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Stefano Genovese Diabetologia e Malattie Metaboliche

Thirteenth International Symposium Heart Failure & Co. “My Sweet Heart” Città della Scienza , Napoli 12-13 April 2013. Session II: Glycemic control, when the lower is not the better Strict glycemic control and cardiovascular diseases. Stefano Genovese Diabetologia e Malattie Metaboliche.

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Stefano Genovese Diabetologia e Malattie Metaboliche

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  1. Thirteenth International Symposium Heart Failure & Co. “My Sweet Heart” CittàdellaScienza, Napoli 12-13 April 2013 Session II: Glycemic control, when the lower is not the betterStrict glycemic control and cardiovascular diseases Stefano Genovese DiabetologiaeMalattieMetaboliche

  2. Questions • Is hyperglycemia an independent risk factor for cardiovascular disease? • Is hyperglycemia an independent risk factor for cardiovascular disease in diabetic patients? • Lowering glycemia reduces the risk for cardiovascular disease?

  3. Fasting blood glucose and cardiovascular mortality in healthy nondiabetic men Bjornholt JV et al . Diabetes Care 1999;22:45.

  4. Intensive Diabetes Treatment and Cardiovascular Disease in Patients with Type 1 Diabetes N Engl J Med 2005;353:2643-53.

  5. UKPDS

  6. Kumamoto ACCORD VADT UKPDS 33 DIGAMI ADVANCE UGDP UKPDS 34 Other Questions Is it feasible an intensive treatment of hyperglycemia? Are CV events reduced by an intensive treatment of hyperglycemia? Is there a first choice drug in intensive treatment to reduce CV events?

  7. In the ACCORD study a HbA1c value <6,5% has been reached in less than one year and maintained ACCORD ACCORD Study Group et al. NEJM 2008;358:2545-59

  8. In the ADVANCE study a HbA1c value <6,5% has been reached in three years and maintained ADVANCE ADVANCE Collaborative Group et al. NEJM 2008;358:2560-72

  9. In the VADT study a HbA1c value around 6,5% has been reached in one year and maintained VADT 10.5 10.0 Standard 9.5 9.0 8.5 8.0 HbA1c (%) Intensive 7.5 7.0 6.5 6.0 5.5 5.0 Baseline 1 year 2 years 3 years 4 years 5 years 6 years Years on Study

  10. Effects of Intensive Glucose Lowering in Type 2 Diabetes - ACCORD Nonfatal myocardial infarction, nonfatal stroke, death from cardiovascular causes p=0,16 p=0,04 ACCORD Study Group et al. NEJM 2008;358:2545-59

  11. Effects of Intensive Glucose Lowering in Type 2 Diabetes - ACCORD ACCORD Study Group et al. NEJM 2008;358:2545-59

  12. Effects of Intensive Glucose Lowering in Type 2 Diabetes - ACCORD ACCORD Study Group et al. NEJM 2008;358:2545-59

  13. Effects of Intensive Glucose Lowering in Type 2 Diabetes - ACCORD ACCORD Study Group et al. NEJM 2008;358:2545-59

  14. Causes of death: • Unexpected or presumed cardiovascular disease • Condition other than cancer or cardiovascular disease • What is the role of hypoglycemia? Causes of death in the ACCORD ACCORD Study Group et al. NEJM 2008;358:2545-59

  15. VADT – Predictors of CVD death Variable Hazard Ratio P Value Prior CVD event 3.116 0.0001 Age (per 10 yr) 2.090 <.0001 HDL (per 10 mg) 0.699 0.0079 Baseline HbA1c per 1% 1.213 0.0150 Severe Hypoglycemia 4.042 0.0076

  16. Hypothesis….. • The ACCORD suggests that outcomes differ according to • HbA1c below or above a 8,0% • Presence of previous CV events • Is there a study on the intensive treatment in T2DM in a population with • Basal HbA1c <8,0% • No previous CV events?

  17. ACCORD vs ADVANCE Dluhy R.G. et al. NEJM 2008;358:2630-3

  18. ACCORD vs ADVANCE Dluhy R.G. et al. NEJM 2008;358:2630-3

  19. ADVANCE does not confirm the reduction of MI suggested by ACCORD Dluhy R.G. et al. NEJM 2008;358:2630-3

  20. In the ADVANCE the intensive treatment reduces the microvascular endpoint Mortality does not increase Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type Diabetes p=0,01 p=0,32 p=0,01 p=0,28 ADVANCE Collaborative Group et al. NEJM 2008;358:2560-72

  21. Hypothesis……. • Is there a study on the intensive treatment in T2DM in a population with • Basal HbA1c <8,0% • No previous CV events? Yes, the …….. UKPDS where participants had basal HbA1c of 7,0% without previous CV events

  22. In the UKPDS the effect of intensive treatment showed p=0,052 and no effect on mortality In the UKPDS-PTM the reduction of MI was statistically significant According to the UKPDS duration the follow-up of ACCORD, ADVANCE e VADT seems to short

  23. Effect of intensive control of glucose on cardiovascularoutcomes and death in patients with diabetes mellitus Lancet 2009; 373: 1765–72

  24. The "bad" metabolic memory increases the macrovascular complications of T2DM Before entering the VADT, intensive treatment arm After entering the VADT, intensive treatment arm 9,5 Generation of “bad glycaemic legacy” Risk of complications 9,0 8,5 8,0 HbA1c (%) 7,5 7,0 6,5 6,0 1 3 5 7 9 11 13 15 17 Time from diagnosis (years) Hypothetical representation of the natural history of diabetic patients enrolled in the study VADT Del Prato S. Diabetologia 2009

  25. Position Statement ADA EASD Diabetologia. 2012 Jun;55(6):1577-96 Diabetes Care. 2012 Jun;35(6):1364-79

  26. Answers Is it feasible an intensive treatment of hyperglycemia? YES Are CV events reduced by an intensive treatment of hyperglycemia? YES, in patients with HbA1c <8% and no previous CV events • Pay attention to: • hypoglycemia • fragile patients • don't hurry • choose the right drug!

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