Update on CVD and Microvascular Complications in T2D

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1 Update on CVD and Microvascular Complications in T2D Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller School of Medicine

2 Commercial Interests Board of Directors Member Dexcom, Moerae Matrix, Paean Therapeutics, VasoPrep Surgical Scientific Advisory Board Member Diavacs, Halozyme, Orgenesis, Sekris, Valeritas, Viacyte Advisor or Consultant Boheringer Ingelheim, Bristol-Myers Squibb/Astra-Zeneca, Elcelyx, Eli Lilly, Ideal Life, Intarcia, Julphar, Roche, Sanofi Stock or Option Holder Dexcom, Ideal Life, Moerae Matrix, Paean Therapeutics, Patton Medical Devices, Tandem Diabetes Care, VasoPrep Surgical Research Support (to University of Miami) Halozyme, Mesoblast

3 Adolescent Renal & Cardiovascular Disease Protection in Type 1 Diabetes AdDIT Study: David Dunger CVD Outcome Studies in Type 2 Diabetes: Angelyn Bethel Prevention of Cardio-Renal Complications: David Maahs

4 CVD in Diabetes

5 Glucose Paradox Glucose levels & hyperglycemic states are closely linked to increased CVD risk Definitive evidence that improving glucose control decreases major CVD events remains elusive

6 Effect of Intensive Glucose Lowering on Macrovascular Complications in T2DM ACCORD ADVANCE VADT Non-fatal MI Primary outcome Non-fatal stroke Non-fatal MI Non-fatal MI CVD death Non-fatal stroke Non-fatal stroke Hospitalization for CVD death CVD death CHF Revascularization HR for primary outcome (95% CI) 0.90 ( ) 0.94 ( ) 0.87 ( ) HR for mortality (95% CI) 1.22 ( )* 1.46)* 0.93 ( ) ( ) *p=0.04 VADT = Veterans Affairs Diabetes Trial VADT study ADVANCE Collaborative Group. N Engl J Med 2008;358: ACCORD Study Group. N Engl J Med 2008;358: VADT Study Group. N Engl J Med 2009;360:

7 Glucose Paradox Glucose levels & hyperglycemic states are closely linked to increased CVD risk Definitive evidence that improving glucose control decreases major CVD events remains elusive Possible reasons: Intervention too late Studies too short, too small

8 Comparison of ACCORD, ADVANCE, 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% Study Duration ACCORD Study Group. N Engl J Med ;358: ADVANCE Collaborative Group. N Engl J Med 358: , Duckworth W for VADT. N Engl J Med 2009;360:129 :129-39

9 Cumulative Incidence of Any Predefined CV Outcome Cumulative Incidence of the First of Any of the Predefined CVD Outcomes Risk reduction 42% 95% CI: Log-rank p=0.016 Conventional treatment Intensive treatment No. at Risk Years Since Entry Intensive Conventional Nathan DM, et al. N Engl J Med 2005;353;

10 Myocardial Infarction Hazard Ratio (fatal or non-fatal MI or sudden death) Intensive (SU/Ins) vs Conventional Glucose Control MI HR=0.84 p=0.052 HR=0.85 p= HR (95%CI) HR Number of Events Con: Int: UKPDS 80. N Eng J Me 2008;359:

11 Meta-analysis: analysis: Major CVD Trials Number of Events (Annual Event Rate, %) More Intensive Less Intensive ΔA1c (%) Favours More Intensive Favours Less Intensive HR (95% CI) Major cardiovascular events ACCORD 352 (2.11) 371 (2.29) ( ) ADVANCE 557 (2.15) 590 (2.28) ( ) UKPDS 169 (1.30) 87 (1.60) ( ) VADT 116 (2.68) 128 (2.98) ( ) Overall 1,194 1, ( ) (Q=1.32, p=0.72, I 2 =0.0%) HR (95% CI) Turnbull FM, et al. Diabetologia 2009; 55:

12 Meta-analysis: analysis: All-cause Mortality Trials Number of Events (Annual Event Rate, %) More Intensive Less Intensive ΔA1c (%) Favours More Intensive Favours Less Intensive HR (95% CI) All-cause mortality ACCORD 257 (1.41) 203 (1.14) ( ) ADVANCE 498 (1.86) 533 (1.99) ( ) UKPDS 123 (0.13) 53 (0.25) ( ) VADT 102 (2.22) 95 (2.06) ( ) Overall ( ) (Q=5.71, p=0.13, I 2 =47.5%) HR (95% CI) Turnbull FM, et al. Diabetologia 2009; 55:

13 Sub-group Analysis for Major CVD Events: History of Macrovascular Disease Pre-specified Subgroups Number of Patients/Events More Intensive Less Intensive Favours More Intensive Favours Less Intensive HR (95% CI) p value for Test of Difference History of macrovascular disease Present 3,974/555 3,947/ ( ) 0.04 Absent 10,346/639 8,782/ ( ) HR (95% CI) p=0.04 Turnbull FM, et al. Diabetologia 2009; 55:

14 Glucose Paradox Glucose levels & hyperglycemic states are closely linked to increased CVD risk Definitive evidence that improving glucose control decreases major CVD events remains elusive Possible reasons: Intervention too late Studies too short, too small A1c difference too small

15 Comparison of ACCORD, ADVANCE, 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% Study Duration Target A1c <6% vs 7 8% 7 <6.5% vs Usual <6% vs 8 9% 8 Achieved A1c 6.4% and 7.5% 6.4% and 7.0% 6.9% and 8.4% ACCORD Study Group. N Engl J Med ;358: ADVANCE Collaborative Group. N Engl J Med 358: , Duckworth W for VADT. N Engl J Med 2009;360:129 :129-39

16 Glucose Paradox Glucose levels & hyperglycemic states are closely linked to increased CVD risk Definitive evidence that improving glucose control decreases major CVD events remains elusive Possible reasons: Intervention too late Studies too short, too small A1c difference too small Post prandial hyperglycemia Adverse CV effects (e.g. from hypoglycemia) Adverse effects of T2D drugs?? Mechanism specific? Excellent control of other risk factors

17 Blood Pressure, Lipid and Aspirin Therapy Study SBP mmhg LDL-C mg/dl (mmol/l) On Statins, % On Aspirin, % ACCORD 127/67 91 (2.35) ADVANCE 136/ (2.63) VADT 127/69 75 (1.94) SBP = systolic blood pressure; LDL-C C = LDL-cholesterol ADVANCE Collaborative Group. N Engl J Med 2008;358: ACCORD Study Group. N Engl J Med 2008;358: VADT Study Group. N Engl J Med 2009;360:

18 Achievement of Goals in US Diabetes Care A1C Survey Participants, % p=0.009 N Engl J Med 2013;368:

19 Achievement of Goals in US Diabetes Care Blood Pressure Survey Participants, % p=0.08 N Engl J Med 2013;368:

20 Achievement of Goals in US Diabetes Care LDL-Cholesterol Survey Participants, % p<0.001 N Engl J Med 2013;368:

21 Achievement of Goals in US Diabetes Care Smoking Status Survey Participants, % p=0.96 *self-report or cotinine >10 ng/ml N Engl J Med 2013;368:

22 Prevalence of Meeting A1C, BP, and LDL Goals Among People With Diabetes Percent % Diabetes Care Publish Ahead of Print February 15, 2013

23 Age-adjusted Death Rates for CVD USA,

24 Deaths due to diseases of the heart (United States: ) 1, Deaths in Thousands Years Go et al. Circulation. 2013;127:e6-e245

25 1,200 1, Deaths in Thousands Go et al. Circulation. 2013;127:e6-e245

26 Deaths in Thousands Males Females Go et al. Circulation. 2013;127:e6-e245

27 U.S. age standardized death rates* from cardiovascular diseases, Deaths per 100, Total CVD Stroke CHD Other CVD** Go et al. Circulation. 2013;127:e6-e245

28 Decline in Age Standardized Mortality Rates from 1997 to 2006 Comparison of a Diabetic Cohort with the UK general population Men Women Diabetic Nondiabetic The study included a cohort of 48,556 subjects with type 2 diabetes first diagnosed between 1996 and 2006, drawn from 197 family practices in the United Kingdom General Practice Research Database (UKGPRD). There were 6,630 deaths observed Gulliford & Charlton. Am J Epidemiol 2009;169:

29 Age-adjusted All-Cause Mortality Rates according to Diabetes Status, Gregg et al. Diabetes Care 35: , 2012

30 Age-adjusted CVD Mortality Rates according to Diabetes Status, Gregg et al. Diabetes Care 35: , 2012

31

32 Blood Pressure in Diabetes

33 ADA 2012

34 ADA 2013

35 ..there is no clear evidence of benefits in general from initiating antihypertensive drug treatment at SBP levels 140 mmhg (high normal BP), nor there is evidence of benefits from aiming at targets 130 mmhg. This is due to the lack of suitable studies correctly investigating these issues ESH/ESC Guidelines for the Management of Arterial Hypertension, European Heart Journal doi: /eurheartj/eht151

36 Ischemic CHD Mortality versus Usual BP Stratified by Age Prospective Studies Collaboration. Lancet. 2002;360:1903.

37 Clinical Trials of BP Lowering in Diabetic Patients: Mean Achieved Systolic (SBP) Trial N Mean SBP less intense Mean SBP more intense CVD Risk Reduction SHEP % Syst-EUR % HOT 1, % UKPDS 1, % ABCD No CVD ADVANCE 11, % mortality ACCORD 4, No CVD

38 ACCORD Blood Pressure Study Systolic Pressures (Mean + 95% CI) Mean # Meds Intensive: Standard: SBP (mm Hg) Average : Standard vs Intensive, Delta = N = Years Post-Randomization Intensive Standard ACCORD Study Group. N Engl J Med 2010; 362:

39 ACCORD Blood Primary Outcome Pressure Study Primary Outcome Nonfatal MI, (Nonfatal Stroke MI, or CVD Nonfatal Death Stroke, or CVD Death) 20 Patients with Events (%) Primary Outcome Nonfatal MI, Nonfatal Stroke or CVD Death HR = % CI ( ) HR = % CI ( ) Years Post-Randomization ACCORD Study Group. N Engl J Med 2010; 362:

40 ACCORD Study Group. N Engl J Med 2010; 362: ACCORD Blood Pressure Study Stroke Outcomes 20 Nonfatal Stroke 20 Total Stroke Patients with Events (%) HR = % CI ( ) Patients with Events (%) HR = % CI ( ) Years Post-Randomization Years Post-Randomization

41 Effects of intensive blood pressure reduction on myocardial infarction and stroke in diabetes. Myocardial Infarction Journal of Hypertension.2011; 29:

42 Effects of intensive blood pressure reduction on myocardial infarction and stroke in diabetes. Stroke Journal of Hypertension.2011; 29:

43 Intensive versus standard blood pressure control and all-cause mortality Bangalore, S. et al. Circulation 2011;123:

44 Intensive versus standard blood pressure control and stroke Bangalore, S. et al. Circulation 2011;123:

45 2013 ESH/ESC Guidelines for the Management of Arterial Hypertension European Heart Journal doi: /eurheartj/eht151

46

47 Lipids in Diabetes

48 ADA/ACC Consensus Statement Treatment Goals in Patients With Cardiometabolic Risk and Lipoprotein Abnormalities Highest-risk patient Known CVD Diabetes plus 1 additional major CVD risk factor* High-risk patients No diabetes or known CVD but 2 major CVD risk factors* Diabetes but no other major CVD risk factors* LDL-C (mg/dl) Non HDL-C (mg/dl) Apo B (mg/dl) <70 <100 <80 <100 <130 <90 *Major risk factors beyond dyslipidemia include smoking, hypertension, and family history or premature CHD. ACC=American College of Cardiology; ADA=American Diabetes Association; Apo B=apolipoprotein B; CHD=coronary heart disease; CVD=cardiovascular disease; HDL-C=high-density lipoprotein cholesterol; LDL-C=low-density lipoprotein cholesterol. Brunzell JD et al. Diabetes Care. 2008;31:

49 Lancet 2008; 371:

50 Lancet 2008;371:117 25

51 Lancet 2008;371:117 25

52 Lancet 2008;371:117 25

53 Lancet 2008;371:117 25

54 Lancet 2008;371:117 25

55 Lancet 2008;371:117 25

56 Lancet 2012; 380:

57 Lancet 2012; 380:

58 Lancet 2012; 380:

59 Vascular deaths avoided (per 1000) by 5-year risk & LDL cholesterol reduction Lancet 2012; 380:

60 Major vascular events avoided (per 1000) by 5-year risk & LDL cholesterol reduction Lancet 2012; 380:

61 Plasma Lipid Levels During Trial Total Cholesterol Placebo Fenofibrate LDL Cholesterol HDL Cholesterol Triglycerides ACCORD Study Group. N Engl J Med 2010; 362:

62

63 Aspirin Therapy in Diabetes

64 Anti-Platelet Therapy Consider aspirin therapy ( mg/day) as a primary prevention strategy in T1D or T2D at increased CVD risk (>10% over 10 yrs), including most men >50 years old and women >60 years old, with additional risk factors (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria) Use aspirin therapy ( mg/day) as a secondary prevention strategy in those with diabetes with a history of CVD. For patients with CVD and aspirin allergy, clopidogrel (75 mg/day) should be used Combination therapy with aspirin ( mg/day) and clopidogrel (75 mg/day) is reasonable for up to 1 year after an acute coronary episode American Diabetes Association. Diabetes Care. 2013; 36 (suppl 1):S11 :S11-S66S66

65 Aspirin for Primary Prevention serious vascular events dropped from 0 57% to 0 51% 0 per year by the use of aspirin risk of major bleeds increased from 0 07% 0 07% to 0 10% 0 per year by the use of aspirin. Antithrombotic Trialists (ATT) Collaboration; Lancet 2009; 373:

66 Serious Vascular Events Antithrombotic Trialists (ATT) Collaboration; Lancet 2009; 373:

67

68 Microvascular Outcomes in T2D

69 Microvascular Outcomes in T2D Trials Nephropathy Retinopathy Neuropathy VADT ACCORD ADVANCE (albuminuria) (albuminuria) (albuminuria) +/-

70 Effects of Intensive vs Standard Therapy for Glycemia on Microvascular End Points in ACCORD, Pretransition and Over 5 years (selected outcomes) End point Pretransition, HR (95% CI) Total follow-up, HR (95% CI) Microalbuminuria 0.79 ( ) 0.90) p= ( ) 0.94) p= Cataract surgery 0.90 ( ) p= ( ) 0.99) p= line change in visual acuity 0.84 ( ) 0.97) p= ( ) p= Loss of ankle jerk during Jendrassik maneuver 0.94 ( ) p= ( ) 0.97) p=0.005 Loss of pressure sensation 0.88 ( ) p= ( ) 0.95) p= Lancet 2010; 376:

71

72 ACCORD Eye Study N Engl J Med 2010;363:233-44

73 Intensive Glucose Control and Renal End Points in T2D Meta-analysis analysis Coca et al. Arch Intern Med 2012; 172:

74 Intensive Glucose Control and Renal End Points in T2D Meta-analysis 7 RCTs of intensive vs. conventional glucose control (ACCORD, ADVANCE, Kumamoto, UKPDS 33, UKPDS 34, VADT, VA-Feasibility) Median follow-up 2 to 11 years Mean duration of DM 6.5 to 12 yrs (except UKPDS) Outcomes Microalbuminuria, Macroalbuminuria Doubling of Serum Creatinine, ESRD, Renal Death Coca et al. Arch Intern Med 2012; 172:

75

76

77 Pooled risk ratios for renal endpoints Event Risk Ratio (95% CI) Microalbuminuria 0.86 ( ) Macroalbuminuria 0.74 ( ) Cr doubling 1.06 ( ) ESRD 0.69 ( ) Renal death 0.99 ( ) Coca et al. Arch Intern Med (2012); 172:

78 American Journal of Kidney Diseases 2012; 60:

79 New onset microalbuminuria New onset macroalbuminuria Doubling of serum creatinine

80 All cause mortality Cardio vascular mortality End stage renal disease

81

82 Conclusions Reducing the complications of type 2 diabetes requires attention to multiple risk factors glycemia, blood pressure, lipids, smoking cessation.

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