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Vascular Protection Strategies in Diabetes Care

Learn about multifaceted management for Type 2 diabetes integrating glucose, lipid, and blood pressure control, healthy behaviors, and vascular protective medications.

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Vascular Protection Strategies in Diabetes Care

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  1. Canadian Diabetes Association Clinical Practice GuidelinesVascular Protection in People with Diabetes Chapter 22 James A. Stone, David Fitchett, Steven Grover, Richard Lewanczuk, Peter Lin

  2. Vascular Protection Checklist 2013 • A• A1C – optimal glycemic control (usually ≤7%) • B•BP – optimal blood pressure control (<130/80) • C•Cholesterol – LDL ≤2.0 mmol/L if decided to treat • D•Drugs to protect the heart (regardless of baseline BP or LDL) A – ACEi or ARB │S – Statin │A – ASA if indicated • E• Exercise / Eating healthily – regular physical activity, achieve and maintain healthy body weight • S•Smoking cessation

  3. Absolute Risk of MI is Higher in Patients with DM Diabetes n = 379,003 No Diabetes n = 9,018,082 Database 1994-2000 Diabetes Men Women 3.0 2.5 2.0 No diabetes Men Women 1.5 No. events per 100 person- years 1.0 0.5 0 MI = myocardial infarction Age group All lines fitted according to a polynomial equation; R2= 0.99–1.00 for each Booth GL, et al. Lancet 2006;368:29-36.

  4. MRFIT: Impact of Diabetes on Cardiovascular Mortality 140 120 100 80 60 40 20 0 125 Nondiabetes (n = 342,815) Diabetes (n = 5,163) 91 59 Mortality per 10,000 47 31 22 12 6 None One only Two only All three Number of risk factors* *Risk factors analyzed: smoking, hypercholesterolemia and hypertension. Stamler J, et al. Diabetes Care 1993; 16(2):434-44

  5. T2DM for > 15 Years Duration Confers a Similar Risk of Fatal CHD as Prior CHD and No Diabetes 20 year follow-up of 121,046 women aged 30 to 55 years in Nurses’ Health Study Hu F, et al. ArchIntern Med. 2001;161:1717-1723.

  6. Multifaceted Management is Essential for T2DM • Intensive multifaceted management in patients with Type 2 diabetes lowers overall mortality • Multifaceted treatment strategy includes: • Glucose, lipid, BP control • Health behavior optimization • Use of vascular protective medications

  7. STENO-2

  8. Multifaceted Approach for CVD Prevention Among Patients with T2DM • Intensive Arm • Therapies to achieve targets in glycemia, lipids, BP and microalbuminuria • Multidisciplinary care q3mo • ASA and ACE inhibitors • (independent of BP) Type 2 Diabetes + Microalbuminuria n = 160 Conventional Arm MD follows clinical practice guidelines 8-year follow-up composite outcome: CV death, MI, CABG, PCI, Stroke, Amputation, or PVD surgery Gaede et al. NEJM. 2003: 348;383-393

  9. STENO-2: Intensive Group Achieved Targets Gaede et al. NEJM. 2003: 348;383-393

  10. Intensive Group had Improved CV Outcomes 60 P = 0.007 53 % RRR 50 Any CV event NNT = 5 Conventional therapy 40 Intensive therapy 30 20 10 0 12 24 36 48 60 72 84 96 Months of Follow-up RRR= relative risk reduction Gaede et al. NEJM. 2003: 348;383-393

  11. STENO 2 – Microvascular Disease Gaede et al. NEJM. 2003: 348;383-393

  12. Use a Multifaceted Vascular Protection Strategy BP <130/80 Healthy Lifestyle/weight Smoking Cessation Physical Activity A1C ≤7% Rx: Statins ACEi/ARB

  13. Vascular protective medications • Statins • ACE-inhibitors or Angiotensin receptor blockers (ARB) • ASA selective use

  14. HPS: Statin Therapy Beneficial Among Patients with Diabetes SIMVASTATIN PLACEBO Rate ratio & 95% CI (10269) (10267) STATIN better PLACEBO better Previous MI 999 (23.5%) 1250 (29.4%) Other CHD (not MI) 460 (18.9%) 591 (24.2%) No prior CHD CVD 172 (18.7%) 212 (23.6%) PVD 327 (24.7%) 420 (30.5%) Diabetes 276 (13.8%) 367 (18.6%) ALL PATIENTS 2033 (19.8%) 2585 (25.2%) 24% reduction (P<0.00001) HPS: Heart protection study 0.4 0.6 0.8 1.0 1.2 1.4 HPS Lancet 2002;360:7-22

  15. CARDS: Effect of Statin for PRIMARY Prevention in DM • n = 2838 • Age 40-75, no history of CVD • T2DM plus one or more: • Retinopathy • Albuminuria • Hypertension • Smoking • Intervention: Atorvastatin 10 mg vs. Placebo • Outcome: ACS, revascularization, stroke Colhoun HM, et al. Lancet 2004;364:685.

  16. CARDS: Statins Reduced CVD in Patients with DM Colhoun HM, et al. Lancet 2004;364:685.

  17. Who Should Receive Statins? (regardless of baseline LDL-C) 2013 • ≥40 yrs old or • Macrovascular disease or • Microvascular disease or • DM >15 yrs duration and age >30 years or • Warrants therapy based on the 2012 Canadian Cardiovascular Society lipid guidelines Among women with childbearing potential,statins should only be used in the presence of proper preconception counseling & reliable contraception. Stop statins prior to conception.

  18. What if baseline LDL-C ≤2.0 mmol/L? • Within CARDS and HPS, the subgroups that started with lower baseline LDL-C still benefited to the same degree as the whole population • If the patient qualifies for statin therapy based on the algorithm, use the statin regardless of the baseline LDL-C and then target an LDL reduction of ≥50% HPS Lancet 2002;360:7-22 Colhoun HM, et al. Lancet 2004;364:685.

  19. Vascular protective medications • Statins • ACE-inhibitors or Angiotensin receptor blockers (ARB) • ASA selective use

  20. Association of SBP and CV Mortality in Men With T2DM 250 No diabetes Diabetes 200 150 CV mortality rate Per 10,000 person-years 100 50 0 <120 120-139 140-159 160-179 180-199 ≥200 SBP (mmHg) Stamler J, et al. Diabetes Care. 1993;16:434-444.

  21. Hypertension in Diabetes UKPDS 50 40 30 20 10 0 Less tight control (mean BP 154/87 mmHg) Tight control (mean BP 144/82 mmHg) Patientswith events (%) Tight BP control:24% reduction of events(95% CI 8-38) 0 1 2 3 4 5 6 7 8 9 Years from randomization UKPDS Study Group. BMJ 1998; 317:703-13.

  22. HOT: BP Control Reduces CV Events Diabetes Subgroup P<0.005 30 24.4 Goal of therapy: target diastolic BP 25 20 18.8 90 mm Hg (n=501) MI, stroke, CV mortality/1000 pt-y 85 mm Hg (n=501) 15  80 mm Hg (n=499) 11.9 10 5 0 Hansson et al. Lancet. 1998;351:1755.

  23. Micro-HOPE (ACEi): CV Benefits All Mortality (NNT 31) 0.16 Primary Outcome (NNT 22) 0.2 Placebo Ramipril 10 mg 0.08 0.1 RR = 0.75 (0.64-0.88) p = 0.0004 RR = 0.76 (0.63-0.92) p = 0.004 0 0 0 400 800 1200 0 400 800 1200 1600 Kaplan-Meier rates 1600 0.12 0.16 0.08 Stroke (NNT 53) CV Death(NNT 29) MI (NNT 37) 0.08 0.04 0.06 RR = 0.67 (0.5-0.9) p = 0.0074 RR = 0.78 (0.64-0.94) p = 0.01 RR = 0.63 (0.49-0.79) p = 0.001 0 0 0 0 1000 2000 0 1000 2000 0 1000 2000 Duration of follow-up (days) HOPE study investigators. Lancet. 2000;355:253-59.

  24. ONTARGET: ARB Therapy is as Effective as ACEi for CVD Prevention ONTARGET study investigators. NEJM. 2008:358:1547-59.

  25. 2013 Who Should Receive ACEi or ARB Therapy?(regardless of baseline blood pressure) • ≥55 years of age or • Macrovascular disease or • Microvascular disease At doses that have shown vascular protection [perindopril 8 mg daily (EUROPA), ramipril 10 mg daily (HOPE), telmisartan80 mg daily (ONTARGET)] Among women with childbearing potential,ACEi or ARB should only be used in the presence of proper preconception counseling & reliable contraception. Stop ACEi or ARB either prior to conception or immediately upon detection of pregnancy EUROPA Investigators, Lancet 2003;362(9386):782-788. HOPE study investigators. Lancet. 2000;355:253-59. ONTARGET study investigators. NEJM. 2008:358:1547-59

  26. Vascular protective medications • Statins • ACE-inhibitors or Angiotensin receptor blockers (ARB) • ASA selective use

  27. What About ASA for 1⁰ Prevention of CVD? Included: Six studies, n = 10,117 participants De Berardis G et al. BMJ 2009;339:b4531

  28. ASA for 1⁰Prevention in DiabetesMeta analysis of 6 studies(n = 10,117) No. of events/No. in group ASA Control/placebo RR (95% CI) RR (95% CI) Major CV events JPAD POPADAD WHS PPP ETDRS Total 68/1262 105/638 58/514 20/519 350/1856 601/4789 86/1277 108/638 62/513 22/512 379/1855 657/4795 0.80 (0.59-1.09) 0.97 (0.76-1.24) 0.90 (0.63-1.29) 0.90 (0.50-1.62) 0.90 (0.78-1.04) 0.90 (0.81-1.00) Myocardial infarction JPAD POPADAD WHS PPP ETDRS PHS Total 28/1262 90/638 36/514 5/519 241/1856 11/275 395/5064 14/1277 82/638 24/513 10/512 283/1855 26/258 439/5053 0.87 (0.40-1.87) 1.10 (0.83-1.45) 1.48 (0.88-2.49) 0.49 (0.17-1.43) 0.82 (0.69-0.98) 0.40 (0.20-0.79) 0.86 (0.61-1.21) • No overall benefit for: • Major CV events • MI • Stroke • CV mortality • All-cause mortality Stroke JPAD POPADAD WHS PPP ETDRS Total 12/1262 37/638 15/514 9/519 92/1856 181/4789 32/1277 50/638 31/513 10/512 78/1855 201/4795 0.89 (0.54-1.46) 0.74 (0.49-1.12) 0.46 (0.25-0.85) 0.89 (0.36-2.17) 1.17 (0.87-1.58) 0.83 (0.60-1.14) Death from CV causes JPAD POPADAD PPP ETDRS Total 1/1262 43/638 10/519 244/1856 298/4275 10/1277 35/638 8/512 275/1855 328/4282 0.10 (0.01-0.79) 1.23 (0.80-1.89) 1.23 (0.49-3.10) 0.87 (0.73-1.04) 0.94 (0.72-1.23) JPAD= Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes POPADAD = Prevention of Progression of Arterial Disease and Diabetes PPP = Primary Prevention Project ETDRS = Early Treatment Diabetic Retinopathy Study PHS = Physicians’ Health Study WHS = Women’s Health Study De Beradis G, et al. BMJ 2009; 339:b4531. All-cause mortality JPAD POPADAD PPP ETDRS Total 34/1262 94/638 25/519 340/1856 493/4275 38/1277 101/638 20/512 366/1855 525/4282 0.90 (0.57-1.14) 0.93 (0.72-1.21) 1.23 (0.69-2.19) 0.91 (0.78-1.06) 0.93 (0.82-1.05) 2 0.03 0.125 0.5 1 8 Favors ASA Favors control/placebo

  29. ASA Not Routinely Recommended for 1⁰ Prevention for CVD Among Patients with DM Insufficient evidence to support use of ASA for primary prevention Risk of bleeding CVD protection 2013

  30. Don`t Forget To………….. • Do your part • Protect their heart • Multifaceted approach • + • Individualize therapy

  31. Vascular Protection Checklist 2013 • A• A1C – optimal glycemic control (usually ≤7%) • B•BP – optimal blood pressure control (<130/80) • C•Cholesterol – LDL ≤2.0 mmol/L if decided to treat • D•Drugs to protect the heart (regardless of baseline BP or LDL) A – ACEi or ARB │S – Statin │A – ASA if indicated • E• Exercise / Eating healthily – regular physical activity, achieve and maintain healthy body weight • S•Smoking cessation

  32. Recommendation 1 • All individuals with diabetes (type 1 or type 2) should follow a comprehensive, multifaceted approach to reduce cardiovascular risk including: • Achievement and maintenance of healthy body weight • Healthy diet • Regular physical activity • Smoking cessation • Optimal glycemic control (usually A1C <7%) • Optimal blood pressure control (<130/80 mmHg) • Additional vascular protective medications in the majority of adult patients [Grade D, consensus for T1DM, children/adolescents; Grade A, Level 1 for T2DM]

  33. Recommendation 2 2013 • Statin therapy should be used to reduce CV risk in adults with type 1 or type 2 diabetes with any of the following features: • Clinical macrovasculardisease [Grade A, Level 1] • Age ≥40 years [Grade A, Level 1 T2DM; Grade D Consensus T1DM] • Age <40 and one of the following: • Diabetes duration > 15 years andage >30 yrs • Microvascular complication • Warrants therapy for other reasons based on the 2012 CCS guidelines for the management of dyslipidemia [Grade D, consensus]

  34. Recommendation 3 2013 • ACE inhibitor or ARB, at doses that have demonstrated vascular protection, should be used to reduce CV risk in adults with type 1 or type 2 diabetes with any of the following: • Clinical macrovascular disease [Grade A, Level 1] • Age ≥55 years [Grade A, Level 1 for those with an additional risk factor or end organ damage; Grade D, consensus for all others] • Age <55 years and microvascular complications [Grade D, consensus]

  35. Among women with childbearing potential, ACE inhibitor, ARB, or statin should only be used if there is reliable contraception.

  36. Recommendation 4 2013 • ASA should not be routinely used for the primary prevention of cardiovascular disease in people with diabetes [Grade B, Level 2] ASA may be used in the presence of additional cardiovascular risk factors [Grade D, Consensus]

  37. Recommendation 5 and 6 • Low-dose ASA therapy (81–325 mg) may be used for secondary preventionin people with established cardiovascular disease [Grade D, Consensus] • Clopidogrel(75 mg) may be used in people unable to tolerate ASA [Grade D, Consensus]

  38. CDA Clinical Practice Guidelines www.guidelines.diabetes.ca – for professionals 1-800-BANTING (226-8464) www.diabetes.ca – for patients

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