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Summary of ACCORD, ADVANCE, and VADT Trials

Summary of ACCORD, ADVANCE, and VADT Trials. ACCORD - Action to Control Cardiovascular Risk in Diabetes ADVANCE - Action in Diabetes to Prevent Vascular Disease VADT - Veterans Administration Diabetes Trail. Stephen Rith-Najarian, Diabetes Consultant Bemidji Area IHS.

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Summary of ACCORD, ADVANCE, and VADT Trials

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  1. Summary ofACCORD, ADVANCE, and VADT Trials ACCORD - Action to Control Cardiovascular Risk in Diabetes ADVANCE - Action in Diabetes to Prevent Vascular Disease VADT - Veterans Administration Diabetes Trail Stephen Rith-Najarian, Diabetes Consultant Bemidji Area IHS ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  2. ACCORD, ADVANCE, and VADT • Background • Study Design and Results • Lessons Learned

  3. American Indian Mortality Rates Trends in Indian Health; Age-adjusted data

  4. Contribution of Diabetes to CHDStrong Heart Study Women Men Hazard Ratio 6.3 3.1 Prevalence 60% 50% Attributable risk 76% 51% Diabetes is the engine driving the increase in CVD

  5. UKPDS Myocardial Infarction (cumulative) 30% Conventional Intensive p=0.052 20% % of patients with an event 10% Risk reduction 16% (95% CI: 0 % to 29%) 0% 0 3 6 9 12 15 Years from randomization fatal or non fatal myocardial infarction, sudden death573 of 3867 patients (15%) UKPDS 35: Lancet. 1998, 352:837-53.

  6. UKPDS HbA1c trend cross-sectional, median values UKPDS 35: Lancet. 1998, 352:837-53.

  7. ACCORD, ADVANCE, and VADT TrialsResearch Question Does Intensive Glucose Control Reduce Risk for Cardiovascular Disease in Type 2 Diabetes? ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  8. ACCORD, ADVANCE, and VADT • Background • Study Design and Results • Lessons Learned

  9. ACCORD, ADVANCE and VADT Study Design ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  10. ACCORD, ADVANCE and VADTDemographics ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  11. ACCORD, ADVANCE and VADT Baseline Clinical Characteristics ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  12. Therapeutic Approach: ACCORD, ADVANCE and VADT ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008

  13. Outcomes: Summary of ACCORD, ADVANCE and VADT *ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial halted intensive glucose group (2/6/08) † significant difference between intensive and standard group ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  14. Adverse Outcomes: ACCORD, ADVANCE and VADT ACCORD Study Group, NEJM 2008, 358:2545-2559. ADVANCE Collaborative Group, NEJM 2008, 358:2560-2572. VADT Study Results ADA Scientific Session San Francisco, 2008 In Press, Diabetes Obesity and Metabolism, 2008

  15. Hazard Ratios for the Primary Outcome and Death from Any Cause in Pre-specified Subgroups: ACCORD Study Prior CVD Age <65 A1c >8.1 N Engl J Med 358;24, 2008

  16. ACCORD, ADVANCE, and VADT • Background • Study Design and Results • Lessons Learned

  17. ACCORD, ADVANCE, and VADT Lessons Learned • Intensive glucose control does not reduce CVD mortality in T2DM, and may increase risk, especially in patients with pre-existing CHD • Aggressive A1c targets (<6.5%) were associated with a 3-fold increased risk hypoglycemia • No excess CVD Mortality was seen with Rosigliatazone

  18. ACCORD, ADVANCE, and VADT Lessons Learned- Continued • Intensive control associated with reduced risk for nephropathy in ADVANCE. • To reach and maintain A1c targets of <6.5 required frequent adjustments of multiple anti-diabetic medications • Aggressive Targets (<6.5) are probably reasonable for healthy patients to reduce risk micro-vascular complications

  19. ADA Consensus Statement on Medical Management of Hyperglycemia in Type 2 Diabetes • Achieve and Maintain near normoglycemia, A1c <7.0 • Initiate Therapy with Lifestyle and Metformin • Rapid addition of medications, and transition to new regimens when targets are not achieved • Early addition of insulin therapy in patients who do not met target goals Nathan, Diabetes Care 2008;31:1-11

  20. ACCORD, ADVANCE, and VADT • Background • Study Design and Results • Lessons Learned

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