The Impact of Intensive Glycemic Control Hemoglobin A1c eag Glucose DM Kendall. International Diabetes Center Adapted from: Skyler JS. Endocrinol Metab Clin North Am Jun;25(2): DCCT Study Group. N Engl J Med 329:977, UKPDS 35. Stratton IM. BMJ 321: , Slide 5 Cardiovascular Disease and Diabetes ~65% of deaths are due to CV disease Coronary heart Cardiovascular Stroke risk disease deaths complications 2- to 4-fold 2- to 4-fold of T2DM Heart failure 2- to 5-fold T2DM = type 2 diabetes mellitus Bell DSH. Diabetes Care. 2003;26: Centers for Disease Control (CDC). Slide 6 Glycemic Control for Vascular Complications: Is Late Too Late? Type 1 Diabetes N Duration of Diabetes Baseline A1C Follow Up (Yrs) Publication DCCT 1441 <5 9.0% Stockholm (SDIS) 102 ~18 9.4% EDIC 1394 ~ % Type 2 Diabetes UGDP 823 <1 ~7% ~ Kumamoto VACSDM ½ 1995 UKPDS 5102 <1 ~9% /2008 ACCORD ½ 2008 ADVANCE VADT

3 Rate of Retinopathy (per 100 patient-years) Complication Rate (%) per 1,000 Person-years Slide 7 Glycemic Control for Macrovascular Complications: Is Late Too Late? UGDP DCCT Kumamoto UKPDS ADVANCE VADT UKPDS + At Risk VA ACCORD EDIC Years of Diabetes Diagnosis SDIS Slide 8 Early Intensive Diabetes Therapy: Reduction in Microvascular Complications HbA1c Retinopathy Nephropathy Neuropathy CV disease DCCT 9 7.1% 63% 54% 60% NS DCCT Research Group. N Engl J Med. 1993;329: Ohkubo Y, et al. Diabetes Res Clin Pract. 1995;28: UKPDS 33: Lancet 1998; 352, Kumamoto % 69% 70% Improved - UKPDS 7.9 7% 17-29% 24-33% - 16% (NS) Slide 9 DCCT and UKPDS Glycemic Control and Microvascular Risk DCCT A1C (%) DCCT Study Group. N Engl J Med 329:977, 1993 UKPDS 35. Stratton IM. BMJ. 2000;321: UKPDS Updated Mean HbA 1c (%)

4 Slide 10 Early Intervention Is It Truly Early? Benefit in Primary and Secondary Prevention Reduction in microvascular disease risk Occurred with both primary and secondary prevention Effect observed in DCCT, UKPDS and Kumamoto Primary Prevention DCCT Research Group. N Engl J Med. 1993;329: Secondary Intervention Slide 11 The Durable Effect of Early Intervention Long Term Follow up from EDIC and UKPDS Follow up cohort with similar glycemic control for years Retinopathy Incidence (%) Intensive EDIC YEAR EDIC Research Group. N Engl J Med 2000;342:381-9 Holman RR. N Engl J Med. 2008;359: A1C achieved = ~8.0% Conventional Intensive (SU/Ins) vs. Conventional control Slide 12 Stockholm Diabetes Intervention Study Is Late Intervention for Glycemic Control of Benefit? SDIS Study Design Intensive insulin therapy A1C Mean duration of diabetes at study entry = ~18 years Significant (but modest) reduction in rates of microvascular disease Reichard P. N Engl J Med 1993;329;

5 Slide 13 Glycemic Control for Prevention of Vascular Complications: UGDP DCCT Kumamoto UKPDS ADVANCE VADT ACCORD EDIC UKPDS + At Risk Diabetes VA Years of Diabetes Diagnosis SDIS Slide 14 Comparison of Recent Glycemia Trials ACCORD, ADVANCE and VADT Characteristic ACCORD ADVANCE VADT N 10,251 11,140 1,791 Mean Age Duration of T2DM 10 yr 8 yr 11.5 yr History of CVD 35% 32% 40% BMI Baseline A1C 8.3% 7.5% 9.4% A1C Achieved 6.4% vs. 7.5% 6.5% vs. 7.3% 6.9% vs. 8.4% RRR CVD Events 0.90 ( ) 0.94 ( ) 0.88 ( ) RRR Mortality 1.22 ( )* 0.93 ( ) 1.07 ( ) ACCORD Study Group. N Engl J Med. 2008;358: ADVANCE Collaborative Group. N Engl J Med 358: , Duckworth W for VADT. N Engl J Med 2009;360: Slide 15 A Broader View of Complications and Diabetes Implications of ACCORD, ADVANCE and VADT Study A1C Microvascular CVD Mortality UKPDS DCCT/EDIC ACCORD / ADVANCE VADT Adapted from Bergenstal RM, Bailey C and Kendall DM. Am J Med 123:374e9-e18, 2010 UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352: Holman RR. N Engl J Med Oct 9;359(15): DCCT Research Group. N Engl J Med 329; , 1993 Nathan DM, et al. N Engl J Med. 2005;353: Gerstein HC, et al. N Engl J Med. 2008;358: Patel A, et al. N Engl J Med. 2008;358: Duckworth W et al N Engl J Med 2009;360: EY Chew for ACCORD. N Engl J Med ( /NEJMoa ) was published on June 29, 2010, at NEJM.org. Initial Trial Long Term Follow-up

6 Slide 16 Epidemiologic Relationships Between A1c and All-cause Mortality in the ACCORD Trial Does A1C achieved predict a risk for all-cause mortality? Riddle M et al. Diabetes Care May;33(5): Slide 17 Epidemiologic Relationships Between A1c & All- Cause Mortality Riddle et al Diab Care 33(5): , 2010 Effects of Intensive Glucose Lowering in the Management of Patients with Type 2 Diabetes Mellitus in ACCORD Circulation 122: ,2010 Baseline A1c >8.5% predicted 64% higher risk of death Also History of taking aspirin Self-report of having neuropathy Slide 18 A Reasonable Hypothesis Intensive glycemic therapy increased all-cause and cardiovascular mortality because there was more overall hypoglycemia with intensive therapy. Duckworth W, Abraira C, Moritz T, Reda D et al NEJM 360: , 2009 ACCORD Study Group. NEJM 358: , 2008.

7 Slide 19 Hypoglycemia and CV Disease Hemodynamic Hypoglycemia Thrombotic Ischemia Inflammatory Wright R et al Diabetes/ Metabolism Research and Reviews, 2008 Slide 20 Intensive Glycemic Control in Diabetes: Implications of ACCORD, ADVANCE and VADT Intensive Glycemic Control in Diabetes Lowering A1C to < 7% significantly reduces the risk of microvascular complications in both type 1 and type 2 diabetes (DCCT, UKPDS, ACCORD) Does not reduce the risk of CVD events in short term studies Does not significantly increase mortality risk across studies (meta-analyses) Adverse effects of more intensive therapies 3-fold greater rates of severe hypoglycemia and risk of significant weight gain Increase in mortality risk in selected populations For some patients lower or higher A1C targets may be appropriate Skyler JS. Diabetes Care. 2009;32(1): Slide 21 Identifying Higher Risk Patients Intensive Glycemic Control in Type 2 Diabetes Conventional Wisdom: Older individuals with established CVD Those who achieved lower A1C values Use of insulin therapy Individuals with long duration diabetes Who May Be at Risk with more intensive Rx Longstanding poor control History of severe hypoglycemia Those less responsive to intensive Rx NO NO NO MAYBE YES YES MAYBE

8 Slide 22 Diabetes and Glycemic Control A Rational Approach to A1C Targets As low as possible As early as possible For as long as possible As safely as possible And as rationally as possible And in the setting of multi-risk factor management Slide 23 Key Concepts in Setting Glycemic Goals Individualized Certain populations require special considerations Higher glycemic goals may be indicated in patients with severe or frequent hypoglycemia Achieving lower glycemic targets may further reduce microvascular complications at the cost of increasing hypoglycemia Postprandial glucose levels may be targeted if HbA1C goals are not met despite reaching pre-prandial glucose goals American Diabetes Association. Diabetes Care. 2007;30:S4-S41 Slide 24 Goals for Glycemic Control HbA1C* <7.0% Pre-prandial capillary glucose Peak postprandial capillary plasma glucose mg/dl <180 mg/dl * For non-pregnant individuals As close to normal (<6%) as possible without significant hypoglycemia American Diabetes Association. Diabetes Care. 2009;32:S13-S61

9 Slide 25 Managing Hypertension in Diabetes Treatment Targets Treatment Approaches Implications of Recent Trials Slide 26 Blood Pressure Goal in Diabetes < 130 extrapolated from benefits in nephropathy Bakris G. AJKD 2004;43(Suppl 1):S120 Slide 27 Summary of Major Hypertension Trials Cooper-DeHoff RM, Egelund EF, Pepine CJ. Nat Rev Cardiol 2010;8:42-49

10 Complication Rate per 1000 person-years Slide 28 Type 2 Diabetes and Blood Pressure: BP Control and Risk in the ACCORD and ADVANCE Era Modified from Adler A. BMJ 321; , Microvascular Myocardial Infarction??? ACCORD -10% ADVANCE -30% UKPDS Mean SBP (mm Hg) ~ 15% reduction in risk for each 10 mm Hg decrease in SBP Slide 29 ADVANCE Trial Blood Pressure Intervention 11,140 subjects Type 2 diabetes and HTN Treated with fixed dose combo (ACEI-diuretic) vs usual care Blood pressure differential ~5 mm Hg (140.3 vs 134.7) Reduced all cause mortality Patel A for the ADVANCE Investigators. Lancet 370: , 2008 Slide 30 Multi-Risk Factor Intervention in Diabetes: The ACCORD Trial Intensive Glycemic Control (HbA1c<6%) Standard Glycemic Control (HbA1c 7-7.9%) Intensive (SBP<120) 2362* BP Trial Standard (SBP<140) Target SBP < 120 vs < 140 Multi-drug therapy Systematic titration Target 1184driven approach 1178 ACCORD Study Group. Am J Cardiol 99(12A):21i-33i, * Group A Statin only * Lipid Trial Group B Statin+Fibrate * *Primary analysis compares marginals for main effects 5128* 5123* 10,251

11 Slide 31 Effects of Intensive Blood Pressure Control The ACCORD Trial ACCORD Study Group. N Engl J Med Apr 29;362(17): Epub 2010 Mar 14. Slide 32 Effects of Intensive Blood Pressure Control The ACCORD Trial More intensive control of SBP did not further reduce CVD risk in type 2 diabetes ACCORD Study Group. N Engl J Med Apr 29;362(17): Epub 2010 Mar 14. Slide 33 The ACCORD Trial Effects of Intensive Blood Pressure Control in Type 2 Diabetes Intensive Standard Events (%/yr) Events (%/yr) HR (95% CI) Primary 208 (1.87) 237 (2.09) 0.88 ( ) 0.20 Reduced rate of CVA and of progression Total Mortality of macroalbuminuria 150 (1.28) 144 with (1.19) more 1.07 intensive ( ) 0.55 blood pressure lowering CV Death 60 (0.52) 58 (0.49) 1.06 ( ) 0.74 The ACCORD Study Group. N Engl J Med Nonfatal Published MI at March (1.13) 14, 2010 ( /NEJMoa ) 146 (1.28) 0.87 ( ) 0.25 Nonfatal Stroke 34 (0.30) 55 (0.47) 0.63 ( ) 0.03 Total Stroke 36 (0.32) 62 (0.53) 0.59 ( ) 0.01 ACCORD Study Group. N Engl J Med Apr 29;362(17): Epub 2010 Mar 14. P

12 Slide 34 Adverse Effects of Intensive Blood Pressure Lowering in ACCORD Slide 35 Hypertension: 2011 Standards of Medical Care Goals A goal systolic blood pressure < 130 mmhg is appropriate for most patients with diabetes. Based on patient characteristics and response to therapy, higher or lower systolic blood pressure targets may be appropriate. Patients with diabetes should be treated to a diastolic blood pressure <80 mmhg. Slide 36 Treatment of Hypertension in Diabetes Patients with a systolic blood pressure of mmhg or a diastolic blood pressure of mmhg - lifestyle therapy alone for a maximum of3 months. Patients with systolic blood pressure 140 or diastolic blood pressure 90 at diagnosis or follow-up - pharmacologic therapy in addition to lifestyle therapy. Lifestyle therapy for hypertension weight loss, if overweight; DASH-style dietary pattern including reducing sodium and increasing potassium intake; moderation of alcohol intake; and increased physical activity.

13 Slide 37 Treatment of Hypertension in Diabetes - continued Pharmacologic therapy should include either an ACE inhibitor or an ARB. If one class is not tolerated, the other should be substituted. A diuretic should be added, if needed to goal BP. Multiple drug therapy (two or more agents at maximal doses) is generally required to achieve blood pressure targets. ACE & ARB are contraindicated in pregnancy Kidney function and serum potassium levels should be monitored. Slide 38 Individualizing Goals: Decision Points # Drugs Little evidence above three How low is too low for diastolic blood pressure? Side effects from medications Dizziness Bradycardia Drug interactions Slide 39 Ambulatory BP Monitoring ABPM is warranted for evaluation of white-coat HTN in the absence of target organ injury. Ambulatory BP values are usually lower than clinic readings. Awake, individuals with hypertension have an average BP of <135/85 mmhg and during sleep <120/75 mmhg. BP drops by 10 to 20% during the night; if not, signals possible increased risk for cardiovascular events.

14 Slide 40 Managing Lipids in Diabetes Treatment Targets Treatment Approaches Implications of ACCORD Slide 41 The ACCORD Trial Lipid Study Protocol Intensive Glycemic Control (HbA1c<6%) Standard Glycemic Control (HbA1c 7-7.9%) Intensive (SBP<120) 2362* BP Trial Standard (SBP<140) ACCORD Study Group. Am J Cardiol 99(12A):21i-33i, * Group A Statin only 2753* Lipid Trial Group B Statin+Fibrate Fenofibrate or Placebo Background statin LDL HDL 1370 < 50 and TG 1391 < * *Primary analysis compares marginals for main effects 5128* 5123* 10,251 Slide 42 The ACCORD Trial Lipid Study Effect on Plasma Lipids The ACCORD Study Group. N Engl J Med Apr 29;362(17): Published at March 14, 2010 ( /NEJMoa )

15 Slide 43 The ACCORD Trial Lipid Study Effect on Major CVD Events No significant added benefit (in reducing MI, stroke or CVD death) with addition of fibrate to statin therapy Post-hoc analyses suggesting potential benefit in those with lowest HDL-c (< 34 mg/dl) and higher TG (> 204 mg/dl) The ACCORD Study Group. N Engl J Med Apr 29;362(17): Published at March 14, 2010 ( /NEJMoa ) Slide 44 Primary Outcome By Treatment Group and Baseline Subgroups Slide 45 Lab Measures During Follow-up Fenofibrate Placebo Laboratory Measures (no. (%)) (N=2765) (N=2753) P value ALT ever > 3X ULN 52 (1.9%) 40 (1.5%) 0.21 ALT ever > 5X ULN 16 (0.6%) 6 (0.2%) 0.03 CK ever > 5X ULN 51 (1.9%) 59 (2.2%) 0.43 CK ever > 10X ULN 10 (0.4%) 9 (0.3%) 0.83 Serum creatinine elevation Women ever > 1.3 mg/dl 235 (27.9%) 157 (18.7%) <0.001 Men ever > 1.5 mg/dl 698 (36.7%) 350 (18.5%) <0.001 Post-randomization incidence of microalbuminuria ( > 30 to < 300 mg/g*) 1050 (38.2%) 1137 (41.6%) 0.01 Post-randomization incidence of macroalbuminuria ( > 300 mg/g*) 289 (10.5%) 337 (12.3%) 0.03

16 LDL Particles (nmol/l) LDL Cholesterol (mg/dl) Slide 46 Relations of LDL Particles and LDL Cholesterol to Levels of HDL Cholesterol and Triglycerides LDL Particles LDL Cholesterol Framingham Offspring Study HDL Cholesterol (mg/dl) Otvos, et al. Amer J Cardiol 2002;90:22i-29i LDL Particles 160 LDL Cholesterol Triglycerides (mg/dl) Slide 47 Non HDL-C as a Predictor of Risk for CHD in Diabetes Slide 48 ADA and ACC Consensus Statement on Lipoprotein Management in Patients with Cardiometabolic Risk TREATMENT GOALS Highest-risk patients, including those with 1) known CVD or 2) Diabetes plus one or more additional CVD risk factor High-risk patients, including those with 1) no diabetes or known clinical CVD but 2 or more additional major CVD risk factors or 2) Diabetes but no other CVD risk factors Brunzell JD, Davidson M, Furberg CD et al. Diabetes Care 2008;31: LDL-C Non-HDL-C ApoB (mg/dl) (mg/dl) (mg/dl) < 70 < 100 < 80 < 100 < 130 < 90

17 Slide 49 Possible Benefits From Nonpharmacologic Therapies Therapy Soluble fiber in diet (2 8 g/d) (oat bran, fruit, and vegetables) Soy protein (20 30 g/d) Stanol esters (1.5 4 g/d) (inhibit cholesterol absorption) Fish oils (3 9 g/d) (n-3 fatty acids) Jones PJ. Curr Atheroscler Rep. 1999;1: Lichtenstein AH. Curr Atheroscler Rep. 1999;1: Rambjor GS et al. Lipids. 1996;31:S45-S49. Ripsin CM et al. JAMA. 1992;267: Result LDL-C 1% to 10% LDL-C 5% to 7% LDL-C 10% to 15% Triglycerides 25% to 35% Avoid trans-fats Slide 50 ACCORD Eye Study: Fenofibrate decreased risk of progression of retinopathy The ACCORD Study Group. NEJM 2010;363: Slide 51 Standards of Medical Care in Diabetes Lipid Management for CVD Risk Lowering LDL Cholesterol Primary goal = LDL cholesterol <100 mg/dl (LDL-C < 70 an option) Statin (+MNT) added in those with known CVD or at higher risk Alternative = 30-40% reduction in LDL-c Targeting Triglycerides and HDL-c Low HDL-C + high TG = most common pattern of dyslipidemia Managing TG and HDL-C Limited evidence that intervention with fibrate on top of statin further reduces risk Data of addition of niacin to statin remains under study Standards of Medical Care in Diabetes 2011 Diabetes Care 34 (Suppl 1), 2011

18 Slide 52 Additional Recommendations: Treatment of Hyperlipidemia in Diabetes Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabetic patients: with overt CVD without CVD who are over the age of 40 and have one or more other CVD risk factors. For lower risk patients than the above, statin therapy should be considered in addition to lifestyle therapy if LDL-C remains above 100 mg/dl or in those with multiple CVD risk factors In individuals with overt CVD, a lower LDL-C goal of <70 mg/dl (1.8 mmol/l), using a high dose of a statin, is an option. If targets are not reached on maximally tolerated doses of statins, combination therapy may be considered, but has not been evaluated in outcome studies for either CVD outcomes. Statin therapy is contraindicated in pregnancy. Slide 53 Antiplatelet Agents in Diabetes, 2011 Primary Prevention ( mg/day): Type 1 or type 2 diabetes at increased CV risk (10 yr risk > 10%), including most men > 50 yr or women >60 yr who have at least one additional major risk factor (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria) (C) Aspirin should not be recommended for CVD prevention for adults with diabetes at low CVD risk (10-year CVD risk <5%) (C) In patients in these age-groups with multiple other risk factors (e.g. 10-year risk 5 10%), clinical judgment is required. (E) Secondary prevention ( mg/day): Use aspirin therapy as a secondary prevention strategy in those with diabetes with a history of CVD (A) For patients with CVD and documented aspirin allergy, clopidogrel (75 mg/day) should be used. (B) ADA Clinical Practice Recommendations, Diabetes Care, January 2011 Slide 54 Basis for Change in Recommendation Reference N Relative risk Confiendece Interval Belch (2008) ( ) NS Ogawa (2008) ( ) NS Belch J et al. BMJ 2008; 357:a1840 Ogawa H et al. JAMA

19 Slide 55 ADA Summary of Recommendations for Adults with Diabetes Measures Targets 2011 Standards of Care A1C < 7% Treatment targets for diabetes as recommended remain Pre-meal glucose mg/dl unchanged as evidence Peak post-meal glucose < supports: 180 mg/dl 1. Targeting A1C < 7% (for reduction in risk of microvascular disease) Blood Pressure: < 130/80 mm Hg 2. SBP target < 130 supported by evidence of reduction in risk of stroke and microvascular disease progression LDL-c < 100 mg/dl 3. LDL lowering with statin (LDL<100 or 30-40%) Triglycerides < 150 mg/dl Further reduction in CVD risk (with added fibrate) of potential benefit HDL-c > 40 mg/dl if low HDL-c and high TG American Diabetes Association. Diabetes Care 33 (Suppl 1), 2010

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