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Difendiamo il cuore

Difendiamo il cuore. Tavola rotonda. Cardiovascular disease in diabetic patients: the facts. Cardiovascular disease accounts for 75% of death causes in Type 2 diabetic patients. According to WHO the prevalence of CVD in diabetic patients ranges within 26 - 36%.

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Difendiamo il cuore

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  1. Difendiamo il cuore Tavola rotonda

  2. Cardiovascular disease in diabetic patients: the facts Cardiovascular disease accounts for 75% of death causes in Type 2 diabetic patients According to WHO the prevalence of CVD in diabetic patients ranges within 26 - 36% The relative risk of CHD is 1.5-1.7 in male and 1.7-4.0 in female diabetic patients In the diabetic patient life expectancy is 5 -10 years lower than in the non-diabetic general population Dr Roberto Anichini

  3. Decrease in CHD mortality rates between 1981 and 2000 – 45% – 62% Data from England and Wales between 1981 and 2000 in men and women aged 35–84 years. There were 68,230 fewer CHD deaths than expected from baseline mortality rates in 1981. Dr Roberto Anichini Unal B, et al. Circulation 2004; 109:1101–1107

  4. Effect of risk factors/ treatments on CHD mortality CHD deaths prevented or postponed by risk factor changes and treatments in England and Wales, 1981 to 2000 10,000 • e.g. diabetes, obesity Risk factors: worse 13% 0 Risk factors: better 71% –10,000 • e.g. smoking, cholesterol, BP –20,000 Deaths prevented or postponed in 2000 –30,000 Treatments 42% –40,000 • 68,230 fewer deaths in 2000 • e.g. secondary prevention, heart failure treatments –50,000 • 2,888 more deaths due to diabetes • 2,662 more deaths due to physical inactivity • 2,097 more deaths due to obesity –60,000 –70,000 1981 Year 2000 Dr Roberto Anichini Unal B, et al. Circulation 2004; 109:1101–1107

  5. UKPDS: reducing blood glucose levels reduces the risk of complications Over 10 years, each 1% reduction in HbA1c was associated with: Any diabetes-related endpoint Diabetes- related death All-cause mortality Myocardial infarction Microvascular disease Stroke 12% 14% 14% 21% 21% 37% Dr Roberto Anichini Relative risk reductions for a 1% fall in HbA1cP < 0.0001 for all reductions except stroke, P = 0.035 Stratton IM, et al. UKPDS 35. BMJ 2000; 321:405–412.

  6. UKPDS: elevated blood glucose levels increase the risk of diabetic complications 80 Microvasculardisease 60 Myocardialinfarction Incidence per1,000 patient-years 40 20 0 0 5 6 7 8 9 1 0 1 1 Updated mean HbA1c (%) Study population: White, Asian Indian and Afro-Caribbean UKPDS patients (n = 4,585) Adjusted for age, sex and ethnic groupError bars = 95% CI Dr Roberto Anichini Adapted from Stratton IM, et al. BMJ 2000; 321:405–412.

  7. 21% 43% 37% 21% 14% 14% 12% 19% UKPDS: increased risk of diabetes-related complications corresponding with a 1% increase in HbA1c Observational analysis from UKPDS study data 50 ** 45 ** 40 35 30 Percentage increase in relative risk corresponding to a 1% rise in HbA1c ** 25 ** ** 20 ** ** * 15 10 5 0 Any diabetes- related endpoint Diabetes- related death All cause mortality Myocardial infarction Stroke Peripheral vascular disease† Micro- vascular disease Cataract extraction †Lower extremity amputation or fatal peripheral vascular disease *P = 0.035; **P < 0.0001 Adapted from Stratton IM, et al. UKPDS 35. BMJ 2000; 321:405–412.

  8. US1 EU2 100 100 80 80 69% 64% Percentuale di soggetti 60 60 Percentuale di soggetti 36% 31% 40 40 20 20 0 0  7% < 7% > 6.5%  6.5% HbA1c (%) HbA1c (%) La maggior parte dei pazienti diabetici di tipo 2 in USA e in Europa non è in adeguato controllo glicemico Dr Roberto Anichini 1 Koro CE, et al. Diabetes Care 2004; 27:17–20. 2 Liebl A. Diabetologia 2002; 45:S23–S28.

  9. Obiettivi glicemici definiti nel DMT2 *1―2 ore postprandiali; **2 ore postprandiali. • American Diabetes Association. Diabetes Care 2004;27(suppl 1):S15―35. • American Association of Clinical Endocrinologists. Endocr Pract 2002;8(suppl 1):43―84. • Japan Diabetes Society. Available at: http://www.jds.or.jp. • International Diabetes Federation. Diabet Med 1999;16:716―30. Dr Roberto Anichini

  10. Treat to target……. Control blood glucoseFPG <130 mg/dl PPG <140 mg/dl HbA1c <6.5% In quali pazienti????? I livelli medi di HBA1c in Italia è di 8,6%...... Dr Roberto Anichini

  11. Steno-2: effect of intensive vs conventional therapy on proportion of patients meeting goals Intensive Therapyn = 67 Conventional Therapyn = 63 P < 0.001 P = 0.21 P = 0.19 P = 0.001 Patients reaching intensive-treatment goals at mean 7.8 y (%) P = 0.06 Glycosylatedhemoglobin <6.5% Cholesterol<175 mg/dl Triglycerides<150 mg/dl Systolic BP<130 mm Hg Diastolic BP<80 mm Hg Adapted from Gaede P, et al. N Engl J Med 2003; 348:383–393. Dr Roberto Anichini

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  14. Studies Type 1 DM Incidence Rate Ratio (95% CI) % weight Incidence Rate Ratio Glycemic control and macrovascular disease Metaanalysis of RCT:s in type 1 & 2 diabetes Dr Roberto Anichini (Stettler et al. Am Heart J 2006; 152:27-38)

  15. Studies Type 2 DM Incidence Rate Ratio (95% CI) % weight Incidence Rate Ratio Glycemic control and macrovascular disease Metaanalysis of RCT:s in type 1 & 2 diabetes Dr Roberto Anichini (Stettler et al. Am Heart J 2006; 152:27-38)

  16. Perché trattare precocemente e in maniera intensiva Dr Roberto Anichini

  17. Time to Death, MI or Stroke Placebo 3-year estimate: 0.15 N events Placebo 358/ 2633 14.4% PIO 301 / 2605 12.3% 0.10 Pioglitazone Kaplan-Meier Event Rate 0.05 HR P value PIO vs placebo 0.841 0.027 0 0 6 12 18 24 30 36 TIME (months) Dr Roberto Anichini

  18. Ictus fatale e non fatale in pazienti con precedente ictus Kaplan-Meier % eventi 0.12 pioglitazone (27 / 486) 0.10 placebo (51 / 498) - 47% 0.08 0.06 0.04 0.02 HR 95% CI p value pioglitazone vs placebo 0.53 0.34, 0.85 0.008 0.00 N a rischio: 984 952 926 903 877 849 132 0 6 12 18 24 30 36 Tempo dalla randomizzazione (mesi) Dr Roberto Anichini

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  24. Studio AccordCirculation.National Heart lung and blood istitute 7.2.08 • NHLBI ha deciso di stoppare il braccio dello studio della terapia intensiva diabetologica per eccesso di mortalità. • Nel gruppo di pazienti con obiettivo metabolico hba1c<6 si è avuto significativo incremento mortalità rispetto a Hba1c >7…. anche se minore rispetto agli studi di controllo. Dr Roberto Anichini

  25. “The Metabolic Memory” Evidence for a long-term persistence of hyperglycaemia-induced damage DCC/EDIC Research Group N Engl J Med, 2005

  26. OAD monotherapyuptitration OAD + multiple dailyinsulin injections OAD monotherapy OAD combination OAD + basal insulin Diet Conservative management of glycemia:traditional stepwise approach 10 9 HbA1c (%) 8 7 6 Duration of diabetes Dr Roberto Anichini

  27. Diet OAD monotherapy OAD combinations OADs uptitration OAD + basal insulin OAD + multiple daily insulin injections Proactive management of glycemia APRROCCIO PRECOCE E AGGRESSIVO (insulin resistance and -cell dysfunction) 10 9 HbA1c (%) 8 7 6 Duration of diabetes • Campbell IW. Br J Cardiol 2000; 7:625–631. Dr Roberto Anichini

  28. Intervention! Intervention! Intervention! Intervention! Intervention! Proactive management of glycemia Early aggressive approach in type 2 management. Intensive therapeutic strategy Immediately upon diagnosis Intervention! 10 9 HbA1c (%) 8 7 6 Duration of diabetes Dr Roberto Anichini

  29. Argomenti di discussione. • Quanto è importante il trattamento glicemico nella prevenzione secondaria delle pcv.?? • A quali livelli glicemici?? • E’ impoetante la durata del diabete nei target di trattamento?? • Trattamento precoce e aggressivo sia nella prevenzione primaria e secondaria ?? (linee guida EASD-ADA) Dr Roberto Anichini

  30. N eventi: stima a 3 anni placebo 358 / 2633 14.4% pioglitazone 301 / 2605 12.3% Intervallo di Tempo fino a: Decesso, IM (Silente Escluso) o Ictus Tasso di eventi Kaplan-Meier 0.15 -16% 0.10 0.05 HR 95% CI p value pioglitazone 0.841 0.722, 0.981 0.0273 vs placebo N at Risk: 0.0 5238 5102 4991 4877 4752 4651 786 (256) 0 6 12 18 24 30 36 Dr Roberto Anichini Tempo dalla randomizzazione (mesi)

  31. N eventi: stima a 3 anni placebo 358 / 2633 14.4% pioglitazone 301 / 2605 12.3% Intervallo di Tempo fino a: Decesso, IM (Silente Escluso) o Ictus Tasso di eventi Kaplan-Meier 0.15 -16% 0.10 0.05 HR 95% CI p value pioglitazone 0.841 0.722, 0.981 0.0273 vs placebo N at Risk: 0.0 5238 5102 4991 4877 4752 4651 786 (256) 0 6 12 18 24 30 36 Dr Roberto Anichini Tempo dalla randomizzazione (mesi)

  32. IM fatale/non fatale (escluso IM silente) Kaplan-Meier event rate 0.10 pioglitazone (65 / 1230) 0.08 placebo (88 / 1215) -28% 0.06 0.04 0.02 0.0 N a Rischio: 2445 2387 2337 2293 2245 2199 399 (139) 0 6 12 18 24 30 36 Dr Roberto Anichini Tempo dalla randomizzazione (mesi)

  33. Kaplan-Meier event rate 0.25 pioglitazone (180 / 1230) 0.20 placebo (217 / 1215) 0.15 0.10 0.05 0.0 0 6 12 18 24 30 36 Endpoint Cardiaco composto (Morte cardiaca, IM non fatale, Rivascolarizzazione coronarica o SCA) -19% N a Rischio: 2445 2350 2260 2186 2116 2036 357 (127) Tempo dalla randomizzazione (mesi) Dr Roberto Anichini

  34. Sindrome Coronarica Acuta (SCA) Kaplan-Meier event rate 0.06 pioglitazone (35 / 1230) 0.05 placebo (54 / 1215) -37% 0.04 0.03 0.02 0.01 0.00 N a Rischio: 2445 2397 2351 2308 2265 2222 406 (139) 0 6 12 18 24 30 36 Tempo dalla randomizzazione (mesi) Dr Roberto Anichini

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